Activities of Sara CERDAS related to 2021/2013(INI)
Plenary speeches (1)
A pharmaceutical strategy for Europe (debate)
Amendments (16)
Amendment 38 #
Motion for a resolution
Recital A
Recital A
A. 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 allnd prevent diseases; whereas patients should be at the centre of all health policies, alongside investment and research;
Amendment 88 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas a competitiveand resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;
Amendment 136 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that investment in research into and the development of innovative medicines 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 and for improving the quality of healthcare given to patients;
Amendment 163 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers and, neurodegenerative diseases or chronic diseases, to deal with antimicrobial resistance (AMR) or to deal with prevent infectious diseases;
Amendment 174 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;
Amendment 212 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, chronic diseases, AMR, prevent infectious diseases, 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 301 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems by providing more treatment options and potentially by helping reduce medicine shortages; 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 359 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for, but not limited to, emergency medicines and unmet therapeutic needs;
Amendment 440 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;
Amendment 531 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; 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; calls on the Commission to establish mechanisms for continuous dialogue between the ECDC, EMA and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety; _________________ 9Regulation (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 556 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU in all EU's official languages;
Amendment 573 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Calls on the Commission to extend the mandate of the EMA further, to allow it to monitor medicines shortages even outside health crises and to ensure it has the necessary resources;
Amendment 676 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Calls on the Commission to include the environmental impacts of pharmaceuticals in the benefit-risk assessment of human medicines, as is already the case for veterinary medicines, provided that marketing authorisations are not delayed nor refused solely on the grounds of adverse environmental impacts;
Amendment 688 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;
Amendment 690 #
Motion for a resolution
Paragraph 22 c (new)
Paragraph 22 c (new)
22 c. Calls on the Commission to speed up the catch-up procedure for environmental risk assessments of human medicines authorised before 2006 where they are not available;
Amendment 693 #
Motion for a resolution
Paragraph 22 d (new)
Paragraph 22 d (new)
22 d. Supports the implementation of the ‘polluter pays principle’ to improve the responsibility of the pharmaceutical industry;