20 Amendments of Anneli JÄÄTTEENMÄKI related to 2016/2057(INI)
Amendment 9 #
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to the Report of the United Nations Secretary-General's High- Level Panel on Access to Medicines
Amendment 11 #
Motion for a resolution
Citation 4
Citation 4
— having regard to the antitrust procedure, Case AT.39612 – Perindopril (Servier), and to paragraphs 249 and 250 of the judgment of the Court of Justice of 14 February 1978 in Case 27/76 on excessive prices,;
Amendment 47 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the high prices of innovative medicines conflicts with the patients' and national health systems' ability to pay for pharmaceutical expenditure and hinders the fundamental right of citizens to health and medical treatment;
Amendment 91 #
Motion for a resolution
Recital E
Recital E
E. whereas the aim of intellectual property is to benefit society, guaranteeing investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereofto diffuse knowledge;
Amendment 111 #
Motion for a resolution
Recital F
Recital F
F. whereas the Commission has had to introduce incentives to promote research in areas such as rare diseases, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial drugs;
Amendment 122 #
Motion for a resolution
Recital G
Recital G
G. whereas the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States, following rules set out in national reimbursement and pricing legislation;
Amendment 130 #
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 entrycontributes to ensuring the sustainability of healthcare systems, and whereas market entry of generics and biosimilars should not be delayed;
Amendment 198 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls that robust clinical trials are necessary to assess the efficacy and safety of medicines;
Amendment 221 #
Motion for a resolution
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Considers innovation in the pharmaceutical sector to be crucial in order to address unmet medical needs;
Amendment 264 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Commission to revise the Transparency Directive with a focus on guaranteeing timely entry into the market for generic and biosimilar medicines, ending patent linkage according to Commission's guidelines, accelerating pricing and reimbursement decisions for generics and precluding the multiple reassessment of the elements supporting marketing authorisation; Believes that this will maximise savings for national health budgets, improve affordability, accelerate patient access and prevent administrative burdens for generic and biosimilar companies;
Amendment 272 #
Motion for a resolution
Paragraph 9 d (new)
Paragraph 9 d (new)
9d. Highlights that some Member States have achieved particularly low prices by the use of large-scale tendering in generic medicines; Notes with concern that excessive focus on short-term cost- savings may lead to medium- and long- term unintended consequences such as market concentration in the generic industry, and increased risk of shortages due to lack of redundancy in the system and lack of financial motivation to produce low-profit margin medicines, as well as low-volume drugs;
Amendment 280 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Notes with concern that data supporting the assessment of the added value of innovative medicines is often scarce and not sufficiently convincing to support solid decision making on pricing;
Amendment 283 #
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Considers that independent and good quality evidence is crucial to determine the cost-effectiveness of new medicines;
Amendment 321 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Stresses the importance of transparency, including as regards clinical data, R&D costs and public funding, marketing strategies, actual prices and reimbursement levels, to improve access to medicines with relevant additional benefits for patient and health systems;
Amendment 324 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Encourages Members States to engage in early dialogue and horizon scanning with industry, patients and payers and to anticipatorily incorporate in their determination of the cost- effectiveness of new medicines the forecasted evolution in the pharmaceutical innovation pipeline while giving due regard to budgetary impact considerations;
Amendment 519 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Council toand the Commission to promote increased 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;
Amendment 521 #
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, ensuring faster patient access to innovative medicines;
Amendment 534 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Council to promote rational use of medicines across the EU, such as avoiding overconsumption of medicines, in particular antibiotics;
Amendment 540 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Calls on the Commission and on Member States to ensure full implementation of the pharmacovigilance legislation;
Amendment 592 #
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, to explore mechanisms to address the withdrawal of effective medicines from the market purely for commercial reasons, such as remarketing for new indications, and to promote the supply of generics;