11 Amendments of Andreas GLÜCK related to 2020/0102(COD)
Amendment 131 #
Proposal for a regulation
Recital 5 b (new)
Recital 5 b (new)
Amendment 209 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) The COVID-19 crisis has revealed the important need for Member States to organize stress tests to assess the resilience of their national health systems to all types of crises. These tests must be carried out on the basis of precise evaluation criteria set by the European Commission. The results of these tests could determine the weaknesses of the national health systems and the areas to be the subject to specific financial support.
Amendment 210 #
Proposal for a regulation
Recital 14 b (new)
Recital 14 b (new)
(14b) The coordination between national health systems is essential to guarantee solidarity within the Union. Joint procurement, coordinated transfer of equipment, reserve and circulation of blood products and organs, transports of patients for cross-border care should be adequately anticipated.
Amendment 213 #
Proposal for a regulation
Recital 14 e (new)
Recital 14 e (new)
(14e) European health agencies, in particular the ECDC and the EMA should be granted strengthened competences, resources and personnel to allow them to better and quicker carry out their duties efficiently to the benefit of European citizens. To anticipate any types of crises, the Commission should also evaluate the needs of the other European health agencies such as EFSA, ECHA and EU- OSHA. A stronger coordination between European Agencies should be guaranteed by the Commission.
Amendment 214 #
Proposal for a regulation
Recital 14 f (new)
Recital 14 f (new)
(14f) The Programme should support the revision of ECDC’s mandate to extend its competencies to the chronical diseases, to elaborate mandatory guidances for Member States and to be able to coordinate laboratory research in times of health crises.
Amendment 215 #
Proposal for a regulation
Recital 14 g (new)
Recital 14 g (new)
(14g) The programme should also support the revision of the EMA’s mandate to extend its competencies on clinical trial’s coordination and management of the shortages of medicines. EMA could therefore meet any future challenges such as monitoring and responding to shortages in coordination with the Member States. In the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers. The reinforcement of the EMA’s personnel should enable the Agency to carry out inspections of production sites established in third countries.
Amendment 217 #
Proposal for a regulation
Recital 14 i (new)
Recital 14 i (new)
(14i) The establishment of a communication portal for the public would allow the Union to share validated information, send alerts to European citizens and fight against disinformation. It could include a wide range of information, prevention campaigns and youth education programs. This portal could also be used to promote, in cooperation with the ECDC, a strong immunization coverage at European level.
Amendment 428 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘crisis relevant products’ means products and substances necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences, included but not limited to: medicinal products - including vaccines - and their intermediates, active pharmaceutical ingredients and raw materials; bloods products and organs; medical devices; hospital and medical equipment (such as ventilators, protective clothing and equipment, diagnostic materials and tools); personal protective equipment; disinfectants and their intermediary products and raw materials necessary for their production);
Amendment 506 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) Support the strengthening of the competences and resources of the European health agencies namely the ECDC and the EMA, the European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and EU- OSHA;
Amendment 550 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5
Article 4 – paragraph 1 – point 5
(5) support actions aimed at strengthening health system’s ability to foster disease prevention and health promotion, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals, their education, training and mobility;
Amendment 713 #
Proposal for a regulation
Annex I – point d – point i a (new)
Annex I – point d – point i a (new)
(ia) Strengthening of European Health agencies namely the European Centre for Disease Prevention and Control Centre(ECDC), the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and European Agency for Safety and Health at Work(EU-OSHA).