Changes between two versions
What changed between the draft committee report and the plenary report
From · draft committee report· 13 Oct 2023
on the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
To · plenary report· 31 Jan 2024
on the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
Changes to the text itself, in document order. Cover page, citations and punctuation-only edits are left out; they are under “Every difference”.
The changes · 31
Change 1
Changed:Recital 1: (1) Pharmaceutical research plays a decisive role in the continuing improvement in public health.health and in ensuring the Union’s competitiveness. 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-based innovative companies can equally benefit from incentives in third countries.
Change 2
Removed:Recital 14 a (new): (14a) To avoid unnecessary an administrative and financial burden both for the pharmaceutical industry and for the national authorities and the Office, certain streamlining measures should be introduced. Electronic applications for unitary and combined applications for supplementary protection certificates should be made possible. An application submitted to the Office should follow the ‘digital by default’ principle and hence be submitted to the Office in electronic form. Applications should be assessed based on the file submitted by the applicant in accordance with this Regulation.
Added:Recital 2 a (new): (2a) That situation leads to a lack of protection which penalises pharmaceutical research and there is a risk that research centres situated in the Member States relocate to countries that offer greater protection.
Removed:Recital 21: (21) 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.
Added:Recital 14 a (new): (14a) To avoid unnecessary administrative and financial burden both for the pharmaceutical industry and for the national authorities and the Office, certain streamlining measures should be introduced. Electronic applications for unitary and combined applications for supplementary protection certificates should be made possible. Applications submitted to the Office should follow the ‘digital by default’ principle and hence be submitted to the Office in electronic form. Applications should be assessed on the basis of the file submitted by the applicant in accordance with this Regulation.
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Removed:Recital 21 a (new): (21a) 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 pharmaceutical systems in the Union and its Member States.
Added:Recital 16: (16) 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.
Removed:Recital 22: (22) Regulation [COM(2023) 231] provides for an exception according to which, under narrowly defined circumstances and subject to various safeguards, the protection conferred by a national supplementary protection certificate for medicinal products does not extend to a product that would be manufactured in the Union by a person other than the holder of that certificate, where it is manufactured for the purpose of being exported to a third country market where protection does not exist or has expired or of being made and stored in the Union in view of entering the market of any Member State upon expiry of the corresponding certificate (‘EU day-one entry’) and any acts related thereto. To avoid discrimination between applicants for certificates under Regulation [COM(2023) 231] and for unitary certificates under this Regulation, similar rights and limitations should be conferred by certificates under Regulation [COM(2023) 231] and by unitary certificates, and therefore that exception should also be available in respect of unitary certificates. The reasons for the introduction for the waiver and the conditions for its application should be applicable for unitary certificates.
Added:Recital 17: (17) 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.
Removed:Recital 22 a (new): (22a) 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.
Added:Recital 20 a (new): (20a) For the purposes of ensuring a broad supply of products protected by supplementary protection certificates, holders of unitary supplementary protection certificates are encouraged to exercise their rights under such certificates in a way that allows the supply of products in markets where they do not have the intention to launch any product. In that respect, holders might reach voluntary agreements to licence the unitary supplementary protection certificate rights in those markets. The objective is to allow the supply of products by licensees where the holders of unitary supplementary protection certificates decide not to put any product on the market.
Added:Recital 21: (21) 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 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.
Added:Recital 21 a (new): (21a) 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
Added:Recital 22: (22) Regulation [COM(2023) 231] provides for an exception according to which, under narrowly defined circumstances and subject to various safeguards, the protection conferred by a national supplementary protection certificate for medicinal products does not extend to a product that would be manufactured in the Union by a person other than the holder of that certificate, where it is manufactured for the purpose of being exported to a third country market, where protection does not exist or has expired or of being made and stored in the Union in view of entering the market of any Member State upon expiry of the corresponding certificate (EU ‘Day-one’ entry) and any acts related thereto. To avoid discrimination between applicants for certificates under Regulation [COM(2023) 231] and for unitary certificates under this Regulation, similar rights and limitations should be conferred by certificates under Regulation [COM(2023) 231] and by unitary certificates, and therefore that exception should also be available in respect of unitary certificates. The reasons for the introduction for the waiver and the conditions for its application should be applicable for unitary certificates.
Added:Recital 22 a (new): (22a) 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 the 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.
Change 3
Removed:Recital 31: (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Added:Recital 26 a (new): (26a) 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 under this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be provided.
Removed:Recital 33: (33) The Office should have the possibility to charge a fee for the application for a unitary certificate and for an application for the extension of duration of a unitary certificate for paediatric medicinal products in accordance with Article 86 of Directive (EU) ... [2023/0132 (COD)], as well as other procedural fees such as those for oppositions, appeals and invalidity. The fees charged by the Office should be laid down by an implementing act.
Added:Recital 29: (29) After the completion of the examination of a unitary certificate 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 Office should implement without undue delay the examination opinion by granting a unitary certificate or rejecting the application, as applicable.
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Removed:Recital 35: (35) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for unitary certificates as well as granted unitary certificates and their status. 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 generics 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.
Added:Recital 30: (30) 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 the designation of additional Member States with a view to the grant of national certificates, a common appeal may be filed.
Removed:Article 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;
Added:Recital 31: (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Added:Recital 33: (33) The Office should have the possibility to charge a fee for the application for a unitary certificate and for an application for the extension of duration of a unitary certificate for paediatric medicinal products in accordance with Article 86 of Directive (EU) .../... [2023/0132(COD)], as well as other procedural fees such as those for oppositions, appeals and invalidity. The fees charged by the Office should be laid down by an implementing act.
Added:Recital 35: (35) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for unitary certificates as well as granted unitary certificates and their status. The register should be available in all official languages of the Union. However, the information provided in the register should not be used in relation 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 4
Changed:Article 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 (EU) ... [2023/0132.../... (COD)],[2023/0132(COD)], with Regulation (EU) 2019/6, or with the centralised procedure under Regulation (EC) No 726/2004, as appropriate;
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Change 5
Removed:Article 5 – paragraph 3 – introductory part: 3. By way of derogation from paragraph 1 and in accordance with Regulation (EU) 2019/933, the unitary certificate shall not confer protection against certain acts which would otherwise require the consent of the unitary certificate holder, if all of the following conditions are met:
Added:Article 3 – paragraph 2 – subparagraph 2: Where two or more applications, whether national or centralised applications for certificates, or applications for unitary certificates, concerning the same product and submitted by two or more holders of different patents are pending in a given Member State, one certificate or unitary certificate for that product may be granted to each of those holders, where they are not economically linked, by a competent national authority or by the Office, as applicable. 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.
Removed:Article 5 – paragraph 3 – point a – point i: (i) making a product, or a medicinal product containing that product, for the purpose of export to third countries; or
Added:Article 5 – paragraph 3 – introductory part: 3. By way of derogation from paragraph 1 and in accordance with Regulation (EU) .../... [2023/0130(COD)], the unitary certificate shall not confer protection against certain acts which would otherwise require the consent of the unitary certificate holder, if all of the following conditions are met:
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Added:Article 5 – paragraph 3 – 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 6
Changed:Article 5 – paragraph 3 – point a – point iii: (iii) making, no earlier than 6 months before the expiry of the unitary certificate, a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of thatthe certificate; or
Change 7
Removed:Article 5 – paragraph 3 – point a – point iv a (new): (iva) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)]
Change 8
Changed:Article 89 – paragraph 41 b– point a – point iv a (new): 4b.(iva) Theinformation applicanton shallany bedirect responsiblepublic forfinancial thesupport accuracyreceived andfor completenessresearch ofrelated to the informationdevelopment andof documentationthe submittedproduct infor relationwhich tothe itsSPC application.is requested.
Change 9
Changed:Article 9 – paragraph 1 – point d a (new): (da) where applicable, the consent of the third party referred to in Article 6(2);6(2) of this Regulation.
Change 10
Removed:Article 9 – paragraph 1 – point d b (new): (db) any information on any direct public financial support received for research related to the development of the product.
Added:Article 10 – paragraph 1: The application for a unitary certificate and, where applicable, the application for an extension of the duration of a unitary certificate, shall be lodged in electronic form with the Office. / The Office shall put the necessary arrangements in place in order to ensure that exchanges of data and information are done electronically and that the commercially confidential nature of the information exchanged is protected. Such arrangements shall be without prejudice to the provisions on regulatory protection.
Change 11
Changed:Article 1012 – paragraph 1: TheIf the application for a unitary certificate and,complies wherewith applicable,Article the11(1), or if an application for an extension of the duration of a unitary certificate,certificate complies with Article 9(3), the Office shall bepublish lodgedthe application in electronicthe formRegister withwithout undue delay and no later than five working days after the Office.application was lodged.
Change 12
Removed:Article 10 – paragraph 1 a (new): The applicant shall seek to ensure that exchanges of data and information are made available in electronic formats and shall protect the commercially confidential nature of the information exchanged and be without prejudice to the provisions on regulatory protection.
Added:Article 13 – paragraph 1: 1. The Office shall assess the application on the basis of all the conditions in Articles 3 and 6(2), for all Member States in which the basic patent has unitary effect.
Change 13
Changed:Article 1213 – paragraph 1:2: If2. Where the application for a unitary certificate compliesand withthe Articleproduct 11(1),to orwhich ifit anrelates applicationcomply forwith anArticles extension3 and 6(2) for each of the durationMember ofStates referred to in paragraph 1, the Office shall issue a unitaryreasoned certificatepositive compliesexamination withopinion Articlein 9(3),respect of the grant of a unitary certificate. The Office shall publishnotify that opinion to the applicationapplicant via the electronic platform and publish it in the Register without undue delay.
Change 14
Changed:Article 13 – paragraph 1:3: 1.3. TheWhere Officethe shallapplication assessfor thea applicationunitary oncertificate and the basisproduct ofto allwhich theit conditionsrelates indoes Articlenot comply with Articles 3 and Article6(2) 6(2),in forrespect allof one or more of those Member StatesStates, inthe whichOffice shall issue a reasoned negative examination opinion on the basicgrant patentof hasa unitary effect.certificate. The Office shall notify that opinion to the applicant via the electronic platform and publish it in the Register without undue delay.
Change 15
Changed:Article 13 – paragraph 2: 2. Where the application4: for4. aThe unitaryOffice certificateshall andtranslate the product toexamination whichopinion itin relatesthe complyofficial withlanguages Articleof 3all anddesignated ArticleMember 6(2)States. forThe eachOffice ofmay theuse Memberverified Statesmachine referredtranslation to in paragraphthat 1,effect. theThe Office shall issue a reasonedpublish positivethe examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicantRegister viaas thesoon registeras andpossible publishafter it on the Register without undueis delay.issued.
Change 16
Removed:Article 13 – paragraph 3: 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3 and Article 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Change 17
Removed:Article 14 – paragraph 1: 1. Any natural or legal person may submit written observations to the Office concerning the eligibility for supplementary protection of the product to which the application relates, in one or more of the Member States in which the basic patent has unitary effect. Such written observations shall be submitted electronically.
Added:Article 13 – paragraph 5 a (new): 5a. The Office shall issue an examination opinion within six months of publication of the application for a unitary certificate. Without prejudice to Articles 14, 25 and 28, 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 issue an examination opinion within four months from the publication of the application for a unitary certificate.
Added:Article 14 – paragraph 1: 1. Any natural or legal person may submit written observations to the Office concerning the eligibility for supplementary protection of the product to which the application relates, in one or more of the Member States in which the basic patent has unitary effect. Such written observations shall be submitted to the Office electronically.
Added:Article 14 – paragraph 3 – subparagraph 2 (new): Whenever the expedited procedure applies in accordance with Article 13(5a), observations shall be submitted within six weeks after publication of the application in the Register.
Change 18
Changed:Article 15 – paragraph 6: 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 the reasoning for its decision to the opponent,opponent as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.
Change 19
Changed:Article 15 – 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 respect of all oppositions filed.filed
Change 20
Changed:Article 15 – paragraph 10: 10. The Office shall issue a decision on the oppositionopposition, including a detailed reasoning for that decisiondecision, within 6 months, unless the complexity of the case requires a longer period.
Change 21
Removed:Article 15 – paragraph 13 a (new): 13a. All exchanges between the Office, the holder and the opponent shall take place electronically.
Added:Article 15 – paragraph 12: 12. 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 publish its full decision in the Register.
Removed:Article 16 – paragraph 1 a (new): 1a. Once a national competent authority is appointed by the Office as a participating office, it shall appoint its designated examiners based on relevant expertise and whether they have sufficient experience for the centralised examination procedure.
Added:Article 15 – paragraph 12 a (new): 12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
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Removed:Article 17 – paragraph 3 – point a: (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates;
Added:Article 15 – paragraph 12 b (new): 12b. All exchanges between the Office, the holder and the opponent shall take place electronically.
Added:Article 16 – 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 applications for unitary certificates based on relevant expertise and sufficient experience required for the centralised examination procedure.
Added:Article 17 – 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;
Added:Article 17 – paragraph 3 – point a a (new): (aa) where possible, geographical balance amongst the participating offices;
Change 22
Changed:Article 18 – paragraph 1 – introductory part: No later than three months1: afterAfter the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions:decisions, without undue delay:
Change 23
Removed:Article 22 – paragraph 1 – point c a (new): (ca) the centralised marketing authorisation has been withdrawn in accordance with Article 14 or there has been a suspension of marketing, a withdrawal from the market of a medicinal product or a withdrawal of a marketing authorisation by the marketing authorisation holder in accordance with Article 24 [revised Regulation (EC) No 726/2004].
Added:Article 22 – paragraph 1 – point a: (a) the certificate was granted contrary to Articles 3 and 6(2);
Removed:Article 22 – paragraph 1 – point c b (new): (cb) the medicinal product is not placed on all Member States market covered by the unitary certificate or combined centralised supplementary protection certificate; where a medicinal product is not placed on a Member State market covered by the unitary certificate or the combined centralised supplementary protection certificate, the applicant shall waive the supplementary protection certificate rights for markets where the medicinal product has not been launched.
Change 24
Changed:Article 28 – paragraph 3: 3. Notice of appeal shall be filed electronically 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 supporting evidence forsupporting those grounds, shall be filed electronically within 4three 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 of 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.
Change 25
Removed:Article 29 – paragraph 4 a (new): 4a. The rules set out in Article 166(9) of Regulation (EU) 2017/1001 shall be respected.
Added:Article 29 – paragraph 4: 4. Members of the Boards of Appeal in matters regarding unitary 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 concerning applications for unitary certificates, due consideration shall be given to their previous experience in matters concerning supplementary protection certificates or patent law.
Added:Article 29 – paragraph 4 a (new): 4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to Boards of Appeal in matters regarding unitary certificates.
Change 26
Removed:Article 32 – paragraph 1 b (new): The applicant shall be responsible for the accuracy of the information and documentation submitted in respect of its application.
Change 27
Added:Article 35 – paragraph 1 – point j: (j) the date and the examination opinion of the Office in respect of each of the Member States in which the basic patent has unitary effect;
Change 28
Changed:Article 35 – paragraph 8 a (new): 8a. By way of derogation from Article 35(7), point (b), publicPublic authorities shall not use the information provided for in the registerRegister for practices of patent linkage, andlinkage. noNo regulatory or administrative decisions related to generics or biosimilars shall be based on information providedin forthe Register. Information in the registerRegistger andshall not be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids.
Change 29
Removed:Article 36 – paragraph 2 a (new): 2a. For the purpose of this database the Office shall make public the format for the electronic submission of acts in accordance with Articles 10, 14, 15 and 28 on applications, oppositions, observations and appeals.
Change 30
Removed:Article 42 – 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.
Added:Article 41 – paragraph 2: deleted
Added:Article 41 – 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.
Added:Article 42 – 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 the case may be, shall 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.
Change 31
Changed:Article 56 – paragraph 1: By ... [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European ParliamentParliament, andthe toCouncil and the Council.European Economic and Social Committee. Special emphasis shall be given to the effects of opposition under Article 15 and whether the possibility of opposition leads to significant delays in granting unitary certificates.certificates and to the effects of this Regulation on the recovery of research and development investments in the light of Directive (EU) XXX/XX [COM(2023)192].