14 Amendments of Aurélia BEIGNEUX related to 2021/2013(INI)
Amendment 32 #
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 safthe pandemic has demonstrated the weakness of European health care systems; whereas safe, innovative, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;
Amendment 47 #
Motion for a resolution
Recital B
Recital B
B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats, more European integcooperation is necessary as well as a greater sharing of epidemiological and health data at European level; whereas a European Health Union, which contributes to an increasingly social Union, is key in this process;
Amendment 72 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, pre-and post-marketing pharmacovigilance, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;
Amendment 221 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
Amendment 230 #
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Considers that antimicrobial resistance constitutes a serious threat to public health, whose cause should be found above all in the incorrect and superficial use of antibiotic drugs; calls on the Commission and Member States to fund projects aimed at improving diagnostics as well as suggesting a protocol for administrating antibiotics and an awareness campaign for health professionals to encourage more targeted treatment based on patients’ real needs;
Amendment 240 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote a well-structured and institutionalised dialogue with the Member States and stakeholders to assess new criteria forhow national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to may encourage investment in R&D in the EU, and guide a harmonised transformation towards an approach based on results and on the basic and most extensive needs of the population, considering the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;
Amendment 271 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increase price transparency, while taking into account the overall R&D efforts of the pharmaceutical industry and its implicit failure rate, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;
Amendment 303 #
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; 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 419 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; calls on the Commission to establish a unified supplementary protection certificate (SPCs) for the internal market, following the excellent results achieved on national basis; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;
Amendment 441 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Underlines the key role of medical gases, such as oxygen, in treating patients; calls on the Commission to simplify the procedures for production and distribution of medical gases as part of the revision of Directive 2001/83/EC1c; _________________ 1c OJ L 311, 28.11.2001, p. 67–128
Amendment 515 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; highlights that eHealth, home care, and technological innovation in addition to education campaigns are key weapons in infection control, treatment of COVID-19 and other infectious diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 532 #
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 creation of a data monitoring committee exclusively for emergency clinical trials to ensure the human dignity of patients involved in research and to avoid duplication of emergency trials; 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 614 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conductachieve a public disclosure, in accordance to Good Clinical Practices, through a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community, with the aim of protecting the dignity of human beings involved in clinical trials and to address weaknesses in the global medicines manufacturing and supply chain;
Amendment 655 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. 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 chainidentify a system of incentives and funding for companies to ensure the achievements of such objectives; 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, highlighting the correlation between packaging and the prescribed treatment, and to bring medical prescriptions into line with real therapeutic needs;