23 Amendments of Alojz PETERLE related to 2016/2057(INI)
Amendment 32 #
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 49 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas patients should have access to the healthcare and treatment options of their choice and preference, including to complementary and alternative therapies and medicines;
Amendment 66 #
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 citizens and seriously affecting the sustainability of the national health care systems;
Amendment 70 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the number of people diagnosed with cancer is rising every year and the combination of increased cancer incidence in the population and new technologically advanced cancer medicines results in a situation where the total cost of cancer is rising, which puts an unprecedented demand on healthcare budgets and makes treatment unaffordable for many cancer patients, thus leading to a risk that affordability or pricing of the medication will become a deciding factor in a patient's cancer treatment.
Amendment 80 #
Motion for a resolution
Recital D
Recital D
D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection between clinical needs and research, unjustified administrative procedures, unavailability of products, rigid patent rules and budget restrictions;
Amendment 123 #
Motion for a resolution
Recital G
Recital G
G. whereas, due to the current international reference pricing system, the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States;
Amendment 133 #
Motion for a resolution
Recital I
Recital I
I. whereas the entry of generics and biosimilars onto the market is an important mechanism to reduce prices, and whereas there are clear concerns about the strategies to delay this entry;
Amendment 154 #
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas parallel trade of medicinal products lead to excessive medicines outflow from member states where lower prices are applied.
Amendment 196 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Stresses that patients' organisations 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 European patients;
Amendment 236 #
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 276 #
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 healthcare systems and preserve the rights of European citizens to access quality healthcare;
Amendment 282 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Recognises that pricing and reimbursement of medicinal products are competences of Member States;
Amendment 356 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. 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 383 #
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 393 #
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 organisations in the definition of research priorities of all its programmes related to health, to promote R&D driven by patients' need;
Amendment 421 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on 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 442 #
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 incentives 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 464 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to take a very cautious approach and guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectiveness; in this respect, calls on the Commission to take into consideration the opinion of non-industry related stakeholders;
Amendment 474 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the Commission to set up a framework to promote, guarantee and reinforce the competitiveness of generic medicineand biosimilar medicines in sustainable market conditions, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101 and 102 of the TFEU, and to present a biannual report in this regard;
Amendment 499 #
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission to propose legislationcarry out an impact assessment 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 506 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the European Medicines Agency 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 522 #
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 the EURIPID project and existing bilateral and multilateral collaborations;
Amendment 601 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission to analyse the causes of shortages, to establish a list of essential medicines and monitor compliance withsubmit a proposal to further specify Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generic and biosimilar medicines;