11 Amendments of Tiemo WÖLKEN related to 2021/2007(INI)
Amendment 12 #
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
– having regard to Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products,
Amendment 14 #
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
Amendment 16 #
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
– having regard to the 2009 Commission's Pharmaceutical Sector Inquiry Report,
Amendment 27 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the Bolar exemption allows the development of generic and biosimilar medicinal products for regulatory approvals during the IP protection of the reference product in order to ensure market entry and free competition as soon as possible after the IP expiry;
Amendment 73 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission to thoroughly evaluate the actual impact that a proposal for a unitary SPC would have on the generic and biosimilar medicines market entry, and on equitable patient access to treatments; at the same time calls on the Commission to take full account of and assess the effective implementation of the SPC Manufacturing Waiver in light of the conditions and limitations to it, especially in regards to stockpiling;
Amendment 78 #
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Recalls the importance of ensuring the highest quality of the European Patent Office (EPO) patent granting process and the removal of the abuses of divisional patent applications together with a clear political accountability of the EPO, as vital for the credibility of the European IP system; asks the Commission to address the issue of abuses of the divisional patent applications at EPO;
Amendment 79 #
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Recalls that innovation should match the most urgent needs of society and that supply of medicines, including generics and biosimilars, should be promoted in this context, as well as affordability and swift availability;
Amendment 119 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Points out that counterfeit goods, in particular counterfeit medicines and fake personal protective equipment and masks in the context of the COVID-19 pandemic, can have serious impacts on the health of EU citizthere is a relation between counterfeited products and risks to the health and safety of consumers; namely, in the context of the COVID-19 pandemic, counterfeiting of medicines, personal protective equipmenst and masks can cause serious harm to public health; suggests that such relation is included and dealt with in the scope of the upcoming review of the EU General Product Safety Directive (GPSD);
Amendment 142 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Welcomes the Commission’s recognition of the importance to tackle the fragmented implementation of the Bolar exemption for medicinal products by clarifying all the actions covered by the Bolar, including the supply of Active Pharmaceutical Ingredients (API) and all the necessary administrative steps to be ready to effectively enter the market immediately after IP expiry;
Amendment 144 #
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Points out that the 2009 Commission's Pharmaceutical Sector Inquiry Report declared patent linkage in the EU legislation as unlawful, as it distorts competition and delays generic and biosimilar market entry, frustrating the objectives of the Bolar exemption; therefore calls on a ban of all forms of patent linkage within EU legislation.
Amendment 155 #
Motion for a resolution
Paragraph 26
Paragraph 26
26. Suggests that an IP and competition coordinator be established at European level in order to ensure a holistic and coordinated approach to EU IP and competition policy and enhance cooperation between the different national IP authorities, the Directorates-General of the Commission and other bodies in charge of IPR, such as the EPO, EUIPO and WIPO;