17 Amendments of Eva KAILI related to 2016/2057(INI)
Amendment 34 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to the report approved by the Committee on the Environment, Public Health and Food Safety and by the European Parliament on the amendment of the regulation 726/2004;
Amendment 63 #
Motion for a resolution
Recital C
Recital C
C. whereas the prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizenharmaceutical expenditures make Member States highly concerned about their long-run financing capability given the anaemic economic growth and the demographic pressures;
Amendment 72 #
Motion for a resolution
Recital D
Recital D
D. whereas in addition to high prices, other barriers to access to medicines include shortages patient access to treatment is not only determined by the cost of medicines but by a variety of factors, including access to healthcare prof essential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, rigidionals and diagnostics, addressing healthcare system inefficiencies, clinical practice and the functioning of national pricing and reimbursement systems, measures aimed at improving patient rules and budget restrictionsaccess should address the determinants holistically;
Amendment 180 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses that patients' organizations should be better involved in the definition of private and public clinical trials research strategies, to ensure that they meet the true unmet needs of the European patients;
Amendment 235 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that mostnew medicines are not examples of genubringineg innovation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extenssufficient added clinical value do not provide genuine innovations;
Amendment 275 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that most national assessment agencies are already using clinical, economic and social benefit criteria to assess new drugs in terms of pricing and reimbursement and stresses the importance of increasing collaboration among Member States in the field of pricing and reimbursement of medicinal products to ensure sustainability of the healthcare systems and preserve the rights of the European citizens to access quality healthcare;
Amendment 379 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Highlights the role of the European Union in monitoring and providing guidance on economic policies within the framework of the European Semester and welcomes the production of country-specific recommendations in the field of healthcare sustainability;
Amendment 384 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices forensure fast and equitable access to innovative medicines;
Amendment 394 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to promote R&D driven by patients’ needs, while fostering social responsibility in the pharmaceutical sector, by setting up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems; calls for transparency on the costs of R&Dinvolve patients and their organizations in the definition of research priorities of all its programs related to health, to promote R&D driven by patients' need;
Amendment 422 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the EU Member states and the pharmaceutical industry to increase transparency on the process of pricing and reimbursement of pharmaceutical products, including the costs of R&D;
Amendment 443 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to reviewupdate the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugsprovide guidance on priority unmet medical needs, and to review existing incentive schemes to facilitate the development of effective, safe and affordable drugs for rare diseases, including rare cancers, compared to the best available alternative and to promote the European register of rare diseases and reference centres;
Amendment 456 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to guarantee safety and efficacy in anypromote fast- track approval process and to introduce the concept of ces for unmet medical needs and to introduce transparent and accountable processes to monditional authorisation based onor safety and effectiveness;
Amendment 492 #
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission to propose legislation on a European system for health technology assessment as soon as possible, and to assess added-value medicines compared with the best available alternative; also calls on the Commission to harmonise pricing and reimbursement criteria to take into account the level of innovation and the social and economic cost-benefit analysis, and to put in place a European classification on the added value level of medicines;
Amendment 515 #
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls on the European Medicines Agency to assess added-value medicines compared with the best available alternative; also calls on the European Commission to harmonize pricing and reimbursement criteria, to take into account the level of innovation as well as the social and economic cost-benefit analysis, and to put in place a European classification on the added value of medicines;
Amendment 523 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Council to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays, based also on the work of EURIPID project and existing bilateral and multilateral collaborations;
Amendment 559 #
Motion for a resolution
Paragraph 31
Paragraph 31
31. Calls on the Commission to propose a new directive on transparency of price-setting procedures and reimbursement systems, taking into account the challenges of the marketreview the existing EU Directive 89/105/EEC and in particular to put in place more solid implementing measures to ensure that Member states abide to the limit of 180 days imposed to them to fix the price of new medicines approved by EMA (Article 6);
Amendment 607 #
Motion for a resolution
Paragraph 36 a (new)
Paragraph 36 a (new)
36a. Calls on the European Commission to assess the impact of parallel trade in hampering access to treatments and creates significant shortages in certain Member States, in view of producing a legislative proposal to control and decrease the phenomenon of parallel trade;