Activities of Kosma ZŁOTOWSKI related to 2021/2013(INI)
Shadow opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (9)
Amendment 8 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that in order to reduce dependence on external suppliers, secure the drug safety of Europeans and make production in the EU competitive, it seems necessary to create appropriate conditions and financial incentives for the industry, which will be a key argument in the context of their investment decisions in the field of API production, intermediates and ready-made drugs;
Amendment 16 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate competition by creating a proper regulatory framework;
Amendment 35 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Urges the Commission to take full account of and assess the effective implementation of the SPC manufacturing waiver in light of the several conditions and limitations posed to it.
Amendment 52 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the importance of generic, biosimilar and value added medicines for consistently increasing equitable access for patients and making the healthcare systems sustainable in a European Union where access is still uneven; calls on the Commission to urgently ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;
Amendment 59 #
Draft opinion
Paragraph 4
Paragraph 4
Amendment 66 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses the importance of timely and healthy competition to deliver equitable access to medicines; calls on the Commission to carefully evaluate any actual impact that any proposal for a unitary or unified SPC would produce on generic and biosimilar medicines, and on equitable patient access to treatments;
Amendment 68 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Call on the Commission to ensure a uniform and efficient application of the conditions for granting preliminary injunctions, including proportionality; recommends a consistent EU application of the IP Enforcement Directive on damages for competitor companies in cases of delayed off-patent competition;
Amendment 69 #
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Welcomes the Commission recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorization applications (so called Bolar provision); calls for urgent European harmonization and enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day -1;
Amendment 81 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses that producers of generic drugs, as opposed to producers of innovative drugs, are usually regional enterprises with less resilience to supply problems and market turbulence; calls to the Commission to promote legal solutions that favour competitiveness in the field of generic production, while maintaining a proper legal balance between generic drugs and innovative drugs;