43 Amendments of Nicolae ŞTEFĂNUȚĂ related to 2021/2013(INI)
Amendment 39 #
Motion for a resolution
Recital A
Recital A
A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EUand equitable access to healthcare are fundamental to the well-being of Europeans; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;
Amendment 46 #
B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats, more European integration is necessary; whereas a European Health Union, which should contributes to an increasingly social Union, is key in this procesd foster closer cooperation, coordination and knowledge sharing on health between Member States and relevant stakeholders;
Amendment 74 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation, the circular economy and climate neutrality;
Amendment 82 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas, to secure the Union's lead position in the pharmaceutical development, the strategy must focus on strengthening the innovative potential of European pharmaceutical research as well as acknowledging and reinforcing the link with the EU industrial strategy, the SME strategy and the European Health Data Space;
Amendment 101 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
C b. whereas there are variances and differences in health care systems, national regulation, implementation of EU-regulation, pricing and authorisation processes in the different Member States; whereas these differences are a result of Member States' legitimate competences on health; whereas the differences can lead to fragmentation and unpredictable circumstances for actors in the pharmaceutical sector that operate outside their own country;
Amendment 112 #
Motion for a resolution
Recital C c (new)
Recital C c (new)
C c. whereas it is both in the interest of the individual patient and the society as such to have a competitive and resilient pharmaceutical industry with strong roots in research; whereas a thriving industry to a higher degree can identify and address patients' medical needs and contribute to advances in public health, economic growth, employment, trade relations and in science and technology;
Amendment 138 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that investment in research into and the development of innovative medicines and treatments, as well as equal access to safe, effective, affordable and high-quality medicines, are essential for making progress in the prevention and treatment of diseases;
Amendment 140 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that investment in research into and the development of innovative medicines, diagnostics 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;
Amendment 142 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Notes with concern that most new medicines are launched earlier in the US than in the EU; notes that this delay is partly due to longer timelines for authorisation procedures in the EU; requests the Commission to assess how the EU’s procedures for authorisation can be made more efficient and timely, in order to allow EU patients to benefit from medicines that can improve their conditions sooner; invites the Commission to propose adequate resources for the EMA to achieve this objective;
Amendment 158 #
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); acknowledges the need to find innovative financing models for incentivizing research and development of novel medicine for diseases that are otherwise perceived as being unattractive to industry due to potentially low market value and revenue;
Amendment 165 #
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,or chronic diseases such as paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);
Amendment 185 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers it imperative that a common EU therapeutic guide for antimicrobials be introduced, setting up traceable antimicrobial use reduction targets at EU level and that communication campaigns on AMR be coordinated through a single calendar at EU level;
Amendment 204 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to further strengthen the current system of incentives for research and the development of new medicines for unmet therapeutic needs and to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet diagnostic and therapeutic needs, while maintaining the overall stability and predictability of the system, and prioritising projects promoted by the pharmaceutical industry combating rare diseases,or chronic diseases such as 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 211 #
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;
Amendment 226 #
4 a. Calls on the Commission to consider setting research targets and milestone prizes as a complement to other research and development incentives, especially for developing medicines and therapies that are of low interest for industry due to market value;
Amendment 248 #
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 a product is ‘MadeDeveloped 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 268 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increaseensuring price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; further calls on the Commission, especially DG Competition, to be alert of anti-competitive conduct and investigate anti-competitive practices in the pharmaceutical industry;
Amendment 277 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Underlines that shortages and unavailability of medicines are multi- factorial issues; believes it is necessary to find solutions to address barriers to timely and effective patient access; calls on the Commission to work with Member States, medicine marketing authorisation holders and other relevant actors to identify and address the root-causes of unavailability of medicines while respecting Member States competences;
Amendment 300 #
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 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; calls on the Commission to address the misuse of the IPR (intellectual property rights) system to delay market entry of generic and biosimilar medicines; 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;
Amendment 332 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Calls on the Commission to start an inquiry into the effects of parallel trade on medicine scarcity and market penetration of novel treatments into Member States with less developed economies;
Amendment 335 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines; stresses that public-private partnership dialogues and academia-pharma cooperation are essential for the exchange of knowledge and information for the benefit of all patients across the Union;
Amendment 344 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Calls on the Commission to draw conclusions from the experience of joint negotiations gained during the pandemic and to promote joint procurement of medicine; points out that a stronger position of different Member States speaking with one voice should be used in joint negotiation with industry to attain high transparency standards, equal and sustainable medicine procurement;
Amendment 360 #
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, orphan medicines and unmet therapeutic needs;
Amendment 364 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Believes it will be beneficial to have a common definition of unmet medical needs as the concept is a key criterion for medical prioritisation as well as a qualifier for adaptive and accelerated authorisation processes; therefore calls on the Commission to initiate talks to establish transparent criteria on how to define unmet needs;
Amendment 370 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Stresses the importance of securing joint medicine stocks to prevent the recurrence of essential medicine scarcity across Member States;
Amendment 396 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Believes that facilitating faster access would be especially beneficial for patients with severe chronical diseases; suggests accordingly to allow patients to take part in the decisions on risk-benefit from early access to new and innovative medicines and treatment;
Amendment 411 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’Welcomes the Commission's objective of improving the innovation capacity and competitiveness in the pharmaceutical industry; insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs and that it is in the interest of patients that the industry is in the strongest possible position to meet their diagnostic and therapeutic needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can underlines that the marketing authorive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Spacesation system should build on the existing legislative framework and prevent duplication and additional administrative burdens, believes that it can thrive globally with a clear, robust and efficient intellectual property system;
Amendment 429 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; highlights the need to promote both primary and secondary use of aggregated health data and the need in this regard for a clearer definition of secondary data use vs. primary data collection; believes that awareness on fragmentation regarding the implementation of GDPR should be raised; further believes that it is of outmost importance to enable and promote trust and data innovation in digital health, which will be possible through education and capability building for regulators, industry and patients;
Amendment 495 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU;
Amendment 498 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Encourages Member States to establish regional business hubs to promote biosolutions and green technology in the production of biosimilar medicines as well as other sustainable and innovative pharmaceutical products; underlines the importance of improving education on biosimilars for health care professionals on Member State level;
Amendment 500 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Calls on the Commission to develop a separate European Life Science strategy drawing on the lessons from the Industrial Strategy, Pharmaceutical strategy and a European Health Union; suggests that the new strategy should be horizontal and include a strategic approach including areas such as industry, research, health union, crisis preparedness and trade;
Amendment 507 #
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 and skill-building in the pharmaceutical sector, facilitating talent retention and mobility at EU level;
Amendment 514 #
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’ initiativegene sequencing 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; calls on the Commission to encourage enhanced data generation on these new products through improved cooperation among regulatory agencies, HTA bodies and patients organizations, healthcare professionals and pharmaceutical companies;
Amendment 550 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicineand to incorporate lessons learned from the extraordinary and accelerated authorisation process where it is relevant, safe and beneficial for patients and for innovative medicinal products for underserved areas; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU;
Amendment 559 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergencyssential medicines; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU;
Amendment 565 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the EMA to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years; encourages the Commission in cooperation with the EMA to consider how already established tools like accelerated authorisation, early dialogue, expanded guidance and the PRIME scheme can be used to make medicine available to patients at a faster pace, especially medicine that has potential to address an urgent public health threat or an unmet medical need;
Amendment 619 #
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 and the research community to address weaknesses and identify opportunities for innovation in the global medicines manufacturing and supply chain;
Amendment 630 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Considers it important that the Internal Market for medicines is safeguarded and that unjustified import and export restrictions, that can cause harm to the internal market and decrease affordability, should be avoided and addressed by the Commission if they occur;
Amendment 646 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Welcomes HERA as a permanent structure that should help facilitate agile and quick decision-making, response and action for future European health crises; stresses that public-private partnerships are a key element in this regard; calls on HERA to facilitate a structured dialogue with industry with the aim of identifying vulnerabilities in the global supply chain of critical medicines and raw materials;
Amendment 672 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Stresses that for pharmaceutical waste should be handled in a safe and hygienic matter with regard to the objections and targets of the circular economy and to protect the environment; believes that the pharmaceutical industry should have the same requirements and standards on packaging and waste management as other sectors; calls on the Commission to create a uniform framework for packaging that takes into account user-friendliness and the circumstances for industry;
Amendment 678 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Calls on the Commission to speed up the catch-up procedure for environmental risk assessments of human medicines authorized before 2006 where they are not available;
Amendment 684 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Calls on the Commission to update environmental risk assessment requirements of human medicine waste to ensure a proper assessment of persistent, bio-accumulative and toxic substances and of mixture effects, and to take into account the risk of antimicrobial resistance developing in the environment.
Amendment 691 #
Motion for a resolution
Paragraph 22 c (new)
Paragraph 22 c (new)
22 c. Calls on the Commission to include environmental criteria in the Good Manufacturing Practice (GMP) framework;