23 Amendments of Frédérique RIES related to 2021/2013(INI)
Amendment 10 #
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
— having regard to its resolution of 10 July 2020 on the EU’s public health strategy post-COVID- 19(2020/2691(RSP)), calling for an EU action plan on rare and neglected diseases,
Amendment 74 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation, the circular economy and climate neutrality;
Amendment 80 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas 40% of medicinal end products marketed in the EU originate in non-EU countries, while 60 - 80% of active pharmaceutical ingredients are produced in China and India; whereas this delocalisation of part of the production of essential components of medicines, vaccines and medical devices has direct consequences on the follow-up of treatments for patients;
Amendment 82 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas, to secure the Union's lead position in the pharmaceutical development, the strategy must focus on strengthening the innovative potential of European pharmaceutical research as well as acknowledging and reinforcing the link with the EU industrial strategy, the SME strategy and the European Health Data Space;
Amendment 112 #
Motion for a resolution
Recital C c (new)
Recital C c (new)
C c. whereas it is both in the interest of the individual patient and the society as such to have a competitive and resilient pharmaceutical industry with strong roots in research; whereas a thriving industry to a higher degree can identify and address patients' medical needs and contribute to advances in public health, economic growth, employment, trade relations and in science and technology;
Amendment 140 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that investment in research into and the development of innovative medicines, diagnostics and treatments, as well as access to safe, effective and high- quality medicines, are essential for making progress in the prevention and treatment of diseases;
Amendment 142 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Notes with concern that most new medicines are launched earlier in the US than in the EU; notes that this delay is partly due to longer timelines for authorisation procedures in the EU; requests the Commission to assess how the EU’s procedures for authorisation can be made more efficient and timely, in order to allow EU patients to benefit from medicines that can improve their conditions sooner; invites the Commission to propose adequate resources for the EMA to achieve this objective;
Amendment 146 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Stresses that in order to develop effective treatments, the patient’s perspective must be taken into account in the research, development but also in regulatory, assessment and appraisal processes for rare diseases therapies;
Amendment 165 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has not been sufficient to meet the diagnostic and therapeutic needs of patients with rare diseases,or chronic diseases such as paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);
Amendment 204 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to further strengthen the current system of incentives for research and the development of new medicines for unmet therapeutic needs and to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet diagnostic and therapeutic needs, while maintaining the overall stability and predictability of the system, and prioritising projects promoted by the pharmaceutical industry combating rare diseases,or chronic diseases such as paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;
Amendment 220 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the European Commission and Member States to establish streamlined regulatory, pricing and reimbursement policies for therapies addressing rare diseases; stresses that these policies should encourage a continuum of evidence generation along the full life cycle of a product or technology as well as the patient journey from diagnosis to treatment access;
Amendment 335 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines; stresses that public-private partnership dialogues and academia-pharma cooperation are essential for the exchange of knowledge and information for the benefit of all patients across the Union;
Amendment 363 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Calls on the European Commission and Member States to strengthen European cooperation in pricing and negotiations, by exploring the feasibility of establishing a European Table of Negotiations, supported by joint procurement initiatives, specifically for rare and complex diseases, together with a functioning cooperation on Health Technology Assessment (HTA);
Amendment 364 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Believes it will be beneficial to have a common definition of unmet medical needs as the concept is a key criterion for medical prioritisation as well as a qualifier for adaptive and accelerated authorisation processes; therefore calls on the Commission to initiate talks to establish transparent criteria on how to define unmet needs;
Amendment 396 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Believes that facilitating faster access would be especially beneficial for patients with severe chronical diseases; suggests accordingly to allow patients to take part in the decisions on risk-benefit from early access to new and innovative medicines and treatment;
Amendment 438 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls for relocation back to the European Union of some of the plants producing active ingredients and medicinal end products of strategic importance for health care, given that breaks in supply put at immediate risk patients with serious conditions who are more often unable to obtain recommended alternative treatments;
Amendment 454 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Invites the Commission to initiate the creation of a “European Fund” to support the generation of additional real- world evidence data in the years following marketing authorisation for selected, innovative and transformative medicines for complex and low prevalence diseases, with true cross-border value;
Amendment 498 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Encourages Member States to establish regional business hubs to promote biosolutions and green technology in the production of biosimilar medicines as well as other sustainable and innovative pharmaceutical products; underlines the importance of improving education on biosimilars for health care professionals on Member State level;
Amendment 500 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Calls on the Commission to develop a separate European Life Science strategy drawing on the lessons from the Industrial Strategy, Pharmaceutical strategy and a European Health Union; suggests that the new strategy should be horizontal and include a strategic approach including areas such as industry, research, health union, crisis preparedness and trade;
Amendment 507 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment and skill-building in the pharmaceutical sector, facilitating talent retention and mobility at EU level;
Amendment 565 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the EMA to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years; encourages the Commission in cooperation with the EMA to consider how already established tools like accelerated authorisation, early dialogue, expanded guidance and the PRIME scheme can be used to make medicine available to patients at a faster pace, especially medicine that has potential to address an urgent public health threat or an unmet medical need;
Amendment 619 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address weaknesses and identify opportunities for innovation in the global medicines manufacturing and supply chain;
Amendment 646 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Welcomes HERA as a permanent structure that should help facilitate agile and quick decision-making, response and action for future European health crises; stresses that public-private partnerships are a key element in this regard; calls on HERA to facilitate a structured dialogue with industry with the aim of identifying vulnerabilities in the global supply chain of critical medicines and raw materials;