Opinion on the Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)

9.11.2023

Mr Adrián Vázquez Lázara

Chair

Committee on Legal Affairs

BRUSSELS

Subject: Opinion on the Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast) (COM(2023)0231 – C90146/2023 – 2023/0130(COD))

Dear Mr Chair,

The Committee on Legal Affairs has examined the proposal referred to above pursuant to Rule 110 on recasting of Parliament's Rules of Procedure.

Paragraph 3 of that Rule reads as follows:

“If the committee responsible for legal affairs considers that the proposal does not entail any substantive changes other than those identified as such in the proposal, it shall inform the committee responsible for the subject matter thereof.

In such a case, over and above the conditions laid down in Rules 180 and 181, amendments shall be admissible within the committee responsible for the subject-matter only if they concern those parts of the proposal which contain changes.

However, amendments to parts of the proposal which remain unchanged may, by way of exception and on a case-by-case basis, be accepted by the Chair of the committee responsible for the subject matter if he or she considers that this is necessary for pressing reasons relating to the internal logic of the text or because the amendments are inextricably linked to other admissible amendments. Such reasons must be stated in a written justification to the amendments.”

Following the here attached opinion of the Consultative Working Party of the Legal Services of the Parliament, the Council and the Commission, which has examined the recast proposal, and in keeping with the recommendations of the Rapporteur, the Committee on Legal Affairs considers that the proposal in question does not include any substantive changes other than those identified as such and that, as regards the codification of the unchanged provisions of the earlier act with those substantive amendments, the proposal contains a straightforward codification of the existing text, without any change in its substance.

In conclusion, at its meeting of 7 November 2023, the Committee on Legal Affairs unanimously decided to recommend that the Committee on Legal Affairs, as the committee responsible, proceed to examine the above proposal in accordance with Rule 110.

Yours sincerely,

Adrián Vázquez Lázara

Encl.: Opinion of the Consultative Working Party

Annex

Brussels, 26 September 2023

OPINION

FOR THE ATTENTION OF THE EUROPEAN PARLIAMENT

THE COUNCIL

THE COMMISSION

Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products

COM(2023)0231 of 27.4.2023 – 2023/0130(COD)

Having regard to the Inter-institutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts, and in particular to point 9 thereof, the Consultative Working Party consisting of the respective legal services of the European Parliament, the Council and the Commission met on 13 July 2023 for the purpose of examining the aforementioned proposal submitted by the Commission.

At that meeting, an examination of the proposal for a Regulation of the European Parliament and of the Council recasting Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products resulted in the Consultative Working Party’s establishing, by common accord, as follows.

1. The following should have been marked with the grey-shaded type generally used for identifying substantive amendments:

- in recital 43, the deletion of the first sentence of recital 5 of Regulation (EU) 2019/933;

- in recital 59, the deletion of the first and second sentences of recital 27 of Regulation (EU) 2019/933;

- in Article 11(1), introductory wording, and in Article 11(2), the adding of the words ‘as soon as possible’.

2. The following should have been identified as formal adaptations:

- in the title of the act, the replacement of the word ‘concerning’ with the word ‘on’;

- in Article 8(1), point (d), the adding of the words ‘for a medicinal product’;

- in Article 8(2), the replacement of the words ‘extended duration’ with the words

‘extension of the duration’.

In consequence, examination of the proposal has enabled the Consultative Working Party to conclude, without dissent, that the proposal does not comprise any substantive amendments other than those identified as such. The Working Party also concluded, as regards the codification of the unchanged provisions of the earlier act with those substantive amendments, that the proposal contains a straightforward codification of the existing legal text, without any change in its substance.

F. DREXLER E. FINNEGAN D. CALLEJA CRESPO

Jurisconsult Jurisconsult Director-General