11 Amendments of Cyrus ENGERER related to 2021/2013(INI)
Amendment 258 #
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 sustainablwork with Member States and medicine marketing authorization holders to identify and address the root-causes of unavailability of medicines, and find adequate solutions to address the outstanding barriers to timely and effective patient access; calls on the Commission to enhance affordability based on the fundamental pricing principle of solidarity across Member States and to increase price transparency via a revision of the Transparency Directive in order to include svolutions that also promote competitionntary/secret agreements, public procurement and generic medicines;
Amendment 331 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Notes that only around 5% of shortages and non-availabilities are EU- wide, and that therefore issues such as non-launch and commercial withdrawals could be addressed via better use of the Internal Market and cross-border tools; Calls on the Commission to include this aspect in an upcoming revision of Directive 2001/83;
Amendment 397 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Considers that unjustified import and export restrictions and/or bans exacerbate shortages and reduce competition in the Internal Market decreasing affordability; calls on the Commission to tackle such unjustified restrictions and/or bans;
Amendment 435 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise- driven scientific assessment on marketing authorisations within the European Medicines Agency (EMA);
Amendment 465 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which would facilitate the conducting of clinical research in Europe;
Amendment 467 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated;
Amendment 469 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. 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 510 #
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 develop appropriate regulatory frameworks, to guide new business modelsstresses the transformative potential of these novel therapies and technologies for patients as well as societies at large, for example by enabling a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission to ensure sufficient regulatory expertise to support intensive dialogue with developers, and to develop appropriate regulatory frameworks, including for new vaccines and therapeutics for use in emergencies and those addressing unmet medical needs, to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 601 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Insists that the Public Service Obligation (PSO) as established in Article 81 of Directive 2001/83 is not sufficient to ensure that the EU as a whole is sufficiently supplied; calls on the Commission to put in place an obligation for MAH’s to report to EMA the total quantities supplied to the Internal Market and to ensure the right to be supplied for wholesalers in order to meet patient demand and to ensure a competitive internal market;
Amendment 679 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;
Amendment 686 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Supports the implementation of the ‘polluter pays principle’ to improve the responsibility of the pharmaceutical industry;