Text · Comparison of two versions
Changes from report parliamentary committee draft to plenary report
JURI-PR-753704 → A-9-2024-0022
- From
- JURI-PR-753704 report parliamentary committee draft of 13 Oct 2023
- To
- A-9-2024-0022 Plenary report of 1 Feb 2024
- Changes
- 19 changes to the text
- Paragraphs
- +81 added · −21 removed · 11 changed
More facts (2)
- Title (from)
- on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)
- Title (to)
- on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)
Changes that matter, 19
Changes to the text in document order — the ones the change notes describe. Cover page, renumbering and punctuation-only edits are left out (see “Every difference”); changes to citations and references stay in and are marked as formal in the notes.
Change 1
ChangedRecital 2: (2) Pharmaceutical research plays a decisive role in the continuing improvement in public health. Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. ItHowever, is,it however,is difficult to establish a direct link between such favourable rules and Union competitiveness because,because while such rules make Union markets more attractive, medicines’ geographical origin and authorised medicines from third countries are equally eligible to receive all Union incentives, just as Union-basedUnion based innovative companies can equally benefit from incentives in third countries.
Change 2
RemovedRecital 5: deleted
AddedRecital 8: (8) 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 and drawings of the patent, on the basis of that person’s general knowledge in the relevant field and of the prior art at the filing date or priority date of the basic patent. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims or, in the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims, provided that each active ingredient 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.
RemovedRecital 13: (13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all biosimilars having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products.
AddedRecital 9: (9) 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, complexes or biosimilars, should not have already been the subject of a prior certificate, whether for the same therapeutic indication or for a different one.
RemovedRecital 24: (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products in accordance with Article [86] of Directive (EU) .../... [2023/0132(COD)], as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act.
AddedRecital 13: (13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all biosimilar having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products.
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RemovedRecital 41 a (new): (41a) The timely entry of generics and biosimilars onto the Union market is important, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in pharmaceutical systems in the Union and its Member States.
AddedRecital 24: (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products in accordance with Article 86 of Directive (EU) .../... [2023/0132(COD)], as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act.
RemovedRecital 45: (45) In those specific and limited circumstances, and in order to create a level playing field between Union-based makers and third country makers, it is appropriate to restrict the protection conferred by a supplementary protection certificate in accordance with Regulation (EU) 2019/933 so as to allow making for the exclusive purpose of export to third countries and any related acts in the Union strictly necessary for making or for the actual export itself, where such acts would otherwise require the consent of a certificate holder (‘related acts’). For instance, related acts could include the possession, supply, offering to supply, import, using or synthesis of an active ingredient for the purpose of making a medicinal product containing that product, or temporary storage of the product or advertising for the exclusive purpose of export to third-country destinations. The exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker.
AddedRecital 30: (30) 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.
RemovedRecital 60: (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 for within the register should not be used in relation to practices of patent linkage, and no regulatory or administrative decisions related to generic or biosimilars should be based on information provided for in the register, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the supplementary protection certificate.
AddedRecital 32 a (new): (32a) To guarantee an effective protection of innovation, in certain urgent situations, including where the expiry of the basic patent is imminent, an expedited examination procedure might be necessary, notwithstanding the possibility for third parties to submit observations and make use of other remedies provided for in this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be provided.
RemovedArticle 2 – paragraph 1 – point 1: (1) ‘medicinal product’ means any substance or combination of substances that fulfils at least one of the following conditions: / (a) any substance or combination of substances that is presented as having properties for treating or preventing disease in human beings; or / (b) any substance or combination of substances that may be used in or administered to human beings with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;
AddedRecital 33: (33) After the completion of the examination of a centralised application, and after the time limits for appeal and opposition have expired, or, the case being, after a final decision on the merits has been issued, the opinion should be transmitted to the respective national patent offices of the designated Member States. The Office shall ensure the transmission takes place within a timeframe allowing national patent offices to grant the certificate or reject the application, as applicable, before the expiry of the basic patent.
AddedRecital 38: (38) 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.
AddedRecital 39: (39) 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.
AddedRecital 41 a (new): (41a) The timely entry of generics and biosimilars onto the Union market is important, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines for patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. On the other hand, it should be borne in mind that intellectual property rights remain one of the cornerstones of innovation, competitiveness and growth in the internal market.
AddedRecital 45: (45) In those specific and limited circumstances, and in order to create a level playing field between Union-based makers and third country makers, the protection conferred by a supplementary protection certificate in accordance to Regulation (EU) 2019/933 should be restricted, so as to allow making for the exclusive purpose of export to third countries and any related acts in the Union strictly necessary for making or for the actual export itself, where such acts would otherwise require the consent of a certificate holder (‘related acts’). For instance, related acts could include the, possession, supply, offering to supply, import, use or synthesis of an active ingredient for the purpose of making a medicinal product containing that product, or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations. The exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker.
AddedRecital 60: (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.
Change 3
RemovedArticle 5 – paragraph 1: 1. Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
AddedArticle 3 – paragraph 1 – point b: (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive .../... [2023/0132(COD)], Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, as appropriate;
RemovedArticle 5 – paragraph 2 – introductory part: 2. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the certificate shall not confer protection against certain acts which would otherwise require the consent of the certificate holder, if all of the following conditions are met:
AddedArticle 3 – paragraph 3: 3. 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.
RemovedArticle 5 – paragraph 2 – point a – point i: (i) making a product, or a medicinal product containing that product, for the purpose of export to third countries; or
AddedArticle 5 – paragraph 2 – introductory part: 2. By way of derogation from paragraph 1, and in accordance with Regulation (EU).../... [2023/0130(COD)], the certificate shall not confer protection against certain acts which would otherwise require the consent of the certificate holder, if all of the following conditions are met:
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AddedArticle 5 – paragraph 2 – point a – point i: (i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or
Change 4
ChangedArticle 58 – paragraph 21 – point d a –(new): point(da) ivif aapplicable, (new):the (iva)consent anyof actthe inthird accordanceparty withreferred Articleto [85]in ofArticle Directive6(2) (EU)of .../...this [2023/0132(COD)].Regulation.
Change 5
RemovedArticle 7 – paragraph 4 a (new): 4a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application.
RemovedArticle 8 – paragraph 1 – point d a (new): (da) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation;
Change 6
ChangedArticle 15 – paragraph 1 – point c a (new): (ca)a: if(a) the marketing authorisation has been withdrawn orcertificate revokedwas ingranted accordancecontrary withto DirectiveArticle (EU)3 .../...or [2023/0132(COD)].6(2);
Change 7
RemovedArticle 20 – paragraph 1: 1. Where the basic patent is a European patent, including a unitary patent, and the authorisation to place the product on the market has been granted, as appropriate, in accordance with Directive (EU) .../... [EC2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply.
AddedArticle 16 – paragraph 2: 2. Any person may submit an application for revocation of the extension of the duration granted under this Chapter to the body responsible under national law for the revocation of the corresponding basic patent or before a competent court of a Member State.
RemovedArticle 24 – paragraph 1: 1. The Office shall assess the application on the basis of all the conditions in Article 3(1) and (3) and Article 6(2) for each of the designated Member States.
AddedArticle 18 – paragraph 2 a (new): 2a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.
RemovedArticle 24 – paragraph 2: 2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) and (3) and Article 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.
AddedArticle 20 – paragraph 1: 1. Where the basic patent is a European patent, including a unitary patent, and the authorisation to place the product on the market has been granted, as appropriate, in accordance with Directive .../... [2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply.
Change 8
ChangedArticle 2423 – paragraph 3: 3.1: WhereIf the centralised application for a certificate and the product to which it relates does not complycomplies with Article 3(1)22, andor (3)if andan Articleapplication 6(2)for inan respectextension of all orthe someduration of thecertificates designatedcomplies Memberwith States,Article 33(2), the Office shall adopt a reasoned negativepublish examinationthe opinionapplication, in respect of such Member States. The Office shall notify thatthe opinionRegister towithout theundue applicantdelay and publish itno onlater thethan Registerfive withoutworking unduedays delay.after.
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Change 9
AddedArticle 24 – paragraph 1: 1. The Office shall assess the application on the basis of all the conditions in Articles 3(1) and (3) and Article 6(2) for each of the designated Member States.
AddedArticle 24 – paragraph 2: 2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) and (3) and Article 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 and publish the opinion on the dedicated register without undue delay.
AddedArticle 24 – paragraph 3: 3. Where the centralised application for a certificate and the product to which it relates does not comply with Article 3(1) and (3) and Article 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 and publish the opinion on the dedicated register without undue delay.
AddedArticle 24 – paragraph 5 a (new): 5a. The Office shall adopt an examination opinion within 6 months after publication of the centralised application in the Register. Without prejudice to Articles 25, 26 and 28 of this Regulation, whenever duly justified for reasons of urgency, the applicant may submit a request for an expedited procedure. Where the request for an expedited examination procedure is deemed justified, the Office shall adopt an examination opinion within 4 months from the publication of the application for a unitary certificate.
AddedArticle 25 – paragraph 3 a (new): 3a. Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within six weeks after publication of the application in the Register.
AddedArticle 26 – paragraph 2: 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.
Change 10
ChangedArticle 26 – paragraph 9: 9. The Office shall issue a decision on the opposition including a detailed reasoning for itsthat decision within 6 months, unless the complexity of the case requires a longer period.
Change 11
ChangedArticle 26 – paragraph 9 a (new): 9a. 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 respectregards ofto all oppositions filed.
Change 12
ChangedArticle 26 – paragraph 10: 10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition,opposition and notify the opponent of its decisiondecision, and the Office shall mention this in the Register.
Change 13
RemovedArticle 28 – paragraph 3 – point a: (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates;
AddedArticle 26 – paragraph 12 a (new): 12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
RemovedArticle 28 – paragraph 3 – point c: (c) that there is no examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).
AddedArticle 27 – paragraph 1: 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 of their experience in the field.
RemovedArticle 29 – paragraph 3: 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 corresponding evidence relied on, shall be filed within 4 months of the date of notification of the decision.
AddedArticle 28 – paragraph 3 – point a: (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;
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AddedArticle 28 – paragraph 3 – point a a (new): (aa) where possible, geographical balance amongst the participating offices;
AddedArticle 28 – paragraph 3 – point c: (c) that there is no examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of this Regulation.
AddedArticle 29 – paragraph 3: 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 corresponding evidence relied on, shall be filed within 3 months of the date of notification of the decision
AddedArticle 29 – paragraph 3 a (new): 3a. Any reply to statement of the grounds of appeal shall be submitted in writing within three months from the date of the notification of the statement of the grounds of appeal. Where applicable, the Office shall set a date for an oral hearing within three months after the filing of the reply to the grounds of appeal or within six months of the filing of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the oral hearing or of the filing of the reply to the statement of grounds of appeal, as applicable.
Change 14
RemovedArticle 32 – paragraph 5 a (new): 5a. The Office shall inform the applicant of its decision without undue delay.
AddedArticle 30 – paragraph 4: 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 should be taken into account.
Change 15
ChangedArticle 3330 – paragraph 4: 4.4 Thirda parties(new): may4a. alsoArticle submit166(9) observationsof orRegulation oppositions(EU) in2017/1001 respectshall ofapply ato centralisedBoards applicationof forAppeal anin extensionmatters ofregarding thecentralised durationapplications offor certificates.
Change 16
AddedArticle 32 – paragraph 1 – subparagraph 1 a (new): Such transmission shall take place without undue delay within a timeframe allowing the competent national authorities of each designated Member State to grant or reject a certificate, as applicable, according to applicable national procedures, before the expiry of the basic patent.
AddedArticle 32 – paragraph 5 a (new): 5a. The competent national authority shall inform the applicant of its decision without undue delay.
AddedArticle 33 – paragraph 4: 4. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of certificates.
AddedArticle 35 – paragraph 1: 1. The Office shall develop, keep and maintain an electronic, searchable and public Register, providing up-to-date information regarding the status of all published centralised applications, and of all centralised applications for an extension of the duration of certificates.
Change 17
AddedArticle 35 – paragraph 2 – point k: (k) the date and the examination opinion in respect of each of the designated Member States;
Change 18
ChangedArticle 35 – paragraph 11 a (new): 11a. By way of derogation fromof Article 35(9), point (b),35(9)(b) public authorities shall not use the information provided for in the register for practices of patent linkage and no regulatory or administrative decisions related to generics or biosimilarsbiosimilar shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations,authorisation, pricing and reimbursement decisions or tender bids.
Change 19
RemovedArticle 45 – paragraph 3: 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 it shall be verified 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.
AddedArticle 44 – paragraph 2: deleted
RemovedArticle 57 – paragraph 2: 2. By [OP, please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also 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.
AddedArticle 44 – paragraph 3: 3. Oral proceedings before an examination panel, an opposition panel or the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the examination panel, the opposition panel or the Boards of Appeal decide otherwise in cases where admission of the public to all or a part of the oral proceedings could have serious and unjustified disadvantages, in particular for a party to the proceedings.
AddedArticle 45 – paragraph 3: 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 verify that the person 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.
AddedArticle 57 – paragraph 2: 2. By … [OJ: please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the application of Chapter III, and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. The evaluation should assess in particular whether the objectives of the provisions in that Chapter have been achieved.
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AddedLETTER OF THE COMMITTEE ON LEGAL AFFAIRS
AddedMr Adrián Vázquez Lázara
AddedChair
AddedCommittee on Legal Affairs
AddedBRUSSELS
AddedSubject: 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))
AddedDear Mr Chair,
AddedThe Committee on Legal Affairs has examined the proposal referred to above pursuant to Rule 110 on recasting of Parliament's Rules of Procedure.
AddedParagraph 3 of that Rule reads as follows:
Added“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.
AddedIn 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.
AddedHowever, 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.”
AddedFollowing 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.
AddedIn 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.
AddedYours sincerely,
AddedAdrián Vázquez Lázara
AddedEncl.: Opinion of the Consultative Working Party
AddedAnnex
AddedBrussels, 26 September 2023
AddedOPINION
AddedFOR THE ATTENTION OF THE EUROPEAN PARLIAMENT
AddedTHE COUNCIL
AddedTHE COMMISSION
AddedProposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products
AddedCOM(2023)0231 of 27.4.2023 – 2023/0130(COD)
AddedHaving 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.
AddedAt 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.
Added1. The following should have been marked with the grey-shaded type generally used for identifying substantive amendments:
Added- in recital 43, the deletion of the first sentence of recital 5 of Regulation (EU) 2019/933;
Added- in recital 59, the deletion of the first and second sentences of recital 27 of Regulation (EU) 2019/933;
Added- in Article 11(1), introductory wording, and in Article 11(2), the adding of the words ‘as soon as possible’.
Added2. The following should have been identified as formal adaptations:
Added- in the title of the act, the replacement of the word ‘concerning’ with the word ‘on’;
Added- in Article 8(1), point (d), the adding of the words ‘for a medicinal product’;
Added- in Article 8(2), the replacement of the words ‘extended duration’ with the words
Added‘extension of the duration’.
AddedIn 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.
AddedF. DREXLER E. FINNEGAN D. CALLEJA CRESPO
AddedJurisconsult Jurisconsult Director-General
Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2024). “Changes between JURI-PR-753704 and A-9-2024-0022”. Text, 1 February 2024. from JURI-PR-753704, to A-9-2024-0022. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/JURI-PR-753704/compare/A-9-2024-0022 (retrieved 25 September 2026). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX
@misc{epw-text-2024-02-01,
author = {{European Parliament}},
title = {{Changes between JURI-PR-753704 and A-9-2024-0022}},
year = {2024},
date = {2024-02-01},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/JURI-PR-753704/compare/A-9-2024-0022}},
url = {https://news.eu-parl.st-solutions.dev/texts/JURI-PR-753704/compare/A-9-2024-0022},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. from JURI-PR-753704, to A-9-2024-0022. Data: European Parliament Open Data (CC BY 4.0)}
}