10 Amendments of Marc TARABELLA related to 2016/2057(INI)
Amendment 176 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Notes with concern an increasing number of examples of market failure in a number of Member States, where patients access to effective and affordable essential medicines is endangered by very high and unsustainable price levels, market withdrawal of products that are out-of- patent or when new products are not introduced to national markets for business economic strategies, and that individual governments have sometimes limited influence in such circumstances;
Amendment 299 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Recognises that innovative pricing solutions which align payment to outcomes and which are flexible enough to account for patients' and public payers' purchasing power, burden of illness and/or preferences, can contribute to the sustainability of healthcare systems and should be more widely used to enhance patients access to innovative medicines while addressing affordability constraints;
Amendment 378 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Encourages Member States to evaluate healthcare pathways and policies with a view to improving patient outcomes and the financial sustainability of the system notably by fostering digital solutions to improve healthcare delivery to patients and identify waste of resources;
Amendment 417 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Invites the Commission to prepare, as soon as possible and with the close involvement of the Member States, an overview of the current EU legislative instruments and related incentives that aim to facilitate the investment in the development of medicinal products and the marketing authorization of medicinal products given to the holders of a marketing authorisation as implemented within the EU: Supplementary Protection Certificates (Regulation EC 469/2009), medicinal products for human use (Directive 2001/83/EC and Regulation EC 726/2004), orphan medicinal products (Regulation EC 141/2000) and paediatrics (Regulation EC 1901/2006); invites also the Commission to prepare an evidence based analysis of the impact of the incentives in these EU legislative instruments, as implemented, on innovation, as well as on the availability, in particular supply shortages and deferred or missed market launches, and accessibility of medicinal products, including high priced essential medicinal products for conditions that pose a high burden for patients and health systems as well as availability of generic medicinal products; calls on the Commission to prepare in the coming months a timetable and methodology for conducting the analysis as mentioned in this paragraph;
Amendment 435 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Stresses that both public and private investments are essential for the research and development of innovative medicinal products; notes that in those cases where public investment has played a major role in the development of certain innovative medicinal products, a fair share of the return on investment in such products should preferably be used for further innovative research in the public health interest for example through agreements made on benefit sharing during the research phase;
Amendment 479 #
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 484 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Underlines the importance of timely availability of generics and biosimilars in order to facilitate patients' access to pharmaceutical therapies and to improve the sustainability of national health systems;
Amendment 507 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the Commission to establish a permanent and single mechanism assessing relative efficacy of new medicinal products at EU level based on harmonized data requirements, so as to enhance patient access to new treatments and avoid duplications in drug assessments;
Amendment 527 #
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Invites the Member States to explore possible strategies on voluntary cooperation to jointly work on relative efficacy assessments of medicines, on common horizon scanning tools to allow for better budgetary planning and on measures enabling joint price negotiations in coalitions of Member States, that have expressed interest to do so;
Amendment 530 #
Motion for a resolution
Paragraph 27 b (new)
Paragraph 27 b (new)
27b. Invites the Member States to consider organising during each EU Presidency an informal meeting of relevant high level representatives from the Member States responsible for pharmaceutical policy (e.g. national directors of pharmaceutical policy), encouraging strategic reflection and discussion on current and future developments in the pharmaceutical system in the EU and its Member States; notes that these discussions could be used, where relevant, as an input for further reflection in the appropriate EU fora, in particular the Working Party on Pharmaceuticals and Medical Devices;