38 Amendments of Jan HUITEMA 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 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 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 182 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers it imperative that a common EU therapeutic guide for antimicrobials be introduced and that communication campaigns on AMR be coordinated through a single calendar at EU levelo create more awareness on antimicrobial resistance, its variants and its consequences at EU level; supports the Commission’s intentions of making the EU a ’best practice region’ and the introduction of interdisciplinary tools, as the future CAP, to tackle AMR;
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 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 264 #
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 alsoto cooperate with relevant stakeholders and Member States to identify the root-causes of the unavailability of medicines and to find systematic, safe and sustainable solutions to address this long-standing issue of medicine shortages for patients while promoteing a competitive industrial market in the European Union;
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 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 350 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of newHighlights the potential of joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needs;; considers that the EU joint procurement has potential as a tool for extraordinary cross-border health threats; suggests that joint public procurement be clearly defined in scope, time, continues to be used on the mandate of Member States on a case-by-case basis and it should not create barriers for patient access, medical innovation or fair competition
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 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 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 516 #
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 models, and to run information campaigns to raise awareness and encourage the use of these innovations; urges the Commission to propose adequate resources for the EMA to meet these objectives effectively;
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 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 586 #
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, toimproved collection of digital information and digital shortages reporting, and an increased public-private collaboration and towhile monitoring 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;
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 627 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Welcomes the strong focus and several initiatives included in the pharmaceuticals strategy on the need to optimise and modernise the existing regulatory framework; urges the Commission to make the best use of existing digital tools at EU level; stresses the need to prioritise a structured dialogue on the manufacturing, the supply chain and the security of supply of Active Pharmaceutical Ingredients (APIs), raw pharmaceutical materials and intermediates; underlines the need to bring all relevant stakeholders together to define a policy roadmap to tackle medicine shortages by enhancing the manufacturing resilience within the European Union;
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 635 #
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
20 b. W Welcomes the reference in the pharmaceutical strategy that actions in the area of public procurement can foster competition and improve access; emphasises the importance of diversified supplies and sustainable procurement practices for pharmaceuticals; urges the Commission, in the context of Directive2014/24/EU, to swiftly propose guidelines for the Member States on the implementation of the most economically advantageous tender (MEAT) criteria, looking beyond the lowest price criteria only; proposes that investments in the manufacturing of Active Pharmaceutical Ingredients (APIs) and medicinal end products in the EU should be considered, as well as the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards;
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 656 #
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 and the insurance of access to safe and effective pharmaceutical treatments for patients; calls on the Commission to develop a framework for environmental protection while manufacturing medicines; urges the Commission to ensure high-quality, safe and environmental sustainabilityle 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;
Amendment 660 #
22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles and value chain of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain; encourages the Commission to consider the potential of e-leaflets to reduce use of paper in packaging while also maintaining equal access to important information; 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, while ensuring convenient and safe handling for patients or consumers with limited mobility, and to bring medical prescriptions into line with real therapeutic needs;
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 677 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Urges the Commission, without further delays, to implement the electronic product information leaflet notice (ePi), made available in all languages for all the member states where the medicine is marketed in order to mitigate shortages and to attain a swifter implementation of the e-leaflet;
Amendment 681 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Calls on the Commission to set up a focused and action-oriented High Level Pharmaceutical Forum on Better Access to Health Innovation by bringing together multi-stakeholder solutions; Asks the Commission to share via this Forum lessons learned from the COVID-19 emergency situation and to establish an effective policy framework to prevent shortages in the long-term and enable access to medicines for patients and innovation;