27 Amendments of Dolors MONTSERRAT related to 2021/2013(INI)
Amendment 35 #
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, and in every aspect of the medicine regulatory lifecycle;
Amendment 51 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted the EU’s dependency on third countries in the health sector; whereas the EU's open strategic autonomy and security of supply should be ensured by diversification of supply chains for essential medicines and medicinal products, including European manufacturing sites, as well as by applying public procurement rules that should not consider price as the sole criterion;
Amendment 91 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;
Amendment 149 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Stresses the importance of improving patients and healthcare professionals’ education on medicines by setting up a dedicated Europe-wide online resource centre;
Amendment 150 #
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Welcomes the upcoming creation of the European Health Emergency Preparedness and Response Authority (HERA) and calls for the allocation of sufficient resources and power autonomy to broadly address all the cross-borders threats to health that EU could face in the middle term and beyond the sole COVID- 19 pandemic, including resources for the development of new therapeutics against viral and bacterial pathogens;
Amendment 175 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;
Amendment 190 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Calls on the Commission to propose as soon as possible a legal framework to encourage innovation for new antibiotics with incentives either comparable to the area of orphan drugs or paediatrics or new innovative incentives to stimulate innovation to bring new antibiotics the market;
Amendment 207 #
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 (especially to incentivise First-in-Child development of paediatric anticancer medicines), 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 247 #
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 invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, or whether it is a generic or biosimilar medicine, and the primary and broader needs of the population;
Amendment 256 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to apply public procurement rules that should not consider price as the sole and main selection criterion;
Amendment 310 #
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 European Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the European Commission to facilitate arrangements such as gainsharing programmes;
Amendment 319 #
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of final products;
Amendment 330 #
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 medicine approval times, setting a time limit for approval 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 EU;
Amendment 339 #
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, only if driven by public interest considerations;
Amendment 398 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Calls on the Commission to create a High-Level Forum on Better Access to Medicines to identify multi-stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;
Amendment 422 #
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; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space, which will integrate data from real-world evidence;
Amendment 434 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on the Commission to expand the role of EMA in the assessment of drug-device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise-driven scientific assessment on marketing authorisations within the European Medicines Agency(EMA);
Amendment 459 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;
Amendment 463 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated; 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;
Amendment 471 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Requests the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;
Amendment 476 #
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12 e. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognize and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasizes the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;
Amendment 519 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanomedicines and nanotechnology, next- generation vaccines, including the m-RNA derivatives, 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 appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 524 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Recognises that ATMPs are fundamentally different from traditional pharmaceuticals as they address the root causes of disease and that their fundamental durability and potential curative nature can allow them to be the future of medicine; acknowledges that regulatory bodies such as the EMA are set to review and approve dozens of ATMPs over the coming years, underlining the need for the Commission to establish in addition to its ATMP Action Plan a robust regulatory landscape that facilitates access for all the eligible European patients, and to continue to build on Europe’s position as a major player in ATMPs in order for Europe to remain globally competitive in ATMP development;
Amendment 527 #
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15 b. Calls on the Commission to establish a coordinating body to facilitate cross-border treatments and to ensure that patients across Europe enjoy equitable access to innovative therapies; urges the Commission to work with the EMA to create a one-stop-shop for ATMP developers to seek guidance and communication on their applications;
Amendment 528 #
Motion for a resolution
Paragraph 15 c (new)
Paragraph 15 c (new)
15 c. Calls on the Commission to establish a regulatory framework for nanomedicines and nanosimilars, and calls for these products to be approved through a compulsory centralised procedure;
Amendment 618 #
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 the root causes of shortages of medicines and the weaknesses in the global medicines manufacturing and supply chain;
Amendment 659 #
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 chain, particularly outside the EU; 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; notes that the creation of electronic systems of information and identification of packaging would be an effective way to reduce it; acknowledges steps taken already by the pharmaceutical industry like, for example, the Eco-Pharmaco- Stewardship initiative;