1104 Amendments of Nathalie COLIN-OESTERLÉ
Amendment 51 #
2023/2130(DEC)
Motion for a resolution
Paragraph 36 a (new)
Paragraph 36 a (new)
36a. Welcomes the resumption of in- presence plenary sessions in Strasbourg; recalls that the EU Treaties stipulate that Parliament shall have its seat in Strasbourg, where the 12 periods of monthly plenary sessions, including the budget session, shall be held; underlines that the suspension of sessions in Strasbourg, the introduction of electronic voting and remote participation are linked to the exceptional circumstances of the COVID-19 pandemic; recalls that any change to the Treaties requires the unanimity of the Member States;
Amendment 60 #
2023/2130(DEC)
Motion for a resolution
Paragraph 44
Paragraph 44
44. Notes with satisfaction that Members were given the opportunity to take part in plenary debates from the EPLOs in their Member States of election, this being as a result of the exceptional measures put in place during the pandemic, this having been facilitated by the actions of DG COMM; welcomes the increased efforts made by DG COMM to make use of new technologies to facilitate the work of Members during the COVID- 19 pandemic; acknowledges that the remote access for national media to the communication activities of Parliament has opened up ways to interact with Union citizens;
Amendment 129 #
2023/2130(DEC)
Motion for a resolution
Paragraph 79
Paragraph 79
79. Recalls that the official languages to be used by the Union institutions, bodies and agencies are established in Regulation No 13; acknowledges that DG TRAD ensures that Parliament’s procedural content is available in all 24 official and working languages of the Union, thereby enabl; regrets that, in practice, just one of the Union’s working languages is used more widely ing Parliament to fulfil its commitment to the policy of multilingualism’s work, and increasingly so in recent years; calls for multilingualism to be respected by ensuring, where necessary, an adequate number of translation and interpreting staff; _________________ 3 Regulation No 1 determining the languages to be used by the European Economic Community (OJ P 017, 6.10.1957, p. 385)
Amendment 24 #
2023/2129(DEC)
Draft opinion
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Recalls the Commission’s commitment to carry out a thorough review of the implementation of HERA’s operations by 2025 and to consider changing its structure and governance, including in order to transform it into a genuine agency with an autonomous budget.
Amendment 51 #
2023/2075(INI)
Motion for a resolution
Recital A
Recital A
A. whereas non-communicable diseases (NCDs) are diseases that are not passed from person to person; whereas non-communicable diseases (NCD’s) cause 90 % of all deaths in the EU4, and whereas that their prevalence continues to rise throughout the EU; _________________ 4 World Health Organization, ‘Monitoring noncommunicable disease commitments in Europe 2021’, 8 December 2021.
Amendment 210 #
2023/2075(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Highlights that NCDs account for 90 % of all deaths in the EU8, which leads to high levels of productivity loss and makes NCDs account for the largest share of countries’ healthcare expenditures; stresses that it is important to reduce the prevalence of NCDs andby means of early diagnosis and screening, including by carrying out integrated check-ups, particularly for people at risk, at primary care level; believes that enhanced health promotion and disease prevention can reduce the prevalence of NCDs by 70 %9in conjunction with, as well as investment in health innovation and technologies; _________________ 8 European Commission, ‘Non- communicable diseases : overview’'. 9 European Commission, ‘The EU ‘Healthier Together’ Non-Communicable Diseases Initiative’, 2022.
Amendment 565 #
2023/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the importance of identifying people with a high risk of developing NCDs and diagnosing people as early as possible, by implementing early-detection programmes for instance, to improve disease management, prevent complications and save downstream costs for healthcare systems;
Amendment 584 #
2023/2075(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages Member States to reduce undiagnosed NCDs by introducing targeted health checks for high-risk individuals addressing the main shared metabolic risk factors, ensuring quality care and support NCD patients’ self- management; stresses the benefits of digital health technologies and telemedicine in monitoring diseases;
Amendment 667 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Considers that each patient faces different obstacles in keeping to their treatment for NCDs; calls on the Member States to offer a range of training courses for health-care professionals in providing patients with therapeutic education;
Amendment 685 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19a. Notes the growing labour shortages in the health-care sector in Europe, which are jeopardising access to good-quality, integrated care for NCDs;
Amendment 711 #
2023/2075(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Notes the need to focus on the quality of life of NCD patients whose illnesses cannot be cured but may be stabilised for a number of years; emphasises the importance of specific EU recommendations to improve the quality of life of patients including by integrating comprehensive supportive care into care, starting with the diagnosis and continuing over the course of the disease and by granting access to specialised support centres, by helping Member States to set up comprehensive cancer centres with multidisciplinary professional teams for example;
Amendment 719 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Considers that regional disparities in access to health care must be addressed as a matter of urgency stresses the need to look into innovative methods of improving access to health care, such as mobile clinics, with a view to fostering a personalised, patient-centred approach to the prevention and treatment of NCDs;
Amendment 725 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Stresses the pivotal role of informal care-givers, who provide patients with NCDs with the majority of their day- to-day care and who are lacking in support (in terms of social rights, training, psychological help, information and recognition); calls on the Commission and the Members States to set up online training platforms as well as therapeutic care programmes granting qualifications and recognising their skills;
Amendment 780 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Notes that patients with NCDs are frequently affected by shortages of medicines and that interruptions in treatment can harm patients, care-givers and families;
Amendment 783 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24b. Calls for improved coordination to avoid the stockpiling of medicines within Member States and to build up a European emergency reserve of essential medicines at high risk of shortages;
Amendment 784 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 c (new)
Paragraph 24 c (new)
24c. Calls on the Commission and the Member States to look into the possibility of creating one or more European non- profit pharmaceutical undertakings which operate in the public interest to manufacture medicines of health and strategic importance for health care, in the absence of existing industrial production, in order to complete and guarantee security of supply and prevent possible shortages of medicines in emergency situation;
Amendment 785 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 d (new)
Paragraph 24 d (new)
24d. Stresses the need to establish arrangements for EU-level monitoring of the risks of shortages and to ensure greater transparency of stocks of medicines in order to better anticipate shortages;
Amendment 786 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 e (new)
Paragraph 24 e (new)
24e. Stresses that public health sovereignty must be a priority for the EU in order to ensure European citizens have access to treatment and that ‘Made in Europe’ would make it possible to achieve this goal; invites the Commission to consider establishing a European sovereignty fund that would be responsible for financing strategic projects in the health-care sector;
Amendment 795 #
2023/2075(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Invites the European Union to support the Member States in implementing the Europe’s Beating Cancer Plan and to ensure that all Member States have national cancer action plans to improve knowledge and information sharing arrangements;
Amendment 306 #
2023/2074(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Is deeply concerned by the poor availability of mental healthcare services in the Member States, as exemplified by the alarmingly long waiting lists for appointments with psychiatrists and psychologists and the limited options for therapeutic treatment, as well as for in- and outpatient clinic treatment; considers that the shortage in staff in this specific sector, the lack of integration of mental health services within healthcare (for example, as part of cancer care) and the lack of funding aggravate the issue;
Amendment 313 #
2023/2074(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Would like to see mental health services included within the comprehensive care delivered to patients with non-transmissible illnesses, such as cancer; points out that a patient-centred approach should take mental health into account throughout their patient journey, from diagnosis to post-treatment;
Amendment 508 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
Amendment 510 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Recognises that the restrictions and lockdowns contributed to an increase in mental health problems that had a disproportionate impact on women, people with disabilities, young people, children, older people, immuno-suppressed people, their carers and other groups of people with limited social contact;
Amendment 63 #
2023/2068(INI)
Motion for a resolution
Recital F
Recital F
F. whereas minors are particularly vulnerable victims of hate speech and hate crime and whereas such attacks endanger their physical and mental integrity and affect their development and mental health; whereas online and offline school bullying is a scourge that can be effectively addressed by European legislation;
Amendment 191 #
2023/2068(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to give particular consideration to minors so as to give them special protection from hate speech and hate crimes, in particular as part of the effort to tackle school bullying, to prevent these incidents from occurring and to minimise their impact on minors’ development and mental health;
Amendment 56 #
2023/2016(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
Amendment 60 #
2023/2016(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 168 #
2023/0132(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.
Amendment 170 #
2023/0132(COD)
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) This Directive should recognize that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.
Amendment 193 #
2023/0132(COD)
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) Patent protection creates a legal framework, which is important for pharmaceutical innovation as it provides companies with financial incentives to cover the research and development (R&D) costs of new medicinal products. The research-based pharmaceutical industry is an essential sector and contributor to ensuring quality manufacturing and supply of medicinal products, to ensuring future innovation to address outstanding, unmet needs, and to supporting the resilience, responsiveness and readiness of healthcare systems to address future challenges, including pandemics.
Amendment 242 #
2023/0132(COD)
Proposal for a directive
Recital 51 a (new)
Recital 51 a (new)
(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients;
Amendment 264 #
2023/0132(COD)
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU should be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.
Amendment 279 #
2023/0132(COD)
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel, on day one a reference medicinal productfter loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ands, obtaining pricing and reimbursement request, and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of the reference medicinal product, there can be no commercial usrelevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 292 #
2023/0132(COD)
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toregulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 303 #
2023/0132(COD)
Proposal for a directive
Recital 65
Recital 65
(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions1a and a resolution of the European Parliament2a. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU 2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine
Amendment 340 #
2023/0132(COD)
Proposal for a directive
Recital 76
Recital 76
(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to placmake the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.
Amendment 368 #
2023/0132(COD)
Proposal for a directive
Recital 130 a (new)
Recital 130 a (new)
(130a) Medium-term harmonisation of the provisions on e-leaflets can be a tool to tackle the problem of shortages of medicinal products. The Commission should be empowered to swiftly harmonise requirements concerning paper or electronic formats. If the electronic format were made generally applicable, a single European system would have to ensure that patients had access to e- leaflets for their products.
Amendment 383 #
2023/0132(COD)
Proposal for a directive
Article premier – paragraph 1
Article premier – paragraph 1
1. This Directive lays down rules for thshall apply to medicinal products for human use intended to be placinged on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of medicinal products for human use in Member States and either prepared industrially or manufactured by a method involving an industrial process.
Amendment 393 #
2023/0132(COD)
Proposal for a directive
Article premier – paragraph 5 – point c a (new)
Article premier – paragraph 5 – point c a (new)
(ca) medicinal products prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital preparations’). Hospital preparations shall be dispensed on medical prescription to one or more patients by the pharmacy supplying the hospital.
Amendment 476 #
2023/0132(COD)
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, including those prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility or developed in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.
Amendment 517 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 31 – point a
Article 4 – paragraph 1 – point 31 – point a
(a) a method involving an industrial process which includes pooling of donations with a view to a future fractionation; or
Amendment 519 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 31 – point b
Article 4 – paragraph 1 – point 31 – point b
(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties; where a process involves the pooling, concentration, separation or isolation of elements in the preparation of SoHOs, or any other method that increases the microbiological quality, it should not be considered a change in their inherent properties;
Amendment 704 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 706 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawnrefused.
Amendment 713 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 715 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 30 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 773 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial for systemic use; or
Amendment 797 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its contractual responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure Marketing authorisation holders comply with their supply obligations.
Amendment 810 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 9
Article 56 – paragraph 9
9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, in the Union or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub- paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product and any data in its possession relating to the volume of prescriptions.
Amendment 1215 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 1225 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 1233 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 1241 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product should be designated as a value added medicinal product.
Amendment 1257 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, for:the purpose of: (i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; (iii) obtaining pricing and reimbursement approval; (iv) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.
Amendment 1317 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), may cover include the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers. This exception shall not cover the placing on the market in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products purposes.
Amendment 1346 #
2023/0132(COD)
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 1454 #
2023/0132(COD)
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure wholesale distributors comply with their supply obligations.
Amendment 1458 #
2023/0132(COD)
Proposal for a directive
Article 168 – paragraph 1 – introductory part
Article 168 – paragraph 1 – introductory part
1. For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in the Member State concerned, the authorised wholesaler must enclosprovide a document, which may be submitted in electronic format, that makes it possible to ascertain the following:
Amendment 1583 #
2023/0132(COD)
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.
Amendment 1618 #
2023/0132(COD)
Proposal for a directive
Annex III – point 2
Annex III – point 2
2. The qualified person shall have acquired practical full-time experience over at least two years, in one or more undertakings that are authorised manufacturers, obtaining sufficient knowledge of manufacture, testing, supply chains, good manufacturing practice and pharmaceutical quality systems as well as regulatory processes and dossier content for ensuring the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.
Amendment 1619 #
2023/0132(COD)
Proposal for a directive
Annex III – point 4
Annex III – point 4
4. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings or not-for-profit entities that are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.
Amendment 1635 #
2023/0132(COD)
Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)
Annex VI – paragraph 1 – point 8 a (new)
(8a) Further to the measures provided for in Article 64(2a), for medicinal products included in the list referred to in Article 112a of [Regulation (EC) No 726/2004 as amended], the following additional statement shall be added: ‘This medicinal product is subject to additional monitoring.’ This statement shall be preceded by the symbol referred to in Article 112 of [Regulation (EC) No 726/2004 as amended] and followed by an appropriate standardised explanatory sentence.
Amendment 207 #
2023/0131(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by creating a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while strengthening the fight against shortages of medicinal products, in particular by ensuring security of supply and addressing environmental concerns.
Amendment 208 #
2023/0131(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) Addressing the issue of shortages of medicinal products has been a long- standing priority for the Member States and European Parliament as illustrated by several reports from the European Parliament such as the European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem1 a, as well as by discussions within the Council of the European Union. However, that issue has remained, to date, unaddressed. _________________ 1 a OJ C 385, 22.9.2021, p. 83.
Amendment 209 #
2023/0131(COD)
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
Amendment 210 #
2023/0131(COD)
Proposal for a regulation
Recital 2 c (new)
Recital 2 c (new)
(2 c) The implementation of the 'Strategic Technologies for Europe Platform' (STEP) should contribute to reducing the Union's dependencies on third countries in the field of biotechnologies and turn into a fully- fledged sovereignty fund for the pharmaceutical industry in the future1 aa. The European pharmaceutical industry must be protected from international competition, and fiscal and financial incentives should be permitted in order to encourage manufacturers to relocate to Europe the production of active ingredients and medicines of strategic importance for healthcare. _________________ 1 aa Regulation of the European Parliament and of the Council establishing the Strategic Technologies for Europe Platform (‘STEP’) and amending Directive 2003/87/EC, Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241.
Amendment 469 #
2023/0131(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a grow, which have increased twentyfold over the past 20 years ing threat to public healthe European Union, are a genuine health scourge, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components, while 45% of medicinal products marketed in the EU are not produced in the EU and 80 to 85% of the active ingredients are imported from China and India. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages of medicinal products included on the Union list of critical medicinal products, and in particular medicines of health and strategic interest (MHSI). The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.
Amendment 476 #
2023/0131(COD)
Proposal for a regulation
Recital 137
Recital 137
(137) To achievecombat shortages of medicinal products, a better security of supply for medicinal products in the internal market and tois a key element contribute therebying to a high level of public health protection,; it is appropriate, therefore, to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe, in particular by making security of supply a criterion as important as the price in public pharmacy contracts and in medicine-related procurement. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe.
Amendment 483 #
2023/0131(COD)
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure continuously and in real time, also based on notifications of marketing authorisation holders. To this end, the Agency should set up a European platform on stocks of medicinal products which is continuously updated in real time with data transmitted by the competent authorities of the Member States, marketing authorisation holders and wholesale distributors. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56, should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation, prioritising medicines of health and strategic interest (MHSI), to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. These recommendations may relate to national stockpiling initiatives to ensure that they are proportionate to needs and do not have undesirable consequences, such as supply tensions in other Member States. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 493 #
2023/0131(COD)
Proposal for a regulation
Recital 139 a (new)
Recital 139 a (new)
(139a) The list of critical medicinal products drawn up at Union level should harmonise existing national lists and should not create confusion for the different actors in the pharmaceutical sector.
Amendment 494 #
2023/0131(COD)
Proposal for a regulation
Recital 139 b (new)
Recital 139 b (new)
(139b) The creation of one of more non- profit pharmaceutical undertakings capable of producing certain medicines of health and strategic interest (MHSI) whose situation is critical or which are no longer profitable for pharmaceutical firms should complement and guarantee security of supply and prevent possible shortages of critical medicinal products.
Amendment 495 #
2023/0131(COD)
Proposal for a regulation
Recital 139 c (new)
Recital 139 c (new)
(139c) Policies on the pricing of pharmaceutical products which only contain expenditure have a negative effect on the reliability of supply. The competent authorities of the Member States should be able to recommend an increase in the prices of products for which a risk of shortages or market consolidation has been identified.
Amendment 496 #
2023/0131(COD)
Proposal for a regulation
Recital 139 d (new)
Recital 139 d (new)
(139d) The Covid-19 pandemic showed that introducing temporary regulatory flexibility measures in the event of a public health emergency can help tackle shortages of medicinal products.
Amendment 497 #
2023/0131(COD)
Proposal for a regulation
Recital 139 e (new)
Recital 139 e (new)
Amendment 498 #
2023/0131(COD)
Proposal for a regulation
Recital 139 f (new)
Recital 139 f (new)
(139f) Public procurement procedures can be an effective tool for tackling shortages of medicinal products. At Member State level, invitations to tender based solely on price and where there is only one bidder increase the risk of shortages of medicinal products by strongly eroding prices, reducing the number of suppliers on the market. At Union level, joint procurement should be recognised as a tool to tackle critical shortages, in particular during a health crisis, as demonstrated by the Covid-19 pandemic.
Amendment 519 #
2023/0131(COD)
Proposal for a regulation
Article premier – paragraph 1
Article premier – paragraph 1
This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to tackling shortages and to the security of supply of medicinal products and lays down the governance provisions of the European Medicines Agency (‘the Agency’) established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6 and other relevant Union legal acts.
Amendment 547 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11
Article 2 – paragraph 2 – point 11
(11) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients andin the short or medium term and which has been identified using the methodology pursuant to Article 130(1), point (a).
Amendment 548 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11a) ‘medicine of health and strategic interest’ (MHSI) means a medicinal product for which an interruption in treatment poses an immediate danger to the life of the patient.
Amendment 558 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply, as defined by Regulation 2022/1231 b, of a medicinal product that is authorised and placed on the market in a Member State does not meet the demand, as defined by Regulation 2022/123, for that medicinal product in that Member State, whatever the cause. _________________ 1 b Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 750 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
1 a. Following the receipt of a notification of the suspension of a medicinal product's marketing issued pursuant to Article 116, the competent authority of the Member State where the medicinal product was marketed can recommend increasing the prices of products for which a risk of shortages or market consolidation has been identified.
Amendment 1395 #
2023/0131(COD)
Proposal for a regulation
Article 112 a (new)
Article 112 a (new)
Amendment 1476 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply, four months if the medicinal product is on the Union list of critical medicinal products established by Article 131 or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1495 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placincluded on the marketUnion list of critical medicinal products established by Article 131. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1503 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1 a (new)
Article 117 – paragraph 1 a (new)
1a. Pursuant to Article 173(2), the Commission may adopt implementing acts listing medicinal products not included on the Union list of critical medicinal products for which a shortage prevention plan is required due to a lack of therapeutic alternatives.
Amendment 1510 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Article 118 – paragraph 1 – subparagraph 1
Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products and send the information to the Agency without undue delay.
Amendment 1513 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 1 a (new)
Article 118 – paragraph 1 a (new)
1a. To carry out that monitoring, the Agency shall establish a European medicine stock platform that is continuously updated in real time with data sent by the competent authorities of the Member States, marketing authorisation holders and wholesale distributors.
Amendment 1521 #
2023/0131(COD)
Proposal for a regulation
Article 119 – paragraph 1 – point b a (new)
Article 119 – paragraph 1 – point b a (new)
(ba) promptly provide information on the stock available and any supply shortages in accordance with Article 130(2), point (da), establishing a European medicine stock platform.
Amendment 1551 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
Amendment 1555 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point c b (new)
Article 121 – paragraph 1 – point c b (new)
(cb) examine the options for regulatory flexibility to alleviate shortages of medicinal products in the event of a health crisis.
Amendment 1576 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 4 – point d
Article 122 – paragraph 4 – point d
(d) specify the methods for the provision of recommendations referred to in Article 123(4), including the introduction of regulatory flexibility;
Amendment 1577 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 4 – point d a (new)
Article 122 – paragraph 4 – point d a (new)
(da) define the tools, working methods and guidelines for the solidarity mechanism referred to in Article 123(3a), in particular any necessary regulatory flexibility allowing for the quick movement of medicinal products between Member States and backed up by appropriate funding.
Amendment 1586 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP to make it a genuine prevention tool by transforming it into a European medicine stock platform that is continuously updated in real time, as provided for in Article 130. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.
Amendment 1598 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 2 a (new)
Article 123 – paragraph 2 a (new)
2a. In accordance with the methods established in Article 122(4), point d, the MSSG may decide to activate the solidarity mechanism to allow available national surplus stocks to be shared to alleviate critical shortages.
Amendment 1641 #
2023/0131(COD)
Proposal for a regulation
Article 128 – paragraph 1 – point e a (new)
Article 128 – paragraph 1 – point e a (new)
(ea) manage and replenish the European reserve of medicines of health and strategic importance (MISSs) established in Article 134(2).
Amendment 1657 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, prioritising medicines of health and strategic importance (MISSs) and in consultation, where appropriate, with relevant stakeholders;
Amendment 1663 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point d a (new)
Article 130 – paragraph 1 – subparagraph 1 – point d a (new)
(da) establish a European medicine stock platform that is continuously updated in real time with data sent by the competent authorities of the Member States, industrial actors and wholesale distributors.
Amendment 1664 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point d b (new)
Article 130 – paragraph 1 – subparagraph 1 – point d b (new)
(db) develop, with the Member States, innovative and coordinated strategies and step up exchanges of good practice in the area of stock management.
Amendment 1665 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point d c (new)
Article 130 – paragraph 1 – subparagraph 1 – point d c (new)
(dc) coordinate, with marketing authorisation holders, the management of the European reserve of medicines of health and strategic importance (MISSs) established in Article 134(2).
Amendment 1672 #
2023/0131(COD)
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC], prioritising medicines of health and strategic importance (MISSs) and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”). The Union list of critical medicinal products shall be drawn up in coordination with the lists established and communicated by the Member States.
Amendment 1689 #
2023/0131(COD)
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on diversification of suppliers and inventory management, pricing mechanisms, tender procedures and the use of regulatory flexibility.
Amendment 1697 #
2023/0131(COD)
Proposal for a regulation
Article 133 a (new)
Article 133 a (new)
Amendment 1698 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – introductory part
Article 134 – paragraph 1 – introductory part
1. The Commission may, where it considers it appropriate and necessaryshall:
Amendment 1700 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – point a
Article 134 – paragraph 1 – point a
(a) take into account the MSSG recommendations and implement the relevant measures;Does not affect the English version.)
Amendment 1701 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – point b
Article 134 – paragraph 1 – point b
(b) inform the MSSG and the Member State authorities of those measures taken by the Commission.
Amendment 1702 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – point c
Article 134 – paragraph 1 – point c
(c) request the MSSG to provide information or an opinion or further recommendations referred to in Article 132(1).Does not affect the English version.)
Amendment 1703 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – point c a (new)
Article 134 – paragraph 1 – point c a (new)
Amendment 1704 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – point c b (new)
Article 134 – paragraph 1 – point c b (new)
(cb) develop, within the framework of the Public Procurement Directive 2014/24/EU1 c, guidelines to support sustainable public procurement practices in the pharmaceutical field, in particular with regard to the implementation of the most economically advantageous tender (MEAT) criteria in order to establish remedies against single-winner, price- only tenders. _________________ 1 c Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94 28.3.2014, p. 65).
Amendment 158 #
2023/0042(COD)
Proposal for a regulation
Recital 27 a (new)
Recital 27 a (new)
(27a) whereas the high cost of purchasing zero-emission urban buses and of adapting the infrastructure could lead to a reverse modal shift due to a possible reduction in the frequency of urban bus services, and new national and European financial support must therefore be envisaged to complement the funding options offered by the Social Climate Fund.
Amendment 318 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Article 3 b
Article 3 b
Article 3b Zero-CO2 emission vehicle target for urban buses
Amendment 319 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Article 3 b – paragraph 1
Article 3 b – paragraph 1
1. For vehicles referred to in point 4.2 of Annex I, manufacturers shall comply with the minimum shares of zero-emission vehicles in their fleet of new heavy-duty vehicles as laid down in point 4.3 of Annex I. For new urban buses the share of zero- emissions vehicles shall be 100% as fromaverage CO2 emissions of the Union fleet shall be reduced by the following percentages compared to the average CO2 emissions of the reporting period of the year 2019: (a) for the reporting periods of the years 2025 to 2029: 80%; (b) for the reporting periods of the years 2030 to 2034: 90%; (c) for the reporting periods from 2035 onwards, a new percentage should be established when reviewing this Regulation, in accordance with Article 15.
Amendment 332 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Article 3 b – paragraph 2
Article 3 b – paragraph 2
Amendment 579 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 4 – subparagraph 4.3 – table 4.3.2
Annex I – paragraph 4 – subparagraph 4.3 – table 4.3.2
4.3.2. The following zero-CO2 emission vehiclereduction targets zevMsg pursuant to Article 3b are applicable to vehicles in the sub-group sg for different reporting periods:: Zero-emission vehicle mandates zevMsg Sub-groups Zero-emission vehicle mandates Reporting period of the years sg zevMsg before 2030 2030 – 2034 2035 – 2039 As from 2040 Urban heavy 31-LF, 31-L1, 31- 0 80% 1090% 100%Review Review 100% buses DD, 33-LF, 33- clause clause L1, 33-DD, 35- FE, 39-FE, 31-L2, 33-L2
Amendment 8 #
2022/2124(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that Frontex is by large the Agency that received more significant budget increases in the last years; recalls that, with the increase in its staffing and in the amount of official travel, the Agency’s budget has skyrocketed from €118 million in 2011 to €741 million in 2021, and to an annual average of €900 million for the 2021-2027 period;
Amendment 25 #
2022/2124(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Notes the drawing up of a fundamental rights strategy and action plan; regretnotes that the obligation included in Article 110(6) of Regulation (EU) 2019/1896 to deploy at least 40 fundamental rights monitors has been met with significant delay; notes that the number of fundamental rights monitors now stands at 46; deeply deplores that despite the significant overall staff increase for the Agency, the Fundamental Rights Officer still lacks adequate human resources; urges the Agency to provide its fundamental rights officer with adequate resources and staffimplemented, and that there are now 46 such fundamental rights monitors;
Amendment 34 #
2022/2124(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Takes the position that the Management Board should play a proactive role in identifying and preventing serious risk of fundamental rights violations; reiterates the importance to implement the standard operating procedures to withdraw the financing of, or suspend or terminate, or not launch Frontex activities infinancing of Frontex’s activities should be guaranteed in the long term, given the successive extensions of its mandate and the aim of establishing a 10 000-strong permanent European border and coases where such risks ariset guard force by 2027;
Amendment 52 #
2022/2124(DEC)
Draft opinion
Paragraph 7
Paragraph 7
7. Reiterates its profound concerns aboutNotes the findings of the OLAF report of 15 February 2022 on investigations into Frontex, and expresses its utter dismay in the behaviour and actions described in the findings and the lack of accountability; considers that the findings of the OLAF report are a matter of public interest and shcould be made public, without further delayhilst upholding the principle of the protection of personal data and the presumption of innocence;
Amendment 56 #
2022/2124(DEC)
Draft opinion
Paragraph 8
Paragraph 8
Amendment 65 #
2022/2124(DEC)
Draft opinion
Paragraph 9
Paragraph 9
9. Notes that Frontex’ structural problems regarding fundamental rights protection of asylum seekers and migrants, transparency, data protection, and alleged sexual harassment within the Agency led the European Parliament to refuse dischargePoints out that the European Parliament refused to grant discharge in respect of the Agency’s 2020 budget;
Amendment 78 #
2022/2124(DEC)
Draft opinion
Paragraph 11
Paragraph 11
11. Recommends that the Committee on Budgetary Control to postpone granting thegrant discharge in respect of the implementation of the Agency’s budget for the financial year 2021, until the structural shortcomings related to respect by Frontex of its fundamental rights obligations have been fully addressed.
Amendment 502 #
2022/2051(INL)
Annex to the motion for a resolution
These areas of crime are the following: terrorism, trafficking in human beings and sexual exploitation of women and children, sexist violence, environmental crime, illicit drug trafficking, illicit arms trafficking, money laundering, corruption, counterfeiting of means of payment, computer crime and organised crime.
Amendment 502 #
2022/2051(INL)
Annex to the motion for a resolution
These areas of crime are the following: terrorism, trafficking in human beings and sexual exploitation of women and children, sexist violence, environmental crime, illicit drug trafficking, illicit arms trafficking, money laundering, corruption, counterfeiting of means of payment, computer crime and organised crime.
Amendment 136 #
2022/2026(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Member States to guarantee the right to education of all children with disabilities, ensuring that they have equal access to inclusive, high- quality teaching, from early childhood to adolescence, through, in particular, the establishment of tailored infrastructures and specialised training for their teachers and assistants;
Amendment 11 #
2022/2015(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Stresses that for there to be effective access to the European institutions' documents, it is not enough for them to be available online – they must also be translated into all the official languages of the European Union; regrets, in this regard, that a great deal of information is only available in English;
Amendment 13 #
2022/2015(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Stresses that the pandemic and the changes in the institutions' working procedures may have slowed down the processing of requests for access to documents; stresses that the institutions must put in place mechanisms to ensure that the highest level of transparency and access to documents is maintained, even in the event of a crisis;
Amendment 21 #
2022/2015(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Invites the EU institutions to ensure the provision of data concerning the implementation of Union policies in an open, machine- readable format, which is especially essential for numerical or financial data;
Amendment 43 #
2022/2015(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Stresses that transparency in the decision-making process increases citizens' willingness to accept the political choices made; regrets, in this regard, that although Article 4(2) of Regulation (EC) No 1049/2001 provides for an exception to access to documents of the institutions where the protection of the commercial interests of a natural or legal person, including intellectual property, is concerned, the Commission has nevertheless failed in its duty of transparency by not making public, in the context of the contracts for the purchase of vaccines against Covid-19, information relating to the manufacturers' liability, the price of the doses sold and the dates and volumes of doses delivered to each Member State;
Amendment 47 #
2022/2015(INI)
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Stresses that European citizens, as taxpayers, have a legitimate interest in knowing how EU funds are used; regrets, in this context, that the written notification sent to Hungary in connection with the application of Article 6(1) of Regulation 2020/2092 was not made public on the grounds that the exceptions referred to in Articles 4(1)(4), 4(2)(2) and (3) and 4(3) of Regulation (EC) No 1049/2001 were applicable, relating in particular to the protection of the public interest of the Union, the protection of court proceedings and legal advice, and the objectives of inspection, investigation and audit activities;
Amendment 49 #
2022/2015(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses that transparency in the decision-making process increases citizens' willingness to accept the political choices made; considers it regrettable, in this regard, that although Article 4(2) of Regulation (EC) No 1049/2001 provides for an exception to access to documents of the institutions where the protection of the commercial interests of a natural or legal person, including intellectual property, is concerned, the Commission has nevertheless failed in its duty of transparency by not making public, in the context of the contracts for the purchase of vaccines against Covid-19, information relating to the manufacturers' liability, the price of the doses sold and the dates and volumes of doses delivered to each Member State;
Amendment 59 #
2022/2015(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that European citizens, as taxpayers, have a legitimate interest in knowing how EU funds are used; regrets, in this context, that the written notification sent to Hungary in connection with the application of Article 6(1) of Regulation 2020/2092 was not made public on the grounds that the exceptions referred to in Articles 4(1)(4), 4(2)(2) and (3) and 4(3) of Regulation (EC) No 1049/2001 were applicable, relating in particular to the protection of the public interest of the Union, the protection of court proceedings and legal advice, and the purpose of inspection, investigation and audit activities;
Amendment 92 #
2022/2015(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Stresses that for there to be effective access to the European institutions' documents, it is not enough for them to be available online – they must also be translated into all the official languages of the European Union; considers it regrettable, in this regard, that a great deal of information is only available in English;
Amendment 127 #
2022/2015(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Emphasises that the pandemic and the changes in the institutions' working procedures resulted in a slowdown in the processing of requests for access to documents; stresses that it is essential for the institutions to put in place mechanisms to ensure that the highest level of transparency and access to documents is maintained, even in the event of a crisis;
Amendment 78 #
2022/0432(COD)
Proposal for a regulation
Recital 2 c (new)
Recital 2 c (new)
(2c) Considering that the European Parliament resolution of 14 December 2022 on the implementation of the New European Agenda for Culture and the EU Strategy for International Cultural Relations (2022/2047(INI)) recalled that the EU must ensure that Europe’s cultural heritage is safeguarded and insisted on the fact that upholding the required level of protection for human health and the environment does not conflict, where appropriate, with the preservation of European heritage, avoiding the closure of many craft enterprises and any negative impact on the restoration, maintenance and conservation of the vast heritage of the EU. The European institutions should consult and involve the heritage sector in all discussions related to regulatory or legislative changes with a direct impact on their activities. The products such as essential oils and natural complex substances, obtained from plants and landscapes, which are part of a cultural heritage, should be preserved.
Amendment 126 #
2022/0432(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) An assessment of the costs incurred by micro, small and medium- sized enterprises, especially producers of essential oils, in implementing this regulation should be carried out by the European Commission. This should be carried out with a view to providing financial support to these entities, if necessary.
Amendment 76 #
2022/0417(COD)
Proposal for a regulation
Article 10 – paragraph 9 a (new)
Article 10 – paragraph 9 a (new)
9a. The Agency shall ensure that the fairness and transparency of the fee system are guaranteed. To that end, the Agency shall provide a detailed assessment of all the costs funded by the fees. On this basis, a cost management and monitoring mechanism shall be put in place to facilitate the regular review of the fairness of the system and allow for adjustments where necessary.
Amendment 165 #
2022/0400(COD)
Proposal for a directive
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. Member States shall ensure that the staff of each equality body have received specific training on all grounds of discrimination referred to in Directives 2006/54/EC and 2010/41/EU and in the forms of violence referred to in Directive of the European Parliament and of the Council on combating violence against women and domestic violence.
Amendment 147 #
2022/0277(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) In the digitalised media market, providers of video-sharing platforms or very large online platformhosting services may fall under the definition of media service provider. In general, such providers play a key role in the content organisation, including by automated means or algorithms, but do not exercise editorial responsibility over the content to which they provide access. However, in the increasingly convergent media environment, some providers of video-sharing platforms or very large online platforms have started to exercise editorial control over a section or sections of their services. Therefore, such an entity could be qualified both as a video-sharing platform provider or a very large online platform provider and as a media service provider.
Amendment 149 #
2022/0277(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The definition of audience measurement should cover measurement systems developed as agreed by industry standards within self-regulatory organisations, like the Joint Industry Committees, and measurement systems developed outside such self-regulatory approaches. The latter tend to be deployed by certain online players who self-measure or provide their proprietary audience measurement systems to the market, which do not necessarily abide by the commonly agreed industry standards. Given the significant impact that such audience measurement systems have on the advertising and media markets, they should be covered by this RegulationSystems developed that do not comply with the industry standards adopted within the self-regulatory organisations should be considered as proprietary audience measurement systems. Given the significant impact that such audience measurement systems have on the advertising and media markets, they should be covered by this Regulation. Media service providers that comply with the commonly accepted industry standards shall not to be considered providers of proprietary audience measurement systems.
Amendment 159 #
2022/0277(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) In order to ensure that society reaps the benefits of the internal media market, it is essential not only to guarantee the fundamental freedoms under the Treaty, but also the legal certainty which the recipients of media services need for the enjoyment of the corresponding benefits. Such recipients should have access to quality media services, which have been produced by journalists and editors in an independent manner and in line with journalistic standards and hence provide trustworthy information, including news and current affairs content. Such right does not entail any correspondent obligation on any given media service provider to adhere to standards not set out explicitly by law. Such quality media services are also an antidote against disinformation, including foreign information manipulation and interference.Does not affect the English version.)
Amendment 160 #
2022/0277(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The protection of editorial independence is a precondition for exercising the activity of media service providers and their professional integrity. Editorial independence is especially important for media service providers providing news and current affairs content given its societal role as a public good. MWithout prejudice to Directive 2010/13/EU and its transposition in the Member States, media service providers should be able to exercise their economic activities freely in the internal market and compete on equal footing in an increasingly online environment where information flows across borders.
Amendment 170 #
2022/0277(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Journalists and editors are the main actors in the production and provision of trustworthy media content, in particular by reporting on news or current affairs. It is essential therefore to protect journalists’ capability to collect, fact-check and analyse information, including information imparted confidentially. In particular, media service providers and journalists (including those operating in non-standard forms of employment, such as freelancers) should be able to rely on a robust protection of journalistic sources and communications, including against deployment of surveillance technologies, since without such protection sources may be deterred from assisting the media in informing the public on matters of public interest. As a result, journalists’ freedom to exercise their economic activity and fulfil their vital ‘public watchdog’ role may be undermined, thus affecting negatively access to quality media services. The protection of journalistic sources contributes to the protection of the fundamental right enshrined in Article 11 of the Charter.Does not affect the English version.)
Amendment 185 #
2022/0277(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Public service media established by the Member States play a particular role in the internal media market, by ensuring that citizens and businesses have access to a variety of quality information and impartial and balanced media coverage, as part of their mission. However, public service media can be particularly exposed to the risk of interference, given their institutional proximity to the State and the public funding they receive. This risk may be exacerbated by uneven safeguards related to independent governance and balanced coverage by public service media across the Union. This situation may lead to biased or partial media coverage, distort competition in the internal media market and negatively affect access to independent and impartial media services. It is thus necessary, building on the international standards developed by the Council of Europe in this regard, tohat Member States put in place legal safeguards for the independent functioning of public service media across the Union. It is also necessary to guarantee that, without prejudice to the application of the Union’s State aid rules, public service media providers benefit from sufficient and stable funding to fulfil their mission that enables predictability in their planning. Preferably, such funding should be decided and appropriated on a multi-year basis, in line with the public service mission of public service media providers, to avoid potential for undue influence from yearly budget negotiations. The requirements laid down in this Regulation do not affect the competence of Member States to provide for the funding of public service media as enshrined in Protocol 29 on the system of public broadcasting in the Member States, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union.
Amendment 192 #
2022/0277(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Media integrity also requires a proactive approach to promote editorial independence by news media companies, in particular through internal safeguards. Media service providers should adopt proportionate measures to guarantee, once the overall editorial line has been agreed between their owners and editors, the freedom of the editors to take individual decisions in the course of their professional activityprotect the editorial freedom of the media in the course of their professional activity, in particular by appointing publishing directors with legal responsibility for the publication of content. The objective is to shield editors from undue interference in their decisions taken on specific pieces of content as part of their everyday work contributes to ensuring a level playing field in the internal market for media services andto ensure the quality of suchtheir services. That objective is also in conformity with the fundamental right to receive and impart information under Article 11 of the Charter. In view of these considerations, media service providers should also ensure transparency of actual or potential conflicts of interest to their service recipients.
Amendment 194 #
2022/0277(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) To mitigate regulatory burdens, micro enterprises within the meaning of ArtMedia servicle 3 of Directive 2013/34/EU of the European Parliament and of the Council50should be exempted from the requirements related to information and internal safeguards with a view to guaranteeing the independence of individual editorial decisions.Moreover,media service providers should be free to tailor the internal safeguards to their needs, in particular if they are small and medium- sized enterprises within the meaning of that Articlproviders should be free to tailor the internal safeguards to their needs or specific editorial line, in particular if they are small and medium- sized enterprises within the meaning of Article 3 of Directive 2013/34/EU of the European Parliament and of the Council referred to above. The Recommendation that accompanies this Regulation51provides a catalogue of voluntary internal safeguards that can be adopted within media companies in this regard. The present Regulation should not be construed to the effect of depriving the owners of private media service providers of their prerogative to set strategic or general goals and to foster the growth and financial viability of their undertakings. In this respect, this Regulation recognises that the goal of fostering editorial independence needs to be reconciled with the legitimate rights and interests of privatemedia owners. _________________ 50 Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19-76). and with the exercise of responsibility of the publishing director. _________________ 51 OJ C , […], […], p. […].
Amendment 245 #
2022/0277(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) Very large online platforms act for many users as a gateway for access to media services. Media service providers who exercise editorial responsibility over their content play an importantessential role in the distribution of information and in the exercise of freedom of information online. When exercising such editorial responsibility, they are expected to act diligently and provide information that is trustworthy and respectful of fundamental rights, in line with the regulatory or self- regulatory requirements they are subject to in the Member States. Therefore, also in view of users’ freedom of information, where providers of very large online platforms consider that content provided by such media service providers is incompatible with their terms and conditions, while it is not contributing to a systemic risk referred to in Article 26 of Regulation (EU) 2022/XXX [the Digital Services Act], they should duly consider freedom and pluralism of media, in accordance with Regulation (EU) 2022/XXX [the Digital Services Act] and provide, as early as possible, the necessary explanations to media service providers as their business users in the statement of reasons under Regulation (EU) 2019/1150 of the European Parliament and of the Council54. To minimise the impact of any restriction to that content on users’ freedom of information, very large online platforms should endeavour to submit the statement of reasons prior to the restriction taking effect without prejudin accordance with Article to their obligations under4(1) of Regulation (EU) 2019/1150 and Article 17(3) ofRegulation (EU) 2022/XXX [the2065 [Digital Services Act] and grant the media service concerned a right to respond to this statement of reasons prior to the suspension or restriction taking effect. In particular, this Regulation should not prevent a provider of a very large online platform to take expeditious measures either against illegal content disseminated through its service, or in order to mitigate systemic risks posed by dissemination of certain content through its service, in compliance with Union law, in particular pursuant to Regulation (EU) 2022/XXX [the Digital Services Act]. _________________ 54 Regulation (EU) 2019/1150 of the European Parliament and of the Council of 20 June 2019 on promoting fairness and transparency for business users of online intermediation services (OJ L 186, 11.7.2019, p. 57-79).
Amendment 253 #
2022/0277(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) To this end, providers of very large online platforms should provide a functionality on their online interface to enable media service providers to declare that they meet certain requirements, while at the same time. On the basis of transparent, objective and proportionate criteria, providers of very large platforms shall retaining the possibility not to accept such self-declaration where they consider that these conditions are not met. Providers of very large online platforms may rely on information regarding adherence to these requirements, such as the machine-readable standard of the Journalism Trust Initiative or other relevant codes of conduct. Guidelines by the Commission may be useful to facilitate an effective implementation of such functionality, including on modalities of involvement of relevant civil society organisations in the review of the declarations, on consultation of the regulator of the country of establishment, where relevant, and address any potential abuse of the functionality to address any potential abuse of the functionality by very large online platforms.
Amendment 268 #
2022/0277(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) Different legislative, regulatory or administrative measures can negatively affect the operationaffect or even restrict transborder operations of news and current affairs programmes of media service providers in the internal market. They include, for example, rules to limit the ownership of media companies by other companies active in the media sector or non-media related sectors; they also include decisions related to licensing, authorisation or prior notification for media service providers. In order to mitigate their potential negative impact on the functioning of the internal market for media services and enhance legal certainty, it is important that such measures comply with the principles of objective justification, transparency, non- discrimination and proportionality.
Amendment 288 #
2022/0277(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) Audience measurement has a direct impact on the allocation and the prices of advertising, which represents a key revenue source for the media sector. It is a crucial tool to evaluate the performance of media content and understand the preferences of audiences in order to plan the future production of content. Accordingly, media market players, in particular media service providers, rights holders and advertisers, should be able to rely on objective audience data stemming from transparent, unbiased and verifiable audience measurement solutions. However, certain new players, such as very large online platforms and very large search engines, that have emerged in the media ecosystem provide their own measurement services without making available information on their methodologies. This does not allow for the comparison of audiences between actors and could result in information asymmetries among media market players and in potential market distortions, to the detriment of equality of opportunities for media service providers in the market.
Amendment 294 #
2022/0277(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) In order to enhance the verifiability and reliability of audience measurement methodologies, in particular online, transparency obligations should be laid down for providers of audience measurement systems that do not abide by the industry benchmarks agreed within the relevant self-regulatory bodies. Under these obligations, such actors, when requested and to the extent possible, should provide advertisers and media service providers or parties acting on their behalf, with information describing the methodologies employed for the measurement of the audience. Such information could consist in providing elements, such as the size of the sample measured, the definition of the indicators that are measured, the metrics, the measurement methods and the margin of error as well as the measurement period. In addition, media service providers and rights holders should be provided with free audience data for their content and services. The obligations imposed under this Regulation are without prejudice to any obligations that apply to providers of audience measurement services under Regulation 2019/1150 or Regulation (EU) 2022/XX [Digital Markets Act], including those concerning ranking or self- preferencing.
Amendment 295 #
2022/0277(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) Codes of conduct, shall be drawn up either by the providers of audience measurement systems or by organisations or associations representing them, canwith the help and advice of media service providers and their representative organisations, rights holders and any other interested parties. These codes of conduct shall contribute to the effective application of this Regulation and should, therefore,all be encouraged. Self- regulation has already been used to foster high quality standards in the area of audience measurement. Its further development could be seen as an effective tool for the industry, with the support of national authorities or regulators, to agree on the practical solutions needed for ensuring compliance of audience measurement systems and their methodologies with the principles of transparency, impartiality, inclusiveness, proportionality, equivalence, non- discrimination and verifiability. When drawing up such codes of conduct, in consultation with all relevant stakeholders and notably media service providers, account could be taken in particular of the increasing digitalisation of the media sector and the objective of achieving a level playing field among media market players.
Amendment 307 #
2022/0277(COD)
Proposal for a regulation
Article premier – paragraph 2 – point a a (new)
Article premier – paragraph 2 – point a a (new)
(aa) Directive 2001/29/EC;
Amendment 308 #
2022/0277(COD)
Proposal for a regulation
Article premier – paragraph 2 – point a b (new)
Article premier – paragraph 2 – point a b (new)
(ab) Directive 2010/13/EU;
Amendment 309 #
2022/0277(COD)
Proposal for a regulation
Article premier – paragraph 2 – point a c (new)
Article premier – paragraph 2 – point a c (new)
Amendment 310 #
2022/0277(COD)
Proposal for a regulation
Article premier – paragraph 2 – point a d (new)
Article premier – paragraph 2 – point a d (new)
(ad) Directive 2019/789/EU;
Amendment 319 #
2022/0277(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 6 a (new)
Article 2 – paragraph 1 – point 6 a (new)
6a. ‘publishing director’ means the legal representative of the media service provider who assumes responsibility, including legal responsibility, for the provision of a media service;
Amendment 320 #
2022/0277(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
(7) ‘editor’ means a natural person or a number of natural persons possibly grouped in a body, regardless of its legal form, status and composition, that takes or supervises editorial decisions within a media service provider;Does not affect the English version.)
Amendment 325 #
2022/0277(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘editorial responsibility’ means the exercise of effective control both over the selection of the programmes or the content of press publications and over their organisation, for the purposes of the provision of a media service, regardless of the existence of liability under national law for the service provided;
Amendment 337 #
2022/0277(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 14
Article 2 – paragraph 1 – point 14
(14) ‘audience measurement’ means the activity of collecting, interpreting or otherwise processing data about the number and characteristics of users of media services or content for the purposes of decisions regarding advertising allocation or prices or the related planning, production or distribution of content;
Amendment 419 #
2022/0277(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. PMember States shall ensure, in their national legal frameworks, that public service media providers shall provide, in an independent and impartial manner, a plurality of information and opinions to their audiences, in accordance with their public service mission.
Amendment 436 #
2022/0277(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Member States shall ensure that public service media providers have adequate and stable financial resources for the fulfilment of both their public service mission. Those resources shall be such that editorial independence is safeguardedremit and the objectives of this Regulation. Those resources and the way in which they are allocated shall be such that editorial independence is safeguarded and they shall, as far as possible, be laid down in a multi-year budget.
Amendment 459 #
2022/0277(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) the name(s) of their direct or indirect owner(s) with shareholdings enabling them to exercise influencewhere the media service provider is a legal person, its name or registered trade name, its registered address, its legal form and the name of its legal representative and onf the operation and strategic decision makingphysical or legal persons holding at least 10% of its capital;
Amendment 483 #
2022/0277(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
1a. Manufacturers of devices or providers of user interfaces controlling or managing access to and use of audiovisual media services shall ensure that the identity of the media service provider bearing the editorial responsibility for the content or services is clearly visible alongside the content and services offered.
Amendment 501 #
2022/0277(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) guarantee thaprotect editors arein their freedom to take individual editorial decisions in the exercise of their professional activity, in particular in the exercise of the responsibility conferred upon the publishing director; and
Amendment 513 #
2022/0277(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 601 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) support the Commission, through technical expertise, in ensuring the correct application of this Regulation as regards audiovisual media services and the consistent implementation of Directive 2010/13/EU across all Member States, without prejudice to the tasks of national regulatory authorities or bodies;
Amendment 603 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) promote cooperation and the effective exchange of information, experience and best practices between the national regulatory authorities or bodies on the application of the Union and national rules applicable to audiovisual media services, including this Regulation and Directive 2010/13/EU, in particular as regards Articles 3, 4 and 7 of that Directive;
Amendment 605 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) advise the Commission, where requested by it, on regulatory, technical or practical aspects pertinent to the consistent application of this Regulation as regards audiovisual media services and implementation of Directive 2010/13/EU as well as on all on other matters related to audiovisual media services within its competence. Where the Commission requests advice or opinions from the Board, it may indicate a time limit, taking into account the urgency of the matter;
Amendment 627 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point e – point iii
Article 12 – paragraph 1 – point e – point iii
(iii) national measures concerning audiovisual media service providers established outside of the Union, in accordance with Article 16(2) of this Regulation;
Amendment 637 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point f – point i
Article 12 – paragraph 1 – point f – point i
(i) national measures which are likely to affect the functioning of the internal market for media services, in accordance with Article 20(4) of this Regulation;
Amendment 640 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point f – point ii
Article 12 – paragraph 1 – point f – point ii
(ii) media market concentrations with a significant impact on media pluralism which are likely to affect the functioning of the internal market for media services, in accordance with Article 22(1) of this Regulation;
Amendment 643 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point g
Article 12 – paragraph 1 – point g
(g) draw up opinions on draft national opinions or decisions assessing the impact on media pluralism and editorial independence of a notifiable media market concentration where such a concentration may affect the functioning of the internal market, in accordance with Article 21(5) of this Regulation;
Amendment 650 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point h – point ii
Article 12 – paragraph 1 – point h – point ii
(ii) factors to be taken into account when applying the criteria for assessing the impact of media market concentrations, in accordance with Article 21(3) of this Regulation;
Amendment 652 #
2022/0277(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point k
Article 12 – paragraph 1 – point k
(k) coordinate national measures related to the dissemination of or access to content of audiovisual media service providers established outside of the Union that target audiences in the Union, where their activities prejudice or present a serious and grave risk of prejudice to public security and defence, in accordance with Article 16(1) of this Regulation;
Amendment 708 #
2022/0277(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a
Article 15 – paragraph 2 – point a
(a) the appropriate prominence of audiovisual media services of general interest under Articles 7a and 13(1) of Directive 2010/13/EU;
Amendment 709 #
2022/0277(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point b
Article 15 – paragraph 2 – point b
(b) making information accessible on the ownership structure of media service providers, as provided under Article 5(2) of Directive 2010/13/EU, and their parent and sister companies and subsidiaries.
Amendment 753 #
2022/0277(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Where a provider of very large online platform decides to restrict or suspend the provision of its online intermediation services in relation to content or services provided by a media service provider that submitted a declaration pursuant to paragraph 1 of this Article, on the grounds that such content isor services are incompatible with its terms and conditions, without that content contributing to a systemic risk referred to in Article 26 of the Regulation (EU) 2022/XXX [Digital Services Act], it shall take all possible measures, to the extent consistent with their obligations under Union law, includingnotify the media service provider concerned, as required by Article 4(1) of Regulation (EU) 2019/1150 and Article 17(3) of Regulation (EU) 2022/XXX2065 [Digital Services Act], to communicate to the media service provider concerned the statement of reasons accompanying that decision, as required by Article 4(1) of Regulation (EU) 2019/1150, prior to the suspension taking effectprior to the suspension taking effect. It shall communicate to the media service provider the detailed grounds for the suspension or restriction, and shall give it the opportunity to send a reasoned reply within a reasonable time frame before the suspension or restriction takes effect. If the provider of a very large online platform subsequently decides to suspend or restrict the content or services, it shall indicate in writing, when the decision takes effect, the detailed grounds for rejecting the media service provider's objections.
Amendment 761 #
2022/0277(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Providers of very large online platforms shall take all the necessary technical and organisational measures to ensure that complaints under Article 11 of Regulation (EU) 2019/1150 and/or Article 20 of Regulation (EU) 2022/2065 [Digital Services Act] by media service providers that submitted a declaration pursuant to paragraph 1 of this Article are processed and decided upon with priority and without undue delayno later than 24 hours after submission of the complaint. If the provider of a very large online platform does not adhere to that time limit, it shall reinstate the restricted or suspended content or services as soon as possible.
Amendment 769 #
2022/0277(COD)
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. Where a media service provider that submitted a declaration pursuant to paragraph 1 considers that a provider of very large online platform frequently restricts or suspends the provision of its services in relation to content provided by the media service provider without sufficient grounds, the provider of very large online platform shall engage in a meaningful and effective dialogue with the media service provider, upon its request, in good faith with a view to finding an amicable solution for terminating unjustified restrictions or suspensions and avoiding them in the future. The media service provider may notify the outcome of such exchanges to the Board. If no amicable solution is found, the media service provider may lodge a complaint with an out-of-court dispute settlement body, in accordance with Article 21 of Regulation (EU) 2022/2065, without prejudice, and in addition, to its right to effective judicial protection.
Amendment 776 #
2022/0277(COD)
Proposal for a regulation
Article 17 – paragraph 5 – point a
Article 17 – paragraph 5 – point a
(a) the numblist broken down by media service provider of instances where they imposed any restriction or suspension on the grounds that the content or service provided by a media service provider that submitted a declaration in accordance with paragraph 1 of this Article is incompatible with their terms and conditions; and
Amendment 781 #
2022/0277(COD)
Proposal for a regulation
Article 17 – paragraph 5 – point b
Article 17 – paragraph 5 – point b
(b) the detailed grounds for imposing such restrictions or suspensions.
Amendment 806 #
2022/0277(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Any legislative, regulatory or administrative measure taken by a Member State that is liable to affect the operation of audiovisual media service providers providing news and current affairs content in the internal market shall be non- discriminatory, duly justified and proportionate. Such measures shall be reasoned, transparent, objective and non- discriminatory.
Amendment 815 #
2022/0277(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. The Board, upon request of the Commission, shall draw up an opinion where aregarding any national legislative, regulatory or administrative measure is likely to affect the functioning of the internal market for media servicesreferred to in paragraph 1. Following the opinion of the Board, and without prejudice to its powers under the Treaties, the Commission may issue its own opinion on the matter. Opinions by the Board and, where applicable, by the Commission shall be made publicly available.
Amendment 822 #
2022/0277(COD)
Proposal for a regulation
Article 20 – paragraph 5
Article 20 – paragraph 5
5. Where a national authority or body adopts a measure that affects individually and directly a media service provider providing news and current affairs content and is likely to affect the functioning of the internal market for media services, it shall communicate, at the request of the Board, and where applicable, of the Commission, without undue delay and by electronic means, any relevant information, including the summary of the facts, its measure, the grounds on which the national authority or body has based its measure, and, where applicable, the views of other authorities concerned.
Amendment 867 #
2022/0277(COD)
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Audience measurement systems and methodologies shall comply with principles of transparency, impartiality, inclusiveness, proportionality, equivalence, non- discrimination and verifiability.
Amendment 869 #
2022/0277(COD)
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. Without prejudice to the protection of undertakings’ business secrets, providers of proprietary audience measurement systems shall provide, without undue delay and free of costs, to media service providers, holders of rights and advertisers, as well as to third parties authorised by media service providers and advertisers, accurate, detailed, comprehensive, intelligible and up-to-date data and information on the methodology used by their audience measurement systems. Holders of rights shall have access to the data collected regarding consumption of their programmes. This provision shall not affect the Union’s data protection and privacy rules.
Amendment 876 #
2022/0277(COD)
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
3. National regulatory authorities or bodies shall encourage the drawing up of codes of conduct by pProviders of audience measurement systems, together with media service providers, their representative organisations and any other interested parties, that arshall draw up codes of conduct with the support of the national authorities or national regulatory bodies. They shall be intended to contribute to compliance with the principles referred to in paragraph 1, including by promoting independent and transparent audits.
Amendment 877 #
2022/0277(COD)
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. The Commission, assisted by the Board, may issue guidelines on the practical application of paragraphs 1, 2 and 3 of this Article, taking into account the national codes of conduct.
Amendment 882 #
2022/0277(COD)
Proposal for a regulation
Article 23 – paragraph 5
Article 23 – paragraph 5
5. The Board shall foster the exchange of best practices related to the deployment of audience measurement systems through a regular dialogue between representatives of the national regulatory authorities or bodies, representatives of providers of audience measurement systems, media service providers and other interested parties.
Amendment 897 #
2022/0277(COD)
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
1a. Public funds or any other consideration or advantage granted by public authorities shall be granted preferentially to media service providers publishing content relating to international, European, national or local political developments.
Amendment 161 #
2022/0216(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commiss and founded on the principle of voluntary and unpaid SoHO donation. Member States should notify the Commission via the SoHO platform set up by this Regulation of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary.
Amendment 196 #
2022/0216(COD)
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) For the performance of supervisory activities, competent authorities should ensure the impartiality and independence of the inspectors and provide them with training.
Amendment 203 #
2022/0216(COD)
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) Health-care personnel should be informed about, and trained in, the functioning of the entire SoHO supply chain, in particular patient blood management, as recommended by the World Health Organization. Awareness- raising and continuous training for prescribers could avoid the application of SoHOs where therapeutic alternatives are available, in particular by ensuring the best possible use is made of SoHOs.
Amendment 239 #
2022/0216(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States and the Union should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Union. Member States are also urged tvoluntary, unpaid donation of SoHOs of high quality and safety, including plasma, used as base material for manufacturing plasma- derived medicinal products. These measures support European self- sufficiency, based on the broadest possible donor base, with a view to ensuring a more resilient supply system and safeguarding the health of donors and recipients. Member States and the Union should also take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 325 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 1
Article 2 – paragraph 3 – subparagraph 1
For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients, quality control testing of SoHOs, and the continuity of supply of these substances, shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 409 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘'EU SoHO Platform’' means the digital platform established by the Commission to exchange information concerning SoHO activities, and interoperable with the other existing Union platforms, to exchange information concerning SoHO activities, in particular between competent authorities, European Union agencies and the Commission;
Amendment 462 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
Amendment 463 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 b (new)
Article 3 – paragraph 1 – point 70 b (new)
(70b) 'patient blood management' means an innovative organisational approach for optimising the care of patients with haemorrhagic disorders, for example anaemia, which is based on the following three pillars: (a) optimising the patient's blood mass; (b) minimising blood loss; (c) improving the patient's tolerance to anaemia;
Amendment 720 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 7 – point a
Article 58 – paragraph 7 – point a
(a) conducting comprehensive process validation and equipment qualification as referred to in Article 41(2), point (a)(vii); , unless the equipment has already been assessed and carries EC certification as provided for in Regulations (EU) 2017/7461 aand (EU) 2017/745 for an identical use; _________________ 1 a Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
Amendment 781 #
2022/0216(COD)
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)
Amendment 385 #
2022/0196(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the different levels of historical progress and differences in intensity of pesticide use between Member States, it is necessary to allow Member States some flexibility when setting their own binding national targets (“national 2030 reduction targets”). Intensity of use is best measured by dividing the total quantity of active substances placed on the market, and therefore used, in the form of plant protection products in a particular Member State by the surface area over which the active substances were applied. Intensity in the use of chemical pesticides, and in particular of the more hazardous pesticides, correlates with greater dependency on chemical pesticides, greater risks to human health and the environment and less sustainable farming practices. It is therefore appropriate to allow Member States to take their lower intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. It is also appropriate to require them to take their higher intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. In addition, in order to give recognition to past efforts by Member States, they should also be allowed to take into account historical progress prior to the adoption of the Farm to Fork Strategy when setting national 2030 reduction targets. Conversely, where Member States have increased, or made only limited reductions in, their use and risk of chemical plant protection products, they should now make a greater contribution to the achievement of the Union 2030 reduction targets, while also taking account of their intensity of pesticide use. In order to ensure a fair and collective effort towards the achievement of Union-wide targets and an adequate level of ambition, minimum limits should be laid down for national 2030 reduction targets. The EU’s outermost regions, as listed in Article 349 of the Treaty, are located in the Atlantic, Caribbean and Indian Ocean. Due to permanent constraints such as their remoteness to the European continent, insularity and high exposure to climate change, the size of the markets, which limits the number of applications for authorisation of plant protection products by the manufacturers of these products, it is appropriate to allow Member States to take into account the specific needs of these regions as regards the use of plant protection products and measures tailored to specific climatic conditions and crops, including the deployment of new varieties derived from new genomic techniques. Member States shall implement specific action plans on plant protection product in the outermost regions with due account for public health and the protection of producers and consumers. In order to ensure a fair and collective effort towards the achievement of Union-wide targets, where a Member State reaches the level of its 2030 national reduction target before 2030, it should not be required to undertake additional reduction efforts, but it should closely monitor annual fluctuations in the use and risk of chemical plant protection products and in the use of more hazardous plant protection products to ensure progress towards meeting the respective 2030 national reduction target. In the interests of transparency, Member State responses to any Commission recommendations in relation to the level of ambition of national targets and the annual progress made towards them should be publicly accessible.
Amendment 636 #
2022/0196(COD)
Proposal for a regulation
Recital 44 a (new)
Recital 44 a (new)
(44a) The objectives of reducing the use of plant protection products must go hand in hand with the introduction of mirror clauses in trade agreements. The EU must pursue an ambitious policy on reducing pesticides on its territory and impose reciprocity of production standards for agricultural products entering the EU. These mirror measures will protect the interests of European farmers by ensuring fair competition, protect the health of Europeans and respond to the climate emergency.
Amendment 2157 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3a. By way of derogation from paragraph 1, rail infrastructure managers may use a plant protection product in a sensitive area, where intervention is required to ensure the safety of operations and there are no non-chemical methods of plant control available that allow infrastructure managers to ensure the safety of rail infrastructure and traffic;
Amendment 301 #
2022/0140(COD)
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) Manufacturers of EHR systems which are not primarily intended to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records shall be encouraged to allow data generated by their device or software to be stored on the EHR system.
Amendment 363 #
2022/0140(COD)
(41a) The secondary use of electronic health data is essential to furthering research, finding new treatments and improving European patients’ health. The sharing of that data promises to foster collaboration between research and development teams from one or more Member States, particularly in certain fields such as cancer, mental illness and rare diseases.
Amendment 405 #
2022/0140(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) As the resources of health data access bodies are limited, they can apply prioritisation rules, for instance prioritising public institutions before private entities, but they should not make any discrimination between the national or from organisations from other Member States within the same category of priorities. The data user should be able to extend the duration of the data permit in order, for example, to allow access to the datasets to reviewers of scientific publication or to enable additional analysis of the dataset based on the initial findings. This would require an amendment of the data permit and may be subject to an additonal fee. However, in all the cases, the data permit should reflect theses additionals uses of the dataset. Preferably, the data user should mention them in their initial request for the issuance of the data permit. In order to ensure a harmonised approach between health data access bodies, the Commission should support the harmonisation of data permit.
Amendment 537 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) ‘European electronic health record exchange format’ means a structured, commonly used and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers; that format shall be easy to read, consolidated and accessible when sent to a natural person in accordance with Article 3 of this Regulation;
Amendment 559 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or software intended by the manufacturerwhose primary purpose is to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records;
Amendment 622 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Natural persons shall have the right to receive an electronic copy or a hard copy of their electronic health data upon request to a health professional, in the European electronic health record exchange format referred to in Article 6, of at least their electronic health data in the priority categories referred to in Article 5.;
Amendment 632 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of this righte right provided for in paragraph 1 whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.
Amendment 659 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Natural persons may insert, access and export their electronic health data in their own EHR or in that of natural persons whose health information they can access, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative.
Amendment 698 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. The information shall be provided immediately and free of charge in a readable, consolidated and accessible format through electronic health data access services.
Amendment 727 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. With a view to meeting the obligations established in paragraph 1 of this article, Member States may provide health professionals with support to ensure that they have the requisite digital skills, infrastructure and tools.
Amendment 779 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1 (new)
Article 5 – paragraph 2 – subparagraph 1 (new)
The list of priority electronic health data categories set out in Annex I must not withdraw or change data useful for health professionals' work.
Amendment 846 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point g
Article 10 – paragraph 2 – point g
(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders, in particular healthcare professionals;
Amendment 887 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives of patients, the industrial sector, SMEs, medical institutions, civil society, the university sector and research bodies. Members of the digital health authority shall avoid any conflicts of interest.
Amendment 894 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 5 a (new)
Article 10 – paragraph 5 a (new)
5a. Member States shall decide upon a selection procedure to ensure that the stakeholders referred to in paragraph 5 of this Article are representative.
Amendment 1052 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 4 a (new)
Article 26 – paragraph 4 a (new)
4a. The Commission shall publish a standard format for the EU declaration of conformity in digital form and accessible in all official EU languages.
Amendment 1259 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data. Health data access bodies shall in general use an opt-out regime for consent. An opt- in regime shall be put in place as an exception for consent from people with rare diseases.
Amendment 1376 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point b
Article 35 – paragraph 1 – point b
(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums or taking any other decisions in relation to a natural person or groups of natural persons to discriminate on the basis of the health data obtained;
Amendment 1401 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(ea) to obtain strategic information about a competitor, such as the production method behind their product or service.
Amendment 1644 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The fees shall be calculated according to objective criteria, in particular the completeness and representativeness of the data, the number of patients concerned, the scarcity of the data and the cost of any processes used to make the data accessible, such as anonymisation. The support received by the data holder from donations, public national or Union fundgrants, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.
Amendment 1676 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the health data access body in accordance with the tasks of the EHDS Board, set out in Article 65 of this Regulation. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from participation in the EHDS for a period of up to 5 years. Where a data holder has been excluded from the participation in the EHDS pursuant to this Article, following manifest intention of obstructing the secondary use of electronic health data, it shall not have the right to provide access to health data in accordance with Article 49.
Amendment 1687 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission mayshall issues guidelines on penalties to be applied by the health data access bodies.
Amendment 1698 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
2. The health data access bodies shall provide the electronic health data in an anonymised format, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user. The health data access bodies shall specify which entity has been tasked with anonymisation and which anonymisation standard has been applied. Specific provisions shall be put in place for data on rare diseases.
Amendment 1783 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 6
Article 45 – paragraph 6
6. The Commission mayshall, by means of implementing acts, set out the templates for the data access application referred to in this Article, the data permit referred to in Article 46 and the data request referred to in Article 47. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 68(2) and shall be limited to what is strictly necessary to avoid any unnecessary administrative burden.
Amendment 1821 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 3
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall not be issued.
Amendment 2057 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point b – point v
Article 65 – paragraph 2 – point b – point v
(v) the establishment, calculation and application of penalties;
Amendment 2065 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point d a (new)
Article 65 – paragraph 2 – point d a (new)
(da) Propose updates of the concepts of personal health data, non-personal health data and anonymisation techniques in line with Regulation (EU) 2016/679 and the existing recommendations at EU and international level;
Amendment 2072 #
2022/0140(COD)
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
3. Stakeholders and relevant third parties, including patients’ and healthcare professionals’ representatives, may be invited to attend meetings of the groups and to participate in their work.
Amendment 298 #
2022/0066(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Violence against women and domestic violence can be exacerbated where it intersects with discrimination based on sex and other grounds of discrimination prohibited by Union law, namely nationality, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation. Member States should therefore pay due regard to victims affected by such intersectional discrimination, through providing specific measures where intersecting forms of discrimination are present. In particular, women living in remote areas, pregnant, lesbian, bisexual, trans, non-binary, intersex and queer (LBTIQ) women, women with disabilities and women with a minority racial or ethnic background are at a heightened risk of experiencing gender- based violence.
Amendment 328 #
2022/0066(COD)
Proposal for a directive
Recital 14 a (new)
Recital 14 a (new)
(14a) Consent must always be assessed in relation to the time when the event took place. Consent must be given freely and voluntarily, namely without external constraints or threats. In certain cases women are unable to give free and voluntary consent, such as when they are not capable of forming a free will due to their physical or mental condition, such as when they are frightened, intimidated, unconscious, intoxicated, asleep, ill, physically injured or disabled.
Amendment 337 #
2022/0066(COD)
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15a) Forced marriage must be considered to be a form of exploitation that primarily affects women. Poverty, unemployment, customs or conflicts are all factors that promote the use of forced marriage. Often, forms of physical and psychological exploitation and violence, such as sexual exploitation, forced labour and begging under coercion, accompany forced marriage. It is therefore necessary for forced marriage to be criminalised in all Member States, with appropriate penalties, and for it to be possible for such marriages to be annulled or dissolved without any excessive administrative or financial burden for victims.
Amendment 351 #
2022/0066(COD)
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
(16a) Deliberately performing surgery which has the purpose or effect of terminating a woman’s ability to naturally reproduce or terminating her pregnancy without her prior and informed free consent must be deemed by Member States to be a criminal offence. Member States should ensure that the prior and informed free consent of a woman to such surgery may not be replaced by the consent of a parent, a legal guardian or a court ruling.
Amendment 358 #
2022/0066(COD)
Proposal for a directive
Recital 16 b (new)
Recital 16 b (new)
(16b) While the right to abortion is a matter for each Member State, a ban on abortion may be a public health issue. When a Member State bans abortion, women, particularly victims of rape or those whose health or life is in danger, are often forced to practise clandestine abortions. Member States must ensure that the right to abortion remains available for such women.
Amendment 378 #
2022/0066(COD)
Proposal for a directive
Recital 19 a (new)
Recital 19 a (new)
(19a) The increase in the volume of pornographic content online and the increased accessibility of such content has highlighted violence against women in the pornography industry. Any non- consensual act that takes place during filming and is committed against an actress is reprehensible. The selling of sexual services cannot justify abuse during filming. Member States are urged to legislate to ensure that consent to certain sexual practices must have been expressed in advance of the filming and may be withdrawn at any time up until the end of filming. The pornography industry should put procedures in place to ensure that the actresses have given their consent, such as by facilitating evidence gathering at filming locations.
Amendment 380 #
2022/0066(COD)
Proposal for a directive
Recital 19 b (new)
Recital 19 b (new)
(19b) The accessibility and proliferation of sexual or pornographic content have a significant impact on children. Confronted with traumatic images on the internet, particularly on social media or messaging apps, children often develop psychological problems or are traumatised. In addition, overexposure to content of this kind, which is often young people’s only reference point for sexual relations, leads to a twisted and violent picture of sexuality. It is therefore vital to put measures in place to check the age of online users and to effectively block access by minors to platforms disseminating pornographic content.
Amendment 389 #
2022/0066(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Minimum rules concerning the offence of cyber harassment should be laid down to counter initiating an attack with third parties or participating in such an attack directed at another person, by making threatening or insulting material accessible to a multitude ofone or more end-users. Such broad attacks, including coordinated online mob attacks, may morph into offline assault or cause significant psychological injury and in extreme cases lead to suicide of the victim. They often target prominent (female) politicians, journalists or otherwise well-known persons, but they can also occur in different contexts, for instance on campuses or in schools. Such online violence should be addressed especially where the attacks occur on a wide-scale, for example in the form of pile- on harassment by a significant amount of people.
Amendment 481 #
2022/0066(COD)
Proposal for a directive
Recital 39
Recital 39
(39) Certain offences covered by this Directive involve the increased risk of repeated, prolonged or even continuous victimisation. That risk occurs especially in relation to offences involving the making accessible to a multitude ofone or more end-users, through information and communication technologies, of material, resulting from certain offences of cyber violence, considering the ease and speed with which such material can be distributed on a large scale and the difficulties that often exist when it comes to removing such material. That risk typically remains even after a conviction. Therefore, in order to effectively safeguard the rights of the victims of those offences, Member States should be required to take suitable measures aimed at the removal of the material in question. Considering that removal at the source may not always be feasible, for instance because of legal or practical difficulties relating to the execution or enforcement of an order to remove, Member States should also be allowed to provide for measures to disable access to such material.
Amendment 496 #
2022/0066(COD)
Proposal for a directive
Recital 45
Recital 45
(45) Assistance and support to victims of violence against women and domestic violence should be provided before, duringimmediately after the individual assessment and for an appropriate period after the criminal proceedings have ended, if such proceedings were initiated, for example where medical treatment is still needed to address the severe physical or psychological consequences of the violence, or if the victim’s safety is at risk in particular due to the statements made by the victim in those proceedings.
Amendment 500 #
2022/0066(COD)
(46) Specialised support services should provide support to victims of all forms of violence against women and domestic violence, including sexual violence, female genital mutilation, forced marriage, forced abortion and sterilisation, sexual harassment and of various forms of cyber violence. Such specialised support services shall be distributed in an adequate manner in sufficient volume in each Member State. They shall be organised in the form of one-stop shops, in which it is possible, in a single location, to carry out in particular the urgent placing of a victim in a shelter, putting a care pathway in place, pre-drafting a protection order, allocating protection tools, carrying out a change of legal address, opening a bank account, contacting social services or assisting a victim in obtaining employment. If these are not in a single location, the specialised support services shall be coordinated through a central contact point or single online access to these services. The data and measures taken shall be stored on the platform set up by each Member State pursuant to Article 35a of this Directive.
Amendment 518 #
2022/0066(COD)
Proposal for a directive
Recital 48
Recital 48
(48) Victims of domestic violence and violence against women typically have multiple protection and support needs. In order to address these effectively, Member States should provide such services at the same premises, or, alternatively, have such services coordinated through a central contact point. To ensure also all victims, including those in remote areas or unable to physically reach such centres are reached, Member States should provide for online remote access to such services. This should entail setting up a single and updated website where all relevant information on and access to available support and protection services is provided (one-stop online access). The website should follow accessibility requirements for persons with disabilities by setting up an app, a website and a helpline that is available 24/7.
Amendment 521 #
2022/0066(COD)
Proposal for a directive
Recital 48 a (new)
Recital 48 a (new)
(48a) It should be possible, through the website and app, to access all relevant information and available support and protection services (one-stop online access). The website and app should be regularly updated, and should comply with requirements regarding accessibility, particularly for people with disabilities, and should be available in all EU official languages.
Amendment 522 #
2022/0066(COD)
Proposal for a directive
Recital 48 b (new)
Recital 48 b (new)
(48b) Member States should ensure that national helplines are operated under the EU-harmonised number [116016]. The EU harmonised telephone number shall be introduced in parallel with any other existing national number. Member States must use all the means available to them to widely advertise this number as a public number, free of charge and available round-the-clock. The helpline must be available to victims, their friends and family and also perpetrators of violence. The support provided should include crisis counselling and should be able to refer to face-to-face services, such as shelters, counselling centres or the police. Perpetrators of violence should be referred to a specialist service.
Amendment 523 #
2022/0066(COD)
Proposal for a directive
Recital 48 c (new)
Recital 48 c (new)
(48c) Member States should set up a national platform for individual monitoring and assessment of the risks faced by victims. The specialist support services and professionals likely to come into contact with victims, including law enforcement authorities, court staff, judges and prosecutors, providers of victim support services, healthcare professionals and social services, shall ensure that the data entered on the platform is of high quality. They shall create or update the file regularly and rapidly with all the elements relevant to the situation of the victim, the perpetrator of violence, any measure taken in compliance with Chapters 3 or 4 of this Directive and any information required that is of interest for the victim’s individual file. The platform shall make it possible to address the victim’s needs in a comprehensive and tailored manner and to establish the degree of risk faced, taking into account the data entered, along the lines of the VioGén system developed in Spain. Access by professionals to the file shall be confined to what is strictly necessary, in order to protect the victim’s privacy.
Amendment 546 #
2022/0066(COD)
Proposal for a directive
Recital 52
Recital 52
Amendment 555 #
2022/0066(COD)
Proposal for a directive
Recital 53
Recital 53
(53) Shelters and other appropriate interim accommodations play a vital role in protecting victims from acts of violence. Beyond providing a safe place to stay, sthey must be solely for women who are victims of domestic and sexual violence. Shelters and other appropriate interim accommodations must be geographically distributed in an appropriate manner, with one family place per 10 000 of population, as recommended by the final activity report of the Council of Europe’s Task Force to Combat Violence against Women, including Domestic Violence (EG-TFV (2008)6). Shelters should provide the necessary support concerning interlocking problems related to victims’ health, professional and financial situation and the well-being of their children, ultimately preparing victims for an autonomous life.
Amendment 564 #
2022/0066(COD)
Proposal for a directive
Recital 53 a (new)
Recital 53 a (new)
(53a) Women who are victims of domestic and sexual violence are at a heightened risk of femicide and retaliation. It is therefore necessary for shelters and interim accommodations to be places that are solely for such female victims and for their location to remain confidential, to ensure the women’s safety.
Amendment 565 #
2022/0066(COD)
Proposal for a directive
Recital 54
Recital 54
(54) To effectively address negative consequences for child victims, support measures to children should include and support them as well as possible, including during court proceedings, multidimensional support measures to children should include, in particular, support from professionals trained in listening to child victims, age- appropriate psychological counselling, legal support provided free of charge, together with paediatric care where necessary, and be provided as soon as competent authorities have reasonable grounds to believe that children might have been victims, including child witnesses of violence. Such measures should be made available on a long-term basis, in line with the victim’s needs. In the provision of support to child victims, the rights of the child, as laid down in Article 24 of the Charter, should be a primary consideration.
Amendment 574 #
2022/0066(COD)
Proposal for a directive
Recital 55
Recital 55
(55) Cases of domestic violence must be systematically taken into account, and the best interests of the child must take precedence, when deciding on custody rights and visiting rights in respect of children, in order not to compromise the rights or safety of victims and in order to avoid secondary and repeat victimisation. In order to ensure the safety of children during possible visits with an offender or suspect who is a holder of parental responsibility with rights of access, Member States should ensure that sufficient numbers of supervised neutral places that are adequately secure and separate from the home, including child protection or welfare offices, are made available so that such visits can take place there in the best interests of the child. If needed, the visits should take place in the presence of child protection or welfare officials. Where it is necessary to provide for interim accommodation, children should as a priority be accommodated together with the holder of parental responsibility who is not the offender or suspect, such as the child’s mother. The best interest of the child should be always taken into account.
Amendment 624 #
2022/0066(COD)
Proposal for a directive
Recital 60
Recital 60
(60) In order to ensure victims of violence against women and domestic violence are identified, are able to lodge complaints and receive appropriate support, Member States should ensure that professionals likely to come into contact with victims receive training and targeted information. Trainings should cover the risk and prevention of intimidation, repeat and secondary victimisation and the availability of protection and support measures for victims. To prevent and appropriately address instances of sexual harassment at work, persons with supervisory functions should also receive training. These trainings should also cover assessments regarding sexual harassment at work and associated psychosocial safety and health risks as referred to under Directive 89/391/EEC of the European Parliament and of the Council45. Training activities should also cover the risk of third party violence. Third party violence refers to violence which staff may suffer at the workplace, not at the hands of a co-worker, and includes cases, such as nurses sexually harassed by a patient. _________________ 45 Council Directive 89/391/EEC of the European Parliament and of the Council of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).
Amendment 667 #
2022/0066(COD)
Proposal for a directive
Article premier – paragraph 1 – point b
Article premier – paragraph 1 – point b
(b) the rights of victims of all forms of violence against women or domestic violence before, during or after criminal proceedings;
Amendment 773 #
2022/0066(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Member States shall ensure that a non-consensual act is understood as an act which is performed without the woman’s consent given voluntarily or where the woman is unable to form a free will due to her physical or mental condition, thereby exploiting her incapacity to form a free will, such as in a state of fear, intimidation, unconsciousness, intoxication, sleep, illness, bodily injury or disability.
Amendment 778 #
2022/0066(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Consent can be withdrawn at any moment during the act. The absence of consent cannot be refuted exclusively by the woman’s silence, verbal or physical non-resistance or past sexual conductConsent shall be assessed as of the time of the offence.
Amendment 785 #
2022/0066(COD)
Proposal for a directive
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. A woman’s silence, verbal or physical non-resistance, past sexual conduct, or existing or past relationship with the offender shall not be sufficient to prove her consent.
Amendment 787 #
2022/0066(COD)
Proposal for a directive
Article 5 a (new)
Article 5 a (new)
Article 5a Forced sterilisation 1. Member States shall ensure that the following intentional conduct is punishable as a criminal offence: (a) performing a procedure that has the purpose or effect of terminating a woman or girl’s ability to naturally reproduce without her prior and informed consent or understanding of the procedure; (b) coercing a woman or girl to undergo any procedure referred to in point (a). 2. Urgent and necessary medical procedures to save a woman's life are not considered to be offences under points (a) and (b) of paragraph 1.
Amendment 789 #
2022/0066(COD)
Proposal for a directive
Article 5 b (new)
Article 5 b (new)
Article 5b Forced abortion 1. Member States shall ensure that the following intentional conduct is punishable as a criminal offence: (a) performing a procedure that has the purpose or effect of terminating a woman or girl’s pregnancy without her prior and informed consent or understanding of the procedure; (b) coercing a woman or girl to undergo any procedure referred to in point (a). 2. Urgent and necessary medical procedures to save a woman's life are not considered to be offences under points (a) and (b) of paragraph 1.
Amendment 790 #
2022/0066(COD)
Proposal for a directive
Article 5 c (new)
Article 5 c (new)
Amendment 791 #
2022/0066(COD)
Proposal for a directive
Article 5 d (new)
Article 5 d (new)
Article 5d Forced marriage Member States shall ensure that the following intentional conduct is punishable as a criminal offence: (a) forcing an adult or child to enter into a marriage; (b) luring an adult or child to the territory of a state other than the one they reside in with the purpose of forcing them to enter into a marriage;
Amendment 796 #
2022/0066(COD)
Proposal for a directive
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) coercing, inciting or procuring a woman or a girl to undergo any of the acts referred to in point (a).
Amendment 822 #
2022/0066(COD)
Proposal for a directive
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) making intimate images, or videos or other material depicting sexualor evoking sexual or intimate activities, of another person without that person’s consent accessible to a multitude ofone or more end-users by means of information and communication technologies;
Amendment 833 #
2022/0066(COD)
Proposal for a directive
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) producing or manipulating and subsequently making accessible to a multitude ofone or more end-users, by means of information and communication technologies, images, videos or other material, making it appear as though another person is engaged in sexual activities or exposing themselves intimately, without that person’s consent;
Amendment 837 #
2022/0066(COD)
Proposal for a directive
Article 7 – paragraph 1 – point b a (new)
Article 7 – paragraph 1 – point b a (new)
(ba) sending to a woman or girl, by means of information and communication technologies, sexual or intimate images, videos or other material without the recipient's consent;
Amendment 849 #
2022/0066(COD)
Proposal for a directive
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
Amendment 859 #
2022/0066(COD)
Proposal for a directive
Article 8 – paragraph 1 – point c
Article 8 – paragraph 1 – point c
(c) making material containing the personal data of another person, without that person’s consent, accessible to a multitude ofone or more end-users, by means of information and communication technologies, for the purpose of inciting those end-users to cause physical or significant psychological harm to the person.
Amendment 865 #
2022/0066(COD)
(-a) persistently engaging in threatening or intimidating conduct directed at another person, by means of information and communication technologies, which causes that person to fear for their own safety or the safety of dependants;
Amendment 868 #
2022/0066(COD)
Proposal for a directive
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) initiating an attack alone or with third parties directed at another person, by making threatening or insulting material accessible to a multitude of end-users,one or more end-users and inciting them to share that material by means of information and communication technologies, with. This behaviour can have the effect of causing significant psychological or financial harm to the attacked person;
Amendment 875 #
2022/0066(COD)
Proposal for a directive
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
(b) participating alone or with third parties in attacks referred to in point (a).
Amendment 907 #
2022/0066(COD)
Proposal for a directive
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. 3a. Member States shall ensure that the criminal offences referred to in Article 5d are punishable by a maximum penalty of at least 3 years of imprisonment.
Amendment 909 #
2022/0066(COD)
Proposal for a directive
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Member States shall ensure that the criminal offence referred to in Article 6 iss 5a, 5b, 5c and 6 are punishable by a maximum penalty of at least 5 years of imprisonment and at least 7 years of imprisonment if the offence was committed under aggravating circumstances referred to in Article 13.
Amendment 943 #
2022/0066(COD)
Proposal for a directive
Article 13 – paragraph 1 – point j
Article 13 – paragraph 1 – point j
(j) the offender has previously been convicted of offences of the samea similar nature;
Amendment 947 #
2022/0066(COD)
Proposal for a directive
Article 13 – paragraph 1 – point o
Article 13 – paragraph 1 – point o
(o) the offence was committed by means of chemical submission, i.e. by causing the victim to take, use or be affected by drugs, alcohol or other intoxicating substances with or without their knowledge.
Amendment 952 #
2022/0066(COD)
Proposal for a directive
Article 13 – paragraph 1 – point o a (new)
Article 13 – paragraph 1 – point o a (new)
(oa) the offence brought profit or gain or had the intention of bringing profit or gain;
Amendment 956 #
2022/0066(COD)
Proposal for a directive
Article 13 – paragraph 1 – point o b (new)
Article 13 – paragraph 1 – point o b (new)
(ob) the offence was driven by a hostile attitude to the victim on the grounds of their race, skin colour, sexual orientation, religion, social origin, beliefs or political or any other opinion.
Amendment 965 #
2022/0066(COD)
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Member States shall take the necessary measures to provide for a limitation period for criminal offences referred to in Article 5 and 5d of at least 20 years from the time when the offence was committed.
Amendment 971 #
2022/0066(COD)
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Member States shall take the necessary measures to provide for a limitation period for criminal offences referred to in Articles 5a, 5b, 5c and 6 of at least 10 years from the time when the offence was committed.
Amendment 989 #
2022/0066(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. In addition to the rights of victims when making a complaint under Article 5 of Directive 2012/29/EU, Member States shall ensure that victims can report criminal offences of violence against women or domestic violence to the competent authorities in an easy and accessible manner with due regard for the victim’s privacy. This shall include the possibility of reporting criminal offences online or through other information and communication technologies, including the possibility to submit evidence, in particular concerning reporting of criminal offences of cyber violence.
Amendment 1004 #
2022/0066(COD)
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
3. Member States shall ensure that the confidentiality rules imposed by national law on relevant professionals, such as healthcare professionals, do not constitute an obstacle to their reporting to the competent authorities if they have reasonable grounds to believe that there is an imminent risk that serious physphysical or psychological harm will be inflicted on a person due to their being subject to any of the offences covered under this Directive. If the victim is a child, the relevant professionals shall be able to report to the competent authorities if they have reasonable grounds to believe that a serious act of violence covered under this Directive has been committed or further serious acts of violence are to be expected.
Amendment 1010 #
2022/0066(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Where children report criminal offences of violence against women or domestic violence, Member States shall ensure that the reporting procedures are safe, confidential, designed and accessible in a child-friendly manner and language, in accordance with their age and maturity. To safeguard the best interests of the child, Member States shall ensure that professionals specialised in caring for and supporting children are there to assist them in reporting procedures. If the offence involves the holder of parental responsibility, Member States should ensure reporting is not conditional upon this person’s consent.
Amendment 1040 #
2022/0066(COD)
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The competent authorities shall promptly refer victims to relevant health care professionals or support services referred to in Articles 27, 28 and 29 to assist in securing evidence, in particular in cases of sexual violence, where the victim wishes to bring charges and make use of such services.
Amendment 1047 #
2022/0066(COD)
Proposal for a directive
Article 17 – paragraph 5 a (new)
Article 17 – paragraph 5 a (new)
5a. Member States shall ensure that the offences listed in Chapter 2 are processed by legal professionals trained in accordance with Article 37 of this Directive or by a court specialised in combating violence against women and domestic violence if criminal proceedings have been brought.
Amendment 1053 #
2022/0066(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
1. In the framework of the individual assessment which is to be carried out under Article 22 of Directive 2012/29/EU, Member States shall ensure that, as regards victims covered by this Directive, the additional elements as set out in paragraphs 2 to 7 of this Article are assessed and integrated into the national platform for monitoring and individual and personalised assessment of the risks incurred by victims referred to in Article 35a.
Amendment 1074 #
2022/0066(COD)
Proposal for a directive
Article 18 – paragraph 5 – point c
Article 18 – paragraph 5 – point c
(c) further measures to protect the victim, such as requiring the offender to wear an electronic anti-approach bracelet or providing the victim with a serious danger phone, or any other measure to manage the offender or suspect’s behaviour, in particular under Article 38 of this Directive.
Amendment 1080 #
2022/0066(COD)
Proposal for a directive
Article 18 – paragraph 6
Article 18 – paragraph 6
6. The individual assessment shall be undertaken using the information contained in the victim’s personal file in accordance with Article 35a of this Directive and in collaboration with all relevant competent authorities depending on the stage of the proceedings, and relevant support services, such as victim protection centres and women’s shelters, social services and healthcare professionals.
Amendment 1085 #
2022/0066(COD)
Proposal for a directive
Article 18 – paragraph 7
Article 18 – paragraph 7
7. Competent authorities shall determine a level of risk for each victim. These authorities shall allocate a series of support and prevention measures based on the level of risk. The authorities shall reassess the victim’s situation at regular intervals. The higher the level of risk, the more regularly the situation shall be reassessed. These authorities shall update the individual assessment at regular intervals to ensure the protection measures relate to the victim’s current situation. This shall include an assessment of whether protection measures, in particular under Article 21, need to be adapted or taken.
Amendment 1125 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Member States shall ensure that, in situations of immediate danger for the victim’s or their dependant’s health or safety, the competent authorities issue orders addressed at an offender or suspect of violence covered by this Directive to vacate the residence of the victim or their dependants for a sufficient given period of time and to prohibit the offender or suspect from entering the residence or to enter the victim’sbeing within a certain distance of the victim, entering or being within a certain distance of the victim’s residence or workplace or contacting the victim or their dependants in any way. Such orders shall have immediate effect and not be dependent on a victim reporting the criminal offence and can be issued independently of the reporting of the criminal offence or the initiation of a prosecution by the victim.
Amendment 1133 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 2 a (new)
Article 21 – paragraph 2 a (new)
2a. Based on the individual assessment referred to in Article 18, the fitting of an anti-approach bracelet on the offender, the provision of a serious danger phone to the victim or any other mechanism may be implemented under paragraphs 1 and 2 of this Article.
Amendment 1138 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 2 b (new)
Article 21 – paragraph 2 b (new)
2b. Where the victim or their dependants are in immediate danger, Member States shall ensure that the competent authorities consider all measures to shelter victims and preserve evidence.
Amendment 1139 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 2 c (new)
Article 21 – paragraph 2 c (new)
2c. Where the offender is subject to detention, Member States shall ensure that the victim and the authorities concerned are informed of their release.
Amendment 1141 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 2 d (new)
Article 21 – paragraph 2 d (new)
Amendment 1147 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 5 a (new)
Article 21 – paragraph 5 a (new)
5a. 6. Where there is a risk of breach of an emergency barring, restraining or protection order or where there is a high risk to the victim, Member States shall ensure that sufficient protective measures are in place.
Amendment 1148 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 5 b (new)
Article 21 – paragraph 5 b (new)
5b. An emergency barring order may require the offender to leave their home, even if they own it, if it is shared with the victim.
Amendment 1161 #
2022/0066(COD)
Proposal for a directive
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) how to conduct the individual assessment under Articles 18 and 19 and to assess the level of risk to the victim and the measures to be applied;
Amendment 1165 #
2022/0066(COD)
Proposal for a directive
Article 23 – paragraph 1 – point b a (new)
Article 23 – paragraph 1 – point b a (new)
(ba) how to complete the individual file referred to in Article 35a;
Amendment 1226 #
2022/0066(COD)
Proposal for a directive
Article 25 a (new)
Article 25 a (new)
Article 25a Compensation granted by the authorities of the Member States Member States shall take all legislative or other measures to enable victims to seek compensation from State authorities where those authorities have failed to apply the necessary preventive or protective measures within their powers.
Amendment 1227 #
2022/0066(COD)
Proposal for a directive
Article 25 b (new)
Article 25 b (new)
Article 25b Civil consequences of forced marriage Parties shall take the necessary legislative or other measures to ensure that forced marriages may be voidable, annulled or dissolved without undue financial or administrative burden placed on the victim.
Amendment 1256 #
2022/0066(COD)
Proposal for a directive
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
(a) advice and information on any relevant legal or practical matters arising as a result of the crime, including on access to financial assistance, housing, education, training and assistance to remain in or find employment;
Amendment 1300 #
2022/0066(COD)
Proposal for a directive
Article 27 – paragraph 7
Article 27 – paragraph 7
7. Member States shall ensure that specialist support services are available to victims before, during and for an appropriate time after criminal proceedings, regardless of their willingness to prosecute offenders.
Amendment 1309 #
2022/0066(COD)
Proposal for a directive
Article 27 a (new)
Article 27 a (new)
Article 27a Financial assistance for women victims of domestic violence or forced marriage 1. Member States shall ensure that any victim of domestic violence or forced marriage can, if necessary, receive financial assistance. 2. This financial assistance should be calculated based on the victim’s income, number of dependants and level of disability. 3. This financial assistance may take the form of an interest-free loan or a donation without repayment.
Amendment 1351 #
2022/0066(COD)
Proposal for a directive
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
2. Member States shall ensure that sufficient measures are in place to prevent and detect situations of sexual violence and harassment at work, in particular through awareness-raising and training programmes in the workplace.
Amendment 1355 #
2022/0066(COD)
Article 30a Specialist support for victims to promote their integration through work 1. Member States shall ensure that employers make temporary adjustments to victims’ employment contracts. 2. Member States shall foster the establishment of a national programme to link employers with civil society organisations – including non- governmental organisations – dealing with women victims of violence, in order to develop partnerships to promote the recruitment of victims.
Amendment 1361 #
2022/0066(COD)
Proposal for a directive
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Member States shall set up state- wide round-the-clock (24/7) telephone helplines, free of charge, to provide advice for women victims of violence against women and domestic violence. Advice shall be provided by qualified individuals confidentially or with due regard for their anonymity. Member States shall ensure the provision of such service also through other information and communication technologies, including online applications providing all national emergency numbers and describing other support mechanisms existing in each Member State.
Amendment 1368 #
2022/0066(COD)
Proposal for a directive
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Member States shall take appropriate measures to ensure the accessibility of services referred to in paragraph 1 for end-users with disabilities, including providing support in easy to understand language and in all the official languages of the EU. Those services shall be accessible in line with the accessibility requirements for electronic communications services set in Annex I to Directive 2019/882/EU of the European Parliament and of the Council52. _________________ 52 Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services, OJ L 151, 7.6.2019, p. 70–115.
Amendment 1369 #
2022/0066(COD)
Proposal for a directive
Article 31 – paragraph 4
Article 31 – paragraph 4
4. [Member States shall ensure that the service under paragraph 1 for women who are victims of violence against womennd domestic violence is operated under the harmonised number at EU level “116 016” and that the end-users are adequately informed of the existence and use of such number via large-scale communication campaigns in each Member State. The EU harmonised telephone number shall be introduced in parallel with any other existing national number, where appropriate.]
Amendment 1379 #
2022/0066(COD)
Proposal for a directive
Article 32 – paragraph 1 a (new)
Article 32 – paragraph 1 a (new)
1a. The shelters and other appropriate interim accommodations shall be specifically for women who are victims of violence and domestic violence. Their location shall be confidential.
Amendment 1390 #
2022/0066(COD)
Proposal for a directive
Article 32 – paragraph 4 a (new)
Article 32 – paragraph 4 a (new)
4a. appropriate interim accommodations.5. The shelters and other appropriate interim accommodations must be geographically distributed in an appropriate manner, with one family place per 10 000 residents.
Amendment 1393 #
2022/0066(COD)
Proposal for a directive
Article 33 – paragraph 1
Article 33 – paragraph 1
1. Member States shall ensure that children are provided specific adequate support as soon as the competent authorities have reasonable grounds to believe that the children might have been subject to, including having witnessed, violence against women or domestic violence. Such support must be offered free of charge and on a long-term basis. Support to children shall be specialised, fast and age-appropriate, respecting the best interests of the child. in accordance with the Charter of Fundamental Rights of the European Union and the United Nations Convention on the Rights of the Child.
Amendment 1398 #
2022/0066(COD)
Proposal for a directive
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Child victims shall be provided with age-appropriate medical care, emotional, psychosocial, psychological and educational support, as well as any other appropriate support tailored in particular to situations of domestic violence. Child victims must also have access, if necessary, to legal support that is free of charge.
Amendment 1402 #
2022/0066(COD)
Proposal for a directive
Article 33 – paragraph 3
Article 33 – paragraph 3
3. Where it is necessary to provide for interim accommodation, children shall as a priority be placed together with other family members, in particular with a non- violent parent in permanent or temporary housing, equipped with support services and tailored to the specific needs of the victims. Placement in shelters shall be a last resort.
Amendment 1405 #
2022/0066(COD)
Proposal for a directive
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3a. Member States shall ensure that experts and associations involved in supporting victims, that specialise in the care of and support for children, operate in accordance with their respective spheres of competence. The relevant actors must take action in a coordinated manner and cooperation between the different support services must be facilitated. The best possible conditions must be ensured for confidentially gathering children’s reports of their experience, where applicable. Specific protocols and systematic procedures for monitoring child victims should be put in place on a long-term basis, and these must seek to avoid causing any trauma to the children.
Amendment 1412 #
2022/0066(COD)
Proposal for a directive
Article 34 – paragraph 1
Article 34 – paragraph 1
Member States shall establish and maintain safe placesufficient numbers of safe places that are adequately secure and separate from the home, which allow a safe contact between a child and a holder of parental responsibilities who is an offender or suspect of violence against women or domestic violence, to the extent that the latter has rights of access. Member States shall ensure supervision by trained professionals, as appropriate, and in the best interests of the child. Domestic violence incidents must be systematically taken into account, in the best interests of the child, when determining custody rights and visiting rights in respect of children, in order not to compromise the rights or safety of victims and in order to avoid secondary and repeat victimisation.
Amendment 1428 #
2022/0066(COD)
Proposal for a directive
Article 35 a (new)
Article 35 a (new)
Article 35a Establishment of a national platform for monitoring and for individual and personalised assessment of the risks faced by victims 1. Member States shall establish a national digital platform for monitoring and assessing the risks faced by victims. 2. That digital platform shall allow an individual and personalised file to be set up for each victim. 3. Professionals likely to come into contact with victims shall set up or update those files. They shall include, in particular, relevant details relating to: (a) the victims’ situation ; (b) the perpetrators of the violence; (c) any measures taken in accordance with Chapters 3 and 4 of this Directive; (d) any necessary information relevant to the victims’ personal files. 4. The platform shall be accessible only to professionals likely to come into contact with victims, including law enforcement authorities, court staff, judges and prosecutors, lawyers, providers of victim support, healthcare professionals, and social services. 5. Professionals likely to come into contact with victims shall work together in order to ensure comprehensive and tailored care for them. 6. Professionals' access to files shall be limited to what is strictly necessary to protect victims’ private life.
Amendment 1461 #
2022/0066(COD)
Proposal for a directive
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Preventive measures shall include awareness-raising campaigns, which also include full information about the impact of such violence on children, research and education programmes, where appropriate developed in cooperation with relevant civil society organisations, social partners, impacted communities and other stakeholders.
Amendment 1507 #
2022/0066(COD)
Proposal for a directive
Article 37 – paragraph 1
Article 37 – paragraph 1
1. Member States shall ensure that professionals likely to come into contact with victims, including law enforcement authorities, court staff, judges and prosecutors, lawyers, providers of victim support and restorative justice services, healthcare professionals, social services, educational and other relevant staff, receive both general and specialist training and targeted information to a level appropriate to their contacts with victims, to enable them to identify, as quickly as possible, prevent and address instances of violence against women or domestic violence and to treat victims in a trauma-, gender-, language-, disability- and child- sensitive manner. This initial and ongoing training should include, among other subjects, information on the short- and long-term impact of such violence on children, their rights, the existing protection measures and clear guidance on the procedures to be taken, prioritising the well-being of the child.
Amendment 1520 #
2022/0066(COD)
Proposal for a directive
Article 37 – paragraph 2
Article 37 – paragraph 2
2. Relevant health professionals, including paediatricians, general practitioners, school nurses, gynaecologists and midwives, shall receive targeted training to identify and address, in a cultural-sensitive manner, the physical, psychological and sexual consequences of female genital mutilationthe offences listed in Chapter 2 of this Directive.
Amendment 1586 #
2022/0066(COD)
Proposal for a directive
Article 41 – paragraph 1 a (new)
Article 41 – paragraph 1 a (new)
This initial and ongoing training should include, among other subjects, information on the short- and long-term impact of such violence on children, their rights, the existing protection measures and clear guidance on the procedures to be taken, prioritising the well-being of the child.
Amendment 1598 #
2022/0066(COD)
Proposal for a directive
Article 43 – paragraph 1 – point c a (new)
Article 43 – paragraph 1 – point c a (new)
(ca) providing consular protection to European citizens who are victims of the offences referred to in this Directive in the territory of a third state.
Amendment 1612 #
2022/0066(COD)
Proposal for a directive
Article 44 – paragraph 2 – point a
Article 44 – paragraph 2 – point a
(a) the number of victims who experienced violence against women or domestic violence during the last 12 months, last five years and lifetime, with an indication of whether those women belonged to one of the at-risk groups identified in Article 35(1) of this Directive;
Amendment 1615 #
2022/0066(COD)
Proposal for a directive
Article 44 – paragraph 2 – point a a (new)
Article 44 – paragraph 2 – point a a (new)
(aa) the type of violence experienced;
Amendment 1616 #
2022/0066(COD)
Proposal for a directive
Article 44 – paragraph 2 – point a b (new)
Article 44 – paragraph 2 – point a b (new)
(ab) the number of women who have lodged a complaint following acts of violence or domestic violence during the last 12 months;
Amendment 1617 #
2022/0066(COD)
Proposal for a directive
Article 44 – paragraph 2 – point a c (new)
Article 44 – paragraph 2 – point a c (new)
(ac) the outcome of the complaint;
Amendment 1618 #
2022/0066(COD)
Proposal for a directive
Article 44 – paragraph 2 – point a d (new)
Article 44 – paragraph 2 – point a d (new)
(ad) the number of women who have died because of their sex or gender;
Amendment 7 #
2021/2229(INL)
Recital C
Amendment 12 #
2021/2229(INL)
Recital D
Amendment 16 #
2021/2229(INL)
Recital E
Amendment 26 #
2021/2229(INL)
Paragraph 4
Amendment 44 #
2021/2229(INL)
Annex to the motion for a legislative resolution
Recital 4
Amendment 50 #
2021/2229(INL)
Annex to the motion for a legislative resolution
resolution 1. The number of representatives in the European Parliament elected in each Member State for the 2024-2029 parliamentary term is set as follows: Belgium 213 Bulgaria 17 Czech Republic 21 Denmark 15 Germany 96 Estonia 78 Ireland 145 Greece 21 Spain 61 France 7981 Croatia 12 Italy 76 Cyprus 6 Latvia 9 Lithuania 11 Luxembourg 6 Hungary 21 Malta 6 Netherlands 31 Austria 20 Poland 523 Portugal 21 Romania 33 Slovenia 9 Slovakia 15 Finland 15 Sweden 21
Amendment 59 #
2021/2229(INL)
Annex to the motion for a legislative resolution
Article 3 – paragraph 2
Amendment 1 #
2021/2180(INI)
Motion for a resolution
Citation 1
Citation 1
— having regard to the Treaty on European Union (TEU), and in particular Article 2, Article 3(1), Article 3(3), second subparagraph, Article 4(3) and Articles 5, 6, 7, 11 and 419 thereof,
Amendment 2 #
2021/2180(INI)
Motion for a resolution
Citation 2
Citation 2
— having regard to the Treaty on the Functioning of the European Union (TFEU), and in particular the articles thereof relating to respect for and the protection and promotion of democracy, the rule of law and fundamental rights in the Union, including Articles 70, 258, 259, 260, 263, 265 and 2657,
Amendment 13 #
2021/2180(INI)
Draft opinion
Paragraph 3
Paragraph 3
Amendment 26 #
2021/2180(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls for the inclusion of an overview per Member State of all enforcement actions undertaken by the Commission, including pending infringement proceedings, pending actions for failure to fulfil obligations, as well as the state of compliance with Court of Justice of the European Union and European Court of Human Rights provisional measures and rulings, feeding into a comprehensive Application of EU Law Scoreboard;
Amendment 29 #
2021/2180(INI)
Draft opinion
Paragraph 5
Paragraph 5
Amendment 38 #
2021/2180(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes Commission proposals to include country-specific recommendations as of 2022, as per Parliament’s resolution of 25 October 2016; calls on the Commission to monitor and reporinclude an assessment onf their implementation in the following year's annual report;
Amendment 44 #
2021/2180(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to link the Rule of Law Report and its recommendations to the instruments ensuring the application of EU law, such as infringement proceedings, preliminary ruling proceedings, Article 7 TEU procedures, and the Rule of Law Conditionality Regulation;
Amendment 46 #
2021/2180(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the EU institutions to read the annual reports on the rule of law in the light of the reports on fundamental rights published by the European Agency of Fundamental Rights, given the close connection between democracy, the rule of law and fundamental rights.
Amendment 46 #
2021/2180(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the Union is founded on the common values enshrined in Article 2 TEU of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities (Article 2 TEU values) – values that are common to the EU Member States and to which candidate countries must adhere in order to join the Union; whereas democracy, the rule of law and fundamental rights are mutually reinforcing values which, when undermined, may pose a systemic threat to the Union; whereas the Union as a whole, its Member States and their subnational entities are bound by the rule of law;
Amendment 49 #
2021/2180(INI)
Draft opinion
Paragraph 8
Paragraph 8
Amendment 62 #
2021/2180(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls on the Council to discuss the report in all transparency and engage in dialogue with the European Parliament; calls on the European Council, too, to discuss the findings of the report, as the values ofupholding the rule of law as set out in Article 2 TEU areis a matter to be addressed at the highest political level.
Amendment 62 #
2021/2180(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the annual rule of law review cycle is a welcome addition to the tools available to preserve the Article 2 TEU values by addressing the situation in all EU Member States in a report based on four pillars with a direct bearing on respect for the rule of law;
Amendment 87 #
2021/2180(INI)
Motion for a resolution
Recital D
Recital D
D. whereas it is necessary to strengthen and streamline existing mechanisms and to develop an effective EU mechanism onto protect democracy, the rule of law and fundamental rights effectively and to ensure that Article 2 TEU values are upheld throughout the Union;
Amendment 96 #
2021/2180(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the Member States introduced emergency measures to respond to the COVID-19 pandemic;
Amendment 123 #
2021/2180(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the fact that the functioning of justice systems, the anti- corruption framework, media pluralism and certain institutional issues related to checks and balances, including civic space to a certain extent, are all part of the Commission’s annual report; regrets, however, that not all rule of law issues were covered in sufficient detail in the 2021 report; calls for the inclusion in the annual report of other important elements of the Venice Commission’s 2016 Rule of Law Checklist; believes that civic space deserves a separate subheading in the report; welcomes the Commission’s analysis of political pressure and influence on the media; calls on the Commission to provide clearer illustrations of systematic disinformation and foreign interference campaigns aimed at reducing public trust in state institutions and independent media;
Amendment 165 #
2021/2180(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 180 #
2021/2180(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Regrets the fact that several Member States, in particular Hungary and Poland, had to be mentioned several times by the Commission as points of concern in the synthesis report and that no tangible improvements have been made since; recalls that since June 2021 Parliament has also addressed the rule of law situation in Hungary, Poland and Slovenia in its plenary resolutions; further recalls that Parliament’s Committee on Civil Liberties, Justice and Home Affairs’ Democracy, Rule of Law and Fundamental Rights Monitoring Group has also addressed similar issues in Bulgaria, Greece, Malta, Slovakia and Slovenia;
Amendment 195 #
2021/2180(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Considers that the annual report should identify cross-cutting trends at EU level; asks the Commission to identify instances where certain measures or practices that undermine the rule of law in one Member State become blueprints for others, or when the gravity and scope of such deficiencies have the potential to affect and to watch out in particular for the risk that others follow suit; calls on the Commission, furthermore, to highlight the negative effect that breaches of the rule of law can have on the Union as a whole;
Amendment 221 #
2021/2180(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 231 #
2021/2180(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on the EU institutions to read the annual reports on the rule of law in the light of the reports on fundamental rights published by the European Agency of Fundamental Rights, given the close connection between democracy, the rule of law and fundamental rights;
Amendment 234 #
2021/2180(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Welcomes the fact that the report includes a section on the impact of the COVID-19 pandemic on the rule of law; urges the Commission to assess in due course whether the measures taken by Member States were indeed time-limited, necessary and proportionate, while observing checks and balances;
Amendment 242 #
2021/2180(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Underlines its concern at the fact that women and people in vulnerable situations, including persons with disabilities, children, religious minorities, particularly at a time of rising antisemitism and anti-Muslim hatred in Europe, Romani people and other persons belonging to ethnic and linguistic minorities, migrants, asylum seekers, refugees, LGBTI+ persons and elderly people, continue to see their rights not being fully respected across the Union; emphasises the obvious link between deteriorating rule of law standards and violations of fundamental rights and minority rights;
Amendment 309 #
2021/2180(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
Amendment 315 #
2021/2180(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 326 #
2021/2180(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to explore the full potential of developing the FRA in accordance with principles relating to the status and functioning of national institutions for the protection and promotion of human rights (the Paris Principles) in order for it to become a fully independent body providing impartial and publicly available positions on country- specific situations in the field of democracy, the rule of law and fundamental rights; underlines that such development should go hand in hand with an increase in available resources;
Amendment 337 #
2021/2180(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Reiterates that the annual report should serve as a basis formust be fit to serve as a reference for the institutions when they are deciding whether to activate one or several relevant tools such as Article 7 TEU, the Rule of Law Conditionality Regulation, the Rule of Law Framework or infringement procedures, including expedited procedures, applications for interim measures before the CJEU and actions regarding non-implementation of CJEU judgments; calls on the institutions to activate such tools without delay;
Amendment 347 #
2021/2180(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Recalls that infringement procedures are the core instrument to protect and defend EU law and the common values enshrined in Article 2 TEU; notes with concern that the number of infringement procedures launched by the Commission has plummeted since 2004; is surprised by the fact that infringement procedures are not triggered systematically as soon as the relevant infringement is documented in the annual report; deplores the Commission’s reluctance to exhaust the possibilities of infringement procedures against Member States as the instrument most tailored to resolve the issues efficiently and without delay; notes that this reluctance resulted in calls on Member States to initiate inter-State cases in accordance with Article 259 TFEU; is concerned that without systematic and timely application the preventive capacity of infringement procedures declinesdeplores the fact that the decision to launch an infringement procedure is not based on purely legal analysis; calls on the Commission to take action in all circumstances, not only when prosecution suits its political agenda;
Amendment 351 #
2021/2180(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Recalls the importance of the preliminary rulings on the rule of law; takes the view that the relevant case-law of the CJEU helped define the rule of law; calls on the Commission to base its analysis on these definitions;
Amendment 376 #
2021/2180(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the Commission to closely monitor the rulings of national courts regarding the primacy of EU law over national legislation and in particular the incompatibility of certain articles of the Treaties with national constitutions; urges the Commission to ensure immediate and adequate responses to refusals to implement and respect CJEU rulings;
Amendment 15 #
2021/2166(INI)
Draft opinion
Paragraph 3a (new)
Paragraph 3a (new)
3a (new) Calls on the institutions to take all necessary measures to ensure the participation of vulnerable people such as disabled people and children in the EU decision-making process; highlights the need for a better access to information for these citizens;
Amendment 18 #
2021/2166(INI)
Draft opinion
Paragraph 3b (new)
Paragraph 3b (new)
3b (new) Highlights the need for the European Parliament to have an oral or written translation at each stage of the legislative process and in all official languages of the EU;
Amendment 58 #
2021/2166(INI)
Draft opinion
Paragraph 9a (new)
Paragraph 9a (new)
9a (new) Considers that when the Treaties are to be revised, the European Parliament as the only directly elected institution should be granted the right of legislative initiative;
Amendment 69 #
2021/2166(INI)
Draft opinion
Paragraph 10a (new)
Paragraph 10a (new)
10a (new) Calls more generally on the Commission, the Council and the European Parliament to implement the Citizens Panels’ recommendations in accordance with the principle of conferral as laid down in Article 5 TEU;
Amendment 10 #
2021/2132(DEC)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Recommends, in particular, that sufficient additional resources be allocated to the EMA to improve its competence in the fight against medicine shortages. Invites the European Commission to evaluate in detail the feasibility of granting the EMA additional capacity to manage shortages, incorporating the desirable future transformation of the European Shortages Monitoring Platform into a proper and effective common European database;
Amendment 23 #
2021/2106(DEC)
Draft opinion
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Regrets that the new European Health Emergency Preparedness and Response Authority (HERA) is ultimately just an agency of the European Commission. Calls on the European Commission to be as transparent as possible in its management of this new authority and to allow the European Parliament full exercise of its budgetary control powers;
Amendment 9 #
2021/2046(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas daily traffic jams, particularly in cross-border areas, hamper freedom of movement and the well-being of people in Europe and cause greenhouse gas emissions that would be prevented if the trans-European transport networks (TEN-Ts) were improved and if national public transport networks were more interconnected;
Amendment 21 #
2021/2046(INI)
Draft opinion
Recital A b (new)
Recital A b (new)
Amendment 50 #
2021/2046(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Takes note of the Commission’s communication entitled ‘Sustainable and Smart Mobility Strategy – putting European transport on track for the future’ and points out shortcomings that need to be overcome; stresses that the sector’s potential to reduce its emissions is greatly dependent on investment in environmentally sustainable public transport systems, – particularly in cross- border areas that are often insufficiently equipped owing to a lack of interconnection between public transport networks – which must give rise to a paradigm shift in mobility, which is overly focused on individual transport;
Amendment 113 #
2021/2046(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Takes the view that a sustainable mobility strategy must encompass all methods of transport, increasing the modal share of the most sustainable means of transport, as well as the different levels of travel – local, regional, national and international – and should be inextricably linked to suitable spatial planning and land use; underlines the particular challenges of mobility in urban and cross-border areas and advocates a public transport pricing policy that incentivises greater use thereof;
Amendment 183 #
2021/2046(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to consider all sustainable and renewable technologies that have the potential to reduce greenhouse gas emissions in the transport sector and to bear in mind how important it is for transport to remain affordable for the people of Europe;
Amendment 40 #
2021/2035(INL)
Motion for a resolution
Citation 15 a (new)
Citation 15 a (new)
– having regard to the LGBTIQ Equality Strategy 2020-2025 of 12 November 2020,
Amendment 44 #
2021/2035(INL)
Motion for a resolution
Citation 15 b (new)
Citation 15 b (new)
– having regard to the EU Strategy on victims’ rights (2020-2025),
Amendment 47 #
2021/2035(INL)
Motion for a resolution
Citation 15 c (new)
Citation 15 c (new)
– having regard to the UN brief ‘COVID-19 and Ending Violence Against Women and Girls’, 20201a _________________ 1a https://www.unwomen.org/- /media/headquarters/attachments/sections /library/publications/2020/issue-brief- covid-19-and-ending-violence-against- women-and-girls-en.pdf?la=en&vs=5006
Amendment 50 #
2021/2035(INL)
Motion for a resolution
Citation 15 d (new)
Citation 15 d (new)
– having regard to the legal opinion of the advocate general of the European Court of Justice on the Istanbul Convention, aimed at clarifying the legal uncertainty about if and how the EU can access and ratify the Convention, delivered on March 11, 20211a, _________________ 1a https://curia.europa.eu/juris/document/do cument.jsf?docid=238745&doclang=en
Amendment 67 #
2021/2035(INL)
Motion for a resolution
Recital C
Recital C
C. whereas gender-based violence is violence directed against women because they are women andor it affects women disproportionately; whereas LGBTI persons are also victims of gender-based violence because of their gender, gender identity, gender expression and sex characteristics; whereas gender-based violence is rooted in gender stereotypes, patriarchal structures and power asymmetriremains one of our societies’ biggest challenges and is deeply rooted in gender inequality and gender stereotypes;
Amendment 98 #
2021/2035(INL)
Motion for a resolution
Recital E
Recital E
E. whereas there is a lack of updated, comprehensive and comparable disaggregated data on all forms of gender- based violence across the Member States;
Amendment 122 #
2021/2035(INL)
Motion for a resolution
Recital F b (new)
Recital F b (new)
Fb. whereas the Council of Europe Convention on preventing and combating violence against women and domestic violence (the ‘Istanbul Convention’) has been signed by all Member States and ratified by 21; whereas disinformation campaigns to undermine gender equality also block progress on the issue of eliminating violence against women, as has been seen in relation to the Istanbul Convention, leading to public opposition and regrettable political decisions in some Member States;
Amendment 124 #
2021/2035(INL)
Motion for a resolution
Recital F d (new)
Recital F d (new)
Fd. whereas gender-based violence is a huge and structural problem in our society, affecting a significant part of the European population, with EU surveys showing that one in three women has experienced sexual and/or physical violence during her life, and one in two women (55%) has experienced sexual harassment1a; _________________ 1aEuropean Union Agency for Fundamental Rights entitled ‘Violence against women: an EU-wide survey’, published in 2014
Amendment 125 #
2021/2035(INL)
Motion for a resolution
Recital F e (new)
Recital F e (new)
Fe. whereas the COVID-19 pandemic has resulted in an increase in domestic violence across Member States, with women and girls, children and LGBTI+ persons shown to be disproportionately impacted by this form of violence, as they can be exposed to abusers for long periods of time and can be cut off from social and institutional support; whereas community support for these vulnerable groups has been dramatically restricted given the measures taken in response to the pandemic;
Amendment 128 #
2021/2035(INL)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Condemns all forms of violence against women and girls and other forms of gender-based violence, such as violence against LGBTI persons, and deplores the fact that women and girls continue to be exposed to psychological, physical, sexual and economic violence, including sexual exploitation and trafficking in human beings, both online and offline online and offline, which is considered to refer to different acts of violence that result in, or are likely to result in, physical, sexual or psychological harm or suffering and which common feature is that they are directed against a person because of that person’s gender or that affects them disproportionately;
Amendment 136 #
2021/2035(INL)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Recalls that “violence against women” is understood as a violation of human rights and a form of discrimination against women and shall mean all acts of gender-based violence that result in, or are likely to result in, physical, sexual, psychological or economic harm or suffering to women, including threats of such acts, coercion or arbitrary deprivation of liberty, whether occurring in public or in private life;
Amendment 137 #
2021/2035(INL)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Recalls that “domestic violence” shall mean all acts of physical, sexual, psychological or economic violence that occur within the family or domestic unit or between former or current spouses or partners, whether or not the perpetrator shares or has shared the same residence with the victim; emphasises that the COVID-19 pandemic has highlighted the volume of gender-based violence experienced by women and girls across the EU, particularly in the form of domestic violence, resulting in an overwhelming need for support services for these victims;
Amendment 143 #
2021/2035(INL)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Denounces femicide as the more extreme form of gender-based violence against women and girls and; stresses that femicide is a very severe violation of human rights and that the EU should draw up a plan to combat this social phenomenon in order to prevent violence, detect issues, and support and protect victims;
Amendment 150 #
2021/2035(INL)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that violence against women and other forms of gender-based violence are the result of the unequal distribution of power, patriarchal structures, and gender stereotypes, that have led to domination over and discrimination against women by men; underlindeeply rooted in structural inequalities in our society and are still shrouded in silence and continue to be one of the most severe violations of human rights; gender-based violence remains widespread and it has a huge impact on victims, their families, and communities; that thise situation is aggravated by social and economic inequalitiefurther exacerbated by gender biases, stereotypes and the continuous manifestation of historically unequal power relations;
Amendment 173 #
2021/2035(INL)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Underlines the wide range of psychological impacts that gender-based violence has on victims, including stress, concentration problems, anxiety, panic attacks, low self-esteem, depression, post- traumatic stress disorder, lack of trust and of sense of control; recalls that gender- based violence also has a social and economic impact; underlines that the mental health impacts can include severe social consequences for the victims regarding, among others, their participation in the society, resulting in their inability to engage as a productive member of a society or fully exercise their rights as EU citizens, and highlights that provision of mental health services for victims of those crimes is often provided as well by NGOs and civil society actors;
Amendment 180 #
2021/2035(INL)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Highlights the detrimental economic impacts that gender-based violence and the subsequent mental health issues it causes, can have on victims, including their ability to seek employment and the financial burden imposed on them by taking legal action; taking into account therefore the estimated annual societal costs of gender- based violence (290 billion) exceeding the estimated annual costs of particularly serious crimes listed under art 83(1)1a; _________________ 1aEPRS interim European Added Values Assessment (EAVA) on gender-based violence, p.35
Amendment 194 #
2021/2035(INL)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Denounces the fact that the combat against gender-based violence is negatively affected by the attack on women’s rights and gender equality; condemns the actions of anti-gender and anti-women movements in Europe and worldwide that aim to overturn existing laws on women’s rights and LGBTI+ rightsFirmly believes that the EU must make combating gender-based violence in all its forms a policy priority; denounces all movements that undermine this goal;
Amendment 208 #
2021/2035(INL)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Insists on actions to prevent gender- based violence by addressing the underlying causes, including counteracting sexism, gender stereotypes and patriarchal values of gender inequality; underlines the need for gender equality to have a central place in education which challenges gender stereotypes and supports the development of non-violent relationships, and the need for an EU-wide awareness-raising campaigns on gender stereotypes, which includes information targeted at educating our younger citizens about gender equality;
Amendment 232 #
2021/2035(INL)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Commission and the Member States to improve the regular availability and comparability of quality, disaggregated data on all forms of gender- based violence at EU and national level and for the harmonisation of data collection systems among Member States, through cooperation with Eurostat, the European Union Agency for Fundamental Rights and the European Institute for Gender Equality; believes that quality data will be essential for clear and measurable targets in the elimination of gender-based violence;
Amendment 238 #
2021/2035(INL)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the need for targeted policies to address the situation of survivorsvictims of gender-based violence who experience intersectional forms of discrimination, such as women refugees, asylum seekers and migrants, indigenous women, racialised women, women from religious and ethnic minorities, lesbian, bisexual and trans women, elderly women and women wibased on several personal characteristics such as race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth, sexual orientation, gender identity, age, state of health, disabilitiey, marital status, migrant or refugee status, or other status;
Amendment 248 #
2021/2035(INL)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Is deeply worried about the nature, extent and gravity of gender-based violence and harassment in the workplaces; welcomes in this regard the recently adopted ILO Convention 190 on violence and harassment in the world of work and calls on the Member States to ratify and implement it without delay; calls also on the Commission and the Member States to adequately complete the existing framework for effective measures to prohibit violence and harassment in the workplace, as well as preventive measures, effective access to gender- responsive, safe and effective complaint and dispute resolution mechanisms, training and awareness-raising campaigns, psychological support services and remedies;
Amendment 252 #
2021/2035(INL)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Recalls that violationEncourages the Commission to promote regular exchanges of good practices between member states and stakeholders ofn sexual and reproductive rights are a form of violence against women and girlshealth rights, within its proposals for additional measures to prevent and combat forms of gender-based violence;
Amendment 274 #
2021/2035(INL)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Notes that the Commission must address the particular situation of migrant women’s protection againstmigrant women are particularly vulnerable to gender-based violence, and; recalls that under Directive 2012/29/EU of the European Parliament and of the Council6 access toall victims of gender- based violence deserve to receive appropriate protecinformation, support services and effective remedies must be available to all victims of gender-based violence, independent ofand protection and are able to participate in criminal proceedings, and that all rights must apply in a non-discriminatory manner, including with respect to their residence status5a; _________________ 65aas set out in Directive 2012/29/EU of the European Parliament and of the Council of 25 October 2012 establishing minimum standards on the rights, support and protection of victims of crime, and replacing Council Framework Decision 2001/220/JHA (OJ L 315, 14.11.2012, p. 57).
Amendment 287 #
2021/2035(INL)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on Member States to take all necessary measures to promote and ensure the protection of women and girls in all their diversity and all survivorvictims of gender- based violence against all forms of violence;
Amendment 293 #
2021/2035(INL)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Underlines the obligation on Member States to ensure that there is support and services for survivorvictims of gender- based violence; recalls the importance, in that context, of support to independent civil society and women’s shelter organisations in particular with regards to the provision of essential psychological and legal consultation supports;
Amendment 312 #
2021/2035(INL)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Member States to improve the resources and training of practitioners, law enforcement officers and all professionals dealing with victims of gender-based violence; calls on Members States to ensure that victims have the right to state-funded legal aid before and during legal proceedings;
Amendment 322 #
2021/2035(INL)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Stresses that gender-based violence is a particularly serious crime and a widespread violation of fundamental rights in the Union which needs to be addressed with greater efficiency and determination on a common basis; stresses that gender-based violence is the result of a patriarchal society that has a cross-border dimension; points, in particular, at the growing anti- gender and anti-women movements, which are well organised and have a cross-border naturewith profound impact on individual fundamental rights and freedoms as well as on the population which needs to be addressed with greater efficiency and determination; stresses the cross-border dimension of gender-based violence, directly stemming from the impact of this offence across the Member States, as well as from the need of a common action at EU level; considers that the great individual, economic and societal impacts across all Member States, taking into account the estimation of the societal cost of 290 billion euros of gender-based violence, reaffirms the need to combat gender-based violence in its multiple dimensions on a common EU basis;
Amendment 336 #
2021/2035(INL)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Strongly advocates for all EU Member States and for the EU to ratify the Istanbul Convention; regrets that six Member States have yet to do so; emphasises that both an EU-wide accession to this Convention together with the parallel recognition of gender-based violence under the TFEU are needed in order to adequately address the problem;
Amendment 347 #
2021/2035(INL)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses that the special need to combat violence against women and girls and other forms of gender-based violence on a common basis also results from the need to establish minimum rules concerning the definition of criminal offences and sanctions, thus contributing to law enforcement in cross border operations;
Amendment 364 #
2021/2035(INL)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to propose a directive on gender-based violence that implements the standards of the Istanbul Convention and includes the following elements: prevention, including through gender-sensitive education programming directed at both girls and boys, and empowerment of women and girls; support services and protection measures for survivorvictims; combating all forms of gender-based violence, including violations of women’s sexual and reproductive health and rights; and minimum standards for law enforcement; and minimum standards for law enforcement, cooperation among Member States and the exchange of best practices, information and expertise; stresses that this new directive shall be complementary to existing and upcoming legislative and non-legislative measures in order to achieve a coherent EU action in gender equality, as well as an eventual ratification of the Istanbul Convention; believes that the implementation of these measures could be facilitated by the national equality bodies;
Amendment 373 #
2021/2035(INL)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 377 #
2021/2035(INL)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to appoint a coordinator against violence against women and other forms of gender-based violence and to set up a European network to combat violence against women, particularly femicide;
Amendment 387 #
2021/2035(INL)
Motion for a resolution
Annex I – Recital 5
Annex I – Recital 5
(5) Gender-based violence is violence directed against women because they are women and it affects women disproportionately. LGBTI persons are also victims of gender-based violence because of their gender, gender identity, gender expression and sex characteristics. Gender- based violence is rooted in gender stereotypes, patriarchal structures and power asymmetries stereotypes are a root cause of gender inequality and affect all areas of society.
Amendment 390 #
2021/2035(INL)
Motion for a resolution
Annex I – Recital 7
Annex I – Recital 7
(7) Gender-based violence constitutes a violation of fundamental rights such as the right to security and the rights to life and to physical integrity, human dignity, prohibition of torture and inhuman or degrading treatment or punishment, prohibition of slavery and forced labour, respect for private and family life enshrined in Articles 61, 2 and 3, 3, 4, 5, 6, 7 of the Charter, respectively.
Amendment 126 #
2021/2013(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare, to secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and to prevent shortages thereof, prioritising the interest and safety of patients;
Amendment 130 #
2021/2013(INI)
Motion for a resolution
Paragraph -1 a (new)
Paragraph -1 a (new)
-1a. Points out that while the Member States are responsible for the definition and organisation of their health policies, the Union is responsible for pharmaceutical legislation as well as various public health policies, and it is incumbent on the EU to coordinate and complement national measures to guarantee access to affordable and high- quality health services for all EU citizens and residents;
Amendment 362 #
2021/2013(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Emphasises that joint European procurement procedures can make it possible to counter shortages, especially in times of health crises, as was the case with the procedure launched following the onset of the COVID-19 epidemic, with simplified and transparent procedures in the interests of improved response times; calls, in particular, for the establishment of EU joint procurement for medicines to treat rare diseases in order to ensure that these medicines are available in all Member States;
Amendment 392 #
2021/2013(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission to develop European health strategies on the basis of a common basket of medicines for the treatment of cancer, infections, rare diseases and other areas particularly affected by shortages; calls on the Commission to consider the option of harmonised pricing criteria to make such medicines affordable;
Amendment 402 #
2021/2013(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Calls on the Commission consider creating a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages;
Amendment 410 #
2021/2013(INI)
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Urges the Commission and the Member States to introduce financial incentives, in line with State aid rules, to preserve and expand the EU’s pharmaceutical industrial base, from the production of active pharmaceutical ingredients to medicine manufacturing, packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies in order to diversify resources and encourage the development of innovative production technologies capable of enhancing the responsiveness of entire production lines; recalls that all public funding must be made conditional on the transparency and traceability of investments, on supply obligations on the European market, and on facilitating the best outcome for patients, including in terms of accessibility of manufactured medicines;
Amendment 571 #
2021/2013(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission, the EMA and the competent authorities to capitalise on all the pragmatic efforts made during the COVID-19 crisis, in particular as regards regulatory flexibility with a view to tackling medicine shortages more effectively;
Amendment 597 #
2021/2013(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Emphasises that security of supply is an essential factor and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tender for the supply of medicines; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the Commission, in the context of Directive 2014/24/EU, to act swiftly in proposing guidelines for the Member States, to look beyond the lowest price criterion, and to ensure that investments in the manufacture of active ingredients and medicinal end products in the EU are also retained as an essential criterion;
Amendment 608 #
2021/2013(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Calls on the Commission and the Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; takes the view that the EMA is the body best suited to be designated as the regulatory authority tasked with preventing shortages of medicines at EU level during emergencies and beyond;
Amendment 610 #
2021/2013(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19c. Calls on the Commission to set up an innovative, user-friendly, transparent and centralised digital platform for reporting and notifying information provided by national agencies and all stakeholders regarding available stocks and shortages of medicines and medical equipment; calls for existing information systems to be evaluated and improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State to prevent overstocking;
Amendment 628 #
2021/2013(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Welcomes the introduction of a structured dialogue with all stakeholders to identify weak links in the global supply chain for critical medicines, pharmaceutical raw materials, intermediate products and active pharmaceutical ingredients; with that in mind, urges the Commission, the Member States and stakeholders to draw up, as soon as possible, a clear and ambitious policy roadmap to secure and modernise Europe’s existing manufacturing capacity for medicines, technology and active pharmaceutical ingredients;
Amendment 291 #
2021/0426(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 26 a (new)
Article 2 – paragraph 1 – point 26 a (new)
26a. ‘healthy indoor climate conditions’ means an indoor environment that complies with the 2009 World Health Organization guidelines, which provide that better performing buildings provide higher comfort levels and well-being for their occupants and improve health, in particular through good indoor air quality and good insulation that prevents water from penetrating buildings and mould from spreading;
Amendment 1642 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 9/23
Annex 1 – part 9/23
Add the following to the comprehensive network: - Colmar - Freiburg rail passengers line
Amendment 1643 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 9/23
Annex 1 – part 9/23
Add the following to the comprehensive network: - Haguenau - Roeschwoog - Rastatt rail passengers line
Amendment 1670 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 13/23
Annex 1 – part 13/23
Add the following to the extended core network: - Colmar-Freiburg rail passengers line (conventional / new construction)
Amendment 139 #
2021/0394(COD)
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) The representative bodies of justice professionals should be involved in the development of new electronic communication processes.
Amendment 38 #
2021/0381(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The Regulation should provide for harmonised transparency requirement applicable to economic actors providing political advertising and related services (i.e. activities that are normally provided for remuneration); those services consist in particular of the preparation, placement, promotion, publication and dissemination of political advertising. The rules of this Regulation that provide for a high level of transparency of political advertising services are based on Article 114 of the TFEU. This Regulation should also address the use of targeting and amplification techniques in the context of the publication, dissemination or promotion of political advertising that involve the processing of personal data. The rules of this Regulation that address the use of targeting and amplification are based on Article 16 of the TFEU. Political advertising directed to individuals in a Member State should includes advertising entirely prepared, placed or published by service providers established outside the Union but disseminated to individuals in the Union. To determine whether a political advertisement is directed to individuals in a Member State, account should be taken of factors linking it to that Member State, including language, context, objective of the advertisement and its means of dissemination.
Amendment 39 #
2021/0381(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) There is no existing definition of political advertising or political advertisement at Union level. A common definition is needed to establish the scope of application of the harmonised transparency obligations and rules on targeting and amplification. This definition should cover the many forms that political advertising can take and any means and mode of publication or dissemination within the Union, regardless of whether the source is locatervice provider is established within the Union or in a third country.
Amendment 41 #
2021/0381(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The publication or dissemination by other actors, such as non-governmental organisations, associations or companies, of a message that is liable to influence the outcome of an election or referendum, legislative or regulatory process or voting behaviour should also constitute political advertising. In order to determine whether the publication or dissemination of a message is liable to influence the outcome of an election or referendum, a legislative or regulatory process or voting behaviour, account should be taken of all relevant factors such as the content of the message, the sponsor, the origin of the sponsor, the language used to convey the message, the context in which the message is conveyed, the objective of the message and the means by which the message is published or disseminated. Messages on societal or controversial issues may, as the case may be, be liable to influence the outcome of an election or referendum, a legislative or regulatory process or voting behaviour.
Amendment 44 #
2021/0381(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Practical information from official sources regarding the organisation and modalities for participation in the elections or referendums should not constitute political advertisingMember State in which the election is taking place should not constitute political advertising if the message only concerns the organisation of and participation in elections or referendums.
Amendment 46 #
2021/0381(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Political views expressed in literary works, in the programmes of audiovisual linear broadcasts or published in printed media without direct payment or equivalent remuneration should not be covered by this Regulation.
Amendment 47 #
2021/0381(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) For the purpose of this Regulation, election should be understood as the elections to the European Parliament as well as all elections or referendums organised at national, regional and local level in the Member States and elections to establish political party leadership. It should not include other forms of elections such as regional, local and privately organised ballots.
Amendment 48 #
2021/0381(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The concept of political actors should also include unelected officials, elected officials, candidates and members of Government at European, or national, regional or local level. Other political organisations should also be included in that definition.
Amendment 49 #
2021/0381(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) In order to cover the broad range of relevant service providers connected to political advertising services, providers of political advertising services should be understood as comprising providany suppliers involved in the preparation, placement, promotion, publication and dissemination of political advertising. The recipient of the political advertisement should be able to trace the whole chain of distribution of the message in order to discover the precise origin of the message, its author and the intermediaries through which it has passed.
Amendment 51 #
2021/0381(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) The transparency requirements should also not apply to the sharing of information through electronic communication services such as electronic message services or telephone calls, as long as no political advertising service is involved. Where a message is sent by or on behalf of a political actor, for example via the sending of electronic messages or the use of telephone calling techniques, such as voicemail, it should also be possible to apply transparency requirements.
Amendment 58 #
2021/0381(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 4 – point d
Article 2 – paragraph 1 – point 4 – point d
(d) a candidate for any elected office at European, national, regional and loc or national level, or for one of the leadership positions within a political party;
Amendment 59 #
2021/0381(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 4 – point e
Article 2 – paragraph 1 – point 4 – point e
(e) an elected official within a public institution at European, or national, regional or local level level when the message is related to his or her mandate;
Amendment 60 #
2021/0381(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 4 – point f
Article 2 – paragraph 1 – point 4 – point f
(f) an unelected member of government at European, or national, regional or local level;
Amendment 66 #
2021/0381(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point b a (new)
Article 6 – paragraph 1 – point b a (new)
(b a) information on the targeting techniques used in the provision of the service;
Amendment 68 #
2021/0381(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The information referred to in paragraph 1 shall be in writing and may be in electronic form. Such information shall be retained for a period of five years from the date of the last preparation, placement, publication or dissemination, as the case may be.
Amendment 70 #
2021/0381(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point c
Article 7 – paragraph 1 – point c
(c) a transparency notice to enable the wider context of the political advertisement and its aims to be understood, or a clear indication of where it can be easily retrieved online.
Amendment 71 #
2021/0381(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) the identity of the sponsor and contact details;
Amendment 73 #
2021/0381(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. Political advertising publishers which are very large online platforms within the meaning of Article 25 of Regulation (EU) 2021/xxx [the DSA] shall ensure that the repositories that they make available pursuant to Article 30 of that regulation [Digital Services Act] make available for each political advertisement in the repository the information referred to in paragraph 2. The repositories of such publishers should be automatically updated on the website of the contact point designated by each Member State.
Amendment 77 #
2021/0381(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. Where requests pursuant to paragraph 1 are manifestly unfounded, unclear or excessive, in particular because of their lack of clarity or repeated, the service provider may refuse to respond. In this case, the relevant service provider shall send a reasoned response to the interested entity making the request.
Amendment 80 #
2021/0381(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Service providers that provide political advertising services in the Union but do not have an establishment in the Union shall designate, in writing, a natural or legal person as their legal representative in one of the Member States where the provider offers its services. They shall transmit the identity and contact details of their legal representative to the European Cooperation Network on Elections.
Amendment 81 #
2021/0381(COD)
Proposal for a regulation
Article 15 – paragraph 7 a (new)
Article 15 – paragraph 7 a (new)
7 a. The contact point shall prepare an inventory and post-election analysis of political advertisements made during the election period. The publication of these elements shall be made within six months after the election date.
Amendment 241 #
2021/0375(COD)
9. Contributions from members of a European political party that have their seat in, or are citizens of, a Member State or from member parties that have their seat in a country belonging to the Council of Europe shall be permitted. The total value of contributions from members shall not exceed 40 % of the annual budget of a European political party. The value of contributions from member parties that have their seat in a country outside the Union shall not exceed 10% of the total contributions from members.
Amendment 252 #
2021/0375(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
Amendment 6 #
2021/0373(CNS)
Proposal for a directive
Recital 5
Recital 5
(5) The electoral procedure related to municipal elections falls within the competences of the Member States that organise them reflecting their specificconstitutional traditions and in accordance with international and European standards. In line with International Covenant on Civil and Political Rights as well as the law of the European Convention on Human Rights, Member States should not only recognise and respect the right of Union citizens to vote and to stand as a candidate but also ensure easy and effective access to their electoral rights and to information by removing as manyll obstacles to their participation in elections as possible.
Amendment 13 #
2021/0373(CNS)
Proposal for a directive
Recital 7
Recital 7
(7) In addition, non-national Union citizens should not be required to fulfil any special conditions in order to exercise the right to vote or stand in municipal elections unless, exceptionally, a different treatment of nationals and non-nationals is justified by exceptional circumstances specific to the latter distinguishing them from the former. Any such difference in treatment must, in any event, be justified.
Amendment 15 #
2021/0373(CNS)
Proposal for a directive
Recital 8
Recital 8
(8) In order to facilitate the exercise by Union citizens of their right to vote and to stand as a candidate in their country of residence, such citizens should be able to be entered on the electoral roll in sufficient time in advance of polling day. Where voting is not compulsory, Member States should be encouraged to enter such citizens on the electoral roll automatically when they are registered as residents. The formalities applicable to their registration should be as simple as possible. It should be sufficient for the Union citizens concerned to produce a valid identity card and, where necessary, a formal declaration that include elements evidencing their entitlement to participate in the elections. Once registered, non- national Union citizens should remain on the electoral roll under the same conditions as Union citizens who are nationals of the Member State concerned, for as long as they satisfy the conditions for exercising the right to vote. Additionally, Union citizens should provide the competent authorities with contact information, enabling those authorities to keep them informed on a regular basis of their rights, the holding of elections and the voting procedures.
Amendment 20 #
2021/0373(CNS)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) To enable European citizens residing in a Member State of which they are not nationals to be eligible in practice to stand as candidates in municipal elections, national political parties should not make membership conditional on having the nationality of the Member State of election.
Amendment 23 #
2021/0373(CNS)
Proposal for a directive
Recital 5
Recital 5
(5) The electoral procedure related to municipal elections falls within the competences of the Member States that organise them reflecting their specificconstitutional traditions and in accordance with international and European standards. In line with International Covenant on Civil and Political Rights as well as the law of the European Convention on Human Rights, Member States should not only recognise and respect the right of Union citizens to vote and to stand as a candidate but also ensure easy and effective access to their electoral rights and to information by removing as manyll obstacles to their participation in elections as possible.
Amendment 26 #
2021/0373(CNS)
Proposal for a directive
Recital 7
Recital 7
(7) In addition, non-national Union citizens should not be required to fulfil any special conditions in order to exercise the right to vote or stand in municipal elections unless, exceptionally, a different treatment of nationals and non-nationals is justified by exceptional circumstances specific to the latter distinguishing them from the former. Any such difference in treatment must, in any event, be justified.
Amendment 27 #
2021/0373(CNS)
Proposal for a directive
Recital 11
Recital 11
(11) Since the duties of the leadership of basic local government units may involve taking part in the exercise of official authority and in the safeguarding of the general interest, Member States should be able to reserve those offices for their nationals in full respect of the principle of proportionality . Any limitation of the right to stand as a candidate must be duly justified by the Member States.
Amendment 28 #
2021/0373(CNS)
Proposal for a directive
Recital 8
Recital 8
(8) In order to facilitate the exercise by Union citizens of their right to vote and to stand as a candidate in their country of residence, such citizens should be able to be entered on the electoral roll in sufficient time in advance of polling day. Where voting is not compulsory, Member States should be encouraged to enter such citizens on the electoral roll automatically when they are registered as residents. The formalities applicable to their registration should be as simple as possible. It should be sufficient for the Union citizens concerned to produce a valid identity card and, where necessary, a formal declaration that include elements evidencing their entitlement to participate in the elections. Once registered, non- national Union citizens should remain on the electoral roll under the same conditions as Union citizens who are nationals of the Member State concerned, for as long as they satisfy the conditions for exercising the right to vote. Additionally, Union citizens should provide the competent authorities with contact information, enabling those authorities to keep them informed on a regular basis of their rights, the holding of elections and the voting procedures.
Amendment 31 #
2021/0373(CNS)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) To enable European citizens residing in a Member State of which they are not nationals to be eligible in practice to stand as candidates in municipal elections, national political parties should not make membership conditional on having the nationality of the Member State of election.
Amendment 33 #
2021/0373(CNS)
Proposal for a directive
Recital 11
Recital 11
(11) Since the duties of the leadership of basic local government units may involve taking part in the exercise of official authority and in the safeguarding of the general interest, Member States should be able to reserve those offices for their nationals in full respect of the principle of proportionality . Any limitation of the right to stand as a candidate must be duly justified by the Member States.
Amendment 33 #
2021/0373(CNS)
Proposal for a directive
Recital 15
Recital 15
(15) The accessibility, clarity and intelligibility of information on electoral rights and procedures is aare key components in ensuring the effective exercise of the right enshrined in Article 20(2), point (b) and Article 22(1) TFEUof the Treaty on the Functioning of the European Union.
Amendment 35 #
2021/0373(CNS)
Proposal for a directive
Recital 15
Recital 15
(15) The accessibility, clarity and intelligibility of information on electoral rights and procedures is aare key components in ensuring the effective exercise of the right enshrined in Article 20(2), point (b) and Article 22(1) TFEUof the Treaty on the Functioning of the European Union.
Amendment 37 #
2021/0373(CNS)
Proposal for a directive
Recital 16
Recital 16
(16) The lack of adequate information, in the context of electoral procedures, affects citizens in the exercise of their electoral rights as part of their rights as Union citizens. It also affects the capacity of competent authorities to exercise their rights and to deliver on their obligations. Member States should be required to designate authorities with special responsibilities for providing appropriate information to Union citizens on their rights under Article 20(2), point (b), and Article 22(1) TFEU and the national rules and procedures regarding participation in and the organization of municipal elections. In order to ensure the effectiveness of communications, information should be provided in clear and comprehensible terms when citizens are registered as residents and sufficiently in advance of the election.
Amendment 38 #
2021/0373(CNS)
Proposal for a directive
Recital 16
Recital 16
(16) The lack of adequate information, in the context of electoral procedures, affects citizens in the exercise of their electoral rights as part of their rights as Union citizens. It also affects the capacity of competent authorities to exercise their rights and to deliver on their obligations. Member States should be required to designate authorities with special responsibilities for providing appropriate information to Union citizens on their rights under Article 20(2), point (b), and Article 22(1) TFEUof the Treaty on the Functioning of the European Union and the national rules and procedures regarding participation in and the organization of municipal elections. In order to ensure the effectiveness of communications, information should be provided in clear and comprehensible terms when citizens are registered as residents and sufficiently in advance of the election.
Amendment 45 #
2021/0373(CNS)
Proposal for a directive
Recital 23
Recital 23
(23) Data regarding the exercise of rights and the application of this Directive can be usefulis necessary in the identification of measures necessary to ensure the effective exercise of Union citizens’ electoral rights. In order to improve the collection and communication of data for municipal elections, it is necessary to introduce, in accordance with a common methodology, regular monitoring and reporting of implementation by Member States, which should include, besides statistical data, information on the measures taken to support participation in elections of non- national Union citizens. The Commission should assess the application of the Directive , including any changes in the electorate that have taken place since its entry into force and submit a report in this connection to the European Parliament and to the Council.
Amendment 50 #
2021/0373(CNS)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
Having regard to the Treaty and to general legal principles, Member States may take appropriate, necessary and proportional measures to ensure that the offices referred to in the first subparagraph can only be held and the interim functions referred to in the second subparagraph can be performed only by their own nationals. Any limitation on the exercise of these functions must be duly justified by the Member States.
Amendment 53 #
2021/0373(CNS)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Only Member States where voting is not compulsory may provide for the automatic registration of voters pursuant to Article 3 on the electoral roll.
Amendment 57 #
2021/0373(CNS)
Proposal for a directive
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) in case of legitimate doubt regarding the content of the declaration pursuant to point (a), to produce before or after the election an attestation from the competent administrative authorities in their home Member State certifying that they have not been deprived of the right to stand as a candidate in that State or that no such disqualification is known to those authorities;
Amendment 57 #
2021/0373(CNS)
Proposal for a directive
Recital 23
Recital 23
(23) Data regarding the exercise of rights and the application of this Directive can be usefulis necessary in the identification of measures necessary to ensure the effective exercise of Union citizens’ electoral rights. In order to improve the collection and communication of data for municipal elections, it is necessary to introduce, in accordance with a common methodology, regular monitoring and reporting of implementation by Member States, which should include, besides statistical data, information on the measures taken to support participation in elections of non- national Union citizens. The Commission should assess the application of the Directive , including any changes in the electorate that have taken place since its entry into force and submit a report in this connection to the European Parliament and to the Council.
Amendment 59 #
2021/0373(CNS)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
Member States that provide for the possibility for nationals to vote by means of advance voting, postal voting, proxy voting and electronic and internet voting in municipal elections shall ensure that such means of voting are also available under the same conditions to voters pursuant to Article 3.
Amendment 61 #
2021/0373(CNS)
Proposal for a directive
Article 11 – paragraph 1 – indent 1 (new)
Article 11 – paragraph 1 – indent 1 (new)
- The information referred to, in addition to being communicated in one or more languages of the host Member State, shall be accompanied by a translation into at least one other official language of the Union which is widely understood by the largest number of Union citizens residing in that state.
Amendment 65 #
2021/0373(CNS)
Proposal for a directive
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) once available, the date of the election and how and where to vote, as well as the measures taken to facilitate the participation in the vote by people with disabilities;
Amendment 67 #
2021/0373(CNS)
Proposal for a directive
Article 12 – paragraph 2 – point c a (new)
Article 12 – paragraph 2 – point c a (new)
(ca) the electoral system of the host Member State.
Amendment 69 #
2021/0373(CNS)
The information referred to in the first subparagraph shall, in addition to being communicated in one or more of the official languages of the host Member State also be accompanied by a translation in at least one other official language of the Union that is broadly understood by the largest possible number of European Union citizens residing on its territory, in accordance with the quality requirements in Article 9 of Regulation (EU) 2018/1724 of the European Parliament and of the Council28. Where possible, this information shall be translated into the mother tongue of the non-national voter. _________________ 28 Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1–38).
Amendment 76 #
2021/0373(CNS)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Within three years of the entry into force of this Directive and every fourive years thereafter, the Member States shall report to the Commission on the application of this Directive in their territory, including on the application of Article 5(3) and (4). The report shall contain statistical data, collected in accordance with a common methodology, on the participation in municipal elections of voters and candidates pursuant to Article 3 and a summary of measures taken in that regardto facilitate and encourage such participation.
Amendment 85 #
2021/0373(CNS)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
Having regard to the Treaty and to general legal principles, Member States may take appropriate, necessary and proportional measures to ensure that the offices referred to in the first subparagraph can only be held and the interim functions referred to in the second subparagraph can be performed only by their own nationals. Any limitation on the exercise of these functions shall be duly justified by the Member States.
Amendment 96 #
2021/0373(CNS)
3. MOnly member States where voting is not compulsory may provide for the automatic registration of voters pursuant to Article 3 on the electoral roll.
Amendment 109 #
2021/0373(CNS)
Proposal for a directive
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) in case of legitimate doubt regarding the content of the declaration pursuant to point (a), to produce before or after the election an attestation from the competent administrative authorities in their home Member State certifying that they have not been deprived of the right to stand as a candidate in that State or that no such disqualification is known to those authorities;
Amendment 115 #
2021/0373(CNS)
Member States that provide for the possibility for nationals to vote by means of advance voting, postal voting, proxy voting, and electronic and internet voting in municipal elections shall ensure that such means of voting are also available under the same conditions to voters pursuant to Article 3.
Amendment 119 #
2021/0373(CNS)
Proposal for a directive
Article 11 – paragraph 1 – indent 1 (new)
Article 11 – paragraph 1 – indent 1 (new)
– The information referred to, in addition to being communicated in one or more languages of the host Member State, shall be accompanied by a translation into at least one other official language of the Union which is widely understood by the largest number of Union citizens residing in that state.
Amendment 133 #
2021/0373(CNS)
Proposal for a directive
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) once available, the date of the election and how and where to vote, as well as the measures taken to facilitate the participation in the vote by people by people with disabilities;
Amendment 138 #
2021/0373(CNS)
Proposal for a directive
Article 12 – paragraph 2 – point c a (new)
Article 12 – paragraph 2 – point c a (new)
(ca) the electoral system of the host Member State.
Amendment 147 #
2021/0373(CNS)
Proposal for a directive
Article 12 – paragraph 3 – subparagraph 1
Article 12 – paragraph 3 – subparagraph 1
The information referred to in the first subparagraph shall, in addition to being communicated in one or more of the official languages of the host Member State also be accompanied by a translation in at least one other official language of the Union that is broadly understood by the largest possible number of European Union citizens residing on its territory, in accordance with the quality requirements in Article 9 of Regulation (EU) 2018/1724 of the European Parliament and of the Council28 . Where possible, this information shall be translated into the mother tongue of the non-national voter. _________________ 28 Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1–38)
Amendment 160 #
2021/0373(CNS)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Within three years of the entry into force of this Directive and every fourive years thereafter, the Member States shall report to the Commission on the application of this Directive in their territory, including on the application of Article 5(3) and (4). The report shall contain statistical data, collected in accordance with a common methodology, on the participation in municipal elections of voters and candidates pursuant to Article 3 and a summary of measures taken in that regard.
Amendment 61 #
2021/0372(CNS)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11a) To enable European citizens residing in a Member State of which they are not nationals to be eligible in practice for election to the European Parliament, national political parties should not make membership conditional on having the nationality of the Member State of election.
Amendment 94 #
2021/0372(CNS)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall take the necessary measures to enable aTo enable a European Union voter who has expressed the wish to be registered as a voter to be entered on the electoral roll, the Member States shall take the necessary measures sufficiently in advance of polling day. to proceed with the registration.
Amendment 103 #
2021/0372(CNS)
Proposal for a directive
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
1a. The information referred to in the first subparagraph, in addition to being communicated in one or more languages of the host Member State, shall be accompanied by a translation into at least one other official language of the Union which is widely understood by the largest number of Union citizens residing in that state.
Amendment 112 #
2021/0372(CNS)
Proposal for a directive
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) the date of the election and how and where to vote, as well as the measures taken to facilitate the participation in the vote by people with disabilities;
Amendment 116 #
2021/0372(CNS)
Proposal for a directive
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(da) information on the electoral system of the European Union enabling the election of Members of the European Parliament;
Amendment 135 #
2021/0372(CNS)
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Member States shall designate an authority with responsibility for collecting, in accordance with a common methodology, and providing relevant statistical data to the public and the Commission, on the participation of Union citizens who are not nationals in elections to the European Parliament.
Amendment 139 #
2021/0372(CNS)
Proposal for a directive
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Within six months after each election to the European Parliament Member States shall send information to the Commission on the application of this Directive in their territory. In addition to general observations, the report shall contain statistical data, comparable and collected in accordance with a common methodology, on the participation in elections to the European Parliament of Union voters and Union citizens entitled to stand as candidates and a summary of the measures taken to support it.
Amendment 1 #
2021/0277(BUD)
Draft opinion
Paragraph 1
Paragraph 1
1. Highlights that the 2022 EU budget and its implementation should meet the expectations of citizens that the recovery from the COVID-19 pandemic and economic crises will be fast, resilient, socially fair and equitable; stresses that the 2022 EU budget should contribute to fostering a strong economic recovery, job creation and European competitiveness;
Amendment 8 #
2021/0277(BUD)
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that this budget should contribute to achieving the revised 2030 EU climate and environmental targets – including halting and reversing biodiversity loss – the EU’s energy targets and the objective of making the EU climate-neutral by 2050 at the latest in line with the Paris Agreement, while ensuring a green and just transition through the European Green Deal; highlights that adequate support should be provided to the Member States that have been most affected by the pandemic and its socio- economic consequences;
Amendment 26 #
2021/0277(BUD)
Draft opinion
Paragraph 4
Paragraph 4
4. Reiterates its call to track climate- and biodiversity-related expenditure using a robust, transparent, reliable and comprehensive methodology for the achievement of the applicable targets; looks forward to the annual consultations on the climate target, as set out in the Interinstitutional Agreement of 16 December 2020; welcomes that existing overlaps between climate and biodiversity goals will be taken into account;
Amendment 32 #
2021/0277(BUD)
Draft opinion
Paragraph 4 d (new)
Paragraph 4 d (new)
4d. Stresses that tracking of climate- and biodiversity-related expenditure should rely on a science based, life cycle approach in order to counteract the risk of ‘greenwashing’;
Amendment 33 #
2021/0277(BUD)
Draft opinion
Paragraph 4 e (new)
Paragraph 4 e (new)
4e. Calls on the Commission to consider the impact of its methodology with regard to administrative burdens on national, regional and local authorities as well as other stakeholders and beneficiaries; highlights that small- and medium sized enterprises (SMEs) are often among first movers with regard to innovation; recalls that SMEs can be particularly vulnerable to administrative burdens;
Amendment 34 #
2021/0277(BUD)
Draft opinion
Paragraph 4 f (new)
Paragraph 4 f (new)
4f. Welcomes the Better Regulation agenda of the Commission which aims to make Union regulation simpler, more targeted and easier to comply with; calls on the Commission to facilitate the achievement of the European Green Deal by tackling obstacles and red tape that may slow down its implementation, while also ensuring that the implementation of the European Green Deal targets is achieved with the lowest possible burden for citizens and businesses, for example by applying a ‘one in, one out’ approach and by paying special attention to the implications and costs of applying legislation, especially for small and medium-sized enterprises;
Amendment 40 #
2021/0277(BUD)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers it essential, that sufficient resources are secured in the 2022 EU budget for the investment in skills; recalls that the European Skills Agenda serves to strengthen competitive sustainability and resilience of the Union; underlines the importance of developing the skills of Europeans in order to grasp the opportunities of the green transition;
Amendment 43 #
2021/0277(BUD)
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes the increase in the budgets for the EU4Health programme and the Union Civil Protection Mechanism (rescEU) in order to support the Health Union and enhance the EU’s capacity to respond to crises and build resilience to future shocks; calls for additional budgetary support for the LIFE programmeon the Commission to ensure sufficient funding from the relevant Union programmes and instruments for the implementation of the Health Union package, notably a Regulation on serious cross-border threats to health repealing Decision No 1082/2013/EU;
Amendment 44 #
2021/0277(BUD)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses that sufficient funding for the Health Union package should be accompanied by measures to support the open strategic autonomy of the Union with regard to pharmaceutical products, as well as research and innovation in the sector to the benefit of patients and society as a whole;
Amendment 45 #
2021/0277(BUD)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Recalls that only 4.3% of the population lives without any pre-existing medical condition; stresses that sufficient funding must be reserved for addressing this challenge in European health policies that can positively impact health outcomes for people with gateway chronic diseases as well as co-morbidities;
Amendment 46 #
2021/0277(BUD)
Draft opinion
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Calls for adequate and targeted funding of competitive European research into the treatment of major non- communicable diseases in order to facilitate innovation as well as contribute to building health system resilience and prioritising the most medically vulnerable in times of health crises; considers that the 2022 EU Budget should ensure that adequate funds are allocated for the appropriate implementation of the Beating Cancer Plan from different sources of funding, notably the EU4Health, the Recovery and Resilience Facility and Horizon Europe; stresses, in particular, the importance to dedicate the necessary funding for enhancing cancer research, prevention and therapeutics innovation; welcomes in this regard the planned Partnership for Personalised Medicine, announced in Europe’s Beating Cancer Plan and to be funded under Horizon Europe;
Amendment 47 #
2021/0277(BUD)
Draft opinion
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Calls on the Commission to ensure that Union funding for biomedical research and development includes clauses that contribute to the availability and affordability of final products;
Amendment 48 #
2021/0277(BUD)
Draft opinion
Paragraph 6 e (new)
Paragraph 6 e (new)
6e. Recalls the importance of the LIFE programme as a funding instrument for climate change mitigation and adaptation; calls for the level of budgetary support for the LIFE programme to be maintained;
Amendment 54 #
2021/0277(BUD)
Draft opinion
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Underlines that as resources are allocated for improved pandemic preparedness and management, note should be taken of lessons learned during the COVID-19 pandemic;
Amendment 55 #
2021/0277(BUD)
Draft opinion
Paragraph 7 d (new)
Paragraph 7 d (new)
7d. Stresses that sufficient resources should be allocated in particular for increasing investments in research and development, which is essential in order to promote European innovation in the development of medicines; stresses that investments in the area of health should contribute to equitable access, availability and affordability of pharmaceutical products;
Amendment 84 #
2021/0241(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) Crypto-assets issued by central banks acting in their monetary authority capacity or by other public authorities should not be subject to the Union framework covering crypto-assets, and neither should services related to crypto- assets that are provided by such central banks or other public authorities.
Amendment 147 #
2021/0241(COD)
Proposal for a regulation
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. This Regulation shall not apply to the European Central Bank and the national central banks of the Member States when acting in their capacity as a monetary authority or other public authority.
Amendment 85 #
2021/0223(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) Therefore, the general principle of technology neutrality should be maintained and market competition between the different alternative technologies should be promoted and protected at Union and national levels, thus providing for the best technological solutions and affordable prices. Targets and milestones should be set at Union and national levels, depending on the market development of different technologies, while net-zero ambition should always be the guiding principle.
Amendment 87 #
2021/0223(COD)
Proposal for a regulation
Recital 5 b (new)
Recital 5 b (new)
(5b) Furthermore, a differentiated approach for the Member States and regions in the EU should be applied, depending on their economy and infrastructure development levels, geographical and national market characteristics, including trans-border infrastructure with third countries. However, no Member State should be exempt from the common EU ambitions, while timetables and milestones might naturally vary.
Amendment 106 #
2021/0223(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The deployment of publicly accessible recharging infrastructure for light-duty electric vehicles has been uneven across the Union. Continued uneven distribution would jeopardize the uptake of such vehicles, limiting connectivity across the Union. Continuing divergence in policy ambitions and approaches at national level will not create the long-term certainty needed for substantive market investment. Mandatory minimum targets for Member States at national level should therefore provide policy orientations and complement National Policy Frameworks. That approach should combine national fleet based targets with distance-based targets for the trans-European network for transport (TEN-T). National fleet based targets should ensure that vehicle uptake in each Member State is matched with the deployment of sufficient publicly accessible recharging infrastructure. A special attention and higher fleet based targets for centres of relatively higher population density and higher electric vehicles market-share is also needed. Distance-based targets for the TEN-T network should ensure full coverage of electric recharging points along the Union’s main road networks and thereby ensure easy and seamless travel throughout the Union.
Amendment 113 #
2021/0223(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) National fleet based targets should be established on the basis of the total number of registered electric vehicles in thatshare of electric vehicles of total passenger vehicle fleet in Member States following a common methodology that accounts for technological developments such as the increased driving range of electric vehicles or the increasing market penetration of fast-charging points which can recharge a greater number of vehicles per recharging point than at a normal recharging point. The methodology also has to take into account the different recharging patterns of battery electric and plug-in hybrid vehicles, as well as population and market share of electric vehicles concentration. A methodology that norms national fleet based targets on the total maximum power output of the publicly accessible recharging infrastructure should allow flexibility for the implementation of different recharging technologies in Member States.
Amendment 259 #
2021/0223(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 38
Article 2 – paragraph 1 – point 38
(38) ‘publicly accessible’ alternative fuels infrastructure means an alternative fuels infrastructure which is located at a site or premise that is open to the general public, irrespective of whether the alternative fuels infrastructure is located on public or on private property, whetherithout access limitations or conditions apply in terms of access to the site or premise and irrespective of the applicable use conditions of the alternative fuels infrastructurespecific to a group of users;
Amendment 279 #
2021/0223(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 1
Article 3 – paragraph 1 – indent 1
— publicly accessible recharging stations for light-duty vehicles are deployed commensurate to the uptake of light-duty electric vehicles, for both passenger and goods transport;
Amendment 288 #
2021/0223(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 2
Article 3 – paragraph 1 – indent 2
— in their territory, publicly accessible recharging stations dedicated to light-duty vehicles are deployed that provide space and sufficient power output for those vehicles in urban areas, in suburban areas and across the TEN-T core and comprehensive network.
Amendment 649 #
2021/0223(COD)
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. Member States shall ensure that airport managing bodies and groundhandling service providers of all TEN-T core and comprehensive network airports ensure the provision of electricity supply to stationary aircraft by:
Amendment 655 #
2021/0223(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. As of 1 January 2030 at the latest, Member States shall take the necessary measures to ensure that the electricity supplied pursuant to paragraph 1 comes from the electricity grid or is generated on site as renewable energyvia zero-emission energies including, in particular, hydrogen technologies.
Amendment 664 #
2021/0223(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point a
Article 13 – paragraph 1 – subparagraph 1 – point a
(a) an assessment of the current state and future development of the market as regards alternative fuels in the transport sector, including, in particular, the situation as regards public transport networks, and of the development of alternative fuels infrastructure, considering intermodal access of alternative fuels infrastructure and, where relevant, cross- border continuity and public transport networks;
Amendment 770 #
2021/0223(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point a – point iv a (new)
Article 18 – paragraph 2 – point a – point iv a (new)
(iva) accessibility for light commercial vehicles, particularly with regard to height, length and width restrictions,
Amendment 777 #
2021/0223(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point c – point iii a (new)
Article 18 – paragraph 2 – point c – point iii a (new)
(iiia) price of parking and any time limit imposed,
Amendment 783 #
2021/0223(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point c – point iii b (new)
Article 18 – paragraph 2 – point c – point iii b (new)
(iiib) payment methods accepted.
Amendment 248 #
2021/0205(COD)
Proposal for a regulation
Article 6 – title
Article 6 – title
Obligations of Union airportstakeholders to provide the infrastructure to Union airports
Amendment 249 #
2021/0205(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
Union airports and ground-handling service providers shall take necessary measures to facilitate the access of aircraft operators to aviation fuels containing shares of sustainable aviation fuels in accordance with Annex I and, shall provide the infrastructure necessary for the delivery, storage and uplifting of such fuels.
Amendment 253 #
2021/0205(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
Where aircraft operators report difficulties to the European Union Aviation Safety Agency (‘the Agency’) in accessing aviation fuels containing sustainable aviation fuels at a given Union airport for lack of adequate airport infrastructure, the Agency may request the Union airport toat stakeholders involved in supplying this airport with fuel provide the information necessary to prove compliance with paragraph 1. The Union airport concerned shall provide the information without undue delay.
Amendment 257 #
2021/0205(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
The Agency shall assess the information received and inform the Commission if such information allows to conclude that the Union airport doesstakeholders are not fulfil itsling their obligations. Union airportsStakeholders involved in fuel supply shall take the necessary measures to identify and address the lack of adequate airport infrastructure in 5 years after the entry into force of the Regulation or after the year when they exceed one of the thresholds in Article 3(a).
Amendment 77 #
2021/0197(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) All sectors of the economy are expected to contribute to achieving those net greenhouse gas emission reductions, including the road transport sector and fuel suppliers.
Amendment 84 #
2021/0197(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In line with Regulation (EU) 2019/631 the emissions of the entire life cycle of vehicles should be taken into account in order to ensure that emissions are reduced in the most effective manner. Given the strengthened target for 2030, it is important to ensure that a methodology of full life-cycle CO2 emissions for vehicles follows suit. It is therefore necessary that the Commission develop no later than December 31, 2023, an harmonized methodology to report the carbon footprint of the life-cycle of vehicles in order to consider the global impact of passenger cars and light commercial vehicles on the environment. This regulation should be reviewed in 2028 to incorporate this harmonized methodology of an extended carbon accounting as new indicator for further reduction targets beyond 2030.
Amendment 100 #
2021/0197(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The strengthened CO2 emission reduction requirements should incentivise an increasing share of net zero-emission vehicles and fuels being deployed on the Union market whilst providing benefits to consumers and citizens in terms of air quality and energy savings, as well as ensuring that innovation and employment levels in the automotive value chain can be maintained in Europe and that mobility remains accessible and affordable for everyone. Within the global context, also the EU automotive chain must be a leading actor in the on- going transition towards net zero-greenhouse gas emission mobility and fuel solutions. The strengthened CO2 emission reduction standards armust be technology neutral in reaching the fleet- wide targets that they set. Different technologies are and remain available to reach the zero-emission fleet wide targets. ZLow and zero-emission vehicles currently include battery electric vehicles, fuel-cell and other hydrogen powered vehicles, depending on their respective full lifecycle emissions and technological innovations are continuing. Zero and low-emission vehicles, which also include well performing plug-in hybrid electric vehicles, and vehicles powered by alternative fuel which can continue to play a role in the transition pathway.
Amendment 102 #
2021/0197(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The strengthened CO2 emission reduction requirements should incentivise an increasing share of zero-emission and low-emission vehicles being deployed on the Union market whilst providing benefits to consumers and citizens in terms of air quality and energy savings, as well as ensuring that innovation in the automotive value chain can be maintained. Within the global context, also the EU automotive chain must be a leading actor in the on- going transition towards zero-emission mobilitycarbon-neutral mobility on the roads. The strengthened CO2 emission reduction standards are technology neutral in reaching the fleet- wide targets that they set. Different technologies are and remain available to reach the zero-emission fleet wide target. Zero-emission vehicles currently include battery electric vehicles, fuel-cell and other hydrogen powered vehicles, and technological innovations are continuing. Zero and low-emission vehicles, which also include well performing plug-in hybrid electric vehicles, canmust continue to play a role in the transition pathwayif they meet strict greenhouse gas emissions reduction criteria.
Amendment 116 #
2021/0197(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Against that background, new strengthened CO2 emission reduction targets should be set for both new passenger cars and new light commercial vehicles for the period 2030 onwards. Those targets should be set at a level that will deliver a strong signal to accelerate the uptake of zero-emission and low-emission vehicles on the Union market and to stimulate innovation in zero-emissioncarbon-neutral technologies in a cost- efficient way that also takes account of purchasing power.
Amendment 127 #
2021/0197(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The targets in the revised CO2 performance standards should be accompanied by a European strategy to address the challenges posed by the scale- up of the manufacturing of zero-emission and low-emission vehicles and associated technologies, as well as the need for up- and re-skilling of workers in the sector and, the economic diversification and reconversion of activities and targeted financial aid designed to enable those in the poorest households to change their vehicles. Where appropriate, financial support should be considered at the level of the EU and Member States to crowd in private investment, including via the European Social Fund Plus, the Just Transition Fund, the Innovation Fund, the Recovery and Resilience Facility and other instruments of the Multiannual Financial Framework and the Next Generation EU, in line with State aid rules. The revised environmental and energy state aid rules will enable Member States to support business to decarbonize their production processes and adopt greener technologies in the context of the New Industrial Strategy.
Amendment 128 #
2021/0197(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The targets in the revised CO2 performance standards should be accompanied by a European strategy to address the challenges posed by the scale- up of the manufacturing of low- and zero- emission vehicles and associated technologies and fuels, as well as the need for up- and re-skilling of workers in the sector and the economic diversification and reconversion of activities while maintaining automotive employment levels in Europe. Where appropriate, financial support should be considered at the level of the EU and Member States to crowd in private investment, including via the European Social Fund Plus, the Just Transition Fund, the Innovation Fund, the Recovery and Resilience Facility and other instruments of the Multiannual Financial Framework and the Next Generation EU, in line with State aid rules. The revised environmental and energy state aid rules will enable Member States to support business to decarbonize their production processes and adopt greener technologies in the context of the New Industrial Strategy.
Amendment 159 #
2021/0197(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Those EU fleet-wide targets are toshould be complemented by the necessary roll-out of recharging and refuelling infrastructure as set out in. For this reason, considering the weak and slow implementation of Directive 2014/94/EU of the European Parliament and of the Council27 . _________________ 27Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on, this proposal should be accompanied by an ambitious proposal for a Regulation on Alternative Fuel Infrastructure, providing for ambitious mandatory targets for the deployment of alternative fuels infrastructure (OJ L 307 28.10.2014, p. 1)throughout the 27 Member States.
Amendment 214 #
2021/0197(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) The regulations review is an important part of tracking the Union progress towards its climate ambitions while ensuring that concrete reduction targets can be met through an harmonized methodology for reporting on the life-cycle of vehicles, and taking into account industrial and social consequences of the defined targets.
Amendment 393 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EU) 2019/631
Article 14a – paragraph 1
Article 14a – paragraph 1
By 31 December 2025, and every two years thereafter, the Commission shall report on the progress towards zero emissioncarbon- neutral road mobility. The report shall in particular monitor and assess the need for possible additional measures to facilitate the transition, including through financial means.
Amendment 403 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9 Regulation (EU) 2019/631
Article 1 – paragraph 1 – point 9 Regulation (EU) 2019/631
In the reporting, the Commission shall consider all factors that contribute to a cost-efficient progress towards climate neutrality by 2050. This includes the deployment of zero- and low-emission vehicles, progress in achieving the targets for the roll-out of recharging and refuelling infrastructure as required under the Alternative Fuels Infrastructure Regulation, the increase in the amount of renewable energy used in the transport sector as required by the Renewable Energy Directive, the level of greenhouse gas emissions throughout the supply chain for materials used to manufacture vehicles, the potential contribution of innovation technologies and sustainable alternative fuels to reach climate neutral mobility, impact on consumers, progress in social dialogue as well as aspects to further facilitate an economically viable and socially fair transition towards zero emissioncarbon- neutral road mobility.’;
Amendment 445 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10 – point b a (new)
Article 1 – paragraph 1 – point 10 – point b a (new)
Regulation (EU) 2019/631
Article 15 – paragraph 6 a (new)
Article 15 – paragraph 6 a (new)
(ba) The following paragraph is added: 6a. In the report referred to in paragraph 1, the Commission shall assess the extent to which this Regulation contributes to the development of publicly accessible alternative fuels infrastructure, as provided for in the Regulation on the deployment of alternative fuels infrastructure. If the results of this assessment reveal that the targets set out in this Regulation are incompatible with the aim of ensuring the availability of alternative fuel infrastructure, the Commission shall initiate a revision of this Regulation no later than 2027.
Amendment 965 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 11 a (new)
Article 3 – paragraph 1 – point 11 a (new)
(11a) ‘testing’ means making the AI system available to a limited and restricted group of users before it is placed on the market or put into service;
Amendment 979 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from known and reasonably foreseeable human behaviour or interaction with other systems;
Amendment 1440 #
2021/0106(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall also be considered high-risk if they pose a threat to the health, safety or fundamental rights of persons.
Amendment 1714 #
2021/0106(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Training, validation and testing data sets shall be relevant, representative, free of errors and complete. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons on which the high-risk AI system is intended to be usedliable, limited in terms of bias, and complete. These characteristics of the data sets may be met at the level of individual data sets or a combination thereof.
Amendment 1757 #
2021/0106(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point 1 (new)
Article 11 – paragraph 1 – point 1 (new)
(1) Technical documentation is not mandatory, but it is recommended for the testing of a high-risk AI system before it is placed on the market or made available.
Amendment 3119 #
2021/0106(COD)
Proposal for a regulation
Annex III – paragraph 1 – point 4 – point b
Annex III – paragraph 1 – point 4 – point b
(b) AI intended to be used for making decisions on promotion and termination of work-related contractual relationships, for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships.
Amendment 16 #
2021/0055(COD)
Proposal for a regulation
Article 1 a (new) Regulation (EC) No 853/2004
Article 1 a (new) Regulation (EC) No 853/2004
Article 1 a Regulation (EC) 853/2004 is amended as follows: In Article 1(3), point (d) is replaced by the following: “(d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer;”.
Amendment 1384 #
2020/2260(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its deep concern about the emergence of zoonotic diseases that are transferred from animals to humans (anthropozoonoses), such as Q fever, avian influenza and the new strain of influenza A (H1N1), which is exacerbated by anthropogenic climate change, the destruction of biodiversity, and environmental degradation, and our current food production systemsencourages the Commission to globally promote high levels of biosecurity;
Amendment 1658 #
2020/2260(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for measures to reduce the burden that highly processed foods with high salt, sugar and fat content place on public health; regrets that the introduction of nutrient profiles is greatly delayed and stresses that a robust set of nutrient profiles must be developed to restrict or prohibit the use of false nutritional claims on foods high in fats, sugars and/or salt; calls for a mandatory EU-wide front-of- pack nutrition labelling system based on independent sciencestresses that an EU-wide front-of-pack nutrition labelling system must be based on independent science and must take account of all available food data; points out that such a system must in no way discriminate against those products that cannot be reduced to a nutrient profile, where they represent a tradition and know-how compatible with a balanced diet; points out, further, that a healthy diet does not depend solely on the nutrient profile of certain foods, but also on eating in moderation and having a varied diet;
Amendment 1702 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
Amendment 1712 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Welcomes the intention to examine whether labelling can be used to help consumers make more sustainable choices that will add value to our European products; calls for the harmonisation of any such labelling that is developed, so that all European consumers within the single market are fully informed;
Amendment 1717 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 c (new)
Paragraph 16 c (new)
Amendment 1842 #
2020/2260(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Stresses the importance of fighting food fraud and counterfeiting in the food sector, and imposing effective penalties;
Amendment 1959 #
2020/2260(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Stresses the need to protect consumers and the European tradition of animal protein production from the development of artificial or cellular meat; calls on the Commission to study the carbon footprint of these new products and their impact on human health;
Amendment 2062 #
2020/2260(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Welcomes the proposed revision of EU rules on date marking; stresses that any change to date marking rules should be science based and should improve the use of date marking by actors in the food chain and its understanding by consumers, in particular ‘best before’ labelling, while at the same time not undermining food safety or quality; stresses that European harmonisation and any changes extending these dates on certain products would help to combat food waste;
Amendment 16 #
2020/2220(INL)
Motion for a resolution
Recital A
Recital A
A. whereas since 1976, when the European Electoral Act paved the way for the election of the representatives of the European Parliament by direct universal suffrage for the first time, the EP has continuously requested the reform of EU electoral law and moves towards a more a genuine, uniformmore harmonised and European electoral procedure;
Amendment 35 #
2020/2220(INL)
Motion for a resolution
Recital F
Recital F
F. whereas, despite some steps forward in defining common standards of electoral procedures for the European Parliament, today EU elections are still mostly governed by national laws and therefore more improvements are needed to establish a genuinely uniformmore harmonised procedure for European elections;
Amendment 39 #
2020/2220(INL)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas although a record turnout was registered at the last European elections in 2019, the turnout for European elections remains well below that for national elections; stresses that communication efforts must be made to increase citizens’ interest in European issues and the role of European political parties and foundations in this regard;
Amendment 69 #
2020/2220(INL)
Motion for a resolution
Recital O
Recital O
O. whereas the right of all citizens of the Union to participate, on an equal basis, in the democratic life of the Union would be promoted by a genuinen increasing harmonisation of the procedure for elections to the European Parliament in all the Member States , which would also strengthen the political dimension of European integration;
Amendment 77 #
2020/2220(INL)
Motion for a resolution
Recital T
Recital T
Amendment 85 #
2020/2220(INL)
Motion for a resolution
Recital T a (new)
Recital T a (new)
Ta. whereas proposals to introduce a joint constituency have been repeatedly rejected by the European Parliament, and whereas such a measure would increase the complexity of the EU electoral system;
Amendment 86 #
2020/2220(INL)
Motion for a resolution
Recital T b (new)
Recital T b (new)
Tb. whereas national and local constituencies enable candidates to forge links with their voters; whereas such links are likely to increase citizens’ interest in European issues;
Amendment 95 #
2020/2220(INL)
Motion for a resolution
Recital W
Recital W
Amendment 107 #
2020/2220(INL)
Motion for a resolution
Recital X
Recital X
X. whereas postal, electronic and internet voting could make the conduct of European elections more efficient and more appealing for voters, whilston condition that such procedures ensuringe the highest possible standards of data protection;
Amendment 115 #
2020/2220(INL)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers it essential to improve the transparency and democratic accountability of the Parliament, by strengthening the European dimension of the elections, notably by shifting the debate in election campaigns away from national topics towards genuinely European issues; in addition, considers it essential to transform the European elections into a single European election, as opposed to the collection of 27 separate national elections, which is the way that European elections are mainly perceived today;
Amendment 131 #
2020/2220(INL)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the European institutions to take into account the priorities identified by European citizens in the context of the Conference on the Future of Europe;
Amendment 144 #
2020/2220(INL)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Welcomes the overall improvement in gender equality in the last elections; stresses, however, that there are significant differences between Member States, with some not having elected to Parliament a single woman;
Amendment 157 #
2020/2220(INL)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Believes that all European voters should be allowed to indicate their preferred candidate for the President of the Commission, and that leading candidates should be able to stand in all Member States, nominated by a European political party, by a movement or by a coalition of European parties, putting forward a common electoral programme;
Amendment 166 #
2020/2220(INL)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on European political parties and movements to nominate their candidates for the position of President of the Commission - or common candidates of a coalition of European parties and movements - at least 12 weeks before the start of the electoral period; considers that binding democratic procedures and transparency in the selection should be ensured; expects candidates to be placed in the first position of the corresponding list of the joint constituency;
Amendment 179 #
2020/2220(INL)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Notes that a coordinated media strategy at European level to ensure coverage and monitoring of the European elections would help to increase citizens’ interest in them;
Amendment 185 #
2020/2220(INL)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 199 #
2020/2220(INL)
Motion for a resolution
Paragraph 16
Paragraph 16
Amendment 210 #
2020/2220(INL)
Motion for a resolution
Paragraph 17
Paragraph 17
Amendment 223 #
2020/2220(INL)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Recalls that the minimum age for eligibility to stand as a candidate across the 27 Member States varies between 18 and 25; calls foron the introduction of a single,Member States to coordinate with a view to harmonising thed age for passive and active voting rights across Member States as a way to ensure real voting equality and to avoid discrimination in the most fundamental area of citizenship, namely the right to participate in the democratic process ;
Amendment 231 #
2020/2220(INL)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Suggests that measures be taken and safeguards be put in place to avoid foreign interference in the electoral process;
Amendment 233 #
2020/2220(INL)
Motion for a resolution
Paragraph 21
Paragraph 21
Amendment 261 #
2020/2220(INL)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Believes that establishing a common European voting day would create a more coherent pan-European election and therefore suggests fixing 9th May as the European election day, regardless of the day of the week on which it falls, with the possibility of that day becoming a public holiday; considers it important that the first official projections of the electoral results are announced simultaneously in all Member States on the election day at 21:00 hours CET;
Amendment 275 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Recital 5
Annex to the motion for a resolution – Recital 5
(5) Article 17(7) of the Treaty on European Union (TEU) gives the European Parliament the right to elect the President of the European Commission. In order to give that right its appropriate expression, the European public sphere should be developed in such a way that all European voters are allowed to indicate their preferred candidate for the President of the European Commission. For this to happen, the lead candidates nominated by a European political party, by a movement or by a coalition of European parties, need to be able to stand behind a common electoral programme in all Member States. Likewise, a Union-wide constituency, in which lists are headed by each political family’s candidate for President of the Commission, should be created, in order to enhance the democratic and pan- European dimension of the European elections. That Union- wide constituency should be subject to clear rules ensuring gender and demographic proportionality, with particular attention to small and medium sized Member States.
Amendment 285 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Recital 6
Annex to the motion for a resolution – Recital 6
(6) According to Article 10(4) of the TEU, political parties at European level contribute to forming European political awareness and to expressing the will of citizens of the Union. European political parties and movements should therefore play a more central role in the European elections’ process, including by giving them the possibility of tabling pan- European lists in the Union-wide constituency, so that they become known by and more visible to electors, both on ballot papers and in campaign materials and publications.
Amendment 300 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Recital 9
Annex to the motion for a resolution – Recital 9
Amendment 321 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Recital 12
Annex to the motion for a resolution – Recital 12
(12) The minimum age for the exercise of active passive voting rights varies across the 27 Member States. AThe Member States should coordinate to introduce a single harmonised age for active and passive voting should be introduced across the Union in order to ensure equality and to avoid discrimination in the most fundamental civic and political right - the right to vote.
Amendment 329 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Recital 13
Annex to the motion for a resolution – Recital 13
(13) The 1976 Electoral act established a common electoral period, giving the Member States the power to set the exact date and the time for the elections within that period. A truly pan-European election requires not just a common period, but a common European voting day. The elections for the European Parliament should be held on 9 May, Europe Day, marking the anniversary of the Schuman Declaration of 9 May 1950.
Amendment 331 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 1
Annex to the motion for a resolution – Article 2 – point 1
(1) ‘political party’ means an association of citizens which pursues political objectives and which is either recognised by, or established in accordance with, the legal order of at least one Member State and that intends to form or to join a European coalition of national political parties and/or national political movements in order to table a list of candidates to, and campaigning for, the Union-wide constituencyor is established in accordance with that legal order;
Amendment 336 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 2
Annex to the motion for a resolution – Article 2 – point 2
Amendment 343 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 3
Annex to the motion for a resolution – Article 2 – point 3
Amendment 350 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 4
Annex to the motion for a resolution – Article 2 – point 4
(4) ‘European political party’ means a political alliance of national political parties which pursues political objectives and is registered with the Authority for European political parties and foundations in accordance with Regulation (EU, Euratom) No 1141/20148 for the purposes of tabling a candidacy to, and campaigning for, the Union-wide constituency; __________________ 8 Regulation (EU, Euratom) No 1141/2014 of the European Parliament and of the Council of 22 October 2014 on the statute and funding of European political parties and European political foundations, OJ 2014/L 317/1.
Amendment 356 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 5
Annex to the motion for a resolution – Article 2 – point 5
Amendment 361 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 6
Annex to the motion for a resolution – Article 2 – point 6
Amendment 367 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 7
Annex to the motion for a resolution – Article 2 – point 7
Amendment 372 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 2 – point 8
Annex to the motion for a resolution – Article 2 – point 8
Amendment 390 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 4
Annex to the motion for a resolution – Article 4
Every European Union citizen from 18 years of age shall havewho, in respect of the right to vote and to stand as a candidate for election to the European Parliament, in both the national and in the Union-wide constituency, without prejudice to those Member States that, at the date of the entry into force of this Regulation, have set the minimum age that is lower than 18 for eligibility to vote and for eligibility to stand as a candidate, satisfies the same conditions which the state in which he or she votes imposes by law on its own nationals shall have the right to vote and to stand as a candidate for election to the European Parliament.
Amendment 403 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 6 – paragraph 1
Annex to the motion for a resolution – Article 6 – paragraph 1
1. No one shall vote more than once in any election of members of the European Parliament in the national constituencies.
Amendment 406 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 6 – paragraph 2
Annex to the motion for a resolution – Article 6 – paragraph 2
2. Member States shall take measures necessary to ensure that double voting in elections to the European Parliament in the national constituencies is subject to effective, proportionate and dissuasive penalties.
Amendment 443 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 12 – paragraph 2
Annex to the motion for a resolution – Article 12 – paragraph 2
2. Members of the European Parliament shall be elected as representatives of the citizens of the Union on the basis of proportional representation, in each Member State and in the Union- wide constituency.
Amendment 451 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 12 – paragraph 4
Annex to the motion for a resolution – Article 12 – paragraph 4
Amendment 466 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 13 – paragraph 2
Annex to the motion for a resolution – Article 13 – paragraph 2
Amendment 471 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 14 – paragraph 2
Annex to the motion for a resolution – Article 14 – paragraph 2
Each Member State shall regulate and set a ceiling for candidates' electoral campaigning expenses in the respective national constituency, in accordance with the respective national provisions.
Amendment 472 #
Amendment 542 #
Amendment 592 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 17 – paragraph 2 – subparagraph 1
Annex to the motion for a resolution – Article 17 – paragraph 2 – subparagraph 1
2. In the national constituencies, tThe ballot papers used in elections to the European Parliament shall give equal visibility to the names and logos of national parties and if applicable, national political movements, and to those of the European political parties, European political movements, and European electoral alliances, when affiliated to any of them.
Amendment 598 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 17 – paragraph 4
Annex to the motion for a resolution – Article 17 – paragraph 4
Amendment 607 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 18 – paragraph 1
Annex to the motion for a resolution – Article 18 – paragraph 1
1. Each Member State shall designate a contact authority responsible for exchanging data on voters and candidates with its counterparts in the other Member States and with the European Electoral Authority established under Article 27.
Amendment 612 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 18 – paragraph 2
Annex to the motion for a resolution – Article 18 – paragraph 2
2. The national authority referred to in paragraph 1 shall, in accordance with the applicable EU law concerning the protection of personal data, begin transmitting to thoseits counterparts and the European Electoral Authority, no later than six weeks before the Election day as defined in Article 19(1), the data indicated in Council Directive 93/109/EC10 concerning citizens of the Union who, in a Member State of which they are not nationals, have been entered on the electoral roll or are standing as candidates. __________________ 10 Council Directive 93/109/EC of 6 December 1993 laying down detailed arrangements for the exercise of the right to vote and stand as a candidate in elections to the European Parliament for citizens of the Union residing in a Member State of which they are not nationals (OJ L 329, 30.12.1993, p. 34).
Amendment 614 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 19 – paragraph 1
Annex to the motion for a resolution – Article 19 – paragraph 1
1. Elections to the European Parliament shall be held on 9 May of the last year of a parliamentary term, as referred to in Article 20a common day determined by the Member States. The election shall end in all Member States by 21:00 hours local time on that day.
Amendment 622 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 19 – paragraph 3
Annex to the motion for a resolution – Article 19 – paragraph 3
Amendment 630 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 22 – paragraph 2
Annex to the motion for a resolution – Article 22 – paragraph 2
For this purpose it shall take note of the results declared officially by the Member States and by the European Electoral Authority, and shall rule on any disputes which may arise out of the provisions of this Regulation other than those arising out of the national provisions to which this Regulation refers.
Amendment 642 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 26 – paragraph 5
Annex to the motion for a resolution – Article 26 – paragraph 5
Amendment 653 #
Amendment 714 #
2020/2220(INL)
Motion for a resolution
Annex to the motion for a resolution – Article 30
Annex to the motion for a resolution – Article 30
Amendment 3 #
2020/2132(INI)
Motion for a resolution
Recital -A (new)
Recital -A (new)
-A. whereas Article 15 of the TEU specifies that the European Council shall not exercise legislative functions;
Amendment 5 #
2020/2132(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas Article 48 of the TEU sets out the Treaty revision procedures, and whereas such procedures are necessary to give the European Parliament a new right of initiative;
Amendment 78 #
2020/2132(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Reiterates the special and reinforced constitutional dignity of the issues that are currently subject to the initiative of Parliament and considers that such an exclusive right should be extended to issues where democratic legitimacy is especially relevantat the areas in which it has a direct right of initiative are currently limited to issues of a constitutional nature; believes that this direct right of initiative should be extended to all areas;
Amendment 89 #
2020/2132(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Considers that the recognition of a direct right of initiative of Parliament would not exclude the possibility of the Commission retaining a concurrent right or keeping a monopoly of initiative in certain areas, such asthe area of the budget; could also envisage that in exceptional areas, the Council would also have a monopolydirect right of initiative in strictly defined areas;
Amendment 1 #
2020/2071(INI)
Motion for a resolution
Citation 7
Citation 7
— having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Article 81 thereof concerning an adequate and uninterrupted supply of medicinal products, and Article 23a thereof on notifying the competent authority if a product ceases to be placed on the market on a temporary or permanent basis,
Amendment 31 #
2020/2071(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand hasin particular has very sharply aggravated shortages of medicines in the EU over the last few years, undermining health services in the Member States and exposing patients to considerable health and other risks; whereas the Member States have a duty to find swift and, effective and coordinated solutions through closer European integration;
Amendment 43 #
2020/2071(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas there are no definitions harmonised between Member States of ‘shortages’, ‘tensions’, ‘supply disruptions’ and ‘overstocking’; whereas a distinction should be made between ‘medicinal products of major therapeutic interest’ (MITMs) and ‘medicines of health and strategic interest’(MISS);
Amendment 45 #
2020/2071(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 88 #
2020/2071(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in the health sector is linked to the relocation of production, with 40 % the volume of medicinal end products marketed in the EU now originating in third countries; whereas the onlyone way to save money is to rely heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 80% of active chemical ingredients are manufactured outside the EU, mainly in China and India;
Amendment 122 #
2020/2071(INI)
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicalactive pharmaceutical ingredients that are cheap and easy to produce and mature medicines which are however essential for public health being in particularly short supply; whereas pharmaceutical firms operate on a just-in-time basis;
Amendment 187 #
2020/2071(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas a strong, innovative and competitive pharmaceutical industry in Europe is in the vital interest of the EU and its Member States;
Amendment 190 #
2020/2071(INI)
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas the pharmaceutical industry needs the right legal framework to do research, development and production of pharmaceuticals within the EU;
Amendment 245 #
2020/2071(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients' interests and safety for closer cooperation between Member States;
Amendment 249 #
2020/2071(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Insists on the importance of a definition harmonised between Member States of ‘shortages’, ‘tensions’, ‘supply disruptions’ and ‘overstocking’; calls on the Commission to work on harmonising these concepts in conjunction with all the players concerned; calls for a distinction to be made between ‘medicinal products of major therapeutic interest’ (MITMs) and ‘medicines of health and strategic interest’(MISS);
Amendment 272 #
2020/2071(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map outensure the conditions for security of supply of health products and local pharmaceutical manufacturing, giving priority to ‘medicinal products of major therapeutic interest’; calls on the Commission and the Member States, with the help of producers, to draw up an evolving map of current and potential production sites within the EUnion with the aim of maintaining them in the long term and modernising and strengthening them where necessary, possible and viable;
Amendment 304 #
2020/2071(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers', the collaboration of national regulatory authorities and the EU’s dependence on third countries;
Amendment 335 #
2020/2071(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce measures to support competitiveness and tax and financial incentives in return for appropriate commitments and to authorise, with due respect for international and EU legislation, state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification, with any public incentive having as a counterpart the transparency and traceability of investments, as well as the obligation to supply the European market;
Amendment 389 #
2020/2071(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that security of supply is an essential factor in combating shortages and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tender for the supply of medicines, as recommended in Article 67 of Directive 2014/24/EU; proposes that investments in the manufacture of active ingredients and medicinal end products in the EU should also be a criterion as well as the number, location of production sites, and the application of social, environmental, ethical and quality standards;
Amendment 428 #
2020/2071(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or more European non-profit pharmaceutical undertakings which operate in the public interest, on the model of army or hospital pharmacies, to manufacture priority medicines of strategic importance for health care in the absence of an existing industrial production facility and ensuring security of supply; stresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings; calls on the Commission to make proposals on the establishment within the Union of public-private partnerships along the lines of the US Biomedical Advanced Research and Development Authority;
Amendment 488 #
2020/2071(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management to bring about greater transparency in the medicine production and distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supplyunit for preventing and managing shortages;
Amendment 512 #
2020/2071(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on the Commission and the Member States to reflect on the establishment of harmonised shortage management plans obliging producers to identify medicines of major therapeutic interest requiring the introduction of preventive and corrective measures in order to avoid or alleviate any disruption in supplies;
Amendment 523 #
2020/2071(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Ccalls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treestablish a financial programme to build up a stock of medicines of strategic importance for health care to ensure that patmient of cancer and infections whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatments have access to treatment; calls on the Commission to examine the possibility of a harmonised price for these essential medicines in order to make up for the shortages;
Amendment 553 #
2020/2071(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create a European contingency reserve of medicines of strategic importance for health care, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods and to make it an emergency European pharmacy;
Amendment 595 #
2020/2071(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; considers that the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff; calls on the Commission to amend existing legislation in order to strengthen the Agency's capacities;
Amendment 611 #
2020/2071(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issued at European level, following a reasoned opinion and under the control of the Commission, in an effort to counter shortages, as has been done following the onset ofinitiated for the COVID-19 virus, simplifying procedures in the interests ofto ensure improved response times;
Amendment 645 #
2020/2071(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling; calls on the Commission and the Member States to set up an early warning system both at national and European level in order to reinforce the obligation to notify pharmaceutical companies of any interruption or tension in the supply of medicines;
Amendment 698 #
2020/2071(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languages for every medicine on the EU market in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensivcalls on the Commission to review the regulations to obtain more precise information on the origin of medicines;
Amendment 38 #
2020/0374(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) A fragmentation of the internal market can only be effectively averted if Member States are prevented from applying national rules which are specific to the types of undertakings and services covered by this Regulation. At the same time, sNothing in this Regulation precludes the Member States from imposing the same or stricter obligations on undertakings in pursuit of legitimate public interests, in accordance with Union law. Legitimate public interests include, among others, consumer protection, the fight against unfair competition, and the protection of freedom and pluralism. In particular, there is nothing in this Regulation to preclude the Member States from pursuing these legitimate public interests by imposing obligations on undertakings with gatekeeper status in accordance with this Regulation. Since this Regulation aims at complementing the enforcement of competition law, it should be specified that this Regulation is without prejudice to Articles 101 and 102 TFEU, to the corresponding national competition rules and to other national competition rules regarding unilateral behaviour that are based on an individualised assessment of market positions and behaviour, including its likely effects and the precise scope of the prohibited behaviour, and which provide for the possibility of undertakings to make efficiency and objective justification arguments for the behaviour in question. However, the application of the latter rules should not affect the obligations imposed on gatekeepers under this Regulation and their uniform and effective application in the internal market.
Amendment 41 #
2020/0374(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) Where the gatekeeper has a number of core platform services, separate authentication factors, for example separate user accounts set up for each core platform service, should be possible. It must not be mandatory to combine or link accounts belonging to business or end users.
Amendment 42 #
2020/0374(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) Gatekeepers may also provide ancillary services aimed at end users, alongside their basic services, and do so in a manner that is indistinguishable for the average user. These ancillary services may compete against the professional users of the platform's basic service and be a significant factor in any market imbalance, leading, ultimately, to an unfair increase in the power of the gatekeeper, including with respect to its commercial partners, such as suppliers of goods and services, who depend on this ancillary service. To prevent gatekeepers from unfairly benefiting from the leverage provided by the ancillary services, these services should also be subject to the obligations applicable to core platform services.
Amendment 60 #
2020/0374(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) In particular gatekeepers which provide access to software application storeCore platform services provided by gatekeepers serve as an important gateway for business users that seek to reach end users. In view of the imbalance in bargaining power between those gatekeepers and business users of their software application stores, those gatekeepers should not be allowed to impose general conditions, including pricing conditions, that would be unfair or lead to unjustified differentiation. Pricing or other general access conditions should be considered unfair if they lead to an imbalance of rights and obligations imposed on business users or confer an advantage on the gatekeeper which is disproportionate to the service provided by the gatekeeper to business users or lead to a disadvantage for business users in providing the same or similar services as the gatekeeper. The following benchmarks can serve as a yardstick to determine the fairness of general access conditions: prices charged or conditions imposed for the same or similar services by another providers of software application storcore platform services; prices charged or conditions imposed by the provider of the software application store for different related or similar services or to different types of end users; prices charged or conditions imposed by the provider of the software application storecore platform services for the same service in different geographic regions; prices charged or conditions imposed by the provider of the software application store for the same service the gatekeeper offers to itself. This obligation should not establish an access right and it should be without prejudice to their ability of providers of software application stores to take the required responsibility in the fight against illegal and unwanted content as set out in Regulation [Digital Services Act].
Amendment 74 #
2020/0374(COD)
Proposal for a regulation
Article premier – paragraph 5
Article premier – paragraph 5
5. Member States shall not impose on gatekeepers further obligations by way of laws, regulations or administrative action for the purpose of ensuring contestable and fair markets. This is without prejudice to rules pursuing other legitimate public interests, in compliance with Union law. In particular, nothing in this Regulation precludes Member States from imposing obligations, which are compatible with Union lawpursue a legitimate public interest, on undertakings, including providers of core platform services where these obligations are unrelated to the relevant undertakings having a status of gatekeeper within the meaning of this Regulation in order to protect consumers or to fight against acts of unfair competition.
Amendment 115 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) refrain from combining personal data sourced from these core platform services with personal data from any other services offered by the gatekeeper or with personal data from third-party services, and from signing in end users to other services of the gatekeeper in order to combine personal data, unless the end user has been presented with the specific choice and provided consent in the sense of Regulation (EU) 2016/679. except when disclosing data to third parties commissioned by one or more professional users to perform independent traffic analytics with a view to ensuring market share transparency and safeguarding the general and/or public interests;
Amendment 119 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) refrain from directly or indirectly preventing or restricting business and end users from raising issues with any relevant public authority relating to any practice of gatekeepers, including by means of the reporting mechanism for professional and end users pursuant to Article 18a;
Amendment 124 #
2020/0374(COD)
(9) A fragmentation of the internal market can only be effectively averted if Member States are prevented from applying national rules which are specific to the types of undertakings and services covered by this Regulation. At the same time, sNothing in this Regulation precludes the Member States from imposing the same or stricter obligations on undertakings in pursuit of legitimate public interests, in accordance with Union law. Legitimate public interests include, among others, consumer protection, the fight against unfair competition, and the protection of freedom and pluralism. In particular, there is nothing in this Regulation to preclude the Member States from pursuing these legitimate public interests by imposing obligations on undertakings with gatekeeper status in accordance with this Regulation. Since this Regulation aims at complementing the enforcement of competition law, it should be specified that this Regulation is without prejudice to Articles 101 and 102 TFEU, to the corresponding national competition rules and to other national competition rules regarding unilateral behaviour that are based on an individualised assessment of market positions and behaviour, including its likely effects and the precise scope of the prohibited behaviour, and which provide for the possibility of undertakings to make efficiency and objective justification arguments for the behaviour in question. However, the application of the latter rules should not affect the obligations imposed on gatekeepers under this Regulation and their uniform and effective application in the internal market.
Amendment 131 #
2020/0374(COD)
(ga) refrain from communicating, or using for its own purposes, sensitive information obtained in the context of an advertising service, or from using it for any purpose other than the performance of the concluded service agreement, unless the gatekeeper and its client have agreed otherwise.
Amendment 133 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) refrain from using, in competition with business users, any data not publicly available, which is generated through activities by those business users, including by the end users of these business users, of its core platform services or ancillary services or provided by those business users of its core platform services or by the end users of these business users via the core platform services or ancillary services;
Amendment 135 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) allowinform end users to un-installupon first use of any pre-installed software applications on its core platform service and of the option to un-install them, without prejudice to the possibility for a gatekeeper to restrict such un-installation in relation to software applications that are essential for the functioning of the operating system or of the device and which cannot technically be offered on a standalone basis by third- parties;
Amendment 139 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d
Article 6 – paragraph 1 – point d
(d) refrain from treating more favourably in rankingor differently in terms of ranking, access or terms of service, or technical features and interfaces, services and products offered by the gatekeeper itself or by any third party belonging to the same undertaking compared to similar services or products of thirdany other party and apply fair and non-discriminatory conditions to such rankingin terms of ranking, access or terms of service, and technical features and interfaces;
Amendment 140 #
2020/0374(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) Where the gatekeeper has a number of core platform services, separate authentication, for example separate user accounts set up for each core platform service, should be possible. It must not be mandatory to combine or link accounts belonging to business or end users.
Amendment 141 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d a (new)
Article 6 – paragraph 1 – point d a (new)
(da) have its online search engine, online social networking or intermediation service display its own advertisements or services following an end user query only if the search results are relevant, and inform the end user, by means of an explicit and easily identifiable statement to that effect, that the search result relates to an advertisement or service belonging to the gatekeeper itself;
Amendment 141 #
2020/0374(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) Gatekeepers may also provide ancillary services aimed at end users, alongside their basic services, and do so in a manner that is indistinguishable for the average user. These ancillary services may compete against the professional users of the platform's basic service and be a significant factor in any market imbalance, leading, ultimately, to an unfair increase in the power of the gatekeeper, including with respect to its commercial partners, such as suppliers of goods and services, who depend on this ancillary service. To prevent gatekeepers from unfairly benefiting from the leverage provided by the ancillary services, these services should also be subject to the obligations applicable to core platform services.
Amendment 142 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point e
Article 6 – paragraph 1 – point e
(e) refrain from technically restricting the ability of end users to switch between and subscribe to different software applications andcontent or services to be accessed using the operating systemcore platform service of the gatekeeper, including as regards the choice of Internet access provider for end users, or the use of a vocal assistant;
Amendment 147 #
2020/0374(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) A fragmentNothing in this Regulation precludes Member States from imposing the same, stricter or different obligations of the internal market can only be effectively averted if Member States are prevented from applying national rules which are specific to the typen undertakings in order to pursue legitimate public interests, in compliance with Union law. Those legitimate public interests can be, among others, the protection of consumers, the fight against acts of unfair competition and the protection of media freedom and pluralism. In particular, nothing in this Regulation precludes Member States from pursuing those legitimate interests by imposing obligations ofn undertakings and services covered by this Regulation. At the same time, shaving a status of gatekeeper within the meaning of this Regulation as well as other undertakings. Since this Regulation aims at complementing the enforcement of competition law, it should be specified that this Regulation is without prejudice to Articles 101 and 102 TFEU, to the corresponding national competition rules and to other national competition rules regarding unilateral behaviour that are based on an individualised assessment of market positions and behaviour, including its likely effects and the precise scope of the prohibited behaviour, and which provide for the possibility of undertakings to make efficiency and objective justification arguments for the behaviour in question. However, the application of the latter rules should not affect the obligations imposed on gatekeepers under this Regulation and their uniform and effective application in the internal market.
Amendment 149 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point g
Article 6 – paragraph 1 – point g
(g) provide advertisers and publishers, or third parties authorised by the advertisers and publishers, upon their request and free of charge, with access to the performance measuring tools of the gatekeeper and the information necessary for advertisers and publishers to carry out their own independent verification of the ad inventory;
Amendment 153 #
2020/0374(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation should also complement, without prejudice to their application, the rules resulting from other acts of Union law regulating certain aspects of the provision of services covered by this Regulation, in particular Regulation (EU) 2019/1150 of the European Parliament and of the Council26 , Regulation (EU) xx/xx/EU [DSA] of the European Parliament and of the Council27 , Regulation (EU) 2016/679 of the European Parliament and of the Council28 , Directive (EU) 2019/790 of the European Parliament and of the Council29 , Directive (EU) 2015/2366 of the European Parliament and of the Council30 , and Directive (EU) 2010/13 of the European Parliament and of the Council31 , as well as national rules aimed at enforcing or, as the case may be, implementing that Union legislation. _________________ 26 Regulation (EU) 2019/1150 of the European Parliament and of the Council of 20 June 2019 on promoting fairness and transparency for business users of online intermediation services (OJ L 186, 11.7.2019, p. 57). 27Regulation (EU) …/.. of the European Parliament and of the Council – proposal on a Single Market For Digital Services (Digital Services Act) and amending Directive 2000/31/EC. 28Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 29Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/ (OJ L 130, 17.5.2019, p. 92.). 30Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC ( OJ L 337, 23.12.2015, p. 35). 31Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p. 1)taken in accordance with that Union legislation.
Amendment 153 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point h
Article 6 – paragraph 1 – point h
(h) provide effective portability of data provided or generated through the activity of a business user or end user and shall, in particular, provide tools, foree of charge, to business users and end users to facilitate the exercise of data portability, in line with Regulation EU 2016/679, including by the provision of continuous and real-time access ;
Amendment 159 #
2020/0374(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) In particular, online intermediation services, (including, among others, marketplaces, app stores, digital voice assistants), online search engines, operating systems, online social networking, video sharing platform services, number- independent interpersonal communication services, cloud computing services and online advertising services all have the capacity to affect a large number of end users and businesses alike, which entails a risk of unfair business practices. They therefore should be included in the definition of core platform services and fall into the scope of this Regulation. Online intermediation services may also be active in the field of financial services, and they may intermediate or be used to provide such services as listed non-exhaustively in Annex II to Directive (EU) 2015/1535 of the European Parliament and of the Council32 . In certain circumstances, the notion of end users should encompass users that are traditionally considered business users, but in a given situation do not use the core platform services to provide goods or services to other end users, such as for example businesses relying on cloud computing services for their own purposes. For marketplaces, an active end user is a user who has completed at least one commercial transaction each month. _________________ 32Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, OJ L 241, 17.9.2015, p. 1.
Amendment 160 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point i
Article 6 – paragraph 1 – point i
(i) provide business users, or third parties authorised by a business user, free of charge, with effective, high-quality, continuous and real-time access and use of aggregated or non-aggregated data, that is provided for or generated in the context of the use of the relevant core platform servicesor ancillary services offered by the gatekeeper by those business users and the end users engaging with the products or services provided by those business users; for personal data, provide access and use only where directly connected with the use effectuated by the end user in respect of the products or services offered by the relevant business user through the relevant core platform service, and when the end user opts in to such sharing with a consent in the sense of the Regulation (EU) 2016/679; ;
Amendment 166 #
2020/0374(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14 a) Gatekeepers may also provide other ancillary services, for instance retailing or distribution activities, that are targeted at end users alongside their core platform services and in a manner that is indistinguishable for the average user. Such ancillary services can compete with business users of the core platform service and contribute significantly to the imbalance in a given market and ultimately increase unfairly the gatekeeper’s power, including in relation to the gatekeeper’s business partners, such as suppliers of goods or services, relying on such ancillary service. To prevent gatekeepers from unfairly benefiting from the leverage provided by provision of parallel services, such ancillary services should also be subject to the obligations applicable to core platform services.
Amendment 167 #
2020/0374(COD)
Proposal for a regulation
Recital 14 b (new)
Recital 14 b (new)
(14 b) The impact of gatekeepers on the market makes their business partners, whether business users or suppliers of ancillary services, highly vulnerable to unfair terms and conditions of the gatekeepers they rely on. As such, gatekeeper should ensure that their terms and conditions are transparent and fair. While appropriate and proportionate sanctions in case of in breach of such terms and conditions should be allowed, they should be formally justified and allow for the sanctioned party to contest them. For this purpose, gatekeepers should provide for an internal system for handling swiftly the complaints of their business users and suppliers of ancillary services, including in their national language if the gatekeeper’s service actively targets the Member State concerned.
Amendment 168 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point k
Article 6 – paragraph 1 – point k
(k) apply fair and non-discriminatory general conditions of access forand treatment to business users of its core platform service, in particular to business users tof its software application store, search engine, online payment service or online social networking service, designated pursuant to Article 3 of this Regulation.;
Amendment 188 #
2020/0374(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
Amendment 191 #
2020/0374(COD)
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Amendment 192 #
2020/0374(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
The Commission may conduct a market investigation with the purpose of examining whether one or more services within the digital sector should be added to the list of core platform services or to detect types of practices that may limit the contestability of core platform services or may be unfair and which are not effectively addressed by this Regulation. It shall issue a public report at the latest within 124 months from the opening of the market investigation.
Amendment 194 #
2020/0374(COD)
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article 18a Reporting mechanism for professional and end users 1. Professional users, including competitors, and end users of the core platform services defined in Article 2(2) may, in a report, notify the Commission or a national competition authority of any practice or behaviour on the part of a gatekeeper that falls within the scope of this Regulation. The Commission shall grant the Member States access to these reports. 2. If the report pursuant to paragraph 1 is received by a national competition authority, it is forwarded directly to the Commission. 3. The Commission shall establish the conditions for submission of the reports referred to in paragraph 1. It shall also establish the conditions in which the Member States, in particular the national competition authorities, are notified of and given access to these reports. 4. The Commission shall have the power to set its priorities for examining the reports referred to paragraph 1. Subject to the provisions of paragraph 5 below and of Article 33, the Commission shall have the power to choose to not examine a report where it does not consider that report to be an enforcement priority. 5. When the Commission considers that a report is an enforcement priority, it may open proceedings pursuant to Article 18 or a market investigation pursuant to Article 14.
Amendment 205 #
2020/0374(COD)
Proposal for a regulation
Article 31 a (new)
Article 31 a (new)
Article 31a Cooperation with the national competition authorities and their powers 1. The Commission shall ensure that the reports forwarded pursuant to Article 16b of this Regulation are made available to the national competition authorities within the European Competition Network, defined in Article 2(1)(5) of Directive (EU) 2019/1. 2. The Commission shall circulate within the European Competition Network the decisions relating to the opening of a market investigation pursuant to Article 14 or proceedings pursuant to Article 18. The national competition authorities may provide the Commission, on a voluntary basis, with any information deemed helpful and necessary for the purpose of the market investigation carried out pursuant to Articles 15, 16, 16a and 17, and provide the Commission with assistance, upon request, in implementing Articles 19, 20 and 21.
Amendment 208 #
2020/0374(COD)
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
1. When three or more Member States request the Commission to open an investigation pursuant to Article 15 because they consider that there are reasonable grounds to suspect that a provider of core platform services should be designated as a gatekeeper4, the Commission shall within four months examine whether there are reasonable grounds to open such an investigation.
Amendment 216 #
2020/0374(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) Because of their position, gatekeepers might, in certain cases, through the imposition of contractual terms and conditions, restrict the ability of business users of their online intermediation services to offer their goods or services to end users under more favourable conditions, including price, through other online intermediation services or their own websites, other distribution channels or the direct online sales channels they own. Such restrictions have a significant deterrent effect on the business users of gatekeepers in terms of their use of alternative online intermediation servicedistribution channels, limiting inter-platform contestability, which in turn limits choice of alternative online intermediation channels for end users. To ensure that business users of online intermediation services of gatekeepers can freely choose alternative online intermediation services and differentiate the conditions under which they offer their products or services to their end users, it should not be accepted that gatekeepers limit business users from choosing to differentiate commercial conditions, including price. Such a restriction should apply to any measure with equivalent effect, such as for example increased commission rates or de-listing of the offers of business users.
Amendment 227 #
2020/0374(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) To prevent further reinforcing their dependence on the core platform services of gatekeepers, the business users of these gatekeepers should be free in promoting and choosing the distribution channel they consider most appropriate to interact with any end users that these business users have already acquired through core platform services provided by the gatekeeper. Conversely, end users should also be free to choose offers of such business users and to enter into contracts with them either through core platform services of the gatekeeper, if applicable, or from a direct distribution channel of the business user or another indirect distribution channel such business user may use. This should apply to the promotion of offers and conclusion of contracts between business users and end users. Moreover, the ability of end users to freely acquire contentdigital content and services, subscriptions, features or other items outside the core platform services of the gatekeeper should not be undermined in any way or restricted, especially through the use of technical restrictions. In particular, it should be avoided that gatekeepers restrict end users from access to and use of such services via a software application running on their core platform service. For example, subscribers to online content purchased outside a software application download or purchased from a software application store should not be prevented from accessing such online content on a software application on the gatekeeper’s core platformlegally acquired digital content and services via hardware or software features that are used by that gatekeeper when providing a similar digital content or digital service, simply because it was purchased outside such software application or software application storthe gatekeeper’s core platform service.
Amendment 238 #
2020/0374(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Identification services areGatekeepers offer a range of ancillary services. To ensure contestability, it is crucial forthat business users to conduct their business, as these can allow them not only to optimise services, to the extent allowed under Regulation (EU) 2016/679 and Directive 2002/58/EC of the European Parliament and of the Council33 , but also to inject trust in online transactions, in compliance with Union or national laware free to choose such ancillary services freely, without having to fear any detrimental effects for the provision of the core platform service. Gatekeepers should therefore not use their position as provider of core platform services to require their dependent business users to include any identificationuse, offer or include any ancillary services provided by the gatekeeper itself as part of the provision of services or products by these business users toor a particular their end usersd party , where other identificationancillary services are available to such business users. _________________ 33Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data andIn particular, gatekeepers shall not make their service dependent on business users including any identification service provided by the gatekeeper itself as part of the protectvision of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37)services or products by these business users to their end users, where alternatives exist.
Amendment 243 #
2020/0374(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) Gatekeepers should not restrict the free choice of end users by technically preventing switching between or subscription to different software applications and services. Gatekeepers should therefore ensure a free choice irrespective of whether they are the manufacturer of any hardware by means of which such software applications or services are accessed and should not raise artificial technical barriers so as to make switching impossiblemore difficult or ineffective. The mere offering of a given product or service to end users, including by means of pre- installation, as well the improvement of end user offering, such as better prices or increased quality, would not in itself constitute a barrier to switching.
Amendment 243 #
2020/0374(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) In particularCore platform services provided by gatekeepers, which provide access to software application stores, serve as an important gateway for business users that seek to reach end users. In view of the imbalance in bargaining power between those gatekeepers and business users of their software application stores, those gatekeepers should not be allowed to impose general conditions, including pricing conditions, that would be unfair or lead to unjustified differentiation. Pricing or other general access conditions should be considered unfair if they lead to an imbalance of rights and obligations imposed on business users or confer an advantage on the gatekeeper which is disproportionate to the service provided by the gatekeeper to business users or lead to a disadvantage for business users in providing the same or similar services as the gatekeeper. The following benchmarks can serve as a yardstick to determine the fairness of general access conditions: prices charged or conditions imposed for the same or similar services by another providers of software application storcore platform services; prices charged or conditions imposed by the provider of the software application store for different related or similar services or to different types of end users; prices charged or conditions imposed by the provider of the software application storecore platform services for the same service in different geographic regions; prices charged or conditions imposed by the provider of the software application store for the same service the gatekeeper offers to itself. This obligation should not establish an access right and it should be without prejudice to their ability of providers of software application stores to take the required responsibility in the fight against illegal and unwanted content as set out in Regulation [Digital Services Act].
Amendment 248 #
2020/0374(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) A gatekeeper may in certain circumstances have a dual role as a provider of core platform services whereby it provides a core platform service to its business users, while also competing with those same business users in the provision of the same or similar services or products to the same end users, including as part of an ancillary service. In these circumstances, a gatekeeper may take advantage of its dual role to use data, generated from transactions by its business users on the core platform or from transactions on its ancillary service, for the purpose of its own services that offer similar services or goods to that of its business users or of its suppliers. This may be the case, for instance, where a gatekeeper provides an online marketplace or app store to business users, and at the same time offer services as an online retailer or provider of application software against those business users or against its suppliers. To prevent gatekeepers from unfairly benefitting from their dual role, it should be ensured that they refrain from using any aggregated or non-aggregated data, which may include anonymised and personal data that is not publicly available to offer similar services to those of their business users. This obligation should apply to the gatekeeper as a whole, including but not limited to its business unit that competes with the business users of a core platform service or with the supplier of an ancillary service.
Amendment 260 #
2020/0374(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The rules that the gatekeepers set for the distribution of software applications may in certain circumstances restrict the ability of end users to install and effectively use third party software applications or software application stores on operating systems or hardware of the relevant gatekeeper and restrict the ability of end users to access these software applications or software application stores outside the core platform services of that gatekeeper. Such restrictions may limit the ability of developers of software applications to use alternative distribution channels and the ability of end users to choose between different software applications from different distribution channels and should be prohibited as unfair and liable to weaken the contestability of core platform services. In order to ensure that third party software applications or software application stores do not endanger the integrity of the hardware or operating system provided by the gatekeeper the gatekeeper concerned may implement proportionate technical or contractual measures to achieve that goal if the gatekeeper demonstrates that such measures are necessary and justified and that there are no less restrictive means to safeguard the integrity of the hardware or operating system. This prohibition on restricting the ability of end users to install and use, or access, third-party software applications or application stores should therefore also be without prejudice to the ability of gatekeepers to take the required responsibility in the fight against illegal content online.
Amendment 268 #
2020/0374(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) Gatekeepers are often vertically integrated and offer certain products or services to end users through their own core platform services, or through a business user over which they exercise control which frequently leads to conflicts of interest. This can include the situation whereby a gatekeeper offers its own online intermediation services through an online search engine. When offering those products or services on the core platform service, gatekeepers can reserve a better position to their own offering, in terms of ranking, as opposed to the products of third parties also operating onusing that core platform service. This can occur for instance with products or services, including other core platform services, which are ranked within or along in the results communicated by online search engines, or which are partly or entirely embedded in search results of online search engines results, groups of results specialised in a certain topic, displayed along with the results of an online search engine, which armay be considered or used by certain end users as a service distinct or additional to the online search engine. Such preferential or embedded display of a separate online intermediation service shall constitute a favouring irrespective of whether the information or results within the favoured groups of specialised results may also be provided by competing services and are as such ranked in anon- discriminatory way. Other instances are those of software applications which are distributed through software application stores, or products or services that are given prominence and display in the newsfeed of a social network, or products or services ranked in search results or displayed on an online marketplace. In those circumstances, the gatekeeper is in a dual- role position as intermediary for third party providers and as direct provider of products or services of the gatekeeper. Consequently, these gatekeepers have the ability to undermine directly the contestability for those products or services on these core platform services, to the detriment of business users which are not controlled by the gatekeeper.
Amendment 275 #
2020/0374(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) In such situations, the gatekeeper should not engage in any form of differentiated or preferential treatment in ranking on the core platform service, whether through legal, commercial or technical means, in favour of products or services it offers itself or through a business user which it cooperates with controls. To ensure that this obligation is effective, it should also be ensured that the conditions that apply to such ranking are also generally fair and the gatekeeper's own products or services do not have more access to information about the ranking or any other competition-relevant aspects than products or services of third parties. Ranking should in this context cover all forms of relative prominence, including among others order, graphic display, rating, linking or voice results. To ensure that this obligation is effective and cannot be circumvented it should also apply to any measure that may have an equivalent effect to the differentiated or preferential treatment in ranking. Such an equivalent effect can for instance be achieved by ad formats that are used by users in a similar manner to the gatekeeper's or third parties' online intermediation services, or that benefit the gatekeeper in a similar manner to the preferential treatment in ranking itself (e.g., in terms of financial gains, user access/traffic or data access). The guidelines adopted pursuant to Article 5 of Regulation (EU) 2019/1150 should also facilitate the implementation and enforcement of this obligation.34 _________________ 34Commission Notice: Guidelines on ranking transparency pursuant to Regulation (EU) 2019/1150 of the European Parliament and of the Council (OJ C 424, 8.12.2020, p. 1).
Amendment 292 #
2020/0374(COD)
Proposal for a regulation
Article premier – paragraph 5
Article premier – paragraph 5
5. Member States shall not impose on gatekeepers further obligations by way of laws, regulations or administrative action for the purpose of ensuring contestable and fair markets. This is without prejudice to rules pursuing other legitimate public interests, in compliance with Union law. In particular, nothing in this Regulation precludes Member States from imposing obligations, which are compatible with Union lawpursue a legitimate public interest, on undertakings, including providers of core platform services where these obligations are unrelated to the relevant undertakings having a status of gatekeeper within the meaning of this Regulation in order to protect consumers or to fight against acts of unfair competition.
Amendment 300 #
2020/0374(COD)
Proposal for a regulation
Recital 55
Recital 55
(55) Business users that use large core platform services provided by gatekeepers and end users of such business users provide and generate a vast amount of data, including data inferred from such use. In order to ensure that business users have access to the relevant data thus generated, the gatekeeper should, upon their request, allow unhindered access, free of charge, to such data. Such access should also be given to third parties contracted by the business user, who are acting as processors of this data for the business user. Data provided or generated by the same business users and the same end users of these business users in the context of other services provided by the same gatekeeper may be concerned where this is inextricably linked to the relevant request. To this end, a gatekeeper should not use any contractual or other restrictions to prevent business users from accessing relevant data and should enable business users to obtain consent of their end users for such data access and retrieval, where such consent is required under Regulation (EU) 2016/679 and Directive 2002/58/EC. The obtaining of this consent should be as user-friendly as possible and under the same conditions, such as the duration and renewal of consent, as those applied to the consent provided by the end user to the gatekeeper for the use of such data for its own services. Gatekeepers should also facilitate access to these data in real time by means of appropriate technical measures, such as for example putting in place high quality application programming interfaces.
Amendment 319 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point h a (new)
Article 2 – paragraph 1 – point 2 – point h a (new)
(ha) web browsers;
Amendment 323 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point h b (new)
Article 2 – paragraph 1 – point 2 – point h b (new)
(hb) voice assistants;
Amendment 351 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 23 a (new)
Article 2 – paragraph 1 – point 23 a (new)
(23a) 'Web browsers': software applications enabling users of client PCs, mobile devices and other devices to access and interact with web content hosted on servers connected to networks such as the Internet.
Amendment 355 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 23 b (new)
Article 2 – paragraph 1 – point 23 b (new)
(23b) 'Voice assistants': a software application that is capable of oral dialogue with a user in natural language and which mediates between end users and professional users providing voice- based apps.
Amendment 396 #
2020/0374(COD)
Proposal for a regulation
Article 1 – paragraph 5
Article 1 – paragraph 5
5. Member States shall not impose on gatekeepers further obligations by way of laws, regulations or administrative action for the purpose of ensuring contestable and fair markets. This is without prejudice toshall not affect rules pursuing other legitimate public interests, in compliance with Union law. In particular, nothing in this Regulation precludes Member States from imposing obligations, which are compatible with Union law, on undertakings, including providers of core platform services where these obligations are unrelated to the relevant undertakings having a status of gatekeeper within the meaning of this Regulation in order to protect consumers or to fight against acts of unfair competition, in order to pursue legitimate public interests.
Amendment 401 #
2020/0374(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation is without prejudice to the application of Articles 101 and 102 TFEU. It is also without prejudice to the application of: national rules prohibiting anticompetitive agreements, decisions by associations of undertakings, concerted practices and abuses of dominant positions; national competition rules prohibiting other forms of unilateral conduct insofar as they are applied to undertakings other than gatekeepersse rules are unrelated to the relevant undertakings having a status of gatekeeper within the meaning of this regulation or amount to imposing additional obligations on gatekeepers; Council Regulation (EC) No 139/200438 and national rules concerning merger control; Regulation (EU) 2019/1150 and Regulation (EU) …./.. of the European Parliament and of the Council39 . In particular, nothing in this Regulation precludes Member States from imposing obligations on undertakings other than gatekeepers or additional obligations on gatekeepers. _________________ 38Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (the EC Merger Regulation) (OJ L 24, 29.1.2004, p. 1). 39Regulation (EU) …/.. of the European Parliament and of the Council – proposal on a Single Market For Digital Services (Digital Services Act) and amending Directive 2000/31/EC.
Amendment 414 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point a
Article 2 – paragraph 1 – point 2 – point a
(a) online intermediation services;, including digital voice assistants.
Amendment 425 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point h
Article 2 – paragraph 1 – point 2 – point h
(h) advertising services, including any advertising networks, advertising exchanges and any other advertising intermediation services, provided by a provider where the undertaking to which it belongs is also a provider of any of the core platform services listed in points (a) to (g);
Amendment 431 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point h a (new)
Article 2 – paragraph 1 – point 2 – point h a (new)
(h a) web browsers;
Amendment 435 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) refrain from combining personal data sourced from these core platform services with personal data from any other services offered by the gatekeeper or with personal data from third-party services, and from signing in end users to other services of the gatekeeper in order to combine personal data, unless the end user has been presented with the specific choice and provided consent in the sense of Regulation (EU) 2016/679. except when disclosing data to third parties commissioned by one or more professional users to perform independent audience measurement with a view to ensuring market share transparency and safeguarding the general and/or public interests;
Amendment 450 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) refrain from directly or indirectly preventing or restricting business and end users from raising issues with any relevant public authority relating to any practice of gatekeepers, including by means of the reporting mechanism for professional and end users pursuant to Article 18a;
Amendment 453 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
(10 a) ‘Web browsers’ are software used by users of client PCs, smart mobile devices and other devices to access and interact with web content hosted on servers that are connected to networks such as the Internet, including standalone web browsers as well as web browsers integrated or embedded in software or similar;
Amendment 469 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 14
Article 2 – paragraph 1 – point 14
(14) ‘Ancillary service’ means services provided in the context of or together with core platform services, including retailing activities, payment services as defined in point 3 of Article 4 and technical services which support the provision of payment services as defined in Article 3(j) of Directive (EU) 2015/2366, fulfilment, identification or advertising services;
Amendment 473 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 18
Article 2 – paragraph 1 – point 18
(18) ‘Ranking’ means the relative prominence given to goods or services offered through online intermediation services or online social networking services, or the relevance given to search results by online search engines, as presented, organised or communicated by the providers of online intermediation services or of online social networking services or by providers of online search engincore platform services, respectively, whatever the technological means used for such presentation, organisation or communication;.
Amendment 479 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
(ga) refrain from communicating, or using for its own purposes, sensitive information obtained in the context of an advertising service, or from using it for any purpose other than the performance of the service agreement concluded, unless the gatekeeper and its client have agreed otherwise.
Amendment 480 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 18 a (new)
Article 2 – paragraph 1 – point 18 a (new)
(18 a) ‘Search results’ is any information in any format, including texts, graphics, voice or other output, returned in response and related to a written or oral search query, irrespective of whether the information is an organic result, a paid result, a direct answer or any product, service or information offered in connection with, or displayed along with, or partly or entirely embedded in, the organic results;
Amendment 483 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 18 b (new)
Article 2 – paragraph 1 – point 18 b (new)
(18 b) ‘Organic results’ are ‘search results’ that are solely based upon the relevance of the information to the end user and allow the end user to access the corresponding information directly;
Amendment 486 #
2020/0374(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 23 a (new)
Article 2 – paragraph 1 – point 23 a (new)
(23 a) ‘interoperability’ means the ability of the digital content or digital service, legally acquired, within a given ecosystem, to function with hardware or software ecosystems different from the one in which the digital content or digital service was originally provided, including the ability to access the digital content or digital service without having to use an application software or other technologies for conversion;
Amendment 495 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) refrain from using, in competition with business users, any data not publicly available, which is generated through activities by those business users, including by the end users of these business users, of its core platform services or ancillary services or provided by those business users of its core platform services or by the end users of these business users via the core platform services or ancillary services;
Amendment 500 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) allowinform end users to un-installupon first use of any pre-installed software applications on its core platform service and of the option to un-install them, without prejudice to the possibility for a gatekeeper to restrict such un-installation in relation to software applications that are essential for the functioning of the operating system or of the device and which cannot technically be offered on a standalone basis by third- parties;
Amendment 509 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d
Article 6 – paragraph 1 – point d
(d) refrain from treating more favourably in rankingor differently in terms of ranking, access or terms of service, or technical features and interfaces, services and products offered by the gatekeeper itself or by any third party belonging to the same undertaking compared to similar services or products of thirdany other party and apply fair and non-discriminatory conditions to such ranking; in terms of ranking, access or terms of service, and technical features and interfaces;
Amendment 518 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d a (new)
Article 6 – paragraph 1 – point d a (new)
Amendment 523 #
2020/0374(COD)
(e) refrain from technically restricting the ability of end users to switch between and subscribe to different software applications andcontent or services to be accessed using the operating systemcore platform service of the gatekeeper, including as regards the choice of Internet access provider for end users, or the use of a voice assistant;
Amendment 543 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point g
Article 6 – paragraph 1 – point g
(g) provide advertisers and publishers, or third parties authorised by the advertisers and publishers, upon their request and free of charge, with access to the performance measuring tools of the gatekeeper and the information necessary for advertisers and publishers to carry out their own independent verification of the ad inventory;
Amendment 550 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point h
Article 6 – paragraph 1 – point h
(h) provide effective portability of data provided or generated through the activity of a business user or end user and shall, in particular, provide tools, foree of charge, to business users and end users to facilitate the exercise of data portability, in line with Regulation EU 2016/679, including by the provision of continuous and real-time access ;
Amendment 557 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point i
Article 6 – paragraph 1 – point i
(i) provide business users, or third parties authorised by a business user, free of charge, with effective, high-quality, continuous and real-time access and use of aggregated or non-aggregated data, that is provided for or generated in the context of the use of the relevant core platform servicesor ancillary services offered by the gatekeeper by those business users and the end users engaging with the products or services provided by those business users; for personal data, provide access and use only where directly connected with the use effectuated by the end user in respect of the products or services offered by the relevant business user through the relevant core platform service, and when the end user opts in to such sharing with a consent in the sense of the Regulation (EU) 2016/679; ;
Amendment 563 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point k
Article 6 – paragraph 1 – point k
(k) apply fair and non-discriminatory general conditions of access forand treatment to business users of its core platform service, in particular to business users tof its software application store, search engine, online payment service or online social networking service, designated pursuant to Article 3 of this Regulation.;
Amendment 598 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) refrain from combining personal data sourced from these core platform services with personal data from any other services offered by the gatekeeper or with personal data from third-party services, and from signing in end users to other services of the gatekeeper in order to combine personal data, unless the end user has been presented with the specific choice and provided consent in the sense of Regulation (EU) 2016/679 without prejudice to the disclosure of data to third parties that have been mandated by one or several business users to provide independent audience measurement in view of ensuring transparency over market shares and to uphold prevailing general and/or public interests and in accordance with the special rules and exemptions provided for these purposes. ;
Amendment 633 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) refrain from directly or indirectly preventing or restricting business users or supplier to the gatekeeper’s ancillary service from raising issues with any relevant public authority or national court relating to any practice of gatekeepers;
Amendment 646 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) refrain from requiring business users and suppliers to use, offer or interoperate with an identification service of the gatekeeper in the context of services offered by the business users using the core platform services of that gatekeeper or its other services;
Amendment 655 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) refrain from requiring business users to use, offer or interoperate with an identification servicey ancillary of the gatekeeper in the context of services offered by the business users using the core platform services of that gatekeeper;
Amendment 659 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point f
Article 5 – paragraph 1 – point f
(f) refrain from requiring business users or end users to subscribe to or register with any other core platform services identified pursuant to Article 3 or which meets the thresholds in Article 3(2)(b), or its other services, as a condition to access, sign up or register to any of their core platform services identified pursuant to that Article or to any other service offered by the gatekeeper;
Amendment 667 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point f a (new)
Article 5 – paragraph 1 – point f a (new)
(f a) A platform must refrain from requiring ‘the acceptance of supplementary conditions or services that, by their nature or according to commercial usage, have no connection with and are not necessary for the provision of the platform or services to its business users’.
Amendment 682 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
Amendment 684 #
2020/0374(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. When the Commission intends to carry out a market investigation in view of the possible adoption of decisions pursuant to Articles 15, 16, 16a and 17, it shall adopt a decision opening a market investigation.
Amendment 689 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
(g a) Refrain from disclosing any commercially sensitive information obtained in connection with one of its advertising services to any third party belonging to the same undertaking and from using such commercially sensitive information for any purposes other than the provision of the specific advertising service unless this is necessary for carrying out a business transaction.
Amendment 702 #
2020/0374(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point g b (new)
Article 5 – paragraph 1 – point g b (new)
(g b) allow Business Users or End Users to annually renew their consent to enroll or register for any of its essential platform services identified under section 3 and its other services, and in the absence of consent, promptly delete all Business User or End User data.
Amendment 710 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) refrain from using, in competition with business users and ancillary service (notably distribution) suppliers, any data not n-publicly available, which is generated through activities by those business users, or suppliers, or their competitors, including by the end users of these business users or their competitors, of its core platform services or provided by those business users, of its core platform servicer suppliers, or their competitors or by the end users of these business users or their competitors;
Amendment 717 #
2020/0374(COD)
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Amendment 719 #
2020/0374(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
The Commission may conduct a market investigation with the purpose of examining whether one or more services within the digital sector should be added to the list of core platform services or to detect types of practices that may limit the contestability of core platform services or may be unfair and which are not effectively addressed by this Regulation. It shall issue a public report at the latest within 124 months from the opening of the market investigation.
Amendment 726 #
2020/0374(COD)
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Amendment 730 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point c
Article 6 – paragraph 1 – point c
(c) allow and technically enable the installation and effective use and interoperability of third party software applications or software application stores using, or interoperating with, operating systems of that gatekeeper and allow and enable these software applications or software application stores or services to be accessed by means other than the core platform services of that gatekeeper. The gatekeeper shall not be prevented from taking proportionate measures to ensure that third party software applications or software application stores or services do not endanger the integrity of the hardware or operating system provided by the gatekeeper. This should be without prejudice to the role gatekeepers play in the fight against illegal content online;
Amendment 744 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d
Article 6 – paragraph 1 – point d
(d) refrain from treating more favourably in ranking and other settings, as well as in access to and conditions for the use of services, functionalities or technical interfaces, services and products offered by the gatekeeper itself or by any third party belonging to the same undertaking compared to similar services or products of othirder partyies, and apply fair and non-discriminatory conditions to such pranking;ctices.
Amendment 755 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d a (new)
Article 6 – paragraph 1 – point d a (new)
(d a) refrain from displaying, in its online search engine, online social networking service or online intermediation service, in response to an end user query, advertising (including paid-for search results) or own services of the gatekeeper if the space occupied by such advertising or own services exceeds in total 25% of the initial result screen visible on the end user’s terminal (mobile, tablet, desktop or other);
Amendment 760 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point e
Article 6 – paragraph 1 – point e
(e) refrain from technically restricting the ability of end users to switch between and subscribe to different software applications and services to be accessed using the operating system of the gatekeeper, including as regards the choice of Internet access provider for end usersonline content or services to be accessed using the core plateform service of the gatekeeper, including as regards the choice of Internet access provider for end users. In connection with the protection of end- users' terminal equipment during the use of the operating system of the gatekeeper, the gatekeeper shall ensure that consent directly expressed by an end-user to a service provider prevails over software settings. Any consent requested and given by an end-user to a service shall be directly implemented, without any further delay, by the applications of the end user’s terminal equipment. The same shall apply if the storage of information or the access of information already stored in the end-user’s terminal equipment is permitted in any other legal basis than consent;
Amendment 768 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point f
Article 6 – paragraph 1 – point f
(f) allow business users and providers of ancillary services access to and interoperability with the same operating system, hardware or software features that are available or used in the provision by the gatekeeper of any core platform or ancillary services. Allow the supply of content exclusively in an open format upon content suppliers’ request. Allow the proper functioning of technological protection measures (TPMs) in cases these are used to manage the rights of the user. However the gatekeeper should ensure that TPMs linked to a file are not solely compliant with a single reading environment. In this case, other suppliers of files and reading service providers should have the possibility to require gatekeepers to provide the information that is necessary for the purpose of interoperability;
Amendment 779 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point f a (new)
Article 6 – paragraph 1 – point f a (new)
(f a) Allow end users of technologically protected digital content or digital service, legally acquired through third party services, access to and interoperability with the hardware or software features that are used by that gatekeeper when providing a similar technologically protected digital content or digital service; and allow end users of technologically protected digital content or digital service acquired through that gatekeeper access to and interoperability with the hardware or software features that are used by third party when providing a similar technologically protected digital content or digital service. Gatekeepers’ suppliers, as well as third-party hardware providers should have the possibility to require gatekeepers to provide the necessary interoperability information to comply with the purpose of this Regulation;
Amendment 785 #
2020/0374(COD)
Proposal for a regulation
Article 31 a (new)
Article 31 a (new)
Article 31a Cooperation with the national competition authorities and their powers 1. The Commission shall ensure that the reports forwarded pursuant to Article 16b of this Regulation are made available to the national competition authorities within the European Competition Network, defined in Article 2(1)(5) of Directive (EU) 2019/1. 2. The Commission shall circulate within the European Competition Network the decisions relating to the opening of a market investigation pursuant to Article 14 or proceedings pursuant to Article 18. The national competition authorities may provide the Commission, on a voluntary basis, with any information deemed helpful and necessary for the purpose of the market investigation carried out pursuant to Articles 15, 16, 16a and 17, and shall provide the Commission with assistance, upon request, in implementing Articles 19, 20 and 21.
Amendment 792 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point h
Article 6 – paragraph 1 – point h
(h) provide effective portability of data provided for or generated through or in the context of the activity of a business user, or end user and shall, in particular, provide tools forgenerated by goods and services provided by a supplier to the gatekeeper’s ancillary service notably distribution or an end user and shall, in particular, provide free of charge tools for business users and end users to facilitate the exercise of data portability, in line with Regulation (EU )2016/679, including by the provision of continuous and real-time access and guarantees their interoperability ;
Amendment 794 #
2020/0374(COD)
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
1. When three or more Member States request the Commission to open an investigation pursuant to Article 15 because they consider that there are reasonable grounds to suspect that a provider of core platform services should be designated as a gatekeeper4, the Commission shall within four months examine whether there are reasonable grounds to open such an investigation.
Amendment 834 #
2020/0374(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. For the purposes of point (a) of paragraph 1, data that is not publicly available shall include any aggregated and non-aggregated data generated by business users or generated by goods and services provided by a supplier to the gatekeeper’s ancillary services notably distribution, that can be inferred from, or collected through, the commercial activities of business users or their customers on the core platform, distribution or other ancillary service of the gatekeeper.
Amendment 940 #
2020/0374(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Where consent for collecting and processing of personal data is required to ensure compliance with this Regulation, a gatekeeper shall take the necessary steps to either enable business users to directly obtain at the level of their own services or products the required consent to their processing, where required under Regulation (EU) 2016/679 and Directive 2002/58/EC, or to comply with Union data protection and privacy rules and principles . The gatekeeper shall not make the obtaining other ways including by providing business users with duly anonymised data where appropriate. The gatekeeper shall not make the obtaining of this consent by the business user more burdensome than for its own servicesf this consent by the business user more burdensome than for its own services. In case consent is directly expressed by the end-user at the level of the services offered by the business user through the relevant core platform service, it shall prevail over any consent provided at the gatekeeper level.
Amendment 1000 #
2020/0374(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. When the Commission pursuant to Article 3(6) designates as a gatekeeper a provider of core platform services that does not yet enjoy an entrenched and durable position in its operations, but it is foreseeable that it will enjoy such a position in the near future, it shall declare applicable to that gatekeeper only obligations laid down in Article 5(b) and Article 6(1) points (e), (f), (h) and (i) as specified in the designation decision. The Commission shall only declare applicable those obligations that are appropriate and necessary to prevent that the gatekeeper concerned achieves by unfair means an entrenched and durable position in its operations. The Commission shall review such a designation in accordance with the procedure laid down in Article 4.
Amendment 240 #
2020/0361(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Considering the particular characteristics of the services concerned and the corresponding need to make the providers thereof subject to certain specific obligations, it is necessary to distinguish, within the broader category of providers of hosting services as defined in this Regulation, the subcategory of online platforms. Online platforms, such asearch engines, social networks or online marketplaces, and live streaming platforms or private messaging providers should be defined as providers of hosting services that not only store information provided by the recipients of the service at their request, but that also disseminate that information to the public, again at their request. However, in order to avoid imposing overly broad obligations, providers of hosting services should not be considered as online platforms where the dissemination to the public is merely a minor and purely ancillary feature of another service and that feature cannot, for objective technical reasons, be used without that other, principal service, and the integration of that feature is not a means to circumvent the applicability of the rules of this Regulation applicable to online platforms. For example, the comments section in an online newspaper could constitute such a feature, where it is clear that it is ancillary to the main service represented by the publication of news under the editorial responsibility of the publisher.
Amendment 265 #
2020/0361(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) The exemptions from liability established in this Regulation should not be available to providers of intermediary services that do not comply with the due diligence obligations in this Regulation. The conditionality should further ensure that the standards to qualify for such exemptions contribute to a high-level of safety and trust in the online environment.
Amendment 301 #
2020/0361(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In order to create legal certainty and not to discourage activities aimed at detecting, identifying and acting against illegal content that providers of intermediary services may undertake on a voluntary basis, it should be clarified that the mere fact that providers undertake such activities does not lead to the unavailability of the exemptions from liability set out in this Regulation, provided those activities are carried out in good faith and in a diligent manner. In addition, it is appropriate to clarify that the mere fact that those providers take measures, in good faith, to comply with the requirements of Union or national law, including those set out in this Regulation as regards the implementation of their terms and conditions, should not lead to the unavailability of those exemptions from liability set out in this Regulation. Therefore, any such activities and measures that a given provider may have taken should not be taken into account when determining whether the provider can rely on an exemption from liability, in particular as regards whether the provider provides its service neutrally and can therefore fall within the scope of the relevant provision, without this rule however implying that the provider can necessarily rely thereon.
Amendment 336 #
2020/0361(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) The orders to provide information regulated by this Regulation concern the production of specific information about individual recipients of the intermediary service concerned who are identified in those orders for the purposes of determining compliance by the recipients of the services with applicable Union or national rules. This information should include the relevant e-mail addresses, telephone numbers, IP addresses and other contact details necessary to ensure such compliance. Therefore, orders about information on a group of recipients of the service who are not specifically identified, including orders to provide aggregate information required for statistical purposes or evidence-based policy-making, should remain unaffected by the rules of this Regulation on the provision of information.
Amendment 347 #
2020/0361(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) In order to achieve the objectives of this Regulation, and in particular to improve the functioning of the internal market and ensure a safe and transparent online environment, it is necessary to establish a clear, effective and balanced set of harmonised due diligence obligations for providers of intermediary services. Those obligations should aim in particular to guarantee different public policy objectives such as the safety and trust of the recipients of the service, including minors and vulnerable users, protect the relevant fundamental rights enshrined in the Charter, to ensure meaningful accountability of those providers and to empower recipients and other affected parties, whilst facilitating the necessary oversight by competent authorities.
Amendment 352 #
2020/0361(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) the order is drafted in the language declared by the provider and is sent to the point of contact, appointed by the provider, in accordance with Article 10. The order may alternatively be drafted in the official language of the Member State whose authority issues the order against the specific item of illegal content; in such case, the point of contact is entitled upon request to atranscription, by said authority, into the language declared by the provider.
Amendment 359 #
2020/0361(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Providers of intermediary services shall, upon receipt of an order to provide a specific item of information about one or more specific individual recipients of the service, issued by the relevant national judicial or administrative authorities on the basis of the applicable Union or national law, in conformity with Union law, inform without undue delay the authority of issuing the order of its receipt and the effect given to the order. , the effect given to the order and, where no effect has been given to the order, a statement of reasons explaining why information cannot be provided to the national judicial or administrative authority issuing the order.
Amendment 365 #
2020/0361(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point a – indent 1
Article 9 – paragraph 2 – point a – indent 1
— a statement of reasons explaining the objective foraccording to which the information is required and why the requirement to provide the information is necessary and proportionate to determine compliance by the recipients of the intermediary services with applicable Union or national rules[, unless such a statement cannot be provided for reasons related to the prevention, investigation, detection and prosecution of criminal offences;
Amendment 380 #
2020/0361(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) the order is drafted in the language declared by the provider and is sent to the point of contact appointed by that provider, in accordance with Article 10;. The order may alternatively be drafted in the official language of the Member State whose authority issues the order against the specific item of illegal content; in such case, the point of contact is entitled upon request to a transcription, by said authority, into the language declared by the provider.
Amendment 381 #
2020/0361(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Providers of hosting services play a particularly important role in tackling illegal content online, as they store information provided by and at the request of the recipients of the service and typically give other recipients access thereto, sometimes on a large scale. It is important that all providers of hosting services, regardless of their size, put in place user-friendly notice and action mechanisms that facilitate the notification of specific items of information that the notifying party considers to be illegal content to the provider of hosting services concerned ('notice'), pursuant to which that provider can decide, based on its own assessment, whether or not it agrees with that assessment and wishes to remove or disable access to that content ('action'). Provided the requirements on notices are met, it should be possible for individuals or entities to notify multiple specific items of allegedly illegal content through a single notice. It may also be possible for online platforms to prevent a content that has already been identified as illegal and that has been removed on the basis of a prior notice, from reappearing. The obligation to put in place notice and action mechanisms should apply, for instance, to file storage and sharing services, web hosting services, advertising servers and paste bins, in as far as they qualify as providers of hosting services covered by this Regulation.
Amendment 391 #
2020/0361(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) Where a hosting service provider decides to remove or disable information provided by a recipient of the service, for instance following receipt of a notice or acting on its own initiative, including through the use of automated means, that provider should prevent future uploads of already notified illegal content resulting from a valid notice and action procedure and should inform the recipient of its decision, the reasons for its decision and the available redress possibilities to contest the decision, in view of the negative consequences that such decisions may have for the recipient, including as regards the exercise of its fundamental right to freedom of expression. That obligation should apply irrespective of the reasons for the decision, in particular whether the action has been taken because the information notified is considered to be illegal content or incompatible with the applicable terms and conditions. Available recourses to challenge the decision of the hosting service provider should always include judicial redress.
Amendment 409 #
2020/0361(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Action against illegal content can be taken more quickly and reliably where online platforms take the necessary measures to ensure that notices submitted by trusted flaggers through the notice and action mechanisms required by this Regulation are treated with priority, without prejudice to the requirement to process and decide upon all notices submitted under those mechanisms in a timely, diligent, effective and objective manner. Such trusted flagger status should only be awarded to entities, and not individuals, that have demonstrated, among other things, that they have particular expertise and competence in tackling illegal content, that they represent collective interesthave significant legitimate interest and a proven record in flagging illegal content with a high rate of accuracy and that they have demonstrated their competence in detecting, identifying and notifying illegal content or represent collective interests or general interest to prevent infringements of Union law or provide redress and that they work in a diligent and objective manner. Such entities can also be public in nature, such as, for terrorist content, internet referral units of national law enforcement authorities or of the European Union Agency for Law Enforcement Cooperation (‘Europol’) or they can be non- governmental organisations and semi- public bodies, such as the organisations part of the INHOPE network of hotlines for reporting child sexual abuse material and organisations committed to notifying illegal racist and xenophobic expressions online. For intellectual property rights, organisations of industry andindividual right-holders, their representatives, duly mandated third parties organisations of industry and other independent entities that have a specific expertise and act in the best interests of right- holders could be awarded trusted flagger status, where they have demonstrated that they meet the applicable conditions. The same should be granted to applicants within the meaning of Regulation (EU) No 608/2013 or in case of complaints pursuant to Regulation (EU) 2019/1020 so as to ensure that existing rules regarding custom enforcement or consumer protection are effectively implemented to online sale. The rules of this Regulation on trusted flaggers should not be understood to prevent online platforms from giving similar treatment to notices submitted by entities or individuals that have not been awarded trusted flagger status under this Regulation, from otherwise cooperating with other entities, in accordance with the applicable law, including this Regulation and Regulation (EU) 2016/794 of the European Parliament and of the Council.43 __________________ 43Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA, OJ L 135, 24.5.2016, p. 53
Amendment 424 #
2020/0361(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The misuse of services of online platforms by frequently providing manifestlyor disseminating illegal content or by frequently submitting manifestly unfounded notices or complaints under the mechanisms and systems, respectively, established under this Regulation undermines trust and harms the rights and legitimate interests of the parties concerned. Therefore, there is a need to put in place appropriate and proportionate safeguards against such misuse. Information should be considered to be manifestly illegal content and notices or complaints should be considered manifestly unfounded where it is evident to a layperson, without any substantive analysis, that the content is illegal respectively that the notices or complaints are unfounded. Under certain conditions, online platforms should temporarily suspend their relevant activities in respect of the person engaged in abusive behaviour. This is without prejudice to the freedom by online platforms to determine their terms and conditions and establish stricter measures in the case of manifestly illegal content related to serious crimes. For reasons of transparency, this possibility should be set out, clearly and in sufficiently detail, in the terms and conditions of the online platforms. Redress should always be open to the decisions taken in this regard by online platforms and they should be subject to oversight by the competent Digital Services Coordinator. The rules of this Regulation on misuse should not prevent online platforms from taking other measures to address the provision of illegal content by recipients of their service or other misuse of their services, in accordance with the applicable Union and national law. Those rules are without prejudice to any possibility to hold the persons engaged in misuse liable, including for damages, provided for in Union or national law.
Amendment 464 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Where a provider of hosting services decides to remove or, disable access to or otherwise restrict the visibility of specific items of information provided by the recipients of the service or to suspend or terminate monetary payments related to those items, irrespective of the means used for detecting, identifying or removing or, disabling access to or reducing the visibility of that information and of the reason for its decision, it shall inform the recipient, at the latest at the time of the removal or disabling of access or the restriction of visibility or the suspension or termination of monetization, of the decision and provide a clear and specific statement of reasons for that decision.
Amendment 471 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a
Article 15 – paragraph 2 – point a
(a) whether the decision entails either the removal of, or the disabling of access to, the restriction of the visibility of, or the demonetization of the information and, where relevant, the territorial scope of the disabling of access or the restriction;
Amendment 477 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 (new)
Article 15 – paragraph 2 – subparagraph 1 (new)
2. When the removing or access disabling to specific items of information is followed by the transmission of these specific items of information in accordance with Article 15a, the information of the recipient mentioned in paragraph 1 is postponed by a period of six weeks in order not to interfere with potential ongoing criminal investigations. This period of six weeks can be renewed only after a motivated decision of the competent authority to which the specific items of information had been transmitted.
Amendment 481 #
2020/0361(COD)
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Amendment 488 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
1. Online platforms shall provide recipients of the service as well as individuals or entities that have submitted a notice, for a period of at least six months following the decision referred to in this paragraph, the access to an effective internal complaint-handling system, which enables the complaints to be lodged electronically and free of charge, against the decision taken by the online platform not to act after having received a notice, and against the following decisions taken by the online platform on the ground that the information provided by the recipients is illegal content or incompatible with its terms and conditions:
Amendment 493 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) decisions to remove or, disable access to or restrict the visibility of the information;
Amendment 496 #
2020/0361(COD)
1 a. decisions to restrict the ability to monetize content provided by the recipients.
Amendment 497 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 b (new)
Article 17 – paragraph 1 b (new)
1 b. 2. When the decision to remove or disable access to the information is followed by the transmission of this information in accordance with Article 15a, the period of at least six months mentioned in paragraph 1 begins to start from the day on which the information was given to the recipient in accordance with Article15(2).
Amendment 509 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. Online platforms shall ensure that recipients of the service are given the possibility, where necessary, to contact a human interlocutor at the time of the submission of the complaint and that the decisions, referred to in paragraph 4, are not solely taken on the basis of automated means.
Amendment 546 #
2020/0361(COD)
Proposal for a regulation
Recital 81
Recital 81
(81) In order to ensure effective enforcement of this Regulation, individuals or representative organisations as well as parties having a legitimate interest and meeting relevant criteria of expertise and independence from any online hosting services provider or platform should be able to lodge any complaint related to compliance with this Regulation with the Digital Services Coordinator in the territory where they received the service, without prejudice to this Regulation’s rules on jurisdiction. Complaints should provide a faithful overview of concerns related to a particular intermediary service provider’s compliance and could also inform the Digital Services Coordinator of any more cross-cutting issues. The Digital Services Coordinator should involve other national competent authorities as well as the Digital Services Coordinator of another Member State, and in particular the one of the Member State where the provider of intermediary services concerned is established, if the issue requires cross- border cooperation.
Amendment 576 #
2020/0361(COD)
Proposal for a regulation
Article 21 – title
Article 21 – title
21 15c. Notification of suspicions of criminal offences
Amendment 577 #
2020/0361(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Where an online platform provider of hosting services becomes aware of any information giving rise to a suspicion that a serious criminal offence involving a threat to the life or safety of persons has taken place, is taking place or is likely to take place, it shall promptly inform the law enforcement or judicial authorities of the Member State or Member States concerned of its suspicion and provide all relevant information available.
Amendment 582 #
2020/0361(COD)
Proposal for a regulation
Article 21 – paragraph 2 – introductory part
Article 21 – paragraph 2 – introductory part
2. Where the online platformprovider of hosting services cannot identify with reasonable certainty the Member State concerned, it shall inform the law enforcement authorities of the Member State in which it is established or has its legal representative or inform Europol.
Amendment 584 #
2020/0361(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1
Article 21 – paragraph 2 – subparagraph 1
For the purpose of this Article, the Member State concerned shall be the Member State where the offence is suspected to have taken place, be taking place and likely to take place, or the Member State where the suspected offender resides or is located, or the Member State where the victim of the suspected offence resides or is located. For the purpose of this Article, each Member State shall notify to the European Commission and to the Council the list of its competent law enforcement or judicial authorities.
Amendment 652 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) ‘consumer’ means any natural person who is acting for purposes which are outside his or her trade, business, craft or profession;
Amendment 660 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d – indent 1
Article 2 – paragraph 1 – point d – indent 1
— a significant number of users in one or more Member States compared to their total population; or
Amendment 675 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f – indent 3
Article 2 – paragraph 1 – point f – indent 3
— a ‘hosting’ service that consists of the storage of information provided by, and at the request of, a recipient of the service and which does not have any active role in data processing;
Amendment 678 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f – indent 3 a (new)
Article 2 – paragraph 1 – point f – indent 3 a (new)
- an online platform as defined in point (h) of this Regulation;
Amendment 688 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g
Article 2 – paragraph 1 – point g
(g) ‘illegal content’ means any information,, which, in itself or by its reference to an activity, including the sale of products or provision of servicesillegal content, products, services or activity, is not in compliance with Union law or the law of a Member State, irrespective of the precise subject matter or nature of that law;
Amendment 699 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h
Article 2 – paragraph 1 – point h
(h) ‘online platform’ means a provider of a hosting service which, at the request of a recipient of the service, stores and disseminates to the public information and optimises its content, unless that activity is a minor and purely ancillary feature of anotherthe main service and, for objective and technical reasons cannot be used without that othermain service, and the integration of the feature into the other service is not a means to circumvent the applicability of this Regulation.;
Amendment 707 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h a (new)
Article 2 – paragraph 1 – point h a (new)
(ha) ‘online marketplace’ means an online platform allowing consumers to conclude distance contracts with traders;
Amendment 708 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h b (new)
Article 2 – paragraph 1 – point h b (new)
(hb) ‘live streaming platform service’ means an information society service the main or one of the main purposes of which is to give the public access to audio or video material that is broadcasted live by its users, which it organises and promotes for profit-making purposes;
Amendment 709 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h c (new)
Article 2 – paragraph 1 – point h c (new)
(hc) ‘private messaging service’ means a number-independent interpersonal communications service as defined in Article 2(7) of Directive (EU) 2018/1972, excluding transmission of electronic mail as defined in Article 2(h) of Directive 2002/58/EC.
Amendment 711 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point i
Article 2 – paragraph 1 – point i
(i) ‘dissemination to the public’ means making information available, at the request of the recipient of the service who provided the information, to a significant and potentially unlimited number of third parties;
Amendment 723 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point p
Article 2 – paragraph 1 – point p
(p) ‘content moderation’ means the activities undertaken by providers of intermediary services, regardless of whether they are automated or processed by a person, which are aimed at detecting, identifying and addressing illegal content or information incompatible with their terms and conditions, provided by recipients of the service, including measures taken that affect the availability, visibility and accessibility of that illegal content or that information, such as demotion, disabling of access to, or removal thereof, or the recipients’ ability to provide that information, such as the termination or suspension of a recipient’s account;
Amendment 758 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) upon obtaining such knowledge or awareness, acts expeditiously toand permanently removes or to disables access to the illegal content; expeditiously means immediately or as fast as possible and in any event no later than within 30 minutes where the illegal content pertains to the broadcast of a live sports or entertainment event.
Amendment 775 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. Paragraph 1 shall not apply when the provider of intermediary services engages in illegal activities.
Amendment 784 #
2020/0361(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
Providers of intermediary services shall not be deemed ineligible for the exemptions from liability referred to in Articles 3, 4 and 5 solely because they carry out voluntary own-initiative investigations or other activities aimed at detecting, identifying and removing, or disabling of access to, illegal content, or take the necessary measures to comply with the requirements of Union law, including those set outwhen they engage in or facilitate illegal activities or when they do not comply with the due diligence obligations laid down in this Regulation.
Amendment 791 #
2020/0361(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
Paragraph 1 shall apply only when intermediary services are compliant with due diligence obligations laid down in this Regulation.
Amendment 834 #
2020/0361(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) the order is drafted in the language declared by the provider and is sent to the point of contact, appointed by the provider, in accordance with Article 10; upon a decision by a Member State an order may be drafted in the official language of the Member State whose authority issued the order against the specific item of illegal content; in such case, the point of contact shall be entitled, upon request, to a transcription by that authority into the language declared by the provider.
Amendment 859 #
2020/0361(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Providers of intermediary services shall, upon receipt of an order to provide a specific item of information about one or more specific individual recipients of the service, issued by the relevant national judicial or administrative authorities on the basis of the applicable Union or national law, in conformity with Union law, inform without undue delay the authority of issuing the order of its receipt and the effect given to the order. Where no effect has been given to the order, a statement shall explain the reasons why the information cannot be provided to the national judicial or administrative authority that issued the order.
Amendment 873 #
2020/0361(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point a – indent 1
Article 9 – paragraph 2 – point a – indent 1
— a statement of reasons explaining the objective foraccording to which the information is required and why the requirement to provide the information is necessary and proportionate to determine compliance by the recipients of the intermediary services with applicable Union or national rules, unless such a statement cannot be provided for official reasons related to the prevention, investigation, detection and prosecution of criminal offences;
Amendment 877 #
2020/0361(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) the order is drafted in the language declared by the provider and is sent to the point of contact appointed by that provider, in accordance with Article 10;. Upon a decision by a Member State, the order may be drafted in the official language of the Member State whose authority issued the order against the specific item of illegal content, In such case, the point of contact shall be entitled, upon request, to a transcription by that authority into the language declared by the provider.
Amendment 898 #
2020/0361(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Providers of intermediary services shall establish a single point of contact allowing for direct communication, by electronic means, with Member States’ authorities, the Commissiwhich do not have an establishment in the Union but which offer services in the Union shall designate, for those already existing as soon as possible, for those to be established prior to the establishment, in writing, a legal or natural person ands the Board referred to in Article 47 for the application of this Regulationir legal representative in one of the Member States where the provider offers its services.
Amendment 915 #
2020/0361(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Providers of intermediary services shall mandate their legal representatives to be addressed in addition to or instead of the provider by the Member States’ authorities, the Commission and the Board on all issues necessary for the receipt of, compliance with and enforcement of decisions issued in relation to this Regulation. Providers of intermediary services shall provide their legal representative with the necessary powers and resource tos in order to guarantee their proper and timely cooperateion with the Member States’ authorities, the Commission and the Board and complyiance with those decisions.
Amendment 919 #
2020/0361(COD)
Proposal for a regulation
Article 11 – paragraph 5 a (new)
Article 11 – paragraph 5 a (new)
5a. Providers of intermediary services that qualify as micro or small enterprises as defined in Recommendation 2003/361/EC, and who have been unsuccessful in obtaining the services of a legal representative after reasonable effort, shall be able to request that the Digital Service Coordinator of the Member State where the enterprise intends to obtain a legal representative facilitates further cooperation and recommends possible solutions, including possibilities for collective representation.
Amendment 1012 #
2020/0361(COD)
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Amendment 1021 #
2020/0361(COD)
Proposal for a regulation
Chapter III – Section 2 – title
Chapter III – Section 2 – title
Additional provisions applicable to providers of hosting services, including online platforms, and to providers of livestreaming platform services and of private messaging services
Amendment 1025 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Providers of hosting servicesivate messaging services and providers of hosting services, including online platforms, shall put mechanisms in place to allow any individual or entity to notify them of the presence on their service of specific items of information that the individual or entity considers to be illegal content. Those mechanisms shall be easy to access, clearly visible, low-threshold, user- friendly, and located close to the content in question allowing for the submission of notices exclusively by electronic means.
Amendment 1050 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) a clear indication of the electronic location of that information, in particular the exact URL or URLs, and, where necessary, additional information enabling the identification of the illegal conten enabling the identification of the illegal content if the application of the service that is used by the recipient allows it;
Amendment 1073 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. Providers of hosting services shall process any notices that they receive under the mechanisms referred to in paragraph 1, and take their decisions in respect of the information to which the notices relate, in a timely, diligent and objective manner. Where they use automated means for that processing or decision-making, they shall include information on such use in the notification referred to in paragraph 4. , including online platforms, and of private messaging services, without prejudice to Article 5(1), point (b), shall process any notices that they receive under the mechanisms referred to in paragraph 1, of this Article, and remove or disable access to the illegal content without undue delay and within seven days of the receipt of the notification at the latest. Resulting from a valid notice and action procedure, providers of hosting services shall prevent future uploads of already notified illegal content putting in place effective, reasonable and proportionate measures.
Amendment 1083 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 6 a (new)
Article 14 – paragraph 6 a (new)
6a. Providers of hosting service shall, without undue delay and within seven days of the receipt of the notification at the latest, inform consumers who have purchased illegal products between the moment they have been uploaded on the provider’s website and the moment the listing has been taken down by the platform following a valid notice.
Amendment 1100 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 2 – introductory part
Article 15 – paragraph 2 – introductory part
2. When the removing or disabling access to specific items of information is followed by the transmission of those specific items of information in accordance with Article 15a, the provision of information to the recipient in accordance with paragraph 1 shall be postponed for a period of six weeks in order not to interfere with potential ongoing criminal investigations. That period of six weeks may be renewed only after a motivated decision of the competent authority to which the specific items of information had been transmitted. The statement of reasons referred to in paragraph 1 shall at least contain the following information:
Amendment 1103 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a
Article 15 – paragraph 2 – point a
(a) whether the decision entails either the removal of, or the disabling of access to, the restriction of the visibility of, or the demonetisation of the information and, where relevant, the territorial scope of the disabling of access or of the restriction of visibility;
Amendment 1126 #
2020/0361(COD)
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Amendment 1133 #
2020/0361(COD)
Proposal for a regulation
Article 15 b (new)
Article 15 b (new)
Article 15b Notification of suspicions of serious criminal offences 1. Where a provider of hosting services becomes aware of any information giving rise to a suspicion that a serious criminal offence involving a threat to the life or safety of persons has taken place, is taking place or is likely to take place, it shall promptly inform the law enforcement or judicial authorities of the Member State or Member States concerned of its suspicion and provide all relevant information available. 2. Where provider of hosting services cannot identify with reasonable certainty the Member State concerned, it shall inform the law enforcement authorities of the Member State in which it is established or has its legal representative or shall inform Europol. For the purpose of this Article, the Member State concerned shall be the Member State where the serious criminal offence is suspected to have taken place, to be taking place or to likely take place, or the Member State where the suspected offender resides or is located, or the Member State where the victim of the suspected serious criminal offence resides or is located. For the purpose of this Article, each Member State shall notify to the Commission the list of its competent law enforcement or judicial authorities.
Amendment 1146 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
1. Online platforms shall provide recipients of the service, as well as individuals or entities that have submitted a notice, for a period of at least six months following the decision referred to in this paragraph, the access to an effective internal complaint-handling system, which enables the complaints to be lodged electronically and free of charge, against the decision taken by the online platform not to act after having received a notice, and against the following decisions taken by the online platform on the ground that the information provided by the recipients is illegal content or incompatible with its terms and conditions:
Amendment 1156 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) decisions to remove or, disable access to or restrict the visibility of the information;
Amendment 1168 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c a (new)
Article 17 – paragraph 1 – point c a (new)
(ca) decisions to restrict the ability to monetise content provided by the recipients.
Amendment 1179 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 1 a (new)
Article 17 – paragraph 2 – subparagraph 1 a (new)
When the decision to remove or disable access to the information is followed by the transmission of this information in accordance with Article 15a, the period of at least six months referred to in paragraph 1 of this Article begins on the day on which the information was given to the recipient in accordance with Article 15.
Amendment 1181 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Online platforms shall handle complaints submitted through their internal complaint-handling system in a timely, diligent and objective manner and without undue delay and at the latest within seven days of the notification. Where a complaint contains sufficient grounds for the online platform to consider that the information to which the complaint relates is not illegal and is not incompatible with its terms and conditions, or contains information indicating that the complainant’s conduct does not warrant the suspension or termination of the service or the account, it shall reverse its decision referred to in paragraph 1 without undue delay.
Amendment 1259 #
Amendment 1323 #
2020/0361(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Online platforms shall, after having issued a prior warning, suspend, for a reasonable period of time and after having issued a prior warning,, or terminate the provision of their services to recipients of the service that frequentpeatedly provide manifestly illegal content.
Amendment 1332 #
2020/0361(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Online platforms shall, after having issued a prior warning, suspend, for a reasonable period of time and after having issued a prior warning,, or terminate the processing of notices and complaints submitted through the notice and action mechanisms and internal complaints- handling systems referred to in Articles 14 and 17, respectively, by individuals or entities or by complainants that frequently submit notices or complaints that are manifestly unfounded.
Amendment 1527 #
2020/0361(COD)
Proposal for a regulation
Article 25 – title
Article 25 – title
Very large online platforms, live streaming platforms, private messaging providers and search engines
Amendment 1532 #
2020/0361(COD)
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
1. This Section shall apply to online platform services, live streaming platform services, private messaging services and search engine services which provide their services to a number of average monthly active recipients of the service in the Union equal to or higher than 45 million, calculated in accordance with the methodology set out in the delegated acts referred to in paragraph 3.
Amendment 1548 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 1 – introductory part
Article 26 – paragraph 1 – introductory part
1. Very large online platform services, live streaming platform services, private messaging services and search engine services shall identify, analyse and assess, from the date of application referred to in the second subparagraph of Article 25(4), at least once a year thereafter, any significant systemic risks stemming from the functioning and use made of their services in the Union. This risk assessment shall be specific to their services and shall include the following systemic risks:
Amendment 1599 #
2020/0361(COD)
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
Article 27 – paragraph 1 – introductory part
1. Very large online platform services, live streaming platform services, private messaging services and search engine services shall put in place reasonable, proportionate and effective mitigation measures, tailored to the specific systemic risks identified pursuant to Article 26. Such measures may include, where applicable:
Amendment 1904 #
2020/0361(COD)
Proposal for a regulation
Article 37 – paragraph 5
Article 37 – paragraph 5
5. If the Commission considers that a crisis protocol fails to effectively address the crisis situation, or to safeguard the exercise of fundamental rights as referred to in point (e) of paragraph 4, it mayshall request the participants to remove and, where necessary, revise the crisis protocol, including by taking additional measures.
Amendment 1907 #
2020/0361(COD)
Proposal for a regulation
Article 38 – paragraph 2 – subparagraph 1
Article 38 – paragraph 2 – subparagraph 1
2. Member States shall designate one of the competent authorities as their Digital Services Coordinator. The Digital Services Coordinator shall be responsible for all matters relating to application and enforcement of this Regulation in that Member State, unless the Member State concerned has assigned certain specific tasks or sectors to other competent authorities. Those competent authorities shall have the same powers to carry out the tasks or supervise the sectors assigned to them as those attributed to the Digital Services Coordinator for the application and enforcement of this Regulation. The Digital Services Coordinator shall in any event be responsible for ensuring coordination at national level in respect of those matters and for contributing to the effective and consistent application and enforcement of this Regulation throughout the Union.
Amendment 1927 #
2020/0361(COD)
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. The Member State in which the main establishment of the provider of intermediary services is located shall have jurisdiction for the purposes of Chapters III and IV of this Regulation, Sections 1 to 4, as well as Chapter IV.
Amendment 1930 #
2020/0361(COD)
Proposal for a regulation
Article 40 – paragraph 1 a (new)
Article 40 – paragraph 1 a (new)
1a. The Member State where the consumers have their habitual residence shall have jurisdiction for the purposes of Chapter III, Section 3.
Amendment 1931 #
2020/0361(COD)
Proposal for a regulation
Article 40 – paragraph 1 b (new)
Article 40 – paragraph 1 b (new)
1b. The Member State where the authority issuing the order is situated shall have jurisdiction for the purposes of Articles 8 and 9.
Amendment 1964 #
2020/0361(COD)
Proposal for a regulation
Article 42 a (new)
Article 42 a (new)
Article 42a In accordance with the conditional exemption from liability laid down in Article 1(1)(a), Member States shall ensure that the penalty for repeatedly failing to comply with the obligations under this Regulation includes the horizontal loss of the liability exemption for the intermediary service provider.
Amendment 1968 #
2020/0361(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
Recipients of the service, as well as other parties having a legitimate interest and meeting relevant criteria of expertise and independence from any online hosting services provider or platform shall have the right to lodge a complaint against providers of intermediary services alleging an infringement of this Regulation with the Digital Services Coordinator of the Member State where the recipient resides or is established. The Digital Services Coordinator shall assess the complaint and, where appropriate, transmit it to the Digital Services Coordinator of establishment. Where the complaint falls under the responsibility of another competent authority in its Member State, the Digital Service Coordinator receiving the complaint shall transmit it to that authority.
Amendment 2066 #
2020/0361(COD)
Proposal for a regulation
Article 48 – paragraph 5
Article 48 – paragraph 5
5. The Board may invite experts and observers to attend its meetings, and mayshall cooperate with other Union bodies, offices, agencies and advisory groups, as well as external experts as appropriate. The Board shall make the results of this cooperation publicly available.
Amendment 270 #
2020/0353(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) The European Union needs to step up innovation in battery manufacturing and recycling, especially in view of the potential of renewable materials to replace traditional critical raw materials.
Amendment 287 #
2020/0353(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) The content of this regulation falls within the scope of the current negotiations at the UNECE, which are expected to be concluded in November 2021 and its provisions must, therefore, take this into account.
Amendment 351 #
2020/0353(COD)
Proposal for a regulation
Article premier – paragraph 3 – point b a (new)
Article premier – paragraph 3 – point b a (new)
(ba) Equipment specifically designed for the safety of nuclear installations, as defined in Article 3 of Council Directive 2009/71/Euratom.1a __________________ 1aCouncil Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p.18).
Amendment 381 #
2020/0353(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
(10) ‘automotive battery’ means any battery used only for automotive starter, lighting or ignition power or other functions necessary for the vehicle’s main uses;
Amendment 455 #
2020/0353(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. When there is an unacceptable risk to human health or the environment, arising from the use of a substance in the manufacture of batteries, or from a substance present in the batteries when they are placed on the market, or during their subsequent life cycle stages, including the waste phase, that needs to be addressed on a Union-wide basis, the Commission shall adopt, in accordance with the REACH Regulation, a delegated act in accordance with the procedure referred to in Article 73 to amend the restrictions in Annex I, pursuant to the procedure laid down in Article 71.
Amendment 491 #
2020/0353(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point e a (new)
Article 7 – paragraph 1 – subparagraph 1 – point e a (new)
(ea) the battery’s carbon footprint upon return to the collection point at the recycling centre;
Amendment 724 #
2020/0353(COD)
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. Portable batteries incorporated in appliances shall be readily removable and replaceable by the end-user or by qualified independent operators during the lifetime of the appliance, if the batteries have a shorter lifetime than the appliance, or at the latest at the end of the lifetime of the appliance.
Amendment 731 #
2020/0353(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
A battery is readily replaceable where, after its removal from an appliance, it can be substituted by a similar battery, without affecting the functioning or the performance of that appliance. or endangering the user.
Amendment 813 #
2020/0353(COD)
Proposal for a regulation
Article 13 – paragraph 6
Article 13 – paragraph 6
6. Labels and QR code referred to in paragraphs 1 to 5 shall be printed or engraved visibly, legibly and indelibly on the battery. Where this is not possible or not warranted on account of the nature and size of the battery, labels shall be affixed to the packaging and to the documents accompanying the battery. For a second- life, or repurposed, battery, labels shall be modified in order to identify clearly where statutory liability lies in connection with potential malfunctions.
Amendment 971 #
2020/0353(COD)
Proposal for a regulation
Article 47 – paragraph 1 – introductory part
Article 47 – paragraph 1 – introductory part
1. Producers of batteries shall have extended producer responsibility for batteries that they make available on the market for the first time within the territory of a Member State, to ensure the attainment of the waste management obligations set out in this Chapter. This responsibility shall be transferred to the new economic operator responsible for giving a second life to or repurposing batteries. This responsibility shall include the obligation to:
Amendment 1235 #
2020/0353(COD)
Proposal for a regulation
Annex II – point 5 – paragraph 5 – indent 5
Annex II – point 5 – paragraph 5 – indent 5
– End -of -life stage, including transport from collection point to recycling centre
Amendment 120 #
2020/0322(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) TIn line with the "One Health" and "Health in all policies" approaches, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. The Union should urge Member States to implement the health-specific country-specific recommendations and support Member States to strengthen the resilience, responsiveness and readiness of healthcare systems in order to address future challenges, including pandemics. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.
Amendment 123 #
2020/0322(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States and all relevant stakeholders, such as industry, supply chain actors, health professionals and patients associations, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.
Amendment 133 #
2020/0322(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Prevention, preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ prevention, preparedness and response plans so as to ensure they are compatible within the regional level structures. To support Member States in this endeavour, targeted training and knowledge exchange activitiParticular attention must be paid to cross- border regions. To support Member States in this endeavour, the Commission and Union agencies should provide targeted training and facilitate the sharing of best practices for healthcare staff and public health staff should be providedto improve their knowledge and ensure necessary skills should be provided by the Commission and Union Agencies. To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
Amendment 152 #
2020/0322(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, the Union should adopt a coordinated approach in fighting against such threats. The joint procurement of medical countermeasures should, therefore, be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. In times of crisis, the Union should also aim to support access to medical countermeasures for Eastern Partnership and low- and middle-income countries. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . The Member States should ensure a sufficient reserve of critical medical products at Member State level to counter the risk of shortages of critical products. _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 160 #
2020/0322(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In order to counteract not only the Union’s dependence on third countries but also the vicissitudes of manufacturing and disruptions in the supply chain, recalls the importance of diversified supplies and procurement practices for pharmaceuticals and the need to swiftly propose guidelines for the Member States, notably on how to best implement the most economically advantageous tender criteria, looking beyond the lowest price criterion only; investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards;
Amendment 163 #
2020/0322(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Joint procurement should be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments should be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 167 #
2020/0322(COD)
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9 b) The joint procurement shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure all actors involved shall fulfil their contractual responsibilities. Clear and transparent stages should be defined for the process, scope, specifications, timelines and formalities;
Amendment 173 #
2020/0322(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Unlike for communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other potentially serious cross- border threats to health do not currently necessitate monitoring by EU Agencies. A risk-based approach, whereby monitoring is carried out by Member States and available information is exchanged through EWRS, is therefore more appropriate for such threats. Nevertheless, the ECDC should have the ability to monitor the impact of communicable diseases on non- communicable diseases, including the continuity of screening, diagnosis, monitoring, treatment and care in the healthcare system;
Amendment 176 #
2020/0322(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance. In times of crisis, particular attention should also be paid to the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and to the mental health implications of the crisis and psychosocial needs of the population.
Amendment 187 #
2020/0322(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) In order to enable medicinal products to be made available during the COVID19 pandemic, marketing authorisation holders were allowed regulatory flexibilities, by for example covering procedures for changes in the suppliers of active pharmaceutical ingredients, the designation of new manufacturing sites and faster import authorisations, in order to better mitigate the shortage of medicines. These solutions should be made permanent in order to be able to respond to future situations and these flexibilities should be applied by Member States in a consistent manner to avoid fragmentation of the internal market and ineffective outcomes.
Amendment 188 #
2020/0322(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) Regular dialogue and exchange of information between authorities, industry, relevant entities of the pharmaceutical supply chain, healthcare professionals' and patients' organizations should also be ensured to start early discussions about expected potential serious cross-border threats to health in the market by way of sharing expected supply constraints or raising of specific clinical needs, allowing better coordination, synergies and appropriate reaction when needed.
Amendment 199 #
2020/0322(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts and representatives of health and care workers, including nurses and medical doctors, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers. All members of the Advisory Committee should provide declarations of interest in line with the applicable rules in each case. The advisory committee should work in close cooperation with national advisory bodies. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, Union export control mechanisms, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.
Amendment 209 #
2020/0322(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) The Commission and the Member States should actively work towards a new global treaty for pandemic preparedness and response under the framework of the World Health Organization and with close involvement of other relevant organizations, building on and improving the existing global health instruments, especially the International Health Regulations (2005)1a to ensure a firm and tested foundation. Such a Treaty should support and focus on strengthening the international health framework and improving cooperation with regard to early detection, prevention, response and resilience to future pandemics. _________________ 1aWorld Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 225 #
2020/0322(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. TIn keeping with "One Health" and "Health in all policies approaches", the implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. The strengthened Union health framework addressing serious cross-border health threats shall work in synergy with and in a manner that is complementary to other Union policies and funds, such as actions implemented under the ESIF, Horizon Europe, the Digital Europe Programme, rescEU, ESI, ESF+ and SMP.
Amendment 235 #
2020/0322(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issue, the surveillance of the impact of such diseases on non- communicable diseases and of related special health issues, such as mental health impacts of the crisis and the impact of deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions.
Amendment 281 #
2020/0322(COD)
Proposal for a regulation
Chapter II – title
Chapter II – title
II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 293 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point b a (new)
Article 5 – paragraph 3 – point b a (new)
(b a) the mapping of the strategic production capacities for the Union as a whole;
Amendment 295 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point c a (new)
Article 5 – paragraph 3 – point c a (new)
(c a) the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions during health emergencies;
Amendment 298 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point g a (new)
Article 5 – paragraph 3 – point g a (new)
(ga) the establishment of a European stock of critical medicines and medical countermeasures as part of the rescEU emergency reserve;
Amendment 308 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Union preparedness and response plan shall include cross-border and interregional preparedness elementplans to establish coherent, multi-sectoral, cross- border public health measures, in particular considering capacities for testing, contact tracing, laboratories, training of healthcare staff and specialised treatment or intensive care across neighbouring regions. The plans shall include preparedness and response means to address the situation of those citizens with higher risks.
Amendment 330 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. Member States shall by the end of November 2021 and every 2 years thereafter provide the Commission with a report on their preparedness and response planning and implementation at national and, where appropriate, regional and cross-border levels.
Amendment 341 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
(i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery at national and, where relevant, regional and cross-border levels; coordination mechanisms;
Amendment 348 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
(ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; access to diagnostic serviceinformation relevant for the internal market and Union strategic reserves of medical products, including national stockpiles and capacities to contribute to the security of supply of critical medical products at Union level; equal access to diagnostic services and tools and medical products during emergencies; the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 359 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; a reserve of critical medical products at Member State level; and dedicated, trained and equipped human resources for emergencies; and
Amendment 363 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii a (new)
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii a (new)
(iii a) pandemic stockpile/strategic stockpile: each State shall provide information on the number and availability of medical countermeasures and other essential medicines and medical devices for the control of the threats set out in Article2(1), as well as the capacity for their safekeeping and storage. In order to have a greater response capacity, storage shall be carried out in the premises and centres closest and most accessible to the population centres, which meet the necessary requirements to provide the service in accordance with the regulations applicable to medicinal products, medical devices and other medical countermeasures.
Amendment 364 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point c
Article 7 – paragraph 1 – subparagraph 1 – point c
(c) implementation of national response plans, including where relevant implementation at the regional and local levels, covering epidemic response; antimicrobial resistance, health care associated infection, mental health impacts, the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and other specific issues.
Amendment 369 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
Amendment 396 #
2020/0322(COD)
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1 a. The Commission report shall include the state of cross-border preparedness and response planning in neighbouring regions.
Amendment 420 #
2020/0322(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
The Commission shall organise those activities in cooperation with the Member States concerned or potentially concerned. In cross-border regions, mandatory joint cross-border training and sharing of best practices for healthcare staff and public health staff shall be organised.
Amendment 433 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health within a reasonable time frame. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 436 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) participation in the joint procurement procedure shall be open to all Members States, European Free Trade Association (EFTA) States and, Union candidate countries in accordance with Article 165(2) of Regulation (EU, Euratom) 2018/1046, as well as Andorra, San Marino and Monaco;
Amendment 444 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
(c) Member States, EFTA States and, Union candidate countries, as well as Andorra, San Marino and Monaco, when participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product;
Amendment 452 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(d a) Joint procurement shall be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments shall be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 456 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d b (new)
Article 12 – paragraph 2 – point d b (new)
Amendment 459 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point e a (new)
Article 12 – paragraph 2 – point e a (new)
(ea) the joint procedure must guarantee the application of the most economically advantageous tender criteria, but should look beyond the lowest price criterion; investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards;
Amendment 472 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3 a. The Union shall strive to also support access to counter-measures for Eastern Partnership and low- and middle- income countries.
Amendment 478 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b a (new)
Article 13 – paragraph 2 – point b a (new)
(b a) monitor the impact of communicable diseases on the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 479 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b b (new)
Article 13 – paragraph 2 – point b b (new)
(b b) monitor the impact of communicable diseases on mental health;
Amendment 482 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point e
Article 13 – paragraph 2 – point e
(e) contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence, complications, hospitalisation and mortality, the mental health impact and deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 486 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point h a (new)
Article 13 – paragraph 2 – point h a (new)
(h a) identify any weakness in the global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of communicable diseases;
Amendment 494 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 3 – point f a (new)
Article 13 – paragraph 3 – point f a (new)
(f a) information on the availability of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of the disease.
Amendment 504 #
2020/0322(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. Human oversight should be ensured.
Amendment 565 #
2020/0322(COD)
Proposal for a regulation
Article 19 – paragraph 3 – point i a (new)
Article 19 – paragraph 3 – point i a (new)
(i a) the existing and potential production sites, with the sole aim of allowing the Union to map the strategic production capacities for the Union as a whole;
Amendment 566 #
2020/0322(COD)
Proposal for a regulation
Article 19 – paragraph 3 – point j
Article 19 – paragraph 3 – point j
(j) requests and offers for cross-border emergency assistance; , such as the medical transfer of patients or provision of healthcare staff by one Member State to another, in particular in cross-border areas in neighbouring regions;
Amendment 581 #
2020/0322(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point b
Article 21 – paragraph 1 – point b
(b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionals. In addition, the Commission shall broaden its communication activity to cover the general public by establishing and managing a portal to share verified information and fight against disinformation;
Amendment 593 #
2020/0322(COD)
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and relevant regional authorities and the Commission on the nature, purpose and scope of those measures, especially in cross-border regions.
Amendment 613 #
2020/0322(COD)
(ii) identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact, including in clinical management and treatment, non- pharmaceutical countermeasures, global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow-up of the disease concerned and public health research needs;
Amendment 619 #
2020/0322(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The Advisory Committee shall be composed of independent experts and representatives of health and care workers, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on sanitary, biomedical, behavioural, social, economic, cultural and international aspects. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad- hoc basis.
Amendment 625 #
2020/0322(COD)
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2 a. All members of the Advisory Committee shall provide declarations of interest in line with the applicable rules in each case.
Amendment 633 #
2020/0322(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
(b) mechanisms to monitor shortages of, develop, procure, ensure security of supply, manage and deploy medical countermeasures;
Amendment 634 #
2020/0322(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)
Article 25 – paragraph 1 – point c a (new)
(c a) A Union export control mechanism with the aim of enabling the Union to guarantee timely and effective access to counter-measures.
Amendment 637 #
2020/0322(COD)
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
5. Personal data may also be exchanged in the context of automated contact tracing, using contact tracing applications, in full compliance with the Regulation (EU) 20176/679 ('GDPR').
Amendment 117 #
2020/0321(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that, by strengthening its capacity and improving cooperation and coordination between the EU Member States, the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States and by the lack of cooperation and coordination between the latter.
Amendment 123 #
2020/0321(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) The COVID-19 crisis has shown that coordination and dialogue between European, national and regional authorities, industry, entities involved in the pharmaceutical supply chain, healthcare professionals and patients’ associations at European level are vital for countering health threats and should continue after the current health crisis ends so that the shortage of one-off and recurrent medicinal products can be tackled effectively. Ongoing dialogue between all such stakeholders should be assured.
Amendment 129 #
2020/0321(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) TDisruptions to the often complex supply chains of medicinal products and medical devices, national export restrictions and bans, border closures impeding the free movement of those goods, and uncertainty related to their supply and demand in the context of the COVID- 19 pandemic, and the lack of production in Europe of certain essential medicinal products or chemical active ingredients have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the Union.
Amendment 135 #
2020/0321(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Dealing with the issue of shortages of medicinal products has been a long- standing priority for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI)Does not affect English version.)
Amendment 136 #
2020/0321(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
Amendment 139 #
2020/0321(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has exacerbated the existing problem of shortages for certain medicinal products considered as essential and critical in addressing the pandemic, and has highlighted the Union’s dependence on third countries such as India or China, particularly in terms of the production of chemical active ingredients, the lack of coordination and cooperation between Member States, the structural limitations in the Union’s ability to rapidly and effectively react to such challenges during public health crises, and the need to support and strengthen the Union’s industrial fabric through appropriate policies.
Amendment 143 #
2020/0321(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) In order to tackle the Union’s dependence on third countries as well as production uncertainties and supply disruptions, emphasis must be placed on the importance of diversifying supplies and contracting practices for pharmaceutical products and on the need to offer prompt guidance to Member States, especially on the best way to apply the most economically advantageous tender criteria, without being confined to just the lowest price criterion. Investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards.
Amendment 148 #
2020/0321(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact on supply and stock shortages. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency and the necessary coordination within the Union.
Amendment 152 #
2020/0321(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions or bans amongst Member States and other national protective measures, such as inappropriate stockpiling, which can seriously impact the functioning of the internal market. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits or suitable PPE such as masks, gloves and protective clothing. It is therefore important to address the question of shortages and to, reinforce and formalise monitoring of critical medicinal products and medical devices, and improve coordination within the Union.
Amendment 162 #
2020/0321(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers or other entities in the pharmaceutical supply chain and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.
Amendment 165 #
2020/0321(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In order to facilitate the supply of medicinal products during the COVID-19 pandemic, marketing authorisation holders were granted regulatory flexibility in relation to, for example, existing procedures for changing suppliers of active ingredients, designation of new production sites and faster processing of import permits, so that shortages of medicinal products could be addressed. Those solutions should remain in place to assist with future situations and those flexibilities should be applied consistently across the Member States to prevent fragmentation of the internal market and ineffective outcomes.
Amendment 169 #
2020/0321(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate and better coordinate the rules on monitoring of shortages of medicinal products and medical devices, and, through increased support for research and innovation, to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises.
Amendment 172 #
2020/0321(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) In order to ensure effective health systems, stress tests should be introduced to assess the resilience of health systems in emergencies with a view to providing an effective means of countering shortages in the event of pandemics and identifying structural risk factors that create shortages.
Amendment 187 #
2020/0321(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) In order to ensure that Member State strategies, particularly in terms of stock management, are correctly implemented and coordinated, the Agency should become the regulatory authority responsible for preventing shortages of medicinal products within the Union, not only during crises but also in normal times, and its mandate and resources should also be strengthened.
Amendment 189 #
2020/0321(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products. The Steering Group should establish a European lists of essential and critical medicinal products, in cooperation with all stakeholders, to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health protection as well as adequate supplies. Priorities should be established for the different types of medicinal product by drawing a distinction in particular between ‘medicinal products of major therapeutic interest’ (MITMs), i.e. medicines for which an interruption of treatment is likely to jeopardise the vital prognosis of patients in the short or medium term or significantly diminishes the patient’s chances with regard to the progressive potential of the disease, or for which there are no suitable therapeutic alternatives available in sufficient quantity, and ‘medicinal products of health and strategic importance’ (MISSs), for which the interruption of treatment causes an immediate threat to the patient’s life.
Amendment 243 #
2020/0321(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) prepare for and manage, coordinate and manage at European level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;
Amendment 250 #
2020/0321(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;
Amendment 275 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical devicethe needs of patients or healthcare professionals;
Amendment 319 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and, marketing authorisation holders to attend its meetingor any other entity in the relevant pharmaceutical supply chain, healthcare professionals and patients’ associations, to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.
Amendment 348 #
2020/0321(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency in coordination with the relevant national or regional authorities.
Amendment 370 #
2020/0321(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
The Medicines Steering Group shall provide advice and recommendations to the Commission and Member States on any appropriate action it believes should be taken at Union level on the medicinal products concerned in accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 726/200418. _________________ 18 Regulation (EC) No 726/2004
Amendment 375 #
2020/0321(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.
Amendment 380 #
2020/0321(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medicines Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 405 #
2020/0321(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
There should also be regular structured dialogue with industry, entities involved in the pharmaceutical supply chain, healthcare professionals and patients’ associations so that any potential or actual shortages of those medicinal products in a public health emergency and/or major event can be managed as effectively as possible.
Amendment 422 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals or patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 433 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 448 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the critical medicines lists;
Amendment 477 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point e
Article 9 – paragraph 3 – point e
(e) sales, available stock, where relevant, and market share data;
Amendment 486 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including production and supply capacity;
Amendment 522 #
2020/0321(COD)
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, Member States or any national competent authority shall, by the deadline set by the Agency:
Amendment 529 #
2020/0321(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States, with the support of the Agency, shall gather information and data on stock levels from wholesale distributorsmarketing authorisation holders, wholesale distributors, community and hospital pharmacies, and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.
Amendment 530 #
2020/0321(COD)
Proposal for a regulation
Article 11 – paragraph 2 a (new)
Article 11 – paragraph 2 a (new)
2a. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States, with the support of the Agency, shall gather information and data on unmet demands from wholesale distributors, community and hospital pharmacies, and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.
Amendment 547 #
2020/0321(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines and recommendations addressed to Member States, marketing authorisation holders, and other entities;
Amendment 569 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point e
Article 14 – paragraph 2 – point e
(e) providing scientific recommendations with regard to the use of any medicinal product, and in particular alternative medicinal products, which may have the potential to address public health emergencies, in accordance with Article 16;
Amendment 572 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point f
Article 14 – paragraph 2 – point f
(f) cooperating with national and regional competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies, as necessary.
Amendment 636 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups to attend its meeting, any other entity in the relevant pharmaceutical supply chain, healthcare professionals and patients’ associations, to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.
Amendment 650 #
2020/0321(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 672 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the public health emergency critical devices list;
Amendment 679 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 3 – point e
Article 23 – paragraph 3 – point e
(e) sales, stock, where relevant, and market share data;
Amendment 686 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) prevention and mitigation plans including production and supply capacity;
Amendment 692 #
2020/0321(COD)
Proposal for a regulation
Article 25 – paragraph 1 – introductory part
Article 25 – paragraph 1 – introductory part
1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, Member States or any national competent authority shall, by the deadline set by the Agency:
Amendment 66 #
2020/0320(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. From the challenges experienced in responding to the pandemic it became clear that the Centre’, which has particularly affected people with chronic non- communicable diseases being more vulnerable to COVID-19 infection. Given the unprecedented challenges experienced in responding to the pandemic and in view of the effectiveness gaps which have been identified in the Centre's performance in that regard, it became clear that its role in the Union’s framework for health crisis preparedness and response should be strengthened to better use the potential of the Union's and Member States' capacities to respond to future pandemics.
Amendment 74 #
2020/0320(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation accordingly expands the mission and tasks of the Centre to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which are relevant to the prevention, preparedness, response planning and combating serious cross- border threats to health in the Union, including cross-border threats, communicable diseases and major chronic diseases and especially the interconnections between them, in accordance with Regulation EU …/… of the European Parliament and of the Council10 [ISC/2020/12524]. __________________ 10Regulation (EU) XXXX/XXXX of the European Parliament and of the Council of DATE on serious cross-border threats to health and repealing Decision No 1082/2013/EU [OJ: please, insert full title and publication reference to Regulation on serious cross border threats to health (SCBTH).]
Amendment 76 #
2020/0320(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) The European Ombudsman's decision of 5 February2021 in strategic inquiry OI/3/2020/TE identified some important effectiveness gaps in the Centre's response to the COVID-19 pandemic, as regards how the Centre gathers information, the transparency of that information and how it communicates with the public, as well as a power asymmetry between the Centre and the Member States, resulting in lack of timely, complete and comparable data and thus affecting the modelling and forecasting potential of the Centre, which should be addressed in this Regulation.
Amendment 80 #
2020/0320(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) In this respect, the Centre should be tasked with providing epidemiological information and its analysis, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases, prevention of excess mortality among patients, notably those suffering from chronic diseases and the increase of infection-caused chronic diseases and other pathogens associated with chronic diseases. This should also contribute to efficiently responding to current and emerging threats to human health posed by non-communicable diseases, either directly or indirectly, due to increasing risks associated with communicable diseases. Its actions should be consistent with a One-Health approach, recognising the interconnections between communicable and chronic diseases, as well as between human and animal health and the environment. It should monitor the capacity of the national health systems to respond to communicable disease threats, in particular given the importance of this information in the preparation of the national preparedness and response plans, with a view to enabling Member States to better assess their health systems' capacities. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, including their interconnection with chronic diseases, provide guidelines for treatment and case management based on a thorough assessment of the latest evidence, support epidemic and outbreak responses in Member States and third countries, including field response, and provide timely objective, reliable and easily accessible information on communicable diseases and their effect on the health-related quality of life of patients with chronic diseases to the public. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health hence contributing to EU’s commitment to reinforcing partners’ preparedness and response capacity. It should also work to ensure that there is sufficient, comparable and high quality data for the Union-wide surveillance and monitoring of major communicable diseases such as HIV, viral hepatitis B and C and Tuberculosis.
Amendment 92 #
2020/0320(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States should be tasked to communicate to the Centre data on the surveillance and monitoring of communicable diseases, the interconnection with chronic conditions and other special health issues such as antimicrobial resistance and health care- associated infections related to communicable diseases, as well as broader health determinants including social determinants, available scientific and technical data and information relevant to the Centre’s mission, to notify the Centre of any serious cross-border threats to health, information on preparedness and response planning and health system capacity, and provide relevant information that may be useful for coordinating the response, as well as identify recognised competent bodies and public health experts available to assist in Union responses to health threats. All timelines, case definitions, indicators, standards, protocols and procedures for communication adopted by the Centre should be agreed with Member States and be mandatory for the Member States thereafter.
Amendment 98 #
2020/0320(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In order to facilitate the analysis of information provided by the Member States, the Centre, working together with the Member States, should establish an overall framework identifying the elements required for this analysis to enable the information provided to be harmonised and to facilitate decision- making.
Amendment 101 #
2020/0320(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) To enhance preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. To this end, the Centre should coordinate and provide technical and scientific expertise to the Commission and Member States through dedicated networks with competent coordinating bodies, including by encouraging cooperation within newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction,.
Amendment 107 #
2020/0320(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) With a view to enhance the effectiveness of epidemiological surveillance of communicable diseases and ofand monitoring of testing and treatment of communicable diseases, their interconnection to non-communicable diseases and the related special health issues in the Union, the Centre should be tasked with the further development of digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence and computer modelling and simulation, in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiologicalhealth surveillance systems. Such digital platforms and applications should be developed with integrated EU space generated data with the intention to be integrate them in the future European Health Data Space as governed by the Union legislation.
Amendment 114 #
2020/0320(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform accurate risk assessment and response, the Centre should in particular monitor, and report on trends in communicable diseases, support and their interconnections with chronic conditions, support, coordinate and facilitate evidence-based approach and response action of the Member States, provide recommendations for improvement of communicable disease prevention and control programmes established at the national and Union level, monitor and assess the capacity of national health systems for diagnosis, prevention and treatment of communicable diseases and their interconnection with and impact on chronic conditions, including in a gender- sensitive way, identify population groups at risk, including vulnerable populations, requiring specific measures, analyse the correlation of disease incidence with societal and environmental factors, consider the impact of co-morbidities on patients with communicable diseases and their treatment and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.
Amendment 132 #
2020/0320(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should, working in conjunction with Member States so as to take account of their experiences and respective situations, develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, awareness of transmission routes, antimicrobial resistance, health education, health literacy and behaviour change. and links with non- communicable diseases including vulnerable groups, health literacy, health promotion and disease prevention and behaviour change. Improving overall population health through disease prevention will help to reduce susceptibility to future infectious outbreaks.
Amendment 139 #
2020/0320(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The Centre should enhance preparedness and response capabilities at national and Union level by providing scientific and technical expertise to the Member States and the Commission. In this context the Centre, in close collaboration with the Member States and the Commission, should carry out various actions, including the development and coordination of Union and national preparedness and response plans and preparedness monitoring and evaluation frameworks, provide recommendations on capacities to prevent, prepare and respond to disease outbreaks and on the strengthening of national health systems. The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, data on interconnections between communicable diseases and chronic conditions and especially on major as well as infection- based chronic diseases, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with agencies, competent bodies and organisations operating in the field of data collection.
Amendment 152 #
2020/0320(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]] provides for the early warning and response system enabling the notification at Union level of alerts related to serious cross-border threats to health which continues to be operated by the ECDC. Given that modern technologies can be of substantial support to combat health threats and to contain and reverse epidemics, the ECDC should work on updating this system to enable the use of artificial intelligence, High Performance Computing, in silico clinical trials and digital twin technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at- risk individuals.
Amendment 157 #
2020/0320(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The Centre should establish appropriate capacities to support international, interregional and field response, in accordance with Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. These capacities should enable the Centre to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’, to assist local responses to outbreaks of diseases. The Centre should therefore ensure permanent capacity to carry out missions to Member States as well as in third countries and to provide recommendations on response to health threats. These teams will also be able to be deployed under the Union Civil Protection Mechanism with the support of the Emergency Response Coordination Centre. The Centre should also support the strengthening of preparedness capacities under the International Health Regulations (IHR) in third countries, in order to address serious cross border threats to health and the consequences thereof.
Amendment 159 #
2020/0320(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) To assist responses to outbreaks, which may spread within or to the Union, the Centre is to develop a permanent EU Health Task Force and a framework for theits mobilisation the EU Health Task Force in accordance with Decision No 1313/2013/EU of the European Parliament and of the Council 11 and facilitate the participation of Union field response experts in international response teams in support of and in close coordination with the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Union and EEA countries, candidate countries and potential candidates, as well as European Neighbourhood Policy countries and EU partner countries as referred to in Regulation (EU) No 233/2014 of the European Parliament and of the Council 12 , to effectively participate in field missions and crisis management. __________________ 11Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). 12Regulation (EU) No 233/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for development cooperation for the period 2014-2020 (OJ L 77, 15.3.2014, p. 44).
Amendment 166 #
2020/0320(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should not confer any regulatory powers on the Centre. However, the Centre should exercise broad coordination competences and the power to provide recommendations at Union, national and interregional level in the form of clear and uniform science- based proposals.
Amendment 185 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
In order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans, their interconnection with chronic conditions and those related special health issues set out in Article 2 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], the mission of the Centre shall be to identify, assess, and report on current and emerging threats to human health from communicable diseases, and provide recommendations for response at Union and national levels, as well as at regional level, if necessarys, and provide recommendations for response and coordinated action at Union and national levels, as well as at interregional and regional level, where appropriate. In providing such recommendations, the Centre shall take into account existing national crisis management plans and the respective circumstances of each Member State. The Centre shall also provide forecasts on the development of the identified health threats, that will help predict the demand of key medical technologies during the evolution of a possible health emergency, and specifically a forecast of Intensive Care Units usage and related device and diagnostic needs.
Amendment 196 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
In the case of other outbreaks of illnesses of unknown origin that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that clearly is not causrelated byto a communicable disease, the Centre shall act only in cooperation with the competent body upon request from that body.
Amendment 219 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point e a (new)
Article 3 – paragraph 2 – point e a (new)
(ea) support national monitoring of the response to major communicable diseases to measure progress in tackling them across the Union;
Amendment 221 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point g
Article 3 – paragraph 2 – point g
(g) provide, upon request of the Commission or the HSCealth Security Committee (‘HSC’)established under Article 4 of Regulation (EU) …/… [the SCBTH Regulation], or on its own initiative, guidelines, recommendations and proposals for coordinated action for treatment and case management of communicable diseases and other special health issues relevant for public health, in cooperation with relevant societies; as well as unpredicted trends in the development of major chronic non- communicable diseases, including in cooperation with relevant organisations with experience and expertise in treatment and case management of those diseases and health issues, while avoiding any duplication of existing guidelines, except in cases where it is necessary to update such guidelines;
Amendment 226 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point h
Article 3 – paragraph 2 – point h
(h) support epidemic and outbreak response in Member States, and in third countries, in complementarity and close coordination with other Union emergency response instruments, in particular the Union Civil protection mechanism;
Amendment 229 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point j
Article 3 – paragraph 2 – point j
(j) provide, upon request of the Commission or the Health Security Committee (‘HSC’),SC, easily accessible and evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them, on their possible interconnection with non-communicable diseases and impact on patients, suffering from severe or major non-communicable diseases and chronic conditions, and on the relevant prevention and control measures.
Amendment 246 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) communicate to the Centre in a timely manner, as soon as possible, regularly and according to agreed case definitions, indicators, standards, protocols and procedures data on the surveillance of communicable diseases and other special health issues undertaken in accordance with Article 13 of Regulation (EU) …/… [OJ: please insert the number of Regulation SCBTH [ISC/2020/12524]], and available scientific and technical data and information relevant to the Centre’s mission, including on preparedness, and health systems capacities to detect, prevent, respond to and recover from outbreaks of communicable diseases;
Amendment 250 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) notify the Centre of any serious cross-border threats to health, including spread of communicable diseases, unpredicted rise of known or unknown severe non-communicable diseases or chronic conditions and health-related environmental hazards, as soon as detected, through the Early Warning and Response System (EWRS), and promptly communicate response measures taken, as well as any relevant information that may be useful for coordinating the response as referred to in Article 21 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]]; and
Amendment 251 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) notify the Centre, in accordance with the general framework developed by the Centre in consultation with the Member States, of any serious cross- border threats to health, as soon as detected, through the Early Warning and Response System (EWRS), and promptly communicate response measures taken, as well as any relevant information that may be useful for coordinating the response as referred to in Article 21 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]]; and
Amendment 253 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) identify, within the scope of the mission of the Centre, recognised competent bodies and public health experts who could be made available to assist in Union responses to health threats, such as by undertaking missions to Member States, cross-border regions or to third countries to provide expert advice and field investigations in the event of disease clusters or outbreaks.;
Amendment 264 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 1
Article 5 – paragraph 2 – subparagraph 1
The Centre shall ensure the integrated operation of the network for the epidemiological surveillance of the communicable diseases and of the related special health issues, such as unpredicted rise of known or unknown severe major non- communicable diseases or chronic conditions and health-related environmental hazards, including those referred to in points (i) and (ii) of point (a) of Article 2(1) of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]].
Amendment 272 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point a
Article 5 – paragraph 2 – subparagraph 2 – point a
(a) ensure the furthercontinuous development of the digital platforms and applications, including the platform for surveillance established under Article 14 of Regulation (EU) .../... [the SCBTH Regulation], supporting epidemiological and health surveillance at Union level, supporting Member States with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services;
Amendment 279 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point b
Article 5 – paragraph 2 – subparagraph 2 – point b
(b) provide quality assurance by monitoring and evaluating epidemiological and health surveillance activities (including setting surveillance standards and monitoring data completeness) of the dedicated surveillance networks to ensure optimal operation;
Amendment 283 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point c
Article 5 – paragraph 2 – subparagraph 2 – point c
(c) maintain database(s) for such epidemiological and health surveillance, coordinate with the hosts of other relevant databases, and work towards harmonised approaches to data collection and modelling;
Amendment 291 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point g
Article 5 – paragraph 2 – subparagraph 2 – point g
(g) ensure the interoperability of the digital platforms for surveillance with digital infrastructures allowing for the health data to be used for healthcare, research, policy making and regulatory purposes and with a view to integrate those platforms and infrastructures in the European Health Data Space, as regulated by Union legislation, and make use of other relevant data, for example environmental factors, or phenomena with potential severe health impact at Union or inter-regional level.
Amendment 296 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point a
Article 5 – paragraph 4 – point a
(a) monitor and report on trends in communicable diseases and their interconnection to chronic conditions and implications for patients with severe non- communicable diseases and chronic conditions over time and across Member States and in third countries, based on agreed indicators, to assess the present situation and facilitate appropriate evidence-based action, including through the identification of specifications for harmonised data collection from member states
Amendment 309 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point f
Article 5 – paragraph 4 – point f
(f) contribute to the assessment of the burden of communicable diseases on the population using data, such as disease prevalence, complications, clinical links with non-communicable diseases, development of chronic co-morbidities, cancers, hospitalisation and mortality, and ensure that this data is disaggregated on age, gender and disability;
Amendment 349 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 3
Article 5a – paragraph 3
3. The Centre shall evaluate and monitor communicable disease prevention and control programmes in order to provide the evidence for recommendations to coordinate, strengthen and improve these programmes at the national, inter- regional and Union level, and where appropriate at the international levels.
Amendment 357 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 851/2004
Article 5b – paragraph 1 – subparagraph 1
Article 5b – paragraph 1 – subparagraph 1
The Centre shall provide scientific and technical expertise to the Member States and the Commission in collaboration with relevant Union bodies and agencies and the EU integrated political crisis response (IPCR) arrangements and international organisations in accordance with appropriate working arrangements established with the Commission in the field of preparedness and response planning.
Amendment 358 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 851/2004
Article 5b – paragraph 1 – subparagraph 1
Article 5b – paragraph 1 – subparagraph 1
The Centre shall provide scientific and technical expertise to the Member States and the Commission in collaboration with relevant Union bodies and agencies and international organisations and civil society in accordance with appropriate working arrangements established with the Commission in the field of preparedness and response planning.
Amendment 409 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Centre shall work with the Commission and the HSC on the EWRS updates, including for the use of modern technologies, such as digital mobile applications, artificial intelligence and computer modelling and simulation models, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States and on defining the functional requirements of the EWRS.
Amendment 414 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 1
Article 8a – paragraph 1
1. The Centre shall provide timelyscientific rapid risk assessments as soon as possible, in accordance with Article 20 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) of that Regulation including a threat to substances of human origin, such as blood, organs, tissues and cells potentially impacted by communicable diseases, or point (d) of Article 2(1) of that Regulation
Amendment 417 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 2
Article 8a – paragraph 2
2. The risk assessment shall includes referred to in paragraph 1 shall include, where possible, general and targeted recommendations for response as a basis for coordination in the HSC. , including, but not limited, to: (a) a forecast on the evolution of a health crisis and the risk of health emergency; (b) a forecast on the demand of medicines, vaccines, medical equipment, protective equipment and hospital capacity; (c) identification of vulnerable groups in the society, such as patients, suffering chronic conditions, patients with severe non-communicable diseases, elderly, children, pregnant women and professions with a high risk of infection or transmission, including specific needs for medicines and hospital capacity for those most vulnerable groups; (d) identification of possible protective measures and assessment of their efficacy; (e) assessment of the possible need for activation of the Health Task Force and the Union Civil Protection Mechanism.
Amendment 419 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 2
Article 8a – paragraph 2
2. The scientific risk assessment shall include general and targeted recommendations for response as a basis for coordination in the HSC.
Amendment 424 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 851/2004
Article 8b – paragraph 1 – point a
Article 8b – paragraph 1 – point a
(a) national or inter-regional responses to the serious cross-border threat to health;
Amendment 427 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 851/2004
Article 8b – paragraph 1 – point b a (new)
Article 8b – paragraph 1 – point b a (new)
(ba) recommendation for the deployment of the Health Task Force or activation of the Union Civil Protection Mechanism.
Amendment 434 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point a
Article 11 – paragraph 1a – point a
(a) epidemiological surveillance of communicable diseases, other health threats such as unpredicted rise of known or unknown severe non-communicable diseases or chronic conditions and related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]];
Amendment 435 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point b
Article 11 – paragraph 1a – point b
(b) the progression of epidemic situations, including for modelling, anticipation and scenario development, the assessment of vulnerable groups and the forecast on specific demand for medicines, equipment and hospital capacity;
Amendment 437 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point c
Article 11 – paragraph 1a – point c
(c) unusual epidemic phenomena or new communicable and non- communicable diseases of unknown origin, including those in third countries;
Amendment 441 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point c
Article 1 – paragraph 1 – point 13 – point c
Regulation (EC) No 851/2004
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
(c) work in close cooperation with the competent bodies of the organisations and relevant counterparts operating in the field of data collection from the Union, third countries, the WHO, and other international organisations; and, the scientific community and civil society, while ensuring robust safeguards concerning transparency and accountability;
Amendment 454 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
1. The Centre shall establish a permanent capacity, as well as an enhanced emergency capacity to mobilise and deploy the EU Health Task Force including the Centre’'s staff and experts from Member States and fellowship programmes, to assist local response to outbreaks of communicable diseases in Member States and in third countries.
Amendment 457 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 2
Article 11a – paragraph 2
2. The Centre shall develop a framework and establish procedures with the Commission to mobilisedeploy the permanent capacity and mobilise the emergency capacity of the EU Health Task Force.
Amendment 460 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 4 – subparagraph 1
Article 11a – paragraph 4 – subparagraph 1
The Centre shall develop with the Commission a framework for the deployment of the permanent capacity and the mobilisation of the EU Health Task Force, in view of action under Decision No 1313/2013/EU*.
Amendment 463 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 6
Article 11a – paragraph 6
6. The Centre shall maintain a permanent capacity to carry out missions to Member States, upon request of the Commission and Member States, to provide recommendations on response to threats to health within its mandate.
Amendment 478 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 16 – point b
Article 1 – paragraph 1 – point 16 – point b
Regulation (EC) No 851/2004
Article 14 – paragraph 5 – point i – subparagraph 1
Article 14 – paragraph 5 – point i – subparagraph 1
determine by unanimity the rules governing the languages of the Centre, including the possibility of a distinction between the internal workings of the Centre and the external communication, taking into account the need to ensure access to, and participation in, the work of the Centre by all interested parties in both cases.
Amendment 90 #
2020/0300(COD)
Proposal for a decision
Recital 4
Recital 4
(4) According to the EEA report ‘The European environment – state and outlook 2020, Knowledge for transition to a sustainable Europe’ (‘SOER 2020’), 2020 representthere is a unique window of opportunity for the Union to show leadership on sustainability and to face the urgent sustainability challenges requiring systemic solutionin the next decade to lead the global response to sustainability challenges. As stated in SOER 2020, the changes in the global climate and ecosystems observed since the 1950s are unprecedented over decades to millennia. The global population has tripled since 1950, while the population living in cities has quadrupled. With the current growth model, environmental pressures are expected to increase further, causing direct and indirect harmful effects on human health and well-being. This is especially true for the sectors with the highest environmental impact – food, mobility, energy as well as infrastructure and buildings. SOER 2020 concludes, in addition, that the 2050 vision of 'living well, within the limits of our planet' requires making sustainability the guiding principle for ambitious and coherent policies and actions across society in order to achieve inclusive and sustainable growth based on the European Green Deal and the concept of sustainable competitiveness.
Amendment 109 #
2020/0300(COD)
Proposal for a decision
Recital 5 a (new)
Recital 5 a (new)
(5a) The One Health principle reflects the fact that the health of people, animals and the environment are interconnected and that diseases may be transmitted from people to animals and vice versa. A One Health approach should be taken to face pandemics and health crises in both the human and veterinary sectors and, therefore, diseases should be tackled in both people and animals, while also taking into special consideration the food chain and the environment, which can be another source of resistant microorganisms. The Commission has an important role in coordinating and supporting the One Health approach to human and animal health and the environment in the Union.
Amendment 115 #
2020/0300(COD)
Proposal for a decision
Recital 6
Recital 6
(6) The European Green Deal underpins the Next Generation EU Recovery Plan which promotes the investments in keythe green and digital transition sectors needed to build resilience, and create growth and jobs in a fair and inclusive society. The Recovery and Resilience Facility which will power the Union’s economic recovery from the coronavirus crisis together with the Union budget for 2021-2027, is also based on the priority objectives set out in the European Green Deal. Furthermore, all initiatives under Next Generation EU Recovery Plan should respect the European Green Deal’s “do no harm” oath“do no significant harm” principle.
Amendment 122 #
2020/0300(COD)
Proposal for a decision
Recital 7
Recital 7
(7) Environment action programmes have guided the development of EU environment policy since the early 1970s. The 7th EAP willhas expired on 31 December 2020 and its Article 4 (3) requires the Commission, if appropriate, to present a proposal for an Eighth Environment Action Programme (8th EAP) in a timely manner with a view to avoiding a gap between the 7th and the 8th EAP. The European Green Deal announced the adoption of a new environment action programme to complement the EGD that will include a new monitoring mechanism to ensure that Europe remains on track to meet its environmental objectives. The Commission will also launch a dashboard to monitor progress against all of the EGD objectives.
Amendment 139 #
2020/0300(COD)
Proposal for a decision
Recital 8
Recital 8
(8) The 8th EAP should support the environment and climate action, endorse and build on the objectives of the European Green Deal in line with the long- term objective to “live well, within the planetary boundaries” by 2050, which is already established in the 7th EAP. It should also be fully aligned with, and contribute to achieving the United Nations’ 2030 Agenda and its Sustainable Development Goals (SDGs).
Amendment 145 #
2020/0300(COD)
Proposal for a decision
Recital 8 a (new)
Recital 8 a (new)
(8a) The SDGs cover the three dimensions of sustainable development (environmental, social and economic) which are integrated and indivisible. Full implementation by the Union of the UN's 2030 agenda for sustainable development and active support for implementation in other regions of the world will be essential if the Union is to provide global leadership in achieving competitive sustainability.
Amendment 149 #
2020/0300(COD)
Proposal for a decision
Recital 9
Recital 9
(9) The 8th EAP should accelerate the transition to a regenerativn inclusive and sustainable economy that gives back to the planet more than it takes. A regenerative growth model, while improving economic opportunities and the state of the environment for future generations. An inclusive and sustainable economy based on the European Green Deal as the Union’s inclusive and sustainable growth strategy, recognises that the wellbeing and prosperity of our societies depend on a stable climate, a healthy environment and thriving ecosystems, which provide a safe operating space for our economies. As the global population and the demand for natural resources continues to grow, economic activity should develop in a sustainable way that does no harm but, on the contrary, reverses climate change and environmental degradation, protects, uses in a sustainable way and restores biodiversity, prevents and minimises pollution and results in maintaining and enriching natural capitalresources, therefore ensuring the abundance of renewable and non-renewable resources. Through continuous innovation, adaptation to new challenges and co-creation, the regenerativinclusive and sustainable economy strengthens resilience, improves economic opportunities and the state of the environment for future generations, and protects present and future generations’ wellbeing.
Amendment 162 #
2020/0300(COD)
Proposal for a decision
Recital 9 a (new)
Recital 9 a (new)
(9a) The Union should commit to a shift towards inclusive and sustainable growth based on the European Green Deal and the concept of sustainable competitiveness, ensuring resilience, improving economic opportunities and the state of the environment, and protecting present and future generations’ wellbeing.
Amendment 165 #
2020/0300(COD)
Proposal for a decision
Recital 9 b (new)
Recital 9 b (new)
(9b) According to the OECD, annual global biodiversity finance from all sources (estimated at USD 78-91 billion) is vastly outweighed by annual government support that is potentially harmful to biodiversity (estimated at around USD 500 billion)1a. Phasing out environmentally harmful subsidies at Union and Member State level without delay was one of the objectives under the 7th EAP. Furthermore, the European Parliament has also called for the phase- out of direct and indirect fossil fuel subsidies in the Union and in the Member States. In order to achieve the thematic objectives of the 8th EAP, one of its enabling conditions should be to support these objectives. __________________ 1a OECD (2020), A Comprehensive Overview of Global Biodiversity Finance.
Amendment 168 #
2020/0300(COD)
Proposal for a decision
Recital 10
Recital 10
(10) The 8th EAP should set out thematic priority objectives in areas of climate neutrality, adaptation to climate change, protecting, use in a sustainable way, and restoring biodiversity, a circular economy, in combination with the zero pollution ambition for a toxic-free environment and reducing environmental pressures from production and consumption. It should furthermore identify the enabling conditions to achieve the long-term and the thematic priority objectives for all actors involved, as well as coordinating actions necessary to achieve these conditions.
Amendment 184 #
2020/0300(COD)
Proposal for a decision
Recital 11
Recital 11
(11) Environment policy being highly decentralised, action to achieve the priority objectives of the 8th EAP should be taken at different levels of governance, i.e. at the European, the national, the regional and the local level, with a collaborative approach to multi-level governance. Implementation, enforcement and accountability are essential. The integrated approach to policy development and implementation should be strengthened with a view to maximising the synergies between economic, environmental and social objectives, while paying careful attention tocomprehensively assessing and taking into account the potential trade-offs and to the needs of vulnerable groups. Moreover, action by local and regional authorities, transparent engagement with non- governmental actors, the private sector and the broader public is important for ensuring the success of the 8th EAP and the achievement of its priority objectives. This includes making the impact assessments on which policies are based public.
Amendment 197 #
2020/0300(COD)
Proposal for a decision
Recital 11 a (new)
Recital 11 a (new)
(11a) Action to achieve the Union's environmental and climate objectives needs to be carried out in conjunction with, and must be fully compatible with, the implementation of the European Pillar of Social Rights.
Amendment 203 #
2020/0300(COD)
Proposal for a decision
Recital 12
Recital 12
(12) Enhanced cooperation with partner countries, good global environmental governance as well as synergies and coherence between all internal and external Union policies are key to reaching the Union’s environmental and climate objectives.
Amendment 206 #
2020/0300(COD)
Proposal for a decision
Recital 13
Recital 13
(13) The European Commission should assess the progress in achieving the priority objectives of the 8th EAP by the Union and the Member States in the context of the just transition towards greater sustainability, wellbeing and resilience. This is in line with calls of the Council27 and the European Economic and Social Committee28 for measuring economic performance and societal progress “beyond GDP”, and moving towards using well-being as a compass for policy, which is also supported by the OECD29 . __________________ 27See e.g. https://data.consilium.europa.eu/doc/docu ment/ST-10414-2019-INIT/en/pdf 28https://www.eesc.europa.eu/en/our- work/opinions-information- reports/opinions/reflection-paper- towards-sustainable-europe-2030. 29See e.g. the OECD Well-being Framework, the OECD Framework for Policy Action on Inclusive Growth, the Better Life Initiative and the New Approaches to Economic Challenges Initiativean inclusive and sustainable economy based on a new growth strategy that will benefit European citizens and companies.
Amendment 212 #
2020/0300(COD)
Proposal for a decision
Recital 14
Recital 14
(14) The assessment of progress towards the priority objectives of the 8th EAP should reflect the latest developments as regards the availability and relevance of data and indicators and should be based on a robust, transparent and comprehensive methodology. It should be coherent with and without prejudice to monitoring or governance tools covering more specific aspects of environment and climate policy, such as in particular Regulation 1999/2018 of the European Parliament and of the Council30 , the Environmental Implementation Review or monitoring tools relating to a circular economy, zero pollution in combination with the zero pollution ambition for a toxic-free environment, biodiversity, air, water, soil, waste, or any other environment policies. Together with other tools used in the European Semester, the Eurostat SDG Monitoring and in the Commission’s Strategic Foresight Report31 , it w, assessment of progress towards the 8th EAP's priority objectives should beform part of a larger, coherent and interconnected set of monitoring and governance tools, covering not only environmental but also social and economic factors. The European Commission should carry out an assessment of existing monitoring frameworks and indicators at Union level, with the aim of ensuring consistent and streamlined indicators where necessary. __________________ 30Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, OJ L 328, 21.12.2018, p. 1–77. 31 COM/2020/493 final.
Amendment 230 #
2020/0300(COD)
Proposal for a decision
Recital 17 a (new)
Recital 17 a (new)
(17a) As the Commission’s Communication on the European Green Deal already contains a roadmap for key actions in the environmental field during the current Commission’s mandate, the 8th EAP, exceptionally, does not define actions to achieve its priority objectives until 2025. To assess progress on the 8th EAP and to inform the priorities of the incoming Commission, a mid-term evaluation should be carried out by 31 March 2024, taking into account the main findings of the European Environment Agency’s report on the state of the environment. This mid-term evaluation should be followed, if needed, by a legislative proposal amending the 8th EAP. The incoming Commission after the 2024 European Parliament elections should produce a report in which it outlines the environment and climate priorities on which it plans to take action during its mandate and how this action is to ensure the full achievement of the 8th EAP’s priority objectives, in light of progress outlined in the mid-term evaluation.
Amendment 232 #
2020/0300(COD)
Proposal for a decision
Recital 17 b (new)
Recital 17 b (new)
(17b) Monitoring progress towards the 8th EAP priority objectives should be done in synergy with what already exists, thus in order to limit the administrative burden. The monitoring framework should be based on a limited number of indicators in order to allow for adequate political guidance and should rely on existing data, such as data of the European Environment Agency.
Amendment 238 #
2020/0300(COD)
Proposal for a decision
Recital 18 a (new)
Recital 18 a (new)
(18a) Pursuant to Article 191 TFEU, Union policy on the environment is to aim at a high level of protection taking into account the diversity of situations in the various regions of the Union and is to be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as apriority be rectified at source and that the polluter should pay.
Amendment 246 #
2020/0300(COD)
Proposal for a decision
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This decisions sets out a general action programme in the field of the environment for the period up to 31 December 2030 (‘the 8th Environment Action Programme’ or ‘8th EAP’). It lays down its priority objectives, identifies enabling conditions, coordinates related actions necessary for their achievement, and sets a framework to measure whether the Union and its Member States are on track to meet those priority objectives.
Amendment 253 #
2020/0300(COD)
Proposal for a decision
Article 1 – paragraph 2
Article 1 – paragraph 2
2. The 8th EAP aims at accelerating the transition to a climate-neutral, sustainable, resource-efficient, clean and circular economy in a just and inclusive way, and endorses the environmental and climate and competitive circular economy with the zero pollution ambition for a toxic-free environment and high-quality jobs, where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use in a just and inclusive way, and at protecting, restoring and improving the quality of the environment and at halting and reversing biodiversity loss and tackling the degradation of ecosystems. It endorses and builds on the objectives of the European Green Deal and its initiatives.
Amendment 273 #
2020/0300(COD)
Proposal for a decision
Article 1 – paragraph 3
Article 1 – paragraph 3
3. The 8th EAP forms the basis for achieving the environmental and climate objectives defined under the United Nations 2030 Agenda and, its Sustainable Development Goals and ithe Paris Agreement. Its monitoring framework constitutes the environment and climate part ofshall contribute to the EU’s efforts to measure progress towards greater sustainability, including climate neutrality and resource efficiency, wellbeing and resilience.
Amendment 279 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 1
Article 2 – paragraph 1
1. The 8th EAP shasll have the long- term priority objective for 2050 thatthat by 2050 citizens live well, within the planetary boundaries in a regenerative economyn inclusive and sustainable economy based on the European Green Deal as the Union’s inclusive and sustainable growth strategy, where nothing is wasted, no net emissions of greenhouse gases are produced and economic growth is decoupled from resource use and environmental degradation. A healthy environment underpins the well-being of citizens, biodiversity thrives and natural capitalthe environment is protected, and restored and valued in ways that. It also allows for the enhancement of resilience to climate change and other environmental risks. The Union sets the pace for ensuring the prosperity of present and future generations globally.
Amendment 295 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
2. The 8th EAP shasll have the following six thematic priority objectives :
Amendment 301 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) irreversible and gradual, predictable and swift reduction of greenhouse gas emissions and enhancement of removals by natural andor other sinks in the Union, in line with the Union's climate and environment objectives, to attain the 2030 greenhouse gas emission reduction target and achieve climate neutrality by 2050 as laid down in Regulation (EU) …/…32 ; __________________ 32 COM/2020/80 final.
Amendment 312 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) continuous progress in enhancing adaptive capacity, strengthening resilience and reducing vulnerability of society, the economy and the environment, to climate change;
Amendment 316 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) Advancing towards a regenerative growth modeln inclusive and sustainable economy based on the European Green Deal as the Union’s inclusive and Sustainable Growth Strategy that gives back to the planet more than it takes, decoupling economic growth from resource use and environmental degradation, and accelerating the transition to a Circular Economy in combination with the zero pollution ambition for a toxic-free environment;
Amendment 334 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) protecting, preserving and restoring biodiversity and enhancing natural capital, notably of air, water, soil, and forest, freshwater, wetland and marine ecosystems, in line with the 2030 Biodiversity Strategy;
Amendment 353 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) promoting environmental sustainability and reducing key environmental and climate pressures related to production and consumption, in particular in the areas of energy, industrial development, buildings and infrastructure, mobility, international trade and the food system.
Amendment 360 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. The thematic priority objectives laid down in paragraph 2 shall cover the targets and actions set out in the EGD as well as all in the strategies, initiatives and frameworks under the EGD.
Amendment 367 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ensuring effective and efficien, predictable and swift implementation of Union legislation on environment and climate and striving for excellence in environmental performance at Union, national, regional and local levels including through providing appropriatesufficient administrative and compliance assurance capacity, as laid out in the regular Environmental Implementation Review, as well as stepping up action against environmental crime,;
Amendment 375 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point a a (new)
Article 3 – paragraph 1 – point a a (new)
(aa) improving incentives, guidance and recommendations, and effective, dissuasive and proportionate sanctions to ensure effective implementation and reduce risks of non-compliance with environmental law, as well as improving cooperation and the effective enforcement of relevant administrative, civil and criminal Union law to protect the environment, with a systematic follow-up of infringement proceedings, including by ensuring that sufficient financial and human resources are allocated at both Union and Member State level for this purpose;
Amendment 381 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b – indent -1 (new)
Article 3 – paragraph 1 – point b – indent -1 (new)
– fully respecting Article 191 TFEU;
Amendment 382 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b – indent 1
Article 3 – paragraph 1 – point b – indent 1
– mainstreaming the priority objectives set out in Article 2 in all relevant strategies, legislative and non- legislative initiatives, programmes, investments and projects at Union, national, regional and local levels so that theyand ensure that all strategies, legislative and non-legislative initiatives, programmes, investments and projects and their implementation do no significant harm to any of the priority objectives set out in Article 2; , in line with Regulation (EU)2020/852 of the European Parliament and of the Council1a; __________________ 1a Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).
Amendment 386 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b – indent 1 a (new)
Article 3 – paragraph 1 – point b – indent 1 a (new)
– reviewing, as set out in the Climate Law, the consistency of Union measures with the climate-neutrality objective set out in that Regulation, as well as the adequacy of Union measures and policies, including sectoral legislation, the Union's external action and the Union's budget, to ensure progress on adaptation;
Amendment 391 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b – indent 1 b (new)
Article 3 – paragraph 1 – point b – indent 1 b (new)
– assessing, as set out in the Climate Law, the consistency of any draft measure, including but not limited to any legislative and budgetary proposal, with the Union climate objectives set out in the Climate Law.
Amendment 396 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b – indent 3
Article 3 – paragraph 1 – point b – indent 3
– paying careful attention tocomprehensively assessing and taking into account synergies and potential trade-offs between economic, environmental and social objectives for all initiatives so as to ensure that citizens’ needs for nutrition, housing and, mobility, energy, water and wellbeing are met in a sustainable way that leaves no- one behind;
Amendment 409 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b – indent 4
Article 3 – paragraph 1 – point b – indent 4
– regularly evaluating existing policies and preparing comprehensive impact assessments for new initiatives and legislation, which are based on wide consultations following procedures that are accountable, inclusive, informed and simple to implement, and which pay due regard to projecduly take into account environmental and climated impacts on environment and climateas part of a comprehensive assessment of all dimensions;
Amendment 414 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b – indent 4 a (new)
Article 3 – paragraph 1 – point b – indent 4 a (new)
– taking into account the cost of inaction when evaluating existing policies and developing new initiatives, paying due regard to the costs to the environment and to health;
Amendment 422 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point c
Article 3 – paragraph 1 – point c
(c) effectiwithout prejudice of the velry integrating environmental and climate sustainability own nature of the European Semester of Economic governance being a cycle of economic policy coordination, further aligning the European Semester of economic governanceprocess, including in the National Reform Programmes and National Recovery and Resilience plans, with the EU’s long-term climate and environmental objectives in line with the Commission’s engagements under the European Green Deal;
Amendment 447 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point e
Article 3 – paragraph 1 – point e
(e) strengthening environmentally positive incentives and phasing out the most environmentally harmful subsidies at Union and national level without delay, making the best use of market-based instruments and green budgeting tools, including those required to ensure a socially fair transition, and supporting businesses and other stakeholders in developing standardised natural capital accounting practices;
Amendment 451 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point e a (new)
Article 3 – paragraph 1 – point e a (new)
(ea) investing in biodiversity protection and restoration in line with the minimum spending targets agreed through the MFF and with the funding objectives in the EU Biodiversity Strategy, which should be tracked through a robust, transparent and comprehensive methodology;
Amendment 454 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point e b (new)
Article 3 – paragraph 1 – point e b (new)
(eb) scaling up the measures against illegal exploitation of natural resources, associated corruption and money laundering, waste crime and illegal exports and increasing cooperation with third countries in relation to these measures;
Amendment 460 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point f
Article 3 – paragraph 1 – point f
(f) ensuring that environmental policies and action are based on the best available scientific knowledge and strengthening the environmental knowledge base and its uptake, including by research, innovation, fostering green skills, engaging with civil society and further building up environmental and ecosystem accounting;
Amendment 490 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point g
Article 3 – paragraph 1 – point g
(g) harnessing the potential of digital and data technologies to support environment policy while minimising their environmental footprint, and ensuring transparency and public accessibility of this data, where relevant and necessary;
Amendment 517 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point k – indent 1
Article 3 – paragraph 1 – point k – indent 1
– engaging with partnerthird countries on climate and environmental action, encouraging and supporting them to adopt and implement rules in these areas that are as ambitious as those of the Union, and ensuring that all products placed on the Union market fully comply with relevant Union requirements in line with the Union’s international commitments, especially regarding the fight against deforestation;
Amendment 521 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point k – indent 1 a (new)
Article 3 – paragraph 1 – point k – indent 1 a (new)
– promoting sustainable corporate governance;
Amendment 538 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point k – indent 5 a (new)
Article 3 – paragraph 1 – point k – indent 5 a (new)
– strengthening the capacity of citizens to act, through awareness raising, lifelong environmental education and civic involvement;
Amendment 542 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. In order to achieve the enabling conditions set out in paragraph 1, the Commission shall take the following actions: (a) carry out the reviews and assessments set out paragraph 1 and propose remedying measures where necessary; (b) develop, where necessary and for the purpose of carrying out comprehensive impact assessments, adequate tools to assess the environmental impacts of new policies, initiatives and legislation where existing tools are insufficient; (c) further streamline the various monitoring frameworks in place at Union level to measure social, economic and environmental progress; (d) conduct comprehensive impact assessments on all legislative proposals under the EAP; (e) provide an up-to-date overview on its website of the objectives under the EGD and the progress towards their achievement;
Amendment 544 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 b (new)
Article 3 – paragraph 1 b (new)
1b. In relation to point (e) of Article 3(1), the Commission shall conduct a comprehensive impact assessment, in cooperation with Member States, evaluating all economic, social and environmental impacts and the need and availability of alternatives, of possible pathways for a phase out of those subsidies;
Amendment 552 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. The relevant Union institutions and Member States shall be responsible for taking appropriate action, with a view to the delivery of the priority objectives set out in the Article 2(1) and (2). Action shall be taken with due account of the principles of conferral, subsidiarity and proportionality, in accordance with Article 5 of the Treaty on European Union.
Amendment 559 #
2020/0300(COD)
Proposal for a decision
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Commission, supported by the European Environment Agency and the European Chemicals Agency, shall monitor, assess and report on the progress of the Union and the Member States with regard to achieving the priority objectives laid down in Article 2 on a regular basis, taking into consideration the enabling conditions laid down in Article 3.
Amendment 567 #
2020/0300(COD)
Proposal for a decision
Article 4 – paragraph 1 b (new)
Article 4 – paragraph 1 b (new)
1b. The assessment referred to in paragraph 1 shall include information on: – progress made towards achieving the priority objectives set out in Article 2(1) and (2), as soon as the monitoring framework allows for this; – distance to the targets set in place to achieve the priority objectives; – related funding, based on the tracking methodology for climate and biodiversity mainstreaming agreed under the MFF; – recommendations to address potential shortfalls and challenges.
Amendment 568 #
2020/0300(COD)
Proposal for a decision
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The assessment referred to in paragraph 1 aims at facilitating strategic political communication. It shall be based on a limited number of headline indicators, identified by the end of 2021 as a result of a broad stakeholder consultation, and shall reflect the latest developments as regards the availability and relevance of data and indicators, building on data available in the Member States and at the Union level, in particular those operated by the European Environment Agency and the European Statistical System, with a view to minimising administrative burden. This assessment shall be coherent and without prejudice to existing monitoring, reporting and governance frameworks and exercises covering environment, social, economic and climate policy.
Amendment 598 #
2020/0300(COD)
Proposal for a decision
Article 5 – paragraph -1 (new)
Article 5 – paragraph -1 (new)
-1. By 31 March 2024, the Commission shall carry out a mid-term review of the progress achieved towards the thematic priority objectives defined in Article 2(2), taking into account the enabling conditions laid down in Article 3 and including the targets under the EGD, based on the assessments carried under Art 4(1), as well as on the outcome of a public consultation, and shall submit a report to the European Parliament and to the Council.
Amendment 603 #
2020/0300(COD)
Proposal for a decision
Article 5 – paragraph -1 a (new)
Article 5 – paragraph -1 a (new)
-1a. In light of progress set out in the mid-term evaluation referred to in paragraph-1, of any other relevant policy developments, and of the European Environment Agency’s report on the state of the environment, the incoming Commission after the 2024 European Parliament elections shall present to the European Parliament and to the Council the actions it plans to take during its mandate in order to ensure the full achievement, by 2030 and 2050 respectively, of the 8th EAP’s priority objectives, as well as a respective timeline of these actions.
Amendment 607 #
2020/0300(COD)
Proposal for a decision
Article 5 – paragraph 1
Article 5 – paragraph 1
By 31 March 2029, the Commission shall carry out an evaluation of the 8th EAP. The Commission shall submit a report to the European Parliament and to the Council containing the main findings of that evaluation, accompanied, if the Commission deems appropriate, by a legislative proposal for the next environmental action programme. Such a legislative proposal shall be presented in a timely manner, with a view to avoiding a gap between the 8th and the 9th EAP.
Amendment 2 #
2020/0108(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Covid-19 pandemic is a major shock to the global and Union economy. Due to the necessary containment measures, economic activity in the EU dropped significantly. The contraction in EU GDP in 2020 is expected to be around 7.5%, far deeper than during the financial crisis in 2009. The outbreak of the pandemic has shown the interconnectivity of global supply chains and exposed some vulnerabilities such as the over-reliance of strategic industries on non-diversified external supply sources. Such vulnerabilities need to be addressed, particularly for small and medium-sized enterprises (SMEs), to improve the Union’s emergency response as well as the resilience of the entire economy, while maintaining its openness to competition and trade in line with its rules. Investment activity is expected to have dropped significantly. Even before the pandemic, while a recovery in investment-to-GDP ratios in the Union could be observed, it remained below what might be expected in a strong recovery and was insufficient to compensate for years of underinvestment following the 2009 crisis. More importantly, the current investment levels and forecasts do not cover the Union’s needs for structural investment to restart and sustain long-term growth in the face of technological change and global competitiveness, including for innovation, skills, infrastructure, small and medium- sized enterprises (SMEs) and the need to address key societal challenges such as sustainability or population ageing. Consequently, in order to achieve the Union's policy objectives, in particular the dual objective of accelerating the climate and digital transitions, and to support a swift, inclusive and healthy economic recovery, support is necessary to address market failures and sub-optimal investment situations and to reduce the investment gap in targeted sectors.
Amendment 14 #
2020/0108(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The InvestEU Fund should contribute to improving the competitiveness and socio-economic convergence and cohesion, cohesion and long-term economic growth of the Union, including in the fields of innovation and digitisation, to the efficient use of resources in accordance with the circular economy, to the sustainability and inclusiveness of the Union's economic growth and to the social resilience and integration of the Union capital markets, including through solutions that address the fragmentation of Union capital markets and that diversify sources of financing for Union enterprises. To that end, the InvestEU Fund should support projects that are technically and economically viable by providing a framework for the use of debt, risk sharing and equity instruments backed up by a guarantee from the Union budget and by financial contributions from implementing partners as relevant. The InvestEU Fund should be demand-driven, while at the same time it should focus on providing strategic, long-term benefits in relation to key areas of Union policy which otherwise would not be funded or would be insufficiently funded, thereby contributing to meeting policy objectives of the Union. Support under the InvestEU Fund should cover a wide range of sectors and regions, but should avoid excessive sectoral or geographical concentration and should facilitate access of projects composed of partner entities in multiplewith high growth potential and in key strategic sectors in all regions across the EU.
Amendment 52 #
2020/0108(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Tourism is an important area for the Union economy and the sector, which, employing more than 22 million people. The tourism sector experienced a particularly severe contraction as a result of COVID-19 pandemic with revenue losses having reached an estimated 85 % for hotels, restaurants, tour operators, travel agencies and long distancerail, and 90 % for cruises and airlines as of May 2020. . The InvestEU Programme should contribute to strengthening its long- term competitiveness by supporting operations promotinga sustainable, innovative and digital tourismrecovery in the tourism sector.
Amendment 56 #
2020/0108(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) In the economic crisis caused by the Covid-19 pandemic, market allocation of resources is not fully efficient and perceived risk impairs private investment flow significantly. Under such circumstances, the key feature of the InvestEU Fund of de-risking economically viable projects to crowd in private finance is particularly valuable and should be reinforced, inter alia in order to counteract the risk of an asymmetric recovery. The InvestEU Programme should be able to provide crucial support to companies in the recovery phase, in particular SMEs, and at the same time ensure a strong focus of investors on the Union’s medium- and long-term policy priorities such as the European Green Deal, the European Green Deal Investment Plan, the Strategy on shaping Europe’s digital future and the Strong Social Europe for Just Transitions. It should significantly increase the risk- taking capacity of the European Investment Bank (EIB) Group and national promotional banks and institutions and other implementing partners in support of economic recovery.
Amendment 84 #
2020/0108(COD)
Proposal for a regulation
Recital 59
Recital 59
(59) In the context of the InvestEU Fund, there is a need to provide support for project development and capacity building to develop the organisational capacities and market development activities needed to originate quality projects. Such support should also target financial intermediaries that are key to help small companies’ access financing and realise their full potential, and it should include technical assistance. Particular emphasis should be put on reducing the administrative burden, in particular for SMEs. Moreover, the aim of the advisory support is to create the conditions for the expansion of the potential number of eligible recipients in nascent market segments, in particular where the small size of individual projects considerably raises the transaction cost at the project level, such as for the social finance ecosystem, including philanthropic organisations, or for the cultural and creative sectors. The capacity- building support should be complementary and in addition to actions taken under other Union programmes that cover specific policy areas. An effort should also be made to support the capacity building of potential project promoters, in particular local organisations and authorities.
Amendment 110 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – introductory part
Article 7 – paragraph 1 – point e – introductory part
(e) a strategic European investment policy window which comprises strategic investment to support final recipients that are established in aone or more Member States and that operate in the Union, and whose activities are of strategic importance to the Union, in particular in view of the green and digital transitions and of enhanced resilience, while enhancing the competitiveness of the Member States' economies, including the need to rebuild the Member States' productive capacity and promote entrepreneurship and job creation, in one of the following areas:
Amendment 115 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point i
Article 7 – paragraph 1 – point e – point i
i) critical healthcare provision, manufacturing and stockpiling of pharmaceuticals, medical deviceines, vaccines, active pharmaceutical ingredients, pharmaceutical raw materials, medical devices, diagnostic tools and medical supplies, strengthening of health crisis response capacity and of the civil protection system;
Amendment 138 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point iv – point c
Article 7 – paragraph 1 – point e – point iv – point c
(c) biomedicine, nanotechnologies, biotechnologies, pharmaceuticals and advanced materials;
Amendment 137 #
2020/0102(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States, as well as a permanent structured and coordinated dialogue between the authorities and the parties concerned, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross- border threats to health and, to safeguard the health and well- being of people in the Union, and to take all necessary measures to combat shortages by increasing the resilience of health systems in order to ensure that European citizens have access to medicines and medical equipment. __________________ 8 Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup on coordinated economic response to the COVID-19 outbreak, COM(2020)112 final of 13.03.2020.
Amendment 175 #
2020/0102(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthening the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include European strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the ‘One Health’ approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 177 #
2020/0102(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices and personal protective equipment needed in the Union during the pandemics. In the event of health crises and pandemics, but also for recurrent shortages, the Programme should promote actions that encourage the production, purchase and management of relevant products by ensuring that they complement other EU instruments.
Amendment 200 #
2020/0102(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuringour dependence on third countries for the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should enable the Commission and the Member States to take all the necessary measures to guarantee European independence in health matters, by provideing support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments.
Amendment 251 #
2020/0102(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, rare diseases and diabetes represent major causes of disability, ill- health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non- communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, combined with efforts to strengthen health systems and the supply of appropriate medicines.
Amendment 289 #
2020/0102(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) Today, there is a lack of awareness about chronic diseases, such as migraines, despite their psychological and socioeconomic impact; it is important to ensure that neurological disorders, including migraines, are given proper consideration in European policies. The EU and the Member States should include migraines and other chronic diseases in their health priorities.
Amendment 350 #
2020/0102(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to develop a pan-European monitoring, reporting and notification system to monitor shortages of medicines, medical devices and other healthcare products to strengthen the Single Market, and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines.
Amendment 387 #
2020/0102(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) The mobility of cross-border medical workers should be guaranteed in order to ensure the continuity of healthcare services within the European Union.
Amendment 436 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
(10a) ‘shortage’ means the temporary unavailability of a medicinal product as a result of an upstream stock shortage and/or a downstream supply shortage;
Amendment 439 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 b (new)
Article 2 – paragraph 1 – point 10 b (new)
(10b) ‘supply strain’ means that the manufacturer has insufficient quantities of medicines available, resulting in a temporary inability to supply the usual market and a risk of disruption;
Amendment 440 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 c (new)
Article 2 – paragraph 1 – point 10 c (new)
(10c) ‘supply disruption’ means the medicine is manufactured but not distributed to all pharmacies;
Amendment 441 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 d (new)
Article 2 – paragraph 1 – point 10 d (new)
(10d) ‘stock shortage’ means a break in the manufacturing chain of the medicines, which may have several explanations: either the medicines cannot be manufactured or they are not allowed to enter the distribution channel because the quality of the medicines does not fully meet the required standards.
Amendment 484 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) support and strengthen existing and future EU health legislation to improve the availability in the EU of medicines, medical devices and other products that are required in case of shortages, and contribute to their accessibility and affordability;
Amendment 508 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) support the creation, development and implementation of a strategy to tackle shortages of medicines and medical devices in order to ensure all patients in the European Union are able to access treatment;
Amendment 519 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2 a (new)
Article 4 – paragraph 1 – point 2 a (new)
(2a) support the creation, development and implementation of a strategy on health personnel in order to ensure an effective public health workforce, with the same high standards across the Union, and promote the excellence of medical and healthcare professionals; to this end, simplify the rules to allow cross-border health workers effective mobility, particularly in the event of a crisis or pandemic;
Amendment 522 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 3
Article 4 – paragraph 1 – point 3
(3) support actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies, by improving information systems so as to provide a clear overview of difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 561 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer; including cancer, cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions, with the aim of improving the quality of life of EU citizens;
Amendment 598 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 9 a (new)
Article 4 – paragraph 1 – point 9 a (new)
(9a) Create one or more non-profit- making European pharmaceutical establishments of general interest to produce certain priority medicines that are important from a health and strategic point of view;
Amendment 650 #
2020/0102(COD)
Proposal for a regulation
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
1a. Stress tests shall be introduced to assess the resilience of health systems in emergencies with a view to providing an effective means of countering shortages in the event of pandemics and identifying structural risk factors that create shortages.
Amendment 675 #
2020/0102(COD)
Proposal for a regulation
Annex I – point c – point i
Annex I – point c – point i
(i) Surveys, studies, collection of centralised and accessible data and statistics, methodologies, classifications, microsimulations, indicators, knowledge brokering and benchmark exercises;
Amendment 681 #
2020/0102(COD)
Proposal for a regulation
Annex I – point c – point iii
Annex I – point c – point iii
(iii) Expert groups and panels, incorporating all of the relevant stakeholders, providing advice, evaluations, data and information to support health policy development and implementation;
Amendment 691 #
2020/0102(COD)
Proposal for a regulation
Annex I – point c – point iii a (new)
Annex I – point c – point iii a (new)
(iiia.) The creation and management of a policy-oriented Pharmaceutical Forum comprising health authorities and stakeholders, with a view to defining specific priorities and measures to be implemented at a technical level;
Amendment 698 #
2020/0102(COD)
Proposal for a regulation
Annex I – point c – point iv
Annex I – point c – point iv
(iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on ‘Consumer Safety’ and on ‘Health, Environmental and Emerging Risks’, and the Expert Group on Health Systems Performance Assessment.
Amendment 706 #
2020/0102(COD)
Proposal for a regulation
Annex I – point d – introductory part
Annex I – point d – introductory part
(d) DEvaluation, development and implementation of Union health legislation and action, in particular through support to:
Amendment 719 #
2020/0102(COD)
Proposal for a regulation
Annex I – point d – point iv
Annex I – point d – point iv
(iv) Development and, operation and maintenance of databases and digital tools and their interoperability, including projects already established, such as the centralised common repository for all medicines in Europe and the SPOR portal, where appropriate with other sensing technologies, such as space-based;
Amendment 722 #
2020/0102(COD)
Proposal for a regulation
Annex I – point d – point v
Annex I – point d – point v
(v) Auditing and, assessment and inspection work in accordance with Union legislation;
Amendment 748 #
2020/0102(COD)
Proposal for a regulation
Annex I – point e – point iv
Annex I – point e – point iv
(iv) Procurement of goods and services, using the MEAT criteria in particular, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 960 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point vi
Annex I – point i – point vi
(vi) Support action to monitor, report and notify shortages of medicines and medical devices occurring in hospitals and community pharmacies, to compile the identified shortages in a centralised database that is interoperable with the drug regulatory databases, to address such shortages, and to increase security of supplies;
Amendment 969 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point viii
Annex I – point i – point viii
(viii) Action to strengthen the environmental risk assessment of pharmaceuticals and to reward such investments in contract award procedures;
Amendment 971 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point ix
Annex I – point i – point ix
(ix) Action to promote the prudent use and disposal of antimicrobialmedicines, especially antimicrobials; technological incentives to neutralise waste in production plants;
Amendment 1072 #
2020/0102(COD)
Proposal for a regulation
Annex II – part 2 – point 8 a (new)
Annex II – part 2 – point 8 a (new)
8a. Common and shared approach to notification, reporting and definition of shortages, reflecting the real impact on patients
Amendment 47 #
2020/0100(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The objective of this Regulation, namely to leverage public investment in territories, most impacted by the transition towards climate neutrality and circular economy by addressing the corresponding development needs, cannot be sufficiently achieved by the Member States alone. The main reasons in this regard are the difficulties for public entities to support investments, which do not generate sufficient streams of own revenues and benefit the territories most negatively impacted by climate transition, without EU grant support and the need for a coherent implementation framework under direct management. Since those objectives can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
Amendment 53 #
2020/0100(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
The Facility shall provide support benefitting Union territories facing serious social, environmental and economic challenges deriving from the transition process towards a climate-neutral and circular economy of the Union by 2050 at the latest.
Amendment 21 #
2019/2816(RSP)
Citation 26 a (new)
- having regard to the Commission Communication of 11 December 2019 entitled ‘The European Green Deal’ (COM(2019)0640),
Amendment 43 #
2019/2816(RSP)
Recital C a (new)
Ca. whereas population increase and climate change will have an impact on the quantity of quality of water resources and on water treatment and re-use;
Amendment 47 #
2019/2816(RSP)
Recital D
D. whereas the excessive and incorrectinappropriate use of antibiotics, particularly in livestock farming, and more generally poor practices in both human and veterinary medicine, have progressively rendered antimicrobial resistance a massive threat to human and animal health;
Amendment 72 #
2019/2816(RSP)
Recital L a (new)
La. whereas human and animal health players and professionals, patients, industry, waste management and water treatment operators, etc., have a role to play in reducing the impact of pharmaceutical products on the environment;
Amendment 85 #
2019/2816(RSP)
Paragraph 5
5. Considers that a holistic approach is needed to tackle pharmaceutical pollution, including all the actors concerned, is needed to tackle the negative impact of pharmaceutical products in the environment, taking into account the entire life cycle of drugs; stresses that regulatory actions have to be taken in line with the precautionary principle; highlights that the polluter pays principle should apply, primarily covering at all stages of the life cycle of pharmaceutical products, covering, primarily but not exclusively, the manufacturing process, but also incentivising better prescription practices and consumer behaviour;
Amendment 100 #
2019/2816(RSP)
Paragraph 7
7. Recalls that studies have shown that residue from pharmaceutical products areis especially present in water bodies, and that they are ineffectively filtered byit is not completely removed by conventional wastewater treatment plants;
Amendment 134 #
2019/2816(RSP)
Paragraph 12
12. Calls on the Member States to share best practices in the preventive use of antibiotics and to apply in full and, if necessary, reinforce the ‘One Health Action Plan Against Antimicrobial Resistance’; reaffirms the positions expressed in its resolution of 13 September 2018 on a European One Health Action Plan against Antimicrobial Resistance;
Amendment 139 #
2019/2816(RSP)
Paragraph 13
13. Calls on the Member States and on the Commission to promote awareness- raising campaigns and training courses among veterinaries and physicianhealthcare professionals on the prudent use of pharmaceuticals, particularly of antimicrobials; calls on actors in the pharmaceutical supply chain to contribute to providing to patients with clear, sufficient information on how incorrectly disposed medicines may negatively impact the environment; calls for on-pack labelling in the form of an appropriate pictogramme to inform consumers how to properly dispose of unused medicines;
Amendment 151 #
2019/2816(RSP)
Paragraph 15
15. Calls on Member States and the Commission to support theresearch, development and innovation of pharmaceuticals intrinsicallywhich are equally effective for patients and less harmful for the environment (‘greener pharmaceuticals’), which degrade more readily, into harmless substances, in wastewater treatment plants and the environment; calls on the Member States and the Commission to boost funding for this;
Amendment 156 #
2019/2816(RSP)
Paragraph 15 a (new)
15a. Calls on the Member States and all stakeholders concerned to make use of EU programmes to invest in technology aimed at improving the effectiveness of the disposal of pharmaceutical products and antimicrobial-resistant genes whilst ensuring that such products are just as effective in terms of meeting patients' needs;
Amendment 174 #
2019/2816(RSP)
Paragraph 20
20. Points to the important role of procurement policy in promoting greener pharmaceuticals which respect the environment; calls on the Commission to develop clear guidance on this issue; by including, for example, environmental criteria in addition to simple economic criteria;
Amendment 211 #
2019/2816(RSP)
Paragraph 28
28. Considers that a review of Directive 86/278/EEC on sewage sludge is long overdue; calls on the Commission to evaluate and, if necessary given the results obtained, to make a legislative proposal to review and update Directive 86/278/EEC no later than by the end of 20201, not least so as to avoid that pharmaceutical residues are spread onto fields;
Amendment 220 #
2019/2816(RSP)
Paragraph 30
30. Calls for the Member States to implement and fully enforcement of the existing provisions with regard to take- back schemes for unused medicines;
Amendment 252 #
2019/2816(RSP)
Paragraph 37
37. Recalls that pharmaceutical environmental information plays a key role for risk management and that this type of information should be made available to relevant stakeholders; therefore calls on the Commission and the relevant authorities to set up a secure, centralised database enabling all the actors concerned to have access to the results of the environmental risk assessments of products;
Amendment 12 #
2019/2804(RSP)
Citation 7 a (new)
– having regard to Special report no 7/2019 of the European Court of Auditors: EU actions for cross-border healthcare: significant ambitions but improved management required
Amendment 13 #
2019/2804(RSP)
Citation 7 b (new)
– having regard to Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format,
Amendment 39 #
2019/2804(RSP)
Paragraph 1 a (new)
1a. Notes that compliance with EU legislation on data protection should be the precondition to this digital transformation of health and care in the Digital Single Market;
Amendment 43 #
2019/2804(RSP)
Paragraph 3
3. Is of the opinion that the digital transformation of health and care needs to be patient-centred; that this transformation should allow for the exchange of information on patient records, electronic prescriptions, laboratory test results, medical imaging and discharge summaries, as well as information on the cost of medicines in each Member State and, in particular, how they are covered and reimbursed;
Amendment 93 #
2019/2804(RSP)
Paragraph 22
22. Considers that there is a need to better advance health promotion, prevent disease and deliver integrated services based on people’s needs, especially during pandemicin the event of pandemics or medicine shortages;
Amendment 94 #
2019/2804(RSP)
Paragraph 22 a (new)
22a. Calls on the Commission and Member States to consider setting up a dedicated and protected IT system for the purpose of exchanging information between national authorities on the cost of medicines in each Member State in order to shed light on patients' decision- making in this regard;
Amendment 111 #
2019/2804(RSP)
Paragraph 26
26. Calls on the Commission and Member States to ensure thasupport health professionals improve competenn the context of the digital transformation of healthcare systems, to step up exchanges of relevant good practices and skillsto consider harmonising training;
Amendment 129 #
2019/2804(RSP)
Paragraph 31 a (new)
31a. Calls on the Commission and Member States to establish a clear timetable of the changes planned in order to create a digital health Europe, with mid-term assessments, and to set targets;
Amendment 130 #
2019/2804(RSP)
Paragraph 31 b (new)
31b. Calls on the Commission and the Member States to implement the Commission's recommendations of February 2019 on a European Electronic Health Record exchange format;
Amendment 72 #
2019/2712(RSP)
Paragraph 7 a (new)
7a. Points out that, according to the 2019 IPBES Global Assessment on Biodiversity and Ecosystem Services, one million species are now threatened with extinction; recalls the crucial role played by biodiversity in enabling humans to adapt and combat global warming; is concerned about the impact of reduced biodiversity on our levels of resilience;
Amendment 170 #
2019/2712(RSP)
Paragraph 22 a (new)
22a. Stresses, therefore, the importance of continuing and strengthening research and innovation in the areas of climate change mitigation, adaptation policies, resource efficiency, low-carbon and zero- emission technologies, the sustainable use of secondary raw materials ('circular economy') and the collection of climate change data to combat this phenomenon; stresses the need to prioritise funding for sustainable energy projects, under the new Horizon Europe programme, for example, given the Union’s commitments within the Energy Union and under the Paris Agreement;
Amendment 194 #
2019/2712(RSP)
Paragraph 24 a (new)
24a. Stresses the crucial role of cities in implementing the objectives of the Paris Agreement, while according to the UN- Habitat 2018 report 'Tracking Progress towards Inclusive, Safe, Resilient and Sustainable Cities and Human Settlements', they are the source of more than 70% of all greenhouse gas emissions, waste and air pollution; welcomes the commitment of 102 cities at the Climate Action Summit to achieve carbon neutrality by 2050; calls on the parties to involve cities more closely in their emission reduction plans;
Amendment 196 #
2019/2712(RSP)
Paragraph 24 b (new)
24b. Recalls that research, innovation and competitiveness are among the five pillars of the EU’s Energy Union strategy; recalls therefore the fundamental role played by researchers in the fight against global warming and accordingly underlines the importance of close scientific cooperation between international partners;
Amendment 237 #
2019/2712(RSP)
Paragraph 32
32. Notes that approximately 60 % of the world’s methane is emitted by sources such as intensive agriculture, landfills and wastewater, and the production and pipeline transport of fossil fuels; recalls that methane is a potent GHG with a 100- year global warming potential, 28 times more powerful than CO2 ; reminds the Commission of its legal obligation to analyse the implications of implementing policies and measures to reduce the short- and medium-term impact of methane emissions on EU greenhouse gas emissions, to explore as soon as possible policy options for rapidly addressing methane emissions as part of a Union strategic plan for methane, and to present legislative proposals to Parliament and the Council to that effect;
Amendment 268 #
2019/2712(RSP)
Paragraph 35
35. Stresses the need to mainstream climate ambition into all EU policies, including trade policy; calls on the Commission to ensure that all new trade and investment agreements signed by the EU are fully compatible with the Paris Agreement and asks the Commission to carry out and publish a comprehensive assessment of the consistency of the existing and forthcoming agreements with the Paris Agreement; calls on the Commission to ensure that any trade agreement contains binding provisions regarding compliance with the Paris Agreement, including provisions concerning the management and sustainable preservation of forests;
Amendment 133 #
2019/2207(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to assess, with a view to further integration, the establishment of an exhaustive list for which surrender could be refused (‘negative list’) instead of, with a view to adding it subsequently to the list of 32 offences;
Amendment 141 #
2019/2207(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses the importance of defining more precisely the duties and competencies of the bodies involved in EAW procedures and ensuring that they are specialised and have practical experience; affirms that a broad margin of discretion for the executing authority is scarcely compatible with mutual recognition; considers that discretion should be strictly limited in cases of double criminality;
Amendment 150 #
2019/2207(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Member States to provide flexibilityensure respect for EAW language regimes by ensuring that Directive 2010/64/EU on the right to interpretation and translation in criminal proceedings is implemented correctly;
Amendment 225 #
2019/2207(INI)
Motion for a resolution
Paragraph 37
Paragraph 37
Amendment 3 #
2018/0902R(NLE)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
— having regard to the Rule of Law Checklist, adopted by the Venice Commission at its 106th plenary session (Venice, 11-12 March 2016),
Amendment 4 #
2018/0902R(NLE)
Draft opinion
Paragraph 1
Paragraph 1
1. Expresses deep concern about the deliberate and systematic efforts of the Hungarian Government to undermine the founding values of the Union enshrined in Article 2 TEU, in particular through the removal of the constitutional checks and balances, by the limitation of the independence of the judiciary, by intentional alterations of the national electoral system and by hampering freedom of expression, education and academic freedom as well as university autonomy; highlights that these trends have substantially worsened since the triggering of Article 7(1) TEU and have been severely amplified by the COVID-19 crisis;
Amendment 4 #
2018/0902R(NLE)
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
— having regard to the Commission Communication of 11 November 2014 entitled ‘A new EU Framework to strengthen the Rule of Law’,
Amendment 8 #
2018/0902R(NLE)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
— having regard to the country chapter on Hungary in the 2020 Rule of Law Report,
Amendment 9 #
2018/0902R(NLE)
Motion for a resolution
Citation 8 b (new)
Citation 8 b (new)
— having regard to country chapter on Hungary in the 2021 Rule of Law Report,
Amendment 25 #
2018/0902R(NLE)
Draft opinion
Paragraph 5
Paragraph 5
5. Insists that the Council’s constitutional obligation to organise hearings, enshrined in Article 7(1) TEU, should be implemented in an open, regular and structured manner; regrets therefore that the Council, invoking the COVID-19 pandemic, and the impossibility to hold physical Council meetings, only organised two hearings under Article 7 TEU since December 2019; insists that in all proceedings related to Article 7 TEU, Parliament and the Commission should be treated equally; calls on the Council to systematically provide the Member State concerned with recommendations including deadlines, and to oversee the implementation thereof on a regular basis, following the hearings under Article 7 TEU;
Amendment 29 #
2018/0902R(NLE)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Recalls that only qualified majority is required to determine that there is a clear risk of a serious breach by a Member State of the values referred to in Article 2; notes that the failure to progress in Article 7 TEU procedure enables continued divergence from the values enshrined in Article 2 TEU, undermining those values and mutual trust between Member States and the EU as a whole; urges the French presidency of the Council to take the appropriate steps in order to move further the procedure under Article7(1) TEU;
Amendment 46 #
2018/0902R(NLE)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Thoroughly condemns the criticism of the re-elected Prime Minister of Hungary of the President of Ukraine and deplores the increasing ties of Hungary with Russia, given the invasion of Ukraine by the latter;
Amendment 194 #
Amendment 205 #
Amendment 227 #
2018/0902R(NLE)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to make full use of the tools available to address the clear risk of a serious breach by Hungary of the values on which the Union is founded, in particular expedited infringement procedures, applications for interim measures before the Court of Justice and actions regarding non- implementation of the Court’s judgments; recalls the importance of the Rule of Law Conditionality Regulation and welcomes the decision to trigger it in the case of Hungary, albeit after a long delay and with a limited scope; calls on the Commission to take immediate action under the regulation as regards other breaches of the rule of law, particularly those relating to the independence of the judiciary; notes the risk of misuse of funds under the Recovery and Resilience Facility and reiterates its call for the Commission to refrain from approval of the Hungarian plan;
Amendment 1 #
2016/0062R(NLE)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
— having regard to the Explanatory Report to the Council of Europe Convention on preventing and combating violence against women and domestic violence of 11 May 2011,
Amendment 82 #
2016/0062R(NLE)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the Covid-19 pandemic has led to an increase in violence against women and domestic violence; highlights the decrease in access to essential services such as emergency accommodation and telephone assistance, which confirms how urgent it is to adopt concrete measures to combat such violence;
Amendment 85 #
2016/0062R(NLE)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas violence against women and domestic violence cause physical, mental or sexual health problems for the women and their children who fall victim to such violence and as such constitute a public health issue;
Amendment 92 #
2016/0062R(NLE)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas certain groups of women, such as women and girls with disabilities, are particularly affected by violence, abuse or exploitation, both outside and inside the home;
Amendment 96 #
2016/0062R(NLE)
Motion for a resolution
Recital E
Recital E
E. whereas gender-based violence against women may take the form of offences such as sexual violence, including rape, female genital mutilaprohibition of abortion in cases of rape, female genital mutilation, forced sterilisation or abortion, trafficking in women for the purposes of sexual exploitation, sexual harassment, ‘honour crimes’ and forced marriages, femicide, stalking and various forms of cyberviolence;
Amendment 141 #
2016/0062R(NLE)
Motion for a resolution
Recital I
Recital I
I. whereas the Istanbul Convention is a uniquen essential tool to combat gender-based violence at European level and beyond;
Amendment 185 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Strongly condemns all forms of gender-based violence, including the denial of access to sexual and reproductive health and rights, against women and girls and against LGBTIQ+ persons;
Amendment 237 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Points out that while all Member States have already signed the Istanbul Convention, six have not ratified it yet and one is threatening to withdraw from it; underlines that the EU’s accession to the Istanbul Convention does not exempt Member States from national ratification and thus strongly encourages the remaining Member States that have not already done so to ratify the Convention without delay;
Amendment 239 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Notes Turkey's withdrawal from the Istanbul Convention as of 1 July 2021, which once again distances Turkey from the values of the European Union, calls on the Commission and the Council to end all funding to Turkey under the Instrument for Pre-Accession Assistance (IPA III) through the current and future multi-annual financial frameworks; insists that all EU-membership negotiations with Turkey be halted immediately;
Amendment 260 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes the Commission’s proposal for a directive on combating violence against women and domestic violence, which will be the first EU act comprehensively to address gender-basedviolence against women and domestic violence, thus helping to harmonise Member States’ differing approaches towards violence against women and domestic violence and to lay down common minimum standards for the protection of victims and survivors of gender-based violence and for improving their access to justice;
Amendment 262 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Stresses that the directive on combating violence against women and domestic violence proposed by the European Commission on 8 March 2022 aims to establish common minimum standards for the protection of victims of gender-based violence by improving their access to justice, by encouraging Member States to set up a mechanism of one-stop shops to provide guidance, counselling and protection to victims, and by developing shelters with an adequate distribution of one family per 10 000 inhabitants, as foreseen in the final activity report of the Council of Europe Task Force to Combat Violence against Women, including Domestic Violence (EG-TFV (2008)6);
Amendment 268 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Reiterates its call on the Council to activate the passerelle clause by adopting a unanimous decision identifying gender- based violence against women and girls as one of the areas of crime listed in Article 83(1) of the TFEU;
Amendment 279 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Recalls, moreover, the commitment of the President of the European Commission to defend the ratification of the Istanbul Convention by the European Union in her speech to the plenary of the European Parliament on the conclusions of the European Council meeting of 25-26 March 2021 and on the outcome of the EU-Turkey meeting of 6 April 2021;