20 Amendments of César LUENA related to 2021/2013(INI)
Amendment 6 #
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
— having regard to the Council conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States,
Amendment 8 #
Motion for a resolution
Citation 6 b (new)
Citation 6 b (new)
— having regard to the Council’s conclusions on innovation for the benefit of patients of 1 December 2014;
Amendment 11 #
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
— having regard to its resolution of 14 February 2017 on EU options for improving access to medicines;
Amendment 12 #
Motion for a resolution
Citation 8 b (new)
Citation 8 b (new)
— having regard to its resolution of 13 September2018 entitled “A European One Health Action Plan against Antimicrobial Resistance”;
Amendment 44 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas the right to health is a fundamental right enshrined in article 35 of the Charter of Fundamental Rights of the European Union;
Amendment 54 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas during the COVID-19 pandemic, uncoordinated actions at national level, such as hoarding and extreme stockpiling, undermined the delivery of equitable supply in all markets; whereas this represents a lesson learnt to avoid in any future crisis situation
Amendment 76 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full cycle of medicines and medical devices, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;
Amendment 84 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas the strategy recognises the key role that generic and biosimilar medicines play in hugely increasing equitable access for patients and for the sustainability of healthcare systems and that their entry into the market after exclusivity expiry should not be delayed;
Amendment 108 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
C b. whereas generic medicines are the majority of prescription medicines dispensed to European patients and have doubled the access to medicines without impacting the healthcare budgets;
Amendment 117 #
Motion for a resolution
Recital C c (new)
Recital C c (new)
C c. whereas biosimilar medicines create opportunities beyond access to medicines, such as benefit sharing across healthcare and thus providing better health and services to patients;
Amendment 120 #
Motion for a resolution
Recital C d (new)
Recital C d (new)
C d. whereas the root causes of medicines shortage should be assessed and tackled in the context of a strategy on medicines shortage;
Amendment 143 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls on the Commission and Member States to take the necessary measures so that non-covid patients do not suffer in terms of access to care and treatments during health crisis, as it has been the case during the COVID-19 emergency; underlines the importance of acting in terms of monitoring, access to diagnosis, screening and treatments, digital solutions and appropriate resources;
Amendment 171 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Recalls its invitation to the Member States, in cooperation with the Commission, to consider the possibility of the establishment of a pooled public platform for R&D financed by all Member States via a minimum contribution of 0.01 % of their GDP; considers that this platform should also be able to directly produce life-saving medicines in the EU in the event of a market failure being identified1a; _________________ 1a P8_TA(2017)0061
Amendment 203 #
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 and mental 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; and on the Member States to support research and development that focuses on the unmet medical needs of all citizens, and to guarantee non-exclusive licensing where R&;D is publicly funded and that access to medical advances in the European Union is non-discriminatory;
Amendment 219 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Stresses the importance of continuous innovation, including in the off-patent segment, to address patients’ unmet needs; calls on the Commission to design a fit-for purpose regulatory framework that will enable the development of the so-called value added medicines as well as recognise this category of affordable innovation and its value for healthcare systems;
Amendment 267 #
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; in this regard, calls on the Commission to submit a legislative proposal on transparency of decisions regulating the prices and the reimbursement of medicinal products in EU countries;
Amendment 296 #
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, and to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;
Amendment 427 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Welcomes the strong focus and several initiatives included in the pharmaceuticals strategy on the need to optimize and modernize the existing regulatory framework, such as the revision of the variations legislation, more digitalised and efficient regulatory processes, the implementation of the Electronic product information (ePI), streamlining API assessment, and better GMP/ Manufacturing management and resources; urges the Commission to advance fast on this agenda making the best use of existing digital tools at EU level (telematics) and enhancing regulatory cost efficiency and fit-for- purpose regulatory measures and processes, supporting this way both security of supply, tackling medicines shortage, as well as manufacturing resilience in Europe;
Amendment 449 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Welcomes the fact that the strategy recognises that the better use of the electronic product information (ePI) will support the better delivery of the information for patients and support a wider availability of medicines, especially in critical situations; calls on the Commission to urgently implement the ePI with a targeted dialogue - between regulators, the industry and all relevant stakeholders – to design a EU roadmap that will define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;
Amendment 612 #
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; believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, including the involvement of policymakers, regulators, payers, industry representatives and patients organizations, among others;