16 Amendments of Petar VITANOV related to 2021/2013(INI)
Amendment 147 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 156 #
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,research and scientific progress has not yet produced sufficiently successful therapies for patients with rare diseases, chronic diseases, cancers, in particular paediatric cancers, and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);
Amendment 208 #
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 public interests and patient safety when assessing projects promoted by the pharmaceutical industry in order to combating rare diseases, cancers, including 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;
Amendment 224 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Underlines that continuous innovation, including in the off-patent segment, should strive to address patients’ unmet needs; in this regard, considers that a fit-for purpose regulatory framework could enable the development of value added medicines as well as recognise the category of affordable innovation;
Amendment 243 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess newadditional criteria for national pricing, such as whether the supply chain management is sufficiently resilient and robust; whether there have been investments in innovation and/or high environmental manufacturing standards; 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 costs as well as to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;
Amendment 281 #
6 a. Calls on the Commission to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage, as well as to limit IP evergreening practices that delay access to medicines;
Amendment 302 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise and widen at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines, as defined by the European Medicines Agency;
Amendment 327 #
Motion for a resolution
Paragraph 8
Paragraph 8
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; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reducefor Member States to work towards making centrally authorised medicines approval times at national level and align them wivailable to patients as close to the European Medicines Agency (EMA) timesapproval times as possible, in order to ensure rapid and equal access to medicines for everyone in the EU and avoid discrimination between EU citizens;
Amendment 382 #
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, and that the ability to pay remains very divergent across EU Member States, leading to unequal access to medicines for EU citizens; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and, to stabilise and balance national drug pricing systems, and to ensure more equitable access for patients across Member States;
Amendment 446 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on the Commission and the Member States to ensure full and harmonised application of the General Data Protection Regulation in regards to conducting clinical research across the EU;
Amendment 451 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Calls for the continuous optimisation and digitalisation of regulatory processes in order to keep up with scientific and technological progress, while maintaining high scientific standards; calls to ensure fit-for-purpose requirements and continuous access to information for patients and healthcare professionals; stresses that the Commission and the Member States should make the best use of information technology for regulatory processes, including digital and telematics tools;
Amendment 464 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Calls on the Commission and Member States to intensify work towards the implementation of the electronic product information (ePI), as it could support the better delivery of information to patients and a wider availability of medicines, especially in critical situations;
Amendment 506 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, in all Member States, ensuring geographical balance and facilitating talent retention and mobility at EU level;
Amendment 520 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, medicine repurposing, 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 models, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 592 #
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 in all Member States; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 644 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them, in full respect of the highest EU standards for personal data protection; encourages the Commission to work with World Trade Organization members to facilitate trade in health products, increase resilience in global supply chains through stable access to raw materials, and contribute to an effective response in the event of a health emergency;