What changed between the plenary report and the adopted text

Removed:LETTER OF THE COMMITTEE ON LEGAL AFFAIRS

Added:(39) Since certain competent national authorities may have limited administrative capacity to conduct a full substantive examination of applications for certificates, competent national authorities should remain able to not verify all the conditions for granting a certificate on the basis of a national application. However, to ensure the quality and uniformity of the certificates granted under the centralised procedure, the Office should examine all of the conditions for grant of a certificate under the centralised procedure.

Removed:Mr Adrián Vázquez Lázara

Added:(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. [Am. 4]

Removed:Chair

Added:(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. [Am. 5]

Removed:Committee on Legal Affairs

Added:(42) Any person may challenge the validity of a certificate granted following the centralised procedure before a competent court of a Member State, which includes the Unified Patent Court where the conditions are met.

Removed:BRUSSELS

Added:(43) 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 and their status, including on certificates granted on that basis by national offices, which should share with the Office any related information. The register should be available in all official languages of the Union.

Removed: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))

Added:(44) Regulation [OP, please insert reference to COM(2023)0221] creates a unitary supplementary protection certificate for plant protection products, which may be requested for those Member States in which the basic patent has unitary effect. The request for such a unitary certificate may be made in a combined application for a certificate under the centralised procedure covered by this Regulation. In such a case, the combined application including both requests should be subject to a single centralised examination procedure. Double protection by both a unitary certificate and a certificate granted pursuant to this Regulation should be excluded.

Removed:Dear Mr Chair,

Added:(45) For the tasks conferred on the Office under this Regulation, the languages of the Office should be all official languages of the Union. The Office should accept verified translations, into one of the official languages of the Union, of documents and information. The Office may, if appropriate, use verified machine translations.

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

Added:(46) Financial provision should be made to ensure that competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.

Removed:Paragraph 3 of that Rule reads as follows:

Added:(47) The necessary set-up costs related to the tasks conferred to the Office, including the costs of new digital systems, should be financed from the Office’s accumulated budgetary surplus.

Removed:“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.

Added:(48) In order to supplement certain non-essential elements of this Regulation, the power to adopt acts, in accordance with Article 290 of the Treaty on the Functioning of the European Union, should be delegated to the Commission in respect of: (i) specifying the content and form of the notice of appeal and the content and the form of the Boards of Appeal’s decision, (ii) specifying the details concerning the organisation of the Boards of Appeal in proceedings relating to certificates, (iii) specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office, (iv) setting out the detailed arrangements for oral proceedings, (v) setting out the detailed arrangements for the taking of evidence, (vi) setting out the detailed arrangements for notification, (vii) specifying the details regarding the calculation and duration of time limits and (viii) setting out the detailed arrangements for the resumption of proceedings. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

Removed: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.

Added:(49) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards: (i) the application forms to be used; (ii) rules on procedures relating to the filing, and procedures regarding the way in which examination panels examine centralised applications and prepare examination opinions, as well as the issuance of examination opinions by the Office, (iii) the criteria in the ways the examination panels are to be set up, and the criteria for the selection of examiners, (iv) the amounts of the applicable fees to be paid to the Office, (v) specifying the maximum rates for costs essential to the proceedings and actually incurred by the successful party, and (vi) rules on the financial transfers between the Office and Member States, the amounts of these transfers, and the remuneration to be paid by the Office regarding the participation of competent national authorities. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

Removed: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.”

Added:(50) The Commission should regularly report on the operation of the centralised procedure, in coordination with that required in Regulation [OP, please insert reference to COM(2023)0231].

Removed: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.

Added:(51) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (‘the Charter’). The rules in this Regulation should be interpreted and applied in accordance with those rights and principles. In particular, this Regulation seeks to ensure full respect for the right to property and the right to health care and the right to an effective remedy in Articles 17 and 47 of the Charter.

Removed: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.

Added:(52) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, with a view to ensuring that the applicable rules and procedures are consistent across the Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Removed:Yours sincerely,

Added:(53) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council and delivered an opinion on 14 November 2023.

Removed:Adrián Vázquez Lázara

Added:(54) Appropriate arrangements should be made to facilitate a smooth transition from the rules provided for in Regulation (EC) No 1610/96 to the rules laid down in this Regulation. To allow for sufficient time for the Office to implement and launch the centralised procedure, the provisions on centralised applications laid down in this Regulation should apply from [one year after the entry into force of this Regulation],

Removed:Encl.: Opinion of the Consultative Working Party.

Added:HAVE ADOPTED THIS REGULATION:

Removed:Annex

Added:CHAPTER I GENERAL PROVISIONS

Removed:Brussels, 1 August 2023

Added:Article 1 Subject matter

Removed:OPINION

Added:This Regulation lays down rules on the supplementary protection certificate (‘certificate’) for plant protection products protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a plant protection product, to an administrative authorisation procedure as laid down in Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

Removed:FOR THE ATTENTION OF THE EUROPEAN PARLIAMENT

Added:Article 2 Definitions

Removed:THE COUNCIL

Added:For the purposes of this Regulation, the following definitions shall apply:

Removed:THE COMMISSION

Added:(1) ‘plant protection products’ means active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:

Removed:Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products

Added:(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;

Removed:COM(2023)0223 of 27.4.2023 – 2023/0128(COD)

Added:(b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);

Removed: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.

Added:(c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;

Removed: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.

Added:(d) destroy undesirable plants; or

Removed: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.

Added:(e) destroy parts of plants, check or prevent undesirable growth of plants;

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

Added:(2) ‘substances’ means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;

Removed:- 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’;

Added:(3) ‘active substances’ means substances or micro-organisms including viruses, having general or specific action: