561 Amendments of Joanna KOPCIŃSKA
Amendment 175 #
2023/0132(COD)
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15 a) It would be valuable to map terms used in ICD 11 an MedDRA, to clearly identify indications and to harmonise terminology used in other healthcare systems.
Amendment 204 #
2023/0132(COD)
Proposal for a directive
Recital 39
Recital 39
(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure by recognising it after it has been closed.
Amendment 219 #
2023/0132(COD)
Proposal for a directive
Recital 47
Recital 47
(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory datamarket protection for market launch shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.
Amendment 224 #
2023/0132(COD)
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. Joint procurement should not have detrimental impact on access to medicines for countries not taking part in the procurement. _________________ 47 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). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 249 #
2023/0132(COD)
Proposal for a directive
Recital 52
Recital 52
(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be incentivisedrecommended, especially in regards to medicines for non rare diseases, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.
Amendment 254 #
2023/0132(COD)
Proposal for a directive
Recital 54
Recital 54
(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory datamarket protection.
Amendment 259 #
2023/0132(COD)
Proposal for a directive
Recital 56
Recital 56
(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of datamarket protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory datamarket protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later.
Amendment 261 #
2023/0132(COD)
Proposal for a directive
Recital 57
Recital 57
(57) The issuing of documentation from the Member States as regards the prolongation of datamarket protection for the purpose of supply of medicinal products in all Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the datamarket protection period.
Amendment 291 #
2023/0132(COD)
Proposal for a directive
Recital 64
Recital 64
(64) It will allow, inter alia, to conduct studies to support pricing and reimbursement all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studies activities to support regulatory 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 of seeking marketing authorisations during that period, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one after of loss of the patent or SPC protection under fair competitive conditions.
Amendment 325 #
2023/0132(COD)
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused unless health benefits from authorisation of medicine outweight the enviromental risk. The ERA should be updated when new data or knowledge about relevant risks become available.
Amendment 498 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antiprotozoals and antifungals;
Amendment 546 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 549 #
2023/0132(COD)
Proposal for a directive
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2 a. Developments lacking therapuetic contributions shall always be granted in accodrance with paragraph 1 and be considered as belonging to the same global marketing authorisation.
Amendment 571 #
2023/0132(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, or there was a reference medicinal product but it is not currently available, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature.
Amendment 575 #
2023/0132(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1
Article 15 – paragraph 3 – subparagraph 1
Where justified for public health reasons and when the active substances cannot be combined within a fixed dose combination medicinal product, a marketing authorisation may, in exceptional circumstances, be granted to a multi- medicinal product packageroduct.
Amendment 577 #
2023/0132(COD)
Proposal for a directive
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
3 a. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by amending Annexes IV to VI by specyfying additional requirements for multi- medicinal product package.
Amendment 604 #
2023/0132(COD)
Proposal for a directive
Article 20 – title
Article 20 – title
Combinations of medicinal products with products other than medical devices
Amendment 605 #
2023/0132(COD)
Proposal for a directive
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
Amendment 708 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 5
Article 34 – paragraph 5
5. Within 1290 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant.
Amendment 710 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 6
Article 34 – paragraph 6
6. Within 690 days of receipt of the assessment report, the competent authorities of the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the competent authority of the reference Member State for the decentralised procedure accordingly. The competent authority of the reference Member State for the decentralised procedure shall record the agreement of all parties, close the procedure and inform the applicant accordingly.
Amendment 717 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 5
Article 36 – paragraph 5
5. If the competent authorities of the Member States concerned so require, the marketing authorisation holder shall request the competent authority of the reference Member State for the mutual recognition procedure to perform or update the assessment report drawn on the medicinal concerned by the application. In that case, the reference Member State shall perform or update the assessment report within 90 days after validation of the application. If the competent authorities of the Member States concerned do not require the performance or the update of the assessment report, the reference Member State shall provide the assessment report within 30 days in case medicinal product was previously authorised in European procedure.
Amendment 741 #
2023/0132(COD)
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
(g) in case of medicinal products for which there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit- risk balance, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 765 #
2023/0132(COD)
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, however with clear prioritization of human health benefits over risk to environment;
Amendment 772 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial; orf systemic administration;
Amendment 775 #
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 779 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point e a (new)
Article 51 – paragraph 1 – point e a (new)
(e a) is an antibiotic; or
Amendment 794 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 5 – point b
Article 51 – paragraph 5 – point b
Amendment 808 #
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, and any data in its possession relating to the volume of prescriptions 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.
Amendment 1210 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo years shall be granted for a medicinal product with respect to a new and previously unknown therapeutic indication not previously authorised in the Union, provided that:
Amendment 1400 #
2023/0132(COD)
Proposal for a directive
Article 123 – title
Article 123 – title
Guidance to facilitate the performance of pharmacovigilance activities
Amendment 1479 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) are antibiotics.
Amendment 1488 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 2
Article 177 – paragraph 2
2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a medical practithealth professioneral for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.
Amendment 1497 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 4
Article 177 – paragraph 4
4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
Amendment 1515 #
2023/0132(COD)
Proposal for a directive
Article 185 – paragraph 1 – point g
Article 185 – paragraph 1 – point g
(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.
Amendment 1536 #
2023/0132(COD)
Proposal for a directive
Article 193 – paragraph 1 – subparagraph 1
Article 193 – paragraph 1 – subparagraph 1
to submit samples from each batch of the bulk or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be directly recognised. Member States shall ensure that any such examination is completed within 360 days of the receipt of the samples.
Amendment 1546 #
2023/0132(COD)
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder with clear prioritatization of public health over risk to environment.
Amendment 1595 #
2023/0132(COD)
Proposal for a directive
Article 214 – paragraph 3
Article 214 – paragraph 3
Amendment 1603 #
2023/0132(COD)
Proposal for a directive
Article 219 – paragraph 1
Article 219 – paragraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by [1824 months after the date of entering into force of this Directive]. They shall immediately communicate the text of those measures to the Commission.
Amendment 79 #
2022/0298(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Since this Directive concerns the protection of the health and safety of workers at the place of work, it should be transposed within twofive years of the date of its entry into force.
Amendment 110 #
2022/0298(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2009/148/WE
Article 19 – paragraph 2
Article 19 – paragraph 2
The employer shallmust enter the information on all the workers engaged in the activities referred to in Article 3(1) in a register. That information shallought to indicate the nature and duration of the activity and the exposure to which they have been subjected. The doctor and/or the authority responsible for medical surveillance shall have access to this register. Each worker shall have access to the results in the register which relate to him or her personally. The workers and/or their representatives shall have access to anonymous, collective information in the register.
Amendment 124 #
2022/0298(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1
Article 2 – paragraph 1 – subparagraph 1
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by twofive years after the date of entry into force of this Directive at the latest. They shall immediately inform the Commission thereof.
Amendment 128 #
2022/0298(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Since this Directive concerns the protection of the health and safety of workers at the place of work, it should be transposed within twofive years of the date of its entry into force.
Amendment 269 #
2022/0298(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2009/148/EU
Article 19 – paragraph 2
Article 19 – paragraph 2
‘The employer shallmust enter the information on all the workers engaged in the activities referred to in Article 3(1) in a register. That information shallould indicate the nature and duration of the activity and the exposure to which they have been subjected. The doctor and/or the authority responsible for medical surveillance shall have access to this register. Each worker shall have access to the results in the register which relate to him or her personally. The workers and/or their representatives shall have access to anonymous, collective information in the register. ’
Amendment 294 #
2022/0298(COD)
Proposal for a directive
Article 2 – paragraph 1 – subparagraph 1
Article 2 – paragraph 1 – subparagraph 1
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by twofive years after the date of entry into force of this Directive at the latest. They shall immediately inform the Commission thereof.
Amendment 171 #
2022/0216(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) This Regulation should not interfere with nNational legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects, shall take precedence over the provisions of this Regulation. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation shouldall also not interfere with decisions of an ethical nature made by Member States. Such ethical decisions might, and, in particular, no provision of this Regulation may be construed as imposing an obligation on Member States to use types of SoHOs that are legally prohibited in that Member State. Decisions concerning the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells, are an exclusive competence of the Member States. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health.
Amendment 194 #
2022/0216(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality, professionalism and transparency. When infringements relate to direct health risks, and the publication of information regarding those infringements can contribute to risk mitigation and the protection of donors, recipients or offspring from medically assisted reproduction, competent authorities should, where necessary, be able to prioritise transparency of their enforcement activities over the protection of confidentiality of the party that has infringed the Regulation. Matters covered by trade secrecy or infringements of the law until such time as the competent court has issued a ruling may not be the subject of such public information.
Amendment 206 #
2022/0216(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Commission experts should be able to perform controls, including audits, in Member States to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems. Commission controls should also serve to investigate and collect information on enforcement practices or probOfficial controls may only be carried out with the agreement of the Member State, in compliance with the organisational rulems, emergencies and new developments in Member Statfunctioning and powers of the national supervisory authorities. Official controls should be performed by personnel who are independent, free from any conflict of interest and in particular who are not in a situation which, directly or indirectly, could affect their ability to carry out their professional duties in an impartial manner.
Amendment 226 #
2022/0216(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as a means to demonstratone of the means to be compliancet with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. Member States may decide that SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the samrecognised guidelines that are based on scientific evidence and achieve an appropriate level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 249 #
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 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 to 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 270 #
2022/0216(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific and donor and patient representative groups and industry experts at Union level in the field of SoHOs. When seeking the input of expert bodies such as the ECDC and the EDQM, the SCB shall have due regard to their respective areas of expertise and avoid duplication.
Amendment 273 #
2022/0216(COD)
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38 a) The Commission shall cooperate with the EDQM in relation to the guidelines issued by that body. Such cooperation is without prejudice to the autonomy of Union law and should take into account Union principles on transparency and stakeholder participation.
Amendment 288 #
2022/0216(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation. In addition, the personal data and curriculum vitae of the persons responsible for the release of SoHOs should not be made public.
Amendment 298 #
2022/0216(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) SoHOs, by definition, relate to persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU) 2018/1725. Data on safety and efficacy of new SoHO preparations in recipients should also be shared, with appropriate protective measures, to allow aggregation at Union level for more robust evidence gathering on the clinical efficacy of SoHO preparations. For all data processing, such processing should be necessary and appropriate with a view to ensuring compliance with this Regulation in order to protect human health. Data on donors, recipients and offspring should hence be limited to the minimum necessary and pseudonymisedrocessed in fully anonymised form, using a donor or donation number. dDonors, recipients and offspring should be informed of the processing of their personal data in line with the requirements of Regulations (EU) 2016/679 and (EU) 2018/1725, and in particular as provided for under this Regulation, including the possibility of exceptional cases where circumstances require such processing.
Amendment 309 #
2022/0216(COD)
Proposal for a regulation
Recital 51 a (new)
Recital 51 a (new)
(51a) In view of the significant systemic changes that will result from the entry into force of this draft Regulation, it is essential to give Member States sufficient time to redesign existing national solutions so that they can comprehensively, coherently and reliably amend national legislation in all areas covered by the Regulation;
Amendment 331 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Where non-viable SoHOs or their derivatives, as defined in Article 2, point (17), of Regulation (EU) 2017/745, incorporate, as an integral part, a medical device, and where the action of the non- viable SoHOs or their derivatives is principal and not ancillary to that of the device, the non-viable SoHOs or their derivatives shall be governed by this Regulation. If the action of the non-viable SoHOs or their derivatives is ancillary to that of the device and not principal, the provisions of this Regulation, insofar as they concern donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, collection of SoHOs from donors or patients, shall apply. In the case of SoHOs whose donation is not regulated by national law, the relevant procedures under health policy programme agreements shall apply.
Amendment 356 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Amendment 376 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 14
Article 3 – paragraph 1 – point 14
Amendment 381 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
Amendment 403 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point h a (new)
Article 3 – paragraph 1 – point 28 – point h a (new)
h a) the transfer of embryos other than those intended.
Amendment 430 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 60
Article 3 – paragraph 1 – point 60
Amendment 446 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of any lossexpenses and inconveniences associated with donation;
Amendment 456 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70 a) ‘risk-based approach’ shall mean one that uses techniques to determine the areas of risk where ‘risk’ is identified as the probability of an event occurring that will have an impact on the achievement of objectives, taking into account the severity of its outcome and/or the likelihood of non-detection by other methods.
Amendment 473 #
2022/0216(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on condition that those national measures are compatible with Union law, and are proportionate to the risk to human healththe law.
Amendment 475 #
2022/0216(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shallmay make available to the public details of measures put in place in accordance with paragraph 1 without undue delay, including on the internet. The SoHO National Authority shall submit the details of any more stringent measure to the EU SoHO Platform referred to in Chapter XI.
Amendment 492 #
2022/0216(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human healtho revoke, suspend or reinstate authorisation for SoHO activities.
Amendment 512 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40.
Amendment 519 #
2022/0216(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point a
Article 16 – paragraph 2 – point a
(a) before any inspection procedure is initiated, declare in writing any direct or indirect interests referred to in Article 7(2) and update that declaration yearly and whenever the declared information changes or any new interest arisesrelating to inspection activities of the entity concerned;
Amendment 522 #
2022/0216(COD)
Proposal for a regulation
Article 17
Article 17
Amendment 523 #
2022/0216(COD)
Proposal for a regulation
Article 18 – paragraph 3 – point e
Article 18 – paragraph 3 – point e
Amendment 537 #
2022/0216(COD)
Proposal for a regulation
Article 25 – paragraph 6 – subparagraph 1 a (new)
Article 25 – paragraph 6 – subparagraph 1 a (new)
Amendment 542 #
2022/0216(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Competent authorities shall provide guidelines and templto facilitates to allow thathe submission of applications from SoHO entities for their authorisation as SoHO establishments are submitted in accordance with Article 49. When developing these guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 543 #
2022/0216(COD)
Proposal for a regulation
Article 27 – paragraph 2 – point a
Article 27 – paragraph 2 – point a
Amendment 544 #
2022/0216(COD)
Proposal for a regulation
Article 27 – paragraph 2 – point b
Article 27 – paragraph 2 – point b
(b) assess the application on the basis of the provisions of national administrative law;
Amendment 551 #
2022/0216(COD)
Proposal for a regulation
Article 28 – paragraph 2 – point a
Article 28 – paragraph 2 – point a
Amendment 552 #
2022/0216(COD)
Proposal for a regulation
Article 28 – paragraph 2 – point b
Article 28 – paragraph 2 – point b
(b) assess the application on the basis of the provisions of national administrative law;
Amendment 557 #
2022/0216(COD)
Proposal for a regulation
Article 29 – paragraph 5 – introductory part
Article 29 – paragraph 5 – introductory part
5. By derogation from paragraph 4, competent authorities may conduct inspections, in full or in part, by means of a remote document reviewinspection, provided that:
Amendment 562 #
2022/0216(COD)
Proposal for a regulation
Article 29 – paragraph 16
Article 29 – paragraph 16
16. For the purpose of standardised inspections referred to in paragraph 1 of this Article, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c), provided that they do not contravene the national legal provisions in force in the Member State concerned.
Amendment 563 #
2022/0216(COD)
Proposal for a regulation
Article 31 – paragraph 4 – subparagraph 2 a (new)
Article 31 – paragraph 4 – subparagraph 2 a (new)
The inspection shall be conducted in the official language of the country concerned, including the inspection report. Forms in all the official languages of the European Union shall be acceptable during the submission of an inspection application.
Amendment 564 #
2022/0216(COD)
Proposal for a regulation
Article 31 – paragraph 6 a (new)
Article 31 – paragraph 6 a (new)
6 a. 7. In exceptional cases, an inspection request may be refused or dismissed if it has not been justified.
Amendment 568 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Competent authorities shall provide inspectors with amay organise specific induction training before inspectors before they take up their duties. For the specific induction training, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 574 #
2022/0216(COD)
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Competent authorities shall be responsible for the management of vigilance associated with SoHO activities. They shall provide guidance and templates for the submission of SAO notifications and of SAO investigation reports as referred to in Article 47.
Amendment 575 #
2022/0216(COD)
Proposal for a regulation
Article 35 – paragraph 10
Article 35 – paragraph 10
10. Competent authorities shall submit to their SoHO National Authorities an annual summary of the SAO notifications and SAO investigation reports received in accordance with the provisions of the national law of the Member State concerned. The SoHO National Authorities shall submit an annual summary of those SAO notifications and investigation reports to the EU SoHO Platform referred to in Chapter XI before 31 May of the subsequent year and shall make an aggregated version of that summary available to the public in their Member State, including on the internet. They shall include in the annual summary the numbers and types of those SAO reported to them that meet thresholds of seriousness and imputability that are agreed at Union level within the SCB.
Amendment 593 #
2022/0216(COD)
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. Where applicable, SoHO entities shall make all reasonable efforts to encourage prospective parents of children born from third party donation to commit to communicate information concerning any genetic conditions that emerge, as those children grow up, to the SoHO entity where they were treated. That entity shall communicate, without undue delay, the information to the SoHO entity that distributed or applied the reproductive cells with a view to preventing further distribution of SoHO from the implicated SoHO donor.
Amendment 597 #
Amendment 598 #
2022/0216(COD)
Proposal for a regulation
Article 51 – paragraph 1 – introductory part
Article 51 – paragraph 1 – introductory part
1. Each SoHO establishment shall designate a physician or embryologist who resides and carries out its tasks in the same Member State and who shall at least fulfil the following conditions and have the following qualifications:
Amendment 599 #
2022/0216(COD)
Proposal for a regulation
Article 51 – paragraph 1 – point a
Article 51 – paragraph 1 – point a
(a) possession of formal qualification as a physician or have a degree in biology, biotechnology or medical analytics;
Amendment 600 #
2022/0216(COD)
Proposal for a regulation
Article 51 – paragraph 2 – introductory part
Article 51 – paragraph 2 – introductory part
2. The physiciaerson referred to in paragraph 1 shall be responsible for at least the following tasks:
Amendment 612 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point j
Article 53 – paragraph 1 – point j
(j) verify, where justified, by means of a registry, that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in Article 56 and demonstrate that their health is not compromised;
Amendment 630 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 6
Article 53 – paragraph 6
Amendment 710 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 3 – point b – introductory part
Article 58 – paragraph 3 – point b – introductory part
(b) where the transmission of genetic conditions is an genuinely identified risk, and in particular in the case of medically assisted reproduction with third party donation:
Amendment 736 #
2022/0216(COD)
Amendment 765 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 2 a (new)
Article 62 – paragraph 2 a (new)
Amendment 823 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point e
Article 68 – paragraph 1 – point e
(e) liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards within their respective areas of expertise, and with the EMA on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2003/63/EC, to support the harmonised implementation of standards and technical guidelines;
Amendment 829 #
2022/0216(COD)
Proposal for a regulation
Article 70 – paragraph 1 – introductory part
Article 70 – paragraph 1 – introductory part
1. The Commission, with the agreement of the Member State and in duly justified cases, shall perform controls, including audits, in the Member States to verify the effective application of the requirements relating to:
Amendment 834 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. Such cooperation is without prejudice to the autonomy of Union law and should take into account Union principles on transparency and stakeholder participation.
Amendment 850 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 4
Article 73 – paragraph 4
Amendment 868 #
2022/0216(COD)
Proposal for a regulation
Article 77 – paragraph 2
Article 77 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 28(10), 42(3), 53(6), 58(15), 69(6), 73(4),69(6) and 76(8) shall be conferred on the Commission for an indeterminate period of time from … [OP please insert the date = date of entry into force of this Regulation].
Amendment 873 #
2022/0216(COD)
Proposal for a regulation
Article 87 – paragraph 1 – subparagraph 2
Article 87 – paragraph 1 – subparagraph 2
Unless otherwise provided for in paragraph 2, it shall apply from … [OP please insert the date = twohree years after the date of entry into force of this Regulation].
Amendment 874 #
2022/0216(COD)
Proposal for a regulation
Article 87 – paragraph 2 – subparagraph 1
Article 87 – paragraph 2 – subparagraph 1
Article 81(3) to (6) and Article 82(3) shall apply from … [OP please insert the date = threefour years after the date of entry into force of this Regulation].
Amendment 299 #
2022/0196(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The European Parliament resolution of 12 February 2019 on the implementation of Directive 2009/128/EC on the sustainable use of pesticides41 noted that the Union must act without delay to transition to a more sustainable use of pesticides and called on the Commission to propose an ambitious Union-wide binding target for the reduction of pesticide use. The European Parliament re-affirmed its call for binding reduction targets, in its resolution of 20 October 2021 on a Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system42 , its call for reduction targets binding at EU level. __________________ 41 P8_TA(2019)0082, 12 February 2019. 42 P9_TA(2021)0425, 20 October 2021.
Amendment 321 #
2022/0196(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Commission Communication entitled ‘the European Green Deal’47 set out a roadmap of key measures, including legislative, to significantly reduce the use and risk of chemical pesticides. In the Farm to Fork Strategy48 , EU Biodiversity Strategy for 203049 and the Zero Pollution Action Plan50 , the Commission committed to take action to reduce by 50% the overall use and risk from chemical pesticides by 2030 and reduce by 50% the use of more hazardous pesticides (plant protection products containing one or more active substances approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council51 and listed in Part E of the Annex to Commission Implementing Regulation (EU) No 540/201152 , or containing one or more active substances listed in the Annex to Commission Implementing Regulation (EU) 2015/40853 ) by 2030. The sustainable use of plant protection products is also complementary to the promotion of organic farming and achieving the Farm to Fork Strategy target of at least 25% of the Union’s agricultural land under organic farming by 2030. It supports the objectives of the EU strategic framework on health and safety at work54 and thereby contributes to the implementation of principle 10 of the European Pillar of Social Rights on a healthy, safe and well- adapted work environment. __________________ 47 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions The European Green Deal COM/2019/640 final. 48 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system, COM/2020/381 final. 49 Communication from the Commission to the European Parliament the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030 Bringing nature back into our lives, COM/2020/380 final. 50 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil', COM(2021) 400 final. 51 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 52 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1). 53 Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ L 67, 12.3.2015, p. 18). 54 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU strategic framework on health and safety at work 2021-2027 Occupational safety and health in a changing world of work, COM/2021/323 final.
Amendment 333 #
2022/0196(COD)
Proposal for a regulation
Recital 8
Recital 8
Amendment 359 #
2022/0196(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Biological control agents are a sustainable control alternative to the use of chemical products for the control of harmful organisms. As noted in Council Decision (EU) 2021/110257 , biological control agents have a growing importance in sustainable agriculture and forestry and have an instrumental role to play in the success of integrated pest management and organic farming. Access to biological controls facilitates moving away from chemical plant protection products. It is appropriate to encourage farmers to switch to low input agricultural methods including organic farming. It is therefore appropriate to define the concept of biological control as a basis for Member States to set indicative targets to increase the percentage of crops on which biological control agents are used. __________________ 57 Council Decision (EU) 2021/1102 of 28 June 2021 requesting the Commission to submit a study on the Union’s situation and options regarding the introduction, evaluation, production, marketing and use of invertebrate biological control agents within the territory of the Union and a proposal, if appropriate in view of the outcomes of the study (OJ L 238, 6.7.2021, p. 81).
Amendment 369 #
2022/0196(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The objective of the Farm to Fork Strategy is to make substantial progress in the reduction of the use of chemical plant protection products in an economically viable way. In order to achieve that aim, it is necessary to set quantified targets at Union and Member State levels for the reduction in the use and risk of chemical plant protection products and the use of more hazardous plant protection products to monitor progress. National targets should be established by national law in order to ensure adequate progress and accountability in relation to them. These binding national targets should also be achieved by Member States by 2030. The reduction in the use of chemical plant protection products is expected to significantly reduce occupational safety and health risks for professional userslevel.
Amendment 382 #
Amendment 407 #
2022/0196(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Member States should draft and publish national action plans. In order for the Member State national action plans to be effective, they should contain quantitative objectives, references to binding national 2030 reduction targets as set out in national law, together with related indicative targets set out in the national action plans, measures, timetables and indicators to reduce risks and impacts of pesticide use on human health and the environment. This will allow for a structured approach to the setting of quantitative objectives and targets, with a clear link to the national 2030 reduction targets. In order to monitor compliance with the provisions of this Regulation, Member States should also be required to report annually on targets and precise quantitative data relating to compliance with provisions on use, training, application equipment and integrated pest management.
Amendment 427 #
2022/0196(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In order to achieve the Union-wide reduction targets (‘Union 2030 reduction targets’) as well as national 2030 reduction targets, it is necessary to increase the availability and use of biological control and other non-chemical alternatives. Availability of these alternatives will incentivise the adoption of low pesticide- input pest management practices such as organic farming.
Amendment 446 #
2022/0196(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure consistency and complementarity with related legislation, Member State national action plans should take into account Directive 2009/147/EC of the European Parliament and of the Council59 , Council Directive 92/43/EEC60 , Directive 2000/60/EC of the European Parliament and of the Council61 , Council Directive 91/676/EEC62 , Directive 2008/50/EC of the European Parliament and of the Council63 , Directive (EU) 2016/2284 of the European Parliament and of the Council64 and Regulation xxx/xxx on nature restoration [reference to adopted act to be inserted] and should be consistent with the Common Agricultural Policy (“CAP”) Strategic Plans drawn-up in accordance with Regulation (EU) 2021/2115 of the European Parliament and of the Council65 . __________________ 59 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). 60 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). 61 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 62 Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1). 63 Directive 2008/50/EC of the European Parliament and of the Council of 21 May 2008 on ambient air quality and cleaner air for Europe (OJ L 152, 11.6.2008, p. 1). 64 Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1). 65 Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013 (OJ L 435, 6.12.2021, p. 1).
Amendment 451 #
2022/0196(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Economic instruments, including those under the CAP that provide support to farmers, can play a crucialsignificant role in the achievement of objectives relating to the sustainable use of plant protection products and, in particular, reducing the use of chemical plant protection products. Member States have to show in their national CAP Strategic Plans that their implementation of the CAP contributes to and supports other relevant Union legislation and their objectives, including objectives under this Regulation.
Amendment 456 #
2022/0196(COD)
Proposal for a regulation
Recital 19
Recital 19
Amendment 464 #
2022/0196(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) An approach to pest control that follows integrated pest management in ensuring careful consideration of all available means that discourage the development of populations of harmful organisms, while keeping the use of chemical plant protection products to levels that are economically and ecologically justified and minimising risks to human health and the environment is necessary for the protection of human health and the environment. ‘Integrated pest management’ emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems, encourages natural pest control mechanisms and uses chemical control only when all other control means are exhausthad been considered. To ensure that integrated pest management is implemented consistently on the ground, it is necessary to lay down clear rules in this Regulation. In order to comply with the obligation to follow integrated pest management, a professional user should consider and implement all methods and practices that avoid the use of plant protection products. Chemical plant protection products should only be used when all other control means have been exhausted. In order to ensure and monitor compliance with this requirement, it is important that professional users keep a record of the reasons why they apply plant protection products or the reasons for any other action taken in line with integrated pest management and of advice received in support of their implementation of integrated pest management from independent advisors. These records are also required for aerial applications.
Amendment 485 #
2022/0196(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to facilitate compliance with integrated pest management, it is necessary to lay down crop-specific rulguidelines that a professional user must followtake into consideration in relation to the specific crop and region in which the professional user operates. Such rulguidelines should convert the requirements of integrated pest management into verifiable criteria that apply to the specific crop. To ensure that the crop-specific rules are in accordance with the requirements of integrated pest management, detailed rules should be laid down as to what they should contain and the Commission should verify their development, implementation and enforcement on the groundindicate the principles of integrated pest management that apply to the specific crop.
Amendment 493 #
2022/0196(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In order to verify compliance by professional users with integrated pest management, an electronic integrated pest management and plant protection product use register should be maintained with the aim of verifying compliance with the ruprinciples on integrated pest management set out in this Regulation and supporting the development of Union policy. Access to the register should also be granted to national statistical authorities for the development, production and dissemination of official statistics in accordance with Chapter V of Regulation (EC) No 223/2009 of the European Parliament and of the Council66 . This register should record any preventative measure or interventionuse of plant protection product and the reasons for that preventative measure or intervention. This will provide the competent authorities with the information necessary to verify whether a professional user has carried out a decision-making process, in accordance with integrated pest management, before determining the specific preventative measure or intervention. The register should also contain details in relation to advice required annually in support of integrated pest management in order to verify that such strategic longer term planning in relation to integrated pest management is taking place. __________________ 66 Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).
Amendment 502 #
2022/0196(COD)
Proposal for a regulation
Recital 25
Recital 25
Amendment 531 #
2022/0196(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Precision farming refers to agricultural management systems carefully tailoring crop management to fit localised conditions such as those found within land parcels. The application of existing technology, including the use of Union space data and services (Galileo and Copernicus), has the potential to significantly reduce pesticide usage. It is therefore necessary to provide for a legislative framework that incentivises the development of precision farming. Application of plant protection products from an aircraft, including application by planes, helicopters and drones, is usually less precise than other means of application and may therefore potentially cause adverse impacts on human health and the environment. Aerial application should therefore be prohibited, with limited derogations on a case-by-case basis where it has a less negative impact on human health and the environment than any alternative application method or there is no viable alternative application method. However, the possibility of protecting forest stands with the use of aerial treatments should be ensured. It is also necessary to record the numbers of aerial applications carried out on the basis of permits granted for aerial application in order to have clear data on how many aerial applications for which permits were granted actually took place.
Amendment 534 #
2022/0196(COD)
Proposal for a regulation
Recital 28
Recital 28
Amendment 561 #
2022/0196(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) Considering the possible risks to human health and the environment from the use of plant protection products, the public should have access to better information on the overall impacts of the use of such products through awareness- raising programmes, information passed on through distributors and other appropriate measureThe public should have access to full, balanced, objective and scientific- based information on plant protection products.
Amendment 568 #
2022/0196(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) In order to better understand the trends regarding acute poisoning incidents and chronic poisoning arising from exposure of persons to plant protection products, information on such trends should be compiled by each Member State. The Commission should also monitor the overall trends at Union level.
Amendment 603 #
2022/0196(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) For the moment, the only robust statistical data available at Union level relating to the marketing and use of plant protection products are the statistics on the quantities of active substances in plant protection products placed on the market, and the data on the number of authorisations for emergency situations in plant protection granted under Regulation (EC) No 1107/2009. Those statistics are used in the calculation of harmonised risk indicators 1 and 2 under Directive 2009/128/EC and in calculating progress towards the binding Union 2030 reduction targets and national 2030 reduction targets based on the Farm to Fork Strategy. The new harmonised risk indicator 2a will be calculated using statistics on the number of authorisations for emergency situations in plant protection, the properties of the active substances in plant protection products subject to these authorisations, and the areas treated under these authorisations to better quantify the risks arising from authorisations for emergency situations in plant protection.
Amendment 610 #
2022/0196(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) For reasons of transparency, and to ensure uniform implementation by all Member States, the methodology for calculating progress towards achieving the two Union and two national 2030 reduction targets and the methodology for the calculation of harmonised risk indicators at Union and national level should be set out in an Annex to this Regulation.
Amendment 616 #
2022/0196(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The EU Biodiversity Strategy for 2030 recognises the need for urgent action to protect biodiversity. There is evidence of a widespread reduction of species, in particular insects and pollinators, in the Union. Biodiversity loss is, amongst other factors, driven by the use of plant protection products, while Member States actions under current Union policy instruments have not yet been able to stop this trend of biodiversity loss. It is therefore essential to ensure that plant protection products are used in such a way as to mitigate the risk of harmful effects of such products on wildlife, through a number of measures including training, inspection of application equipment in professional use and protection of the aquatic environment and sensitive areas.
Amendment 634 #
2022/0196(COD)
Proposal for a regulation
Recital 44
Recital 44
Amendment 640 #
2022/0196(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) In order to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend technical aspects of the provisions on obligations of professional users and advisors related to integrated pest management, inspection of application equipment in professional use, calculation of harmonised risk indicators, the data to be provided in annual progress and implementation reports and the notification form in relation to application equipment as well as Annexes II III, IV, V and VI. Likewise, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to supplement this Regulation by specifying precise criteria in relation to certain factors regarding unmanned aircraft, once technical progress and scientific developments allow for the development of such precise criteria. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Inter- institutional Agreement of 13 April 2016 on Better Law-Making76 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. __________________ 76 OJ L 123, 12.5.2016, p. 1.
Amendment 2200 #
2022/0196(COD)
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article 18a Use of plant protection products in sensitive areas 1. Where Member State concludes, based on sound scientific risk analysis, that safety precautions adopted based on the Regulation 1107/2009 and included in labels of plant protection products do not eliminate the risk posed by the use of plant protection products in specific areas or objects, it shall define such areas or objects in national legislation and shall lay down: (a) appropriate measures to eliminate identified risk, (b) the rules of implementation of measures referred to in letter (a), (c) users of plant protection products obliged to implement measures referred to in letter (a), if applicable, (d) derogations from measures referred to in letter (a) and procedures of granting such derogations, if applicable. 2. Measures referred to in paragraph 1 letter (a) may include one or more of the following elements: (a) the ban of the use of all of plant protection products or specified groups of plant protection products in defined areas or objects, (b) restriction concerning the use of plant protection products in defined areas or objects, (c) obligation for professional users to apply appropriate buffer zone when using plant protection products in proximity of defined areas or objects, (d) obligation for professional users to apply anti-drift techniques, when using plant protection products in the close vicinity of defined areas or objects, (e) obligations for professional users to apply appropriate warning measures, (f) closing of defined areas or objects for the period of application of plant protection products, (g) other measures necessary to eliminate identified risk. 3. The measures referred to in paragraph 1 letter (a) are without prejudice to the Union and national law and powers of the competent authorities in scope of eradication and containment of quarantine pests, pests referred to in art 29 and 30 of the Regulation 2016/2031, vectors of above mentioned pests and Invasive Alien Species.
Amendment 2237 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 2 – point b – introductory part
Article 20 – paragraph 2 – point b – introductory part
(b) the aerial application has a less negative impact on human health and the environment than any alternative application method either because the aerial application equipment can be deployed on the relevant terrain in a faster timescale than land-based equipment and avoids a situation where the number of plant pests increases due to the longer time period required for land-based deployment or because it minimizes soil erosion when adverse weather conditions make the land unsuitable for land vehicles, and all of the following conditions are met: or
Amendment 2238 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 2 – point b – point i
Article 20 – paragraph 2 – point b – point i
Amendment 2239 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 2 – point b – point ii
Article 20 – paragraph 2 – point b – point ii
Amendment 2241 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 2 – point b – point iii
Article 20 – paragraph 2 – point b – point iii
Amendment 2243 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 2 – point b a (new)
Article 20 – paragraph 2 – point b a (new)
(ba) the aerial application is to be carried out for the purpose of forest stands protection.
Amendment 2244 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 2 – point b b (new)
Article 20 – paragraph 2 – point b b (new)
Amendment 2252 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 4 – point c
Article 20 – paragraph 4 – point c
Amendment 2254 #
2022/0196(COD)
Proposal for a regulation
Article 20 – paragraph 4 – point e
Article 20 – paragraph 4 – point e
Amendment 2267 #
2022/0196(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. WBy way of derogation from Article 20(1) where certain categories of unmanned aircraft fulfil the criteria set out in paragraph 2, a Member Statethe Commission may exempt aerial application by such unmanned aircraft from the prohibition laid down in Article 20(1) prior to any aerial application of plant protection products. Provisions of Article 20 paragraph 2 to 5 do not apply to such unmanned aircraft.
Amendment 2275 #
2022/0196(COD)
Proposal for a regulation
Article 21 – paragraph 2 – introductory part
Article 21 – paragraph 2 – introductory part
2. An aerial application by an unmanned aircraft may be exempted by the Member State from the prohibition laid down in Article 20(1) where factors related to the use of the unmanned aircraft demonstrate that the risks from its use are lower than the risks arising from other aerial equipment andare sufficient to keep risks from its use at the level equal or lower than posed by land- based application equipment. These factors shall include criteria relating to:
Amendment 2280 #
2022/0196(COD)
Proposal for a regulation
Article 21 – paragraph 2 – point d
Article 21 – paragraph 2 – point d
Amendment 2284 #
2022/0196(COD)
Proposal for a regulation
Article 21 – paragraph 2 – point f
Article 21 – paragraph 2 – point f
Amendment 2285 #
2022/0196(COD)
Proposal for a regulation
Article 21 – paragraph 2 – point g
Article 21 – paragraph 2 – point g
Amendment 2294 #
2022/0196(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. By … [OP: please insert the date of application of this Regulation], Member States shall have in place effective measures and establish the necessary structure= the first day of the month following 2 years after the date of entry into force of this Regulation], Member States shall have in place national law-regulations to facilitate in a manner that does not endanger human health or the environment, the safe disposal of any unused plant protection products, any dilute solutions containing plant protection products and any packaging.
Amendment 2314 #
2022/0196(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1 a (new)
Article 23 – paragraph 1 – subparagraph 1 a (new)
Representatives of the plant protection products producers or distributors, providing information for professional users on the use of plant protection products shall poses valid certificate or a proof of entry in a central electronic register confirming accomplishment of the training course for advisors.
Amendment 2323 #
2022/0196(COD)
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. A distributor shall only sell a plant protection product authorised for professional use to a purchaser or his or her representative when that distributor has checked, at the time of purchase, that the purchaser or representative is a professional user and holds a training certificate for following courses for professional users issued in accordance with Article 25 or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5). In case when purchaser does not meet requirements referred to in first sentence, a distributor shall refuse to sell plant protection product. The distributor has the right to check the purchaser's identity document.
Amendment 2337 #
2022/0196(COD)
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. A distributor shall directinform a purchaser of a plant protection product tobeing a non-professional user that he or she should read its label prior to use and to use the product in accordance with the instructions on the label and shall inform the purchaser of the website referred to in Article 27.
Amendment 2341 #
2022/0196(COD)
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
4. A distributor shall provide general information to non-professional users on the risks to human health and the environment of the use of plant protection products, including the information on hazards, exposure, proper storage, handling, application and safe disposal in accordance with Directive 2008/98/EC of the European Parliament and of the Council86 , and shall recommend alternative low-risk plant protection products and ways in which risks can be mitigated when using plant protection products. __________________ 86 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312 22.11.2008, p. 3).
Amendment 2345 #
2022/0196(COD)
Proposal for a regulation
Article 24 – paragraph 5
Article 24 – paragraph 5
5. Each distributor shall ensure that it has sufficient staff that hold a training certificate for following courses for distributors issued in accordance with Article 25 or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5) available at the time of sale to provide adequate responses to requests of purchasers of plant protection products at the moment of sale on their use, related health and environmental risks and the appropriate safety instructions to manage those risks.
Amendment 2350 #
2022/0196(COD)
Proposal for a regulation
Article 24 – paragraph 6
Article 24 – paragraph 6
Amendment 2357 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 1 – introductory part
Article 25 – paragraph 1 – introductory part
1. A competent authority designated in accordance with paragraph 2 shall appoint one or more bodies to provide the following training: initial and follow up training to professional users, distributors and advisors, taking into account the subjects listed in Annex III and relevance of this subjects for particular groups of participants. Certificates issued before the entry into force of this Regulation shall remain valid for the time they have been issued. Member states may adopt national regulations concerning: (a) requirements for bodies conducting trainings, concerning qualifications of lecturers and necessary equipment that should be used during trainings, (b) detailed programs of particular types of training, including different programs for different types of users of plant protection products (c) examination procedure for training participants.
Amendment 2359 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
Amendment 2364 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
Amendment 2368 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point c
Article 25 – paragraph 1 – point c
Amendment 2387 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 4 – point b
Article 25 – paragraph 4 – point b
Amendment 2390 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 4 – point d
Article 25 – paragraph 4 – point d
(d) the date on which sufficient knowledge of the relevant subjects listed in Annex III was demonstraf issuance of the training certificate or entry in the central electronic registedr;
Amendment 2392 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 4 – point f
Article 25 – paragraph 4 – point f
Amendment 2399 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 5
Article 25 – paragraph 5
5. 5. A competent authority designated in accordance with paragraph 2 or body referred to in paragraph 1 shall provide electronic proof of entry in a central electronic register to a professional user, distributor or advisor at the time the entry is made. Such electronic proof shall include a record of the period of validity of the entry in the central electronic register.
Amendment 2407 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 6
Article 25 – paragraph 6
6. A training certificate or an entry in a central electronic register shall be valid for 105 years in the case of a distributor or, professional user and for 5 years in the case of an advisor.
Amendment 2409 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 7
Article 25 – paragraph 7
7. Subject to paragraph 6, a training certificate or an entry in a central electronic register shall only be made or renewed if the holder of the certificate or the person whose name has been entered in the central electronic registeprofessional user, distributor or advisor demonstrates satisfactory completion of an initial andor follow up training or extensive training referred to in paragraph 1, point (a) or (c)and passes an exam on the knowledge covered by the training.
Amendment 2413 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 8
Article 25 – paragraph 8
8. Notwithstanding paragraph 6, a training certificate may be issued to a person who can demonstrate prior training through formal qualifications that demonstrate a more extensive knowledge of the subjects listed in Annex III than would be received in the training referred to in paragraph 1knowledge equal to knowledge covered by the training. If such knowledge has been obtain during education process, it should be proved by a secondary school or a university.
Amendment 2416 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 9 – subparagraph 1a (new)
Article 25 – paragraph 9 – subparagraph 1a (new)
A competent authority designated in accordance with paragraph 2 shall withdraw a training certificate in case of serious violation of the law concerning providing an advice, sales, storage or use of plant protection product by a certificate holder. .
Amendment 2431 #
2022/0196(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
Amendment 2439 #
2022/0196(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
Amendment 2460 #
2022/0196(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Each Member State shall designate a competent authority to provide information to the public, in particular through awareness-raising programmes, in relation to the risks associated withrelation to the use of plant protection products.
Amendment 2466 #
2022/0196(COD)
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. The competent authority referred to in paragraph 1 shall establish a website or websites dedicated to providing information on risks associated with the use of plant protection products. That information may be provided directly or by providing links to relevant websites of other national or international bodies.
Amendment 2476 #
2022/0196(COD)
Proposal for a regulation
Article 27 – paragraph 3 – point a a (new)
Article 27 – paragraph 3 – point a a (new)
(aa) the reason why plant protection products are used and their role in agriculture;
Amendment 2478 #
2022/0196(COD)
Proposal for a regulation
Article 27 – paragraph 3 – point a b (new)
Article 27 – paragraph 3 – point a b (new)
(ab) risk posed by pests, in particular quarantine pests and invasive alien species;
Amendment 2499 #
2022/0196(COD)
Proposal for a regulation
Article 28 – title
Article 28 – title
Information on acute and chronic poisoning
Amendment 2504 #
2022/0196(COD)
Proposal for a regulation
Article 28 – paragraph 1 – introductory part
Article 28 – paragraph 1 – introductory part
1. Each Member State shall designate a competent authority to maintain or put in place systems for gathering and keeping the following information on acute and chronic poisoning incidents arising from exposure of persons to plant protection products:
Amendment 2506 #
2022/0196(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point a
Article 28 – paragraph 1 – point a
(a) the name and authorisation number of the plant protection product and the active substances involved in the acute or chronic poisoning incident;
Amendment 2529 #
2022/0196(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. By … [OP please insert the date = first day of the month following 9 month5 years after the date of entry into force of this Regulation], an owner of application equipment in professional use shall enter the fact that he or she is the owner of the application equipment in the electronic register of application equipment in professional use referred to in Article 33, using the form set out in Annex V, unless the Member State in which the owner uses the equipment has exempted that equipment from inspection in accordance with Article 32(3).
Amendment 2535 #
2022/0196(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. If application equipment in professional use is sold, the seller and the buyer shall enter the fact of the sale, within 30 days after the sale, in the electronic register of application equipment in professional use referred to in Article 33, using the form set out in Annex V, unless the application equipment in professional use has been exempted from inspection in the relevant Member State(s) in accordance with Article 32(3). A similar obligation to enter a transfer of ownership in the electronic register applies in the case of any other changes of ownership of application equipment in professional use that has not been exempted from inspection in the relevant Member State(s) in accordance with Article 32(3).
Amendment 2576 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. The competent authority referred to in Article 30 or a body designated by it shall inspect application equipment in professional use every three years, starting from the date of first purchase. The competent authority shall ensure that there is sufficient staff, equipment and other resources necessary for the inspection of all application equipment due for inspection, within the three year cycleInspections of application equipment in professional use carried out prior to the entry into force of this regulation remain valid.
Amendment 2579 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The inspection shall be carried out at a location where the risk of pollution and water contamination can be avoided or with the use of efficient measures eliminating risk of such pollution or contamination. The influence of external conditions on the reproducibility of the results of the inspection, such as effects of wind and rain, shall be minimised by the authority or body carrying out the inspection.
Amendment 2580 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 4
Article 31 – paragraph 4
4. All equipment necessary for an inspection and used by the inspector for testing the application equipment shall be accurate, in good condition and checked and, where necessary, calibrated at regular intervals. The person carrying out the inspection should be properly trained. Member States may adopt national law specifying the more detailed requirements for equipment to be used during inspections of the application equipment in professional use. Member States may adopt national law specifying detailed requirements for the training of persons conducting inspections of the application equipment in professional use.
Amendment 2581 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 5
Article 31 – paragraph 5
5. The owner of the application equipment in professional use shall ensure that the application equipment is clean and safe before the inspection starts. In case the application equipment in professional use is not clean or safe the competent authority or body delegated by it refuse to conduct the inspection.
Amendment 2584 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 6
Article 31 – paragraph 6
6. The results of each inspection for which application equipment in professional use passes the test shall be recorded by the competent authority referred to in Article 30 in the central electronic register of application equipment in professional use referred to in Article 33.
Amendment 2586 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 7 – point a
Article 31 – paragraph 7 – point a
(a) issued by the competent authority referred to in Article 30 or body delegated by it to the owner of application equipment in professional use where that equipment complies with the requirements listed in Annex IV; and
Amendment 2588 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 7 – point b
Article 31 – paragraph 7 – point b
(b) recorded by that competent authority or body delegated by it in the central electronic register of application equipment in professional use referred to in Article 33.
Amendment 2596 #
2022/0196(COD)
Proposal for a regulation
Article 31 – paragraph 10
Article 31 – paragraph 10
10. The Commission is empowered to adopt delegated acts in accordance with Article 40 amending this Article and Annex IV in order to take into account technical progress and scientific developments.
Amendment 2600 #
2022/0196(COD)
Proposal for a regulation
Article 32 – paragraph 1 – subparagraph 1
Article 32 – paragraph 1 – subparagraph 1
A Member State may, after carrying out the risk assessment referred to in paragraph 2, lay down less stringent inspection requirements and provide for different inspection intervals than those set out in Article 31 to application equipment in professional use which represents a very low scale of use estimated by way of the risk assessment referred to in paragraph 2 and which is listed in the national action plan referred to in Article 8.
Amendment 2602 #
2022/0196(COD)
Proposal for a regulation
Article 32 – paragraph 1 – subparagraph 2 – point c – point i (new)
Article 32 – paragraph 1 – subparagraph 2 – point c – point i (new)
(i) the risk assessment conducted before entry into force of this regulation can be used for the purpose of this paragraph.
Amendment 2607 #
2022/0196(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. A Member State may exempt from inspection referred to in Article 31 handheld application equipment or knapsack sprayers, in professional use, based on a risk assessment on their potential impact on human health and the environment, which shall include an estimation of the scale of use. The competent authority referred to in Article 30 shall maintain a copy of the risk assessment for control by the Commission. The risk assessment conducted before entry into force of this regulation can be used for the purpose of this paragraph.
Amendment 2623 #
2022/0196(COD)
Proposal for a regulation
Article 33 – paragraph 2 – point e
Article 33 – paragraph 2 – point e
Amendment 2627 #
2022/0196(COD)
Proposal for a regulation
Article 33 – paragraph 2 – point h
Article 33 – paragraph 2 – point h
Amendment 2630 #
2022/0196(COD)
Proposal for a regulation
Article 33 – paragraph 2 – point j
Article 33 – paragraph 2 – point j
Amendment 2645 #
2022/0196(COD)
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
1. The methodology for calculating progress towards achieving the two Union 2030 reduction targets and the two national 2030 reduction targets until and including 2030 is laid down in Annex I. This methodology shall be based on statistical data collected in accordance with Regulation (EC) No 1185/2009.
Amendment 2654 #
2022/0196(COD)
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
2. Using the methodology set out in Annex I, the Commission shall calculate the results of progress towards achieving the two Union and two national 2030 reduction targets annually until and including 2030 and publish those results on the website referred to in Article 7.
Amendment 2663 #
2022/0196(COD)
Proposal for a regulation
Article 35 – paragraph 4
Article 35 – paragraph 4
4. The Commission is empowered to adopt delegated acts in accordance with Article 40 amending this Article and Annex VI in order to take into account technical progress, including progress in the availability of statistical data, and scientific and agronomic developments. Such delegated acts may modify the existing harmonised risk indicators or provide for new harmonised risk indicators, which may take into account Member States’ progress towards achieving the target of having 25% of their utilised agricultural area devoted to organic farming by 2030 as referred to in Article 8(1), point (d).
Amendment 2674 #
2022/0196(COD)
Proposal for a regulation
Article 36
Article 36
Amendment 2692 #
2022/0196(COD)
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – paragraph 1
By … [OP: please insert the date = the first day of the month following six monthtwo years after the date of entry into force of this Regulation], each Member State shall inform the Commission of the competent authorities designated in accordance with this Regulation.
Amendment 2737 #
2022/0196(COD)
Proposal for a regulation
Article 45 – paragraph 2
Article 45 – paragraph 2
It shall apply from … [OP: please insert the date = the first day of the month following …24 months after the date of entry into force of this Regulation].
Amendment 2745 #
2022/0196(COD)
Proposal for a regulation
Annex I – subheading 1
Annex I – subheading 1
METHODOLOGY FOR CALCULATING PROGRESS TOWARDS ACHIEVING THE TWO UNION AND TWO NATIONAL 2030 REDUCTION TARGETS
Amendment 2748 #
2022/0196(COD)
Proposal for a regulation
Annex I – paragraph 1 – introductory part
Annex I – paragraph 1 – introductory part
This Regulation is the instrument used to achieve the pesticide reduction targets contained in the Farm to Fork Strategy by requiring each Member State to contribute to achieving by 2030 a 50 % Union-wide reduction of both the use and risk of chemical plant protection products (‘Union 2030 reduction target 1’) and the use of more hazardous plant protection products (‘Union 2030 reduction target 2’). This Regulation also regulates the contribution of each Member State to these Union targets. Each Member State contribution, set in the form of a national target, to Union 2030 reduction target 1 is referred to as a ‘national 2030 reduction target 1’, while a Member State contribution to Union 2030 reduction target 2 is referred to as a ‘national 2030 reduction target 2’. The methodology for calculating progress towards achieving these targets is set out below:
Amendment 2760 #
2022/0196(COD)
Proposal for a regulation
Annex I – paragraph 1 – subparagraph 1 – subheading 1
Annex I – paragraph 1 – subparagraph 1 – subheading 1
Amendment 2762 #
2022/0196(COD)
Proposal for a regulation
Annex I – paragraph 1 – subparagraph 1 – point 1
Annex I – paragraph 1 – subparagraph 1 – point 1
1. The methodology shall be based on statistics on the quantities of chemical active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission (Eurostat) under Annex I to Regulation (EC) No 1185/2009 of the European Parliament and of the Council91 and the Utilized Agricultural Area (UAA) under Regulation (EC) 2018/1091 of the European Parliament and of the Council of 18 July 2018 on integrated farm statistics and repealing Regulations (EC) No 1166/2008 and (EU) No 1337/2011, Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1). __________________ 91 Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1).
Amendment 2778 #
2022/0196(COD)
Proposal for a regulation
Annex I – paragraph 1 – subparagraph 1 – point 3 – paragraph 1
Annex I – paragraph 1 – subparagraph 1 – point 3 – paragraph 1
Progress towards achieving reduction target 1 shall be calculated by multiplying the annual quantities of active substances in plant protection products placed on the market for each group in the Table in this Annex by the relevant hazard weighting set out in row (iii), followed by the aggregation of the results of these calculations and divided by the utilized agricultural area (UAA) (iv.).
Amendment 2818 #
2022/0196(COD)
Proposal for a regulation
Annex II – Part 1
Annex II – Part 1
Amendment 2825 #
2022/0196(COD)
Proposal for a regulation
Annex II – Part 2 – paragraph 1 – point 1
Annex II – Part 2 – paragraph 1 – point 1
1. the percentagenumber of professional users controlled for integrated pest management implementation;
Amendment 2826 #
2022/0196(COD)
Proposal for a regulation
Annex II – Part 2 – paragraph 1 – point 2
Annex II – Part 2 – paragraph 1 – point 2
2. the percentagenumber of professional users failing to comply with the obligation to keep electronic records on integrated pest management implementation;
Amendment 2829 #
2022/0196(COD)
Proposal for a regulation
Annex II – Part 2 – paragraph 1 – point 3
Annex II – Part 2 – paragraph 1 – point 3
3. the percentagenumber of professional users that failed to comply with the obligation to keep pesticide use data electronically;
Amendment 2834 #
2022/0196(COD)
Proposal for a regulation
Annex II – Part 2 – paragraph 1 – point 8
Annex II – Part 2 – paragraph 1 – point 8
8. the estimated quantities of illegal plant protection products used and the quantities of illegal plant protection products detected;
Amendment 2837 #
2022/0196(COD)
Proposal for a regulation
Annex II – Part 2 – paragraph 2 – point 10
Annex II – Part 2 – paragraph 2 – point 10
10. the percentagenumber of professional users, advisors and distributors trained in the subjects listed in Annex III and holding a training certificate in accordance with Article 25 or who has a proof of entry in a central electronic register in accordance with Article 25(5), broken down by professional users, advisors and distributors;
Amendment 2840 #
2022/0196(COD)
Proposal for a regulation
Annex II – Part 2 – paragraph 2 – point 11
Annex II – Part 2 – paragraph 2 – point 11
Amendment 2854 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 3
Annex III – point 1 – paragraph 3
Amendment 2855 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 4
Annex III – point 1 – paragraph 4
Amendment 2856 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 5
Annex III – point 1 – paragraph 5
Amendment 2857 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 7
Annex III – point 1 – paragraph 7
Amendment 2858 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 8
Annex III – point 1 – paragraph 8
Amendment 2859 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 9
Annex III – point 1 – paragraph 9
Amendment 2860 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 10
Annex III – point 1 – paragraph 10
Amendment 2861 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 11
Annex III – point 1 – paragraph 11
Amendment 2862 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 12
Annex III – point 1 – paragraph 12
Amendment 2863 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 14
Annex III – point 1 – paragraph 14
Amendment 2864 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 15
Annex III – point 1 – paragraph 15
Amendment 2865 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 16
Annex III – point 1 – paragraph 16
Amendment 2866 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 17
Annex III – point 1 – paragraph 17
Amendment 2867 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 3 – introductory part
Annex III – point 3 – introductory part
3. The hazards of and risks associated with improper use of plant protection products, and how to identify and control them, including the following subjects:
Amendment 2869 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 3 – point a
Annex III – point 3 – point a
(a) potential risks to human health;
Amendment 2870 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 3 – point b
Annex III – point 3 – point b
(b) symptoms of plant protection product poisoning and appropriate first aid measures in case of such poisoning;
Amendment 2871 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 3 – point c
Annex III – point 3 – point c
(c) potential risks to non-target plants and insects, wildlife, biodiversity and the environment in general.
Amendment 2872 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 4
Annex III – point 4
4. IWhen relevant: integrated pest management strategies and techniques, integrated crop management strategies and techniques, organic farming principles, biological pest control methods, harmful organism control methods, the obligation to apply integrated pest management as set out in Articles 12 and 13 of this Regulation, and the obligation to enter records in the electronic integrated pest management and plant protection product use register, as set out in Article 14 of this Regulation.
Amendment 2875 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 5
Annex III – point 5
5. When plant protection products are needed, how to choose the plant protection products with the least sidtaking into consideration possible effects on human health, non- target organisms and the environment among all authorised products for a given pest problem, in a given situation.
Amendment 2877 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 6 – introductory part
Annex III – point 6 – introductory part
6. Measures to minimise potential risks to humans, non-target organisms and the environment, including:
Amendment 2879 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 7
Annex III – point 7
7. Procedures for preparing application equipment for operation, including its calibration, with minimum potential risks to the user, other persons, non-target animal and plant species, biodiversity and the environment, including water resources.
Amendment 2880 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 8
Annex III – point 8
8. Practical training on the use of application equipment and its maintenance, and on risk mitigation measures including specific spraying techniques, use of new technology including precision farming techniques, as well as the technical check of sprayers in use and ways to improve spray quality. In this subject special attention shall be paid to the drift-reduction nozzles and the recommendations made by the manufacturers concerning optimal conditions of their use. Specific potential risks linked to use of handheld application equipment or knapsack sprayers and the relevant risk management measures. Practical training shall also cover the specific risks linked to the sowing of seeds treated with plant protection products.
Amendment 2881 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 11
Annex III – point 11
Amendment 2882 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 13
Annex III – point 13
Amendment 2883 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 14 – point a – paragraph 1
Annex III – point 14 – point a – paragraph 1
Amendment 2884 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 14 – point a – paragraph 2
Annex III – point 14 – point a – paragraph 2
Amendment 2885 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 14 – point d
Annex III – point 14 – point d
(d) use of other mitigation measures which minimise the potential risk of off- site pollution caused by spray drift, drain- flow and run-off, including in particular mandatory buffer zones adjacent to surface waters courses and groundwater and aquifers;
Amendment 2886 #
2022/0196(COD)
Proposal for a regulation
Annex III – point 14 – point e
Annex III – point 14 – point e
Amendment 2889 #
2022/0196(COD)
Proposal for a regulation
Annex IV – paragraph 2
Annex IV – paragraph 2
The application equipment in professional use shall function reliably and be used only in accordance with its manual of operation for its intended purpose ensuring that plant protection products can be accurately applied in line with good agricultural practice (GAP) as defined in Article 3(2), point (a), of Regulation (EC) 396/2005 of the European Parliament and the Council111 . __________________ 111 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
Amendment 2890 #
2022/0196(COD)
Proposal for a regulation
Annex IV – paragraph 3
Annex IV – paragraph 3
The equipment shall be in such a condition to allow it to be filled and emptied safely, easily and completely and to prevent any leakage of either spray solution or concentrated product. It shall permit easy and thorough cleaning. It shall also allow for safe operation, and be capable of being immediately stopped from the position of the operator. It shall be simple to perform any necessary adjustments. Such adjustments shall be accurate and capable of being reproduced.
Amendment 2891 #
2022/0196(COD)
Proposal for a regulation
Annex IV – paragraph 4 – Part 4 – paragraph 1
Annex IV – paragraph 4 – Part 4 – paragraph 1
Agitation or mixing devices shall ensure a proper recirculation in order to achieve an even concentration of the whole volume of the liquid spray mixture in the tank.
Amendment 2893 #
2022/0196(COD)
Proposal for a regulation
Annex IV – paragraph 4 – Part 6 – paragraph 1
Annex IV – paragraph 4 – Part 6 – paragraph 1
All devices for measuring, switching on and off and adjusting pressure or flow rate shall be properly calibrated and work correctly. The controls to be operated during the application operation shall be operable from the operator’s position, the necessary instruments to control the operation shall be present and accurate and the instrument displays shall be readable from the operator’s position. For equipment to apply liquid products, pressure adjustment devices shall maintain a constant working pressure at constant revolutions of the pump, in order to ensure that a stable volume application rate is applied. Additional equipment to dose or inject plant protection products shall function accurately and correctly.
Amendment 753 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – introductory part
Article 5 – paragraph 1 – subparagraph 1 – introductory part
Where data is processregistered in electronic format, Member States shall implement access to and exchange of personal electronic health data for primary use fully or partially falling under the following categories:
Amendment 769 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 819 #
2022/0140(COD)
Proposal for a regulation
Article 8
Article 8
Amendment 927 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 7
Article 12 – paragraph 7
7. The national contact points for digital health shall act as joint controllers of the electronic health data communicated through ‘MyHealth@EU’ for the processing operations in which they are involved. The Commission shall act as processor, with the limitation to the central platform MyHealth@EU to provide services supporting and facilitating the electronic exchange of health data between national digital health contact points.
Amendment 933 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 9
Article 12 – paragraph 9
9. The approval for individual authorised participants to join MyHealth@EU for different services, or to disconnect a participant shall be issued by the Joint Controllership groupEHDS board, based on the results of the compliance checks performed by the Commission .
Amendment 952 #
2022/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter and following the transitional periods laid down in Article 72.
Amendment 1164 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
Amendment 1201 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 1215 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 a (new)
Article 33 – paragraph 1 a (new)
1 a. This Regulation shall not apply to activities concerning public security, defence and national security.
Amendment 1420 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
This Regulation shall not apply to activities concerning public security, defence and national security.
Amendment 1637 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. Where the data in question are not held by the health data access body or a public sector body, the fees may also include compensation for part of the costs for collecting the electronic health data specifically under this Regulation in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the health data holder’s costs shall be paid to the health data holder and shall also reflect market value of the data in question.
Amendment 1684 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission may, without undue delay, shall issues guidelines on penalties to be applied by the health data access bodies.
Amendment 1695 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 1 a (new)
Article 44 – paragraph 1 a (new)
1 a. Data anonymisation shall be carried out as much as possible by health data holders, following a common methodology, ensuring that the process is reduced at the level of health data access bodies.
Amendment 1696 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
Amendment 1965 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 14
Article 52 – paragraph 14
14. The approval for individual authorised participant to join HealthData@EU orSubject to a positive outcome of this compliance check, the Commission shall, by means of implementing acts, take decisions to disconnect a participant from the infrastructure shall be issued by the Joint Controllership group, based on the results of the compliance checksindividual authorised participants to join the respective infrastructure or to disconnect them. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68.
Amendment 2112 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
It shall apply from 124 months after its entry into force.
Amendment 2116 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 3 – point a
Article 72 – paragraph 3 – point a
(a) from 13 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data.;
Amendment 2118 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 3 – point b
Article 72 – paragraph 3 – point b
(b) from 35 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;
Amendment 2123 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 35 years after date of entry into application.
Amendment 2124 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 4 a (new)
Article 72 – paragraph 4 a (new)
Chapter IV shall apply 4 years after the date of entry into force of this Regulation.
Amendment 28 #
2022/0092(COD)
Proposal for a directive
Recital 1
Recital 1
(1) In order to tackle unfair commercial practices which prevent consumers from making sustainable consumption choices, such as practices associated with the early obsolescence of goods, hindering or preventing their servicing, misleading environmental claims (“greenwashing”), non-transparent and non-credible sustainability labels or sustainability information tools, specific rules should be introduced in Union consumer law. This would enable national competent bodies to address those practices effectively. By ensuring that environmental claims are fair, consumers will be able to choose products that are genuinely better for the environment than competing products. TOn the other hand, a transparent and coherent EU-wide consumer information system on the expected durability of purchased goods and their reparability, especially for electronic equipment, will not only help to protect the environment through reduced use of appliances but will also bring real savings for households. In addition, this will encourage competition towards more environmentally sustainable products, thus reducing negative impact on the environment.
Amendment 49 #
2022/0092(COD)
Proposal for a directive
Recital 7
Recital 7
(7) The displaying of sustainability labels which are not based on a certification scheme or not established by public authorities should be prohibited by including such practices in the list in Annex I to Directive 2005/29/EC. The certification scheme should fulfil minimumadequate transparency and credibility conditions. The displaying of sustainability labels remains possible without a certification scheme where such labels are established by a public authority, or in case of additional forms of expression and presentation of food in accordance with Article 35 of Regulation (EU) No 1169/2011. This rule complements point 4 of Annex I to Directive 2005/29/EC which prohibits claiming that a trader, the commercial practices of a trader, or a product has been approved, endorsed or authorised by a public or private body when it has not, or making such a claim without complying with the terms of the approval, endorsement or authorisation.
Amendment 64 #
2022/0092(COD)
Proposal for a directive
Recital 14
Recital 14
(14) In order to improve the welfare of consumers, the amendments to Annex I to Directive 2005/29/EC should also address several practices associated with early obsolescence, including planned obsolescence practices, understood as a commercial policy involving deliberately planning or designing a product with a limited useful life so that it prematurely becomes obsolete or non-functional after a certain period of time. Purchasing products that are expected to last longer than they actually do causes consumer detriment. Furthermore, early obsolescence practices have an overall negative impact on the environment in the form of increased material waste. Therefore, addressing those practices aretackling such abuse is also likely to reduce the amount of waste, contributing to a more sustainable consumption. The practices of planned obsolescence and planned failure of products should be prohibited.
Amendment 73 #
2022/0092(COD)
Proposal for a directive
Recital 16
Recital 16
(16) It should also be prohibited to omit to inform the consumer about the existence of a feature of the good introduced to limit its durabilityplan equipment failure or intentionally equip a good with functions that specifically limit its useful life. For example, such a feature could be software which stops or downgrades the functionality of the good after a particular period of time, or it could be a piece of hardware which is designed to fail after a particular period of time. TheSuch prohibition of omitting to inform consumers of such features of the goods complements and does not affect the remedies available to consumers when they constitute a lack of conformity under Directive (EU) 2019/771 of the European Parliament and of the Council26 . For such a commercial practice to be considered unfair, it should not be necessary to demonstrate that the purpose of the featureunction is to stimulate the replacement of the respective good. The use of features limiting the durability of the goods should be distinguished from manufacturing practices using materials or processes of general low quality resulting in limited durability of the goods. Lack of conformity of a good resulting from the use of low quality materials or processes should continue to be governed by the rules on the conformity of goods set out in Directive (EU) 2019/771. __________________ 26 Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28).
Amendment 79 #
2022/0092(COD)
Proposal for a directive
Recital 22
Recital 22
(22) In order for consumers to take better informed decisions and stimulate the demand for, and the supply of, more durable goods, specific information about a product’s durability and reparability should be provided for all types of goods before concluding the contract. Moreover, as regards goods with digital elements, digital content and digital services, consumers should be informed about the period of time during which free software updates are available. Therefore, Directive 2011/83/EU of the European Parliament and of the Council27 should be amended to provide consumers with pre-contractual information about durability, reparability and the availability of updates. Information should be provided to consumers in a clear and comprehensible manner and in line with the accessibility requirements of Directive 2019/88228. The obligation to provide this information to consumers complements and does not affect the rights of consumers provided in Directives (EU) 2019/77029 and (EU) 2019/77130 of the European Parliament and of the Council. Information on the durability and reparability of a product for all types of goods should be provided in a way that is easily accessible to and understandable for consumers, in the official EU language or languages of the Member State in whose territory the good is placed on the market and put into service. __________________ 27 Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). 28 Directive 2019/882/EU 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). 29 Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, p. 1). 30 Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28).
Amendment 86 #
2022/0092(COD)
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) Another observed commercial practice which should be classified as unfair in all circumstances is where the manufacturer applies different warranty and repair conditions for the same product model depending on the Member State in which the product is to be placed on the market; for example, for the same washing machine model a manufacturer offers a five-year warranty in one Member State and only three years in another, which creates discrimination and double standards in the treatment of consumers in the target markets; without prejudice to the provisions of Article 17 of Directive 2019/771, such practices should be prohibited;
Amendment 114 #
2022/0092(COD)
Proposal for a directive
Recital 33 a (new)
Recital 33 a (new)
(33a) The new requirements for compliance with the directives will place a certain burden on national authorities and the SME sector; the European Commission should therefore monitor to ensure that the transposition of the amended directives does not create excessive administrative burdens and that these operators benefit as predicted from a clearer legal framework, fair market practices and the expected elimination of barriers to cross-border trade;
Amendment 118 #
2022/0092(COD)
Proposal for a directive
Recital 35
Recital 35
(35) Since the objectives of this Directive, namely, enabling better informed transactional decisions by consumers to promote sustainable consumption, eliminating practices that cause damage to the sustainable economy and mislead consumers away from sustainable consumption choices, and ensuring a better and consistent application of the Union consumer legal framework, cannot be sufficiently achieved by the Member States individually but can rather, by reason of the Union-wide character of the problem, including persistent non- tariff barriers to cross-border trade caused by unilateral measures put in place by individual EU countries, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve those objectives.
Amendment 242 #
2022/0092(COD)
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
By [5 years from adoption], the Commission shall submit a report on the application of this Directive to the European Parliament and to the Council. The report shall analyse in detail the impact of the new rules on the elimination of existing non-tariff barriers to cross- border trade, on the effectiveness of action by national consumer protection authorities and on the level of adjustment burden in the SME sector.
Amendment 282 #
2022/0092(COD)
Proposal for a directive
Annex I – paragraph 1 – point 4
Annex I – paragraph 1 – point 4
Directive 2005/29/EC
Annex I – point 23 e
Annex I – point 23 e
23e. Omitting to inform the consumer about the existence of a feature of a good introducedPlanning the failure of a good by equipping it with functions or properties intended solely to limit its durability.
Amendment 299 #
2022/0092(COD)
Proposal for a directive
Annex I – paragraph 1 – point 4
Annex I – paragraph 1 – point 4
Directive 2005/29/EC
Annex I – point 23 i
Annex I – point 23 i
23i. Omitting to inform thaPlacing on the market a good that is designed to limit its functionality when using consumables, spare parts or accessories that are not provided by the original producer.
Amendment 302 #
2022/0092(COD)
Proposal for a directive
Annex I – paragraph 1 – point 4
Annex I – paragraph 1 – point 4
Directive 2005/29
Annex I – point 23 i a (new)
Annex I – point 23 i a (new)
23ia. Without prejudice to the provisions of Article 17 of Directive 2019/771, the offering by the same manufacturer of different warranty and repair conditions for the same product model in different EU Member States in whose territory the good is placed on the market and put into service;
Amendment 33 #
2021/2013(INI)
Motion for a resolution
Recital A
Recital A
A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU Member States’ national health policies; whereas safe, effective and affordable medicines are needed to combat all diseases; whereas patientsublic interest and patient safety and well-being should be at the centre of all health policies, alongside investment and research;
Amendment 316 #
2021/2013(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Highlights that the take-up of new and innovative treatments, as well as their successful delivery to patients, depends on the knowledge, preparedness of and technical base at the disposal of medical personnel; calls on the Commission and on Member States to further cooperate through sharing knowledge and best practices regarding emerging innovative medicines and treatments, to better prepare their medical professionals;
Amendment 349 #
2021/2013(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needsmedicines during health crises, as well as unmet therapeutic needs, while taking into account the need for a better balance between public and private interests, including clear rules on liability for manufacturers, as well as the need for sufficient flexibility for Member States, as well as respect for the principle of subsidiarity, due to national specificities or divergent financial capacities across the EU;
Amendment 504 #
2021/2013(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level in all EU Member States, facilitating geographical balance, talent retention and employment opportunities across the whole EU;
Amendment 555 #
2021/2013(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work in close cooperation with the EMA to consider extending the application of rolling reviews to other emergency medicines, while safeguarding high level of safety, quality and effectiveness; further calls on the Commission to work with the EMA to developfurther accelerate the use of electronic product information for all medicines in the EU;
Amendment 560 #
2021/2013(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Welcomes the Commission’s acknowledgement of the difficulties faced by SMEs during the regulatory approval, licensing and product launch processes; highlights that the heavy administrative burden may hinder SMEs’ ability to develop and bring to patients innovative medical products, including for unmet medical needs and rare diseases; reiterates that the administrative burden often forces SMEs into buyouts by larger pharmaceutical companies or into leaving the EU altogether; calls on the Commission and Member States to take SMEs under special consideration when ensuring a level playing field in the process for simplifying and streamlining procedures, due to the fact that, unlike large pharmaceutical companies, SMEs cannot easily absorb administrative costs; calls on the Commission to bring up to date the capabilities of EMA for providing information and assistance to SMEs during the authorisation process; calls on the Member States to establish One-Stop- Shop contact points for SMEs, providing all necessary information, as well as expert help and assistance, to facilitate compliance with national standards and procedures;
Amendment 621 #
2021/2013(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conduct a structured dialogue with playerelevant actors in the pharmaceutical value chain, public authorities, non- governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain;
Amendment 649 #
2021/2013(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Insists that the quality of raw material imports for the pharmaceutical industry from outside the EU must be ensured at all times; calls on the Commission and on Member States to improve quality control and introduce penalties for repeat offenders;
Amendment 707 #
2021/2013(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a robust and clear regulatory framework facilitating trade agreements that prize innovation- based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;
Amendment 52 #
2021/0277(BUD)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Considers that sufficient resources should be secured in the 2022 EU budget for the implementation of the Health Union proposals, as amended during the legislative process; calls, therefore, on the Commission to revise the Financial Statements for the extended mandates of the European Medicines Agency and the European Centre for Disease Prevention and Control to take into account the additional tasks set out in the revised proposals.
Amendment 53 #
2021/0277(BUD)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Emphasises, furthermore, that appropriate resources should be secured in the 2022 EU budget for the implementation of the Health Union proposals, as amended during the legislative process; calls, therefore, on the Commission to revise the Financial Statements for the extended mandates of the European Medicines Agency and the European Centre for Disease Prevention and Control to take into account the additional tasks set out in the revised proposals;
Amendment 76 #
2021/0106(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3 a) AI can serve in climate change mitigation for example through the European Union's Earth observation programme Copernicus that has the potential to be the programme needed to acquire accurate scientific information that secures science-based decision- making and implementation of the Union’s climate, biodiversity and other environmental policies.
Amendment 79 #
2021/0106(COD)
Proposal for a regulation
Recital 3 b (new)
Recital 3 b (new)
(3 b) The United Kingdom's withdrawal from the European Union has caused a significant funding gap to the aforementioned Copernicus programme, which endangers the whole future of Copernicus and which needs to be acutely solved by guaranteeing sufficient funds as well as data processing support so that advanced and automatized technology and AI based monitoring and analysing of all central environmental indicators will be guaranteed in the future.
Amendment 108 #
2021/0106(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) AI systems could produce adverse outcomes to health and safety of persons, in particular when such systems operate as components of products. Consistently with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate. Digital health should not dehumanise care nor diminish the doctor-patient relationship, but should provide doctors with assistance in diagnosing and/or treating patients more effectively, all the while keeping in mind the necessary human oversight and abiding by relevant data protection rules. The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high-risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, and non- discrimination, consumer protection, workers’ rights, rights of persons with disabilities, right to an effective remedy and to a fair trial, right of defence and the presumption of innocence, right to good administration. In addition to those rights, it is important to highlight that children have specific rights as enshrined in Article 24 of the EU Charter and in the United Nations Convention on the Rights of the Child (further elaborated in the UNCRC General Comment No. 25 as regards the digital environment), both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons.
Amendment 115 #
2021/0106(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) AI systems used in education or vocational training, notably for determining access or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education should be considered high-risk, since they may determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. It requires appropriate training and preparation for health and administrative personnel to prevent a digital divide, specifically bearing in mind our ageing societies and potential challenges to healthcare systems in the post-pandemic world. When improperly designed and used, such systems may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination.
Amendment 120 #
2021/0106(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, rule of law, individual freedoms as well as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and opacity, as well as related serious ethical concerns regarding machine autonomy and decision-making, it is appropriate to qualify as high-risk AI systems intended to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. Such qualification should not extend, however, to AI systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks or allocation of resources.
Amendment 122 #
2021/0106(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) To mitigate the risks from high-risk AI systems placed or otherwise put into service on the Union market for users and affected persons, certain mandatory requirements should apply, taking into account the intended purpose of the use of the system and according to the risk management system to be established by the provider and the digital services should not dehumanise care nor diminish any human relationship, but should provide assistance in a more effective way.
Amendment 124 #
2021/0106(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) Requirements should apply to high- risk AI systems as regards the quality of data sets used, technical documentation and record-keeping, transparency and the provision of information to users, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health (threatening patient preference, and privacy), safety and fundamental rights, as applicable in the light of the intended purpose of the system, and no other less trade restrictive measures are reasonably available, thus avoiding unjustified restrictions to trade.
Amendment 137 #
2021/0106(COD)
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
(48 a) The recommendations regarding human oversight from the Opinion of the Committee on the Environment, Public Health and Food Safety for the Committee on Legal Affairs with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies (2020/2012(INL)) are to complement this Regulation.
Amendment 200 #
2021/0106(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the high-risk AI system in question and, where applicable, the authorised representative and importers accordingly. The need for a regulatory framework stipulating the ethical principles to be applied to the design, development, implementation and functioning of all this technology - from data access to strict outcome monitoring.
Amendment 259 #
2021/0106(COD)
Proposal for a regulation
Annex III – paragraph 1 – point 5 – point a
Annex III – paragraph 1 – point 5 – point a
(a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for public assistance benefits and services, including healthcare service and health literacy as well as to grant, reduce, revoke, or reclaim such benefits and services;
Amendment 9 #
2020/2209(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas there are approximately 87 million persons with disabilities in Europe1a; _________________ 1aCommissioner Dalli on Rights of Persons with Disabilities https://ec.europa.eu/commission/presscor ner/detail/en/SPEECH_21_1015
Amendment 11 #
2020/2209(INI)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas nearly one in four EU citizens surveyed reported some degree of functional limitations due to health conditions1b; _________________ 1bhttps://ec.europa.eu/eurostat/statistics- explained/index.php?title=Functional_an d_activity_limitations_statistics
Amendment 30 #
2020/2209(INI)
Draft opinion
Recital C
Recital C
C. whereas it is generally acknowledged that persons with disabilities continue to face multiple obstacles and discrimination in everyday life and that they do not enjoy the fundamental freedoms and rights laid down in numerous EU and UN documents, such as mutual recognition of disability status between Member States, access to public transport, accessibility of the builtphysical1c environment, use of sign languages, financing of and equal access to education and vocational training, access to personal assistance and community inclusion; _________________ 1c https://www.un.org/development/desa/disa bilities/convention-on-the-rights-of- persons-with-disabilities/article-9- accessibility.html
Amendment 38 #
2020/2209(INI)
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. whereas the average gap between the employment rates of persons with and without disabilities in the EU is 25%1d; _________________ 1dCOM(2019)653/F1 - PL (europa.eu), p.89
Amendment 51 #
2020/2209(INI)
Da. whereas, due to the difficult situation during the COVID-19 crisis, institutions for persons with disabilities and older people, such as day centres or schools have been temporarily closed; whereas in this emergency situation the care of persons with intellectual disabilities has fallen to their family members; whereas petitioners have appealed to the Committee on Petitions regarding the institutions that have remained open, pointing to the difficult health situation, the lack of staff, the lack of protective and disinfectant products and, as a consequence, the high rates of illness and death in these institutions;
Amendment 57 #
2020/2209(INI)
Draft opinion
Recital D b (new)
Recital D b (new)
Db. whereas the catalogue of allowances and rights deriving from disability status varies from one Member State to another, as do the entities which define and recognise these rights;
Amendment 69 #
2020/2209(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that Member States should step up their efforts in providing support for persons with disabilities in the following priority areas: health, education, accessibility, employment and working conditions, independent living, coordination, living conditions, social protection and raising awareness;
Amendment 103 #
2020/2209(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission and the Member States to harmonise the definition of disability andMember States to ensure mutual recognition of disability status across Member States based on the Convention definition of disability, so as to ensure the free movement of persons with disabilities and their enjoyment of their EU citizenship rights;
Amendment 164 #
2020/2209(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses that persons with disabilities should be guaranteed access to health care and education, including during crises such as the COVID-19 pandemic, and Member States should tackle all forms of discrimination and exclusion in this area;
Amendment 7 #
2020/2081(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
— having regard to a joint statement on Belarus of EPP, S&D, Renew Europe, Greens/EFA and ECR groups in the European Parliament of 17 August 2020,
Amendment 29 #
2020/2081(INI)
Motion for a resolution
Recital A
Recital A
A. whereas despite the fundamental restrictions on basic freedoms and human rights that remain in Belarus, the EU policy of critical engagement with Belarus has produced some results in the form of signed agreements and increased cooperation; whereas future relations between the EU and Belarus will be defined in the Partnership Priorities to be agreed by both sideEU and new legitimate, democratically elected authorities in Belarus;
Amendment 32 #
2020/2081(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the people of Belarus share common European heritage and culture, while directly neighbouring three EU Member States; whereas situation in Belarus may have direct impact on the EU;
Amendment 45 #
2020/2081(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the OSCE ODIHR International Election Observation Mission noted an overallnone of either the parliamentary or presidential elections held in Belarus from 1994 to date have been free and fair, but despite these harsh undemocratic conditions the people of Belarus clearly voted for a change, after more than two decades of oppression; whereas recent presidential elections were neither free nor fair and even more than the previous ones were marred with disregard for the fundamental freedoms of assembly, association and expression during the 2019 parliamentary elections, whichand took place after a limited amount of campaigning and within an extremely restrictive environment that did not provide for a meaningful or competitive political contest overall;
Amendment 52 #
2020/2081(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the 2020 presidential elections have thus far followed the same pattern as the parliamentary electionssimilar pattern as previous elections; whereas after publication of falsified results, Belarusian people immediately organised peaceful protests, which were suppressed by brutal force, which resulted in thousands of protestors being arrested, tortured, wounded, and some even killed; whereas the United Nations human rights investigators alarmed on 01/09 that they had received reports of hundreds of cases of torture, beatings and mistreatment of anti-government protesters by police in Belarus and urged the authorities to stop any such abuse;
Amendment 88 #
2020/2081(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas human rights and democracy in Belarus have been deliberately and brutally restricted by the Belarusian authorities over the past decades, while representatives of the opposition, civil society and media in the country have been regularly arrested or otherwise persecuted;
Amendment 94 #
2020/2081(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas the Belarusian regime seeks to intimidate and to disperse the Coordination Council of Belarus by targeting its members and launching a criminal case against them;
Amendment 96 #
2020/2081(INI)
Motion for a resolution
Recital E d (new)
Recital E d (new)
Ed. whereas Belsat TV channel, which is officially registered in Poland, so far has not been registered in Belarus, while its activities are under constant pressure and attacks, including brutal detentions of its journalists and fines imposed to its contributors amounting to USD 101,791 as of 18 June 2020;
Amendment 109 #
2020/2081(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas 26 years in power or Lukashenka had been marked by policies of undermining sovereignty and independence of the country and weakening of Belarusian identity, heritage and culture;
Amendment 162 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point a
Paragraph 1 – point a
(a) acknowledge territorial integrity of Belarus and support the sovereignty of Belarus against pressure from the Russian Federation for deeper integration and remind Belarus that the European Union is open to further development of relations with the country both bilaterally and within the Eastern Partnership framework if Belarus meets conditions linked to democracy, the rule of law, international law, human rights and fundamental freedoms;
Amendment 165 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point a a (new)
Paragraph 1 – point a a (new)
Amendment 221 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point e
Paragraph 1 – point e
(e) pay close attention to the presidential election campaign and insist that a lack of progress in conducting elections according to international standards and further crackdowns against the opposition will have direct adverse effects on relations wicall for holding new and transparent Presidential and Parliamentary elections in Belarus that would meet the democratic standards and call on the EU, OSCE, CoE to engage in dialogue with the Belarusian civil society with a view to launch a new electoral process, under the supervision of a new Electoral Commission, a body that can be trusted by all the parties including international observers, under the the EUight international scrutiny;
Amendment 226 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point e a (new)
Paragraph 1 – point e a (new)
(ea) deny recognition of the results of the elections held in Belarus on 9 August 2020 and Alexander Lukashenko as a legitimate leader President of Belarus; accordingly, call on him to respect the decision of the people of Belarus and peacefully step down;
Amendment 231 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point e b (new)
Paragraph 1 – point e b (new)
(eb) applaud the Belarusian people for their courage and determination and to strongly support their desire for democratic change and freedom and basing their country’s future on principles of democracy, rule of law and human rights, so as to ensure freedom, independence, sovereignty and prosperity of the Republic of Belarus;
Amendment 233 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point e c (new)
Paragraph 1 – point e c (new)
Amendment 236 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point e d (new)
Paragraph 1 – point e d (new)
(ed) deplore persecution of the members of the opposition Coordination Council and call the authorities to enter into the dialogue with the protestors in order to end the violence and repressions and prepare a new elections;
Amendment 248 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point f a (new)
Paragraph 1 – point f a (new)
(fa) condemn efforts of the Belarusian regime to deny entrance to the country for Belarusians critical towards it, as well as independent journalists, human rights workers, as well as representatives of international community, including Members of the European Parliament;
Amendment 254 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point g a (new)
Paragraph 1 – point g a (new)
Amendment 264 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point g b (new)
Paragraph 1 – point g b (new)
(gb) uphold the decision of EU’s foreign affairs ministers and the European Council to blacklist those responsible for violence and fake presidential elections and impose individual sanctions against Belarusian officials who are liable for or have contributed to the falsification of the results of the presidential elections in Belarus and are responsible or have contributed to violations of civil and human rights; this list should be constantly updated and extended according to the level of crimes committed by Lukashenko regime;
Amendment 270 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point g c (new)
Paragraph 1 – point g c (new)
(gc) note that China's president was the first to congratulate Lukashenka after the elections; to express concerns over increasing Chinese investments in strategic infrastructure and warn about the effect of dependency it might create for Belarus;
Amendment 289 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point i
Paragraph 1 – point i
(i) condemn the ongoing intimidation and persecution of opposition figures, including presidential hopefuls, civil society activists and independent journalists; strongly condemn the suppression of internet and media, road blockades, and intimidation of journalists in order to stop the flow of information about the situation in the country as well as denial of access to Belarus for international media, members of parliament or government of democratic community;
Amendment 300 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point i b (new)
Paragraph 1 – point i b (new)
(ib) welcome numerous acts of solidarity with the people of Belarus, including fundraising, charity and humanitarian assistance; in this regard condemn stopping of humanitarian aid transport organised by "NSZZ Solidarnosc";
Amendment 304 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point j a (new)
Paragraph 1 – point j a (new)
(ja) approve the European universal human rights sanctions (European Magnitsky Act) as a regime providing, at the EU level, for restrictive measures, including entry bans and freezing of funds, against individuals liable for violations of human rights and freedoms and responsible for other crimes;
Amendment 325 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point l a (new)
Paragraph 1 – point l a (new)
Amendment 362 #
2020/2081(INI)
Motion for a resolution
Paragraph 1 – point o b (new)
Paragraph 1 – point o b (new)
(ob) work together with the European Commission in order to develop a comprehensive programme for Belarus after the new presidential elections are held, which would allow Belarus to transition towards a free market economy and an open democratic state;
Amendment 6 #
2020/2071(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to the Regulation 2020/561 amending Regulation 2017/745 on medical devices, as regards the dates of application of certain of its provisions,
Amendment 17 #
2020/2071(INI)
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regard to the Court's Judgments C-468/06-C-478/06 of 16 September 2008,
Amendment 30 #
2020/2071(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand within the pharmaceutical supply chain, which has been exacerbated by the COVID-19 pandemic, has aggravated shortages of medicines in the EU, which has serious consequences, undermining health services in the Member States and exposing patients to considerable risks; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 34 #
2020/2071(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the causes underlying medicine shortages are complex and multi-factorial, and include manufacturing challenges, industry quotas, legal parallel trade, as well as economic elements, such as the pricing of medicinal products, which is a competence of the Member States;
Amendment 101 #
2020/2071(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the EU-based manufacturers of generics have an important role to play in satisfying the growth in the demand for affordable medicines in the Member States;
Amendment 119 #
2020/2071(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the relocation of production to sites outside the EU to maximise profits combined with excessive reliance on individual drugs for certain health conditions and insufficient incentives to invest in new innovative medicines might have contributed to rise and spread of antimicrobial resistance;
Amendment 126 #
2020/2071(INI)
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicals that are cheap and easy to produce and mature medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in-time basis which can leave manufacturers vulnerable to supply shocks where there are unanticipated production and supply chain interruptions, and market demand fluctuations;
Amendment 140 #
2020/2071(INI)
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements todifferential pricing between Member States facilitates ‘parallel exports’ to countries where the medicine in question is more expensive;
Amendment 151 #
2020/2071(INI)
Motion for a resolution
Recital G
Recital G
G. whereas, in the absshortage of medicine supplies, experienced of a regulatory authority,r anticipated, can lead to inappropriate stockpiling in some Member States is leadingand therefore to a market imbalance;
Amendment 167 #
2020/2071(INI)
Motion for a resolution
Recital H
Recital H
Amendment 179 #
2020/2071(INI)
Motion for a resolution
Recital J
Recital J
J. whereas there is an increasing correlation between the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are facilitating, and the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens; whereas further research is needed to establish a clear causal link;
Amendment 202 #
2020/2071(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secensure itsthe supply of affordable medicines and medical equipment;
Amendment 218 #
2020/2071(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate and complement, complement and encourage cooperation among national measures to guarantee affordable and high-quality health services for European citizens, prevent and manage diseases, mitigate sources of danger to human health, and promote investment in research;
Amendment 280 #
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 out potential production sites in the EU;Member States to map out, in cooperation with the Commission, potential production sites in the EU; underlines that this analysis should only be used for advisory purposes.
Amendment 306 #
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’s well as industry’s dependencey on third countries for manufacturing capacity, the supply of active pharmaceutical ingredients (APIs) and starting materials;
Amendment 398 #
2020/2071(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that procurement procedures with only one successful tenderer may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to introduce procurement procedures under which contracts may be awarded to a number of successful tenderers, including joint tenderers, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality treatment for patients;
Amendment 429 #
2020/2071(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or moreonsider establishing European non-profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health care; underlines the necessity of increased diversification at the European level by establishing several new manufacturing businesses to satisfy the EU’s high demand, where every product should have at least two alternative sources of production; 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;
Amendment 527 #
2020/2071(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatment; emphasises that any attempt at price harmonisation must be adjusted for purchasing power parity in all Member States;
Amendment 546 #
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, albased ong the lines of the ‘RescEU’ mechanismMember States’ reserves of strategic medicines, in order to alleviate shortages outside crisis periods;
Amendment 565 #
2020/2071(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European regulatory authority to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to the Member Staton the Commission to accompany the joint definition with rules on the distribution of these strategic reserves;
Amendment 586 #
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 authorhave increased resources and responsibilities to help Member States, working in conjunction wityh tasked withhe European Centre for Disease Prevention and Control, better preventing shortages of essential medicines, with a correspondingly wider rlife-saving medicines and commonly used drugs in light of possible future epidemitcs and more staffpandemics;
Amendment 642 #
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 intensify market surveillance and to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;ensuring a well-designed supply chain from the manufacturer, to the wholesaler to the healthcare entity.
Amendment 715 #
2020/2071(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, extension of validity of Good Manufacturing Practices certificates, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission, the EMA and national regulatory authorities to monitor strictly the use of these arrangements, ensure that patient safety is not compromised and to keep them available in the event of problems or shortages; welcomes in this regard also the extension of the date of application of the Medical Devices Regulation.
Amendment 733 #
2020/2071(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Takes the view that the introduction of stress tests to assess the resilience of health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and of identifyingform the basis of an early warning system that identifies the structural risk factors which go to create shortages;
Amendment 10 #
2020/2012(INL)
Draft opinion
Recital B
Recital B
B. Wwhereas the artificial intelligence (AI) global leadership race, which will determine the source of ethical values and standards shaping the sector worldwide, is picking up the pace is picking up the pace but should not be separated from ethical values and standards;
Amendment 13 #
2020/2012(INL)
Draft opinion
Recital B a (new)
Recital B a (new)
Amendment 33 #
2020/2012(INL)
Draft opinion
Recital D b (new)
Recital D b (new)
Db. whereas there are serious ethical concerns about the autonomy of machines and their influence on the doctor-patient relationship;
Amendment 35 #
2020/2012(INL)
Draft opinion
Recital D a (new)
Recital D a (new)
Da. whereas AI will play an increasingly significant role, bearing in mind our ageing societies and possible shortages of healthcare professionals;
Amendment 43 #
2020/2012(INL)
Draft opinion
Recital E a (new)
Recital E a (new)
Ea. Whereas solutions which stress the need to include scientific research as the basis for development strategies by creating repositories of medical data (e.g. neurological and cardiological data) and sharing data from this research can produce tangible social benefits in the context of public safety and health;
Amendment 59 #
2020/2012(INL)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that the Union must undertake all necessary steps to guarantee that its ethical values, as expressed in the acquis, apply effectively to all AI areas within its territory and to promote its standards worldwide; emphasises in this regard that technological developments in AI must always be to the benefit of humankind;
Amendment 77 #
2020/2012(INL)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points out that the safety standards laid down in the Medical Devices Regulation may not be sufficient for the challenges of the mass employment of artificial intelligence systems; calls on the Commission to monitor the challenges in this field and to put forward proposals where necessary;
Amendment 103 #
2020/2012(INL)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Warns against attempts to give machines some kind of 'personality' which might result in the removal of human liability in the event of treatment errors;
Amendment 104 #
2020/2012(INL)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Calls on the Commission to initiate an open, transparent sectoral dialogue giving priority to health care in order to then present an action plan to facilitate the development, testing and introduction of AI in research and innovation and the wide application of these in public health services;
Amendment 111 #
2020/2012(INL)
Draft opinion
Paragraph 5
Paragraph 5
5. Strongly supports the Commission in establishing a minimal common Union AI ethical framework to counter the shortcomings caused by AI internal market fragmentation, including environmental, healthcare, and food safety applications, and to prevent AI double standards across Member States for AI developed in Union and beyond, inter alia in areas such as consumer data management, protection and privacy in smart grids, waste management, equal access to services, patient-doctor relationship standards, data protection and privacy, civil liability in AI-assisted public healthcare, civil liability regarding autonomous vehicles or machinery;
Amendment 133 #
2020/2012(INL)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Member States to align medical education and training programmes to developments in AI, as well as an awareness of the ethical challenges associated with the application of AI;
Amendment 108 #
2020/0322(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness and response to all cross- border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, as set out in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators, and cooperation by Member States with the European Centre for Disease Prevention and Control (ECDC). Moreover, in order to ensure effective Union response to novel cross- border threats to health, the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies while respecting the data protection rules.
Amendment 122 #
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, 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. These mechanisms should look for synergies between measures taken at the EU and national levels, as well as try to avoid duplications with measures undertaken in the context with the WHO framework. 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 145 #
2020/0322(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR)15 . In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits inevaluations of Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. _________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 156 #
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, joint procurement of medical countermeasures should 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 to strengthen the negotiating position of the Member States and allow for preferable purchasing conditions concerning the quantity, availability or price of a procured medical countermeasure. 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 . _________________ 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 161 #
2020/0322(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Since one of the primary responsibility of the Member States is to ensure the protection of their citizens, additional flexibility is needed when it comes to being able to adjust contractual provisions after the initial contract has been established, in order to increase, decrease or cancel the order for the medical counter measures, taking into account significant changes in circumstances which may occur. In order to protect the contractors directly engaged in activities that serve Union policies, such contractual adjustments should be duly justified by the national authorities participating in the joint procurement procedure, by explaining the seriousness or urgency of the circumstances in question and such adjustments should be enforced in close cooperation with contracted partners and taking due account of the commitments made up to date of contractual adjustment.
Amendment 177 #
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 or major non-communicable diseases.
Amendment 222 #
2020/0322(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b – point ii
Article 1 – paragraph 1 – point b – point ii
(ii) reporting and auditingevaluation on preparedness;
Amendment 238 #
2020/0322(COD)
Proposal for a regulation
Article 2 – paragraph 4
Article 2 – paragraph 4
4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to in Article 2(1), especially in relation to major non-communicable diseases, if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health.
Amendment 239 #
2020/0322(COD)
Proposal for a regulation
Article 2 – paragraph 5
Article 2 – paragraph 5
5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at international level, Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross- border threats to health.
Amendment 247 #
2020/0322(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental, climate or unknown origin which spreads or entails a significant risk of coming from third countries to the territories of Member States and/or spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 250 #
2020/0322(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Article 3 – paragraph 1 – point 7 a (new)
(7 a) ‘major non-communicable disease’ means a disease as defined in point (4a) of Article 2 of Regulation (EU) [ECDC regulation, correct reference to be inserted];
Amendment 264 #
2020/0322(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 (new)
Article 4 – paragraph 2 – subparagraph 1 (new)
The relevant Union agencies shall be involved in fulfilling the tasks of the HSC.
Amendment 268 #
2020/0322(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The HSC shall be chaired by a representative of the Commission without the right to vote. The HSC shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State.
Amendment 284 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Commission, in cooperation with Member States and the relevant Union agencies and taking into account the WHO framework, shall establish a Union health crisis and pandemic plan (‘the Union preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level.
Amendment 325 #
2020/0322(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When preparing national preparedness and response plans each Member State shall coordinate with the Commission in order to reach synergies and consistency withof the Union preparedness and response plan, and national plans and shall also inform without delay the Commission and the HSC of any substantial revision of the national plan.
Amendment 344 #
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 and, if appropriate, regional policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery; coordination mechanisms;
Amendment 356 #
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 services during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 373 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2 a (new)
Article 7 – paragraph 1 – subparagraph 2 a (new)
The report shall also include, as far as feasible, information on major non- communicable diseases as referred to in Article 2 - paragraph 1 - point 4a (new) [ECDC regulation, correct reference to be inserted], in particular those whose developments and treatments are impacted significantly by pandemics, such as cancer, diabetes or mental illness
Amendment 380 #
2020/0322(COD)
Proposal for a regulation
Article 8 – title
Article 8 – title
Amendment 382 #
2020/0322(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Every 3 years, the ECDC shall conduct auditevaluations in the Member States aimed at ascertaining the state of implementation of the national plans and their coherence withsynergies and consistency between them and the Union plan. Such auditevaluations shall be implemenconducted with the relevant Union agencies, aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in Article 7(1).
Amendment 389 #
2020/0322(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point c
Article 8 – paragraph 2 – subparagraph 1 – point c
(c) overview reports of audits series, which present cases of good practice.
Amendment 390 #
2020/0322(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 a (new)
Article 8 – paragraph 2 – subparagraph 1 a (new)
If a Member States decides not to follow the recommendation, it shall state reasons for doing so.
Amendment 393 #
2020/0322(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. On the basis of the information provided by the Member States in accordance with Article 7, and of the results of the auditevaluations referred to in Article 8, the Commission shall by July 2022 and every 2 years afterwards, transmit to the European Parliament and to the Council a report on the state of play and progress on preparedness and response planning at Union level and national levels.
Amendment 404 #
2020/0322(COD)
Proposal for a regulation
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. The Commission and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen andor at least maintain their capacities for the monitoring, early warning and assessment of, and response to serious cross-border threats to health.
Amendment 461 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 (new)
Article 12 – paragraph 2 – subparagraph 1 (new)
Member States joining a joint procurement may change the demand expressed earlier, including resignation from participation in the procurement, if there has been a significant change in circumstances resulting from a legitimate public interest.
Amendment 503 #
2020/0322(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The ECDC shall ensure the furthercontinuous 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, based on a data protection impact assessment (DPIA) to be conducted prior to their deployment, for the purpose of supporting communicable disease prevention and control.
Amendment 535 #
2020/0322(COD)
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. Each Member States willing to participate shall designate the competent authorities responsible within their territory for the services supporting transfusion, transplantation and medically assisted reproduction as referred to in paragraph 1. If the participation in the network is made mandatory in accordance with Articles 5(8) and 31 of the [ECDC Regulation], this obligation shall be extended to each Member State.
Amendment 563 #
2020/0322(COD)
Proposal for a regulation
Article 19 – paragraph 3 – point f
Article 19 – paragraph 3 – point f
(f) public health risks, to the extent feasible including impacts on the major con-communicable diseases;
Amendment 573 #
2020/0322(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point a
Article 20 – paragraph 1 – point a
(a) the ECDC in accordance with Article 8a of Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/ 12527]] in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) including substances of human origin: blood, organs, tissues and cells potentially impacted by communicable diseases; or point (d) of Article 2(1); and/or
Amendment 590 #
2020/0322(COD)
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, inform and consult the other Member States, in particular neighbouring Member States, and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary.
Amendment 605 #
2020/0322(COD)
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
3. Before recognising a situation of public health emergency at Union level, the Commission shouldall liaise with the WHO in order to share the Commission’s analysis of the situation of the outbreak and to inform the WHO of its intention to adopt such a decision.
Amendment 607 #
2020/0322(COD)
Proposal for a regulation
Article 23 – paragraph 4 – subparagraph 1
Article 23 – paragraph 4 – subparagraph 1
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(23).
Amendment 608 #
2020/0322(COD)
Proposal for a regulation
Article 23 – paragraph 4 – subparagraph 2
Article 23 – paragraph 4 – subparagraph 2
Amendment 617 #
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, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. Member States may propose experts to the Commission. The Committee shouldall have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects and shall, as far as possible, respect the geographical balance of the Union. The representatives of the ECDC and of the EMA shall 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 642 #
2020/0322(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
By 2025… [please insert date five years after the date of entry into force of this Regulation], and every 5 years thereafter the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall be conducted in accordance with the Commission’s better regulation guidelines. The evaluation shall include, in particular, an assessment of the operation of the EWRS and the epidemiological surveillance network, as well as the coordination of the response with the HSC.
Amendment 643 #
2020/0322(COD)
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
Based on the evaluation referred to in the previous subparagraph, the Commission shall, where appropriate, submit a legislative proposal to amend this Regulation.
Amendment 228 #
2020/0321(COD)
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) The Commission retains the right to adjust the Agency's proposed resources and staffing allocation following the upcoming publication of the legislative proposal to establish a European Biomedical Research and Development Agency (BARDA) / European Health Emergency Preparedness and Response Authority (HERA).
Amendment 292 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘major non-communicable disease’ means a chronic disease which tends to be of long duration and is the result of a combination of genetic, physiological, environmental and behavioural factors, such as a cardiovascular disease, cancer, respiratory disease, diabetes or mental illness, and which affects a significant number of people in the Union.
Amendment 317 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one authorised senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.
Amendment 334 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The agenda, minutes and recommendations of the Medicines Steering Group shall be made available to the public through the Agency's online portal.
Amendment 344 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity;
Amendment 413 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly reportport on a systematic, structured, and timely basis the results of its monitoring to the Commission and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.
Amendment 420 #
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 and patient organisations, 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 431 #
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 coordinated measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals and patient organisations, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 503 #
2020/0321(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
Amendment 525 #
2020/0321(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) submit the set of available information to Member States requested by the Agency including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);
Amendment 527 #
2020/0321(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 532 #
2020/0321(COD)
Proposal for a regulation
Article 11 – paragraph 4 – point a
Article 11 – paragraph 4 – point a
(a) take into accountacknowledge any recommendations and guidelines and comply with any measures taken at Union- level pursuant to Article 12;
Amendment 542 #
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 addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals, in order to support their work and communication with patients;
Amendment 586 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Emergency Task Force shall establish its rules of procedure including rules on the adoption of recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The agenda and minutes of the Task Force shall be made public through the Agency's online portal.
Amendment 600 #
2020/0321(COD)
Proposal for a regulation
Article 16 – paragraph 6
Article 16 – paragraph 6
6. In the preparation of its recommendations provided pursuant to paragraphs 3, the Emergency Task Force may consult the concerned Member State and request it to provide any information and data, which informed the Member State’s decision to make the medicinal product available for compassionate use. Following such a request, the Member State shall provide all of the best available requested information.
Amendment 645 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. The Medical Devices Steering Group shallmay be supported in its work by a working party comprised of single points of contact from national competent authorities for medical devices established in accordance with Article 23(1).
Amendment 652 #
2020/0321(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The Medical Devices Steering Group shall adopt a set of information necessary to only monitor the supply and demanddata for the long-term safety assessment of medical devices included on the public health emergency critical devices list and inform its working party thereof.
Amendment 659 #
2020/0321(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. On the basis of the public health emergency critical devices list and the information and data provided in accordance with Articles 24 and 25, the Medical Devices Steering Group shall monitor supply and demand ofupdate the medical devices included on thate list compiled by the Medical Device Coordination Group (MDCG) with a view to identifying any potential or actual shortages of those medical devices. As part of that monitoring, the Medical Devices Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]22 and the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 22 [insert reference to adopted text referred to in footnote 4]
Amendment 660 #
2020/0321(COD)
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
Amendment 663 #
2020/0321(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
Amendment 664 #
2020/0321(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
Amendment 688 #
2020/0321(COD)
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
Amendment 704 #
2020/0321(COD)
Proposal for a regulation
Article 26 – paragraph 1 – point d a (new)
Article 26 – paragraph 1 – point d a (new)
(da) work in conjunction with the European Centre for Disease Prevention and Control (ECDC) to categorise and establish different priority levels for the medicinal products identified as critical.
Amendment 716 #
2020/0321(COD)
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3 a. The Commission shall carry out an impact assessment prior to the entry into force of this Regulation.
Amendment 88 #
2020/0320(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) In order to have high-performing health systems accessible for all, there is a need for a holistic approach to public health. The Centre should be tasked with the monitoring of non-communicable diseases and of the impact that infectious diseases have on health systems at large. Based on the Centre's vast experience with Union-level surveillance and monitoring of communicable diseases, its existing tool for data collection (TESSy) and its links to national public health bodies responsible for both communicable and non-communicable diseases, the Centre is in a unique position to deliver effectively a one-stop-shop for health information that can be used for policy decision-making.
Amendment 149 #
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 technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at- risk individuals, noting in particular references to the risks posed by Artificial Intelligence (AI), for example biased datasets, flawed system design, lack of quality data, overdependence on automated decision-making etc., and the importance of establishing safeguards to mitigate these risks during the design and implementation phases of AI technologies.
Amendment 169 #
2020/0320(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
Amendment 173 #
2020/0320(COD)
Proposal for a regulation
Recital 20 b (new)
Recital 20 b (new)
Amendment 178 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 851/2004
Article 2 – paragraph 1 – point 4 a (new)
Article 2 – paragraph 1 – point 4 a (new)
(4a) ‘major non-communicable disease’ means a chronic disease which tends to be of long duration and is the result of a combination of genetic, physiological, environmental and behavioural factors, such as a cardiovascular disease, cancer, respiratory disease, diabetes or mental illness, and which affects a significant number of people in the Union;
Amendment 187 #
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 and related diseases and health issues, including 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 related diseases and health issues, and provide recommendations for response at Union and national levels, as well as at regional level, if necessary.
Amendment 228 #
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 a (new)
Article 3 – paragraph 2 – point h a (new)
(ha) collect information, within its existing infrastructure, on major non- communicable diseases, in particular those whose developments and treatments are impacted significantly by pandemics, such as cancer, diabetes or mental illness;
Amendment 260 #
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 – subparagraph 1 a (new)
Article 4 – paragraph 1 – subparagraph 1 a (new)
Member States shall also, together with the Centre, establish timelines, case definitions, indicators, standards, protocols and procedures for exchange of the information on major non- communicable diseases referred to in point (ha) of Article 3(2).
Amendment 267 #
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 ofrelated diseases and health issues, including those 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 274 #
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 further development of the digital platforms and applications supporting epidemiological surveillance at Union level, based on a data protection impact assessment (DPIA) to be conducted prior to their deployment, which shall be used to 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 280 #
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 surveillance, coordinate with the hosts of other relevant databases, and work towards harmonised approaches to data collection and modelling; in fulfilling this role, the Centre shall minimise the risks that may emerge from the transfer of inaccurate, incomplete or ambiguous data from one database to another, as well as establish robust procedures for data quality review.
Amendment 284 #
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 a (new)
Article 5 – paragraph 2 – subparagraph 2 – point c a (new)
(ca) collect and analyse information provided by Member States on the impact of pandemics on the causes and treatment of relevant major non-communicable diseases;
Amendment 299 #
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 c
Article 5 – paragraph 4 – point c
(c) contribute to the evaluation and monitoring of communicable disease prevention and control programmes, as well as prevention and control programmes in relation to major non- communicable diseases, in order to provide the evidence for recommendations to strengthen and improve these programmes at the national and Union levels;
Amendment 308 #
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, hospitalisation and mortality, and ensure that this data is disaggregated on age, gender and disability, as well as contribute to the assessment of the causes and treatment of major non-communicable diseases;
Amendment 366 #
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 2 – point h
Article 5b – paragraph 1 – subparagraph 2 – point h
(h) develop targeted activities addressing at-risk groups and community preparedness, in particular taking into account the risks associated with the causes and treatment of major non- communicable diseases;
Amendment 412 #
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 5
Article 8 – paragraph 5
5. The Centre as processor shall have the responsibility to ensure the security and confidentiality of the processing operations of personal data carried out within the EWRS and in the context of interoperability of contact tracing applications, in accordance with the obligations laid down in Articles 33, 34(2) and 36 of Regulation (EU) 2018/1725 of the European Parliament and of the Council*
Amendment 433 #
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
Article 11 – paragraph 1a
1a. TUnder the supervision of the Commission, the Centre shall collect data and information, and will ensure links to relevant research data and outputs on:
Amendment 444 #
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 d
Article 11 – paragraph 2 – point d
(d) develop solutions to access relevant health data, including anonymous data and pseudonymous data, in line with the principle of data minimisation as defined in point (c) of Article 5(1) of Regulation (EU) 2016/679, where such data are made available or exchanged through digital infrastructures, in accordance with data protection rules, allowing for the health data to be used for healthcare, research, policy making and regulatory purposes; and provide and facilitate controlled access to health data to support public health research.;
Amendment 487 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) No 851/2004
Article 21 – paragraph 6
Article 21 – paragraph 6
6. The Centre shall develop, deploy and operate an information system capable of exchanging classified and sensitive non- classified information as specified in this Article, in accordance with Articles 27 and 33 of Regulation (EU) 2018/1725.
Amendment 23 #
2020/0262(COD)
Proposal for a directive
Recital 3
Recital 3
(3) Binding occupational exposure limit values are an important component of the general arrangements for the protection of workers established by Directive 2004/37/EC and must not be exceeded. Limit values and other directly related provisions should be established for all those carcinogens or mutagens for which the available information, including scientific and technical data, make this possible.
Amendment 26 #
2020/0262(COD)
Proposal for a directive
Recital 5
Recital 5
(5) This Directive strengthens the protection of workers’ health and safety at their workplace. New limit values should be set out in Directive 2004/37/EC in the light of available information, including new scientific and technical data and should also be based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace, also differentiating and analysing impacts and available infrastructures in different regions and member states of the Union. That information should, if possible, include data on residual risks to the health of workers, opinions of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), as well as opinions of the Advisory Committee on Safety and Health at Work (ACSH). Information related to residual risk, made publicly available at Union level, is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens.
Amendment 31 #
2020/0262(COD)
Proposal for a directive
Recital 7
Recital 7
(7) It is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagens, including the possibility of uptake through the skin, in order to ensure the best possible level of protection. Encourages the Commission, in close cooperation with the Member States and relevant authorities to continue their close cooperation with research centers, academia and other relevant stakeholders, to ensure the most up to date information available.
Amendment 36 #
2020/0262(COD)
Proposal for a directive
Recital 10
Recital 10
(10) With regard to acrylonitrile, a limit value of 1 mg/m³ (0.45 ppm) and a short- term limit value of 4 mg/m³ (1.8 ppm) may be difficult to be complied with in the short term. A transitional period of at least four years after entry into force of this Directive should be introduced from which these Occupational Exposure Limit (OEL) values shall apply, allowing for full adaptation in all member states.
Amendment 37 #
2020/0262(COD)
Proposal for a directive
Recital 5
Recital 5
(5) The amendments to Directive 2004/37/EC provided for in this Directive aim to strengthens the protection of workers’ health and safety at their workplace. New limit values should be set out in Directive 2004/37/EC in the light of available information, including new scientific and technical data and should also be based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace. That information should, if possible, include data on residual risks to the health of workers, opinions of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), as well as opinions of the Advisory Committee on Safety and Health at Work (ACSH). Information related to residual risk, made publicly available at Union level, is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens.
Amendment 37 #
2020/0262(COD)
Proposal for a directive
Recital 12
Recital 12
(12) With regard to nickel compounds, limit values of 0.01 mg/m³ for the respirable fraction and 0.05 mg/m³ for the inhalable fraction may be difficult to be complied with in a number of sectors or processes, including specifically mining, smelting, refineries and weldingwelding, casting, and refineries. Furthermore, since identical risk management measures can be used both for chromium (VI) and nickel compounds, the transitional measures aiming to reduce the exposure to these two groups of carcinogens should be aligned. Therefore, a transitional period until 17 January 2025 inclusive should be introduced during which a limit value of 0.1 mg/m³ for the inhalable fraction of the nickel compounds should apply. This transitional period would ensure alignment with the date of application of the OEL for Chromium (VI) compounds adopted in Directive 2017/2398/EU48 . __________________ 48 Directive (EU) 2017/2398 of the European Parliament and of the Council of 12 December 2017 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. Available at: https://eur- lex.europa.eu/legal- content/EN/TXT/?qid=1571906530859&ur i=CELEX:32017L2398.
Amendment 38 #
2020/0262(COD)
Proposal for a directive
Recital 13
Recital 13
(13) Benzene meets the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and is therefore carcinogen within the meaning of Directive 2004/37/EC. Benzene can also be absorbed through the skin and has in particular been found to also be a cause of various types of leukemia. The limit value set out in Annex III to Directive 2004/37/EC for benzene should be revised in the light of more recent scientific data and it is appropriate to keep the skin notation. The ACSH, based on the RAC opinion, agreed on the usefulness of the biomonitoring for benzene. This should be considered when developing guidance on the practical use of biomonitoring.
Amendment 47 #
2020/0262(COD)
Proposal for a directive
Recital 12
Recital 12
(12) With regard to nickel compounds, limit values of 0.01 mg/m³ for the respirable fraction and 0.05 mg/m³ for the inhalable fraction may be difficult to be complied with in a number of sectors or processes, including specifically smelting, refineries and welding. Furthermore, since identical risk management measures can be used both for chromium (VI) and nickel compounds, the transitional measures aiming to reduce the exposure to those two groups of carcinogens should be aligned. Therefore, a transitional period untilof six years, up to and including 17 January 2025 inclusive7, should be introduced during which a limit value of 0.1 mg/m³. From two years up to four the inhalable fraction of the nickel compounds should apply. This transitional period would ensure alignment with the date of application of the OEL for Chromium (VI) compounds adopted in Directive 2017/2398/EU48. __________________ 48Directive (EU) 2017/2398 of the European Parliament and of the Council of 12 December 2017 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. Available at: https://eur- lex.europa.eu/legal- content/EN/TXT/?qid=1571906530859&u ri=CELEX:32017L2398years after the entry into force, a transitional limit value of 0.1 mg/m³ for the inhalable fraction of the nickel compounds should apply.
Amendment 47 #
2020/0262(COD)
Proposal for a directive
Recital 18
Recital 18
(18) Given that this Directive concerns the protection of the health and safety of workers at their workplace, it should be transposed within twofour years of the date of its entry into force, allowing for another two years of transitional phase for all member states to adapt accordingly.
Amendment 53 #
2020/0262(COD)
Proposal for a directive
Recital 14
Recital 14
(14) With regard to benzene, a revised limit value of 0.2 ppm (0.66 mg/m³) may be difficult to be complied with in some sectors in the short term. A transitional period of 4six years should be introduced, up to and including 17 January 2027, after the entry into force of this Directive should be introduced. From two years up to four years after entry into force, a transitional limit value of 0.5 ppm (1.65 mg/m³) should apply.
Amendment 118 #
2020/0262(COD)
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [twofour years] after the date of entry into force of this Directive at the latest. They shall forthwith communicate to the Commission the text of those provisions.
Amendment 84 #
2020/0104(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Past experiences have shown that investment is often drastically cut during crises. However, it is essential to support investment in this particular situation to speed up the recovery and strengthen long- term growth potential. Investing in green and digital technologies, capacities and processes aimed at assisting clean energy transition, boosting energy efficiency in housing, and other key sectors of the economic are important to achieve sustainable growth and help create quality jobs. It will also help make the Union more resilient and less more independent by diversifying key supply chains.
Amendment 111 #
2020/0104(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure its contribution to the objectives of the Facility, the recovery and resilience plan should comprise measures for the implementation of reforms and public investment projects through a coherent recovery and resilience plan. The recovery and resilience plan should be consistent with the relevant country- specific challenges and priorities identified in the context of the European Semester, with the national reform programmes, the national energy and climate plans, the just transition plans, and the partnership agreements and operational programmes adopted under the Union funds. To boost actions that fall within the priorities of the European Green Deal and the Digital Agenda, the plan should also set out measures that are relevant for the green and digital transitions. The measures should enable a swift deliver of targets, objectives and contributions set out in national energy and climate plans and updates thereof. All supported activities should be pursued in full respect of the climate and environmental priorities of the Union.
Amendment 122 #
2020/0104(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to ensure the national ownership and a focus on relevant reforms and investments, Member States wishing to receive support should submit to the Commission a recovery and resilience plan that is duly reasoned and substantiated. The recovery and resilience plan should set out the detailed set of measures for its implementation, including targets and milestones, and the expected impact of the recovery and resilience plan on growth potential, job creation and economic and social resilience; it should also include measures that are relevant for the green and the digital transitions; it should also include an explanation of the consistency of the proposed recovery and resilience plan with the relevant country-specific challenges and priorities identified in the context of the European Semester. Close cooperation between the Commission and the Member States should be sought and achieved throughout the process.
Amendment 132 #
2020/0104(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) To ensure that the financial support is frontloaded in the initial years after the crisis, and to ensure compatibility with the available funding for this instrument, the allocation of funds to the Member States should be made available until 31 December 20243. To this effect, at least 60 percent of the amount available for non- repayable support should be legally committed by 31 December 2022. The remaining amount should be legally committed by 31 December 20243.
Amendment 134 #
2020/0104(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The request for a loan should be justified by the financial needs linked to additional reforms and investments included in the recovery and resilience plan, notably relevant for the green and digital transitions, and by therefore, by a higher cost of the plan than the maximum financial contribution (to be) allocated via the non-repayable contribution. It should be possible to submit the request for a loan together with the submission of the plan. In case the request for loan is made at a different moment in time, it should be accompanied by a revised plan with additional milestones and targets. To ensure frontloading of resources, Member States should request a loan support at the latest by 31 August 2024. For the purposes of sound financial management, the total amount of all the loans granted under this Regulation should be capped. In addition, the maximum volume of the loan for each Member State should not exceed 4.76.8% of its Gross National Income. An increase of the capped amount should be possible in exceptional circumstances subject to available resources. For the same reasons of sound financial management, it should be possible to pay the loan in instalments against the fulfilment of results.
Amendment 169 #
2020/0104(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Until 31 December 20243, upon request from a Member State, the Commission may grant to the Member State concerned a loan support for the implementation of its recovery and resilience plans.
Amendment 170 #
2020/0104(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. The loan support to the recovery and resilience plan of the Member State concerned shall not be higher than the difference between the total cost of the recovery and resilience plan, as revised where relevant, and the maximum financial contribution referred to in Article 10. The maximum volume of the loan for each Member State shall not exceed 4.76.8% of its Gross National Income.
Amendment 179 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The recovery and resilience plans shall be consistent with the relevant country- specific challenges and priorities identified in the context of the European Semester, in particular those relevant for or resulting from the green and digital transition. The recovery and resilience plans shall also be consistent with the information included by the Member States in the national reform programmes under the European Semester, in their national energy and climate plans and updates thereof under the Regulation (EU)2018/199921 , in the territorial just transition plans under the Just Transition Fund22 , and in the partnership agreements and operational programmes under the Union funds. __________________ 21Regulation (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. 22 […]
Amendment 242 #
2020/0104(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
The Member State concerned shall report on a quarterlysemi-annual basis within the European Semester process on the progress made in the achievement of the recovery and resilience plans, including the operational arrangement referred to in Article 17(6). To that effect, the quarterlysemi- annual reports of the Member States shall be appropriately reflected in the National Reform Programmes, which shall be used as a tool for reporting on progress towards completion of the recovery and resilience plans.
Amendment 62 #
2020/0103(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The specific objectives of the technical support instrument should be to assist national authorities in their endeavours to design, develop and implement reforms, including through exchange of data and good practices, appropriate processes and methodologies and a more effective and efficient human resources management.
Amendment 68 #
2020/0103(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) With a view to helping Member States address reform needs in all the key economic and societal areas, technical support should continue to be provided by the Commission, upon request from a Member State, in a broad range of policy domains, which include areas related to public financial and asset management, institutional and administrative reform, business environment, the financial sector, markets for products, services and labour, education and training, sustainable development, infrastructure, demographic change, public health and social welfare. Specific emphasis should be given to the actions that foster the green and digital transitions.
Amendment 96 #
2020/0103(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
To achieve the general objective set out in Article 3, the instrument shall have the specific objectives of assisting national authorities in improving their capacity to design, develop and implement reforms, including through exchange of data and good practices, appropriate processes and methodologies and a more effective and efficient human resources management. Those specific objectives shall be pursued in close cooperation with the Member States concerned.
Amendment 101 #
2020/0103(COD)
Proposal for a regulation
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
The specific objectives set out in Article 4 shall refer to policy areas related to cohesion, competitiveness, education, productivity, research and innovation, smart, fair, sustainable, and inclusive growth, jobs and, investment and infrastructure, with specific emphasis to actions that foster the green and digital transitions, and in particular to one or more of the following:
Amendment 106 #
2020/0103(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) business environment, including for small and medium-sized enterprises and social economy enterprises, re- industrialisation, private sector development, product and service markets, investment, public participation in enterprises, privatisation processes, trade and foreign direct investment, competition and public procurement, sustainable sectoral development and support for research and, innovation and, digitisation and automation;
Amendment 116 #
2020/0103(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) education and training, labour market policies, including social dialogue, for the creation of jobs, lifelong learning, individualized up- and re-skilling, in particular digital skills, media literacy, active citizenship, the fight against poverty and excessive income inequality, gender equality, the promotion of social inclusion, adequate and inclusive social security and social welfare systems, accessible and affordable public health and healthcare systems, as well as cohesion, asylum, migration and border policies;
Amendment 120 #
2020/0103(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) policies for implementing the digital and the green transitions, e- government solutions, e-procurement, connectivity, data access and governance, e-learning and digital education, use of Artificial Intelligence based solutions, the environmental pillar of sustainable development and environmental protection, climate action, mobility, promoting the circular economy, energy and resource efficiency, renewableclean energy sources, achieving energy diversification and ensuring energy security, and for the agricultural sector, soil and biodiversity protection, fisheries and the sustainable development of rural, remote and depopulating areas; and
Amendment 123 #
2020/0103(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point e a (new)
Article 5 – paragraph 1 – point e a (new)
Amendment 117 #
2020/0102(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Article 168 TFEU provides that the Union is to complement and support national health policies, encourage cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of theeach Member States for the definition of to define their own health policiesy and theo organisation and delivery ofe, deliver and manage health services and medical care.
Amendment 125 #
2020/0102(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. Thatis pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human sufferingsince become the defining global health crisis of our time, causing severe socio-economic consequences and human suffering. The extent, depth and breadth of this crisis has demonstrated the added value of the EU's actions, which serve to complement national policies in the field of public health.
Amendment 133 #
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 levelscope for the Union to better deliver on public health policy within the existing parameters of the Treaties to support cooperation and coordination among the Member States in order to improve the prevention and control of the spread of severe human diseases across borders, to develop, test and make available products for the prevention and treatment of diseases, to combat other serious cross- border threats to health and to safeguard the health and well-being of people in the Union. __________________ 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 13.03.220.
Amendment 163 #
2020/0102(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis and ensure that resilient health care systems and services are in place. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].
Amendment 165 #
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 strengthen 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 creating strategic stockpilingreserves of essential medical supplies or advancing capacity building initiatives in crisis response at the Member State level, preventive measures related to vaccination and immunisation, and 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, which reflects the fact that the health of people, animals and the environment are interconnected and that diseases can be transmitted from people to animals and vice versa. 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 181 #
2020/0102(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) As iIn the time of health crisis emergencycontext of public health crises, health technology assessment as well asnd clinical trials can contribute to the rapid development of medical countermeasures, and the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11 on Health Technology Assessment (HTA)TA to support cooperation on health technology assessment at Union level. Notes, however, that there has been limited progress on the proposal in Council as some Member States have challenged its compatibility with the subsidiarity principle and objected to the mandatory uptake of joint HTA reports. __________________ 11Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018.
Amendment 202 #
2020/0102(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics noting, in particular, its dependency on third countries for manufacturing capacity, the supply of active pharmaceutical ingredients and starting materials. The Programme therefore should provide support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments.
Amendment 208 #
2020/0102(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
Amendment 237 #
2020/0102(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Keeping people healthy and active longer and empowering them to take an active role in managing their health will have positive effects on health, health inequalities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national budgets. Recognition of innovation, which has a profound impact on health outcomes and costs, also serves to address the challenges of achieving sustainability in the health sector and the impact of changing demographics. Moreover, action to reduce inequalities in the provision of healthcare in rural and remote areas is important for the purposes of achieving inclusive growth. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well- being for all at all ages".13 The Programme therefore should contribute to the actions taken towards reaching these goals. __________________ 13 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Next steps for a sustainable European future. European action for sustainability COM (2016) 739 final of 22.11.2016.
Amendment 249 #
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, 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 have sufficient financial resources, follow a "Health in all Policies" (HIAP) approach, provide an integrated response focusing on health promotion and primary prevention across sectors and policy fields, combined with efforts to strengthen health systems that will have a direct impact on the long-term public health policy of all Member States.
Amendment 278 #
2020/0102(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits andbalanced diets and obesity, physical inactivity, mental health and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
Amendment 325 #
2020/0102(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) The Programme will work in synergy and complementarity with other EU policies, programmes and funds such as actions implemented under the Digital Europe Programme, Horizon Europe, rescEU reserve under the Union Civil Protection Mechanism, Emergency Support Instrument, European Social Fund+ (ESF+, including as regards synergies on better protecting the health and safety of millions of workers in the EU), including the Employment and Social Innovation Strand (EaSI), the InvestEU fund, Single Market Programme, European Regional Development Fund (ERDF), Recovery and Resilience Facility including the Reform Delivery Tool, Erasmus, European Solidarity Corps, Support to mitigate Unemployment Risks in an Emergency (SURE), and EU external action instruments, such as the Neighbourhood, Development and International Cooperation Instrument and the Instrument for Pre-accession Assistance III. Where appropriate, common rules will be established in view of ensuring consistency and complementarity between funds, avoiding any overlap or duplication of financing, while making sure that specificities of these policies are respected, and in view of aligning with the strategic requirements of these policies, programmes and funds, such as the enabling conditions under ERDF and ESF+.
Amendment 327 #
2020/0102(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The health workforce has a vital role in building resilient health systems and in reaching the highest attainable standard of health. The Programme should therefore underpin the Commission’s work on effective, accessible and resilient healthcare and health systems, and support the development and implementation of a strategy on the health workforce. In synergy with European Social Fund Plus (ESF+), and in particular Employment and Social Innovation (EaSI), the Programme should provide under the Strategy the means for harmonized training and education for the purpose of improving the curricula of health professionals and their digital skills, in order to obtain a patient-oriented and outcome-based health approach. The Programme should also support, via the Strategy, Member States to address the brain drain and migration of the healthcare workforce from Member States of the eastern flank of the European Union and implement retention policies. Being able to deliver high quality, standardised, targeted and integrated care, and improve health service coverage depends on the availability, accessibility, acceptability, adaptability and quality of the health workforce.
Amendment 340 #
2020/0102(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor, prevent and manage shortages of medicines, medical devices and other healthcare products 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 and treatment, promote incentives to develop such medicinal products as antimicrobialsboost the production capacity for antimicrobials, personalised treatment and vaccination, and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of clinical practice. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should offer some support to the implementation of the Pharmaceutical strategy for Europe.
Amendment 362 #
2020/0102(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given that infections caused by antibiotic-resistant bacteria were responsible for 33,110 deaths in the European Union and European Economic Area in 2015, according to data from the European Center for Disease Control, as well as the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. Notes moreover that the spread of Antimicrobial Resistance will require a greater emphasis in the Programme on preventing infections due to Gram-negative bacteria because there are relatively few existing treatment options for them and a limited number of new antibiotics in development. __________________ 14Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017.
Amendment 370 #
2020/0102(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) Effective international collaboration is key to controlling HAIs and Antimicrobial Resistance and the EU has an important role in supporting Member States in this area, for example through research programmes, the surveillance systems operated by the ECDC and the development of EU wide point prevalence survey methodology.
Amendment 376 #
2020/0102(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross-border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and, working in conjunction with key partners such as the EMA and the ECDC, provide high quality, comparable and reliable data to underpin policymaking and monitoring.
Amendment 385 #
2020/0102(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) Cross-border cooperation in the provision of healthcare to patients moving between Member States, as provided for under Directive 2011/24/EU, includes European Reference Networks (‘ERN’). This is an example where integrated work among Member States has been shown to have strong added value and great potential to increase the efficiency of health systems and therefore health in general. However, it is still to be fully elaborated in terms of Union legislation, implementation and resources. The Programme should therefore aim at ensuring that such integrated and coordinated work is developed and implemented to its full potential in areas such as ERN. That work would serve to foster the implementation of high-impact practices aimed at distributing, in the most effective way, available resources to the relevant population so as to maximise their impact.
Amendment 395 #
2020/0102(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and chronic non- communicable diseases such as cancer and neurodegenerative diseases. __________________ 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 450 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) support health promotion, health literacy and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;
Amendment 462 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) support existing and future Union health legislation, improve the availability in the Union of medicines, medical devices and other crisis relevant producttreatments and medical devices, contribute to their accessibility and affordability, and support innovationthe safe and effective use of medicines, and advance research in healthcare;
Amendment 500 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Article 4 – paragraph 1 – point 1
(1) in full accordance with Article 168(5) of the Treaty on the Functioning of the European Union, strengthen the capability of the Union, including the EMA and the ECDC, for prevention, preparedness and response to serious cross- border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and surveillance;
Amendment 570 #
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, the early diagnosis of neurogenerative and other brain diseases, and notably of cancer;
Amendment 601 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 9 a (new)
Article 4 – paragraph 1 – point 9 a (new)
(9 a) advance health literacy through specific programmes in areas such as health promotion, prevention and patient- centred care;
Amendment 618 #
2020/0102(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. The Programme shall be implemented in direct management in accordance with Regulation (EU, Euratom) 2018/1046 or in indirect management with the bodies referred to in Article 62(1) (c) of Regulation (EU, Euratom) 2018/1046, to ensure there is no overlap or duplication with other funding programmes at the Union level.
Amendment 639 #
2020/0102(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, as well as relevant Union decentralised agencies and other relevant stakeholders, such as representatives of civil society organisations, and in particular patients’ organisations, on the work plans established for the Programme and its priorities and strategic orientations and its implementation.
Amendment 747 #
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, based on the most economically advantageous tender (MEAT) criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 811 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point viii
Annex I – point g – point viii
(viii) Support capacity building of national systems for the implementation of legislation on substances of human origin, and for the promotion of the sustainable and safe supply of such substances through networking activitiea Union framework to cooperation among Member States in order to enable Member States to deliver and exchange timely, reliable and high quality joint clinical assessments, joint scientific consultations and other relevant activities to support decision-makers;
Amendment 896 #
2020/0102(COD)
Proposal for a regulation
Annex I – point h – point vii
Annex I – point h – point vii
(vii) Actions supporting quality in cancer prevention and, treatment, and follow- up care including diagnosis and treatment;
Amendment 909 #
2020/0102(COD)
Proposal for a regulation
Annex I – point h – point x
Annex I – point h – point x
(x) Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of cancer care.
Amendment 934 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials, including those involving collaboration between Member States, increased coordination at Union level and with the European Medicines Agency, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines;
Amendment 950 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point v
Annex I – point i – point v
(v) Support action that builds on EU achievements including the launch of the New Drugs for Bad Bugs (ND4BB) programme and the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR), to encourage the development of innovative products and of less commercially interesting products such as antimicrobials;
Amendment 980 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x
Annex I – point i – point x
(x) Support action to foster international regulatory convergence on medicines and medical devices.
Amendment 1085 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 14
Annex II – part B – point 14
Amendment 4 #
2020/0100(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Commission adopted a Communication on the European Green Deal on 11 December 20199 , drawing its roadmap towards a new growth policy for Europe and setting ambitious objectives to counter climate change and for environmental protection. In line with the objective to achieve Union climate neutrality in the Union by 2050 in an effective and fair manner, and in the spirit of European solidarity, the European Green Deal announced a Just Transition Mechanism to provide means for facing the climate challenges of the transition while leaving no one behind. The most vulnerable regions and people are the most exposed to the harmful effects of climate change and environmental degradation. At the same time, managing the transition requires significant structural changes. _________________ 9 COM(2019) 640 final.
Amendment 6 #
2020/0100(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) Different communities and citizens, depending on their social, geographic and historic circumstances, will be affected in different ways. Not all Member States, regions and cities start the transition from the same point or have the same capacity to respond. At the same time, it is important to recognize that not all regions and communities will benefit equally from a transition to a climate neutral economy and its socio-economic footprint, including welfare and jobs, will vary owing to a broad range of factors. The increase in employment opportunities in the transition forecast is unevenly distributed across different regions whereas job creation in new sectors is not necessarily neatly aligned, temporally or geographically, with job losses.
Amendment 8 #
2020/0100(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Commission adopted a Communication on the European Green Deal Investment Plan10 on 14 January 2020, establishing the Just Transition Mechanism which focuses on the regions and sectors that are most affected by the transition given their dependence on fossil fuels, including coal, particular coal, but also peat and oil shale or greenhouse gas-intensive industrial processes but have less capacity to finance the necessary investments required by Union climate policies. The Just Transition Mechanism consists of three pillars: a Just Transition Fund implemented under shared management, a dedicated just transition scheme under InvestEU, and a public sector loan facility to mobilise additional investments to the regions concerned. _________________ 10 COM(2020) 21 final.
Amendment 19 #
2020/0100(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) A public sector loan facility (the ‘Facility’) should be provided. It constitutes the third pillar of the Just Transition Mechanism, supporting public sector entities in their investments. Such investments should meet the development needs resulting from the transition challenges described in the territorial just transition plans as adopted by competent authorities and approved by the Commission. The activities envisaged for support should be consistent with and complement those supported under the other two pillars of the Just Transition Mechanism.
Amendment 28 #
2020/0100(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to enhance the economic diversification of territories impacted by the transition, the Facility should cover a wider range of investments as compared to the first pillar, on condition that they contribute to meet the development needs in the transition towards a Union climate neutral economy, as described in the territorial just transition plans. The investments supported may cover energy and transport infrastructure, district heating networks, green mobility, smart waste management, clean energy and energy efficiency measures including renovations and conversions of buildings, support to transition to a circular economy, land restoration and decontamination, as well as up- and re-skilling, training and social infrastructure, including social housing. Infrastructure developments may also include solutions leading to their enhanced resilience to withstand disasters. Investment in natural gas as a bridging technology towards renewable energy sources (RES) and an efficient and affordable way of fuel switching from higher emissive sources should be taken into account. Comprehensive investment approach should be favoured in particular for territories with important transition needs. Investments in other sectors could also be supported if they are consistent with the adopted territorial just transition plans. By supporting investments that do not generate sufficient revenues, the Facility aims at providing public sector entities with additional resources necessary to address the social, economic and environmental challenges resulting from the adjustment to climate transition. In order to help identify investments with a high positive environmental impact eligible under the Facility, the EU taxonomy on environmentally sustainable economic activities may be used.
Amendment 33 #
2020/0100(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union apply to this Regulation. These rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also concern the protection of the Union's budget in case of generalised deficiencies as regards the rule of law in the Member States, as the respect for the rule of law is an essential precondition for sound financial management and effective EU funding.
Amendment 41 #
2020/0100(COD)
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16 a) Given the relatively low grant component level, a number of projects could have an insufficient funding stream in order to be supported only by the Facility. This could lead to a lack of expected absorption in less developed regions where a lower-income public sector could experience difficulties in co- financing. Therefore, eligible projects should combine support under other Union programmes.
Amendment 61 #
2020/0100(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The general objective of the Facility is to address serious socio- economic challenges deriving from the transition process towards a climate-neutral economy of the Union for the benefit of the Union territories identified in the territorial just transition plans prepared by the Member States in accordance with Article 7 of Regulation [JTF Regulation].
Amendment 83 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the projects achieve measurable impact in addressing serious social, economic or environmental challenges deriving from the transition process towards a Union climate-neutral economy and benefit territories identified in a territorial just transition plan, even if they are not located in those territories;
Amendment 88 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
Amendment 95 #
2020/0100(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The amount of the grant shall not exceed 15% of the amount of the loan provided by the finance partner under this Facility. For projects located in territories in NUTS level 2 regions with a GDP per capita not exceeding 75% of the average GDP of the EU-27 as referred to in Article [102(2)] of Regulation [new CPR], the amount of the grant shall not exceed 205% of the amount of the loan provided by the finance partner. For projects located in territories in NUTS level 2 regions with a GDP per capita of between 75 % and 100 % of the average GDP of the EU-27 as referred to in Article [102(2)] of [Regulation (EU) 2020/XXX of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, and the European Maritime and Fisheries Fund and financial rules for those and for the Asylum and Migration Fund, the Internal Security Fund and the Border Management and Visa Instrument ("Common Provisions Regulation")], which in the 2014-2020 programming period were classified as less developed regions, the amount of the grant shall not exceed 25 % of the amount of the loan provided by the finance partner.
Amendment 58 #
2020/0006(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The transition to a climate-neutral and circular economy constitutes one of the most important policy objectives for the Union., although the COVID-19 pandemic will have a significant impact on this objective On 12 December 2019, the European Council endorsed the objective of achieving a climate-neutral Union by 2050, in line with the objectives of the Paris Agreementwith one Member State indicating that it cannot commit itself to this objective. While fighting climate change and environmental degradation will bring general benefit alls in the long term and provides opportunities and challenges for all in the medium term, not all regions and Member States start their transition from the same point or have the same capacity to respond. Some are more advanced than others, whereas the transition entails a wider social and economic impact for those regions that rely heavily on fossil fuels - especially coal, and lignite, as well as peat and oil shale - or greenhouse gas intensive industries. Such a situation not only creates the risk of a variable speed transition in the Union as regards climate action, but also of growing disparities between regions, detrimental to the objectives of social, economic and territorial cohesion.
Amendment 91 #
2020/0006(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation establishes the Just Transition Fund (‘JTF’) which is one of the pillars of the Just Transition Mechanism implemented under cohesion policy. The aim of the JTF is to support the transition towards a climate- neutral economy and actions to mitigate the adverse effects of the climate transition by supporting the most affected territories and workers concerned. In line with the JTF specific objective, actions supported by the JTF should directly contribute to alleviate the impact of the transition by financing the diversification and modernisation of the local economy and by mitigating the negative repercussions on employment. This is reflected in the JTF specific objective, which is established at the same level and listed together with the policy objectives set out in Article [4] of Regulation EU [new CPR].
Amendment 108 #
2020/0006(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) In view of the importance of tackling climate change in line with the Union’s commitments to implement the Paris Agreement, the commitment regarding the United Nations Sustainable Development Goals and the increased ambition of the Union as proposed in the European Green Deal, the JTF should provide a key contribution to mainstream climate actions. Resources from the JTF own envelope are additional and come on top of the investments needed to achieve the overall target of 25% of the Union budget expenditure contributing to climate objectives. Resources transferred from the ERDF and ESF+ willmay contribute fully to the achievement of this target, provided that the Member States so decide.
Amendment 115 #
2020/0006(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) On basis of the European Investment Bank’s guidelines, funding should be permitted for up to 75 % of the assumed costs of a project supported by the JTF.
Amendment 130 #
2020/0006(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Transitioning to a climate-neutral economy is a challenge for all Member States. It will be particularly demanding for those Member States that rely heavily on fossil fuels, as well as orn greenhouse gas intensive industrial activities which need to be phased out or which need to adapt due to the transition towards climate neutrality and that lack the financial means to do so. The JTF should therefore cover all Member States, but ttarget mainly those Member States where the magnitude of the challenges is greatest, mainly due to their dependence on generating energy from coal and lignite. The distribution of its financial means should reflect the magnitude of the challenges and the capacity of Member States to finance the necessary investments to cope with the transition towards climate neutrality.
Amendment 192 #
2020/0006(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to enhance the economic diversification of territories impacted by the transition, the JTF should provide support to productive investment in SMEs. Productive investment should be understood as investment in fixed capital or immaterial assets of enterprises in view of producing goods and services thereby contributing to gross-capital formation and employment. For enterprises other than SMEs, productive investments should only be supported ifwhen they are necessary forcontribute to mitigating job losses resulting from the transition, by creating or protecting a significant number of jobs and they do not lead to or result from relocation. Investments in existing industrial facilities, including those covered by the Union Emissions Trading System, should be allowed if they contribute to the transition to a climate-neutral economy by 2050 and go substantially below the relevant benchmarks established for free allocation under Directive 2003/87/EC of the European Parliament and of the Council14 and if they result in the protection of a significant number of jobs. Any such investment should be justified accordingly in the relevant territorial just transition plan. In order to protect the integrity of the internal market and cohesion policy, support to undertakings should comply with Union State aid rules as set out in Articles 107 and 108 TFEU and, in particular, support to productive investments by enterprises other than SMEs should be limited to enterprises located in areas designated as assisted areas for the purposes of points (a) and (c) of Article 107(3) TFEU. _________________ 14Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32).
Amendment 201 #
2020/0006(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) In order to provide flexibility for the programming of the JTF resources under the Investment for jobs and growth goal, it should be possible to prepare a self- standing JTF programme or to programme JTF resources in one or more dedicated priorities within a programme supported by the European Regional Development Fund (‘ERDF’), the European Social Fund Plus (‘ESF+’) or the Cohesion Fund. In accordance with Article 21a of Regulation (EU) [new CPR], JTF resources shcould be reinforced with complementary funding from the ERDF and the ESF+. The respective amounts transferred from the ERDF and the ESF+ should be consistent with the type of operations set out in the territorial just transition plans.
Amendment 213 #
2020/0006(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The JTF support should be conditional on the effective implementation of a transition process in a specific territory in order to achieve a climate-neutral economy. In that regard, Member States should prepare, in cooperation with the relevant stakeholders and supported by the Commission, territorial just transition plans, detailing the transition process, consistently with the basis of their National Energy and Climate Plans. To this end, the Commission should set up a Just Transition Platform, which would build on the existing platform for coal regions in transition to enable bilateral and multilateral exchanges of experience on lessons learnt and best practices across all affected sectors.
Amendment 225 #
2020/0006(COD)
Proposal for a regulation
Recital 16
Recital 16
Amendment 255 #
2020/0006(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes the Just Transition Fund (‘JTF’) to provide support to territories facing serious socio-economic challenges deriving from the transition process towards a climate-neutral economy of the Union by 2050.
Amendment 281 #
2020/0006(COD)
Proposal for a regulation
Article 3 – paragraph 2 – subparagraph 1
Article 3 – paragraph 2 – subparagraph 1
The resources for the JTF under the Investment for jobs and growth goal available for budgetary commitment for the period 2021-2027 shall be EUR 7.5X1a billion in 2018 prices, which may be increased, as the case may be, by additional resources allocated in the Union budget, and by other resources in accordance with the applicable basic act. _________________ 1aThe resources of the Fund should be significantly higher than the EUR 7.5 billion foreseen, in order to meet the requirements of a just transition.
Amendment 287 #
2020/0006(COD)
Proposal for a regulation
Article 3 – paragraph 2 – subparagraph 1
Article 3 – paragraph 2 – subparagraph 1
The resources for the JTF under the Investment for jobs and growth goal available for budgetary commitment for the period 2021-2027 shall be EUR 7.5X1a billion in 2018 prices, which may be increased, as the case may be, by additional resources allocated in the Union budget, and by other resources in accordance with the applicable basic act. _________________ 1aThe resources of the Fund should be significantly higher than the EUR 7.5 billion foreseen, in order to meet the requirements of a just transition.
Amendment 318 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point a
Article 4 – paragraph 2 – subparagraph 1 – point a
(a) productive investments in SMEs, including in SMEs and start-ups, leading to economic diversification and reconversion;
Amendment 337 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point c
Article 4 – paragraph 2 – subparagraph 1 – point c
(c) investments in research and innovation activities and fostering the transfer of advanced technologies that are marketable;
Amendment 365 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point d a (new)
Article 4 – paragraph 2 – subparagraph 1 – point d a (new)
(da) investments relating to the production, processing, distribution, storage and combustion of natural gas;
Amendment 374 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point d b (new)
Article 4 – paragraph 2 – subparagraph 1 – point d b (new)
(db) investments in energy efficiency and renewables, including investments in district heating;
Amendment 412 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point g a (new)
Article 4 – paragraph 2 – subparagraph 1 – point g a (new)
(ga) investments in energy efficiency and renewables, including investments in district heating;
Amendment 419 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point g b (new)
Article 4 – paragraph 2 – subparagraph 1 – point g b (new)
(gb) investments that contribute to reducing emissions from transport;
Amendment 487 #
2020/0006(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) investment related to the production, processing, distribution, storage or combustion of solid fossil fuels;
Amendment 532 #
2020/0006(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The JTF priority or priorities shall comprise the JTF resources consisting of all or part of the JTF allocation for the Member States and the resources transferred in accordance with Article [21a] of Regulation (EU) [new CPR]. The total of the ERDF and ESF+ resources that can be transferred to the JTF priority shall be at least equal to one and a half times the amount of support from the JTF to that priority but shallshould not exceed three times that amount.
Amendment 536 #
2020/0006(COD)
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2a. Projects funded by the JTF that contribute to its specific objective may receive funding of up to 75% of the assumed costs.
Amendment 559 #
2020/0006(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) a description of the transition process at national level towards a climate- neutral economy, including a timeline for key transition steps which are consistent withdeveloped on the basis of the latest version of the National Energy and Climate Plan (‘NECP’);
Amendment 580 #
2020/0006(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point e
Article 7 – paragraph 2 – point e
Amendment 612 #
2020/0006(COD)
Proposal for a regulation
Article 9
Article 9
Amendment 633 #
2020/0006(COD)
Proposal for a regulation
Annex I – paragraph 1 – point a – point i
Annex I – paragraph 1 – point a – point i
(i) greenhouse-gas emissions of industrial facilities in NUTS level 2 regions where the carbon intensity, as defined by the ratio of greenhouse gas emissions of industrial facilities as reported by Member States in accordance with Article 7 of Regulation (EC) No 166/2006 of the European Parliament and of the Council28 compared to the gross value added of the industry, exceeds by a factor of two the EU-27 average. Where that level is not exceeded in any NUTS level 2 regions in a given Member State, greenhouse-gas emissions of industrial facilities in the NUTS level 2 region with the highest carbon intensity is taken into account (weighting 4925%), _________________ 28Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 33, 4.2.2006, p. 1).
Amendment 643 #
2020/0006(COD)
Proposal for a regulation
Annex I – paragraph 1 – point a – point ii
Annex I – paragraph 1 – point a – point ii
(ii) employment in the mining of coal and lignite (weighting 2549%),
Amendment 658 #
2020/0006(COD)
Amendment 4 #
2019/2816(RSP)
Citation 1 a (new)
- having regard to Article 191 (2) of the Treaty on the Functioning of the European Union,
Amendment 13 #
2019/2816(RSP)
Citation 26 a (new)
- having regard to the Council conclusions of 24 June 2019 on the next steps towards making the EU a best practice region in combatting antimicrobial resistance,
Amendment 31 #
2019/2816(RSP)
Citation 12 a (new)
- having regard to the OECD study of November 2019 Pharmaceutical Residues in Freshwater - Hazards and Policy Responses,
Amendment 40 #
2019/2816(RSP)
Recital B
B. whereas the wide use of pharmaceuticals in human and veterinary medicines, including antimicrobial agents, has increased their concentrations in many environmental reservoirs such as soils, sediments and waterbodies in the past 20 years; whereas with changes to the size and age of population this trend may increase; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;
Amendment 58 #
2019/2816(RSP)
Recital G
G. whereas there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment; including the protection of water resources in line with the Water Framework Directive
Amendment 112 #
2019/2816(RSP)
Paragraph 9
9. Points to the need to regulate pharmaceuticals under water legislation; recalls that interinstitutional negotiations are on-going on a review of the Directive on the quality of water intended for human consumption and on a regulation on minimum requirements for water reuse; asks that regulation for other compartments such as soils be implement as well;
Amendment 141 #
2019/2816(RSP)
Paragraph 13
13. Calls on the Member States and on the Commission to promote awareness- raising campaigns amongnd training among pharmacists, veterinaries, and physicians on the prudent use of pharmaceuticals, particularly of antimicrobials; calls on actors in the pharmaceutical supply chain to contribute to providing to patients with 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 178 #
2019/2816(RSP)
Paragraph 20
20. Points to the important role of procurement policy in promoting greener pharmaceuticals in design and manufacturing; calls on the Commission to develop clear guidance on this issue;
Amendment 203 #
2019/2816(RSP)
Paragraph 27
27. Considers that the overall per capita drug consumption should be reduced, without jeopardising patients’ health; is of the opinion that the overall per animal veterinary medicines consumption should also decrease without compromising animal health and welfare;
Amendment 236 #
2019/2816(RSP)
Paragraph 32
32. Is concerned that monitoring of pharmaceuticals in the environment, notably in soil, is still very limited; stresses the need to strengthen post-marketing control mechanisms into comprehensive monitoring, also with regard to environmental effects, as the current surveillance system (pharmacovigilance) is not adequately and systematically covering the environmental data deficit;
Amendment 23 #
2019/2804(RSP)
Recital D
D. whereas data concerning the health of EU citizens is a key enabler for digital transformation, and must be strictly protected against misuse; whereas the availability of data varies greatly across Member States, and whereas, due to the lack of interoperability and market fragmentation across health systems, citizens cannot yet fully benefit from the digital single market;
Amendment 32 #
2019/2804(RSP)
Recital H
H. whereas the implementation and use of digital health are at different levels between Members States, including the use of updated technology, support infrastructures to digital transformation and the use of electronic health records in healthcare services; whereas the establishment of a comprehensive digital healthcare system will be hugely expensive in many countries;
Amendment 45 #
2019/2804(RSP)
Paragraph 3
3. Is of the opinion that the digital transformation of health and care needs to be patient-centred; stresses, at the same time, that the needs of patients who are unable to keep up with the digital transformation must not be disregarded;
Amendment 53 #
2019/2804(RSP)
Paragraph 5
5. Stresses that health data could be used for research, to implement evidence based health policies and for a better understanding of diseases and early detection of events that threaten public health, whilst complying with the principles of patient confidentiality;
Amendment 92 #
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 pandemics, and that the European Centre for Disease Prevention and Control (ECDC) must play a central role in these efforts;
Amendment 108 #
2019/2804(RSP)
Paragraph 25
25. Calls on the Commission to work with the relevant actors to support more cooperation across borders and enlarge the deployment of digitally enabled care models, and to do this without encroaching on Member State competences;
Amendment 116 #
2019/2804(RSP)
Paragraph 27
27. Calls on the Commission to work with Member States and regions to develop networks to educate citizens in the use of digital healthcare, enabling universal access; considers that, in order to achieve that goal, there is a need to improve systems’ interoperability and users skills, with the highest possible protection of sensitive data with tools and mechanisms provided by the public health systems;
Amendment 126 #
2019/2804(RSP)
Paragraph 30
30. Calls on the Commission to assist Member States into creatinge strategies to avoid total dependency on electronic data, in the event of blackouts;
Amendment 127 #
2019/2804(RSP)
Paragraph 30 a (new)
30a. Supports the efforts of the European Centre for Disease Prevention and Control (ECDC) to develop strategies to make better use of existing computerised systems, to use data to limit the spread of infectious diseases, and to help Member States gather and process data;
Amendment 63 #
2019/2182(INL)
Motion for a resolution
Paragraph 3 – point e a (new)
Paragraph 3 – point e a (new)
(ea) Notes that the initiatives presented as part of this strategy will entail significant financial and administrative burdens both for public authorities and for businesses, especially SMEs; stresses, therefore, that this needs to be taken into account by providing adequate support and introducing appropriate transition periods;
Amendment 103 #
2019/2182(INL)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Underlines that leading medical researchers from the International Commission of Occupational Health (ICOH) conclude that exposure limits do not protect properly against cancer and propose an occupational limit value of 1 000 fibres/m3 (0,001 fibres/cm3); calls for an updated exposure limit to be set at 0,001 fibres/cm3 (1 000 fibres/m3); stresses the need for a sufficiently long transition period to implement the new methodology and new exposure values;
Amendment 188 #
2019/2182(INL)
Motion for a resolution
Annex II – paragraph 1 – point 18 – Annex 1 b – indent 6
Annex II – paragraph 1 – point 18 – Annex 1 b – indent 6
Amendment 189 #
2019/2182(INL)
Motion for a resolution
Annex II – paragraph 1 – point 18 – Annex 1 b – indent 7
Annex II – paragraph 1 – point 18 – Annex 1 b – indent 7
Amendment 191 #
2019/2182(INL)
Motion for a resolution
Annex II – paragraph 1 – point 18 – Annex 1 b – indent 8
Annex II – paragraph 1 – point 18 – Annex 1 b – indent 8
Amendment 3 #
2019/2079(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. RegretsPoints out, concerning the implementation of the independence policy of the Centre, that not all the required annual declarations of interest were submitted, particularly by the designated management board members (96 %) and advisory forum members (89 %); stresses, however, that all the members who took part in the deliberations at these two bodies did submit the required declarations and that the Centre's internal independence rules were approved by the European Commission;
Amendment 25 #
2019/2028(BUD)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls on the Commission to swiftly implement pilot projects and preparatory actions (PP-PAs), in particular all PP-PAs that concern public health or aim at improving the well-being of European citizens;
Amendment 40 #
2018/0213(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The degree of implementation of structural reforms in the Member States is still not sufficient across the Union. Experience with the implementation of the economic policy coordination mechanism under the European Semester shows that, in general, the implementation of structural reforms has been slow and uneven and that national reform efforts should be reinforced and incentivised. In order to achieve this, the process must be accompanied by closer dialogue between the Commission and the Member States, taking into account the role of national parliaments in the implementation of reforms.
Amendment 63 #
2018/0213(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) With regard to the reform delivery tool, it is necessary to identify the types of reforms that should be eligible for financial support. To ensure their contribution to the objectives of the Programme, the eligible reforms should be those addressing the challenges identified in the context of the European Semester of economic policy coordination, including those proposed to address the country-specific recommendations. The process of preparing and agreeing on the content of the recommendations to Member States should take into account the recommendations set out in the governments’ positions, as this will increase states’ sense of shared responsibility for the reforms.
Amendment 78 #
2018/0213(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In order to ensure the ownership of and a focus on relevant reforms, the Member States should identify the reform commitments in response to challenges identified in the context of the European Semester (including those challenges identified in country specific recommendations) and propose a detailed set of measures for their implementation, which should contain appropriate milestones and targets and a timetable for implementation over a maximum period of three years. CloseA genuine improvement in cooperation between the Commission and the Member States should be sought and achieved throughout the process. , which would translate into much more effective implementation of the reforms.