Activities of Marie TOUSSAINT related to 2021/2013(INI)
Shadow opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (11)
Amendment 5 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Whereas the preparation to next global health crisis urges decision and policy making to bring solutions allowing long-term resilience in society, and in particular to design an industrial ecosystem in the pharmaceutical sector where the balance between the different interests at stake is duly considered in the light of the circumstances, in order for the EU to be able to respond to health crisis;
Amendment 12 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Whereas the European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19 (2020/2691(RSP)) has called on the Commission to assess the impact of intellectual property incentives on biomedical innovation and to explore credible and effective alternatives to exclusive protections for the financing of medical R&D, such as the numerous tools based on delinkage mechanisms;
Amendment 26 #
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises the key importance of an adapted intellectual property protection regime in the EU, which is essential if the EU is not to be in order to respond to urgent health needs in the EU and worldwide; Calls on the Commission to authorise State aid and to supervise public funding as an incentives for manufacturers to relocate the manufacture of the active ingredients of medicinal products to Europe, so that the EU is not dependent on third countries and ihas the means to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry, research and patient representatives, ands well as other civil society stakeholders, with a view to identifying shared approaches and best practices with short-term and long-term effect, in particular to the challenges posed by the COVID-19 pandemic;
Amendment 46 #
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the importance of supporting research in the EU, not least in order to increase the number of; further emphasises that public and private investment in research, including into and the development of innovative medicines and treatments, shall be driven by public health and unmet medical needs, with the involvement of regulators, academia, healthcare professionals and patients filed in the Member Statat early stages of R&D, to ensure research priorities respond to societal needs and enable as well as access to safe, effective and high-quality medicines; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector, such as orphan and paediatric drugs; whereas high degree of transparency should apply in publicly funded medical research from decision-making to investment and open science;
Amendment 53 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Commission and the Member States to incorporate collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for the exploitation of the final products, in all current and future calls for funding and investment;
Amendment 55 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Highlights the key role of European scientific research in developing new pharmaceutical products and treatments, and the importance to remove all unnecessary barriers, especially in case of health crisis, to enable researchers to find scientific solutions under exceptional time and efficiency constraints; supports all legal incentives to develop innovative R&D projects, such as ‘VACCELERATE’, and to make them sustainable on the long- term; encourages the Commission to assess the outcome of the COVID-19 Technology Access Pool (C-TAP), in terms of allowing maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data;
Amendment 56 #
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Prompts the Commission to proceed to an early evaluation of Regulation (EU) 2019/933 concerning the supplementary protection certificate (SPC) for medicinal products, so that the effectiveness of the SPC waiver can be reviewed in the light of the recent exceptional circumstances, and in the light of the aim to restore a global level playing field for makers of generics and biosimilars in the Union; such evaluation should also study the impact of the exception of SPC protection on research and production of innovative medicines in the Union by certificate holders and consider the balance between the different interests at stake, in particular as regards public health, public expenditure and, in this context, access to medicines within the Union;
Amendment 57 #
Draft opinion
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Draws attention to the key role played by AI and, more generally, by data, and their potential as a driver of research and development in the health and pharmaceutical sector; nonetheless signals that health data should be subject of close legal scrutiny with respect to their interference with the GDPR and with the future Data Governance Act;
Amendment 60 #
Draft opinion
Paragraph 4
Paragraph 4
Amendment 62 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Recalls the importance that non- exclusive licensing can have in mitigating shortages and in stabilising prices of medicines, especially in times of health emergency; urges the Commission to call for a review of the legal provisions of the TRIPS Agreement regarding the implementation of compulsory licenses, in order to foster patent flexibilities, as stated in Resolution of 17 September 2020 (2020/2071(INI)); calls on the Commission to introduce waivers of patents, of data and of market exclusivity in exceptional circumstances, in order to enable global access to crucial health products to swiftly overcome health crisis in Europe and worldwide;
Amendment 80 #
Draft opinion
Paragraph 6
Paragraph 6
6. Stresses, lastly, the importance for European companies, in strategic sectors such as pharmaceuticals, of contractual freedom in the areas of licensing and the protand of effectionve and effectivebalanced enforcement of intellectual property rights, including in third countries where they operate; calls on the Commission to develop and implement new measures and tools for this purpose and to improve existing ones, such as the Intellectual Property Helpdesk for SMEs.