16 Amendments of Jessica POLFJÄRD related to 2020/0102(COD)
Amendment 174 #
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 strategic stockpilingand proportionate reserves of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 332 #
Proposal for a regulation
Recital 21
Recital 21
(21) In accordance with Article 114 TFEU, a high level of health protection should be ensured in the legislation adopted by the Union for the establishment and the functioning of the internal market. On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a considerable body of Union acquis was developed which guarantees the high standards of quality and safety for medicinal products and medical devices. Given the rising healthcare demand, Member States’ healthcare systems face challenges in the availability, accessibility and affordability of medicines and medical devices. To ensure a better public health protection as well as the safety and empowerment of patients in the Union, it is essential that patients and health systems have access to high quality healthcare products and can fully benefit from them. Such access could be promoted through improved coordination between Member States and through the maintenance of an open and well–functioning internal market at all times.
Amendment 352 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability, accessibility and affordability of those products while limiting the dependency of their supply chains on a small number of manufacturers and evaluating the Union's dependency on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines.
Amendment 423 #
Proposal for a regulation
Recital 43
Recital 43
(43) Given the nature and potential scale of cross-border threats to human health, the objective of protecting people in the Union from such threats and to increase crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union, action at Union level can also be taken to support Member States’ efforts in the pursuit of a high level of protection of public health, to improve the availability, accessibility and affordability in the Union of medicines, medical devices and other crisis relevant products, to support innovation and to support integrated and coordinated work and implementation of best practices among Member States, and to address inequalities in access to health throughout the EU in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Amendment 471 #
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 other crisis relevant products, contribute to their accessibility and affordability, and support innovation;
Amendment 474 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) strengthen health systems and the healthcare workforcemake them more resilient and responsive to crises, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, in order to increase the general level of public health.
Amendment 491 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) support the prevention of communicable diseases within the Union;
Amendment 518 #
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;
Amendment 594 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9
Article 4 – paragraph 1 – point 9
(9) support integrcoordinated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, and scaling up networking through the European Reference Networks and other transnational networks;
Amendment 607 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10 a (new)
Article 4 – paragraph 1 – point 10 a (new)
(10a) ensure that the Union remains a world leader in research and innovation in health care;
Amendment 610 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10 b (new)
Article 4 – paragraph 1 – point 10 b (new)
(10b) ensure that the Union's health initiatives are people-centred and outcome-driven;
Amendment 611 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10 c (new)
Article 4 – paragraph 1 – point 10 c (new)
(10c) Support measures to eliminate vaccine preventable diseases;
Amendment 741 #
Proposal for a regulation
Annex I – point e – introductory part
Annex I – point e – introductory part
(e) Structural stockpilereserves and crisis preparation:
Amendment 746 #
Proposal for a regulation
Annex I – point e – point ii
Annex I – point e – point ii
(ii) Establishment and management of EU reserves and stockpiles of crisis relevant products in complementarity with other Union instruments;
Amendment 1060 #
Proposal for a regulation
Annex II – part 2 – point 3
Annex II – part 2 – point 3
3. Number of vaccine doses distributed and immunisation coverage rates
Amendment 1083 #
Proposal for a regulation
Annex II – part 2 – point 12
Annex II – part 2 – point 12
12. Deaths and diseases attributable to antimicrobial resistant infections