16 Amendments of Karin KADENBACH related to 2016/2057(INI)
Amendment 51 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas pharmaceuticals are one of the main pillars of healthcare rather than mere objects of trade;
Amendment 88 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to and promote innovation, and whereas there is concern about the abuse/misuse thereof; notes the Council Conclusions of 17 June 2016 inviting the Commission to conduct an evidence-based analysis on the overall impact of IP in promoting innovation;
Amendment 309 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. 13. Believes that a fair price should coverfor a medicine delivering additional benefit to patients should take into account the cost of the drug development and production, plus a margin of profit;
Amendment 314 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Believes that a fair price should cover the cost of the drug development and production, plus a margin of profitprices of medicines should be adequate to the specific economic situation of the country where they are marketed;
Amendment 317 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Stresses the importance of transparency across the field (including as regards clinical data, R&D costs and public funding, marketing strategies, actual prices and reimbursement levels) to improve access to medicines with additional patient and health system relevant benefits;
Amendment 347 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the European procedure for joint procurement of medicines used for the acquisition of vaccines in accordance with Decision No 1082/2013/EU; encourages the possible use of the procedure in case of shortages of infant vaccines;
Amendment 401 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to promote R&D driven by patients’ublic health 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&D;
Amendment 413 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to analyse the overall impact of IP in promoting innovation and on patient access, especially the impact of supplementary protection certificates (SPCs), data exclusivity or market exclusivity on competitiveness and quality of innovation, and to set strict limits on these practices;
Amendment 419 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the Commission to adopt a targeted SPC manufacturing waiver for export purposes to allow EU-based manufacturers of generic and biosimilar medicines to compete on equal footing with competitors from non-EU countries, thus avoiding the outsourcing of production and helping to maintain and create additional jobs and growth in the EU;
Amendment 455 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to maintain and set up if necessary strong rules aimed at guaranteeing safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectivenessensure that such approvals are made possible only in exceptional circumstances where a clear unmet medical need has been identified;
Amendment 472 #
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 and use of generic medicineand biosimilar medicines in sustainable market conditions, guaranteeing their faster entry onto the market and monitoring unfair practices in accordance with Articles 101l and 1l 02 of the TFEU, and to present a biannual report in this regard;
Amendment 485 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Reiterates that European collaboration on HTA allows Member States to pool their expertise and use their resources more effectively, thus helping them to better meet the increasing demand for assessments;
Amendment 542 #
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission and the Council to explore new measures to control prices, such as horizontal scanningdevelop a framework for ensuring "fair access" that maximises patient access and societal benefit whilst avoiding unacceptable impact on healthcare budgets; including exploration of different measures, such as horizon scanning, early dialogue, innovative pricing models, mechanisms for systematic collection of real-world data, and coordinating joint procurements;
Amendment 560 #
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, with a view to extending transparency to the market authorisation holder, and taking into account the challenges of the market;.
Amendment 581 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to examine and compare the actual prices of medicines in the EU and to present an annual report to Parliament in this regard;
Amendment 603 #
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 with Article 81 of Directive 2001/83/EU on shortages of supply, and to promote the supply of generic and biosimilar medicines;