12 Amendments of Christel SCHALDEMOSE related to 2016/2057(INI)
Amendment 150 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas Regulation 141/2000/EC on orphan medicinal products provides extra incentives to develop medicine for medicine for patients with rare diseases;
Amendment 155 #
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. Whereas to date the EU has not had a strategic plan for combating HCV;
Amendment 207 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that the interests of the pharmaceutical industry favour short trials and fast access to the market; but recalls that clinical trials are necessary to assess the efficacy and safety of medicines;
Amendment 214 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Note with concerns that industry 'interactions with health-sector stakeholders are poorly regulated, which may lead to conflict of interest and biased decisions;
Amendment 251 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Stresses that the provisions in 141/2000/EC should only be applicable for rare diseases, when a substantial development has taken place and other best alternatives are not already available; the legislation should not be misused for driving up prices;
Amendment 267 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Deplores that a number of drugs shortages occur because of unfair business economic strategies such as "pay for delay" in the pharmaceutical sector;
Amendment 440 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to review the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to better determine the level of new development, 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 and to ensure the correct implementation of the legislation;
Amendment 487 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Calls on the Commission to observe and reinforce the EU competition legislation and its competencies on the pharmaceutical market to counter abuse and to promote fair prices for patients;
Amendment 528 #
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Calls on the Commission to consider a model in which a maximum price for a pharmaceutical product is set when approved for the European Market by EMA in accordance with Directive 2001/83/EC and Regulation 2004/726/EC; this maximum price should be based on the cost of research, development and production with a fair profit margin;
Amendment 568 #
Motion for a resolution
Paragraph 32 a (new)
Paragraph 32 a (new)
32a. Calls on the Commission to continue and where possible intensify the monitoring, and investigation of potential cases of market abuse including so called "pay for delay", excessive pricing as well as other market restrictions specifically relevant to the pharmaceutical companies operating within the EU, in accordance with Articles 101 and 102 of the Treaty on Functioning of the European Union;
Amendment 610 #
Motion for a resolution
Paragraph 36 a (new)
Paragraph 36 a (new)
36a. Calls on the Commission to put forward, with wide stakeholder input, a set of clear definitions for medicines shortages and to enhance a policy dialogue on the topic;
Amendment 616 #
Motion for a resolution
Paragraph 36 b (new)
Paragraph 36 b (new)
36b. Calls on the Commission to conduct an annual report on the status of medicines shortages across the EU;