Changes from report parliamentary committee draft to plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

▸8 unchanged paragraphs

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

(COM(2023)0222 – C90148/2023 – 2023/0127(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0222),

– having regard to Article 294(2) and Article 118, first paragraph, of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90148/2023),

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

– having regard to Rule 59 of its Rules of Procedure,

Changed– having regard to the report of the Committee on Legal Affairs (A90000/2023),(A9-0019/2024),

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

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

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

Change 1

ChangedRecital 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

RemovedRecital 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.

AddedRecital 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.

RemovedRecital 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.

AddedRecital 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.

RemovedRecital 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.

AddedRecital 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.

RemovedRecital 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.

AddedRecital 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.

RemovedRecital 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.

AddedRecital 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.

AddedRecital 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.

AddedRecital 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

AddedRecital 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.

AddedRecital 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.

Recital 26: (26) The examination of an application for a unitary 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 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 procedure, in particular as regards qualification and conflicts of interest.

Change 3

RemovedRecital 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.

AddedRecital 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.

RemovedRecital 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.

AddedRecital 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.

RemovedRecital 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.

AddedRecital 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.

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 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.

AddedRecital 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.

AddedRecital 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.

Article 2 – paragraph 1 – point 9 a (new): (9a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder.

Change 4

ChangedArticle 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;

Change 5

RemovedArticle 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:

AddedArticle 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.

RemovedArticle 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

AddedArticle 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:

AddedArticle 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

Article 5 – paragraph 3 – point a – point ii: (ii) any related act that is strictly necessary for that making in the Union or for the actual export itself; or

Change 6

ChangedArticle 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

Article 5 – paragraph 3 – point a – point iv: (iv) any related act that is strictly necessary for the making in the Union as referred to in point (iii), or for the actual storing itself, provided that such related act is carried out no earlier than 6 months before the expiry of the certificate.

Change 7

RemovedArticle 5 – paragraph 3 – point a – point iv a (new): (iva) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)]

Article 8 – paragraph 4 a (new): 4a. The application for a unitary certificate shall be lodged electronically, using the formats made available by the Office.

Change 8

ChangedArticle 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

ChangedArticle 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

RemovedArticle 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.

AddedArticle 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

ChangedArticle 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

RemovedArticle 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.

AddedArticle 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

ChangedArticle 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

ChangedArticle 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.