20 Amendments of Nessa CHILDERS related to 2016/2057(INI)
Amendment 3 #
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to article 81 of Directive 2001/83/EC on ensuring appropriate and continued supplies of medicinal products,
Amendment 13 #
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
- having regard to the importance of the recommendations of the report prepared by the High-Level Panel on Access to Health Technologies, convened by the United Nations Secretary-General, published in September 2016
Amendment 81 #
Motion for a resolution
Recital D
Recital D
Da. whereas the gradual ageing of the population will lead to an increase in healthcare costs and whereas the Member States will have to guarantee that a sufficient part of their budget is spent on the health and wellbeing of their citizens;
Amendment 132 #
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 136 #
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. whereas access to affordable and suitable diagnostic tests and vaccines is as critical as access to safe, effective and affordable medicines.
Amendment 195 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that full transparency of the cost of developmentR&D and clinical trials is crucial in order to set a fair price;
Amendment 241 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Contests the adequacy of secondary patenting where marginal or insignificant changes in therapeutic effect are observed;
Amendment 244 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that the high level of public funds used for R&D is not reflected in the pricing; underlines the need to require full transparency and public disclosure of research and development costs when EU funds are invested in the development of new medicines
Amendment 338 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public; further notes that IMI2 is largely financed by EU taxpayers, stressing the necessity of enhanced EU leadership in prioritizing public health needs of IMI2 research and the inclusion of broad data sharing and pro-public health IP management policies;
Amendment 399 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to promote R&D driven by public health and 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 full transparency on the costs of R&D;
Amendment 408 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to analyse the overall impact of IP in promoting innovation,needs-driven innovation, affordability and commensurably improved therapeutic outcomes especially the impact of supplementary protection certificates (SPCs), data exclusivity orand market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practicesamend legislation accordingly;
Amendment 430 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to promote open data in private research, especially where public funding is involved, and to establish conditionsrequire conditions to ensure a public health return on investment in biomedical research, such as affordable pricing and non-exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020;
Amendment 444 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to fully and comprehensively review 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 drugs compared to the best available alternative and to promote the European register of rare diseases and reference centres;
Amendment 466 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectiveness, within the scope of the circumstances identified in Regulation EC/507/2006;
Amendment 477 #
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 and biosimilar medicines, 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 533 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Council to promote rational use of medicines across the EU, including a better use of pharmacist expertise in procurement and patient advice;
Amendment 573 #
Motion for a resolution
Paragraph 33 a (new)
Paragraph 33 a (new)
33a. Calls on the Council and the Commission to safeguard access to clinical trial and pharmacovigilance data from any trade secret or commercial confidentiality provisions in international trade negotiations, as well as information exchanged between parties' national authorities as regards matters of safety and overriding public interest;
Amendment 574 #
Motion for a resolution
Paragraph 33 b (new)
Paragraph 33 b (new)
33b. Calls on the Council and the Commission to exclude any provisions concerning price and reimbursement criteria or procedures from international trade negotiations;
Amendment 575 #
Motion for a resolution
Paragraph 33 c (new)
Paragraph 33 c (new)
33c. Calls on the Council and the Commission to fully safeguard the practicability of biomedical innovation models other than patent-based intellectual property regimes in international trade negotiations;
Amendment 590 #
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission to better define the concept, and analyse the causes of, medicines shortages, from the perspective of timely patient access, to establish a list of essential medicines and monitor compliance with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of genericwhich are to be reported on by the Commission on an annual basis, to promote the supply of generics, and to seek solutions to secure the continued availability of effective but commercially discontinued medicines;