Activities of Marie TOUSSAINT related to 2023/0130(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)
Amendments (19)
Amendment 45 #
Proposal for a regulation
Recital 3
Recital 3
Amendment 47 #
Proposal for a regulation
Recital 5
Recital 5
Amendment 60 #
Proposal for a regulation
Recital 24
Recital 24
(24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products, in accordance with Article [86] of Directive (EU) .../... [2023/0132(COD)], as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act.
Amendment 69 #
Proposal for a regulation
Recital 41 a (new)
Recital 41 a (new)
(41 a) The timely entry of generics and biosimilars onto the Union market is key for public health purposes, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in pharmaceutical systems in the Union and its Member States.
Amendment 70 #
Proposal for a regulation
Recital 60
Recital 60
(60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. However, the information provided for within the register should not be used in relation to practices of patent linkage, and no regulatory or administrative decisions related to generic or biosimilars should be based on information provided for in the register, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the supplementary protection certificate.
Amendment 75 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the certificate shall not confer protection against certain acts which would otherwise require the consent of the the certificate holder, if all of the following conditions are met:
Amendment 76 #
Proposal for a regulation
Article 5 – paragraph 2 – point a – point iv a (new)
Article 5 – paragraph 2 – point a – point iv a (new)
(iv a) any act in accordance with Article [85] of Directive (EU) .../... [2023/0132(COD)].
Amendment 77 #
Proposal for a regulation
Article 7 – paragraph 4 a (new)
Article 7 – paragraph 4 a (new)
4 a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application.
Amendment 79 #
Proposal for a regulation
Article 8 – paragraph 1 – point d a (new)
Article 8 – paragraph 1 – point d a (new)
(d a) information on any direct public financial support received for research related to the development of the product.
Amendment 81 #
Proposal for a regulation
Article 11 – paragraph 1 – point f a (new)
Article 11 – paragraph 1 – point f a (new)
(f a) information on any direct public financial support received for research related to the development of the product.
Amendment 84 #
Proposal for a regulation
Article 15 – paragraph 1 – point c a (new)
Article 15 – paragraph 1 – point c a (new)
(c a) the marketing authorisation has been withdrawn or revoked in accordance with Directive (EU) .../... [2023/0132(COD)].
Amendment 87 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Where the basic patent is a European patent, including a unitary patent, and the authorisation to place the product on the market has been granted, as appropriate, in accordance with Directive (EU) .../... [EC2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply.
Amendment 107 #
Proposal for a regulation
Article 28 – paragraph 3 – point -a (new)
Article 28 – paragraph 3 – point -a (new)
(-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates;
Amendment 110 #
Proposal for a regulation
Article 28 – paragraph 3 – point c
Article 28 – paragraph 3 – point c
(c) no more than onethat there is no examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).
Amendment 117 #
Proposal for a regulation
Article 29 – paragraph 5
Article 29 – paragraph 5
5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards mayshall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States.
Amendment 126 #
Proposal for a regulation
Article 35 – paragraph 2 – point j a (new)
Article 35 – paragraph 2 – point j a (new)
(j a) information on any direct public financial support received for research related to the development of the product;
Amendment 136 #
Proposal for a regulation
Article 35 – paragraph 11 a (new)
Article 35 – paragraph 11 a (new)
11 a. By way of derogation from Article 35(9), point (b), public authorities shall not use the information provided for in the register for practices of patent linkage and no regulatory or administrative decisions related to generics or biosimilars shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids
Amendment 144 #
Proposal for a regulation
Article 45 – paragraph 3
Article 45 – paragraph 3
3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summoned, it shall be verified that that expert is free of any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period.
Amendment 151 #
Proposal for a regulation
Article 57 – paragraph 2
Article 57 – paragraph 2
2. By [OP, please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the application of Chapter III and present a report on the main findings to the European Parliament and to the Council.