Changes from plenary report to adopted text

RemovedLETTER OF THE COMMITTEE ON LEGAL AFFAIRS

Added(53) Labelling in this Regulation should be without prejudice to labelling requirements of third countries.

RemovedMr Adrián Vázquez Lázara

Added(54) Any act not covered by the exception provided for in this Regulation should remain within the scope of the protection conferred by a certificate. Any diversion onto the Union market, during the term of the certificate, of any product, or any medicinal product containing that product, made under the exception, should remain prohibited.

RemovedChair

Added(55) This exception is without prejudice to other intellectual property rights that could protect other aspects of a product, or a medicinal product containing that product. This exception does not affect the application of Union acts that aim to prevent infringements, and facilitate enforcement, of intellectual property rights, including Directive 2004/48/EC and Regulation (EU) No 608/2013 of the European Parliament and of the Council .

RemovedCommittee on Legal Affairs

Added(56) This exception does not affect the rules on the unique identifier, provided for in Directive 2001/83/EC of the European Parliament and of the Council. The maker should ensure that any medicinal product made for the purpose of export does not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/161 , to ensure that such a product may be identified if it were illicitly re-imported into the Union . However, under that Delegated Regulation, the requirement to carry such an active unique identifier applies to medicinal products intended to be placed on the market of a Member State upon expiry of the corresponding certificate ; accordingly, the prohibition of a unique identifier does not apply to such products .

RemovedBRUSSELS

Added(57) This exception does not affect the application of Directive 2001/83/EC and Regulation (EU) 2019/6, in particular the requirements relating to the manufacturing authorisation of medicinal products made for export. This includes compliance with the principles and guidelines of good manufacturing practices for medicinal products and using only active substances which have been manufactured in accordance with good manufacturing practices for active substances and distributed in accordance with good distribution practices for active substances.

RemovedSubject: 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))

Added(58) To safeguard the rights of certificate holders, the exception provided for in this Regulation should not apply to a certificate that had already taken effect at the date of entry into force of Regulation (EU) 2019/933 of the European Parliament and of the Council . To ensure that the rights of certificate holders are not excessively restricted, the exception should apply to certificates that are applied for on or after the date of entry into force of Regulation (EU) No 2019/933 . Given that a certificate takes effect at the end of the lawful term of the basic patent, which can be a relatively long time after the date of filing of the application for the certificate, it is justified that the exception set out in this Regulation also covers , over a certain period of time, a certificate that was applied for before the date of entry into force of Regulation (EU) No 2019/933 , but had not yet taken effect before that date, irrespective of whether or not that certificate was granted before that date. The exception applied , therefore, from 2 July 2022 to a certificate that took effect from the date of entry into force of Regulation (EU) No 2019/933. The concept of ‘certain period of time’ for each individual certificate that takes effect after the date of entry into force of that Regulation should ensure that the exception be applied, on a progressive basis, to such a certificate, depending on the date on which it took effect and on its duration. Such application of the exception would allow the holder of a certificate that had been granted, but that had not yet taken effect by the date of the entry into force of Regulation (EU) 2019/933 , a reasonable period of transition to adapt to the changed legal context, while at the same time ensuring that makers of generics and biosimilars can benefit effectively, without excessive delay, from the exception.

RemovedDear Mr Chair,

Added(59) The exception should apply on the basis of the date of the filing of the application for a certificate , in order to promote uniformity and limit the risk of disparities.

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

Added(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 in the register should not be used in regards to practices of patent linkage and no regulatory or administrative decisions related to generics or biosimilars, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC, should be based on information provided for in the register. [Am. 14]

RemovedParagraph 3 of that Rule reads as follows:

Added(61) Regulation [COM(2023) 222] creates a unitary supplementary protection certificate for medicinal 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“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(62) 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.

RemovedIn 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(63) Financial provision should be made to ensure that competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.

RemovedHowever, 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(64) 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.

RemovedFollowing 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(65) 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.

RemovedIn 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.

Added(66) 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.

RemovedYours sincerely,

Added(67) The Commission should carry out a regular evaluation of this Regulation , in particular in order to assess the impact on the exception on the competitiveness of the pharmaceutical sector of the Union. That evaluation should take into account, on the one hand, exports to outside the Union, and on the other hand , the effects of storing on the swifter entry of generics and especially biosimilars into markets in the Union as soon as possible after a certificate expires. Such regular evaluation should also address the effects of this exception on the making of generics and biosimilars in the Union by makers of generics and biosimilars established in the Union. In that context, it is important to ascertain whether making that was previously taking place outside of the Union are being moved to within Union territory. In particular, the evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for makers of generics and biosimilars in the Union. The evaluation should also study the impact of the exception on research and production of innovative medicines in the Union by certificate holders and consider the balance between the different interests at stake, in particular as regards public health, public expenditure and, in that context, access to medicines within the Union. It should also study whether the period provided for as regards the making of generics and biosimilars for the purpose of storing is sufficient to achieve the objective of EU day-one entry, including its effects on public health. The Commission should also regularly evaluate the centralised procedure.

RemovedAdrián Vázquez Lázara

Added(68) This Regulation respects fundamental rights and observes the principles recognised 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 35 and 47 of the Charter. This Regulation should maintain the core rights of the certificate, by limiting the exception provided for in this Regulation to the making of a product, or a medicinal product containing that product, only for the purpose of export outside the Union or for the purpose of storing for a limited period of time with a view to entry into the Union market upon expiry of the protection, and to the acts strictly necessary for such making or for the actual export or the actual storing. In the light of those fundamental rights and principles, the exception provided for in this Regulation does not go beyond what is necessary and appropriate in the light of the overall objective of this Regulation, which is to promote the competitiveness of the Union by avoiding relocation and allowing makers of generics and biosimilars established in the Union to compete, on the one hand, on fast-growing global markets where protection does not exist or has already expired, and on the other, on the Union market upon expiry of the certificate. In addition, the removal of the possibility to file a national application for a certificate with a competent national authority, where the requirements to use the centralised procedure are met, is proportionate in the light of the risk of divergences. Where the requirements do not apply, national applications may still be filed.

RemovedEncl.: Opinion of the Consultative Working Party

Added(69) The establishment of a centralised procedure for the grant of certificates should not affect in any manner the national applications for certificates still pending before competent national authorities, nor the certificates granted on the basis of national applications.

RemovedAnnex

Added(70) 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.

RemovedBrussels, 26 September 2023

Added(71) 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 XXX [OP, please add reference once available].

RemovedOPINION

Added(72) Appropriate arrangements should be made to facilitate a smooth transition from the rules provided for in Regulation (EC) No 469/2009 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 should apply from [OP – insert the date - one year after the entry into force of this Regulation],

RemovedFOR THE ATTENTION OF THE EUROPEAN PARLIAMENT

AddedHAVE ADOPTED THIS REGULATION:

RemovedTHE COUNCIL

AddedCHAPTER I GENERAL PROVISIONS

RemovedTHE COMMISSION

AddedArticle 1 Subject matter

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

AddedThis Regulation lays down rules on the supplementary protection certificate (‘certificate’) for medicinal products protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC , Regulation (EC) No 726/2004 or Regulation (EU) 2019/6 .

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

AddedArticle 2 Definitions

RemovedHaving 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.

AddedFor the purposes of this Regulation, the following definitions shall apply:

RemovedAt 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.

Added(1) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

Removed1. The following should have been marked with the grey-shaded type generally used for identifying substantive amendments:

Added(2) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product;

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

Added(3) ‘basic patent’ means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;

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

Added(4) ‘application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and Article 36 of Regulation (EC) No 1901/2006 ;