18 Amendments of György HÖLVÉNYI related to 2016/2057(INI)
Amendment 19 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Welcomes that the Conclusions of the Council on strengthening the balance in the pharmaceutical system in the EU and its Members States outline the most relevant challenges of the pharmaceutical sector and important actions towards a fairer and a more patient-centred healthcare system;
Amendment 33 #
Draft opinion
Paragraph 4
Paragraph 4
4. Recognises as key obstacles to access to medicinesthat the lack of affordability and availability of medicines, the budgetary cuts resulting fromimpact of the financial crisis, the high price of medicines and theresulting from monopolies of large companies in the market and the uncontrolled parallel trade constitute considerable obstacles to access to medicines;
Amendment 58 #
Draft opinion
Paragraph 7
Paragraph 7
7. IdentifiesNotes that patent rights as a majornd other innovation promotion measures often create obstacles to access to medicines, and urges public policy makers to take proactive steps towards making generic and biosimilar medicines available in a timely manner, always taking into account the need to ensure the same beneficial effects, continuity of patient care and prevention of any risk of abuse or misuse of the regulatory framework;
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 67 #
Draft opinion
Paragraph 8
Paragraph 8
8. Calls on the Member States to support research and development (R&D) that focuses on the unmet medical needs of all citizens and to guarantee affordable and non-discriminatory access to medical advances in the European Union; emphasizes the importance of further investments through the Horizon2020 and the Innovative Medicines Initiative, as well as the involvement of the European Medicines Agency in the development of innovative medicines;
Amendment 98 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the pharmaceutical sector takes advantage of various innovation incentives such as supplementary protection certificate, data exclusivity or market exclusivity which aim at promoting valuable innovation fulfilling unmet medical needs, and whereas these incentives do not always prove to attain those objectives.
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 148 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. Whereas the European Parliament has shown its strong political commitment to this matter, above all by opening its current legislature to a more open policy for access to medicines;
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 197 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that marketing cost contribute to the price of medicines to a much higher extent than R&D costs.
Amendment 388 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for EU-wide and regional measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices for medicines;
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 556 #
Motion for a resolution
Paragraph 31
Paragraph 31
Amendment 576 #
Motion for a resolution
Paragraph 34
Paragraph 34
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;