4 Amendments of Radka MAXOVÁ related to 2021/2013(INI)
Amendment 206 #
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, 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; recalls the need to facilitate access to treatment across borders for patients with rare diseases when not available in their country of origin;
Amendment 273 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increase price transparency, highlightconduct an assessment of the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;
Amendment 538 #
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 reduce the red tape and 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; _________________ 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 579 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. 19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; considers it imperative to increase the EU’s manufacturing production and ensure sustainable, diversified and robust supply chains; calls on the Commission to define a robust supply chain, conduct an assessment of causes and drivers of vulnerabilities and dependencies of the supply chain and of cost implications of increasing the robustness of the supply chains, conduct a mapping of the EU manufacturing capacity, and identify the products critical from the public health view; 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; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; stresses in this regard the importance of monitoring and fighting against counterfeit pharmaceuticals;