6 Amendments of Billy KELLEHER related to 2021/2013(INI)
Amendment 2 #
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
— having regard to the Commission communication of 5 May 2021 on Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe's recovery (COM(2021)350),
Amendment 418 #
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; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; calls on the Commission to develop guidance to promote the secondary use of data for research and to ensure fair, transparent and non-discriminatory access to data throughout Europe;
Amendment 447 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls for the Commission and Member States to use real-world data for regulatory decisions on medicines to complement evidence from randomised- controlled clinical trials;
Amendment 513 #
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 have a transformative potential and can bring enormous benefits to patients and societies in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to ensure sufficient regulatory expertise to support dialogue with developers, to develop appropriate regulatory frameworks, to guide new business models without compromising safety standards and product efficacy, and to run information campaigns to raise awareness and encourage the use of these innovations; calls on Member States to authorize the use of these innovative treatments abroad in an effective and timely manner and to accelerate the reimbursement process for cross-border treatment of patients;
Amendment 537 #
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 clinical trials that are more patient- centred as well as 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 580 #
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; recognises the multiple drivers of shortages; stresses the importance to involve all stakeholders including manufacturers, wholesalers and pharmacists to prevent and manage medicines’ shortages; recommends, when shortages of medicine occur, to inform healthcare professionals and patients about available alternatives; 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, parallel trade activities, export bans and unexpected manufacturing or quality problems, while limiting the administrative burdens on stakeholders and safeguarding confidentiality; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;