67 Amendments of Tilly METZ related to 2021/2013(INI)
Amendment 13 #
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
— having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,
Amendment 15 #
Motion for a resolution
Citation 12 b (new)
Citation 12 b (new)
— having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,
Amendment 17 #
Motion for a resolution
Citation 12 c (new)
Citation 12 c (new)
— having regard to Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use,
Amendment 19 #
Motion for a resolution
Citation 12 d (new)
Citation 12 d (new)
— having regard to the Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,
Amendment 20 #
Motion for a resolution
Citation 12 e (new)
Citation 12 e (new)
— having regard to the proposal for a Regulation of the European Parliament and of the Council on health technology assessment and the work of EUNetHTA Joint Actions,
Amendment 21 #
Motion for a resolution
Citation 12 f (new)
Citation 12 f (new)
— having regard to 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,
Amendment 22 #
Motion for a resolution
Citation 12 g (new)
Citation 12 g (new)
— having regard to Directive 2010/63/EU of the European Parliament and of the Council of22 September 2010 on the protection of animals used in scientific procedures,
Amendment 23 #
— having regard to its resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)),
Amendment 24 #
Motion for a resolution
Citation 12 i (new)
Citation 12 i (new)
— having regard to the Council conclusions of 17 June2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States,
Amendment 25 #
Motion for a resolution
Citation 12 j (new)
Citation 12 j (new)
— having regard to Articles 101 and 102 TFEU laying down rules on competition,
Amendment 26 #
— having regard to the Doha Declaration on the Agreement on Trade- Related Aspects of Intellectual Property Rights and Public Health (WTO/MIN(01/DEC/2) and to the implementation of Paragraph 6 of the Doha Declaration of 1 September 2003(WTO/L/540),
Amendment 27 #
Motion for a resolution
Citation 12 l (new)
Citation 12 l (new)
— having regard to the 72nd World Health Assembly Resolution of May 2019 on Improving the transparency of markets for medicines, vaccines, and other health products,
Amendment 28 #
Motion for a resolution
Citation 12 m (new)
Citation 12 m (new)
— having regard to its resolution of 17 September 2020 on a strategic approach to pharmaceuticals in the environment,
Amendment 29 #
Motion for a resolution
Citation 12 n (new)
Citation 12 n (new)
— having regard to Article 35 of the Charter of Fundamental Rights in the EU and Article 6(1) TEU on right to health protection for European citizens,
Amendment 30 #
Motion for a resolution
Recital A
Recital A
A. whereas thealth is fundamental to the well-being of Europeans and Charter of Fundamental Rights of the European Union recognises the fundamental right of citizens to health, quality of life and medical treatment and public health systems are crucial to guaranteeing equitable access to health care 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 poand safe, effective and affordable medicines; whereas patients should be at the centre of all health policies and involved throughout the medicines regulatory pathway; whereas access inequalities exist between and within Member States and special regard should be paid to people in vulnerable situation with specific health risks, including women, children, the elderly, pregnant women, persons with disabilicties, alongside investment and researchpatients with chronic conditions and comorbidities, patients in intensive care units (ICU) and persons on long-term medication;
Amendment 41 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas the increasing burden of chronic diseases and health needs of aging populations combined with high and rising prices of medicinal products and an increase in the societal cost of providing care cause budgetary and affordability constraints and serious threats to the sustainability of European health systems; whereas the adoption of integrated models of care for chronic and other long term conditions, underpinned by a person-centred and multi- disciplinary approach to health care is essential to deliver high quality health services;
Amendment 52 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the increasing levels of medicine shortages across Europe pose severe threats to patient safety and adversely impact patient outcomes and the patient care continuum; whereas the COVID-19 pandemic further highlighted the fragility of supply chains of medicinal products; whereas the understanding of root causes of medicine shortages are crucial for constructing an appropriate European response to this long-standing challenge;
Amendment 57 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
B b. whereas there exists a large duplication in medical research which predominantly focuses on limited therapeutic areas; whereas public investment should be driven by public health and unmet medical needs; whereas a high degree of transparency should apply in publicly funded medical research from decision-making, investment to open science;
Amendment 58 #
Motion for a resolution
Recital B c (new)
Recital B c (new)
B c. whereas pharmaceutical companies receive public financial support at both national and EU level for the development and production of medicines; whereas these grants and subsidies are currently not conditioned by obligations to supply the market with subsidised products for affordable prices;
Amendment 60 #
Motion for a resolution
Recital B d (new)
Recital B d (new)
B d. whereas gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring benefits in relation to the prevention, diagnosis, treatment and care of all diseases, provided they are effective, safe, affordable and accessible to all patients who need them;
Amendment 61 #
Motion for a resolution
Recital B e (new)
Recital B e (new)
B e. whereas accelerated approvals of medicinal products granted by the European Medicines Agency (EMA) should not compromise safety and efficacy of new treatments coming the EU market, not even in the times of public health crises; whereas all new treatments should demonstrate added clinical benefit and cost-effectiveness compared to existing products;
Amendment 62 #
Motion for a resolution
Recital B f (new)
Recital B f (new)
B f. whereas access to generics and biosimilars can generate substantial savings that can be reinvested in improved healthcare provision, as the EU annually spends 274billion USD (224 billion EUR) on pharmaceuticals, of which 76% (or 170 billion EUR)on patented medicinal products, compared to an annual expenditure of 24% (54billion EUR) on generic products; whereas robust competition rules and scrutiny is needed to enable entry of generics onto the market, reducing prices and ensuring the sustainability of healthcare systems and improving timely access for patients to affordable medicines;
Amendment 63 #
Motion for a resolution
Recital B g (new)
Recital B g (new)
B g. whereas supplementary protection certificate (SPC) extends patent protection up to 5additional years, after the 20 years of patent expiry, with no proven direct link to innovation, by which it delays access to more affordable generic and biosimilar products, placing an unnecessary financial burden on national healthcare systems and hampering patients access to needed medicines;
Amendment 64 #
Motion for a resolution
Recital B h (new)
Recital B h (new)
B h. whereas the aim of intellectual property and regulatory incentives to benefit society and promote innovation in areas of public health and unmet medical needs should not be misused/abused nor pose threats to affordability and patient access to pharmaceuticals; whereas awarding such incentives and public funds should be conditioned by transparency of public funding, research data, R&D and other associated costs, and product prices, to ensure affordability and fair return on public investment;
Amendment 65 #
Motion for a resolution
Recital B i (new)
Recital B i (new)
B i. whereas, during a health emergency, the EU should support the introduction of waivers of patents, data and market exclusivity to enable global access to crucial health products to swiftly overcome the crisis;
Amendment 66 #
Motion for a resolution
Recital B j (new)
Recital B j (new)
B j. whereas rising prices of medicines and growing uncertainty on their real-life effectiveness pose challenges to health decision-making; whereas collaboration on horizon scanning, health technology assessment (HTA), joint price negotiations and joint procurement is crucial to achieve high quality evaluation, affordability and equal access to medicines throughout the EU;
Amendment 67 #
Motion for a resolution
Recital B k (new)
Recital B k (new)
Amendment 68 #
Motion for a resolution
Recital B l (new)
Recital B l (new)
B l. whereas action is required throughout the lifecycle of medicines to reduce resource use, emissions and levels of pharmaceutical waste and residues in the environment;
Amendment 70 #
Motion for a resolution
Recital C
Recital C
C. whereas, in the spirit of the ‘One Health’ approach, 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 animal welfare should be ensured by meeting the goal of Directive 2010/63/EU for full replacement of all animals that are used for scientific purposes;
Amendment 124 #
Motion for a resolution
Subheading 1
Subheading 1
Putting patients at the centre of all health policiesnd public health at the centre of pharmaceutical research and decision-making
Amendment 127 #
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Calls for national and European measures to guarantee the rights of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies; calls on Member States to guarantee the sustainability of public healthcare systems; stresses that patient access to medicines is a shared responsibility of all actors in the healthcare system;
Amendment 132 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that public and private investment in research, into andcluding the development of innovative medicines and treatments, as well astreatments, shall be driven by public health and unmet medical needs, defined with the involvement of regulators, academia, healthcare professionals, patients and payers at early stages of R&D, to ensure research priorities respond to societal needs and enable access to safe, effective and, high-quality medicines, are essential for making progress in the prevention and treatment of diseasand affordable medicines, while ensuring collaboration and minimum duplication in ongoing studies;
Amendment 159 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has not been sufficient in relation to quality of life and late effects of treatments, to meet the specific therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR); calls for gender equality and additional research inpatient populations regularly excluded from clinical studies, such as children, pregnant women and the elderly;
Amendment 170 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
Amendment 181 #
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 level; the ‘One Health’ approach guides reduction and use optimisation for antimicrobials, as well as the development of new medicines, including antimicrobial agents; stresses the importance of investment into the development of new non-animal methodologies, such as in silico and organoids, to shorten pre-clinical observation periods, increase efficiency in research and reduce unnecessary and often less reliable experiments on animals;
Amendment 199 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to incWelcomes the intention to revise pharmaceutical legislation forp orate new criteria into the systephan and paediatric medicines and addressing AMR, with the aim of fincentives 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 systemsding more affordable therapeutic options and meeting the needs of patients and health systems; calls on the Commission to provide public research funding to investigate the use of repurposed, off-label and off-patent products that can be used safely and effectively in patients; stresses that medicines resulting from publicly funded research must be equally available across the Union for a fair and affordable price; 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 215 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Member States and the Commission to support research, development and innovation in the field of pharmaceuticals that are equally effective for patients and intrinsically less harmful for the environment, given that ‘greener pharmaceuticals’ are not toxic for the environment, do not bioaccumulate, and degrade more readily, into harmless substances, in wastewater treatment plants and the environment;
Amendment 237 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promotfacilitate and enable dialogue withamong the Member States and stakeholders to assess new criteria for national pricing, such as 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 value of the therapeutic benefitto steer cooperation in horizon scanning, pricing and reimbursement, including best practice and information exchange related to national pricing strategies, taking into account levels of public investment, cost of R&D, added therapeutic benefit and cost-effectiveness; such dialogue should further encourage cooperation in pricing negotiations and joint procurement and guidance on principles and costing methods for establishing R&D costs of medicines and their use at the national level; calls ofn the medicine, and the primary and broader needs of the populCommission to promote information sharing among Member States on medicine net prices through the EURIPID collaboration;
Amendment 250 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to implement the World Health Assembly Resolution of May 2019on Improving the transparency of markets for medicines, vaccines, and other health products, by requiring companies to publicly disclose the costs of R&D and manufacturing, public funding contributions, regulatory dossiers containing clinical trial data, active pharmaceutical ingredient (API) sources and supply chains, number and status of patents and patent applications; calls for the revision of Directive 89/105/EEC to enhance the transparency of medicine pricing and reimbursement decisions;
Amendment 262 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to periodically evaluate and review the incentive system and its criteria, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; on and off-patent competition and the timely entry to market of generics and biosimilars; stresses the right balance between awarding incentives in medicines development, particularly where there exist no treatment alternatives, and preventing competition distortion and unintended effects on affordability and availability of medicinal products;
Amendment 282 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls on the Commission to evaluate the added value and if appropriate remove the supplementary protection certificate (SPC) mechanism in order to prevent delays in access to generic medicines and improve financial sustainability of healthcare systems;
Amendment 304 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that timely access to generic and biosimilar medicines ais key to ensure 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;
Amendment 322 #
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 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 EUwelcomes and supports Commission action against abuses of dominant positions in the pharmaceutical sector;
Amendment 334 #
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; stresses that such collaboration must guarantee that research priorities are driven by patient and public health needs and public funds are invested in a transparent manner, ensuring availability and affordability of products resulting from these partnerships and other public funds; 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; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;
Amendment 342 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing of intellectual property and know-how to scale-up the production and availability of COVID-19 products; supports the Commission’s plan to set up a Health Emergency Preparedness and Response Authority (HERA); 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 348 #
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; calls for exploration of such practices in areas of high priced medicines, including for rare diseases and cancer with a clear outline of milestones, objectives and commitments undertaken by all parties involved; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of COVID-19 products;
Amendment 381 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that the affordability of medicines remains a systemic challenge for national health systems, a key access barrier for patients 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 prith often uncertain added clinical benefit; stresses the need for solid evidence, based on well- designed comparative randomised clinical trials to meet health needs with meaningful endpoints and to evaluate medicine; stresses that the regulatory framework must facilitate the best possible outcomes for patients and public ing systemsterest;
Amendment 408 #
Motion for a resolution
Subheading 2
Subheading 2
Supporting a transparent competitive and innovative EU pharmaceutical industry to respond to public health needs
Amendment 414 #
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 agi and predictable regulatory environment; bwelievcomes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiativee initiative to support real world evidence generation and to build interoperable digital infrastructure forwithin the European Health Data Space, while ensuring privacy and security of health data;
Amendment 490 #
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 505 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of recognition and creating quality jobs in the EU along the entire pharmaceutical value chain and the medical field, including the health workforce, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutmedical sector, facilitating talent retention and mobility at EU level;
Amendment 508 #
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 530 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation, including for blood, tissues and cells products; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse-purposing 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; stresses the need for more comparative and collaborative, multi-centre platform trials; stresses that comparative randomised double-blind well-designed clinical trials with relevant endpoints are necessary to meet the health needs and respond to questions or regulators, health technology assessment and health payers; _________________ 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 552 #
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 as a primary source of information for patients;
Amendment 575 #
Motion for a resolution
Subheading 3
Subheading 3
Increasing resilience: prevention of medicine shortages, secure supply chains, sustainable medicines, crisis preparedness and response mechanisms
Amendment 577 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficientCalls on the Commission to heed the recommendations of the European Parliament stated in resolution of 17 September 2020 on the shortage of medicines; Recalls that the EU’s open strategic autonomy, particularly focused on production of critical products, contributes to the availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on atransparency of medicines' stocks and on a centralised European information network on supply problemmedicine shortages, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability and stocks of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains and impose dissuasive sanctions in the event of emergencies; non-compliance;
Amendment 606 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 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;
Amendment 607 #
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19 b. Stresses the need for the publication of concrete and legally binding shortage management and prevention plans as part of the medicine supply obligations of marketing authorisation holders based on an analysis of the manufacturing and distribution risks, including minimum stock levels, measures allowing for the diversification of raw materials supply sources, and the development of other manufacturing sites when necessary;
Amendment 609 #
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19 c. Urges the Commission to address medicine shortages specifically aimed at women such as female hormonal medicines used for contraception and hormone replacement therapy (HRT); stresses the importance to take into account the threats posed by such shortages to women’s and girls’ sexual and reproductive health and rights, particularly among those most vulnerable such as older women or transgender women; highlights the importance of enhancing the control and management of the manufacturing, stockpiling and marketing of those medicines to ensure continuity in supply chains, fair pricing and availability;
Amendment 613 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. SConsiders it essential to improve early communication with healthcare professionals and patients on the availability of medicines; supports the Commission in its efforts to conduct a transparent and inclusive structured dialogue with players in the pharmaceutical value chain, public authorities, healthcare professionals, 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 658 #
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 heed the calls of the European Parliament in its resolution of 17September 2020 on a strategic approach to pharmaceuticals in the environment, in particular to revise the pharmaceutical legislation to strengthen the environmental risk assessment requirements and conditions of approval and use for medicines by including the environmental impacts of pharmaceuticals in the benefit-risk assessment of human medicines; calls on the Commission to strengthen inspection and auditing throughout the production chain; 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;
Amendment 696 #
Motion for a resolution
Subheading 4
Subheading 4
Amendment 704 #
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 711 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Urges the Commission to issue a proposal in the framework of paragraph 9 of Article218 TFEU to update the EU position regarding ongoing WTO TRIPS flexibilities so as in times of health emergency, to allow for use of TRIPS waiver, as well as lifting data and market exclusivity, to enable use of compulsory licensing by the Member States and third countries as an important public health safeguard, and to evaluate the TRIPS+ commitments in EU trade agreements;
Amendment 714 #
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Calls on the Commission to ensure due diligence, transparency, ethical and responsible behaviour throughout the pharmaceutical sector to promote trust in health decision-making and protect the environment and societal welfare;
Amendment 716 #
Motion for a resolution
Paragraph 23 c (new)
Paragraph 23 c (new)
23 c. Calls on the Commission to ensure adequate consultation with stakeholders, in particular consumer, patient and healthcare professionals and non-profit research organisations throughout the implementation of the Pharmaceutical Strategy;
Amendment 717 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Reiterates its commitment to continue working with the Commission and the World Health Organization to standardise effective, safe and sustainable regulatory frameworks for medicinal productimprove access to safe, effective and affordable medicines;