56 Amendments of Kateřina KONEČNÁ related to 2021/2013(INI)
Amendment 34 #
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 EU; 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; whereas patients should be involved in every aspect of the medicine regulatory lifecycle;
Amendment 37 #
Motion for a resolution
Recital A
Recital A
A. whereas health is fundamental to the well-being of Europeansall and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongsidend investment and research should be patient-centred;
Amendment 42 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. A. whereas over time, trust in the pharmaceutical sector and its ability to promote the development of medical innovations while ensuring sustainable access has been eroded, and confidence in how this system works needs to be restored;
Amendment 48 #
Motion for a resolution
Recital B
Recital B
B. whereas COVID-19 has had an huge impact on people’s health, physical and mental, 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 contributes to an increasingly social Una certain level of European integration, is key in this pronecessary;
Amendment 69 #
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 and climate neutrality; whereas the strategy offers the opportunity to restore balance in the pharmaceutical sector between public and private interests in order to fulfil the Union’s primary mission in the pharmaceutical sector, which is to ensure patients’ access to affordable medicines that bring additional therapeutic benefits;
Amendment 83 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. Whereas the pandemic has revealed the Union’s neglect of the EU pharmaceutical sector’s capacity to combat cross-border health threats by underfunding biomedical innovation and entrusting R&D necessary to meet public health needs to private companies operating for the purpose of making profit;
Amendment 135 #
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 access to safe, effective and high-quality and affordable medicines, are essential for making progress in the prevention and treatment of diseases and for improving the quality of healthcare given to patients;
Amendment 137 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that public investment in research into and the development of innovative medicines and treatments, as well as ensuring access to safe, effective and high-quality medicines, are essential for making progress in the prevention and treatment of diseases;
Amendment 164 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has not been sufficient to meet the therapeutic needs of many patients with chronic diseases – including those with rare diseases, paediatric cancers and neurodegenerative diseases, or to deal with antimicrobial resistance (AMR);
Amendment 166 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that public investment in research has not been sufficient to meet the therapeutic needs of patients, particularly patients with rare diseases, paediatric cancers and neurodegenerative diseases, or to deal with antimicrobial resistance (AMR);
Amendment 189 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Considers that while the public co- creates and is a major investor in health technologies, their exploitation is largely left to the discretion of industry driven by commercial interests alone, resulting in many of their promises not been fully translated into available and affordable clinical advances;
Amendment 192 #
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Considers that the current R&D system is biased towards high revenue generating diseases, leading to an increasing gap between real unmet medical needs and investment;
Amendment 195 #
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3 c. Calls on the Commission to play an active role in defining directions for health innovation to create a system that is aligned with medical and social needs, rather than leaving it to be driven by commercial interests alone;
Amendment 196 #
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
3 d. Calls on the Commission to reshape the system of incentives to foster the development of relevant health innovations and more actively explore alternative models for encouraging innovation which, instead of relying on the IPR system, decouple investment in innovation from medicine sales volumes and high prices; calls on the Commission to review thoroughly the Supplementary Protection Certificate(SPC) to assess its necessity to cover industry R&D costs and its impact on the medicines’ accessibility;
Amendment 210 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to incorporate new criteria into the system of incentives forpromote public health driven research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combatingsuch as in the field of rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options at affordable prices 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 228 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Stresses that a common understanding of concepts such as innovation, value and added therapeutic value should be agreed in dialogue with patient organisations;
Amendment 236 #
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 ‘Made in Europe’, whether the EU investany type of public funding was used 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 and the wider patient community; stresses the need to promote discussion as well on what constitutes a socially acceptable profit margin for pharmaceutical products; calls for the timely development by the Commission and Member States of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;
Amendment 254 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to make all forms of public investment in the R&D process, incentives and rewards subject to concrete commitments (e.g. on pricing, transparency, or availability) to guarantee fair return on public investments;
Amendment 255 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Stresses that affordable medicines can be best guaranteed through public R&D coupled with public production of medicines, and urges Member States to invest accordingly;
Amendment 270 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system so it contributes to innovation and medicine affordability, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition and the timely entry to market of generics and biosimilars;
Amendment 274 #
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;
Amendment 295 #
7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systembroadly increasing patient access to treatments as well as to the budgetary sustainability of healthcare systems by providing more treatment options and potentially by helping reduce medicine shortages and by generating cost savings while maintaining equal quality of care, freeing up resources also for the development of new treatments; 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; 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; keeping the patient always informed and at the centre of all decision-making;
Amendment 299 #
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; 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; calls for the removal of barriers to the production and distribution of generic medicines; calls on Member States to increase public production of generic and biosimilar medicines;
Amendment 308 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Stresses that cost savings generated from the use of biosimilars should be reinvested in a transparent and tangible way; calls on the Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the Commission to facilitate arrangements such as gainsharing programmes that allow savings from biosimilar competition to stream back to hospitals and be used to improve patient care in a given healthcare setting; calls on the Commission to launch a ‘Best Practice Network’ where Member States as well as hospitals can share best practices on reinvestment of the freed-up budget;
Amendment 318 #
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Stresses the importance of improving education on biosimilars; calls on the European Commission to promote relevant educational and communication activities amongst healthcare professionals by setting up a dedicated Europe-wide online resource centre;
Amendment 321 #
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 reduce mediccalls on the Commission to tackle the problem of diverging market launches of medicines by linking the centralised marketing authorisation to a commitment on the part of pharmaceutical companies, i.e., once authorised, medicinal products have to be launched ine 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 EUll EU countries in a timely manner and pharmaceutical companies should not be allowed to subsequently withdraw these products from particular markets for commercial reasons;
Amendment 337 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefits ofproblems related to public- private partnership tenders for national health systems in funding research into and the production of innovative medicines, such as concentration of research and development in profitable medicinal areas; underscores how this model has contributed to the neglect of rare diseases in particular;
Amendment 338 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefitsrole of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines; calls on the Commission to ensure that the European Partnership for Health Innovation is driven by public interest considerations and to maximise public return on public investment;
Amendment 353 #
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, but not limited to, emergency medicines and unmet therapeutic needs; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of COVID-19 vaccines;
Amendment 365 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end-products; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;
Amendment 371 #
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10 b. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing intellectual property and know-how to scale-up the production and availability of vaccines against new COVID-19 variants; calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;
Amendment 375 #
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10 c. Stresses the importance of the World Health Assembly Resolution of May 2019 on Improving the transparency of markets for medicines, vaccines, and other health products; calls on the Commission to promote information sharing among Member States on medicine net prices through the EURIPID collaboration; calls for the revision of Directive 89/105/EEC to enhance the transparency of medicine pricing and reimbursement decisions.
Amendment 376 #
Motion for a resolution
Paragraph 10 d (new)
Paragraph 10 d (new)
10 d. Highlights the need to ensure that the revision of the general pharmaceutical legislation contributes to the strengthening of evidentiary requirements on medicine safety and efficacy; calls on the EMA and national medicine agencies to prioritise the submission of data from randomised controlled clinical trials that compare an investigational medicine against the standard treatment; stresses the importance of this type of evidence in health technology assessments and for clinical decisions on treatment;
Amendment 377 #
Motion for a resolution
Paragraph 10 e (new)
Paragraph 10 e (new)
10 e. Calls on the Commission to ensure adequate consultation with consumer and patient representatives throughout the implementation of the Pharmaceutical Strategy;
Amendment 379 #
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 competition and to stabilise and balance national drug pricing systems; draws attention to the fact that national pricing policies in some Member States use different price levels to reduce expenditure on national health budgets by encouraging the links in the supply chain to buy medicines intended for patients in other Member States, thereby causing the secondary unavailability of those medicines for the patients for whom they were originally intended;
Amendment 385 #
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 competition and to stabilise and balance national drug pricing systems; strongly believes that the pricing of medicines should not be left to fluctuations in the market;
Amendment 390 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that the affordability of medicines remains a challenge for patients and national health systems, and that innovative medicines are expensive; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems;
Amendment 409 #
Motion for a resolution
Subheading 2
Subheading 2
Supporting a competitive and innovativen EU pharmaceutical industry that meets peoples' needs
Amendment 413 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a focus on competitiveness for the EU pharmaceutical industry is strategic and more responsive tocontrary to meeting patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environto be regulated to ensure patients' needs are ment; 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 Spacthe industry can provide an essential public good by providing medicines to people in need rather than profits to patent-holders; recalls the contribution to global public health from the act of avoiding the intellectual properly system, such as with the development of the highly-successful polio vaccine;
Amendment 491 #
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 523 #
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 the appropriate regulatory frameworks, to guidregulate new business models, and to run information campaigns to raise awareness and encouragsure the usptake of these innovations;
Amendment 554 #
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 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; stresses that electronic product information should complement, but not replace, the package information leaflet;
Amendment 572 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
Amendment 591 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s odepen strategic autonomy is linked todence on 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; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 593 #
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; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies and beyond;
Amendment 603 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Urges the Commission to address transparency in the entire pharmaceutical system, including transparency of the costs of developing new therapies, transparency of clinical trials, and transparency of the decision-making process and criteria to patients and citizens;
Amendment 611 #
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 in the global medicines manufacturing and supply chain; stresses the need to discuss key health policies directly with representatives of patient organisations, health service providers, industry, regulators and other key stakeholders, on the basis of the High-Level Forum format, which has proven successful in coordinating joint action against COVID- 19;
Amendment 617 #
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 in the global medicines manufacturing and supply chain; calls on the Commission to ensure a balanced representation of stakeholders;
Amendment 629 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Calls on the Commission to recognise patients as the end-users of medicines and thus an essential stakeholder group in the assessment of the value of new medicines; calls for investment in frameworks, structures and methodologies for meaningfully incorporating patients in setting research priorities, regulatory and Health Technology Assessment, and pricing and reimbursement decision-making;
Amendment 633 #
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
Amendment 640 #
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; 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; calls on the Commission to promote the use of TRIPS flexibilities to improve access to medicines and to support that Member States can import medicines produced under a compulsory license by reversing their opt-out of Article 31bis of the TRIPs agreement;
Amendment 647 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages; stresses the need to put the focus on preventative measures such as the diversification of supply chains; calls for obliging medicine manufacturers to submit shortage prevention and management plans to the EMA and national authorities;
Amendment 702 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitivenesare based on peoples' needs, in order to make the pharmaceutical sector a strategic pillaand public sector of the EU;
Amendment 705 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries.
Amendment 713 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Believes the EU Member States have a responsibility to ensure equitable access to medicines and therapeutics worldwide; calls on the EU to advocate access to medicines globally, and to commit to ensuring that none of its actions block access to medicines and therapeutic care, including in the WTO;
Amendment 723 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25 a. Calls on the Commission to address the systemic problems embedded in the global pharmaceutical sector to ensure that the development and allocation of essential pharmaceuticals is driven by medical and social needs, not profit, and governed by public mechanisms instead of being left to the discretion of private interests, particularly during health emergencies;