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EU Parl Watch

Plenary report, 1 February 2024

On the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast)

Report A-9-2024-0023 · (COM(2023)0223 – C90149/2023 – 2023/0128(COD))

Committee on Legal Affairs · Rapporteur: Tiemo Wölken

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AI:In short

The Committee on Legal Affairs adopts Parliament's position at first reading on the proposed regulation on the supplementary protection certificate for plant protection products, a recast of Regulation (EC) No 1610/96. The amendments clarify how a product must be protected by the basic patent, and require that no more than one certificate may protect the same product in a member state. They set rules for centralised examination by the Office with national examiners, for oppositions, appeals and the Register, and require the Commission to evaluate the regulation every five years.

Position. The Committee on Legal Affairs adopts Parliament's position at first reading with 33 amendments to the Commission proposal, clarifying patent protection, limiting certificates per product, and setting rules for centralised examination, oppositions and appeals.

Key points

  1. The report adopts Parliament's position at first reading on the Commission's proposal for a recast regulation on the supplementary protection certificate for plant protection products.
  2. The Consultative Working Party found the proposal contains no substantive amendments other than those identified as such, and is a straightforward codification of existing texts.
  3. A certificate should require that the product falls within the scope of one or more claims of the basic patent, as interpreted by the person skilled in the art in light of the description and prior art.
  4. No more than one certificate, national or unitary, may protect the same product in a member state, and the product must not already have been the subject of a prior certificate.
  5. A new definition of 'economically linked' holders is added, and holders of different patents for the same product may each be issued one certificate where they are not economically linked.
  6. Applications must include, where applicable, the consent of the third party referred to in Article 6(2), and a certificate may be declared invalid if granted contrary to Articles 3 and 6.
  7. Centralised examination is conducted by an examination panel including one Office member and two national patent office examiners, with relevant expertise and sufficient experience.
  8. The Office adopts reasoned positive or negative examination opinions based on compliance with Articles 3(1) and 6(2), and oppositions may be filed on those grounds.
  9. Opposition procedures must be transparent and open to public participation, with joint decisions on multiple oppositions and a decision within 6 months unless complexity requires longer.
  10. Appeals must be filed within 2 months, with grounds and evidence within three months, and the Boards of Appeal shall annul or alter an examination opinion not in line with their decision.
  11. The Register must record the examination opinion, the status and outcome of oppositions and appeals, and the Office must inform the applicant of decisions without undue delay.
  12. The Commission shall evaluate the application of Chapter III five years after the date of application and every five years thereafter, reporting to Parliament and the Council.

Who is affected

  • Applicants for supplementary protection certificates for plant protection products, who must meet the conditions on patent protection and prior certificates.
  • Holders of basic patents, who may not be granted more than one certificate for the same product unless not economically linked.
  • National patent offices, whose examiners participate in centralised examination and must have relevant expertise and experience.
  • The Office, which examines applications, issues opinions, handles oppositions and appeals, and maintains the Register.
  • The Commission, which must evaluate the regulation every five years and report to Parliament and the Council.

Figures and deadlines

  • 2 months to file an appeal against a decision of the Office.
  • three months to file a written statement of grounds of appeal.
  • 6 months for the Office to issue a decision on an opposition, unless complexity requires longer.
  • at least 1 month notice for a summons to give evidence orally.
  • five years after the date of application, and every five years thereafter, for the Commission's evaluation.
  • a minimum of five years of experience in the examination of patents and supplementary protection certificates for at least one examiner.

Legal basis. Article 294(2) and Article 114(1) of the Treaty on the Functioning of the European Union.

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Full text

Jump to an amendment (33)
Draft european parliament legislative resolution 147 paragraphs

(COM(2023)0223 – C90149/2023 – 2023/0128(COD))

(Ordinary legislative procedure – recast)

The European Parliament,

–having regard to the Commission proposal to Parliament and the Council (COM(2023)0223),

–having regard to Article 294(2) and Article 114(1) Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90149/2023),

–having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–having regard to the opinion of the European Economic and Social Committee of 27 September 2023,

–having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts,

–having regard to Rules 110 and 59 of its Rules of Procedure,

–having regard to the opinion of the Committee on Agriculture and Rural Development,

–having regard to the report of the Committee on Legal Affairs (A9-0023/2024),

A.whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

Read the rest (135 paragraphs)

1.Adopts its position at first reading hereinafter set out;

2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment 1

Proposal for a regulation

Recital 11

Text proposed by the CommissionAmendment
(11) One of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art by the description of the patent on its filing date. This should not necessarily require that the active substance of the product be explicitly identified in the claims. Or, in the event of a preparation, this should not necessarily require that each of its active substances be explicitly identified in the claims, provided that each of them is specifically identifiable in the light of all the information disclosed by that patent.(11) One of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art in light of the description of the patent on the basis of that person’s general knowledge in the relevant field and on the prior art at the filing date or priority date of the basic patent. This should not necessarily require that the active substance of the product be explicitly identified in the claims or, in the event of a preparation, this should not necessarily require that each active substances be explicitly identified in the claims, provided that each active substance is specifically identifiable in the light of all the information disclosed by that patent on the basis of the prior art at the filing date or priority date of the basic patent.

Amendment 2

Proposal for a regulation

Recital 12

Text proposed by the CommissionAmendment
(12) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any derivative such as salts, esters, ethers, isomers, mixtures of isomers, or complexes, equivalent to the product from a phytosanitary perspective, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same application or for a different one.(12) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any derivative such as salts, esters, ethers, isomers, mixtures of isomers, or complexes, equivalent to the product from a phytosanitary perspective, should not have already been the subject of a prior certificate, whether for the same application or for a different one.

Amendment 3

Proposal for a regulation

Recital 32

Text proposed by the CommissionAmendment
(32) The examination of a centralised application for a certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates matters, located today at national offices only. To ensure an optimal quality of the examination, suitable criteria should be laid down in respect of the participation of specific examiners in the centralised procedure, in particular as regards qualification and conflicts of interest.(32) The examination of a centralised application for a certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the Office and the competent national authorities should make sure that designated examiners have the relevant expertise and sufficient experience in the assessment of supplementary protection certificates. Additional suitable criteria should be laid down in respect of the participation of specific examiners in the centralised procedure, in particular as regards qualification and conflicts of interest.

Amendment 4

Proposal for a regulation

Recital 40

Text proposed by the CommissionAmendment
(40) Where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including a request for a unitary certificate, a common appeal may be filed.(40) To safeguard procedural rights and ensure a complete system of remedies, where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including a request for a unitary certificate, a common appeal may be filed.

Amendment 5

Proposal for a regulation

Recital 41

Text proposed by the CommissionAmendment
(41) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account.(41) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.

Amendment 6

Proposal for a regulation

Article 2 – paragraph 1 – point 15 a (new)

Text proposed by the CommissionAmendment
(15a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder.

Amendment 7

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the CommissionAmendment
2. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for that product may be issued to each of those holders , where they are not economically linked .2. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for that product may be issued to each of those holders, where they are not economically linked. The same principle shall apply mutatis mutandis to applications submitted by the holder concerning the same product for which one or more certificates or unitary certificates have been previously granted to other different holders of different patents.

Amendment 8

Proposal for a regulation

Article 8 – paragraph 1 – point c a (new)

Text proposed by the CommissionAmendment
(ca) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation;

Amendment 9

Proposal for a regulation

Article 15 – paragraph 1 – point a

Text proposed by the CommissionAmendment
(a) the certificate was granted contrary to Article 3;(a) the certificate was granted contrary to Articles 3 and 6;

Amendment 10

Proposal for a regulation

Article 23 – paragraph 2

Text proposed by the CommissionAmendment
2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant.2. Where the centralised application for a certificate and the product to which it relates comply with Articles 3(1) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant.

Amendment 11

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the CommissionAmendment
3. Where the centralised application for a certificate and the product to which it relates does not comply with Article 3(1) in respect of all or some of the designated Member States, the Office shall adopt a reasoned negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant.3. Where the centralised application for a certificate and the product to which it relates does not comply with Articles 3(1) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant.

Amendment 12

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the CommissionAmendment
2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 are not fulfilled for one or more of the designated Member States.2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 or 6 are not fulfilled for one or more of the designated Member States.

Amendment 13

Proposal for a regulation

Article 26 – paragraph 4 – point c a (new)

Text proposed by the CommissionAmendment
(ca) any evidence the opponent relies on in support of the opposition.

Amendment 14

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the CommissionAmendment
6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this to opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate its decision as well as its reasoning for that decision to the opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.

Amendment 15

Proposal for a regulation

Article 26 – paragraph 8 a (new)

Text proposed by the CommissionAmendment
8a. In cases where several oppositions have been filed against an examination opinion, the Office shall deal with the oppositions jointly and issue one single decision in respect of all oppositions filed.

Amendment 16

Proposal for a regulation

Article 26 – paragraph 9

Text proposed by the CommissionAmendment
9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period.9. The Office shall issue a decision on the opposition, including a detailed reasoning for that decision, within 6 months, unless the complexity of the case requires a longer period.

Amendment 17

Proposal for a regulation

Article 26 – paragraph 10

Text proposed by the CommissionAmendment
10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition, and the Office shall mention this in the Register.10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition, and notify the opponent of its decision, and the Office shall mention this in the Register.

Amendment 18

Proposal for a regulation

Article 26 – paragraph 11

Text proposed by the CommissionAmendment
11. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, and the Office shall mention this in the Register.11. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, notify the opponent of its decision and the Office shall mention this in the Register.

Amendment 19

Proposal for a regulation

Article 26 – paragraph 12 a (new)

Text proposed by the CommissionAmendment
12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.

Amendment 20

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the CommissionAmendment
1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications.1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications, on the basis of their relevant expertise and their experience in the field.

Amendment 21

Proposal for a regulation

Article 28 – paragraph 3 – point a

Text proposed by the CommissionAmendment
(a) geographical balance amongst the participating offices;(a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one examiner has a minimum of five years of experience in the examination of patents and supplementary protection certificates;

Amendment 22

Proposal for a regulation

Article 28 – paragraph 3 – point a a (new)

Text proposed by the CommissionAmendment
(aa) where possible, geographical balance amongst the participating offices;

Amendment 23

Proposal for a regulation

Article 28 – paragraph 3 – point c

Text proposed by the CommissionAmendment
(c) no more than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).(c) that there is than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).

Amendment 24

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the CommissionAmendment
3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision.3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, including the evidence supporting these grounds, shall be filed within three months of the date of notification of the decision.
Any reply to the statement of grounds of appeal shall be submitted in writing no later than three months from the date of the filing of the statement of grounds of appeal. The Office shall, where applicable, fix a date for oral proceedings within three months following the filing of the reply or within six months following the filing of the statement of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the date of the oral hearing, or of the filing of the reply to the statement of grounds of appeal, as applicable.

Amendment 25

Proposal for a regulation

Article 29 – paragraph 4 a (new)

Text proposed by the CommissionAmendment
4a. The Office shall inform the applicant of its decision without undue delay.

Amendment 26

Proposal for a regulation

Article 29 – paragraph 5

Text proposed by the CommissionAmendment
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 may annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States.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 shall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States.

Amendment 27

Proposal for a regulation

Article 30 – paragraph 4

Text proposed by the CommissionAmendment
4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166 (5) of Regulation (EU) 2017/1001.4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166(5) of Regulation (EU) 2017/1001. When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters shall be taken into account.

Amendment 28

Proposal for a regulation

Article 30 – paragraph 4 a (new)

Text proposed by the CommissionAmendment
4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to the Boards of Appeal in matters regarding centralised applications for certificates.

Amendment 29

Proposal for a regulation

Article 34 – paragraph 1 – point j

Text proposed by the CommissionAmendment
(j) the date and a summary of the examination opinion in respect of each of the designated Member States;(j) the date and the examination opinion in respect of each of the designated Member States;

Amendment 30

Proposal for a regulation

Article 34 – paragraph 1 – point l

Text proposed by the CommissionAmendment
(l) where applicable, the filing of an opposition, and its outcome, including where applicable a summary of the revised examination opinion;(l) where applicable, the filing of an opposition, its status and its outcome, including where applicable a summary of the revised examination opinion;

Amendment 31

Proposal for a regulation

Article 34 – paragraph 1 – point m

Text proposed by the CommissionAmendment
(m) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion;(m) where applicable, the filing of an appeal, its status and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion;

Amendment 32

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the CommissionAmendment
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. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period.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 summonsed, the Office or the relevant panel, as applicable, shall be verify 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 33

Proposal for a regulation

Article 56 – paragraph 1

Text proposed by the CommissionAmendment
By [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall carry out an evaluation of the application of Chapter III.By … [OJ: please insert: five years after the date of application], and every five years thereafter, the Commission shall 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.
Annex: entities or persons from whom the rapporteur has received input 4 paragraphs

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the report, until the adoption thereof in committee:

Entity and/or person
CropLife Europe
Verband der Chemischen Industrie e.V.

The list above is drawn up under the exclusive responsibility of the rapporteur.

29.6.2023

Letter of the committee on agriculture and rural development 15 paragraphs

Mr Adrián Vázquez Lázara

Chair

Committee on Legal Affairs

BRUSSELS

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

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.

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.

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.

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

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

Yours sincerely,

Norbert Lins

6.11.2023

Letter of the committee on legal affairs 38 paragraphs

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 plant protection products (recast) (COM(2023)0223 – C90149/2023 – 2023/0128(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 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,

Adrián Vázquez Lázara

Encl.: Opinion of the Consultative Working Party.

Annex

CONSULTATIVE WORKING PARTY OF THE LEGAL SERVICES

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

Procedure pages

How the committees handled the text, and how their members voted on it.

Procedure – committee responsible 1 paragraph
TitleSupplementary protection certificate for plant protection products (recast)
ReferencesCOM(2023)0223 – C9-0149/2023 – 2023/0128(COD)
Date submitted to Parliament27.4.2023
Committee responsible Date announced in plenaryJURI 11.9.2023
Committees asked for opinions Date announced in plenaryENVI 11.9.2023IMCO 11.9.2023AGRI 11.9.2023
Not delivering opinions Date of decisionENVI 17.7.2023IMCO 23.5.2023
Rapporteurs Date appointedTiemo Wölken 19.7.2023
Discussed in committee7.11.202329.11.2023
Date adopted24.1.2024
Result of final vote+: –: 0:20 0 0
Members present for the final votePascal Arimont, Ilana Cicurel, Ibán García Del Blanco, Virginie Joron, Pierre Karleskind, Sergey Lagodinsky, Gilles Lebreton, Sabrina Pignedoli, Jiří Pospíšil, Franco Roberti, Raffaele Stancanelli, Adrián Vázquez Lázara, Axel Voss, Marion Walsmann, Tiemo Wölken
Substitutes present for the final votePascal Durand, Angelika Niebler, Witold Pahl, Nacho Sánchez Amor, Jana Toom
Substitutes under Rule 209(7) present for the final voteBenoît Biteau, Christian Ehler
Date tabled1.2.2024
Final vote by roll call in committee responsible 3 paragraphs

20 · For

ECR
Raffaele Stancanelli
ID
Virginie Joron, Gilles Lebreton
No group
Sabrina Pignedoli
EPP
Pascal Arimont, Christian Ehler, Angelika Niebler, Jiří Pospíšil, Axel Voss, Marion Walsmann
Renew
Ilana Cicurel, Pierre Karleskind, Jana Toom, Adrián Vázquez Lázara
S&D
Pascal Durand, Ibán García Del Blanco, Franco Roberti, Nacho Sánchez Amor, Tiemo Wölken
Greens
Sergey Lagodinsky

0 · Against

0 · Abstained