What changed

29.6.2023

6.11.2023

Mr Adrián Vázquez Lázara

BRUSSELS

Ref.: IPOL-COM-AGRI D(2023)23992

Subject: Opinion on the Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast) (COM(2023)0223 – C90149/2023 – 2023/0128(COD))

Subject: Opinion on the Commission’s proposals for regulations on the unitary supplementary protection certificate and the supplementary protection certificate for plant protection products (COM(2023)0221 – C90152/2023 – 2023/126(COD)) and (COM(2023)0223 – C90149/2023 – 2023/128(COD))

Dear Mr Chair,

I refer to the Commission’s proposals for regulations on the unitary supplementary protection certificate [2023/0126 (COD)] and the supplementary protection certificate [2023/0128 (COD)] for plant protection products.

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

AGRI Coordinators considered the matter at their meeting of 23 May. They noted that the proposals are intended to complement the unitary patent system, and would not substantially modify the existing regime for supplementary protection certificate.

Paragraph 3 of that Rule reads as follows:

Unitary supplementary protection certificates are an important tool for this kind of products and for fostering innovation. Since the adoption of Regulation (EC) No 1107/2009, only very few substances have been approved while more and more substances are losing their approval, which leaves farmers with less tools to achieve the Union’s goals. We urge the Committee on Legal Affairs to consider the situation of farmers.

“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.

Consequently, Coordinators recommended not to give an opinion on the above legislative proposals and to convey this position to you.

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.

This recommendation was endorsed by the AGRI Committee at its meeting on 6 July 2023.

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 24 October 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,

Norbert Lins

Adrián Vázquez Lázara

Encl.: Opinion of the Consultative Working Party.

Annex

Brussels, 1 August 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 plant protection products

COM(2023)0223 of 27.4.2023 – 2023/0128(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 6 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 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products resulted in the Consultative Working Party’s establishing, by common accord, as follows.

1. The deletion of recitals 13 and 14 of Regulation (EC) No 1610/96 should have been marked with the grey-shaded type generally used for identifying substantive amendments.

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

- in the title of the act, the replacement of the words ‘concerning the creation of a supplementary protection certificate’ with the words ‘on the supplementary protection certificate’;

- in Article 3(1), introductory wording, the adding of the word ‘and’;

- in Article 8(1), point (a)(iv) and point (c), the replacement of the words ‘to place’ with the words ‘for placing’;

- in Article 8(2), the replacement of the word ‘require’ with the word ‘provide’;

- in Article 12, the adding of the word ‘that’ and the deletion of the word ‘to’ before the words ‘be subject’.

3. In Article 3(1), point (b), and in Article 8(1), point (c), the words ‘medicinal product’ should be replaced by the words ‘plant protection product’.

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