13 Amendments of Roberta METSOLA 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 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 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 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 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 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 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;