16 Amendments of Biljana BORZAN 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 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 318 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Underlines the importance of transparency across the field (including as regards clinical data, research and development costs and public funding, marketing strategies, pricing and reimbursement) 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 402 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Calls on the European Commission to promote EMA's initiative on the safe use of adaptive pathways where it is deemed appropriate, to reduce the time to bring to the market medicines that address unmet medical needs and to ensure that marketing authorization will be granted without compromising patient safety, and only if there is a positive balance of benefits and risks for a defined patient population;
Amendment 414 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to analyse the overall impact of IP in promoting innovation and 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 450 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to analyse the adequacy of the legislative framework to the current situation with the parallel export and re-export of medicines, and underlines the need to strike the right balance between public health and economic considerations;
Amendment 478 #
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 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 488 #
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24b. Calls on the European Commission to enhance dialogue on unmet medical needs between all relevant stakeholders, patients, healthcare professionals, regulators, HTA bodies, payers and developers throughout the life span of medicines.
Amendment 502 #
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission to propose legislation 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 reimbursementHTA criteria to take into account the level of innovation, value for patients, and the social and economic cost- benefit analysis, and to put in place a European classification on the added value level of medicines;
Amendment 535 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Council to promote rational use of medicines, and especially antimicrobials, across the EU;
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 561 #
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 593 #
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, and to promote the supply of generics;