13 Amendments of Alexander BERNHUBER related to 2021/2013(INI)
Amendment 167 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research hasand scientific progress have not been sufficient to meet the therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);
Amendment 246 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote a high level dialogue with the Member States and stakeholders, including patients and representatives from the health sector to assess new criteria for 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 the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population such as quality and capacity of supply;
Amendment 266 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; Calls on the Commission to collaborate with Member States and EMA to identify and address the causes of shortages of medicines, find solutions and guarantee effective patient access to medicine;
Amendment 328 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. WStrongly welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; Calls on the Commission to implement innovative solutions to reduce medicine shortage; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;
Amendment 354 #
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 emergency medicines and unmet therapeutic needssuch as extraordinary health threats like the COVID-19 pandemic; stresses that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU;
Amendment 384 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and toensure equal access to medicines and medical products across the Member States and stabilise and balance national drug pricing systems;
Amendment 399 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
Amendment 425 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry based on research 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;
Amendment 518 #
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; urges the Commission to promote sufficient expertise and to develop appropriate regulatory frameworks, to guide new business models and consistently ensure high standards for safe products, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 536 #
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 continuous dialogue between ECDC, EMA, and vaccines developers; _________________ 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 589 #
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; 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; calls on the Commission for measures of flexibility to mitigate shortages when they occur;
Amendment 605 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
Amendment 706 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework promoting the highest standards on quality and safety at international level, facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;