36 Amendments of Nicolás GONZÁLEZ CASARES related to 2021/2013(INI)
Amendment 2 #
Draft opinion
Recital A
Recital A
A. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccineal products, including vaccines; whereas ensuring the strategic autonomy in the field of medicines and diversifying pharmaceutical manufacturing and supply chains represents an essential step in effectively tackling future pandemics;
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 79 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Highlights the need to prioritise R&D for innovative medicines and treatments that better address patients needs, as well as to create incentives for up-skilling, re-skilling and out-skilling of workers for health care careers in order to be better prepared for potential emergency and crisis situations;
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 109 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run counter to the right to health; underlines that public interest and patient safety should be at the centre of all health policies, alongside investment and research;
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 127 #
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2 c. Underlines the potential of Big Data to complement the evidence from clinical trials and fill knowledge gaps on medicines, as well as to help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems;
Amendment 130 #
Draft opinion
Paragraph 2 e (new)
Paragraph 2 e (new)
2 e. Underlines the importance of data sharing and data accessibility in deploying the full potential of AI in the field of healthcare, while putting in place robust ethical requirements;
Amendment 131 #
Draft opinion
Paragraph 2 f (new)
Paragraph 2 f (new)
2 f. Recalls that the processing of data for health research purposes should comply with the provisions of GDPR under Article 9 on the processing of special categories of data;
Amendment 134 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to develop a new incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investment and prioritisation of public interest;
Amendment 139 #
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 medicines, are essential for making progress in the prevention, diagnostics and treatment of diseases;
Amendment 142 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Highlights the latest evolution of pharmaceutical products towards disease and patient-specific therapeutics, involving scrupulous manufacturing steps and the need to take into account the high sensitivity to environmental and transport conditions and complicating supply chain logistics; invites the Commission to maximise synergies between European funds and other EU instruments and policies, to support the design and operation of robust manufacturing processes and distribution networks ensuring agile, responsive and reproducible manufacturing;
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 162 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Considers that the interconnection and interoperability of High Performance Computing infrastructures with the European Health Data Space would ensure the availability of large, high- quality health data sets which are critically important for research and treatment of pathologies, especially rare diseases and paediatric conditions;
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 174 #
Draft opinion
Paragraph 5
Paragraph 5
5. Calls for public investment in R&D to be made transparent and for it to be reflected in product availability and pricing; Calls in this regard on the Commission to increase price transparency when it comes to the costs calculated in the prices, while also addressing the causes limiting affordability;
Amendment 201 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to promote joint procurement favourable to all member states and apply most economically advantageous tender (MEAT) criteria more stringently, while taking into account the need for more balance between public and private interests, including clear liability for manufacturers, as well as the need for sufficient flexibility for member states in line with national specificities; underlines the importance to improve security of supply and to enhance EU countries' preparedness to mitigate cross-border threats to health;
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 415 #
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 agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property systemthe current intellectual property system should be reviewed in order to ensure that it incentives innovation, while ensuring a universal and equitable access to medicinal products, especially in emergency situations; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;
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 540 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16 a. Urges the Commission to ensure more transparency in clinical trial results, with pharmaceutical companies sharing participant-level data, both positive and negative results (avoiding bias derived from lack of public access to negative trials that weakens the conclusions of systematic reviews and provides a false sense of reassurance on the efficacy or safety of medicinal products), protocols and other trial documents, in a timely manner (urgently in case of emergency);
Amendment 583 #
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,, the Member States and the European Medicines Agency to develop an electronic platform capable of determining the volume of stock existing at any given moment, as well as the actual level of demand, providing data capable of detecting, predicting and preventing shortages of medicinal products; calls also 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 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;
Amendment 643 #
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, while developing a strategic autonomy in Europe for certain essential raw materials, and contribute to an effective response in the event of a health emergency;