23 Amendments of Elisabetta GARDINI related to 2016/2057(INI)
Amendment 32 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to the report approved by the Committee on the Environment, Public Health and Food Safety and by the European Parliament on the amendment of the Regulation 726/2004;
Amendment 115 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas the Advanced Therapy Medicinal Products (ATMPs) have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate, and whereas only few ATMPs have been authorised so far;
Amendment 175 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. RegretNotes that the research priorities of the pharmaceutical industry are profit- oriented rather than patient-orientedencompass ensuring better treatment for patients and generating financial returns;
Amendment 196 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Stresses that patients' organisations should be better involved in the definition of private and public clinical trials research strategies, to ensure that they meet the true unmet needs of European patients;
Amendment 206 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that, in case of unmet medical needs, the interests of the patients and the pharmaceutical industry favourmay require short trials and fast access to the market;
Amendment 224 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Recalls that IP rights allow a legal monopoly, which needs to be carefully regulatedprovide a limited period of exclusivity, which is carefully regulated and monitored by the authorities to avoid conflict with the right to health protection and to promote quality of innovation and competitiveness;
Amendment 236 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that mostnew medicines are not examples of genubringineg innovation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extenssufficient added clinical value do not provide genuine innovations;
Amendment 276 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that most national assessment agencies are already using clinical, economic and social benefit criteria to assess new drugs in terms of pricing and reimbursement and stresses the importance of increasing collaboration among Member States in the field of pricing and reimbursement of medicinal products to ensure sustainability of healthcare systems and preserve the rights of European citizens to access quality healthcare;
Amendment 282 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Recognises that pricing and reimbursement of medicinal products are competences of Member States;
Amendment 300 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Stresses that in the framework of pricing and reimbursement decisions, Member States should not re-assess the elements on which the European marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product leading to delayed access for patients;
Amendment 332 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes initiatives such as the Innovative Medicines Initiative (IMI), but regrets that only a few of them are entirely public; which bring together the private and public sectors in order to stimulate research and accelerate patients' access to innovative therapies;
Amendment 356 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights the role of the European Union in monitoring and providing guidance on economic policies within the framework of the European Semester, and welcomes the production of country-specific recommendations in the field of healthcare sustainability;
Amendment 383 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of Member States in order to achieve fair prices forensure fast and equitable access to innovative medicines;
Amendment 393 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to promote R&D driven by patients’ 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&Dinvolve patients and their organisations in the definition of research priorities of all its programmes related to health, to promote R&D driven by patients' need;
Amendment 421 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on EU Member States and the pharmaceutical industry to increase transparency on the process of pricing and reimbursement of pharmaceutical products, including the costs of R&D;
Amendment 442 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to reviewupdate the regulatory framework for orphan medicines, to define clearly the concept of unmet medical needs, to assess the impact of incentives to develop effective, safe and affordable drugsprovide guidance on priority unmet medical needs, and to review existing incentives schemes to facilitate the development of effective, safe and affordable drugs for rare diseases, including rare cancers, compared to the best available alternative and to promote the European register of rare diseases and reference centres;
Amendment 451 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission for further actions to foster the development and the patients access to ATMPs, with a particular focus on the lack of harmonisation regarding the conditions required by Member States for the application of the Hospital Exemption;
Amendment 457 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to guarantee safety and efficacy in anypromote fast- track approval process and to introduce the concept of conditional authorisation based ones for unmet medical needs, and to introduce transparent and accountable process to monitor safety and effectiveness;
Amendment 491 #
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 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 506 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the European Medicines Agency 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 522 #
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, based also on the work of the EURIPID project and existing bilateral and multilateral collaborations;
Amendment 558 #
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, taking into account the challenges of the marketreview the existing EU Directive 89/105/EEC, and in particular to put in place more solid implementing measures to ensure that Member States abide to the limit of 180 days imposed to them to fix the price of new medicines approved by EMA (Article 6);
Amendment 609 #
Motion for a resolution
Paragraph 36 a (new)
Paragraph 36 a (new)
36a. Calls on the European Commission to assess the impact of parallel trade in hampering access to treatments, in view of producing a legislative proposal to control and decrease the phenomenon of parallel trade;