Activities of Joanna KOPCIŃSKA related to 2020/0102(COD)
Plenary speeches (2)
Programme for the Union's action in the field of health for the period 2021-2027 (“EU4Health Programme”) (debate)
Programme for the Union’s action in the field of health for the period 2021-2027 (‘EU4Health programme’) (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health –for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (“EU4Health Programme”)
Amendments (34)
Amendment 117 #
Proposal for a regulation
Recital 3
Recital 3
(3) Article 168 TFEU provides that the Union is to complement and support national health policies, encourage cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of theeach Member States for the definition of to define their own health policiesy and theo organisation and delivery ofe, deliver and manage health services and medical care.
Amendment 125 #
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. Thatis pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human sufferingsince become the defining global health crisis of our time, causing severe socio-economic consequences and human suffering. The extent, depth and breadth of this crisis has demonstrated the added value of the EU's actions, which serve to complement national policies in the field of public health.
Amendment 133 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union levelscope for the Union to better deliver on public health policy within the existing parameters of the Treaties to support cooperation and coordination among the Member States in order to improve the prevention and control of the spread of severe human diseases across borders, to develop, test and make available products for the prevention and treatment of diseases, to combat other serious cross- border threats to health and to safeguard the health and well-being of people in the Union. __________________ 8 Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup on coordinated economic response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220.
Amendment 163 #
Proposal for a regulation
Recital 9
Recital 9
(9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis and ensure that resilient health care systems and services are in place. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].
Amendment 165 #
Proposal for a regulation
Recital 10
Recital 10
(10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include creating strategic stockpilingreserves of essential medical supplies or advancing capacity building initiatives in crisis response at the Member State level, preventive measures related to vaccination and immunisation, and strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” approach, which reflects the fact that the health of people, animals and the environment are interconnected and that diseases can be transmitted from people to animals and vice versa. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 181 #
Proposal for a regulation
Recital 11
Recital 11
(11) As iIn the time of health crisis emergencycontext of public health crises, health technology assessment as well asnd clinical trials can contribute to the rapid development of medical countermeasures, and the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11 on Health Technology Assessment (HTA)TA to support cooperation on health technology assessment at Union level. Notes, however, that there has been limited progress on the proposal in Council as some Member States have challenged its compatibility with the subsidiarity principle and objected to the mandatory uptake of joint HTA reports. __________________ 11Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018.
Amendment 202 #
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics noting, in particular, its dependency on third countries for manufacturing capacity, the supply of active pharmaceutical ingredients and starting materials. The Programme therefore should provide support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments.
Amendment 208 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
Amendment 237 #
Proposal for a regulation
Recital 16
Recital 16
(16) Keeping people healthy and active longer and empowering them to take an active role in managing their health will have positive effects on health, health inequalities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national budgets. Recognition of innovation, which has a profound impact on health outcomes and costs, also serves to address the challenges of achieving sustainability in the health sector and the impact of changing demographics. Moreover, action to reduce inequalities in the provision of healthcare in rural and remote areas is important for the purposes of achieving inclusive growth. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well- being for all at all ages".13 The Programme therefore should contribute to the actions taken towards reaching these goals. __________________ 13 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Next steps for a sustainable European future. European action for sustainability COM (2016) 739 final of 22.11.2016.
Amendment 249 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non-communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to have sufficient financial resources, follow a "Health in all Policies" (HIAP) approach, provide an integrated response focusing on health promotion and primary prevention across sectors and policy fields, combined with efforts to strengthen health systems that will have a direct impact on the long-term public health policy of all Member States.
Amendment 278 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits andbalanced diets and obesity, physical inactivity, mental health and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
Amendment 325 #
Proposal for a regulation
Recital 20
Recital 20
(20) The Programme will work in synergy and complementarity with other EU policies, programmes and funds such as actions implemented under the Digital Europe Programme, Horizon Europe, rescEU reserve under the Union Civil Protection Mechanism, Emergency Support Instrument, European Social Fund+ (ESF+, including as regards synergies on better protecting the health and safety of millions of workers in the EU), including the Employment and Social Innovation Strand (EaSI), the InvestEU fund, Single Market Programme, European Regional Development Fund (ERDF), Recovery and Resilience Facility including the Reform Delivery Tool, Erasmus, European Solidarity Corps, Support to mitigate Unemployment Risks in an Emergency (SURE), and EU external action instruments, such as the Neighbourhood, Development and International Cooperation Instrument and the Instrument for Pre-accession Assistance III. Where appropriate, common rules will be established in view of ensuring consistency and complementarity between funds, avoiding any overlap or duplication of financing, while making sure that specificities of these policies are respected, and in view of aligning with the strategic requirements of these policies, programmes and funds, such as the enabling conditions under ERDF and ESF+.
Amendment 327 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The health workforce has a vital role in building resilient health systems and in reaching the highest attainable standard of health. The Programme should therefore underpin the Commission’s work on effective, accessible and resilient healthcare and health systems, and support the development and implementation of a strategy on the health workforce. In synergy with European Social Fund Plus (ESF+), and in particular Employment and Social Innovation (EaSI), the Programme should provide under the Strategy the means for harmonized training and education for the purpose of improving the curricula of health professionals and their digital skills, in order to obtain a patient-oriented and outcome-based health approach. The Programme should also support, via the Strategy, Member States to address the brain drain and migration of the healthcare workforce from Member States of the eastern flank of the European Union and implement retention policies. Being able to deliver high quality, standardised, targeted and integrated care, and improve health service coverage depends on the availability, accessibility, acceptability, adaptability and quality of the health workforce.
Amendment 340 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor, prevent and manage shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines and treatment, promote incentives to develop such medicinal products as antimicrobialsboost the production capacity for antimicrobials, personalised treatment and vaccination, and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of clinical practice. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should offer some support to the implementation of the Pharmaceutical strategy for Europe.
Amendment 362 #
Proposal for a regulation
Recital 23
Recital 23
(23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given that infections caused by antibiotic-resistant bacteria were responsible for 33,110 deaths in the European Union and European Economic Area in 2015, according to data from the European Center for Disease Control, as well as the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. Notes moreover that the spread of Antimicrobial Resistance will require a greater emphasis in the Programme on preventing infections due to Gram-negative bacteria because there are relatively few existing treatment options for them and a limited number of new antibiotics in development. __________________ 14Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017.
Amendment 370 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) Effective international collaboration is key to controlling HAIs and Antimicrobial Resistance and the EU has an important role in supporting Member States in this area, for example through research programmes, the surveillance systems operated by the ECDC and the development of EU wide point prevalence survey methodology.
Amendment 376 #
Proposal for a regulation
Recital 25
Recital 25
(25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross-border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and, working in conjunction with key partners such as the EMA and the ECDC, provide high quality, comparable and reliable data to underpin policymaking and monitoring.
Amendment 385 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) Cross-border cooperation in the provision of healthcare to patients moving between Member States, as provided for under Directive 2011/24/EU, includes European Reference Networks (‘ERN’). This is an example where integrated work among Member States has been shown to have strong added value and great potential to increase the efficiency of health systems and therefore health in general. However, it is still to be fully elaborated in terms of Union legislation, implementation and resources. The Programme should therefore aim at ensuring that such integrated and coordinated work is developed and implemented to its full potential in areas such as ERN. That work would serve to foster the implementation of high-impact practices aimed at distributing, in the most effective way, available resources to the relevant population so as to maximise their impact.
Amendment 395 #
Proposal for a regulation
Recital 27
Recital 27
(27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and chronic non- communicable diseases such as cancer and neurodegenerative diseases. __________________ 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 450 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) support health promotion, health literacy and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;
Amendment 462 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) support existing and future Union health legislation, improve the availability in the Union of medicines, medical devices and other crisis relevant producttreatments and medical devices, contribute to their accessibility and affordability, and support innovationthe safe and effective use of medicines, and advance research in healthcare;
Amendment 500 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Article 4 – paragraph 1 – point 1
(1) in full accordance with Article 168(5) of the Treaty on the Functioning of the European Union, strengthen the capability of the Union, including the EMA and the ECDC, for prevention, preparedness and response to serious cross- border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and surveillance;
Amendment 570 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, the early diagnosis of neurogenerative and other brain diseases, and notably of cancer;
Amendment 601 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9 a (new)
Article 4 – paragraph 1 – point 9 a (new)
(9 a) advance health literacy through specific programmes in areas such as health promotion, prevention and patient- centred care;
Amendment 618 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. The Programme shall be implemented in direct management in accordance with Regulation (EU, Euratom) 2018/1046 or in indirect management with the bodies referred to in Article 62(1) (c) of Regulation (EU, Euratom) 2018/1046, to ensure there is no overlap or duplication with other funding programmes at the Union level.
Amendment 639 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, as well as relevant Union decentralised agencies and other relevant stakeholders, such as representatives of civil society organisations, and in particular patients’ organisations, on the work plans established for the Programme and its priorities and strategic orientations and its implementation.
Amendment 747 #
Proposal for a regulation
Annex I – point e – point iv
Annex I – point e – point iv
(iv) Procurement of goods and services, based on the most economically advantageous tender (MEAT) criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 811 #
Proposal for a regulation
Annex I – point g – point viii
Annex I – point g – point viii
(viii) Support capacity building of national systems for the implementation of legislation on substances of human origin, and for the promotion of the sustainable and safe supply of such substances through networking activitiea Union framework to cooperation among Member States in order to enable Member States to deliver and exchange timely, reliable and high quality joint clinical assessments, joint scientific consultations and other relevant activities to support decision-makers;
Amendment 896 #
Proposal for a regulation
Annex I – point h – point vii
Annex I – point h – point vii
(vii) Actions supporting quality in cancer prevention and, treatment, and follow- up care including diagnosis and treatment;
Amendment 909 #
Proposal for a regulation
Annex I – point h – point x
Annex I – point h – point x
(x) Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of cancer care.
Amendment 934 #
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials, including those involving collaboration between Member States, increased coordination at Union level and with the European Medicines Agency, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines;
Amendment 950 #
Proposal for a regulation
Annex I – point i – point v
Annex I – point i – point v
(v) Support action that builds on EU achievements including the launch of the New Drugs for Bad Bugs (ND4BB) programme and the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR), to encourage the development of innovative products and of less commercially interesting products such as antimicrobials;
Amendment 980 #
Proposal for a regulation
Annex I – point i – point x
Annex I – point i – point x
(x) Support action to foster international regulatory convergence on medicines and medical devices.
Amendment 1085 #
Proposal for a regulation
Annex II – part B – point 14
Annex II – part B – point 14