Activities of Simona BALDASSARRE related to 2021/2013(INI)
Plenary speeches (1)
A pharmaceutical strategy for Europe (debate)
Shadow reports (1)
REPORT on a pharmaceutical strategy for Europe
Amendments (36)
Amendment 16 #
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas the production chain for medicines, and therefore vaccines, is dependent on supplies of the raw materials needed not only for medicinal products, but also for the medical equipment used to manufacture medicines;
Amendment 32 #
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 safthe pandemic has demonstrated the weakness of European health care systems; whereas safe, innovative, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;
Amendment 47 #
Motion for a resolution
Recital B
Recital B
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 integcooperation is necessary as well as a greater sharing of epidemiological and health data at European level; whereas a European Health Union, which contributes to an increasingly social Union, is key in this process;
Amendment 59 #
Draft opinion
Recital B d (new)
Recital B d (new)
Bd. whereas the European Union is the world's second-largest market for pharmaceutical products, evidence of our continuing international importance, a status which must be safeguarded at all costs;
Amendment 72 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, pre-and post-marketing pharmacovigilance, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;
Amendment 85 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. Whereas, to make Europe fit for the future, the strategy must focus on strengthening the innovative potential of European pharmaceutical research; whereas this requires a close link with the EU industrial strategy and the European Health Data Space;
Amendment 125 #
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Underlines that COVID-19 has brought challenges for health systems, their sustainability, but also had a dramatic impact on non-covid patients, including those suffering from chronic conditions, and their ability to access treatments and care; calls on the Commission and Member States to take seriously the impact for non-covid patients and to work collaboratively to ensure no patient is left behind and continuity of care is ensured even during emergency situations;
Amendment 133 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to develop a new incentive model, make provision for marketing gestures geared on a pro rata basis to the aid received, 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;
Amendment 134 #
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 and treatment of diseases; underlines that women are under-represented in clinical trials, resulting in late-stage studies with no sound data on the efficacy or side-effects of a drug in the female population, and that it is therefore necessary to differentiate safety data and analyses by sex;
Amendment 192 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to keep the regulatory constraints on undertakings to a minimum, so that their operating costs are not excessive and so that ultimately prices can be set which are affordable for everyone, with no loss of medicine quality;
Amendment 205 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to further strengthen the system of incentives for research and the development of new medicines for unmet therapeutic needs and incorporate new criteria into the system of incentives for research into and the development of newadvanced diagnostics and medicines for unmet therapeutic needs, while maintaining the overall stability and predictability of the system, 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 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 217 #
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 with appropriate incentives and its value for healthcare systems;
Amendment 221 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
Amendment 224 #
Draft opinion
Paragraph 8
Paragraph 8
8. Regrets the excessive influencUrges the Commission to broaden the scope of its industry interest groups, which is detrimental toconsultations to include all stakeholders in the medicines production and distribution chain, public- health, patient and consumer associations and to trade unions.
Amendment 230 #
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Considers that antimicrobial resistance constitutes a serious threat to public health, whose cause should be found above all in the incorrect and superficial use of antibiotic drugs; calls on the Commission and Member States to fund projects aimed at improving diagnostics as well as suggesting a protocol for administrating antibiotics and an awareness campaign for health professionals to encourage more targeted treatment based on patients’ real needs;
Amendment 240 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote a well-structured and institutionalised dialogue with the Member States and stakeholders to assess new criteria forhow 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 may encourage investment in R&D in the EU, and guide a harmonised transformation towards an approach based on results and on the basic and most extensive needs of the population, considering the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;
Amendment 271 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increase price transparency, while taking into account the overall R&D efforts of the pharmaceutical industry and its implicit failure rate, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;
Amendment 303 #
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;
Amendment 311 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Underlines that biosimilars and generics can be an important component within the pharmaceutical strategy for Europe, however it underlines that there is no identity with the originator, therefore their interchangeability should not be automatic but subject to the evaluation of the physician; pharmacovigilance should be a key tool in the evaluation of biological drugs in terms of efficacy and safety, for which continuous monitoring can provide all the useful elements for decision-making in both clinical and regulatory contexts; highlights the need for an EMA- authorized reference platform for generics and biosimilars;
Amendment 340 #
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 and medicines repurposing;
Amendment 351 #
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; stresses that joint EU procurement should be implemented only in exceptional circumstances and for extraordinary cross-border public health threats, such as the COVID-19 pandemic, if the purchase of products cannot be secured as efficiently by other means, to ensure patient’s access to emergency medicines and unmet therapeutic needs;
Amendment 380 #
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 expensivethe ability to pay remains very different across EU Member States ; believes that the solution to this challenge lies in a transition towards an outcomes-based approach which recognizes the value of medicines to patients and the economic benefits brought to healthcare systems and society; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systemimprove access for patients across Member States;
Amendment 419 #
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 system; calls on the Commission to establish a unified supplementary protection certificate (SPCs) for the internal market, following the excellent results achieved on national basis; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;
Amendment 441 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Underlines the key role of medical gases, such as oxygen, in treating patients; calls on the Commission to simplify the procedures for production and distribution of medical gases as part of the revision of Directive 2001/83/EC1c; _________________ 1c OJ L 311, 28.11.2001, p. 67–128
Amendment 443 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Encourages European federated data networks to improve research, development and healthcare delivery; highlights the importance of defining more clearly Secondary data use vs. Primary data collection;
Amendment 457 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Supports adapting existing frameworks to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;
Amendment 515 #
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; highlights that eHealth, home care, and technological innovation in addition to education campaigns are key weapons in infection control, treatment of COVID-19 and other infectious 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;
Amendment 525 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Urges the European Commission and EMA to consider the full life-cycle of all innovative medicines and therapies including gene and cell therapies, personalised medicine, nanotechnology, next generation vaccines, and ensure a fit-for-purpose framework for off-patent competition at the time of loss of exclusivity;
Amendment 532 #
Motion for a resolution
Paragraph 16
Paragraph 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; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the creation of a data monitoring committee exclusively for emergency clinical trials to ensure the human dignity of patients involved in research and to avoid duplication of emergency trials; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 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 558 #
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 and the EU regulatory network to develop the use of electronic product information for all medicines in the EU;
Amendment 569 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Emphasises that the term medical device means any instrument, device, item of equipment, software package, implant, reagent, material or other article intended by the manufacturer for use on human beings. If the medical device is to be used alone or in combination with other substances, the Commission is asked to refer to rule 21 in Annex VIII to Regulation 745/2017 on the classification of medical devices;
Amendment 584 #
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 improved collection of digital information linked to telematics and digital shortages reporting, 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 599 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Recalls the importance to look at the root causes of medicines shortage and to implement systemic sustainable policies, before applying any disproportionate regulatory requirements, obligation to supply, penalties or ill- conceived stockpiling fragmenting the single market or threatening products’ economic sustainability, which may lead to further shortages; underlines that root causes include economic causes, increasing regulatory burdens, unforeseen surges in demand, supply chain interdependencies and manufacturing challenges;
Amendment 614 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conductachieve a public disclosure, in accordance to Good Clinical Practices, through a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community, with the aim of protecting the dignity of human beings involved in clinical trials and to address weaknesses in the global medicines manufacturing and supply chain;
Amendment 655 #
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 chainidentify a system of incentives and funding for companies to ensure the achievements of such objectives; 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, highlighting the correlation between packaging and the prescribed treatment, and to bring medical prescriptions into line with real therapeutic needs;
Amendment 669 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Calls on the Commission, on top of the structured dialogue on manufacturing and supply chain, to set up a focused, action oriented High Level Pharmaceutical Forum involving Ministers of Health and policy makers, regulators, payers, industry and other concerned stakeholders of the Healthcare supply chain; underlines that the key objective would be to share the learnings from the COVID19 situation and draw the conclusions to establish a pan European and effective policy framework to prevent shortages in the long term and ensuring a well-functioning, sustainable industry that continues to act as a catalyst to enable sustainable access to medicines for patients and innovation;