557 Amendments of Catherine AMALRIC
Amendment 5 #
2023/2081(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
Amendment 6 #
2023/2081(INI)
Motion for a resolution
Citation 12 b (new)
Citation 12 b (new)
– having regard to the Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services and amending Directive 2000/31/EC (Digital Services Act) 1a, _________________ 1a OJ L 277, 27.10.2022, p. 1.
Amendment 43 #
2023/2081(INI)
Motion for a resolution
Recital I
Recital I
I. whereas, in 2012, the Commission established an ‘on-hold’ list of 2 078 health claims relating to plant substances, mainly due to the absence of human intervention studies, which led to the suspension of the EFSA assessment and authorisation procedure in 2010; whereas the ‘on-hold’ health claims – both those negatively assessed and those not yet reviewed – may still be used on the EU market according to the transitional measures set out in the NHCR, until a decision on the ‘on-hold’ list is taken; whereas consumers are thus exposed to unsubstantiated health claims and may believe that the stated beneficial effects have been scientifically evaluated when this is not the case;
Amendment 63 #
2023/2081(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out an increasing consumer interest in food information13 ; stresses the need to ensure that information about the nutritional or health values of foods appearing on labels and being used for presentation, marketing and advertising purposes is accurate, science-based and meaningful; _________________ 13 European Union, ‘Eurobarometer – Making our food fit for the future – new trends and challenges’, October 2020.
Amendment 64 #
2023/2081(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls for the regular updating and assessment of the list of health claims made on food to consider scientific developments in the fields of food and nutrition.
Amendment 77 #
2023/2081(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Reminds that claims should not mislead consumers about the true nutrient value of a product; highlights that, in the absence of nutrient profiles, claims can stress a positive aspect of an overall unhealthy product; underlines that the development of nutrient profiles is necessary in order to achieve the consumer protection objective of the NHCR; calls for the swift publication of a Commission proposal on nutrient profiles and a strong coherence with the objectives of the NHCR regulation to limit the use of nutrition and health claims on unhealthy foods; underlines that the future nutrient profiles, based on robust and independent scientific evidence, could encourage and help consumers to make informed, healthy and sustainable choices about food products;
Amendment 81 #
2023/2081(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers that the EU4Health programme could invest more in food and nutrition education by developing actions in schools with a view to teaching young people to eat a healthy and balanced diet, according to a quantitative or qualitative nutrition education.
Amendment 84 #
2023/2081(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls for the launch of information and awareness campaigns to support the marketing of foodstuffs with claims and to explain to consumers the usefulness of these claims and the evaluation process that precedes them;
Amendment 87 #
2023/2081(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights that consumers tend to overconsume food products bearing claims to promote better health, which is known as the ‘halo-effect’; advocates for the inclusion of both minimum and maximum usage thresholds on product labels, along with a recommendation to consult a healthcare professional before consuming food supplements in order to avoid potential adverse interactions with specific treatments and to avoid reinforcing potential eating disorders;
Amendment 104 #
2023/2081(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Strongly supports the on-going publication by EFSA of specific guidelines according to the use of a claim;
Amendment 105 #
2023/2081(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Supports the establishment of prior consultations between manufacturers and the EFSA to enable the agency to present its expectations in the context of submitting their claim request, while respecting the principle of the independence of the EFSA;
Amendment 110 #
2023/2081(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Highlights the imperative need to address the ‘on-hold’ list of claims on botanicals; is concerned that the continued use of the ‘on-hold’ claims under the transitional measures of Article 27 of the NHCR could mislead and constitutes a health risk for consumers, who may falsely assume that the ‘on-hold’ claims have been scientifically assessed and risk managed; considers, furthermore, that the ‘on-hold’ list creates unfair competition for food business operators and discourages innovation as the uncertainty surrounding the situation deters long-term investments;
Amendment 127 #
2023/2081(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses the need to ensure that the NHCR remains relevant in the online environment, especially because young people and certain more vulnerable populations, such as women, may be particularly sensitive to certain health claims and food information shared on social medias, and this represents a health risk as well as a psychosocial risk (eating disorders); considers it important, in this regard, to define what constitutes commercial communication on foods and food supplements on social media;
Amendment 134 #
2023/2081(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Invites the Commission to draft comprehensive guidelines for the enforcement of the NHCR online; considers that these guidelines should outline clear procedures and standards for monitoring and regulating health claims online, ensuring the accuracy and transparency of such claims and safeguarding the well-being of consumers in the framework of the Digital Services Act;
Amendment 1 #
2023/2075(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
– having regard to Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices,
Amendment 2 #
2023/2075(INI)
Motion for a resolution
Citation 9 b (new)
Citation 9 b (new)
– having regard to 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,
Amendment 3 #
2023/2075(INI)
Motion for a resolution
Citation 9 c (new)
Citation 9 c (new)
– having regard to Regulation (EU) 2022/370 of the European Parliament and of the Council of 23 November 2022 amending Regulation (EC) No 851/2004 establishing a European centre for disease prevention and control,
Amendment 7 #
2023/2075(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
– having regard to to its resolution of 15 January 2020 on the European Green Deal (2019/2956(RSP))and the Commission communication of 11 December 2019 on the European Green Deal (COM(2019)0640),
Amendment 8 #
2023/2075(INI)
Motion for a resolution
Citation 4
Citation 4
– having regard to its resolution of 10 July 2020 on the Chemicals Strategy for Sustainability and the Commission communication of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment’ (COM(2020)0667),
Amendment 9 #
2023/2075(INI)
Motion for a resolution
Citation 5
Citation 5
– having regard to its resolution of 24 November 2021 on a pharmaceutical strategy for Europe (2021/2013(INI)) and the Commission communication of 25 November 2020 entitled ‘Pharmaceutical Strategy for Europe’ (COM(2020)0761),
Amendment 10 #
2023/2075(INI)
Motion for a resolution
Citation 6
Citation 6
– having regard to its resolution of 16 February 2022 on strengthening Europe in the fight against cancer – towards a comprehensive and coordinated strategy and the Commission communication of 3 February 2021 entitled ‘Europe’s Beating Cancer Plan’ (COM(2021)0044),
Amendment 15 #
2023/2075(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
– having regard to the European Parliament resolution of 12 July 2023 on the COVID-19 pandemic entitled 'Lessons learned and recommendations for the future' (2022/2076(INI)),
Amendment 24 #
2023/2075(INI)
Motion for a resolution
Citation 9 g (new)
Citation 9 g (new)
– having regard to the Council Recommendation of 13 June 2023 on stepping up EU actions to combat antimicrobial resistance in a One Health approach (AMR),
Amendment 25 #
2023/2075(INI)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
– having regard to the Commission communication of 12 May 2021 entitled ‘Pathway to a Healthy Planet for All-EU Action Plan: ‘Towards Zero Pollution for Air, Water and Soil’’ (COM(2021)0400),
Amendment 28 #
2023/2075(INI)
Motion for a resolution
Citation 9 d (new)
Citation 9 d (new)
– having regard to the Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority,
Amendment 29 #
2023/2075(INI)
Motion for a resolution
Citation 9 e (new)
Citation 9 e (new)
– having regard to the Commission’s proposal for a regulation on the European health data space (COM(2022)0197),
Amendment 30 #
2023/2075(INI)
Motion for a resolution
Citation 9 f (new)
Citation 9 f (new)
– having regard to the Commission’s proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency and a Directive on the Union code relating to medicinal products for human use,
Amendment 31 #
2023/2075(INI)
Motion for a resolution
Citation 9 h (new)
Citation 9 h (new)
– having regard to the Commission communication of 20 November 2022 entitled ‘EU Global Health Strategy – Better Health for All in a Changing World’ (COM(2022)0675),
Amendment 32 #
2023/2075(INI)
Motion for a resolution
Citation 9 i (new)
Citation 9 i (new)
– having regard to the 2030 Agenda for Sustainable Development, in particular Sustainable Development Goal (SDG) 3 target 4, to reduce by one third premature mortality from non- communicable diseases through prevention and treatment and promote mental health and well-being, and SDG 3 target 8, to achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all,
Amendment 33 #
2023/2075(INI)
Motion for a resolution
Citation 9 j (new)
Citation 9 j (new)
– having regard to the European Pillar of Social Rights, in particular its principle 16 (healthcare) and 18 (long- term care),
Amendment 54 #
2023/2075(INI)
Motion for a resolution
Recital A
Recital A
A. whereas non-communicable diseases (NCDs) are diseases that are not passed from person to person; whereas non-communicable diseases (NCD’s) cause 90 % of all deaths in the EU4 ; and NCDs continue to grow across the EU; _________________ 4 World Health Organization, ‘Monitoring noncommunicable disease commitments in Europe 2021’, 8 December 2021.
Amendment 71 #
2023/2075(INI)
Ba. whereas the ‘Health in All Policies’ and ‘One Health’ approaches should be promoted further, and efforts to fight non-communicable diseases should be integrated into all EU policies;
Amendment 77 #
2023/2075(INI)
Motion for a resolution
Recital C
Recital C
C. whereas NCDs account for the largest share of countries’ healthcare expenditures, costing EU economies and are predicted to lead to the loss of potential productive years among employees impacted by such conditions, resulting in a cost of EUR 115 billion, or 0.8 % of GDP annually as well as entailing other societal costs such as loss of productivity and workforce; whereas in 2018, no more than 2.8 % of total health expenditure in the EU was spent on prevention, whereas the costs of treating NCDs remains high5 ; _________________ 5 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 15, June 2022.
Amendment 89 #
2023/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the increasing burden of NCDs affecting individuals and societies and the health needs of ageing populations represent challenges to the health systems of the Member States;
Amendment 96 #
2023/2075(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas NCDs such as type 2 diabetes increasingly affect children; whereas many people living with NCDs such as diabetes are often diagnosed too late and many people already show signs of complications; 1a _________________ 1a https://link.springer.com/article/10.1007/s 11892-014-0508-y Diabetes Research and Clinical Practice, Volume 183, 2022, 109118, ISSN 0168-8227 https://doi.org/10.1016/j.diabres.2021.109 118.
Amendment 102 #
2023/2075(INI)
Motion for a resolution
Recital D b (new)
Recital D b (new)
Amendment 121 #
2023/2075(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas smoking increases the risk of being hospitalised with a mental illness by 250 per cent; 1a _________________ 1a https://tech.au.dk/en/about-the- faculty/news/show/artikel/smoking- significantly-increases-the-risk-of- depression
Amendment 131 #
2023/2075(INI)
Motion for a resolution
Recital F
Recital F
F. whereas most NCDs are impacted by environmental risk factors such as air pollutionindoor and outdoor air, water, soil and food pollution, noise and chemicals in the environment and the workplace, second- hand smoke, and some infectious agent;
Amendment 132 #
2023/2075(INI)
Motion for a resolution
Recital F
Recital F
F. whereas most NCDs are impacted by environmental risk factors such as air pollutionindoor and outdoor air pollution, chemical exposure as well as food, water and soil pollution; whereas most NCDs are impacted by socioeconomic inequalities;
Amendment 166 #
2023/2075(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas antimicrobial resistance (AMR) is a challenge for medical procedures such as surgeries and cancer treatments; whereas AMR leads to increased disease incidence, hospitalisations, mortality rates and healthcare expenses; 1a _________________ 1a https://www.thelancet.com/journals/lancet /article/PIIS0140-6736(21)02724- 0/fulltext
Amendment 169 #
2023/2075(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas not all NCDs can be prevented as some factors are not modifiable such as age, family history, genetics, gender, auto-immunity (e.g. type 1 diabetes) and/or not known such as some neurological disorders;
Amendment 180 #
2023/2075(INI)
Motion for a resolution
Recital H
Recital H
H. whereas innovation with regard to development of technologies, medicines and healthcare practises is crucial to ensure the elimination or reduction of harm caused by preventable risk factors, early detection, improved disease management, integration of care and new and better treatments for NCDs;
Amendment 189 #
2023/2075(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas people suffering from NCDs run a higher risk of being affected by communicable diseases such as COVID-19; whereas data shows that people suffering from NCD’s run a higher risk of complications and dying from COVID-19; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 22-06/eu-ncd- initiative_publication_en_0.pdf page 57
Amendment 199 #
2023/2075(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
Hb. whereas WHO has set a goal to reduce premature deaths from NCDs by 25% by 2025 and world leaders reaffirmed their commitment at the G20 Health Ministers meeting to achieving the UN’s Sustainable Development Goal (UNSDG) 3.4: to reduce premature deaths from NCDs by one-third by 2030; 1a _________________ 1a https://www.who.int/teams/noncommunic able-diseases/on-the-road-to-2025
Amendment 220 #
2023/2075(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 246 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Strongly believes that comprehensive preventive actions against non-communicable diseases, through measures supporting the elimination or reduction of harm caused by modifiable risk factors, should be implemented across all relevant European policies and funding programmes; calls on the Commission and the Member States to integrate public awareness-raising campaigns about non-communicable diseases prevention into all relevant policies; strongly believes that preventive actions should be evidence-based; therefore, calls on the Commission and Member States to increase the funding for scientific research into the causes of non- communicable diseases and the efficiency and implementation of preventive measures;
Amendment 248 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls on the Commission and Member States to design and implement effective prevention measures at national and EU level, which are based on independent scientific expertise, best practices and lessons learned, and clinical guidance;
Amendment 249 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Deplores the significant health inequalities and inequities in the EU in non-communicable diseases prevention; insists on the need to identify, as well as to pay special attention to, vulnerable, marginalised, socially excluded populations and people living in remote areas (such as in rural, isolated or outermost regions far from medical centres), in order to ensure their access to prevention services; considers in this regard that prevention measures also need to be framed in the context of social justice, entailing the need for systemic changes through population-wide public policies beyond changes in individual behaviour;
Amendment 287 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – introductory part
Paragraph 5 – introductory part
5. Supports Europe’s Beating Cancer Plan to achieve a Tobacco-Free Generation and support the Commission’s proposals to review the Tobacco Products Directive11 and the Tobacco Taxation Directive12 and the proposal to update the Council recommendation of 30 November 2009 on smoke-free environments13 ; calls for a full implementation of the WHO Framework Convention on Tobacco Control; calls on the Commission and the Member States to: _________________ 11 Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, OJ L 127, 29.4.2014, p. 1. 12 Council Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to manufactured tobacco, OJ L 176, 5.7.2011, p. 24. 13 OJ C 296, 5.12.2009, p. 4.
Amendment 289 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – introductory part
Paragraph 5 – introductory part
5. Strongly supports the Commission’s proposals to review the Tobacco Products Directive11 and the Tobacco Taxation Directive12 and the proposal to update the Council recommendation of 30 November 2009 on smoke-free environments13 ; calls for a full implementation of the WHO Framework Convention on Tobacco Control; calls on the Commission and the Member States to: _________________ 11 Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, OJ L 127, 29.4.2014, p. 1. 12 Council Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to manufactured tobacco, OJ L 176, 5.7.2011, p. 24. 13 OJ C 296, 5.12.2009, p. 4.goal of a ‘tobacco-free generation’, as set out in the Europe’s Beating Cancer Plan, whose aim is for less than 5% of the population to use tobacco by 2040, compared to around 25% today; Supports the Commission’s proposals to review the Tobacco Products Directive and the Tobacco Taxation Directive, to introduce the following:
Amendment 317 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b a (new)
Paragraph 5 – point b a (new)
ba. an increase and an upward convergence in minimum excise duties for all tobacco products and their final market price, which would improve prevention by reducing tobacco uptake and use, notably among current smokers, and prevent young people from starting smoking;
Amendment 320 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b b (new)
Paragraph 5 – point b b (new)
bb. a requirement for standardised plain packaging and the obligation to include health warnings on 80% of the front and back of tobacco product packaging, including pictorial warnings;
Amendment 339 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
Amendment 340 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Supports the Commission’s proposal to update the Council recommendation of 30 November 2009 on smoke-free environments1a to extend its coverage to emerging products, such as e- cigarettes and heated tobacco products, and to extend smoke-free environments to include outdoor spaces; _________________ 1a OJ C 296, 5.12.2009, p. 4.
Amendment 354 #
2023/2075(INI)
Motion for a resolution
Paragraph 7 – introductory part
Paragraph 7 – introductory part
7. Welcomes the Commission’'s objective tof achieving a 10 %e a reduction in harmful alcohol consumptionof at least 10% in the harmful use of alcohol by 2025; calls on the Commission and the Member States to:
Amendment 386 #
2023/2075(INI)
8. Notes that an unhealthy diet is one of the major risk factors for NCDs, including cardiovascular diseases, cancer, diabetes and other conditions linked to obesity15 ; emphasises the role of a healthy diet in preventing and limiting the incidence and the recurrence of non- communicable diseases, and stresses that individual risks can be reduced by an increased consumption of sustainably- produced plants and plant-based foods, such as fresh fruits and vegetables, whole grains and legumes; emphasises, furthermore, the need to address the overconsumption of meat and ultra- processed products, and products high in sugars, salt and fats; acknowledges that obesity is considered a risk factor for several NCDs; calls on the Commission and the Member States to: _________________ 15 World Health Organization Regional Office for the Eastern Mediterranean, ‘Noncommunicable diseases’.
Amendment 423 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b
Paragraph 8 – point b
b. pPropose a New EU Action Plan for childhood obesity; calls on the Member States to actively fight against obesity by making available healthy dietary choices and the practices of sports, not only by educating and encouraging citizens to make the right choices, but also by including integral programmes in primary healthcare that help patients suffering from obesity to lose weight in a healthy way; calls on the Commission and Member States to support research and innovation related to obesity aiming to describe the influence of genetic factors, the human microbiota or psychological status, among others, on body weight, and to explore the most effective interventions;
Amendment 454 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Welcomes the Commission’s intention to tackle the presence of carcinogenic contaminants in food; urges the Commission to swiftly come forward with regulatory proposals;
Amendment 456 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Calls on the Commission to heed Parliament’s various calls in its resolution of 16 January 2019 to improve the Union’s authorisation procedure for pesticides;
Amendment 470 #
2023/2075(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers the European Green Deal to be instrumental in preventing NCDs in the EUnion by reducing of air, food, water and soil pollution and chemical exposure; calls on the Commission to ensure that the common agricultural policy helps farmers to reduce the use of pesticides; encourages the research into, the use and the development of medicines that are safer for the environment, and encourages the implementation of efficient waste removal mechanisms that avoid polluting the environment, in line with the objectives of the Pharmaceutical Strategy for Europe; highlights that prevention of chronic respiratory diseases besides tobacco cessation also includes the prevention of exposure to dust and other indoor pollutants;
Amendment 498 #
2023/2075(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that some per- and polyfluorinated alkyl substances (PFAS) can lead to health problems such as obesity, diabetes 1a and cancer16 ; calls on the Commission to implement the PFAS restriction proposal submitted to European Chemicals Agency on 13 January 202317 ; _________________ 1a https://www.clinicaltrialsarena.com/comm ent/high-exposure-pfas-diabetes-women/ 16 European Environment Agency, ‘What are PFAS and how are they dangerous for my health?’. 17 European Chemicals Agency, ‘ECHA publishes PFAS restriction proposal’, 2023.
Amendment 508 #
2023/2075(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. RDeeply regrets the slow implementation of the Chemicals Strategy for Sustainability, and, in particular, expects thereiterates its call for a revision of REACH Regulation18 to be revised in order to be able to identify all substances of concern manufactured or imported in the EU; calls on the Commission to adopt effective guidance and legislation to reduce citizens’ exposure to carcinogenic substances; Fully supports the Commission’s proposal to amend the Regulation on the classification, labelling and packaging of chemicals (Regulation (EC) No 1272/2008) to introduce new hazard classes on, inter alia, EDs, including suspected EDs, and to update the information requirements in all relevant legislation to allow their identification; _________________ 18 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 396, 30.12.2006, p. 1.
Amendment 516 #
2023/2075(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Recalls that the Commission’s Communication ‘Chemicals strategy for sustainability towards a toxic-free environment’ highlighted the need to protect workers from those substances; calls therefore on the Commission to consider extending the scope of Directive 2004/37/EC to endocrine disruptors;
Amendment 521 #
2023/2075(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
Amendment 532 #
2023/2075(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Encourages the Commission and the Member States to achieve the UN Sustainable Development Goals that target communicable diseases in order to promote the prevention of NCDs such as cancer related to infectious diseases; welcomes vaccination programmes in this regard such as in the fight against human papillomavirus transmission; stresses the need for coordinated actions targeting carcinogenic viruses, such as HPV and the hepatitis B virus (HBV), in order to prevent their transmission; calls for more harmonisation of HPV and HBV vaccination within Member States’ national programmes, while ensuring the provision of information about vaccination and promoting equal access for vulnerable and at-risk adult groups; encourages the regular monitoring of current HPV and HBV vaccination at EU level using a tracking system similar to the COVID-19 vaccine tracker developed by the European Centre for Disease Prevention and Control (ECDC), that will also encourage Member States to adopt best practice and maintain momentum; supports further research on vaccine and innovative treatment options development against other viruses such as the hepatitis C virus and the human immunodeficiency virus (HIV); considers that in the meantime therapeutic solutions should be used massively to reach the WHO’s goal of eradicating hepatitis C by 2030, and calls on the Commission to use financial resources under the Recovery and Resilience Fund to reach these targets by funding screening efforts; further considers that greater political commitment and strong partnership and collaboration between authorities and all concerned actors is needed to reach the WHO's goal of ending the HIV/AIDS epidemic by 2030, including in Europe, and calls on the Commission and Member States to step up their support to ensure that all, including vulnerable communities more at risk, can be tested, diagnosed and have rapid access and are retained to the best care innovative options; also calls on the Commission and Member States to invest in and support high-impact innovative combination prevention approaches as a key additional tool to end the HIV epidemic in Europe; calls for cooperation with Member States and international organisations to combat the impact of misinformation on vaccination and to address vaccine hesitancy; calls for the EU4Health and other EU funding streams to be used for this purpose, including for supporting awareness-raising efforts for citizens, education providers and healthcare professionals, as well as for support to behavioural research under the Horizon Europe programme; recommends a strengthened application of the EU’s Code of Practice on Disinformation particularly with regard to vaccine misinformation;
Amendment 549 #
2023/2075(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Stresses that primary prevention is crucial for reducing the occurrence of many types of NCDs; notes that secondary prevention is key for the optimal management of NCDs and contributes to reduce the risk of complications, comorbidities and death;
Amendment 550 #
2023/2075(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls for the implementation of prevention programmes to be inclusive by involving regions and municipalities, citizens, the social partners, civil society and patient organisations at all steps of the decision-making process,
Amendment 552 #
2023/2075(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Encourages the Commission and the Member States to further promote health literacy on NCDs’ risks and determinants as well as digital literacy that is linked to it, to develop educational tools for prevention, and to support the creation of e-learning platforms and applications; calls for particular attention be paid to disadvantaged, vulnerable, socially excluded and marginalised people, and underlines that specific awareness-raising campaigns for groups with particular health literacy needs are essential;
Amendment 562 #
2023/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the importance of identifying people with a high risk of developing NCDs and diagnosing people as early as possible for example through the implementation of health checks and early detection programmes in order to improve disease management, prevent complications and save downstream costs for healthcare systems;
Amendment 568 #
2023/2075(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Welcomes the European Beating Cancer Plan; stresses the importance of early detection and that 25 Member States had introduced population-based screening programmes for breast cancer, 22 for cervical cancer and 20 for colorectal cancer in their National Cancer Control Plans in 2020; welcomes the 2022 Council Recommendation on strengthening prevention through early detection: A new EU approach on cancer screening which include strategies for earlier detection of breast, cervical, colorectal cancer and extend recommended screenings in Europe for lung, prostate and gastric cancers; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 22-02/eu_cancer-plan_en_0.pdf: page 14
Amendment 574 #
2023/2075(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
Amendment 581 #
2023/2075(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages Member States to reduce undiagnosed NCDs by introducing targeted health checks ofor high-risk individuals addressing the main shared metabolic risk factors, ensuring timely access to high-quality care and support NCDs patients’ self- management; calls on the Commission and the Member States to support the development and the use of novel tools to diagnose NCDs in at-risk populations;
Amendment 590 #
2023/2075(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights the importance of early intervention in the case of mental health problems; stresses that daycares, schools and workplaces can play an important role in recognising mental health problems at early stages and that timely support can be provided; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 23-06/com_2023_298_1_act_en.pdf
Amendment 595 #
2023/2075(INI)
17. Notes that some NCDs are closely linked such as diabetes and cardiovascular diseases and cancer and depression and that important synergies can be achieved by improving diagnosis and integrated care19 ; 1a _________________ 1a https://www.ejcancer.com/article/S0959- 8049(16)32595-3/fulltext 19 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 30, June 2022.
Amendment 607 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Regrets the disparities in terms of access to high-quality healthcare services among Member States, and also among different regions within Member States, and asks the Commission to address those disparities through the appropriate legislative measures in order to ensure equal rights in the EU;
Amendment 660 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Notes that the Covid-19 pandemic has highlighted how serious health threats can put severe pressure on the capacities of healthcare systems, with a negative impact on the provision of healthcare for patients with non- communicable diseases, such as the continuity of healthcare, delay of or interruption to treatment for patients and people with mental health issues1a; underlines that the impact of serious cross-border threats to health may thus pose further challenges in ensuring a high level of human health protection; stresses the need for Member States to anticipate and to monitor the impact of public health emergencies on the provision of healthcare services for other diseases and conditions, while respecting the responsibilities of Member States for the definition of their health policy and for the organisation and delivery of health services and medical care; _________________ 1a Invisible numbers: the true extent of NCDs and what to do about them. Geneva: World Health Organization; 2022.
Amendment 674 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Highlights the importance of addressing social determinants, health literacy, and digital literacy to reduce the overall burden of NCDs;
Amendment 677 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Calls for the adoption of an EU strategy to anticipate and monitor the impacts of serious health threats on people affected by communicable and non-communicable diseases/other diseases or conditions; proposes to constitute a European NCD specialists emergency reserve composed of voluntary NCDs experts trained and ready to be deployed to ensure care to people living with NCDs in any Member State or neighboring country in crisis time;
Amendment 681 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Strongly welcomes digital health solutions such as telemedicine, which can enable better accesses to healthcare in rural areas as well protect immunosuppressed NCD patients from exposure to infectious diseases;
Amendment 693 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 d (new)
Paragraph 19 d (new)
19d. Asks for enhanced communication between health professionals, patients, survivors, caregivers, parents and public authorities regarding the effectiveness and safety of health interventions, in particular NCDs’ diagnosis and treatment, and for increased awareness campaigns for prevention in times of crisis;
Amendment 697 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 e (new)
Paragraph 19 e (new)
19e. Calls on the Member States and relevant authorities to recognise the pivotal role of informal carers, integrate them into health and care teams and empower them with the possibility of making informed choices regarding available supportive measures with the support of healthcare professionals; recognises that the COVID-19 pandemic has exacerbated the crucial role of informal carers, who provide most of the daily care for NCDs patients and who face a clear lack of practical and policy support, including as regards social rights, training, psychological help, information and recognition; points to the high percentage of informal carers among the EU population and to the disparities regarding the way in which they are supported and how their rights are recognised across Member States; calls on the Commission to consider the formalisation of informal care, which would ensure the recognition of a certain minimum standard of rights, especially for those who are providing long-term care;
Amendment 705 #
2023/2075(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls that patient empowerment and health literacy areis crucial for an EUuropean NCDs strategy and that treatment and care should be patient- centred; encourages the promotion of well- informed patients who are actively involved in their own treatment and calls for the therapeutic training of caregivers and patients and their empowerment in the care programmes; calls for participatory decision-making, with personalised and understandable evidence-based information to be provided to patients, calls for the support of such initiatives and actions to empower cancer patients through EU funding, especially the EU4Health Programme;
Amendment 716 #
2023/2075(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Notes the need to focus on the quality of life of NCD patients whose illnesses cannot be cured but may be stabilised for a number of years; emphasises the importance of specific EU recommendations to improve the quality of life of patients including by integrating comprehensive supportive care into care, starting with the diagnosis and continuing over the course of the disease and by granting access to specialised support centres;
Amendment 721 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Stresses that NCDs’ patients should not suffer a ‘double punishment’ in their daily lives; calls for the adoption of an anti-discrimination directive, as well as for the fair and equal implementation of directives on financial services, such as the Consumer Credit Directive, without any discrimination against NCDs’ patients and survivors;
Amendment 723 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
Amendment 724 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Encourages the Member States to take into account the frequent exhaustion of the families and relatives of NCDs patients and to provide them with psychological and socioeconomic assistance, especially to the most vulnerable, and rest periods in the workplace, throughout the course of the disease, as well as with bereavement support; encourages, furthermore, the development of integrated, adequate and accessible support schemes for NCDs’ patients and their families, that take health, community and social services into account;
Amendment 726 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 c (new)
Paragraph 21 c (new)
21c. Acknowledges the central role of independent patients’ and carers’ associations in relation to patient advocacy and accompaniment, services provided to NCDs’ patients and caregivers, dissemination of health literacy, awareness raising and ongoing support both at EU and national level; calls on the Commission and the Member States to take into account the formal participation of these associations, as well as their requests and recommendations, when formulating NCDs’ policies and legislation, and to provide them with public support in the form of both operating grants and project-related grants in order to guarantee their independence from private funding; calls on the Commission to set clear criteria according to which public financial support can be awarded.
Amendment 731 #
2023/2075(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Welcomes the pharmaceutical package and calls for the strengthening of the European medicines market to ensure equal access to medicines and alleviate medicine shortages,, including innovations and personalised medicines, alleviate medicine shortages, overcome the problem of high prices for innovative technologies and treatments, encourage the use of generic and biosimilar medicine and reduce barriers to cross- border business, while strengthening incentives for investments in innovation; underlines that data protection and intellectual property rights are crucial to ensure competitiveness in the EU by incentivising innovators to develop new products and further ongoing research efforts;
Amendment 734 #
2023/2075(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Welcomes the pharmaceutical package and calls for the strengthening of the European medicines market to ensure access to medicines and alleviate medicine shortages, reduce barriers to cross-border business, while strengthening incentives for investment in innovation; underlines that data protection and intellectual property rights are crucial to ensure competitiveness in the EU by incentivising innovators to develop new products and further ongoing research efforts; notes that a narrow definition of unmet medical need can harm development of important therapies for people living with NCDs;
Amendment 739 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Welcomes the creation of the IPCEI on Health to support innovation and to improve quality and access to care for European patients; considers the Health IPCEI should facilitate the development of innovative and greener technologies and production processes for drug manufacturing, of gene and cell therapies and innovation in strategic treatments;
Amendment 745 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22b. Considers that the future European Sovereignty Fund could help restore EU's strategic autonomy on medical products;
Amendment 747 #
2023/2075(INI)
22c. Calls for the adoption of a Critical Medicines Act to support the European green, digital manufacturing of critical medicines, APIs and intermediate ingredients to diversify the EU pharmaceutical supply chains and to secure the strategic autonomy of critical medicines, in parallel of the review of the European pharmaceutical legislation;
Amendment 748 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 d (new)
Paragraph 22 d (new)
22d. Notes that NCDs’ patients are frequently affected by medicine shortages and that severe disruptions in the supply of their treatments are highly detrimental to them, their carers and their families; calls on the Commission and the Member States to work together to prevent and manage shortages of all medicines and medical products and of NCDs medicines in particular, including shortages of inexpensive essential NCDs medicines; supports the development of a common basket of NCDs’ drugs of which there may be shortages to ensure that patients have continuous access to appropriate treatment, based on transparently and appropriately defined patient needs;
Amendment 749 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 e (new)
Paragraph 22 e (new)
22e. Calls for the reinforcement and diversification of the supply chain of medicines within the EU, close monitoring of supply tensions and shortages, and the creation of a strategic stockpile of critical medicines, active ingredients and raw materials, particularly where the number of suppliers is limited; stresses the importance of the role of sustainable procurement practices in preventing medicine shortages;
Amendment 750 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 f (new)
Paragraph 22 f (new)
22f. Urges the Commission to submit a proposal for the revision of Council Directive 89/105/EEC on the transparency of measures regulating the prices of medicinal products in order to ensure effective scrutiny and greater transparency of the procedures used to determine the price of and reimbursement amount for medicines, particularly cancer medicines, in all Member States;
Amendment 751 #
2023/2075(INI)
22g. Insists on the need to ensure equal access to affordable drugs to every European citizen; calls for collective negotiation on the price of medicines with pharmaceutical industries, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valetta Declaration;
Amendment 752 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 h (new)
Paragraph 22 h (new)
22h. Strongly advocates the extension of joint procurement procedures for NCDs medicines to counter shortages and improve affordability and access to those treatments at EU level; recalls that Joint Procurement Agreements should be carried out in a transparent, timely and effective way; underlines, in this respect, that clear and transparent stages for the process, scope, tender, specifications, timelines and formalities should be defined;
Amendment 753 #
2023/2075(INI)
Motion for a resolution
Paragraph 22 i (new)
Paragraph 22 i (new)
Amendment 815 #
2023/2075(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Commission to create a European NCD Health Knowledge Centre to improve data collection and research on NCDresearch in NCDs and collection of comparable, robust data on NCDs at EU level, to outline the cost effectiveness of prevention strategies and stimulate investment in the area – ensuring synergies and integration with European Health Data Space plans; stresses the need for further research in NCD co-morbidities and management;
Amendment 824 #
2023/2075(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Stresses that good quality data are important to support development of evidence-based and targeted policies for improved health; notes that correlating health data with environmental, social and economic data and strengthening elements of existing health monitoring systems such as European Health Data Space is important in this regard;
Amendment 830 #
2023/2075(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Welcomes tThe Commission Expert Group on Public Health and the sub-group on NCDnon- communicable diseases; calls on the Commission to establish a European expertise network for prevention and control of NCD co- morbidities and complications, based on the model of the European Reference Networks (ERNs);
Amendment 835 #
2023/2075(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Belives that the EU has a role in supporting global health, including in respect to the international rise of NCDs;
Amendment 5 #
2023/2074(INI)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
– having regard to the Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services and amending Directive 2000/31/EC (Digital Services Act),
Amendment 7 #
2023/2074(INI)
Motion for a resolution
Citation 4 e (new)
Citation 4 e (new)
– having regard to its resolution of 5 July 2022 on mental health in the digital world of work (2021/2098(INI)),
Amendment 10 #
2023/2074(INI)
Motion for a resolution
Citation 4 b (new)
Citation 4 b (new)
– having regard to its resolution of 12 July 2023 on the COVID-19 pandemic: lessons learned and recommendations for the future (2022/2076(INI)),
Amendment 18 #
2023/2074(INI)
Motion for a resolution
Citation 2 f (new)
Citation 2 f (new)
– having regard to its resolution from 21 January 2021 on The right to disconnect 2019/2181(INL),
Amendment 19 #
2023/2074(INI)
Motion for a resolution
Citation 2 g (new)
Citation 2 g (new)
– having regard to the 2022 European Parliament Report on Mental Health in a Changing World of Work,
Amendment 21 #
2023/2074(INI)
Motion for a resolution
Citation 4 c (new)
Citation 4 c (new)
– having regard to its resolution of 5 July 2022 on Towards a common European action on care (2021/2253(INI)),
Amendment 22 #
2023/2074(INI)
Motion for a resolution
Citation 4 d (new)
Citation 4 d (new)
– having regard to its report of 10 March 2022 on a new EU strategic framework on health and safety at work post 2020 (including a better protection of workers from exposure to harmful substances, stress at work and repetitive motion injuries) (2021/2165(INI)),
Amendment 24 #
2023/2074(INI)
Motion for a resolution
Citation 2 a (new)
Citation 2 a (new)
– having regard to the Council conclusions of 24 October 2019 on the economy of well-being, calling for a comprehensive EU mental health strategy,
Amendment 26 #
2023/2074(INI)
Motion for a resolution
Citation 2 c (new)
Citation 2 c (new)
– having regard to the 2008 European Pact for Mental health and wellbeing,
Amendment 28 #
2023/2074(INI)
Motion for a resolution
Citation 2 b (new)
Citation 2 b (new)
– having regard to the Commission Green paper of 14 October 2005 entitled ‘improving the mental health of the population – ‘Towards a strategy on mental health for the European Union,
Amendment 33 #
2023/2074(INI)
Motion for a resolution
Citation 2 h (new)
Citation 2 h (new)
– having regard to the 2022 European Care Strategy,
Amendment 48 #
2023/2074(INI)
Motion for a resolution
Citation 2 d (new)
Citation 2 d (new)
– having regard to the EU-OSHA report of 7 October 2011 entitled ‘Mental health promotion in the workplace – a good practice report’,
Amendment 49 #
2023/2074(INI)
Motion for a resolution
Citation 2 e (new)
Citation 2 e (new)
– having regard to the 2017 EU Framework for Action on Mental Health,
Amendment 56 #
2023/2074(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas mental health should have equal parity with physical health;
Amendment 63 #
2023/2074(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the urgent need for better and wider awareness and understanding of mental health and for effective action to prevent and address mental ill health has increasingly being recognised in recent years, with the COVID19 pandemic highlighting this crucial need;
Amendment 139 #
2023/2074(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1 EU Strategy and Year on Mental health Welcomes the recent Communication on a "Comprehensive Approach to Mental Health" and calls on the Commission to come forward with a comprehensive and integrated EU Strategy on mental health to address the full spectrum of mental health, i.e. prevention, promotion, support, care, treatment and cure by bringing together and engaging relevant stakeholders through a bottom-up approach; coordinated by a dedicated internal and formal Commission structure, backed with sufficient resources, such a Strategy should ensure the development of national mental health action programmes, building on the outcome of past EU actions on mental health and have clear and measurable objectives, which should be assessed and adapted if required; Stresses that a European Year for Mental Health could be a useful tool to raise awareness of the importance of mental health and contribute to combatting stigma and discrimination while functioning as a stepping stone towards the abovementioned EU Strategy; calls on the Commission to designate such a Year in the near future;
Amendment 141 #
2023/2074(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the COVID-19 pandemic, the war in Ukraine and the socio- economic crisis underlined and exacerbated existing mental health issues, while creating new ones, especially for young people;
Amendment 145 #
2023/2074(INI)
Motion for a resolution
Subheading 2
Subheading 2
Preventing mental health conditions and promoting mental health among vulnerable groups in societyfor all
Amendment 152 #
2023/2074(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Highlights that, at any point in their life, any person can become more susceptible to poorer mental health and thus become part of a vulnerable group in society;find themselves in a vulnerable situation; underlines the need to prioritise mental health as a public health problem, stresses that addressing mental health conditions requires a thorough understanding of the different determinants of mental health and that; calls for an intersectional approach is necessary to prevent and mitigate the impacts on individuals, communities and societies through a mental-health-in-all- policies approach;
Amendment 158 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Understands the broader societal implications of declining mental health, including its economic, social, and political repercussions for the EU.
Amendment 160 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Stresses that mental health is shaped by a blend of socio-economic, environmental, and genetic factors and is influenced by early life experiences which have an important role in forming and conditioning the wellbeing of every person;
Amendment 162 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Underlines that a comprehensive approach to mental health requires a thorough understanding of the different determinants of mental health to prevent and mitigate the impacts on individuals, communities and societies;
Amendment 164 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Emphasizes that mental health recovery is not just the alleviation of symptoms, but a personal journey towards leading a meaningful life with values, purposes, and relationships, despite the challenges posed by a mental health problem;
Amendment 167 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Acknowledges that gender plays a pivotal role in shaping mental health experiences with disparities in prevalence, types of disorders, and access to mental health care being largely influenced by gender;
Amendment 168 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 f (new)
Paragraph 1 f (new)
1f. Is aware that families and caregivers of individuals with mental health problems bear unique burdens and should be afforded comprehensive, multidisciplinary support, tailored to their distinct needs;
Amendment 171 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 g (new)
Paragraph 1 g (new)
1g. Recognises the deep and lasting impact of the COVID-19 lockdowns on mental health, social development, and the increased reliance on digital technologies;
Amendment 173 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 h (new)
Paragraph 1 h (new)
1h. Acknowledges both the benefits and risks of digital technologies, from connectivity and access to information to potential digital addiction and reduced real-world interactions;
Amendment 175 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 i (new)
Paragraph 1 i (new)
1i. Appreciates the important role of the workplace with regard to mental health;
Amendment 176 #
2023/2074(INI)
Motion for a resolution
Paragraph 1 j (new)
Paragraph 1 j (new)
1j. Reminds the urgent need to raise awareness of mental health problems and the importance of talking about them openly, through efficient awareness- raising campaigns aimed at all audiences throughout the European Union; stresses the importance of culture and sporting activities in this awareness-raising role;
Amendment 197 #
2023/2074(INI)
2. HighlightAcknowledges the complex interconnections between physical health and mental health; whereas mental health stigma and discrimination remain prevalent in society and lead people to disregard mental health compared to physical health, impacting the quality and accessibility of mental health care, as well as the allocation of funds to mental health services; Notes that mental health conditions are the leading cause of years of healthy life loss due to disability in the EU and that people who are diagnosed with severe mental health conditionproblems are likelier to die prematurely;
Amendment 200 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 – subparagraph 1 (new)
Paragraph 2 – subparagraph 1 (new)
Preventing mental health conditions and promoting mental health among vulnerable groups
Amendment 204 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Highlights that some people might be more at risk of experiencing poor mental health and less likely to access tailored mental health care. This is the case of people living in vulnerable situations or people experiencing intersectional discrimination; Notes that the links between these identity or socio- economic factors and mental health need to be clearly taken into consideration to develop tailored support and preventive measures;
Amendment 206 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Underlines the heightened vulnerability to mental health problems in specific groups, namely: children and youth, the elderly, those experiencing dual disorders, people with physical or mental disabilities, individuals experiencing significant loneliness due to insufficient social connections, people living with HIV, displaced individuals including refugees and migrants, LGBTI people, victims of violence, incarcerated individuals, individuals with chronic conditions, rare diseases and those residing in rural or isolated areas. Their increased vulnerability is due to unique challenges faced by each group, which can exacerbate mental health issues;
Amendment 213 #
2023/2074(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the importance of social policies that tackle social exclusion,risk factors for social exclusion, including but not limited to poverty, homelessness, substance-related disorders, unemployment and economic vulnerabilities in order to prevent mental health conditions and address their root causes; underlines the need to provide better instrumentand accessible instruments and services to help people to cope with problems;
Amendment 223 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the EU and the Member States to apply a proportionate universalism approach with a targeted extra support to those who may need it at a given time in their lives/situations;
Amendment 224 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Recognises that young Europeans today are growing up in a volatile and challenging environment marked by the COVID-19 pandemic, energy crises, war, a worsening economic outlook, and a pressing climate, nature and pollution crisis, acknowledges the potential for the present societal shifts to leave a lasting impact on the younger generation's mental health and their societal expectations;
Amendment 232 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Observes with concern the rising difficulties young people face, including economic instability, difficulty accessing affordable housing, and achieving societal satisfaction amidst rising inflation and job competition;
Amendment 235 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Alarmingly notes the high number of young Europeans aged 10-19 diagnosed with a mental disorder, and that suicide rates among this demographic are notably high;
Amendment 237 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Notes with concern the rise of climate anxiety among young Europeans and the potential adverse effects it has on their mental well-being;
Amendment 240 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 f (new)
Paragraph 3 f (new)
3f. Acknowledges that psychiatric comorbidity is highly prevalent among people who use substances (up to over 80% of people in drug treatment) and is associated with increased levels of clinical and social severity. The relevance of the comorbidity of substance use and mental health disorders is related not only to its high prevalence, but also to its difficult management and its association with poor outcomes for those affected;
Amendment 243 #
2023/2074(INI)
Motion for a resolution
Subheading 3
Subheading 3
Amendment 245 #
2023/2074(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Considers mental health information systems an important tool to collect data and measure the effectiveness of mental health interventions,collect data, in adherence to the principles of transparency, legitimate purpose and proportionality, and measure the prevalence, clinical severity and effectiveness of mental health interventions; calls for the EU to facilitate the collection and routinely reporting of comparable, disaggregated mental health data across Europe; stresses indicators should factor in people's actual experiences to better reflect the social determinants of mental health and calls for them to be systematically implemented, improved and updated;
Amendment 252 #
2023/2074(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to introduce a mental health impact assessment to evaluate the effect of different EU actions, policies and funding programmes on mental health;
Amendment 255 #
2023/2074(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Underlines the need for a detailed mapping of the state of mental health care across the EU as a basis for action and priority setting;
Amendment 258 #
2023/2074(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. CUrges the Commission to develop a long-term European Mental Health Strategy, with a clear timeline, adequate budget, concrete targets, objectives, as well as indicators to monitor progress; calls on the Commission to assist the Member States in collecting and spreading best practice, via the EU Best Practice Portal, with regard to targeted campaigns for supporting vulnerable groups; believes the Commission should utilise its influence to strengthen effective leadership and governance to go beyond the usual approach of “sharing” best practices;
Amendment 262 #
2023/2074(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Urges the Member States to develop long-term National Mental Health Action Plans with a clear timeline, adequate budget, concrete targets, objectives, as well as indicators to monitor progress;
Amendment 272 #
2023/2074(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Is deeply concerned that, despite progress in some countries, peopleindividuals with mental health conditionshallenges, including those with psychosocial disabilities, frequently experienface discrimination and stigma and often. Often, they do not have access to adequate healthcare, which cantimely, accessible, affordable, and adequate healthcare and health services, leading to severeinsufficient promotion and protection of their rights and potential human rights violations;
Amendment 277 #
2023/2074(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recognises the need to use language and terminology that frames the topic in an inclusive and non-stigmatising way and reflects the variety of mental health experiences;
Amendment 279 #
2023/2074(INI)
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the EU and Member States to invest in mental health literacy and include mental health in school curricula and the curricula of teaching staff; Calls on the European Commission and the Member States to promote training and re-training of professionals to comply with the standards and obligations of the UN CRPD;
Amendment 284 #
2023/2074(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. CUrges the Commission to follow the recommendations of the Conference on the Future of Europe and designate a European Year of Mental Health; calls for the EU and the Member States to raise awareness of the importance of mental health in a coordinated and timely manner, through a mental-health-in- all-policies approach; Notes mental health mainstreaming could be applied in all EU policies – both internal and external – ensuring that mental health considerations are built into the design, implementation, monitoring and evaluation of policy, legislation and spending programmes;
Amendment 295 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls for specific programmes to improve mental health literacy as these will contribute to fighting stigma as well as to increasing empowerment and resilience;
Amendment 300 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Underlines that the principles of equitable, affordable, and easy access to care, empowerment of those living with mental health problems, choice of desired treatment and patient-centeredness should underpin mental health systems across the EU;
Amendment 301 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Calls on EU Member States to strengthen their mental health systems by building community-based networks of interconnected services that move away, where possible, from custodial care in psychiatric hospitals and cover a broad spectrum of care and support needs, within and beyond the health sector;
Amendment 302 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 d (new)
Paragraph 7 d (new)
7d. Calls on Member States to step up investments in mental health, not just by securing appropriate funds and human resources across health and other sectors to meet mental health needs, but also through committed leadership, pursuing evidence-based policies and practice;
Amendment 304 #
2023/2074(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Is deeply concerned by the poor availability of mental healthcare services in the Member States, as exemplified by the alarmingly long waiting lists for appointments with psychiatrists and psychologists and the limited options for therapeutic treatment, as well as for in- and outpatient clinic treatment and lack of relevant expense coverage by health insurance providers; considers that the shortage in staff in this specific sector and the lack of funding aggravate the issue; underlines that the cost of mental health services cannot and must not be an obstacle for citizens;
Amendment 331 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Underlines the need to effectively respond to the coexistence of mental health and other disorders; dual disorders represent a challenge for treatment services; often patients are referred from one service to the other, making their treatment access more difficult;
Amendment 348 #
2023/2074(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers that mental health conditions are underdiagnosed in the EUUnderlines the importance of early diagnosis and intervention for mental health problems, access to controlled medicines while preventing their diversion, hazardous overmedication or self-medication and considers that the current state of under-, late- and misdiagnosis of mental health conditions need urgent attention; underlines that every diagnosis must be individual, adapted to the person and that every mental health condition is different for each person; reminds that every diagnosis and treatment must be patient-centred;
Amendment 359 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Recognises that many mental health needs are unmet. Underlines the importance of identifying these needs at their onset. Early intervention may prevent these risks from escalating, with also potential benefits in terms of healthcare system costs;
Amendment 363 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Encourages the consideration of both biomedical and psychosocial models of mental health in EU actions and initiatives hence ensuring a balanced approach, which recognizes the importance of both biological determinants and the impact of social and environmental factors on mental health;
Amendment 366 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Reminds the key role of the prevention of mental health within the digital space and social medias; calls on the Member States to fully implement the Digital Services Act in order to prevent, tackle and avoid any online hate and harassment, especially for young and vulnerable people, such as women; calls for the reinforcement of support, listening and alert platforms for victims of gender- based and sexual violence; Calls on the Commission –primary regulator for very large online platforms and very large online search engines under the DSA –to move towards a safer and healthier digital space for all, by guaranteeing an upward convergence and setting the highest/safest benchmarks;
Amendment 378 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 d (new)
Paragraph 11 d (new)
11d. Acknowledges people with mental health problems and psychosocial disabilities have the right to lead full and meaningful lives;
Amendment 379 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 e (new)
Paragraph 11 e (new)
Amendment 385 #
2023/2074(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Highlights the essential role of a multidisciplinary health workforce and the clinical, financial and organisational benefits of community-based healthcare; recognises the importance of ensuring suitable standards of training and regulation for mental health care providers;
Amendment 387 #
Amendment 390 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Stresses that the European care strategy proposed by the European Commission should, among other things, comprehensively address the impact of digitalisation on working conditions and the effects of teleworking and telecommuting on mental health; reiterates its call on the Commission to propose, in consultation with the social partners, a directive on psychosocial risks and well-being at work;
Amendment 397 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Recalls that healthcare professionals were in the front line during the Covid crisis and that their own mental health has been significantly impacted; calls for healthcare professionals and essential workers to have easier access to mental health support services;
Amendment 399 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. believes that mental health protection and promotion should be an integral part of Occupational Health and Safety preparedness plans for future health crises;
Amendment 405 #
2023/2074(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Member States to improve access to care, treatment and support for mental health conditions by implementing holistic multidisciplinary care and enhancing integrated pathways between services for people with mental health disorders and other comorbidities while taking account of social, psychological as well as biological factors, patient centeredness and patient choice;
Amendment 410 #
2023/2074(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the EU and the Member states to increase efforts to ensure more meaningful cooperation with civil society and the communities they represent, experts and particularly persons with lived experience; highlights holistic approaches to mental health prevention, support and services should be developed alongside affected communities, including meaningful involvement of people with psychosocial disabilities, through co- creation and in a non-tokenistic manner;
Amendment 418 #
2023/2074(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Acknowledges that social prescribing is a useful, practical, holistic and effective approach that can be integrated into the primary care setting within a national health serviceystem, as pointed out by the WHO in its toolkit on how to implement social prescribing3 ; _________________ 3 https://apps.who.int/iris/rest/bitstreams/142 4690/retrieve.
Amendment 426 #
2023/2074(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission to promote policies around best practice in social prescribing in the Member Statesevidence based practices of meaningful collaboration among mental health services and social sector services in the Member States, in line with a mental health in all policies approach and social prescribing;
Amendment 433 #
2023/2074(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Highlights the role of the revision of the Pharmaceutical package by the European Commission, in order to guarantee a better and equal access to treatments for every patients in Europe, including medicines to treat mental health conditions;
Amendment 461 #
2023/2074(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Invites the Commission and the Member States to invest in further research on brain and mental health, in consultation with relevant stakeholders regarding priority topics;
Amendment 475 #
2023/2074(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Member States to develop new social prescribing interventions for people with mental health conditions or who will benefit from such interventions; calls on the Commission to promote discussions with Member States on bestevidence based practices in social prescribing;
Amendment 476 #
2023/2074(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
Amendment 478 #
2023/2074(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Emphasises the need to integrate mental health into the routine health information systems and identify, collate, routinely report and use core mental health data disaggregated by gender, age and other grounds to properly capture intersectionality issues. Indicators on determinants of mental health should also be available in population (mental) health information and monitoring systems (as recommended by WHO);
Amendment 499 #
2023/2074(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Invites the Commission to further develop its Mental Health Strategy and draw upbuild upon its Communication on a Comprehensive Approach to Mental Health to draw up a comprehensive and integrated EU Strategy on mental health with concrete targets and goals for the future, including more in-depth initiatives, from in consultation with all relevant stakeholders following a bottom-up perspectiveapproach;
Amendment 13 #
2023/0199(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) Strengthening the manufacturing capacity of key technologies in the Union will not be possible without a sizeable skilled workforce. However, labour and skills shortages have increased in all sectors including those considered key for the green and digital transition and endanger the rise of key technologies, also in the context of demographic change. Therefore, it is necessary to address the root causes of such shortages and boost the activation of more people to the labour market relevant for strategic sectors, in particular through the creation of quality jobs and apprenticeships for young, disadvantaged persons, in particular, young people not in employment, education or training. At the same time, it is necessary to increase the attractiveness of technical careers, especially among women. Such support will complement a number of other actions aimed at meeting the skills needs stemming from the transition, outlined in the EU Skills Agenda.45 __________________ 45 Communication on a European Skills Agenda for sustainable competitiveness, social fairness and resilience, COM(2020) 274 final.
Amendment 22 #
2023/0199(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) A Sovereignty Seal should be awarded to projects contributing to the two STEP objectives, provided that the project has been assessed and complies with the minimum quality requirements, in particular eligibility, exclusion and award criteria, provided by a call for proposals under Horizon Europe, the Digital Europe programme,50 the EU4Health programme,51 the European Defence Fund or the Innovation Fund, and regardless of whether the project has received funding under those instruments. These minimum quality requirements will be established with a view to identify high quality projects. This Seal should be used as a quality label, to help projects attract public and private investments by certifying its contribution to the STEP objectives. Moreover, the Seal will promote better access to EU funding, notably by facilitating cumulative or combined funding from several Union instruments. __________________ 50 Regulation (EU) 2021/694 establishing the Digital Europe Programme (OJ L 166, 11.5.2021, p. 1). 51 Regulation (EU) 2021/522 establishing a Programme for the Union’s action in the field of health, EU4Health Programme (OJ L 107, 26.3.2021, p. 1).
Amendment 29 #
2023/0199(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) In order to help accelerate investments and provide immediate liquidity for investments supporting the STEP objectives under the ERDF, the ESF+59 and the JTF, an additional amount of exceptional pre-financing should be provided in the form of a one-off payment with respect to the priorities dedicated to investments supporting the STEP objectives. The additional pre-financing should apply to the whole of the JTF allocation given the need to accelerate its implementation and the strong links of the JTF to support Member States towards the STEP objectives. The rules applying for those amounts of exceptional pre-financing should be consistent with the rules applicable to pre-financing set out in Regulation (EU) 2021/1060. Moreover, to further incentivise the uptake of such investments and ensure its faster implementation, the possibility for an increased EU financing rate of 100% for the STEP priorities should be available. When implementing the new STEP objectives, managing authorities are encouraged toshould apply certain social criteria or promote social positive outcomes, such as creating apprenticeships and jobs for young disadvantaged persons, in particular young persons not in employment, education or training, applying the social award criteria in the Directives on public procurement when a project is implemented by a body subject to public procurement, and paying the applicable wages as agreed through collective bargaining. __________________ 59 Regulation (EU) 2021/1057 establishing the European Social Fund Plus (ESF+) (OJ L 231, 30.6.2021, p. 21).
Amendment 35 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – introductory part
Article 2 – paragraph 1 – introductory part
1. To strengthen European sovereignty and security, accelerate the Union’s green and digital transitions and enhance its competitiveness, reduce its strategic dependencies, favour a level playing field in the Single Market for investments throughout the Union, and promote inclusive access to training and attractive, quality jobs, the Platform shall pursue the following objectives:
Amendment 36 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a – introductory part
Article 2 – paragraph 1 – point a – introductory part
(a) supporting the development or manufacturing throughout the Union, or safeguarding and strengthening the respective value chains, of critical technologies in the following fields:
Amendment 37 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a – point ii
Article 2 – paragraph 1 – point a – point ii
(ii) clean technologies, included those listed in [Regulation 2023/0081]
Amendment 38 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
Amendment 41 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 (new)
Article 2 – paragraph 1 – subparagraph 1 (new)
While following this objective, the Platform shall contribute to addressing shortages of labour and skills critical to all kinds of quality jobs related to technologies listed under points (i), (ii) and (iii) and apply social criteria in order to contribute to the achievement of social positive outcomes. Addressing the skills shortages in these technologies shall be made in close cooperation with existing education and training initiatives, in particular the European Net Zero Industry Academies, not least by using the learning content developed by them.
Amendment 45 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4a. The social criteria referred to in paragraph 1 includes the compliance with Union and national labour law, social rights and workers’ rights as well as with applicable collective agreements. It also includes well-defined objectives in terms of skilling, upskilling and reskilling workers, and the promotion of inclusive labour markets through measures aimed at improving gender equality and diversity at work, such as via the inclusion of people with disability or young people not in education, training or employment (NEETs), or at developing quality and paid apprenticeships. These social criteria shall also be part of the assessment in public procurement procedures when a project is implemented by a body subject to public procurement.
Amendment 51 #
2023/0199(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Commission shall award a Sovereignty Seal to any action contributing to any of the Platform objectives, provided the action has been assessed and complies with the minimum quality requirements, in particular eligibility, exclusion and award criteria, provided by a call for proposals under Regulation (EU) 2021/695, Regulation (EU) 2021/694, Regulation (EU) 2021/697, Regulation (EU) 2021/522, or Commission Delegated Regulation (EU) 2019/856.
Amendment 57 #
2023/0199(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point c a (new)
Article 6 – paragraph 1 – point c a (new)
(ca) ongoing and upcoming calls for proposals and calls for tender linked to the European Net Zero Academies, the deployment of their learning programmes and other training initiatives in net-zero technologies ;
Amendment 64 #
2023/0199(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point 1
Article 12 – paragraph 1 – point 1
In addition to the pre-financing for the programme provided for in Article 90(1) and (2) of Regulation (EU) 2021/1060, where the Commission approves an amendment of a programme including one or more priorities dedicated to operations supported by the ESF+ contributing to the STEP objectives referred to in Article 2 of Regulation .../...66 [STEP Regulation], it shall make an exceptional pre-financing of 30% on the basis of the allocation to those priorities. This exceptional pre-financing shall benefit operations which contribute to the deployment of the learning programmes of the European Net Zero Academies as well as the training of young people and the skilling, upskilling and reskilling of workers in net-zero technologies. The exceptional pre- financing shall be paid by 31 December 2024, provided the Commission has adopted the decision approving the programme amendment by 31 October 2024. __________________ 66 Regulation …/… of the European Parliament and of the Council … [insert full title and OJ reference]. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en ([Regulation 2023/0081])
Amendment 144 #
2023/0132(COD)
Proposal for a directive
Recital 2
Recital 2
(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post- authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal treatments, inappropriate or highly burdensome treatments or treatments addressing subpopulations of a disease only. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.
Amendment 147 #
2023/0132(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, and establishes a conducive environment for the research, development, and manufacturing of pharmaceuticals within the Union while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 150 #
2023/0132(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 151 #
2023/0132(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3 a) In parallel of this revision, the Union should build a new European pharmaceutical ecosystem to accelerate research and development of a new medicinal product and support innovation through the establishment of public- private partnerships, the multiplication of University Hospital Institutes, centres of excellence and bioclusters.
Amendment 153 #
2023/0132(COD)
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3 b) With the financial support from the Horizon Europe programme, the Union should participate to the establishment of a sustainable network of centres of excellence complementing each other to enable transnational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of any diseases. These scientific and technical centres are expected to provide access and advance translatable, quality-controled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs. They are also expected to explore the establishment of connections with clinical networks.
Amendment 155 #
2023/0132(COD)
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
(4 a) This revision should align with the EU's ambitions in industry, digitalization, and trade, acknowledging the critical role of the European life sciences sector, especially the pharmaceutical industry, in upholding the EU's competitive edge. Bolstering robust European research and development is crucial for European sovereignty within the ambit of a globally competitive geopolitical landscape. The pharmaceutical legislative framework should be attuned to the broader EU industrial strategy, echoing the Council's emphasis from 23 March 2023 on amplifying incentives for investment in innovation and the 2016 Council's guidance that any amendments, including those affecting the incentive system, should not hinder the creation of drugs for rare disease treatment. Advancements in innovation are pivotal for enhancing patient health outcomes and the wider public health sector.
Amendment 156 #
2023/0132(COD)
Proposal for a directive
Recital 4 b (new)
Recital 4 b (new)
(4 b) This Directive should acknowledge that fostering a competitive pharmaceutical industry within the EU, bolstering EU-based clinical trials, and localizing the manufacture of active pharmaceutical ingredients are complementary objectives that enhance the Union's strategic health autonomy while increasing the affordability, accessibility, and availability of medicinal products, thereby supporting a more resilient and sustainable European health ecosystem.
Amendment 164 #
2023/0132(COD)
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the UnionEU's pharmaceutical industry, in particular of SMEs. Furthermore, it should aim to prioritize the expansion of EU-based clinical trials and the local production of active pharmaceutical ingredients, thereby reinforcing the strategic autonomy of the European health ecosystem. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need, EU-based innovation and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 188 #
2023/0132(COD)
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18 a) The Agency should create a program aimed at assisting academic institutions and non-profit organizations in navigating the centralized marketing authorization process. This initiative should be informed by insights from the EMA's pilot program that began in September 2022, which provided specialized support to academic and non- profit developers of advanced therapy medicinal products.
Amendment 220 #
2023/0132(COD)
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, cooperation in this area is essential in order to avoid that decisions in one Member State create shortages in other Member States. For this reason, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicines, including for Member States with lower purchasing power. The Commission may support joint price negotiation with pharmaceutical companies, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on national pricing, reimbursment and public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 222 #
2023/0132(COD)
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, tcooperation and dialogue with all stakeholders in this areas could help to avoid that decisions in one Member State contribute to unavailability in other Member States. The Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 225 #
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, antibiotics and generic and biosimilar medicinal products. _________________ 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 251 #
2023/0132(COD)
Proposal for a directive
Recital 53 a (new)
Recital 53 a (new)
(53 a) During negotiations, developers and Member States should imperatively respect and adhere to the timelines set out by Directive 89/105/EEC, to accelerate and widen the availability of innovative therapies to patients.
Amendment 262 #
2023/0132(COD)
Proposal for a directive
Recital 58
Recital 58
(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith. In addition, the timelines set by Directive 89/105/EEC should be respected during the negotiations between Member States and marketing authoriation holder to ensure a fast and timely patient's access to medicines.
Amendment 266 #
2023/0132(COD)
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Supply assurance can also be achieved through national strategies that facilitate patient access, such as programs for named patients, tailored individual patient initiatives, and the uptake and optimization of cross-border healthcare options, as stipulated in Directive 2011/24/EU. It is crucial to bolster cross- border healthcare, especially for treatments that require specialized infrastructure or technical expertise that may be lacking in certain Member States.
Amendment 308 #
2023/0132(COD)
Proposal for a directive
Recital 67
Recital 67
(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States who. Member States should ensure appropriate collection system for all medicinal products.
Amendment 316 #
2023/0132(COD)
Proposal for a directive
Recital 69 a (new)
Recital 69 a (new)
(69 a) A progressive reform towards unitary packaging of medicines, in particular in hospital pharmacies, could result in a decrease of the materials used for the packaging of medicines, a reduction of the carbon footprint of the transport of medicines, a reduction in medicines waste, a better management of pollution from pharmaceutical waste, a prevention of tension and shortages of medicines, and an innovative tool to fight against antimicrobial resistance. The use of single dose unit containing all usefull information, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.
Amendment 324 #
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. The ERA should be updated when new data or knowledge about relevant risks become available. The Commission may explore creating an ecolabeling of medicinal products which respect the ERA's guidelines during their entire life cycle.
Amendment 346 #
2023/0132(COD)
Proposal for a directive
Recital 93
Recital 93
(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance as well as for the raw and initial materials employed in the production of cell and gene therapies, such as cytokines, culture media, reagents, plasmids, and viral vectors.
Amendment 357 #
2023/0132(COD)
Proposal for a directive
Recital 123
Recital 123
(123) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorised to supply medicinal products to the public certain public service obligations. Those Member States should be able to continue to impose those obligations on wholesalers established within their territory. They should also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those that they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection. Member States should also impose certain obligations of public services to wholesalers within the limits of their responsibilities to ensure that medicinal products made available on one market are not placed on another market to avoid creating a shortage for patients.
Amendment 359 #
2023/0132(COD)
Proposal for a directive
Recital 123 a (new)
Recital 123 a (new)
(123 a)Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor their proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive use of electronic package leaflets.
Amendment 363 #
2023/0132(COD)
Proposal for a directive
Recital 128
Recital 128
(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should be lifted for medicinal products not intended for self- administration by the patient.
Amendment 367 #
2023/0132(COD)
Proposal for a directive
Recital 130
Recital 130
(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi- language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and introducing the obligation to use the international non-proprietary name for medicinal products not intended for self- administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.
Amendment 387 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
Amendment 395 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 5 – point c a (new)
Article 1 – paragraph 5 – point c a (new)
(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’). Hospital formulae are supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.
Amendment 396 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 5 – point c b (new)
Article 1 – paragraph 5 – point c b (new)
(c b) radiopharmaceuticals, prepared in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, or in accordance with a pharmacopoeia and if the radiopharmaceutical is intended to be used in-house, for diagnostic as well as therapeutic applications.
Amendment 400 #
2023/0132(COD)
6. Medicinal products referred to in paragraph 5, point (a), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven daysaccording to appropriate stability.
Amendment 408 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 10 – point a
Article 1 – paragraph 10 – point a
Amendment 419 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner and a hospital pharmacist, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).
Amendment 430 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.
Amendment 434 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to thegood pharmacy preparation practices that are adapted to hospital proceesses and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).
Amendment 443 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, safety, quality and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.
Amendment 447 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 5
Article 2 – paragraph 5
5. If a hospital exemption approval is revoked due to safety, quality, or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.
Amendment 456 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety, quality and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a publicly accessible repository of that data in the form of an EU-wide registry.
Amendment 465 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.
Amendment 466 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for harmonised implementation of preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.
Amendment 497 #
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, antiparasitics and antifungals;
Amendment 514 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)
Article 4 – paragraph 1 – point 30 a (new)
(30 a) platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established, and which is prepared in a separate document by the owner of the platform technology. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to
Amendment 522 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 33
Article 4 – paragraph 1 – point 33
(33) ‘environmental risk assessment’ means the evaluation of the risks to the environment, including global warming, or risks to public health, posed by the release of the medicinal productmanufacture, use and disposal of the medicine, as well as its release into the environment from the use and disposal of the medicinal product and. The assessment includes the identifictermination of riskmeasures to prevention, limitation and mitigation measuree these risks. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;
Amendment 550 #
2023/0132(COD)
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1 (new)
Article 6 – paragraph 2 – subparagraph 1 (new)
The marketing authorisation application shall include the results of controlled clinical trials randomised versus an established medicinal product of proven therapeutic value with clinical endpoints or versus placebo in case of lack of established medicinal product of proven therapeutic value. Any other design shall be duly justified and accepted only for exceptional situations.
Amendment 551 #
2023/0132(COD)
Proposal for a directive
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. The marketing authorisation application shall include the particulars and documentation listed in Annex I, submitted in accordance with Annex II. Where justified for therapeutic purposes, a marketing authorisation may be granted for a medicinal product for which an active substance master file, an additional quality master file and/or a platform technology master file exists and is referred to in the application.
Amendment 593 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities corresponding to the duration of treatment. If an antimicrobial can not be dispensed per unit, the marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.
Amendment 596 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 (new)
Article 17 – paragraph 3 – subparagraph 1 (new)
Pharmacists should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.
Amendment 598 #
2023/0132(COD)
Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2
Article 18 – paragraph 1 – subparagraph 2
As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device, particularly for paediatric patients, encompassing aspects such as storage, assembly, cleanliness, and the technique required for application or intake.
Amendment 607 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, and guidelines relating to the assessment of the greenhouse gas emissions footprint of a medicine, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.
Amendment 618 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment. When necessary, it shall also include information on available techniques and on the techniques that will be used to reduce the discharges and emissions of the medicinal product, in particular those occuring in manufacturing effluents before these effluents leave the manufacturing sites.
Amendment 622 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU during the manufacture and use of the medicine. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 630 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
3 a. The applicant also includes in the ERA an assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product. It specifies risk mitigation measures aimed at limiting greenhouse gas emissions during the production and use of the medicine. The applicant explains in detail that the proposed mitigation measures are appropriate and sufficient to limit these emissions in line with the European Union's climate objectives of Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework required to achieve climate neutrality.
Amendment 632 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including also by the healthcare professionnals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 648 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. The results of the ERA assessment, including data provided by the marketing authorisation holder, shall be made publicly available by the Agency or, where appropriate, by the competent authority of the Member State after deletion of any information of a commercially confidential nature.
Amendment 650 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 7 b (new)
Article 22 – paragraph 7 b (new)
7 b. With regard to medicinal products referred to in Articles 9 to 12, the applicant may take into account the ERAs carried out for the reference medicinal product when carrying out the ERA.The Commission is empowered to adopt delegated acts in accordance with Article 215, in order to supplement this Directive by specifying: a) reference methodologies for assessing the greenhouse gas emissions footprint of the production and use of the medicinal product; (b) the minimum data on which to base the assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product; (c) reference methodologies for the assessment of environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product; d) the minimum data on which to base the assessment of the environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product.
Amendment 652 #
2023/0132(COD)
Proposal for a directive
Article 22 a (new)
Article 22 a (new)
Article 22a In accordance with Article 6(2), applicants for marketing authorization are required to incorporate data on patient experiences within their application dossiers. If inclusion of such data is not feasible, applicants must present a comprehensive explanation to the Agency. The Agency shall cooperate with patient organizations, Member State authorities, and other pertinent entities to develop guidance on the creation, execution, analysis, and reporting of studies that integrate substantial and significant patient experience data for regulatory purposes.
Amendment 668 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 4 a (new)
Article 23 – paragraph 4 a (new)
4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.
Amendment 678 #
2023/0132(COD)
Proposal for a directive
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance, preparation or other material present or used in the manufacture of a medicinal product including cell and gene therapies;
Amendment 690 #
2023/0132(COD)
Proposal for a directive
Article 28 – paragraph 1 – point b a (new)
Article 28 – paragraph 1 – point b a (new)
(b a) the creation of the product occurred within a regulatory sandbox as outlined by Article 114 (2) of [revised Regulation (EC) No 726/2004], unless exceptions are warranted by scientific and technical reasoning.
Amendment 693 #
2023/0132(COD)
Proposal for a directive
Article 28 – paragraph 6 a (new)
Article 28 – paragraph 6 a (new)
6 a. When enacting delegated acts under this Article, the Commission shall engage in dialogue with the Agency, national competent authorities, the Pharmaceutical Committee, and pertinent interested parties.
Amendment 694 #
2023/0132(COD)
Proposal for a directive
Article 28 – paragraph 6 b (new)
Article 28 – paragraph 6 b (new)
6 b. The Commission shall submit a report on the acquired experience with adapted frameworks to the European Parliament and the Council of the European Union. The first report is due five years following [insert date = 18 months post-implementation of this Directive] and on a five-year cycle subsequently. Based on the report's findings, the Commission may propose legislative changes to the overarching pharmaceutical laws, reflecting the practical insights gained from employing adapted frameworks. d frameworks.
Amendment 763 #
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, with the exception of medicinal products authorised before 30 October 2005 to avoid restricting patients' access to existing treatments;
Amendment 771 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial of systemic administration; or
Amendment 789 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may setdecide to make an antimicrobial other than those referred to in paragraph 1 point (e) subject to prescription, and additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 1383 #
2023/0132(COD)
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or healthcare professionals.
Amendment 1384 #
2023/0132(COD)
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or healthcare professionals.
Amendment 1397 #
2023/0132(COD)
Proposal for a directive
Article 112 a (new)
Article 112 a (new)
Amendment 1445 #
2023/0132(COD)
Proposal for a directive
Article 160 – paragraph 2 a (new)
Article 160 – paragraph 2 a (new)
2. The Commission is empowered to adopt delegated acts in order to supplement this Directive by establishing, within good manufacturing practices for medicinal products and active substances, principles, guidelines and detailed guidelines to ensure that water pollution , soil and air linked to their manufacture are reduced as much as possible, in accordance with the state of scientific knowledge. The obligations created by the delegated acts will first have been the subject of a feasibility study including at least an assessment of their impacts in terms of environmental risk management and security of supply for the European market.
Amendment 1457 #
2023/0132(COD)
Proposal for a directive
Article 167 – paragraph 3 a (new)
Article 167 – paragraph 3 a (new)
Amendment 1474 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 1 – subparagraph 1 (new)
Article 177 – paragraph 1 – subparagraph 1 (new)
Member States shall monitor the digital market services or products, websites, applications likely to broadcast advertising for prescription medicinal products for which advertising is prohibited according to article 177, paragraph 1.
Amendment 1545 #
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 the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.
Amendment 1555 #
2023/0132(COD)
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments.
Amendment 1565 #
2023/0132(COD)
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.
Amendment 1567 #
2023/0132(COD)
Proposal for a directive
Article 201 – paragraph 1
Article 201 – paragraph 1
1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. The Agency shall oversee the examination and results of inquiries and disclose pertinent information, ensuring any commercially sensitive data is removed prior to publication.
Amendment 1582 #
2023/0132(COD)
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the medicinal products gathered are managed appropriately, preventing any technically preventable environmental leakage.
Amendment 1588 #
2023/0132(COD)
Proposal for a directive
Article 207 – paragraph 1 – subparagraph 1 (new)
Article 207 – paragraph 1 – subparagraph 1 (new)
Member States shall promote awareness- raising and educational campaigns for the general public on the environmental risks of pharmaceuticals and on how to improve disposal practices.
Amendment 1590 #
2023/0132(COD)
Proposal for a directive
Article 208 – paragraph 1
Article 208 – paragraph 1
1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality and their independance. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary.
Amendment 1594 #
2023/0132(COD)
Proposal for a directive
Article 208 – paragraph 2 a (new)
Article 208 – paragraph 2 a (new)
2 a. 3. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work.
Amendment 1598 #
2023/0132(COD)
Proposal for a directive
Article 216 – paragraph 1
Article 216 – paragraph 1
By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, in particular regarding the prolongation of data protection period to take into account the evolution of scientific knowledge and innovation.
Amendment 204 #
2023/0131(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by creatingaiming to create an attractive environment for research, development and production of medicines in the Union, along with a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while ensuring security of supply and addressing environmental concerns.
Amendment 206 #
2023/0131(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by creatingsupporting a conducive environment for the research, development, and manufacturing of pharmaceuticals within the Union along with a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while ensuring security of supply and addressing environmental concerns.
Amendment 212 #
2023/0131(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Addressing unequal patient access of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe as has been highlighted by the Council and the European Parliament. Member States and the Parliament have called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring patient access and availability of medicinal products in all Member States.
Amendment 218 #
2023/0131(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) The pharmaceutical framework should be aligned with the EU's ambitions in industry, digitalization and trade, acknowledging the critical role of the European life sciences sector, especially the pharmaceutical industry, in upholding the EU's competitive edge. Bolstering robust European research and development is crucial for European sovereignty within the ambit of a globally competitive geopolitical landscape. The pharmaceutical legislative framework should be attuned to the broader EU industrial strategy, echoing the Council's emphasis from 23 March 2023 on amplifying incentives for investment in innovation and the 2016 Council's guidance that any amendments, including those affecting the incentive system, should not hinder the creation of drugs for rare disease treatment. Advancements in innovation are pivotal for enhancing patient health outcomes and the wider public health sector.
Amendment 230 #
2023/0131(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Promising medicinal products that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support, including through supporting innovative patient-relevant in vitro and in silico technologies which are key to the development of these products. Such support will ultimately help patients benefit from new therapies as early as possible.
Amendment 248 #
2023/0131(COD)
Proposal for a regulation
Recital 30 a (new)
Recital 30 a (new)
(30 a) For informed policy development, the Agency should maintain its authority to carry out pilot programs, fostering a regulatory environment that is adaptive to future challenges. Efforts like the 2022 pilot program that provided augmented assistance to academic and non-profit developers of advanced therapy medicinal products should inform policy decisions and refine regulatory guidance.
Amendment 261 #
2023/0131(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals. The composition, responsibilities, operating methods, and areas of expertise of the Committees, Working Parties, and Working Groups, along with their work programs and suggestions, will be disclosed to the public and may be opened for stakeholder feedback.
Amendment 263 #
2023/0131(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients, their caregivers and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 269 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and their caregivers, healthcare professionals, industry, associations representing payers, academia, or other stakeholders, as relevant.
Amendment 270 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and their caregivers, healthcare professionals, academia, industry, associations representing payers, or other stakeholders, as relevant.
Amendment 272 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and their caregivers, healthcare professionals, industry, associations representing payers, or other stakeholders, as relevant.
Amendment 285 #
2023/0131(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes49 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of live animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available Agency and the International Committee for Harmonisation (ICH) guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use ofgiving priority to new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D) cell culture models, organoids and human stem cells- based models; in silico tools or read-across models. _________________ 49 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 306 #
2023/0131(COD)
Proposal for a regulation
Recital 60
Recital 60
(60) Regulatory decision-making on the development, authorisation and supervision of medicinal products may be supported by access and analysis of health data, including real world data, where appropriate, i.e. health data generated outside of clinical studies and/or through the use of in silico methods, such as computational modelling and simulation (CM&S) which includes PBPK, molecular modelling and mechanistic modelling, digital twin & artificial intelligence (AI). The Agency should be able to use such data, including via the Data Analysis and Real World Interrogation Network (DARWIN) and the European Health Data Space interoperable infrastructure. Through these capabilities the Agency may take advantage of all the potential of supercomputing, artificial intelligence and big data science to fulfil its mandate, without compromising privacy rights. Where necessary the Agency may cooperate with the competent authorities of the Member States towards this objective.
Amendment 310 #
2023/0131(COD)
Proposal for a regulation
Recital 66
Recital 66
(66) Expedited Regulatory Pathways are a well-utilised tool to make assessments of pharmaceuticals more efficient and to modernise regulatory systems. Through the Priority Medicines (PRIME) scheme, the Agency has gained experience of the provision of early scientific and regulatory support to developers of certain medicinal products that, based on preliminary evidence, are likely to address an unmet medical need and are considered promising at an early stage of development. IGiven the objectives of this Regulation – to futureproof and simplify the European regulatory system, it is appropriate to recognise and strengthen this early support mechanism, including for priority antimicrobials and repurposed medicinal products when they fulfil the criteria for the scheme, and allow the Agency, in consultation with the Member States and the Commission, to establish selection criteria for promising medicinal products.
Amendment 316 #
2023/0131(COD)
Proposal for a regulation
Recital 71 a (new)
Recital 71 a (new)
(71 a) Phased reviews have been a success during the COVID-19 pandemic and led to a rapid authorisation of the urgently needed vaccines. An application in times outside of public health emergencies is therefore appropriate and the procedure should be extended to orphan medicinal products and medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition. Moreover, the Commission should evaluate the performance of the phased reviews with the aim to further expand the category of medicinal products for which this procedure may apply.
Amendment 318 #
2023/0131(COD)
Proposal for a regulation
Recital 73
Recital 73
(73) To optimise the use of resources for both applicants for marketing authorisations and competent authorities assessing such applications, a single assessment of an active substance master file should be introduced. The outcome of the assessment should be issued through a certificate. To avoid duplication of assessment, the use of an active substance master file certificate should be mandatory for subsequent applications or marketing authorisations for medicinal products for human use containing that active substance from an active substance master file certification holder. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to extend the certification scheme to additional quality master files, e.g. in case of novel excipients, adjuvantsmaster files, such as quality master files for active substances other than chemical active substances or for other substances present or used in the manufacture of a medicinal product e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and, active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance and conjugates, or such as platform technology master files for platform technologies used in the manufacturing process of one or more medicinal products.
Amendment 319 #
2023/0131(COD)
Proposal for a regulation
Recital 73
Recital 73
(73) To optimise the use of resources for both applicants for marketing authorisations and competent authorities assessing such applications, a single assessment of an active substance master file should be introduced. The outcome of the assessment should be issued through a certificate. To avoid duplication of assessment, the use of an active substance master file certificate should be mandatory for subsequent applications or marketing authorisations for medicinal products for human use containing that active substance from an active substance master file certification holder. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to extend the certification scheme to additional quality master files, e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.
Amendment 350 #
2023/0131(COD)
Proposal for a regulation
Recital 79
Recital 79
Amendment 352 #
2023/0131(COD)
Proposal for a regulation
Recital 79
Recital 79
Amendment 359 #
2023/0131(COD)
Proposal for a regulation
Recital 80
Recital 80
Amendment 360 #
2023/0131(COD)
Proposal for a regulation
Recital 80
Recital 80
Amendment 364 #
2023/0131(COD)
Proposal for a regulation
Recital 81
Recital 81
Amendment 366 #
2023/0131(COD)
Proposal for a regulation
Recital 81
Recital 81
Amendment 369 #
2023/0131(COD)
Proposal for a regulation
Recital 82
Recital 82
Amendment 370 #
2023/0131(COD)
Proposal for a regulation
Recital 82
Recital 82
Amendment 373 #
2023/0131(COD)
Proposal for a regulation
Recital 83
Recital 83
Amendment 374 #
2023/0131(COD)
Proposal for a regulation
Recital 83
Recital 83
Amendment 377 #
2023/0131(COD)
Proposal for a regulation
Recital 84
Recital 84
Amendment 379 #
2023/0131(COD)
Proposal for a regulation
Recital 84
Recital 84
Amendment 383 #
2023/0131(COD)
Proposal for a regulation
Recital 87 a (new)
Recital 87 a (new)
(87 a) The European Parliament adopted a resolution of 10 July 2020 concerning the EU's post-COVID-19 public health strategy, which called for an EU Action Plan specifically targeting rare diseases.
Amendment 389 #
2023/0131(COD)
Proposal for a regulation
Recital 88
Recital 88
(88) Regulation (EC) No 141/2000 of the European Parliament and of the Council55 has proved to be successful in boosting developments of orphan medicinal products in the Union; therefore an action at Union level remains preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Union trade. The Union should not neglect or disregard the success of the Regulation since its entry into force in 2000, and build on its success driving and ensuring a similar degree of innovation under this Regulation. _________________ 55 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
Amendment 399 #
2023/0131(COD)
Proposal for a regulation
Recital 92 a (new)
Recital 92 a (new)
(92 a) Significant benefit should remain the main determining factor for eligibility for orphan status when assessing an orphan medicinal product that meets the incidence threshold.
Amendment 401 #
2023/0131(COD)
Proposal for a regulation
Recital 92 b (new)
Recital 92 b (new)
(92 b) What constitutes significant benefit in a patient population can change over time, therefore, the concept should remain sufficiently flexible to ensure a future-proof regulatory framework while ensuring predictability through additional guidance developped in consultation with patient organisations.
Amendment 405 #
2023/0131(COD)
(93) If a satisfactory method of diagnosis, prevention or treatment of the condition in question has already been authorised in the Union, the orphan medicinal product will have to be of significant benefit to those affected by that condition. In this context, a medicinal product authorised in one Member State is generally deemed as being authorised in the Union. It is not necessary for it to have Union authorisation or to be authorised in all Member States to be considered as a satisfactory method. In addition, commonly used methods of diagnosis, prevention or treatment that are not subject to a marketing authorisation may be considered satisfactory if there is scientific evidence of their efficacy and safety. In certain cases, medicinal products prepared for an individual patient in a pharmacy according to a medical prescription, or according to the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by the pharmacy, may be considered as satisfactory treatment if they are well known and safe and this is a general practice for the relevant patient population in the Union. This only applies to medicinal products that are not advanced therapy medicinal products and that do not otherwise contain complex active substances.
Amendment 411 #
2023/0131(COD)
Proposal for a regulation
Recital 96 a (new)
Recital 96 a (new)
Amendment 419 #
2023/0131(COD)
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentivise research and development of orphan medicinal products addressing high unmet needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; pioneering orphan medicinal products addressing high unmet medical needareas where there is a total lack of approved treatments benefit from the longest market exclusivity, while market exclusivity for well-established use orphan medicinal products, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 428 #
2023/0131(COD)
Proposal for a regulation
Recital 104
Recital 104
(104) To maximise the potential benefit of clinical research, continued exploration of new indications should be encouraged. To reward research into and development of new therapeutic indications, an additional period of one year of market exclusivity is provided for a new therapeutic indication (with a maximum of two indications). To continue incentivising innovation, especially in underserved areas, while also allowing generic entry, any subsequent new orphan marketing authorisations granted to the marketing authorisation holder should receive three years of market exclusivity bound to the indication, not the active substance. This will allow generic competition in the first two orphan indications, while allowing for continued research for those patients who could still benefit.
Amendment 433 #
2023/0131(COD)
Proposal for a regulation
Recital 105 a (new)
Recital 105 a (new)
(105 a)One of the overarching goals of this Regulation is to help meeting the medical needs of patients with rare diseases, to improve the affordability of orphan medicinal products and the patient access to orphan medicinal products across the Union, and to encourage innovation in areas of need. While other Union programmes and policies also contribute to these goals, people living with a rare disease continue to face common challenges that are many and multifactorial, including delayed diagnoses, lack of available transformative treatments, and difficulties to access treatments where they live, reflecting the fragmentation of the market across the Member States. The European added value to addressing the needs of people living with a rare disease being exceptionally high due to the rarity of patients, experts, data, and resources, it is appropriate for the Commission to develop, to complement this Regulation, a dedicated framework for rare diseases to bridge relevant legislation, policies and programmes, and support national strategies with a view to better meet the unmet needs of people living with rare diseases and their carers. This framework should be needs driven and goals based, and developped in consultation with the Member States and patient organisations as well as, where relevant, other interested parties.
Amendment 438 #
2023/0131(COD)
(126) It is necessary to take measures for the supervision of medicinal products authorised by the Union, and in particular for the intensive supervision of undesirable effects of these medicinal products, and the collection of real-world data within the framework of Union pharmacovigilance activities, so as to ensure the rapid withdrawal from the market of any medicinal product presenting a negative benefit-risk balance under normal conditions of use.
Amendment 440 #
2023/0131(COD)
Proposal for a regulation
Recital 129
Recital 129
(129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data- driven and multiplying the possibilities to access evidence and real-world data, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On this basis, the Agency should take initiative to update the summary of product characteristics in case new efficacy or safety data has an impact on the benefit- risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.
Amendment 452 #
2023/0131(COD)
Proposal for a regulation
Recital 133
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, regulatory methods services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products, including where medical devices or in- vitro diagnostics are used as combination products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.
Amendment 457 #
2023/0131(COD)
Proposal for a regulation
Recital 134
Recital 134
(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected. Whenever possible, priority should be given to the use of non-animal approaches.
Amendment 470 #
2023/0131(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment, including longer delays or interruptions in care or therapy, longer periods of hospitalisation, increased risks of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.
Amendment 477 #
2023/0131(COD)
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against medicine shortages, in respect of the commitments taken in the framework of the "Voluntary Solidarity Mechanism for medicines". It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe.
Amendment 482 #
2023/0131(COD)
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. Health professional and patient organisations should be consulted before the adoption of the list. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency minimum safety-stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 484 #
2023/0131(COD)
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. The MSSG should develop in coordination with the Agency a Voluntary Solidarity Mechanism to allow Member States where stocks of important medicines are critically low and where other available options have been exhausted to send out on a voluntary basis a notification, to which other Members States may respond on a voluntary basis to provide temporary relief. This mechanism should leverage existing structures, including the European Shortages Monitoring Platform (‘ESMP’), established by Regulation (EU) 2022/123, and should invite manufacturers and wholesalers to participate where relevant. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 488 #
2023/0131(COD)
Proposal for a regulation
Recital 138 a (new)
Recital 138 a (new)
(138 a)In addition to existing and planned policy, legislative and regulatory measures, the Union need a strategic and coordinated industrial approach to ensure the security of supply of the most critical medicines. The Critical Medicines Alliance and the future Critical Medicines Act could allow national authorities, industry, civil society representatives, the Commission and the EU agencies to develop together coordinated actions at Union level against the shortages of medicines, in compliance with the competition rules and the Union’s international commitments. The future Critical Medicines Act could support the European green, digital manufacturing of critical medicines, APIs and intermediate ingredients, diversify the EU pharmaceutical supply chains and secure the strategic autonomy of critical medicines.
Amendment 489 #
2023/0131(COD)
Proposal for a regulation
Recital 138 a (new)
Recital 138 a (new)
(138 a)To avoid that measures foreseen or taken by a Member State to prevent or mitigate a shortage at national level when responding to the legitimate needs of its citizen increase the risk of shortages in another Member State, the Agency should assess those measures with regards to their potential or actual impact on the availability and security of supply in other Member States and at European level, and inform of its assessment the Member States and the MSSG.
Amendment 490 #
2023/0131(COD)
Proposal for a regulation
Recital 138 b (new)
Recital 138 b (new)
(138 b)One of the aims of this Regulation is to set out a framework for the activities to be deployed by the Member States and the Agency to improve the Union's capacity to react efficiently and in a coordinated manner to support shortage management and security of supply of medicinal products, in particular critical medicinal products, to EU citizens, at all times. Those shortages are a persistent problem that has been increasingly affecting the health and lives of Union citizens for decades and the root causes are multifactorial. Therefore, this Regulation should be a first step towards improving the Union response to that persistent problem. The Commission should subsequently expand that framework to continue addressing the causes of shortages of medicinal products, and better prevent and mitigate their effects.
Amendment 491 #
2023/0131(COD)
Proposal for a regulation
Recital 138 c (new)
Recital 138 c (new)
(138 c) To complement this Regulation and as a first step to a more structural, long term approach to reduce Union dependencies for critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries, the Commission should propose by (OP: 24 months after the date of entry into force of this Regulation) a legislative initiative for an EU Critical Medicines Act for supporting the European green, digital manufacturing of key medicines, active pharmaceutical ingredients, and intermediate pharmaceutical ingredients for which the Union is dependent on one country or a limited number of manufacturers.
Amendment 492 #
2023/0131(COD)
Proposal for a regulation
Recital 138 d (new)
Recital 138 d (new)
(138 d)It is appropriate for the Commission to build upon the Communication addressing medicine shortages in the European Union of 24 October 2023 and the many tools which can be used to promote a coordinated industrial approach, bringing together public and private actors from the European health and industrial ecosystem.
Amendment 505 #
2023/0131(COD)
Proposal for a regulation
Recital 143
Recital 143
(143) To ensure uniform conditions for the implementation of this Regulation in relation to marketing authorisations for medicinal products for human use, implementing powers should be conferred on the Commission. The implementing powers related to the granting of centralised marketing authorisations and for suspending, revoking or withdrawing those authorisations, for granting vouchers, establishing and modifying regulatory sandboxes and decisions on the regulatory status of medicinal products should be exercised in accordance with Regulation (EU) 182/2011.
Amendment 506 #
2023/0131(COD)
Proposal for a regulation
Recital 143
Recital 143
(143) To ensure uniform conditions for the implementation of this Regulation in relation to marketing authorisations for medicinal products for human use, implementing powers should be conferred on the Commission. The implementing powers related to the granting of centralised marketing authorisations and for suspending, revoking or withdrawing those authorisations, for granting vouchers, establishing and modifying regulatory sandboxes and decisions on the regulatory status of medicinal products should be exercised in accordance with Regulation (EU) 182/2011.
Amendment 508 #
2023/0131(COD)
Proposal for a regulation
Recital 145
Recital 145
(145) Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, including some advanced therapy medicinal products, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and consent by the competent authority of a Member State is complex and can take a significant amount of time.
Amendment 517 #
2023/0131(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to the monitoring and management of shortages and critical shortages and security of supply of medicinal products, and lays down the governance provisions of the European Medicines Agency (‘the Agency’) established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6 and other relevant Union legal acts.
Amendment 521 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal product sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);
Amendment 531 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 7 a (new)
Article 2 – paragraph 2 – point 7 a (new)
(7 a) 'adverse reaction' means a response to a medicinal product that is noxious and unintended, and includes medication errors and uses outside of the terms of the marketing authorisation, including the misuse and abuse of the medication product;
Amendment 549 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) ‘demand’ means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;
Amendment 550 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) ‘demand’ means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;
Amendment 559 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet the demand for that medicinal product in that Member State.or medical device at a national level, whatever the cause
Amendment 560 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet the demand for that medicinal product or medical device in that Member State, whatever the cause.
Amendment 565 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(12 a) ‘supply’ means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 572 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 14 a (new)
Article 2 – paragraph 2 – point 14 a (new)
(14 a) 'Healthcare professionals’ organisations’ means not-for-profit organisations that have an interest in patient care, and where healthcare professionals represent a majority of members in governing bodies.
Amendment 574 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 14 b (new)
Article 2 – paragraph 2 – point 14 b (new)
(14 b) ‘Patients’ organisations’ means as not-for-profit organisations which are patient focused, and where patients and/or carers (the latter when patients are unable to represent themselves) represent a majority of members in governing bodies.
Amendment 577 #
2023/0131(COD)
Proposal for a regulation
Article 4 – title
Article 4 – title
Member State authorisation of generics of centrally authorisedspecific categories of medicinal products
Amendment 583 #
2023/0131(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) the application for marketing authorisation is submitted in accordance with Article 9, 10, 13 of [revised Directive 2001/83/EC], or for active substances used in fixed dose combination medicinal products that have previously been used in the composition of authorised medicinal products;
Amendment 585 #
2023/0131(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the generic medicinal product was marketed and where the applicant for the generic medicinal product has requested not to include this information in their marketing authorisation.
Amendment 589 #
2023/0131(COD)
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Within 20 days of receipt of an application, the Agency shall check whether all the information and documentation required in accordance with Article 6 have been submitted, that the application does not contain critical deficiencies as defined in guidelines established under paragraph 7 that may prevent the evaluation of the medicinal product and decide whether the application is valid.
Amendment 591 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
The documentation shall include a declaration to the effect that clinical trials carried out outside the Union meet the ethical requirements of Regulation (EU) No 536/2014. Those particulars and documentation shall take account of the unique, Union nature of the authorisation requested and, otherwise than in exceptional cases relating to the application of the law on trademarks pursuant to Regulation (EU) 2017/1001 of the European Parliament and of the Council66 , shall include the use of a single name for the medicinal product. The use of a single name does not exclude: (a) the use of additional qualifiers where necessary to identify different presentations of the medicinal product concerned. (b) the use of identified versions of the summary of product characteristics as referred to in article 62 of [Revised Directive] in situations where elements of the product information are still covered by patent law or supplementary protection certificates for medicinal products. (c) the use of additional qualifiers where necessary to identify different presentations of the medicinal product concerned. _________________ 66 Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, p. 1).
Amendment 599 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment, including with regard to the quality of life of a relevant patient population or subpopulation, of a life- threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 602 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For orphan medicinal products and medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 607 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Where appropriate, the application may include an active substance master file certificate or an application for an active substance master file or any other quality master file certificate or application as referred to in Article 25 and Article 26 of [revised Directive 2001/83/EC].
Amendment 608 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. When scientifically reliable non-animal testing alternatives are unavailable, applicants utilizing animal testing must adhere to the principles of replacement, reduction, and refinement of animal testing for scientific purposes. This adherence must be in accordance with Directive 2010/63/EU for any animal study carried out to support their application.
Amendment 616 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 1520 days.
Amendment 621 #
2023/0131(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article6a Parallel application for one or more new indications (1) During the scientific assessment of an initial marketing authorisation application of a medicinal product by the Agency, the applicant may submit to the Agency a separate parallel application for one or more new indications concerning the same medicinal product. (2) The parallel application shall be assessed by the Agency as a marketing authorisation application in accordance with this Regulation, subject to the following: (a) To the extent the Committee for Medicinal Products for Human Use can assess the parallel application within the timeframe applicable to the initial marketing authorisation application, leading to the same outcome for both applications it shall group the applications and issue a single opinion. (b) To the extent the said Committee cannot issue an opinion on the parallel application within the timeframe applicable to the initial marketing authorisation application the parallel application shall be converted to a Type II variation application in accordance with Commission Regulation (EC) No 1234/2008. (c) If the initial marketing authorisation application is withdrawn or receives a negative opinion from the Committee for Medicinal Products for Human Use, the Committee will pursue the assessment of the parallel application as a standalone marketing authorisation application.
Amendment 629 #
2023/0131(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) identification and characterisation of hazards for the environment, animals and for human health throughout the life cycle of the medicine, including during its production; these risks include those linked to the greenhouse gas emissions footprint;
Amendment 643 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point h
Article 12 – paragraph 4 – point h
(h) where appropriate, details of any recommended obligation to conduct any other post-authorisation studies, including post-authorisation treatment optimisation studies, to improve the safe and effective use of the medicinal product;
Amendment 668 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – 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, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments;
Amendment 676 #
2023/0131(COD)
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1
Article 16 – paragraph 3 – subparagraph 1
The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature and following consultation of patients’ organisations.
Amendment 677 #
2023/0131(COD)
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1
Article 16 – paragraph 3 – subparagraph 1
The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature and subsequent consultation of patient organisations.
Amendment 724 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favourable. After consultation with the marketing authorisation holder, the Agency shall lay down deadlines and criteria for the fulfilment of these conditions, and make them publicly available.
Amendment 726 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favourable. The Agency shall establish and publish specific deadlines and criteria for meeting these conditions, making them accessible to the public.
Amendment 741 #
2023/0131(COD)
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
The granting of a marketing authorisation as well as the granting of a temporary emergency marketing authorisation shall not affect the civil or criminal liability of the manufacturer or of the marketing authorisation holder pursuant to the applicable national law in Member States.
Amendment 756 #
2023/0131(COD)
Proposal for a regulation
Article 25 – paragraph 1 – subparagraph 2 – point a
Article 25 – paragraph 1 – subparagraph 2 – point a
(a) if one of its indications or, posologies, pharmaceutical forms, methods or routes of administration or any other element is protected by a patent or a supplementary protection certificate in one or more Member States;
Amendment 757 #
2023/0131(COD)
Proposal for a regulation
Article 25 – paragraph 1 – subparagraph 3
Article 25 – paragraph 1 – subparagraph 3
As soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall withdraw the initial or duplicate marketing authorisation or where appropriate vary the term of the marketing authorisation to include the relevant SmPC information for which the corresponding patent(s) or supplementary protection certificate(s) has(ve) expired.
Amendment 762 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.
Amendment 766 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 4 – subparagraph 2
Article 26 – paragraph 4 – subparagraph 2
In the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, including real world data, where available, taking into account the reliability of those data.
Amendment 767 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. The Agency shall keep an up-to- date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a centralized database for compassionate use programs on its website.
Amendment 770 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. The Agency shall keep an up-to- date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a central repository for compassionate use on its website.
Amendment 775 #
2023/0131(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. The granting of periods of regulatory protection shall be published and updated where appropriate by the Agency in a designated registry.
Amendment 782 #
2023/0131(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
During a public health emergency, the Commission may grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life- threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information.
Amendment 786 #
2023/0131(COD)
Proposal for a regulation
Article 31 – paragraph 1 – introductory part
Article 31 – paragraph 1 – introductory part
A temporary emergency marketing authorisation or a temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council67 and where the following requirements are met: _________________ 67 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 (OJ L 314, 6.12.2022, p. 26).
Amendment 789 #
2023/0131(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point a
Article 31 – paragraph 1 – point a
(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation of the medicinal productr temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;
Amendment 799 #
2023/0131(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation.
Amendment 801 #
2023/0131(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the Commission shall set specific conditions with respect to the temporary emergency marketing authorisation, in particular the conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices. If necessary, the conditions may specify the batches of the medicinal product concerned by the temporary emergency marketing authorisation, after consultation with the applicant or marketing authorisation holder.
Amendment 803 #
2023/0131(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency, in consultation with the applicant or marketing authorisation holder.
Amendment 805 #
2023/0131(COD)
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
The temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371.
Amendment 809 #
2023/0131(COD)
Proposal for a regulation
Article 34 – paragraph 1 a (new)
Article 34 – paragraph 1 a (new)
1a. When the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with paragraph 1 of this Article, the Agency may set a transitional period after consultation with the marketing authorisation holder in order to avoid any disruption in supply of the medicinal product concerned.
Amendment 814 #
2023/0131(COD)
Proposal for a regulation
Article 35 – paragraph 2 a (new)
Article 35 – paragraph 2 a (new)
2a. Where the Commission adopts any such implementing act, the provisions of Article 34, paragraph 1a shall apply.
Amendment 817 #
2023/0131(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
For the purpose of regulatory data protection, the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, and any subsequent marketing authorisation, as referred to in subparagraph 1, shall be considered as part of the same global marketing authorisation.
Amendment 828 #
2023/0131(COD)
Proposal for a regulation
Article 40
Article 40
Amendment 829 #
2023/0131(COD)
Proposal for a regulation
Article 40 – title
Article 40 – title
Amendment 832 #
2023/0131(COD)
1. Following a request by the applicant when applying for a marketing authorisation, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referrThe Commission shall establish a Union scheme of push and pull incentives to promote and accelerate the development of new priority antmicrobials and the access to existing and new antimicrobials. This scheme shall be financed through public reasearch funding and benefit from Union programmes. Member States shall also be encouraged to in paragraph 4 based on a scientific assessment by the Agencyticipate to the Union scheme. The Union scheme shall be coordinated by the Commission, through DG HERA.
Amendment 838 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 1 – subparagraph 1 (new)
Article 40 – paragraph 1 – subparagraph 1 (new)
The Commission is empowered to adopt delegated acts in accordance with Article 175 to define further the Union scheme and its funding.
Amendment 839 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 2
Article 40 – paragraph 2
Amendment 871 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – introductory part
Article 40 – paragraph 4 – subparagraph 1 – introductory part
To be granted the voucherany incentive from the scheme foreseen in paragraph 1 by the Commission, the applicant shall:
Amendment 880 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 2 a (new)
Article 40 – paragraph 4 – subparagraph 2 a (new)
By [18 months after the date of entry into force of this Regulation], the Commission shall have developed the Union scheme of push and pull incentives.
Amendment 881 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 2 b (new)
Article 40 – paragraph 4 – subparagraph 2 b (new)
By [10 years after the date of entry into force of this Regulation], the Commission shall submit a report to the European Parliament and the Council assessing the implementation of the Union scheme of push and pull incentives.
Amendment 888 #
2023/0131(COD)
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article40a Push and pull incentives scheme to boost the development of priority antimicrobials 1. The Commission shall establish a Union push and pull incentives scheme to promote and urgently accelerate the development of novel antimicrobials, as well as promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union level scheme. 2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding, which shall include i.a. the following incentives: (a) research grants under Union funds; (b) milestone prizes for novel antimicrobial developers; (c) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales; 3. The Union push and pull incentives scheme shall be coordinated and managed by the Commission. 4. By ... [one year after the date of entry into force of this Regulation], the Commission shall have developed, and commenced the implementation of the Union push and pull incentives scheme. 5. By ... [7 years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and to the Council reviewing the application of the scheme laid down in this Article.
Amendment 903 #
2023/0131(COD)
Proposal for a regulation
Article 41
Article 41
Amendment 904 #
2023/0131(COD)
Proposal for a regulation
Article 41
Article 41
Amendment 905 #
2023/0131(COD)
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
Amendment 906 #
2023/0131(COD)
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
Amendment 909 #
2023/0131(COD)
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2
Article 41 – paragraph 1 – subparagraph 2
Amendment 915 #
2023/0131(COD)
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 3
Article 41 – paragraph 1 – subparagraph 3
Amendment 916 #
2023/0131(COD)
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
Amendment 918 #
2023/0131(COD)
Amendment 921 #
2023/0131(COD)
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
Amendment 929 #
2023/0131(COD)
Proposal for a regulation
Article 42
Article 42
Amendment 930 #
2023/0131(COD)
Proposal for a regulation
Article 42
Article 42
Amendment 942 #
2023/0131(COD)
Proposal for a regulation
Article 43
Article 43
Amendment 944 #
2023/0131(COD)
Proposal for a regulation
Article 43
Article 43
Amendment 946 #
2023/0131(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
Amendment 962 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 1
Article 48 – paragraph 1 – subparagraph 1
An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non- clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.
Amendment 963 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 1
Article 48 – paragraph 1 – subparagraph 1
An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non- clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.
Amendment 968 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 2
Article 48 – paragraph 1 – subparagraph 2
The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need.
Amendment 970 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 2
Article 48 – paragraph 1 – subparagraph 2
The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need.
Amendment 975 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 3
Article 48 – paragraph 3
3. Article 81(2), point (c) of [revised Directive 2001/83/EC] shall notmay apply for variations under this Article.
Amendment 977 #
2023/0131(COD)
Proposal for a regulation
Article 52 – paragraph 2 – subparagraph 1 – point a
Article 52 – paragraph 2 – subparagraph 1 – point a
(a) to lend its assistance by participating in a joint inspection with the supervisory authority of the site to assess the respect of the good manufacturing practice (GMP) including the practices relating to the environmental and social standards. In that case the supervisory authority leads the inspection and the follow up thereof. After completion of the inspection, the supervisory authority grants the relevant good manufacturing practice (GMP) certificate and enters the certificate in the Union database; or
Amendment 979 #
2023/0131(COD)
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
Where the Agency concludes that a holder of a marketing authorisation, or a new therapeutic indication, including when grouped with an extension of the marketing authorisation, granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.
Amendment 984 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 2
Article 58 – paragraph 1 – subparagraph 2
Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC], and for medicinal products used with an in vitro diagnostic medical device.
Amendment 986 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 2
Article 58 – paragraph 1 – subparagraph 2
Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC] and for medicinal products used with an in vitro diagnostic medical device.
Amendment 991 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
3. In the preparation of the scientific advice referred to in paragraph 1 and in duly justified cases, the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or other public bodies established in the Union, as applicable. To avoid any conflict of interest, the Agency shall ensure a separation between the experts responsible for providing scientific advice to a medicinal product developer and those subsequently involved in evaluating marketing authorisation for the same medicine. In the absence of a sufficient panel in the context of a rare disease, an exception may be granted.
Amendment 993 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
4. The Agency shall include in the European public assessment report the key areas of the scientific advice. The Agency shall also indicate the names of experts, rapporteurs and coordinators giving scientific advice. This report shall be made publicly available once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature.
Amendment 996 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. When granting scientific advice, the Agency shall ensure to the greatest extent possible that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating a marketing authorisation application for the same medicinal product. The Agency shall ensure that at least one of the two rapporteurs for a marketing authorisation application should not have taken part in any pre- submission activities concerning the medicinal product. The reasons for any exceptions shall be documented and published with the European Public Assessment Report.
Amendment 1000 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. Disclosed conflicts of interest and the mitigating actions implemented by the concerned individual(s) must be documented in the abridged minutes of the meetings, following the stipulations of Article 147(2).
Amendment 1010 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency mayshall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil the following conditions:
Amendment 1022 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products and are likely to address a high unmetlisted on the register of designated orphan medicinal need aproducts referred to in Aarticle 70(1); 67 (1) of this Regulation;
Amendment 1041 #
2023/0131(COD)
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1
Article 61 – paragraph 1 – subparagraph 1
For products under development which may fall within the categories of medicinal products to be authorised by the Union listed in Annex I, a developer or a competent authority of the Member States may submit a duly substantiated request to the Agency for a scientific recommendation with a view to determining on scientific grounds whether the concerned product is potentially a ‘medicinal product’, including an ‘advanced therapy medicinal product’ as defined in Article 4 (7), (29) and (30) of [revised Directive 2001/83/EC] and Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council71 . _________________ 71 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
Amendment 1098 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 1 – introductory part
Article 68 – paragraph 1 – introductory part
1. The orphan medicine sponsor mayshall, prior to the submission of an application for marketing authorisation, request advice from the Agency on the following:
Amendment 1125 #
2023/0131(COD)
Proposal for a regulation
Article 70
Article 70
Amendment 1152 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and, the authorities or, bodies and stakeholders referred to in Article 162.
Amendment 1157 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineeight years for orphan medicinal products other than those referred to in points (b), (ba) and (c);
Amendment 1159 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nine years for orphan medicinal products other than those referred to in points (b), (c) and (ca);
Amendment 1182 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) twelven years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;where no satisfactory treatment has been approved in the Union for the indication in question.
Amendment 1192 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
Amendment 1194 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
(b a) twelve years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70 in the paediatric population;
Amendment 1209 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 3
Article 71 – paragraph 3
3. Where a marketing authorisation holder holds more than one orphan marketing authorisations for the same active substance, other than in cases foreseen in Article 72, paragraph 2, subparagraph 2, those authorisations shall not benefit from separate market exclusivity periods. The duration of the market exclusivity shall start from the date when the first orphan marketing authorisation was granted in the Union.
Amendment 1222 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
Amendment 1251 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 12 months for orphan medicinal products referred to in Article 71(2), points (a), (b) and (ba), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
Amendment 1259 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 a (new)
Article 72 – paragraph 2 – subparagraph 2 a (new)
Any subsequent marketing authorisation obtained by the marketing authorisation holder for one or more new therapeutic indications for different orphan conditions shall receive a separate market exclusivity of three years, starting from the expiration date of the market exclusivity for the entire product under Article 71, where relevant as extended under paragraphs 1 and 2 of this article.
Amendment 1264 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 a (new)
Article 72 – paragraph 2 a (new)
2 a. The period of market exclusivity shall be prolonged by an additional 12 months for orphan medicinal products referred to in Article 71(2), points (a), (b), and (ba) if the orphan medicinal product is not authorised for the indication in question in any third country at the time of granting the authorisation.
Amendment 1282 #
2023/0131(COD)
Proposal for a regulation
Article 73 a (new)
Article 73 a (new)
Article 73a European Framework for Rare Diseases By (OP: 24 months after the date of entry into force of this Regulation), the Commission shall, following appropriate consultation with the Member States, patient organisations and, where relevant, other interested parties, propose a needs driven and goals based European Framework for Rare Diseases with a view to bridge relevant Union legislation, policies and programmes, and support national strategies to better meet the unmet needs of people living with rare diseases, and their carers.
Amendment 1288 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point b
Article 75 – paragraph 1 – point b
(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless wthen the product is directed at a molecular target thatre is medical plausibility that the product, due to its mechanism of action and on the basis of existing scientific data, is responsible forcould address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population;
Amendment 1293 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point c
Article 75 – paragraph 1 – point c
(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients.
Amendment 1294 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 1 a (new)
Article 75 – paragraph 1 a (new)
1 a. The Agency shall, after consultation with the Commission and relevant interested parties, draw up guidelines for the application of this Article.
Amendment 1302 #
2023/0131(COD)
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.
Amendment 1341 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 a (new)
Article 87 – paragraph 2 a (new)
2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.
Amendment 1344 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 b (new)
Article 87 – paragraph 2 b (new)
2 b. Within 20 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re- examination. Within 30 days following receipt of a request for re-examination pursuant to paragraph 2b, the Agency shall confirm or revise its previous scientific conclusions.The Agency shall be able to question the applicant directly.The applicant may also offer to be questioned.Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re- examining the above mentioned scientific conclusions. If, within the 15-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive. The Agency shall adopt a decision within a period not exceeding 15 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions.
Amendment 1354 #
2023/0131(COD)
Proposal for a regulation
Article 88 – paragraph 1
Article 88 – paragraph 1
Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation no less than six months before the discontinuation or as soon as possible.
Amendment 1359 #
2023/0131(COD)
Proposal for a regulation
Article 91 – paragraph 3
Article 91 – paragraph 3
3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, including dosage accuracy, and may vary the marketing authorisation accordingly.
Amendment 1368 #
2023/0131(COD)
Proposal for a regulation
Article 101 – paragraph 1 – subparagraph 3
Article 101 – paragraph 1 – subparagraph 3
The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.
Amendment 1390 #
2023/0131(COD)
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving, including those that record adverse reactions including medication errors, processes and standards for medication safety, and implement digital technologies, with a view to achieve high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.
Amendment 1399 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 1 – point a
Article 113 – paragraph 1 – point a
(a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;
Amendment 1404 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 1 a (new)
Article 113 – paragraph 1 a (new)
1 a. The creation of a regulatory sandbox is intended to fulfill the following objectives: a) enabling competent authorities to offer advice to potential marketing authorization applicants to ensure adherence to this Regulation, or other pertinent EU legislation as applicable: b) assisting prospective marketing authorization applicants in the experimentation and advancement of innovative medicinal products or product categories; c) facilitating regulatory learning within a managed setting.
Amendment 1408 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 2 – subparagraph 1
Article 113 – paragraph 2 – subparagraph 1
The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114, while balancing patient safety and innovation in regulatory process.
Amendment 1413 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. The Agency may establish a dialogue framework with regulatory bodies both within and outside the Union to aid in its oversight role. Additionally, the Agency is tasked with creating and routinely revising a roster of nascent medicinal or health products that could be considered for a regulatory sandbox environment.
Amendment 1418 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and mayshall engage with them in preliminary discussions.
Amendment 1430 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, including, where relevant, of HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1431 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia . The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1484 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected and forecasted duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1494 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. TWithin 18 months of the entry into force of the present Regulation, the marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1505 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 2
Article 117 – paragraph 2
2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c), shall and following consultation with health professionals and patient organisations, shall assess the plan and draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.
Amendment 1511 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Article 118 – paragraph 1 – subparagraph 1
Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products through their national IT surveillance systems or data bases.
Amendment 1512 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 1 a (new)
Article 118 – paragraph 1 a (new)
Amendment 1515 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117, where this has not already been requested following paragraph 9 of article 127. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1522 #
2023/0131(COD)
Proposal for a regulation
Article 119 – paragraph 1 – point e a (new)
Article 119 – paragraph 1 – point e a (new)
(e a) issue forecast of demand to provide early-warning of potential critical shortages.
Amendment 1524 #
2023/0131(COD)
Proposal for a regulation
Article 119 – paragraph 3 a (new)
Article 119 – paragraph 3 a (new)
3 a. For the purposes of developing the shortage mitigation plan referred to in Article 118, the marketing authorization holder within the meaning of Article 116(1) shall include the minimum set of information provided for in Annex IV on primary packaging, in order to allow dispensation by unit upon request from the competent authorities of the Member State.
Amendment 1525 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 1
Article 120 – paragraph 1
1. Wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] to the public may report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority in that Member State. In addition, wholesale distributors shall submit regular information on the available stocks of the medicines they supply to the competent authority.
Amendment 1533 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 1541 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish information on actualll notified shortages of medicinal products, in cases in whichas soon as thate competent authority has assessed the shortage, on a publicly available website;
Amendment 1542 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Article 121 – paragraph 1 – point b a (new)
(b a) create a system that is user- friendly and straightforward, allowing patients and patient organizations to report shortages of medicinal products.
Amendment 1543 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Article 121 – paragraph 1 – point b a (new)
(b a) establish an accessible and easily understandable system for patients and patient organisations to report shortages of medicinal products;
Amendment 1552 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) address recommandations to health professionals and patients on the alternative medicinal products to use to pursue treatments;
Amendment 1554 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point c b (new)
Article 121 – paragraph 1 – point c b (new)
(c b) launch information campaign to discourage hoarding or to avoid waste, at any level of the supply chain, from wholesalers to patients.
Amendment 1560 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 2 a (new)
Article 121 – paragraph 2 a (new)
2 a. After the expansion of the ESMP referred to in article 122 (6) and for the purpose of articles 118 (1), and 121 (2), point (a), competent authorities of the Member States shall set up national IT systems which are interoperable with the ESMP and allow for the automated exchange of information with the ESMP while avoiding duplication of reporting.
Amendment 1565 #
2023/0131(COD)
Proposal for a regulation
Article 121 a (new)
Article 121 a (new)
Article121a National websites on medicines shortages The website referred to in article 121 paragraph 1(b) shall include at least the following information: (a) trade name of the medicinal product and international non-proprietary name, for interoperability purposes; (b) indication; (c) reasons of the shortages; (d) start and end dates of the shortages; (e) information for healthcare professionals and patients, including information about therapeutic alternatives available.
Amendment 1567 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 1
Article 122 – paragraph 1
1. For the purposes of Article 118(1) and 118(1a)(new), the Agency may request additional information from the competent authority of the Member State, through the working party referred to in Article 121(1), point (c). The Agency may set a deadline for the submission of the information requested.
Amendment 1569 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 1 a (new)
Article 122 – paragraph 1 a (new)
1 a. For the purpose of Article 118 (1a) (new) and based on the information provided pursuant to articles 121 (1), point (d), and 121 (2), the Agency shall assess the actions taken or foreseen by a Member State to mitigate a shortage at national level with regards to any potential or actual negative impacts of these actions on the availability and security of supply in another Member State and at European level. The Agency shall inform the Member State in question of its assessment in a timely manner and the MSSG and the Member States potentially or actually impacted through the single point of contact working party referred to in Article 3(6) of Regulation (EU) 2022/123. The Agency shall also inform the Commission of its assessment.
Amendment 1575 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 4 – introductory part
Article 122 – paragraph 4 – introductory part
4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with patients' organisations and the working party referred to in Article 121(1), point (c):
Amendment 1584 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and, where relevant, with other relevant IT systems and databases, without duplication of reporting. Data included in the ESMP shall contain information on the expected duration of the shortages and the mitigation measures to resolve it. The ESMP shall be fully digitalised and automated and shall use artifical intelligence to provide information about trends in demand and supply from existing data.
Amendment 1596 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 2
Article 123 – paragraph 2
2. The MSSG shall review the status of the critical shortage whenever necessary and shall update the list when it considers that a medicinal product needs to be added or that the critical shortage has been resolved based on the report pursuant to Article 122(5). The MSSG may recommend monitoring forecasts of supply and demand for medicinal products for human use in the EU/EEA and monitoring of available stocks in the whole supply chain.
Amendment 1597 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 2 – subparagraph 1 (new)
Article 123 – paragraph 2 – subparagraph 1 (new)
After adopting the list of critical shortages of medicinal products, the MSSG may analyse the vulnerabilities in the supply chain of those medicines.
Amendment 1601 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG mayshall provide recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1606 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 4 – subparagraph 1 (new)
Article 123 – paragraph 4 – subparagraph 1 (new)
Member States, within the MSSG, may decide to activate the “Voluntary Solidarity Mechanism for medicines” to (a) notify a critical shortage of a medicinal product at national level to other Member States and the Commisison, (b) identify, with the support of the Agency, the availabilities of the medicinal product in other Member States, (c) organise, with the support of the Agency, meetings with the issuing Member States, the donating part and other relevant parties to discuss operational requirements, (d) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicines.
Amendment 1610 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 2 – subparagraph 2
Article 124 – paragraph 2 – subparagraph 2
For the purposes of this paragraph, the Agency mayshall set a deadline for the submission of the information requested.
Amendment 1613 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 2 a (new)
Article 124 – paragraph 2 a (new)
2 a. The Agency shall assess actual critical shortages of medicinal products and provide recommendations to healthcare professionals and patients
Amendment 1617 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and inlcude reference to alternative treatment options or products and appropriate communication that counteracts the hoarding of medicines as a result of the publication.
Amendment 1619 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actualll notified critical shortages of medicinal products in cases in whichas soon as the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).
Amendment 1622 #
2023/0131(COD)
Proposal for a regulation
Article 125 – paragraph 1 – point a
Article 125 – paragraph 1 – point a
(a) provide any additional information that the Agency may request, including regular information on the available stocks of medicines;
Amendment 1631 #
2023/0131(COD)
Proposal for a regulation
Article 126 – paragraph 2 a (new)
Article 126 – paragraph 2 a (new)
2 a. The Commission shall take the appropriate steps to address any concerns raised by the assessment of the Agency referred to in Article 122 (1a) (new).
Amendment 1634 #
2023/0131(COD)
Proposal for a regulation
Article 127 – paragraph 1
Article 127 – paragraph 1
1. The competent authority of the Member State shall identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a), following a consultation with national health professionals and patients organisations.
Amendment 1637 #
2023/0131(COD)
Proposal for a regulation
Article 127 – paragraph 3
Article 127 – paragraph 3
3. For the purposes of the identification of critical medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information including the shortage prevention plan referred to in Article 117 and information on the available stocks of medicines from the marketing authorisation holder as defined in Article 116(1).
Amendment 1647 #
2023/0131(COD)
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 1654 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with patient organisations and the working party referred to in Article 121(1), point (c), ensure the following:
Amendment 1655 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with patient organisations and the working party referred to in Article 121(1), point (c), ensure the following:
Amendment 1669 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 5
Article 130 – paragraph 5
5. Following the adoption of the Union list of critical medicinal products in accordance with Article 131, the Agency shall assess and report to the MSSG on any relevant information received from the marketing authorisation holder pursuant to Article 133 and the competent authority of the Member State in accordance with Article 127, paragraphs 7 and 8.
Amendment 1670 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 6 a (new)
Article 130 – paragraph 6 a (new)
Amendment 1679 #
2023/0131(COD)
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) and health professionals and patients organisations. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).
Amendment 1683 #
2023/0131(COD)
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on increase of manufacturing capacity, reorganisation of manufacturing capacity, diversification of suppliers and, inventory management, establishment of minimum safety stock and if necessary, redistribution of available stock among Member States to address urgent needs.
Amendment 1687 #
2023/0131(COD)
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on diversification of suppliers and, inventory management, on pricing mechanisms, tender practices and cost-containment measures, and on the use of regulatory flexibilities.
Amendment 1693 #
2023/0131(COD)
Proposal for a regulation
Article 132 – paragraph 1 b (new)
Article 132 – paragraph 1 b (new)
1 b. The MSSG shall set up a Voluntary Solidarity Mechanism to allow Member States to request assistance in obtaining stocks of a medicine during critical shortages. The MSSG shall specify the procedures and criteria to launch the Voluntary Solidarity Mechanism in consultation with the Member States, the Agency and the Commission.
Amendment 1705 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 a (new)
Article 134 – paragraph 1 a (new)
1 a. The Commission shall also work with the European Centre for Disease prevention and Control on building reliable forecasts of potentiel threats and potential shortages.
Amendment 83 #
2022/0400(COD)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) In accordance with the case law1a of the Court of Justice of the European Union, the scope of the principle of equal treatment of men and women shall not be limited to the prohibition of discrimination based on sex as it also applies to discrimination arising from gender, gender identity and gender expression. _________________ 1a Judgment of 30 April 1996, P. v S., C- 13/94; Judgment of 7 January 2004, K.B., C-117/01; Judgment of 26 June 2018, MB, C-451/16
Amendment 86 #
2022/0400(COD)
Proposal for a directive
Recital 3
Recital 3
(3) The purpose of this Directive is to lay down minimum requirements for the functioning of equality bodies to improve their effectiveness and guarantee their mandate and independence in order to strengthen the application of the principle of equal treatment as enshrined in the TEU, TFEU and the Charter of Fundamental Rights and derived from Directives 2006/54/EC58 and 2010/41/EU59 . _________________ 58 Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation (OJ L 204, 26.7.2006, p. 23). 59 Directive 2010/41/EU of the European Parliament and of the Council of 7 July 2010 on the application of the principle of equal treatment between men and women engaged in an activity in a self-employed capacity and repealing Council Directive 86/613/EEC (OJ L 180, 15.7.2010, p. 1).
Amendment 90 #
2022/0400(COD)
Proposal for a directive
Recital 7
Recital 7
(7) Directive 2000/43/EC60 of the Council and Directive 2004/113/EC61 of the European Parliament and the Council also provide for the designation of equality bodies. for the promotion, analysis, monitoring and support of equal treatment of all persons, without discrimination on grounds of sex, race or ethnic origin. _________________ 60 Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin (OJ L 180, 19.7.2000, p. 22). 61 Council Directive 2004/113/EC of 13 December 2004 implementing the principle of equal treatment between men and women in the access to and supply of goods and services (OJ L 373, 21.12.2004, p. 37).
Amendment 93 #
2022/0400(COD)
Proposal for a directive
Recital 9
Recital 9
(9) Directives 2006/54/EC and 2010/41/EU leave a wide margin of discretion to Member States as regards the structure and functioning of equality bodies. This results in significant differences between the equality bodies established in the Member States, in terms of the bodies' mandates, competences, structures, resources and operational functioning. This, in turn, means that protection against discrimination differs from one Member State to another. Levels of discrimination remain high, victims’ awareness of their rights remains low and underreporting is still a considerable problem. Public awareness about and knowledge of discrimination remain limited and a lack of sufficient powers and resources hampers equality bodies’ ability to assist victims effectively or to prevent and address the development of new forms of discrimination based on gender identity, health or socio-economic status or resulting from developments in technology.
Amendment 100 #
2022/0400(COD)
(12) This Directive should apply to equality bodies’ action as regards the matters covered by Directives 2006/54/EC and 2010/41/EU. The standards should only concern the functioning of equality bodies and should not extend the material or personal scope of those Directivand the competences of equality bodies.
Amendment 101 #
2022/0400(COD)
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
(12a) Equality bodies’ action to ensure the application of the principle of equal opportunities and equal treatment of men and women should include grounds of discrimination such as gender, gender identity, gender expression and those listed in article 21 of the Charter of Fundamental Rights such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation, as well as intersectional discrimination.
Amendment 103 #
2022/0400(COD)
Proposal for a directive
Recital 14
Recital 14
(14) The proposed DirectiveDirective (EU) 2023/970 to strengthen the application of the principle of equal pay for equal work or work of equal value between men and women through pay transparency and enforcement mechanisms69 should be considered lex specialis to the enforcement provisions of Directive 2006/54/EC that will be replaced by this Directive. Any hHigher minimum standards established by the future Directive on Pay Transparency for equality bodies in matters relating to equal pay for the same work or work of equal value, including in pay transparency, as compared to those set out in this Directive, should prevail over those set out in this Directive. _________________ 69 Proposal for a Directive of the European Parliament and of the Council to strengthen the application of the principle of equal pay for equal work or work of equal value between men and women through pay transparency and enforcement mechanisms (COM/2021/93 final).
Amendment 107 #
2022/0400(COD)
Proposal for a directive
Recital 15
Recital 15
(15) In promoting equal treatment, preventing discrimination and assisting victims of discrimination, equality bodies should pay particular attention to multiple and instersectional discrimination based on several of the grounds protected by Directives 79/7/EEC, 2000/43/EC, 2000/78/EC, 2004/113/EC, 2006/54/EC and 2010/41/EU.
Amendment 112 #
2022/0400(COD)
Proposal for a directive
Recital 16
Recital 16
(16) Equality bodies can only effectively play their role if they are able to act with complete independence without being subject to any external influence. For that purpose, Member States should take into account a number of criteria that contribute to the independence of equality bodies. Equality bodies should not be set up as part of a ministry or body taking or seeking instructions directly from the government. Any permanent or temporary staff member or person holding a managerial position – for example as member of a board managing the equality body, head of the equality body, or deputy or in case of interim – should be independent, qualified for their position, and selected through a transparent process. The transparency in this process can be ensured, for example, by publishing vacancy notices publicly. Equality bodies should be able to manage their own budget and resources, including by selecting and managing their own staff, and be able to set their own priorities.
Amendment 120 #
2022/0400(COD)
Proposal for a directive
Recital 17
Recital 17
(17) To ensure that equality bodies can exercise all their competences and fulfil all their tasks, Member States should ensure thatguarantee the autonomy of equality bodies in the determination of their internal structure of equality bodiesin a way that allows the independent exercise of their various competences. Particular attention should be paid to situations where bodies are required both to be impartial and to offer support to victims. This is particularly relevant where the equality body holds binding decision- making powers requiring impartiality or is part of a multi-mandate body where another mandate requires impartiality. An internal structure ensuring a strict separation between the relevant competences and tasks should guarantee that the equality body can effectively exercise them.
Amendment 126 #
2022/0400(COD)
(18) The lack of appropriatedequate human, material, technical and financial resources is a key issue hampering the ability of equality bodies to adequateffectively fulfil their tasks. Therefore, Member States should ensure that equality bodies receive sufficientadequate funding, can hire qualified staff and, have appropriate premises and infrastructure to carry out each of their tasks effectively, within a reasonable time and within the deadlines established by national law. Their and have budgetary allocation should be stable, except in case of increase in competencend financial autonomy. Member States should ensure that human, material, technical and financial allocation of equality bodies increase proportionally to any extention of their missions and field of intervention or additional competences, especially their rights to act in court proceedings, planned on a multi-annual basis, and allow them to cover costs that may be difficult to anticipate such as increases in complaints and costs linked to litigation. To ensure that equality bodies are provided with sufficient resources, their budget should for instance not suffer cuts that are significantly higher than the average cuts to other public entities; similarly, their annual growth should at least be pegged to the average growth in funding to other entities. Resources should increase proportionally if equality bodies’ tasks and mandate are expandedadequate resources, their annual growth should at least be pegged to the average growth in funding to other similar public entities.
Amendment 131 #
2022/0400(COD)
Proposal for a directive
Recital 19
Recital 19
(19) Automated systems, including artificial intelligence, represent a useful tool to identify discrimination patterns, but algorithmic discrimination is also a risk. Equality bodies should therefore have access to qualified staff or services, able to use automated systems for their work on the one hand and to assess them as regards their compliance with non-discrimination rules on the other hand. Particular attention should be devoted to equipping equality bodies with appropriate digital resources, training and expertise, be it directly or by way of subcontracting. Automated systems should comply with accessibility requirements for persons with disabilities in accordance with Annex I of Directive (EU) 2019/882.
Amendment 137 #
2022/0400(COD)
Proposal for a directive
Recital 20
Recital 20
(20) Equality bodies, alongside other actors, have a key role to play in the prevention of discrimination and the promotion of equality. To address the structural aspects of discrimination and to contribute to social change, tequality bodies should be empowered to carry out activities to prevent discrimination and to promote equal treatment. They should promote equality duties, good practices, positive action and equality mainstreaming among public and private entities, and provide them with relevant training, information, advice, guidance and support, without prejudice to the competences of labour inspectorates or other enforcement bodies, as well as the social partners. They should communicate with public and private entities and groups at risks of discrimination in order to ensure an intersectional approach and to combat underreporting and engage in public debate in order to combat stereotypes and raise awareness about diversity and its benefits, a key pillar of the Union’s equality strategies.
Amendment 141 #
2022/0400(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Beyond prevention, a central task of equality bodies is to provide assistance to victims of discrimination. This assistance should always be free of charge and include the provision of key information to complainants and a preliminary assessment of their complaint, based on the initial information gathered from the parties on a voluntary basis. Member States should beincluding whether the procedure will be closed or there are grounds to pursue it further. This preliminary assessment should be based on the initial information gathered from the parties on a voluntary basis or handed over upon request. In order to guarantee a simple and quick procedure, Member States should ensure that the equality body is in charge of defining the modalities under which ithe equality body would issue this assessment, such as the timeframe of the process or procedural safeguards against repetitive or abusive complaints.
Amendment 147 #
2022/0400(COD)
Proposal for a directive
Recital 22
Recital 22
(22) To ensure that all victims are able to complain, it should be possible to submit complaints in various ways, including orally, in writing and online and through a designated representative. Member States should also pay due regard to Commission Recommendation 2018/951 under which submission of complaints should be possible in a language of the complainant's choosing which is common in the Member State where the equality body is located. To address one of the causes of underreporting, namely, fear of reprisals, and without prejudice to Directive (EU) 2019/1937 on the protection of persons who report breaches of Union law70 , confidentiality should be offered to witnesses and whistle-blowers, and as far as possible, to complainants and alleged perpetrators. _________________ 70 Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, p. 17).
Amendment 153 #
2022/0400(COD)
Proposal for a directive
Recital 23
Recital 23
(23) To offer a possibility for a quick, affordable, out of court resolution of disputes, Member States should provide for the possibility for parties to seek an amicabllternative resolution to their disputes, by the equality body or another existing dedicated entity. They should define the modalities of the amicabllternative dispute settlement process according to national law and practice. They also ensure that initiating such a procedure does not prevent the parties from exercising their right of access to justice.
Amendment 154 #
2022/0400(COD)
Proposal for a directive
Recital 25
Recital 25
(25) Evidence is key in determining whether discrimination has taken place and it is often in the hands of the alleged perpetrator. Equality bodies should therefore be able to compel access to the necessary information and documents to establish discrimination and cooperate with the relevant public services – such as labour inspectorates or education inspectorates and social partners. Member States should establish an appropriate framework for the exercise of this competence, in accordance with national rules and procedures. Equality bodies may fully or partially entrust another competent body with conducting or collaborating on inquiries. This competent body should provide the equality body, upon its request, with the results of the inquiry.
Amendment 157 #
2022/0400(COD)
Proposal for a directive
Recital 26
Recital 26
(26) On the basis of the evidence gathered, either voluntarily or through an investigation, equality bodies should be empowered to provide their assessment to the complainant and the alleged perpetrator. Member States should determine the legal value of this assessment that can be a non- binding opinion or a binding enforceable decision. Both should state the reasons for the assessment and include, where necessary, measures to remedy any breach found and to prevent further occurrences. To ensure the effectiveness of equality bodies’ work, Member States should adopt appropriate measures for the follow-up of opinions and the enforcement of decisions.
Amendment 159 #
2022/0400(COD)
Proposal for a directive
Recital 27
Recital 27
(27) To promote their work and equality law, equality bodies should be able to publish a summary of their opinions and decisions without disclosing personal data. Equality bodies should be able to disclose personal data where such disclosure is provided for under national law, for example as a penalty for a finding of discrimination.
Amendment 162 #
2022/0400(COD)
Proposal for a directive
Recital 28
Recital 28
(28) Equality bodies should have the right to act in court proceedings in civil or administrative law matters in order to contribute to ensuring the respect of the principle of equal treatment laid down in Directives 2006/54/EC and 2010/41/EU. While those court proceedings should be subject to national procedural law, including national rules on admissibility of actions, such rules, and in particular any condition of legitimate interest, cannot be applied in a way so as to undermine the effectiveness of the equality bodies’ right to act. The powers of investigation and decision-making and the right to act in court proceedings given to equality bodies by this Directive will facilitate the practical implementation of the current provisions of Directives 2000/43/EC, 2000/78/EC and ,2004/113/EC and (EU) 2019/1158 on the burden of proof and defence of rights. Under the conditions provided for in this Directive, equality bodies will be able to establish facts “from which it may be presumed that there has been direct or indirect discrimination”, thereby fulfilling the conditions provided for in Article 8 of Directive 2000/43/EC, Article 10 of Directive 2000/78/EC and Article 9 of Directive 2004/113/EC and Article 12 and 15 of Directive (EU) 2019/1158. Their support will therefore facilitate access to justice for victims.
Amendment 167 #
2022/0400(COD)
Proposal for a directive
Recital 31
Recital 31
(31) Equality bodies should also be able to submit oral or written statements to the courts as third-party interventions - e.g. amicus curiae – as a lightern additional way to support cases with their expert opinion.
Amendment 168 #
2022/0400(COD)
Proposal for a directive
Recital 32
Recital 32
Amendment 173 #
2022/0400(COD)
Proposal for a directive
Recital 35
Recital 35
(35) The effectiveness of equality bodies’ work also depends on giving groups at risk of discrimination full access to their services. In a survey conducted by the European Union Fundamental Rights Agency72 , 71% of members of ethnic or immigrant minority groups reported to be unaware of any organisation offering support or advice to victims of discrimination. A key step to support this access is for Member States to ensure that people know their rights and are aware of the existence of and services offered by equality bodies. This is particularly important for disadvantaged groups and groups whose access to that information can be hindered, for example by their health or socio-economic status, theirage, disability, their literacy, nationality, membership of a national minority, language, residence status, remote and rural geographic locations or their lack of access to online tools. _________________ 72 FRA EU-MIDIS II Survey.
Amendment 177 #
2022/0400(COD)
Proposal for a directive
Recital 36
Recital 36
(36) Access to equality bodies’ services and publications on an equal basis for all should be guaranteed. For that purpose, potential barriers to access to equality bodies’ services should be identified and addressed. Services should be free of charge for all complainants. Member States should also make sure that the services of equality bodies are available to all potential victims throughout their territory, for example through the establishment of local offices, including mobile ones, easy-to-use digital tools and solutions, the organisation of local campaigns or ,cooperation with local delegates orand civil society organisations, and the creation of partnerships with labour and educational inspectorates, social partners and companies.
Amendment 184 #
2022/0400(COD)
Proposal for a directive
Recital 37
Recital 37
(37) The Union and all Member States are parties to the UN Convention on the Rights of Persons with Disabilities73 (UNCRPD), which includes the obligation to prohibit discrimination on the basis of disability and to guarantee to persons with disabilities equal and effective legal protection against discrimination on all grounds. This Directive should be interpreted in a manner consistent with the UNCRPD. To guarantee equal and effective legal protection and access for persons with disabilities to all services and activities of equality bodies, it is necessary to ensure accessibility, in accordance with requirements set out in Directives (EU) 2016/2102 and (EU) 2019/882, and reasonable accommodation. Equality bodies should ensure physical and digital74 accessibility by preventing and removing the barriers that persons with disabilities may face in accessing their services and information, and provide reasonable accommodation, taking necessary and appropriate modification and adjustments where needed in a particular case. Equality bodies should ensure that all forms of discrimination faced by persons with disabilities are addressed in their activities in line with the UNCRPD, including direct and indirect discrimination, denial of reasonable accommodation, discrimination by association, harassment, instruction to discriminate, as well as victimisation and hate speech. _________________ 73 OJ L 23, 27.1.2010, p. 37. 74 See Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016 p.1-15) and related Implementing Decision.
Amendment 188 #
2022/0400(COD)
Proposal for a directive
Recital 38
Recital 38
(38) Enabling equality bodies to regularly coordinate and cooperate at different levels, on a long-term basis, is key for mutual learning, coherence and consistency, and it may broaden the outreach and impact of their work. Equality bodies should cooperate, in particular, with other equality bodies in the same Member State and in other Member States – including in the framework of the European Network of Equality Bodies (Equinet) – and with relevant public and private entities at local, regional, national, Union and international level, such as civil society organisations, EU agencies, data protection authorities, trade unionsocial partners, labour and education inspectorates, law enforcement bodies, agencies with responsibility at national level for the defence of human rights, national statistical offices, authorities managing Union funds, National Roma Contact Points, consumer bodies, and national independent mechanisms for the promotion, protection and monitoring of the UNCRPD. Such cooperation should not involve the exchange of personal data (i.e. equality data in the form that individuals can be identified).
Amendment 195 #
2022/0400(COD)
Proposal for a directive
Recital 40
Recital 40
(40) Equality data are crucial for raising awareness, sensitising people, quantifying discrimination, showing trends over time, proving the existence of discrimination, evaluating the implementation of equality legislation, demonstrating the need for positive action, and contributing to evidence-based policymaking75 . Equality bodies have a role to play in contributing to the development of relevant equality data for those purposes, for example by organising regular roundtables gathering all relevant entities. They should also collect and analyse disaggregated data on their own activities or conduct surveys and should be able to accessand commission surveys, reports and research and should be able to access, in an easily accessible format, and make use of statistical information collected by other public or private entities – such as the national statistical offices, national courts, labour and education inspectorates, trade unionsocial partners or civil society organisations - concerning the matters they are entrusted with under Directives 2006/54/EC and 2010/41/EU. That statistical information should not contain any personal data. e personal data collected shall be anonymised and, where not possible, pseudonymised. _________________ 75 Report from the Commission to the European Parliament and the Council on the application of Council Directive 2000/43/EC implementing the principle of equal treatment between persons irrespective of racial or ethnic origin (‘the Racial Equality Directive’) and of Council Directive 2000/78/EC establishing a general framework for equal treatment in employment and occupation (‘the Employment Equality Directive’) SWD(2021) 63 final.
Amendment 204 #
2022/0400(COD)
(43) In order to assess the effectiveness of this Directive it is necessary to establish a mechanism to monitor its application and, in addition to monitoring compliance, assess its practical effects. The Commission should be in charge of that monitoring and regularly draw up an application report, based on the information received from Member States and additional relevant data collected at national and Union level, in particular from stakeholders, and by the European Union Agency for Fundamental Rights, the European Institute for Gender Equality and equality bodies, including the European Network of Equality Bodies (Equinet). In order to ensure uniform conditions for the implementation of Member States’ reporting obligations pursuant to Article 16(2) as regards the practical effects of this Directive, implementing powers should be conferred on the Commission to establish a list of relevant indicators, on the basis of which data should be collected. This monitoring should not involve the processing of personal data.
Amendment 209 #
2022/0400(COD)
Proposal for a directive
Recital 48
Recital 48
(48) Where the fulfilment of the tasks of equality bodies requires the processing of special categories of personal data, namely data on racial or ethnic origin, religion or belief, disability or sexual orientationreferred to in Article 9(1) of Regulation (EU) 2016/679, Member States should also ensure that national law respects the essence of the right to data protection and provides for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject, in accordance with Article 9(2), point (g), of Regulation (EU) 2016/679. Such safeguards should include for example internal policies and measures to ensure data minimisation, including through anonymisation of personal data, where possible; to apply pseudonymisation and encryption to personal data; to prevent unauthorised access and transmission of personal data; and to ensure that personal data is not processed longer than is necessary for the purposes for which they are processed.
Amendment 210 #
2022/0400(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Directive lays down minimum requirements for the functioning of equality bodies to improve their effectiveness and guarantee their mandate and independence in order to strengthen the application of the principle of equal treatment as enshrined in the TEU, TFEU, Charter of Fundamental Rights and derived from Directives 2006/54/EC and 2010/41/EU.
Amendment 215 #
2022/0400(COD)
Proposal for a directive
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2a. The application of the principle of equal treatment shall not be limited to the prohibition of discrimination based on sex as it also applies to discrimination arising from gender, gender identity and gender expression as derived from the case law of the Court of Justice of the European Union.
Amendment 219 #
2022/0400(COD)
Proposal for a directive
Article 1 – paragraph 2 b (new)
Article 1 – paragraph 2 b (new)
2b. This Directive is without prejudice to the more specific provisions contained in Directive 2023/970/EU.
Amendment 226 #
2022/0400(COD)
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Member States shall take measures to ensure that equality bodies are independent and free from external influence in performing their tasks and exercising their competences, in particular as regards their legal structure, accountability, budget and resources, staffing, and organisational matters. Equality bodies shall not be set up as part of a ministry or body taking or seeking instructions directly from the government.
Amendment 238 #
2022/0400(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall provide for transparent rules and safeguards concerning the selection, appointment, revocation and potential conflict of interest of the staff of equality bodies, in particular persons holding a managerial position, including members of a board managing the equality body, in order to guarantee their competence and independence.
Amendment 244 #
2022/0400(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure thatguarantee the autonomy of equality bodies in the determination of appropriate safeguards are in place, in particular in their internal structure of equality bodies, to guarantee the independent exercise of their competences, notably where some require impartiality and others focus on support to victims.
Amendment 248 #
2022/0400(COD)
Proposal for a directive
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Member States shall ensure that appropriate safeguards are in place in the internal structure and operation of multi- mandate bodies to guarantee the autonomouseffective exercise of the equality mandate.
Amendment 252 #
2022/0400(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall ensure that each equality body has budgetary and financial autonomy and is provided with the human, material, technical and financial resources necessary to perform all its tasks and to exercise all its competences effectively, on all the grounds and in all fields covered by Directives 2006/54/EC and 2010/41/EU including in the event of increases in competences, increases in complaints, litigation costs and the use of special expertise in developing areas with the potential for discrimination such as the use of automated systems.
Amendment 257 #
2022/0400(COD)
Proposal for a directive
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. Member States shall ensure that human, material, technical and financial resources of equality bodies are adequate and commensurate to any evolution of their mission and fields of intervention or increase in competences, especially their rights to act in court proceedings.
Amendment 265 #
2022/0400(COD)
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) adopt a strategy to raise awareness of the general population, throughout their territory, with particular attention to individuals and groups at risk of discrimination, young people, on the rights under Directives 2006/54/EC and 2010/41/EU and on the existence of equality bodies and their services;
Amendment 268 #
2022/0400(COD)
Proposal for a directive
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) ensure thate conditions for equality bodies to engage in the prevention of discrimination and in the promotion of equal treatment, and guarantee independence for equality bodies in adopting a strategy defining how they will engage in public dialogue, communicate with individuals and groups at risk of discrimination, ensure an intersectional approach in combatting multiple discrimination as well as underreporting, provide training and guidance, and promote equality duties, equality mainstreaming and positive action among public and private entities.
Amendment 278 #
2022/0400(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
In doing so, Member States and equality bodies shall take into consideration the most appropriate communication tools and formats for each target group. They shall focus in particular on disadvantaged groups whose access to information can be hindered, for example by their health or socio-economic status, age, disability, literacy, nationality, residence statusmembership of a national minority, language, residence status, remote and rural geographic locations, or their lack of access to online tools.
Amendment 287 #
2022/0400(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
Amendment 293 #
2022/0400(COD)
Proposal for a directive
Article 6 – paragraph 3 – subparagraph 1
Article 6 – paragraph 3 – subparagraph 1
Equality bodies shall provide assistance to victims, or their designated representatives, initially by informing them on the legal framework, including advice targeted to their specific situation, on the services offered by the equality body and related procedural aspects, as well as on available remedies, including the possibility to pursue a case in court.
Amendment 298 #
2022/0400(COD)
Proposal for a directive
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
Equality bodies shall issue a preliminary assessment of a complaint on the basedis onf information voluntarily submitted by the parties involved. Member States shall or handed over upon request. Member States shall ensure that equality bodies define the precise modalities under which the equality body will issue such preliminary assessment, ensuring that they contribute to a simple and rapid handling of complaints.
Amendment 301 #
2022/0400(COD)
Proposal for a directive
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
Equality bodies shall inform the complainants of their preliminary assessment and whether it will close their complaint or whether there are grounds to pursue it further, including via the procedures laid down in Articles 7, 8, 8a and 9.
Amendment 302 #
2022/0400(COD)
Proposal for a directive
Article 7 – title
Article 7 – title
Amicable settlementslternative dispute resolution
Amendment 305 #
2022/0400(COD)
Proposal for a directive
Article 7 – paragraph 1
Article 7 – paragraph 1
Equality bodies or other existing dedicated entities shall be able to offer the parties the possibility to seek an amicabllternative resolution to their dispute. That process shall be subject to the agreement of the parties and may be led by the equality body itself or by another existing dedicated entity, in which case the equality body may formulate observations to that entity. The parties shall have the possibility to be assisted by designated representatives. Engaging in such a process shall not prevent the parties from exercising their right of access to court.
Amendment 309 #
Amendment 311 #
2022/0400(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States shall ensure that equality bodies are empowered to effectively conduct inquiries where, following a complaint or on their own initiative, equality bodiesthey consider that the principle of equal treatment laid down in Directives 2006/54/EC and 2010/41/EU may have been breached, those bodies are empowered to further investigate the case.
Amendment 314 #
2022/0400(COD)
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
In particular, that framework shall provide equality bodies with effective rights to access information and documents which isare necessary to establish whether discrimination has occurred. It shall also provide for appropriate mechanisms for equality bodies to cooperate with relevant public bodies for that purpose such as labour inspectorates.
Amendment 318 #
2022/0400(COD)
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Member States mayshall also provide that the alleged perpetrator and any third party is legally bound to provide any information and documents requested by equality bodies. Equality bodies shall act with due regard towards the confidentiality of all information and documents received.
Amendment 319 #
2022/0400(COD)
Proposal for a directive
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3a. Equality bodies may also fully or partially entrust another competent body with the powers referred to in paragraphs 1 and 2. Where such a competent body is responsible for or collaborates with the equality body on inquiries, it shall provide the equality body, upon its request, with information on the results thereof.
Amendment 321 #
2022/0400(COD)
Proposal for a directive
Article 8 – paragraph 4 – subparagraph 1
Article 8 – paragraph 4 – subparagraph 1
Amendment 324 #
2022/0400(COD)
Proposal for a directive
Article 8 – paragraph 4 – subparagraph 2
Article 8 – paragraph 4 – subparagraph 2
Amendment 327 #
2022/0400(COD)
Proposal for a directive
Article 8 – paragraph 4 – subparagraph 3
Article 8 – paragraph 4 – subparagraph 3
Amendment 331 #
2022/0400(COD)
Proposal for a directive
Article 8 a (new)
Article 8 a (new)
Article8a Opinions and decisions 1. Member States shall ensure that equality bodies are empowered to record in writing their assessment of a case, including establishing the facts and a reasoned conclusion on the existence of discrimination. Member States shall determine whether this is to be done by means of non-binding opinions or by means of binding enforceable decisions. 2. Where appropriate, opinions and decisions shall include specific measures to remedy any breach found and to prevent further occurrences. Member States shall establish appropriate mechanisms for follow-up to opinions, such as feedback obligations, and for enforcement of decisions. 3. Equality bodies shall publish summaries of their opinions and decisions, without disclosing personal data. They shall be able to disclose personal data where such disclosure is provided for under national law.
Amendment 332 #
2022/0400(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall ensure that equality bodies have the right to act in court proceedings in administrative and civil law matters relating to the implementation of the principle of equal treatment laid down in Directives 2006/54/EC and 2010/41/EU in accordance with paragraphs 2 to 53, without prejudice to national rules on the admissibility of actions.
Amendment 337 #
2022/0400(COD)
Proposal for a directive
Article 9 – paragraph 2 – point a
Article 9 – paragraph 2 – point a
(a) the right of the equality body to act as a party in proceedings on the enforcement or judicial review of a decision taken pursuant to Article 8(4)a;
Amendment 339 #
2022/0400(COD)
Proposal for a directive
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) the right of the equality body to submit observations to the court as a third- party intervention such as amicus curiae;
Amendment 350 #
2022/0400(COD)
Proposal for a directive
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Member States shall ensure that the equality body can initiate court proceedings in its own name, in particular in order to address structural and systematic discrimination or in order to defend the public interest in cases selected by the equality body because of their abundance, their seriousness or their need for legal clarification.
Amendment 354 #
2022/0400(COD)
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 358 #
2022/0400(COD)
Proposal for a directive
Article 9 – paragraph 5
Article 9 – paragraph 5
Amendment 361 #
2022/0400(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
Member States shall ensure that, in the procedures referred to in Articles 6, 7, 8, 8a and 9, the rights of defence of natural and legal persons involved are duly protected. Member States shall ensure that equality bodies guarantee confidentiality of witnesses and whistle-blowers, and as far as possible, of complainants and alleged perpetrators.
Amendment 364 #
2022/0400(COD)
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
Decisions referred to in Article 8(4)a shall be subject to judicial review, in accordance with national law and practice.
Amendment 366 #
2022/0400(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall guarantee access to equality bodies’ services and publications on an equal basis for all and ensure that there are no barriers to submission of complaints or to assistance of victims.
Amendment 367 #
2022/0400(COD)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Member States shall ensure that equality bodies provide all their services at no cost to complainants, throughout their territory, including in rural and remote areas. Member States shall ensure attention is paid to specific territorial characteristics, such as those of outermost regions and regions suffering from severe and permanent natural or demographic handicaps, such as northernmost regions with very low population density, islands, cross-border and mountain regions. Member States shall ensure that equality bodies offer tailor-made solutions to provide their services to all complainants such as mobile offices, itinerant solutions, digital tools and platforms.
Amendment 371 #
2022/0400(COD)
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Member States shall ensure accessibility, including in accordance with Directives (EU) 2016/2102 and (EU) 2019/882, and provide reasonable accommodation for persons with disabilities to guarantee their equal access to all services and activities of equality bodies, including assistance to victims, complaint handling, amicable settlementsubmission and handling, alternative dispute resolution mechanisms, information and publications, and prevention, promotion and awareness- raising activities.
Amendment 375 #
2022/0400(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
Member States shall ensure that equality bodies, without prejudice to their independence, have appropriate mechanisms in place to cooperate, within their respective fields of competence, with other equality bodies within the same Member State, with equality bodies of other Member States, including in the framework of the European Network of Equality Bodies (Equinet), and with relevant public and private entities, including civil society organisations, relevant EU agencies, social partners, labour and education inspectorates at national, regional, local level as well as in other Member States and at Union and international level.
Amendment 389 #
2022/0400(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States shall ensure that equality bodies can access in an accessible format statistics related to the rights and obligations derived from Directives 2006/54/EC and 2010/41/EU collected by public and private entities including public authorities, trade unionsocial partners, companies, and civil society organisations where they deem such statistics necessary to make an overall assessment of the situation regarding discrimination in the Member State, and for drawing up the report referred to in Article 15, point (c).
Amendment 391 #
2022/0400(COD)
Proposal for a directive
Article 14 – paragraph 4
Article 14 – paragraph 4
4. Member States shall allow equality bodies to make recommendations on which data is to be collected in relation to the rights and obligations derived from Directives 2006/54/EC and 2010/41/EU, to public and private entities including public authorities, trade unionsocial partners, companies and civil society organisations, and require feedback from the authorities concerned. Member States shall also allow equality bodies to play a coordination role in the collection of equality data.
Amendment 395 #
2022/0400(COD)
Proposal for a directive
Article 14 – paragraph 5
Article 14 – paragraph 5
5. Member States shall ensure that equality bodies may conduct independent surveys, reports and research concerning discrimination. They shall also ensure that equality bodies can commission such studies and reports.
Amendment 398 #
2022/0400(COD)
Proposal for a directive
Article 15 – paragraph 1 – point c
Article 15 – paragraph 1 – point c
(c) publish a report, with recommendations, ensuring an intersectional approach, at least every four years, on the state of equal treatment and discrimination, including potential structural issues, in their Member State.
Amendment 408 #
2022/0400(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The Commission shall, by means of an implementing act, establish a list of common indicators to measure the practical effects of this Directive. When preparing the indicators, the Commission may seek advice from the European Union Agency for Fundamental Rights and, the European Institute for Gender Equality and equality bodies, including the European Network of Equality Bodies (Equinet). Those indicators shall cover the resources, independent functioning, activities, accessibility and effectiveness of equality bodies, as well as evolutions in their mandate, powers, appointments or structure, ensuring the comparability, objectivity and reliability of the data collected at national level.
Amendment 411 #
2022/0400(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
2. By [53 years after the date of transposition], and every 5 years thereafter, Member States shall provide the Commission with all relevant information regarding the application of this Directive, including data on its practical effects collected on the basis of the indicators referred to in paragraph 1 of this Article, and in particular taking into account the reports drawn up by the equality bodies under Article 145, points (b) and (c).
Amendment 415 #
2022/0400(COD)
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The Commission shall draw up a report on the application and practical effects of this Directive, based on the information referred to in paragraph 2 and additional relevant data collected at national and Union level, in particular from stakeholders, by the European Union Agency for Fundamental Rights and, the European Institute for Gender Equality and equality bodies, including the European Network of Equality Bodies (Equinet). The Commission shall issue recommendations as part of the European Semester framework if it identifies shortcomings in Member States' equal treatment and discrimination policies.
Amendment 418 #
2022/0400(COD)
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The implementation of this Directive shall under no circumstances constitute grounds for a reduction in the level of protection against discrimination already afforded by Member States in the matters covered by this Directives 2006/54/EC, 2010/41/EU and 2023/970/EU.
Amendment 421 #
2022/0400(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Member States shall ensure that when equality bodies process special categories of personal data, namely data on racial or ethnic origin, religion or belief, disability or sexual orientationreferred to in Article 9(1) of Regulation (EU) 2016/679, suitable and specific measures are provided to safeguard the fundamental rights and the interests of the data subject.
Amendment 423 #
2022/0400(COD)
Proposal for a directive
Article 19 – paragraph 2
Article 19 – paragraph 2
References to the bodies for the promotion of equal treatment referred to in those Articles, as well as Article 15 of Directive (EU) 2019/1158, shall be construed as references to the equality bodies referred to in Article 2 of this Directive.