19 Amendments of Christian EHLER related to 2020/0102(COD)
Amendment 136 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States in order to improve the prevention and control of the spread of severe human diseases across borders, to develop and guarantee the availability and accessibility of products for the prevention and treatment of diseases, to ensure that all Member States have fair access to medical products, to combat other serious cross- border threats to health and to prevent and respond to medicines shortages in a timely manner that takes fairly and comprehensively into account the individual needs of each Member State, and to safeguard the health and well-being of all people in the Union, including by combating vaccine hesitancy that may decrease immunisation coverage among certain population groups. __________________ 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 154 #
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6b) While the Union´s action in the field of health is limited, the Union should have the capacity to face future risks, realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and environmental health threats, and also to support Member States in addressing the challenges of an ageing population, of chronic and rare diseases, or disease prevention, and preparing their health systems for emerging technologies in order to fully benefit from the digital revolution while seeking synergies with other relevant EU programmes such as Horizon Europe, Digital Europe, Connecting Europe Facility programme or Space Programme.
Amendment 160 #
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 healthcare and health systems are in place in preparation for future pandemics and other health crises. Full advantage should be taken of the opportunities that digitalisation, artificial intelligence, robotics and new innovative technologies, in health and care can provide while ensuring the security of data, the right to privacy and data protection, while deploying adequate resources to ensure protection against cyber threats. 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 188 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups as well as the varying impacts in terms of gender. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to telemedicine taking account of varying levels of digital literacy, at-home administration of medication, promote innovative digital solutions for health and care in synergy with Horizon Europe and its relevant Missions and Partnerships and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients, .
Amendment 199 #
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuring the supply ofcluding the EU’s dependency on third countries in ensuring the supply of chemical raw and starting materials, active pharmaceutical ingredients, medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions which foster the production,will increase the security of supply of medicines in the EU and reduce dependency on third countries by encouraging the diversification of supply chains, fostering the production in the EU, joint procurement and management of crisis relevant products ensuring complementarity with other Union instruments.
Amendment 323 #
Proposal for a regulation
Recital 19 c (new)
Recital 19 c (new)
(19c) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. The Programme should therefore contribute to the investment in early diagnosis and screening, and to promotion and awareness raising in relation to the benefits of early diagnosis and screening, in line with or going beyond WHO, UN and EU recommendations, and in synergy with Horizon Europe, its Mission on Cancer and the relevant partnerships.
Amendment 324 #
Proposal for a regulation
Recital 19 d (new)
Recital 19 d (new)
(19d) Paediatric cancers are a category of age- and biologically-specific rare malignancies that cannot be appropriately addressed by extrapolation of adult cancer approaches and require a dedicated effort across the research and care continuum. The Programme should provide for actions oriented at paediatric cancer, in particular aiming to address the limitations of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council1a in this disease area and support cross-border research collaboration by granting appropriate allocations in synergy with Horizon Europe, its Mission on Cancer and the relevant partnerships. __________________ 1aRegulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) (OJ L 378, 27.12.2006, p. 1).
Amendment 337 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor and mitigate 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, personalized treatment and vaccination, and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines. The programme should also strengthen decision-making on medicines by enabling access to and analysis of real- world healthcare data by regulators and HTA bodies. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of health innovation, including innovations in rare diseases, in healthcare systems and 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 support the implementation of the Pharmaceutical strategy for Europe to foster a competitive pharmaceutical industry taking into account that EU remains by far the world’s first manufacturing region of active ingredients for patent medicines.
Amendment 378 #
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 provide high quality, comparable and reliable data, including real-world healthcare data, thereby contributing to the development of the European health data space, to underpin policymaking and monitoring.
Amendment 459 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) improve the availability in the Union of medicines, medical devices and osupport existing and future Union health legislation, improve the availability and sustainable production capacity of medicines, treatments and medical devices in the Union and to ensure their crisis relevant products, contribute to their affordability, and support innovationaccessibility and affordability, support safe and effective use, and boost research and innovation in healthcare without duplicating efforts under programmes, including Horizon Europe;
Amendment 481 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) strengthen health systems and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and comparable and interoperable data sharing, to increase the general level of public health.
Amendment 514 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
(2) ensure the availability in the Union of reserves or stockpiles of crisis relevant products, and a reserve of medical, healthcare and support staff to be mobilised in case of a crisis or shortage, ensure that such a reserve is available for fair access by all Member States in the Union;
Amendment 525 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3 a (new)
Article 4 – paragraph 1 – point 3 a (new)
(3a) support actions to increase research and development, including for unmet medical needs, in full synergy with Horizon Europe and its Missions and Partnerships, including through clinical trials, in the Union of crisis-relevant products, and access to and analysis on data from the use of such products in healthcare systems, including through the European Open Science Cloud;
Amendment 543 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4 b (new)
Article 4 – paragraph 1 – point 4 b (new)
(4b) support the Union’s health related innovation ecosystems in full synergy with Horizon Europe and its Missions and Partnerships to ensure the development and uptake of preventive actions, the next generation of medicines, vaccines and medical devices to meet increasing healthcare challenges and expectations that arise including the ones that come with rare disease prevention, diagnosis, treatment, and innovation;
Amendment 589 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9
Article 4 – paragraph 1 – point 9
(9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, the identification of health technologies meant to benefit from a Union assessment, and scaling up networking through the European Reference NetworkRNs and other transnational networks in full synergy with Horizon Europe and its Missions and Partnerships;
Amendment 716 #
Proposal for a regulation
Annex I – point d – point iv
Annex I – point d – point iv
(iv) Development and operation of databases and digital tools and their interoperability, including where appropriate with other sensing technologies, such as space-based, and to support cross-border exchange, access to and analysis of data from real world healthcare settings, including within the framework of the European health data space and the EMVS (European Medicines Verification System) data repositories at aggregated level as a tool to oversee shortages while ensuring respect of personal data in line with GDPR and ensuring appropriate cyber security solutions are deployed;
Amendment 889 #
Proposal for a regulation
Annex I – point h – point v b (new)
Annex I – point h – point v b (new)
(vb) Support implementing policies, national programmes and guidelines to overcome inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe in full synergy with Horizon Europe and its missions and partnerships;
Amendment 958 #
Proposal for a regulation
Annex I – point i – point v c (new)
Annex I – point i – point v c (new)
(vc) Action to sustain a strong, balanced and adequate intellectual property framework, incentives and reward mechanisms for R&D, in order to attract investments in the Union for the development, manufacturing and distribution of the next generation of medicines, vaccines and medical devices, including personalised medicine;
Amendment 996 #
Proposal for a regulation
Annex I – point j – point ii
Annex I – point j – point ii
(ii) Support to thinvestments for the sustainable digital transformation of health care and health systems including through benchmarking and capacity building for the uptake of innovative tools and technologies; and strengthening the safe use and re-use of health data, in line with GDPR support and implement digital upskilling of health care professsionals;