Activities of Joanna KOPCIŃSKA related to 2021/2013(INI)
Plenary speeches (1)
A pharmaceutical strategy for Europe (debate)
Amendments (9)
Amendment 33 #
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 Member States’ national health policies; whereas safe, effective and affordable medicines are needed to combat all diseases; whereas patientsublic interest and patient safety and well-being should be at the centre of all health policies, alongside investment and research;
Amendment 316 #
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Highlights that the take-up of new and innovative treatments, as well as their successful delivery to patients, depends on the knowledge, preparedness of and technical base at the disposal of medical personnel; calls on the Commission and on Member States to further cooperate through sharing knowledge and best practices regarding emerging innovative medicines and treatments, to better prepare their medical professionals;
Amendment 349 #
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 emergency medicines and unmet therapeutic needsmedicines during health crises, as well as unmet therapeutic needs, while taking into account the need for a better balance between public and private interests, including clear rules on liability for manufacturers, as well as the need for sufficient flexibility for Member States, as well as respect for the principle of subsidiarity, due to national specificities or divergent financial capacities across the EU;
Amendment 504 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level in all EU Member States, facilitating geographical balance, talent retention and employment opportunities across the whole EU;
Amendment 555 #
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 in close cooperation with the EMA to consider extending the application of rolling reviews to other emergency medicines, while safeguarding high level of safety, quality and effectiveness; further calls on the Commission to work with the EMA to developfurther accelerate the use of electronic product information for all medicines in the EU;
Amendment 560 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Welcomes the Commission’s acknowledgement of the difficulties faced by SMEs during the regulatory approval, licensing and product launch processes; highlights that the heavy administrative burden may hinder SMEs’ ability to develop and bring to patients innovative medical products, including for unmet medical needs and rare diseases; reiterates that the administrative burden often forces SMEs into buyouts by larger pharmaceutical companies or into leaving the EU altogether; calls on the Commission and Member States to take SMEs under special consideration when ensuring a level playing field in the process for simplifying and streamlining procedures, due to the fact that, unlike large pharmaceutical companies, SMEs cannot easily absorb administrative costs; calls on the Commission to bring up to date the capabilities of EMA for providing information and assistance to SMEs during the authorisation process; calls on the Member States to establish One-Stop- Shop contact points for SMEs, providing all necessary information, as well as expert help and assistance, to facilitate compliance with national standards and procedures;
Amendment 621 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conduct a structured dialogue with playerelevant actors 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;
Amendment 649 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Insists that the quality of raw material imports for the pharmaceutical industry from outside the EU must be ensured at all times; calls on the Commission and on Member States to improve quality control and introduce penalties for repeat offenders;
Amendment 707 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a robust and clear regulatory framework facilitating trade agreements that prize innovation- based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;