Activities of Françoise GROSSETÊTE related to 2016/2057(INI)
Plenary speeches (1)
Options for improving access to medicines (debate) FR
Amendments (22)
Amendment 76 #
Motion for a resolution
Recital D
Recital D
D. whereas in addition to high prices, other barriers to access to medicines include shortages of essential medicines, the poor connection betweendifficulty with always reconciling research and clinical needs and research, unjustified administrative procedures, rigid patent rules and budget restrictions and delays to marketing authorisation, patent rules which are sometimes too rigid and budget choices with regard to reimbursement;
Amendment 85 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
E. whereas the aim ofsystem for protecting intellectual property is to benefit society, guaall too often used to generanteeing investment returns to promote innovation, and whereas there is concern about the abuse/misuse thereof economic benefits for pharmaceutical companies beyond lawful profit margins instead of according to the needs of patients, resulting in an irreconcilable conflict with the fundamental right to health;
Amendment 96 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas several years ago, a high- level European dialogue (the ‘G10’ between 2001 and 2002 then the Pharmaceutical Forum between 2005 and 2008) which brought together the key decision-makers and stakeholders in the health world decided to develop a shared strategic vision and to take specific steps to help with the competitiveness of the pharmaceutical sector;
Amendment 113 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas the gap between the growing resistance to antimicrobial agents and the development of new antimicrobial agents is widening, and whereas 25 000 people die each year in the EU owing to lack of access to adequate antimicrobial agents;
Amendment 163 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that in a European Union which is suffering deindustrialisation, the pharmaceutical sector remains an important industrial pillar and a driving force for job creation;
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 179 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Criticises the fact that health expenses continue to be seen only as a cost and not as an investment, and that medicine is always the first variable in economic measures in our healthcare systems;
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 237 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that most medicines are not examples of genuine innovation, but often ‘me-too’ or ‘evergreening’ products, which are permitted notably by complementary patent extensions; calls on the Commission to propose measures for limiting this phenomenon to the Member States;
Amendment 257 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Deplores the large number of litigation cases aimingStresses the importance of having generic medicines and biosimilar medicines in good time in order to dhelay generic entry;p patients to access pharmaceutical therapies,
Amendment 281 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. points out that competence for pricing and reimbursement decisions falls exclusively to 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 307 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Believes that a fair price should cover complex factors, such as the cost of the drug development and production, plus a margin of profitthe risk inherent in pharmaceutical research, the added value that the treatment represents and the results 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 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 447 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to review 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 drugs comparHighlights the success of Regulation (EC) No 141/2000 on orphan medicinal products, which enabled a number of innovative products for misdiagnosed patients or patients deprived of treatment to be placed ton the best available alternative andmarket; calls on the Commission to promote the European register of rare diseases and reference centres;
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 500 #
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 assessWelcomes the HTA multi-annual work programme 2016-2020 and recognises the 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 classificof European cooperation when it comes to assessing health technology; calls on the Commission to propose legislation on establishing a system for health technology assessment as soon as possible; calls for that system to be developed in close collaboration onwith the added value level of medicines;European Medicines Agency.
Amendment 536 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Stresses that antimicrobial resistance has become a serious problem that needs to be urgently tackled; therefore calls on the Commission and the Member States to tackle the key scientific, regulatory and economic challenges facing the development of antimicrobial agents, particularly by creating incentives for investments in research and development as well as new financing models to address the most urgent needs of the public healthcare sector and at the same time safeguard the sustainability of public healthcare systems in order to improve and ensure future access to suitable antimicrobial agents;
Amendment 552 #
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Calls on the Commission to launch a new high-level European strategic dialogue for the pharmaceutical sector that brings together representatives of the Commission, the European Parliament and the Member States, along with key stakeholders from the healthcare world: payers, patients, representatives from the academic and scientific world and manufacturers, including SMEs;