8 Amendments of Dan NICA related to 2020/2071(INI)
Amendment 48 #
Draft opinion
Paragraph -1 (new)
Paragraph -1 (new)
-1. Calls on the Commission to publish without any further delays the roadmap on EU Pharmaceutical Strategy which will identify root causes of medicine shortages; urges the Commission to propose ambitious and specific regulatory measures with an objective of making medicines available, affordable, sustainable and equally accessible; calls on the Commission to promote measures which will increase EU security of supply of medicines and reduce dependency on third countries;
Amendment 90 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Stresses the importance of ensuring the smooth functioning of the Internal Market in order to eliminate barriers to the access of medicines, medical devices and protective equipment to all citizens, especially those living in Member States that, due to their small size or to their remote position, heavily rely on imports and do not have easy access to the supply chain;
Amendment 93 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Whereas the coronavirus pandemic has highlighted Europe’s dependency on third countries for the production of essential medicines and medical devices, including active pharmaceutical ingredients(APIs), calls on the Commission to provide adequate financial resources under Horizon Europe and other EU programs to strengthen Union’s R&I activities supporting manufacturing in key industrial sectors, such as the pharmaceutical industry; calls on the Commission to reduce the R&I divide within the Union by ensuring broad geographical coverage and participation of low R&I performing Member States in collaborative projects; underlines that Horizon Europe and other EU programs need to support rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that research, best practices, clinical trials, and medication pertaining to rare diseases be made accessible for the benefit of citizens of all the Member States;
Amendment 107 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Having regard to the European Strategy for Data and the digital transformation of healthcare, urges the Commission to promote implementation of interoperable technologies in the Member State’s health sector which will facilitate delivery of innovative health solutions to patients; encourages the creation of a fully operational European Health Data Space with a governance framework which fosters creation of an innovative data-driven ecosystem and which encourages sharing of information and critical data across the Union; asks the Commission to promote next generation standards, tools and infrastructure to store and process data suitable for research and the development of innovative products and services, while ensuring processing of patients personal data is in compliance with European data protection framework;
Amendment 115 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Calls on the Commission to take stock of the impact of coronavirus on industry and SMEs and to present a renewed EU industrial strategy; considers that the industrial recovery of Europe needs to prioritize twin digital and ecological transformation of our societies and building of resilience to external shocks; stresses the importance of promoting private-public partnerships in high value-added and innovative sectors, such as the pharmaceutical industry; stresses the importance of manufacturing for jobs, growth and competitiveness;
Amendment 127 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Notes with concern market failure in several Members States where patients' access to effective and affordable medicines and medical devices remains threatened by very high and often unsustainable price levels, market withdrawal of products that are out-of- patent or a failure to introduce new products to national markets due to business strategies; recognises that access to medicines and medical devices in the Member States with smaller markets requires particular consideration in the new EU Pharmaceutical Strategy;
Amendment 137 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Taking into account that timely notification of shortage of medicines is essential for ensuring alternative treatments for patient care and for mitigating negative effects on the security of supply, calls on the Commission to introduce obligation for marketing authorization holders to notify shortage of medicines to the competent authorities at a minimum two months in advance;
Amendment 144 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Calls on the Commission to expand its joint European response to include joint procurement actions for all developed vaccines, medication, medical equipment and medical technology; insists that this joint response be a priority post-pandemic, and be easily accessible for citizens in every Member State especially those that are particularly vulnerable from a public health and economical perspective due to their remote location or small size;