Activities of Véronique TRILLET-LENOIR related to 2021/2013(INI)
Plenary speeches (1)
A pharmaceutical strategy for Europe (debate)
Amendments (21)
Amendment 14 #
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
— having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Amendment 16 #
Motion for a resolution
Citation 12 b (new)
Citation 12 b (new)
— having regard to the Commission communication of 11 December 2019 on ‘The European Green Deal’
Amendment 18 #
Motion for a resolution
Citation 12 c (new)
Citation 12 c (new)
— having regard to its resolution of 15 January 2020 on the European Green Deal
Amendment 31 #
Motion for a resolution
Recital A
Recital A
A. whereas ensuring patient access to medicines is one of the core objectives of the EU and the WHO, and of Sustainable Development Goal 3; whereas universal access to medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination; whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;
Amendment 75 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, assessment, testing, authorisation, production, access, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;
Amendment 148 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls for the strengthening of the European Medicines Market to speed up patient access to medicines, improve public health, make care more affordable and maximize savings in national health budgets;
Amendment 151 #
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Considers that Member States should converge on the evaluation of medical technologies; looks forward to a timely adoption of the Regulation on Health Technology Assessment (HTA) by the European Parliament and the Council to ensure rapid access to innovative treatments;
Amendment 279 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Considers that the European Union should encourage pharmaceutical companies to settle or return to European territory through state aids or via the Instrument for Important Projects of Common Interest (PIIEC); points out that incentives should be conditioned on companies' full compliance with the EU environmental and societal standards;
Amendment 285 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Insists on the need to ensure equal access to affordable drugs within the EU; promotes collective negotiation of the price of medicines with pharmaceutical industries such as the Beneluxa initiative and the Valetta Declaration; considers that pharmaceutical industries should respect a conditionality on the affordable price of medicines in the framework of publicly funded research;
Amendment 288 #
Motion for a resolution
Paragraph 6 c (new)
Paragraph 6 c (new)
6 c. Calls on the Commission to present a revision of Directive 89/105 /EEC on transparency in order to ensure effective controls and full transparency of the procedures used to determine the prices and reimbursement of medicines in the Member States;
Amendment 298 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Points out that generic and biosimilar medicines enable treatment efficacy and safety,increased competition, reduced prices and savings for healthcare systems, thus helping to improve access to medicines for patients ; Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;
Amendment 343 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Welcomes the Commission’s intention to adopt a legislative proposal to establish a Health Emergency Preparedness and Response Authority (HERA); considers that the Authority should identify health threats, initiate and support the development of innovation, establish at European level a list of medicinal products of major therapeutic interest, facilitate their production within the EU, promote the joint purchase and build up strategic stocks of those medicines;
Amendment 357 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of newongly supports the use of joint EU public procurement contractprocedures by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needsmedicinal products of major therapeutic interest, emergency medicines and unmet therapeutic needs to improve their affordability and their access at EU level;
Amendment 368 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Considers that, in times of crisis, part of the Union joint procurement should, in the spirit of solidarity, be pre- allocated to low- and middle-income countries, in particular African countries.
Amendment 444 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Supports the conclusion of industrial agreements between actors of the EU pharmaceutical industry to ensure a stronger EU production of medicines and improve the constant access to affordable medicines;
Amendment 450 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Underlines that in times of crisis, other mechanisms should be used to enable a global response and crises mitigation, including a Union export control mechanism, enhanced cooperation agreements on the production of medical countermeasures, pre- allocating part of the Union joint procurement, and both voluntary and compulsory technology know-how pools and licensing agreements between companies, which should guarantee access to counter-measures to low- and middle-income countries, in particular the African countries;
Amendment 503 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Underlines that the pharmaceutical sector remains an important industrial pillar as well as a driving force in terms of job creation; Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the Next Generation EU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level;
Amendment 529 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to fully implement the Clinical Trials Regulation9 to facilitate the launch of large clinical trials carried out in a harmonized and coordinated manner at European level; stresses that patient associations should be more involved in defining research strategies for public and private clinical trials, in order to ensure that they meet the unmet needs of European patients; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.
Amendment 576 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; recalls that medicines shortages have a direct impact on patients' health, safety and the continuation of their treatment; stresses that for patients, the consequences of drug shortages include: progression of the disease and / or worsening of symptoms due to delay in treatment, avoidable transmission of infectious diseases, increased risk of exposure to falsified medicines and significant psychological distress for patients and their families; notes that the risks are particularly high amongst vulnerable populations such as children, the elderly, pregnant women, people affected by a disability, patients with chronic diseases or cancer or people in intensive care unit (ICU); calls on the Commission to present a specific strategy for managing shortages of medicines and medical products in Europe; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 626 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an analysis of manufacturing and distribution risks and include measures on building up stocks of medicinal products of major therapeutic interest , diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production; underlines that several Member States have already established alert systems which facilitate the anticipation and prevention of shortages; calls for the establishment of alert systems to anticipate shortage of medicines at national and European levels;
Amendment 662 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Considers that the European Green Deal constitutes a major opportunity to encourage pharmaceutical manufacturers to participate to the green recovery plan by producing in compliance with environmental and ecological standards; Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;