Activities of Tiemo WÖLKEN related to 2021/2013(INI)
Shadow opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (31)
Amendment 9 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
— having regards to its resolution of 13 September 2018 on a European One Health Action Plan against Antimicrobial Resistance
Amendment 97 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas there is a need for coordination and interlinkage between the Pharmaceutical Strategy, the Beating Cancer plan, the Industrial Strategy for Europe and the Health Data Space;
Amendment 109 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
C b. whereas the entry of generic and biosimilar medicines play a key role in increasing equitable access for patients and hence market entry should not be unduly delayed;
Amendment 133 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that investment in research into and the development of innovative diagnostics and medicines and treatments, as well as access to safe, effective and high-quality medicines, are essential for making progress in the prevention and treatment of diseases; points out that embedding meaningful patient involvement throughout the entire life cycle of medicines and other therapies will be an indispensable requirement to achieve high-value innovation, patient benefit and patient safety; further underlines that EU Funding Programmes such as the future Framework Programme (Horizon Europe) must prioritize research on public health needs, especially those in the area neglected by the for-profit private sector, hence contributing to the development of medicines that bring actual added therapeutic value;
Amendment 162 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has 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) concerning all AMR pathogens, or prevent infectious diseases outbreaks;
Amendment 168 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has not been sufficient to meet the diagnostic and therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);
Amendment 187 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Calls on the Commission to further look into new delinked pull incentives models such as market exclusivity transfer and the subscription model for the development of new antibiotics; stresses that financial incentives are needed to re-creatre an investment friendly environment for research and innovation in this field and thus enable long-term investments into the AMR field;
Amendment 193 #
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Points out that it is essential to promote and/or maintain incentives in areas of low profitability such as rare diseases, paediatrics and AMR;
Amendment 194 #
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3 c. Points out that science and research play a crucial role in the development of standards in the fight against AMR; asks the Commission to also look into alternative antibiotic therapies such as bacteriophage therapy, building up on the EU-funded Project Phagoburn; notes that so far no bacteriophage therapies have been authorized at EU Level and thus reiterates its call on the Commission to propose a Framework for bacteriophage therapy based on the latest scientific research;
Amendment 227 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Stresses that a common European understanding of key concepts such as "unmet needs" and "added therapeutic value" such as a definition or a set of common criteria is needed at Union level;
Amendment 244 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘ and to include procurement criteria in national tenders such as "resilient and robust supply chains management", investment in research, development and manufacturing within the Union (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;
Amendment 263 #
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; in the same vein asks the Commission to work together with Member States and industry to identify and address the root-causes of unavailability of medicines in order to find solutions to address the outstanding barriers to timely and effective patient access;
Amendment 276 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Underlines the importance of generic and biosimilar and value added medicines for increasing equitable access for patients and making the Unions healthcare systems sustainable where access is still uneven; Calls on the Commission to ensure healthy competition upon the expiry of intellectual property (IP) exclusivities by removing all barriers to access competitions such as patent linkage, IP evergreening and other misuse and abusive of IP related incentives and practices that unduly delay access to medicines;
Amendment 315 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Stresses the need for the Commission to continue preventing anti- competitive practices and agreements by the pharmaceutical industry including pay-for-delay or abuse of dominant position to ensure a competitive market of generic and biosimilar;
Amendment 326 #
8. 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; stresses the need of a complementary study looking into multi-factorial causes of access delays and inequality; 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 389 #
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 and timely competition and to stabilise and balance national drug pricing systems in order to ensure more equitable access for patients within the Union;
Amendment 393 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Points out that medicines are often pulled form markets due to company low commercial interest in them; Calls on the Commission to look into policy options that help secure that centrally authorized medicines are marketed in all EU Member States and not just in those that are commercially interesting;
Amendment 400 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11 b. Welcomes the creation of the new EU agency HERA and underlines its key role to address the needs of patients when health emergencies occur, thus filling gaps in foresight, stockpiling essential medicines and medical devices, and coordinating the EU's Response to cross- border health threats;
Amendment 405 #
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11 c. Points out that new health technologies should demonstrate their clinical added-value and cost- effectiveness compared to what is already available on the market; emphasizes that health technology assessment is a tool to support this analysis and inform national pricing and reimbursement decisions and that currently such assessment is highly fragmented within the Union, although it can enable cooperation on clinical evidence requirements and clinical trial design and therefore support Member States’ timely and evidence-based decision making on patient access to new medicines; once again stresses the need for more cooperation on HTA on Union level;
Amendment 417 #
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 and that should build on the existing framework and prevent duplication and additional bureaucratic burdens; 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 to leverage the full potential of real-world-date and access to rare therapies;
Amendment 433 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Asks the Commission to assess the need for a supportive legislative framework which goes beyond the scope of the GDPR when it comes to the uses of real-world data or artificial intelligence in medicines development; underlines in this regards that all information systems where health data is generated, used or stored must be designed to meet the highest quality and safety standards;
Amendment 496 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Calls on the Commission to thoroughly evaluate the actual impact that a proposal for a unitary SPC would have on the generic and biosimilar medicines market entry, and on equitable patient access to treatments; at the same time calls on the Commission to take full account of and assess the effective implementation of the SPC Manufacturing Waiver in light of the conditions and limitations to it, especially in regards to stockpiling;
Amendment 535 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to fully implement the Clinical Trials Regulation9 , actively monitor its implementation on Member States Level and enforce trial sponsors' compliance with transparency provisions; 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; _________________ 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 588 #
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; underlines that shortages are a critical public health problem that can seriously harm patients' health and safety, quality of care, professionals' ability to deliver care and health system functioning; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 620 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations, pharmacists and the research community to address weaknesses in the global medicines manufacturing and supply chain;
Amendment 663 #
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 chain, particularly outside the Union; 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, and to bring medical prescriptions into line with real therapeutic needs; notes that that eProduct information should be available as a complementary tool to the paper version;
Amendment 675 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Calls on the Commission to include the environmental impact of pharmaceuticals in the benefit-risk assessment of human medicines, as it is already the case for veterinary medicines, provided that marketing authorisation are not delayed nor refused solely on the grounds of adverse environmental impact;
Amendment 687 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;
Amendment 689 #
Motion for a resolution
Paragraph 22 c (new)
Paragraph 22 c (new)
Amendment 694 #
Motion for a resolution
Paragraph 22 d (new)
Paragraph 22 d (new)
22 d. Calls on the Commission to include compulsory environmental criteria in the Good Manufacturing practice (GMP) Framework;
Amendment 695 #
22 e. Supports the "polluter pays principle" to improve the responsibility of the Pharmaceutical industry;