Considerations on COM(2023)231 - Supplementary protection certificate for medicinal products (recast) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)231 - Supplementary protection certificate for medicinal products (recast). |
|---|---|
| document | COM(2023)231 |
| date | April 27, 2023 |
Council Regulation (EC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products has been substantially amended several times20. In the interests of clarity and rationality the said Regulation should be codified.
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(1) Regulation (EC) No 469/2009 of the European Parliament and of the Council21 has been substantially amended22. Since further amendments are to be made, that Regulation should be recast in the interests of clarity.
🡻 469/2009 recital 2
(2) Pharmaceutical research plays a decisive role in the continuing improvement in public health.
🡻 469/2009 recital 3 (adapted)
(3) Medicinal products, especially ⌦ in particular ⌫ those that are the result of long, costly research will not continue to be developed in the Community ⌦ Union ⌫ and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.
🡻 469/2009 recital 4 (adapted)
(4) At the moment, Tthe period that elapses between the filing of an application for a patent for a new medicinal product and ⌦ the ⌫ authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
🡻 469/2009 recitals 5 and 6 (adapted)
(5) ⌦That⌫This situation leads to a lack of protection which penalises pharmaceutical research ⌦ and there is ⌫. There exists a risk of ⌦ that ⌫ research centres situated in the Member States ⌦ relocate ⌫ relocating to countries that offer greater protection.
🡻 469/2009 recital 7 (adapted)
(6) A uniform solution at Community ⌦ Union ⌫ level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community ⌦ Union ⌫ and thus directly affect the functioning of the internal market.
🡻 469/2009 recital 8 (adapted)
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(7) Therefore, the provision of a supplementary protection certificate ⌦ (‘certificate’) ⌫ granted, under the same conditions, by each of the Member States at the request of the holder of a national ⌦ patent ⌫ or European patent ⇨, with or without unitary effect, ⇦ relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument. ⇨ The certificate should provide its holder with an adequate additional period of effective protection subsequent to the expiry of the basic patent. An application for such a certificate should be filed with the competent industrial property office (‘competent national authority’) of the Member State concerned. ⇦
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(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 by the description of the patent on its filing date. 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 of them is specifically identifiable in the light of all the information disclosed by that patent.
(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 therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one.
(10) Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate should extend only to the product, namely the active ingredient or combinations thereof, covered by the authorisation to place it on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
(11) To ensure balanced protection, however, a certificate should entitle its holder to prevent a third party from manufacturing not only the product identified in the certificate but also therapeutically equivalent derivatives of that product, such as salts, esters, ethers, isomers, mixtures of isomers or complexes, as well as biosimilars, even where such derivatives are not explicitly mentioned in the product description on the certificate. There is therefore a need to consider that the protection conferred by the certificate extends to such equivalent derivatives, within the limits of the protection conferred by the basic patent.
(12) As a further measure to ensure that no more than one certificate may protect the same product in any Member State, the holder of more than one patent for the same product should not be granted more than one certificate for that product. However, where two patents protecting the product are held by two holders, one certificate for that product should be allowed to be granted to each of those holders, where they can demonstrate that they are not economically linked. Furthermore, no certificate should be granted to the proprietor of a basic patent in respect of a product which is the subject of an authorisation held by a third party, without that party’s consent.
(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 therapeutically equivalent products 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.
(14) In order to ensure maximum flexibility and not unduly discriminate between holders of different types of patents, there should be no limitation on the type of patent on which a national certificate can be applied for before a competent national authority. Therefore, this should continue to be possible on the basis of a national patent or of a European patent and, in particular, this should also be possible in respect of a European patent with unitary effect (‘unitary patent’).
🡻 469/2009 recital 9 (adapted)
(15) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains ⌦ an ⌫ authorisation to be placed on the market in the Community ⌦ Union ⌫.
🡻 469/2009 recital 10 (adapted)
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(16) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this ⌦ that ⌫ purpose, ⌦ it should not be possible to grant a ⌫ the certificate cannot be granted for a period exceeding ⌦ 5 ⌫ years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the ⌦ Union ⌫ market as a medicinal product. ⇨ In addition, the timely entry of generics and biosimilars into the Union market is also important, particularly in order to increase competition, to reduce prices and to ensure that national healthcare systems are sustainable and that patients in the Union have better access to affordable medicines. ⇦
🡻 469/2009 recital 11
Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law.
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(17) In order to promote the development of paediatric medicinal products, it should be possible to extend the period of overall maximum exclusivity of 15 years and the maximum period of validity of the certificate of 5 years where the paediatric extension provided for in Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council23 applies.
(18) Since the creation of supplementary protection, certificates were only applied for and granted nationally, thus requiring several similar applications to be filed and examined in parallel in a number of Member States. This has resulted in duplication of work for both applicants and competent industrial property offices (‘competent national authorities’) conducting separate examination proceedings in respect of a given product, as well as in occasional discrepancies in the decisions taken by the competent national authorities in different Member States. Such differences usually pertain to the conditions for the grant or refusal of a certificate and include the grant of a certificate in one Member State but the refusal in another Member State regarding the same product or differences in the application of the conditions that apply to prior marketing authorisation or whether the product has already been the subject of a supplementary protection certificate. This leads to legal uncertainty and is inconsistent with the aims of the internal market.
(19) There is a centralised procedure for granting European patents, as well as a centralised procedure for obtaining marketing authorisations for medicinal products. In addition, the ‘unitary patent’ as laid down in Regulation (EU) No 1257/2012 of the European Parliament and of the Council24 is to enter into force in June 2023 in respect of the Member States having ratified the Agreement on a Unified Patent Court (‘UPC’).
(20) Therefore, it is necessary to complement the existing national procedures for the grant of certificates for medicinal products with a centralised procedure. That procedure should make it possible, where the basic patent is a European patent, including a unitary patent, to request the grant of national certificates for two or more designated Member States through the filing and examination of a single ‘centralised’ application. Following the grant of certificates under the centralised procedure, those certificates should be equivalent to the certificates granted under national procedures and be subject to the same rules.
(21) Regulation (EU) No 2017/1001 of the European Parliament and of the Council25 has established, under its Article 2, a European Union Intellectual Property Office (‘the Office’). In the interest of the internal market, the centralised procedure should be carried out by a single examining authority. This can be achieved by the Office being given the task of examining applications for certificates under the centralised procedure in accordance with this Regulation.
(22) In order to provide for a simplified examination of a centralised application, its filing should be available only on the basis of a European patent, including a unitary patent. The centralised application should not be available on the basis of a set of independent national patents, as their claims are likely to be different, resulting in greater complexity in examination compared to the situations where the basic patent is a European patent.
(23) The centralised procedure should apply only to a medicinal product that is based on a centralised marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council26 or Regulation (EU) No 2019/6 of the European Parliament and of the Council27. These authorisations refer to human medicinal and veterinary medicinal products respectively. Such an authorisation, unlike national authorisations, relates to the same medicinal product throughout the Union, and will facilitate the examination of centralised applications.
(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, 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.
(25) To ensure consistency amongst the certificates granted based on the same basic patent and for the same product in Member States, to reduce the global examination workload, and to ensure an appropriate application of the conditions for grant in all Member States where protection is sought for a given product, it is necessary that the centralised procedure be the only option available as regards those Member States for which the related requirements are fulfilled, namely that the basic patent be a European patent, including a unitary patent, and that the marketing authorisation be a centralised one. To this end, a national application for a certificate filed with a competent national authority, should be rejected by that national office where the requirements to use the centralised procedure are met. This measure is proportionate considering the risk of divergences, and does not apply to those situations where those requirements do not apply, in which case national applications may still be filed.
(26) An applicant should also be allowed to lodge a ‘combined application’ that would include an application for a unitary certificate as set out in Regulation [COM(2023) 222]. Such a combined application should undergo a single examination procedure.
(27) In order to avoid double protection, it should not be possible to grant certificates – whether national certificates or unitary certificates – for the same product in the same Member State based on both a national application and a centralised application.
(28) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the centralised application, to submit within 3 months observations to the Office while the centralised examination is being performed. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
(29) The Office should examine the centralised application for certificates and issue an examination opinion. That opinion should state the reasons for which it is positive or negative in respect of each of the designated Member States.
(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 matters, located today at national offices only. To ensure an optimal quality of the examination, 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.
(31) Where the Office finds that the conditions for grant of a certificate are fulfilled in one or more of the Member States designated in a centralised application, but are not fulfilled in one or more of the other ones, including where in one of the designated Member States the basic European patent has different claims which do not cover the product, the Office should issue a positive opinion for those designated Members States in which the conditions for obtaining a certificate are fulfilled, and a negative opinion for those in which the conditions are not fulfilled.
(32) To safeguard third parties’ procedural rights and ensure a complete system of remedies, third parties should be able to challenge an examination opinion, by initiating opposition proceedings within a short duration following the publication of that opinion, and that opposition may result in that opinion being amended.
(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.
(34) Where the examination opinion is positive for one or several Member States, the respective competent national authorities should grant a certificate in accordance with the applicable domestic rules, in particular as regards publication, registration in relevant databases and the payment of annual fees.
(35) Where the examination opinion is negative for one or several Member States, the respective competent national authorities should reject the application in accordance with the applicable domestic rules.
(36) For the sake of coherence and legal certainty, the same substantive provisions should apply to national applications and to centralised applications regarding in particular the scope, the conditions for obtaining certificates, the subject-matter of protection and effect of certificates, and their publication. The centralised procedure would result in the grant of national certificates fully identical to those granted on the basis of national applications.
(37) Since certain competent national authorities may have limited administrative capacity to conduct a full substantive examination of applications for certificates, competent national authorities should remain able to not verify all the conditions for granting a certificate on the basis of a national application. However, to ensure the quality and uniformity of the certificates granted under the centralised procedure, the Office should examine all of the conditions for grant of a certificate under the centralised procedure.
(38) 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.
(39) 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.
(40) Any person may challenge the validity of a certificate granted following the centralised procedure before a competent court of a Member State, which includes the Unified Patent Court where the conditions are met.
(41) To reduce administrative burden and costs for certificate holders, there is a need for the centralised procedure to provide for a swift way of applying for, and granting, an extension of the duration of a set of equivalent certificates for a given medicinal product, granted under the new centralised procedure, in accordance with Regulation (EC) No 1901/2006. As for certificates, such extensions should be granted by competent national authorities, subject to a positive examination of the centralised application for an extension of the duration.
(42) In 2019, the Union introduced an exception in Regulation (EU) 2019/933 of the European Parliament and of the Council28 from the protection granted to holders of supplementary protection certificates for medicinal products. It noted the absence of any exception to the protection conferred by the certificate has had the unintended consequence of preventing makers of generics and biosimilars established in the Union from making generics and biosimilars in the Union, even for the purpose of export to third country markets in which protection does not exist or has expired or for the purpose of storing with a view to day-one placement on the Union market entry. Those circumstances put makers of generics and biosimilars established in the Union at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. The reasons for the introduction for the waiver and the conditions for its application remain applicable at the present time.
🡻 2019/933 recital 5 (adapted)
(43) Those circumstances put makers of generics and biosimilars established in the Union at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. The Union should strike Aa balance ⌦ should be struck ⌫ between restoring a level playing field between those makers ⌦ of generics and biosimilars established in the Union and makers based in third countries that offer less or no protection ⌫ and ensuring that the essence of the exclusive rights of holders of certificates (‘certificate holders’) is guaranteed in relation to the Union market.
🡻 2019/933 recital 8 (adapted)
(44) The aim of this Regulation is to promote the competitiveness of the Union, thereby enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions, by allowing makers of generics and biosimilars established in the Union to make in the Union products, or medicinal products containing those products, for the purpose of export to third-country markets in which protection does not exist or has expired, thereby also helping those makers to compete effectively in those third-country markets. This Regulation should also allow such Mmakers ⌦ of generics and biosimilars established in the Union should be allowed ⌫ to make and store products, or medicinal products containing those products, in a Member State for a defined period pending the expiry of the certificate, for the purpose of entering the market of any Member State upon expiry of the corresponding certificate, thereby helping those makers to compete effectively in the Union immediately after protection has expired (‘EU day-one entry’). This Regulation should also complement the efforts of the Union’s trade policy to ensure open markets for makers of products, or medicinal products containing those products, established in the Union. Over time, this Regulation should benefit the entire pharmaceutical sector in the Union by allowing all players, including newcomers, to reap the benefits of the new opportunities opening up in the fast-changing global pharmaceutical market. Furthermore, the general interest of the Union would be promoted given that, by reinforcing Union-based supply chains for medicines and by allowing storing with a view to entry into the Union market upon expiry of the certificate, medicines would become more accessible to patients in the Union after the expiry of the certificate.
🡻 2019/933 recital 9 (adapted)
(45) In those specific and limited circumstances, and in order to create a level playing field between makers established in the Union and third-country makers, it is appropriate to provide for an exception to the protection conferred by a certificate so as to allow the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or of storing, and any related acts in the Union strictly necessary for that making or for the actual export or the actual storing ⌦ (‘related acts’) ⌫, where such acts would otherwise require the consent of ⌦ the ⌫ a certificate holder (‘related acts’). For instance, such related acts could include: ⌦ the ⌫ possessing,; offering to supply,; supplying,; importing,; using or synthesising ⌦ of ⌫ an active ingredient for the purpose of making a medicinal product.; or ⌦They could also consist of ⌫ temporary storing or advertising ⌦ of the product ⌫ for the exclusive purpose of export to third-country destinations. That ⌦ The ⌫ exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker.
🡻 2019/933 recital 10 (adapted)
(46) The exception should apply to a product, or a medicinal product containing that product, protected by a certificate. It ⌦ and ⌫ should cover the making of the product protected by ⌦ the ⌫ a certificate in the territory of a Member State and the making of the medicinal product containing that product.
🡻 2019/933 recital 11
(47) The exception should not cover placing a product, or a medicinal product containing that product, which is made for the purpose of export to third countries or of storing with a view to EU day-one entry, on the market of a Member State where a certificate is in force, either directly or indirectly after export, nor should it cover re-importation of such a product, or medicinal product containing that product, into the market of a Member State in which a certificate is in force. Moreover, it should not cover any act or activity carried out for the purpose of import of products, or medicinal products containing those products, into the Union merely for the purposes of repackaging and re-exporting. In addition, the exception should not cover any storing of products, or medicinal products containing those products, for any purposes other than those set out in this Regulation.
🡻 2019/933 recital 12 (adapted)
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(48) By limiting the scope of the exception to ⌦ the ⌫ making ⌦ of a product, or a medicinal product containing that product, ⌫ for the purpose of export outside the Union or to making for the purpose of storing, and to acts strictly necessary for such making or for the actual export or the actual storing, the exception provided for in this Regulation should ⇨ will ⇦ not conflict with the normal exploitation of the product, or the medicinal product containing that product, in the Member State in which the certificate is in force, namely with the core exclusive right of the certificate holder to make that product for the purpose of placing it on the Union market during the term of the certificate. In addition, that exception should not unreasonably prejudice the legitimate interests of the certificate holder, whilst taking account of the legitimate interests of third parties.
🡻 2019/933 recital 13 (adapted)
(49) Effective and proportionate safeguards should apply in relation to the exception in order to increase transparency, to help the holder of a certificate ⌦ holder to ⌫ enforce its protection in the Union and check compliance with the conditions set out in this Regulation, and to reduce the risk of illicit diversion onto the Union market during the term of the certificate.
🡻 2019/933 recital 14 (adapted)
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(50) This Regulation should ⇨ To ensure better transparency and legal certainty, it is necessary to ⇦ impose an information obligation on the maker, namely the person established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export or storing, is carried out. It is possible that the maker directly carries out the making ⌦ That obligation should apply also where the making is directly carried out by the maker ⌫. That information obligation should consist of requiring the maker to provide certain information to the competent industrial property office, or another designated authority, which granted the certificate (‘the authority’) in the Member State where the making is to take place. A standard form for notification should be provided for this purpose. The information should be provided before the making of a product, or a medicinal product containing that product, starts for the first time in that Member State, or before any related act prior to that making, whichever is the earlier. The information should be updated as and when appropriate. The making of a product, or a medicinal product containing that product, and the related acts, including those performed in Member States other than the one of making in cases where the product is also protected by a certificate in those other Member States, should only fall within the scope of the exception where the maker has sent the notification to the authority of the Member State of making, and where the maker has informed the holder of the certificate granted in that Member State. Where making takes place in more than one Member State, a notification should be required in each of those Member States. In the interests of transparency, the authority should be required to publish, as soon as possible, the information received, together with the date of notification of that information. Member States should be allowed to require that notifications, and updates to notifications, be subject to the payment of a one-off fee. That fee should be set at a level which does not exceed the administrative cost of processing notifications and updates.
🡻 2019/933 recital 18
(51) For reasons of proportionality, failure to comply with the requirement regarding a third country should only affect exports to that country, and exports to that country should, thus, not benefit from the exception provided for in this Regulation. It should be the responsibility of the maker established in the Union to verify that protection does not exist or has expired in a country of export, or whether that protection is subject to any limitations or exemptions in that country.
🡻 2019/933 recital 20 (adapted)
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(52) This Regulation should impose cCertain due diligence requirements ⌦should be imposed⌫ on the maker as a condition to use the exception ⇨ , so as to ensure better transparency and legal certainty ⇦. The maker should be required to inform persons within its supply chain in the Union, including the exporter and the person carrying out the storing, through appropriate and documented means, in particular contractual means, that the product, or the medicinal product containing that product, is covered by the exception provided for in this Regulation and that the making is intended for the purpose of export or storing. A maker who fails to comply with those due diligence requirements should not benefit from the exception, nor should any third party performing a related act in the Member State of making or in a different Member State in which a certificate conferring protection for the product is in force. The holder of the relevant certificate ⌦ will ⌫ would, therefore, be entitled to enforce its rights under the certificate, while having due regard to the general obligation, provided for in Directive 2004/48/EC of the European Parliament and of the Council29, not to engage in abusive litigation.
🡻 2019/933 recital 21 (adapted)
(53) This Regulation should impose labelling requirements on the maker in respect of products, or medicinal products containing those products, to be exported, in order to facilitate, by means of a logo, identification of such products or such medicinal products as being exclusively intended for the purpose of export to third countries. Making for the purpose of export and related acts should only fall within the scope of the exception if the product, or the medicinal product containing that product, is labelled in the manner provided for in this Regulation. That lLabelling obligation ⌦ in this Regulation ⌫ should be without prejudice to labelling requirements of third countries.
🡻 2019/933 recital 22
(54) Any act not covered by the exception provided for in this Regulation should remain within the scope of the protection conferred by a certificate. Any diversion onto the Union market, during the term of the certificate, of any product, or any medicinal product containing that product, made under the exception, should remain prohibited.
🡻 2019/933 recital 23
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(55) This Regulation ⇨ exception ⇦ is without prejudice to other intellectual property rights that could protect other aspects of a product, or a medicinal product containing that product. This Regulation ⇨ exception ⇦ does not affect the application of Union acts that aim to prevent infringements, and facilitate enforcement, of intellectual property rights, including Directive 2004/48/EC and Regulation (EU) No 608/2013 of the European Parliament and of the Council30 (7).
🡻 2019/933 recital 24
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(56) This Regulation ⇨ exception ⇦ does not affect the rules on the unique identifier, provided for in Directive 2001/83/EC of the European Parliament and of the Council31. The maker should ensure that any medicinal product made for the purpose of export, pursuant to this Regulation, does not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/16132 ⇨ , to ensure that such a product may be identified if it were illicitly re-imported into the Union ⇦. However, under that Delegated Regulation, the requirement to carry such an active unique identifier applies to medicinal products intended to be placed on the market of a Member State upon expiry of the corresponding certificate ⇨ ; accordingly, the prohibition of a unique identifier does not apply to such products ⇦.
🡻 2019/933 recital 25
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(57) This Regulation ⇨ exception ⇦ does not affect the application of Directives 2001/82/EC and 2001/83/EC and Regulation (EU) 2019/6, in particular the requirements relating to the manufacturing authorisation of medicinal products made for export. This includes compliance with the principles and guidelines of good manufacturing practices for medicinal products and using only active substances which have been manufactured in accordance with good manufacturing practices for active substances and distributed in accordance with good distribution practices for active substances.
🡻 2019/933 recital 26 (adapted)
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(58) To safeguard the rights of certificate holders, the exception provided for in this Regulation should not apply to a certificate that has ⌦ had ⌫ already taken effect at the date of entry into force of this Regulation ⌦ (EU) 2019/933 of the European Parliament and of the Council ⌫. In order tTo ensure that the rights of certificate holders are not excessively restricted, the exception should apply to certificates that are applied for on or after the date of entry into force of this Regulation ⌦ (EU) No 2019/933 ⌫. Given that a certificate takes effect at the end of the lawful term of the basic patent, which can be a relatively long time after the date of filing of the application for the certificate, and in order to achieve the aim of this Regulation, it is justified that ⇨ the exception set out in ⇦ this Regulation also cover ⌦ covers ⌫, over a certain period of time, a certificate that was applied for before the date of entry into force of this Regulation ⌦ (EU) No 2019/933 ⌫, but has ⌦ had ⌫ not yet taken effect before that date, irrespective of whether or not that certificate was granted before that date. The exception ⌦ applied ⌫ should apply, therefore, from 2 July 2022 to a certificate that takes ⌦ took ⌫ effect from the date of entry into force of this Regulation ⌦ (EU) No 2019/933⌫. The concept of ‘certain period of time’ for each individual certificate that takes effect after the date of entry into force of ⌦ that ⌫ this Regulation should ensure that the exception is ⌦ be ⌫ applied, on a progressive basis, to such a certificate, depending on the date on which it takes ⌦ took ⌫ effect and on its duration. Such application of the exception would allow the holder of a certificate that has ⌦ had ⌫ been granted, but that has ⌦ had ⌫ not yet taken effect by the date of the entry into force of this Regulation ⌦ (EU) 2019/933 ⌫, a reasonable period of transition to adapt to the changed legal context, while at the same time ensuring that makers of generics and biosimilars can benefit effectively, without excessive delay, from the exception.
🡻 2019/933 recital 27 (adapted)
(59) Typically, an applicant for a certificate files an application at approximately the same date in each Member State of filing. However, due to differences in national procedures for the examination of applications, the date of grant of the certificate might vary significantly from one Member State to another, thereby creating disparities in the legal situation of the applicant in the Member States in which the certificate was applied for. Introducing tThe exception ⌦ should apply ⌫ on the basis of the date of the filing of the application for a certificate would, therefore, ⌦ in order to ⌫ promote uniformity and limit the risk of disparities.
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(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.
(61) Regulation [COM(2023) 222]33 creates a unitary supplementary protection certificate for medicinal products, which may be requested for those Member States in which the basic patent has unitary effect. The request for such a unitary certificate may be made in a combined application for a certificate under the centralised procedure covered by this Regulation. In such a case, the combined application including both requests should be subject to a single centralised examination procedure. Double protection by both a unitary certificate and a certificate granted pursuant to this Regulation should be excluded.
(62) For the tasks conferred on the Office under this Regulation, the languages of the Office should be all official languages of the Union. The Office should accept verified translations, into one of the official languages of the Union, of documents and information. The Office may, if appropriate, use verified machine translations.
(63) Financial provision should be made to ensure that competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.
(64) The necessary set-up costs related to the tasks conferred to the Office, including the costs of new digital systems, should be financed from the Office’s accumulated budgetary surplus.
(65) In order to supplement certain non-essential elements of this Regulation, the power to adopt acts, in accordance with Article 290 of the Treaty on the Functioning of the European Union, should be delegated to the Commission in respect of: (i) specifying the content and form of the notice of appeal and the content and the form of the Boards of Appeal’s decision, (ii) specifying the details concerning the organisation of the Boards of Appeal in proceedings relating to certificates, (iii) specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office, (iv) setting out the detailed arrangements for oral proceedings, (v) setting out the detailed arrangements for the taking of evidence, (vi) setting out the detailed arrangements for notification, (vii) specifying the details regarding the calculation and duration of time limits and (viii) setting out the detailed arrangements for the resumption of proceedings. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.34 In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(66) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards: (i) the application forms to be used; (ii) rules on procedures relating to the filing, and procedures regarding the way in which examination panels examine centralised applications and prepare examination opinions, as well as the issuance of examination opinions by the Office, (iii) the criteria in the ways the examination panels are to be set up, and the criteria for the selection of examiners, (iv) the amounts of the applicable fees to be paid to the Office, (v) specifying the maximum rates for costs essential to the proceedings and actually incurred by the successful party, and (vi) rules on the financial transfers between the Office and Member States, the amounts of these transfers, and the remuneration to be paid by the Office regarding the participation of competent national authorities. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council35.
🡻 2019/933 recital 28 (adapted)
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(67) The Commission should carry out a regular evaluation of this Regulation ⇨, in particular in order to assess the impact on the exception on the competitiveness of the pharmaceutical sector of the Union⇦. Pursuant to the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, that evaluation should be based on the five criteria of effectiveness, efficiency, relevance, coherence and added value and should provide the basis for impact assessments of possible further measures. That evaluation should take into account, on the one hand, exports to outside the Union, and on the other ⌦ hand ⌫, the effects of storing on the swifter entry of generics and especially biosimilars into markets in the Union as soon as possible after a certificate expires. Such regular evaluation should also address the effects of this Regulation ⇨ exception ⇦ on the making of generics and biosimilars in the Union by makers of generics and biosimilars established in the Union. In that context, it ⌦ is ⌫would be important to ascertain whether making that was previously taking place outside of the Union would be ⌦ are being ⌫ moved to within Union territory. In particular, ⌦ the ⌫ that evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for makers of generics and biosimilars in the Union. ⌦ The evaluation ⌫ It should also study the impact of the exception on research and production of innovative medicines in the Union by certificate holders and consider the balance between the different interests at stake, in particular as regards public health, public expenditure and, in ⌦ that ⌫ this context, access to medicines within the Union. It should also study whether the period provided for as regards the making of generics and biosimilars for the purpose of storing is sufficient to achieve the objective of EU day-one entry, including its effects on public health. ⇨ The Commission should also regularly evaluate the centralised procedure. ⇦
🡻 2019/933, recital 30 (adapted)
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(68) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union (‘the Charter’). ⇨ The rules in this Regulation should be interpreted and applied in accordance with those rights and principles. ⇦ In particular, this Regulation seeks to ensure full respect for the right to property and the right to health care ⇨ and the right to an effective remedy ⇦ set out respectively in Articles 17 and 35 ⇨ and 47 ⇦ of the Charter. This Regulation should maintain the core rights of the certificate, by limiting the exception provided for in this Regulation to the making of a product, or a medicinal product containing that product, only for the purpose of export outside the Union or for the purpose of storing for a limited period of time with a view to entry into the Union market upon expiry of the protection, and to the acts strictly necessary for such making or for the actual export or the actual storing. In the light of those fundamental rights and principles, the exception provided for in this Regulation does not go beyond what is necessary and appropriate in the light of the overall objective of this Regulation, which is to promote the competitiveness of the Union by avoiding relocation and allowing makers of generics and biosimilars established in the Union to compete, on the one hand, on fast-growing global markets where protection does not exist or has already expired, and on the other, on the Union market upon expiry of the certificate. Indeed, it is necessary to benefit from the positive economic effects arising from the exception, as otherwise the Union would risk substantially weakening its position as a hub for pharmaceutical development and manufacturing. It is, therefore, appropriate to introduce that exception in order to increase the competitive position of makers of generics and biosimilars established in the Union in third countries whose markets are in any event open to competition, whilst leaving the scope and duration of the protection granted by the certificate in the Union untouched. The appropriateness of the measure is further ensured by providing for appropriate safeguards regulating the use of the exception. This Regulation should allow sufficient time for public authorities to put in place the necessary arrangements to receive and publish notifications. ⇨ In addition, the removal of the possibility to file a national application for a certificate with a competent national authority, where the requirements to use the centralised procedure are met, is proportionate in the light of the risk of divergences. Where the requirements do not apply, national applications may still be filed. ⇦
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(69) The establishment of a centralised procedure for the grant of certificates should not affect in any manner the national applications for certificates still pending before competent national authorities, nor the certificates granted on the basis of national applications.
(70) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, with a view to ensuring that the applicable rules and procedures are consistent across the Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(71) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council36 and delivered an opinion on XXX [OP, please add reference once available].
(72) Appropriate arrangements should be made to facilitate a smooth transition from the rules provided for in Regulation (EC) No 469/2009 to the rules laid down in this Regulation. To allow for sufficient time for the Office to implement and launch the centralised procedure, the provisions on centralised applications should apply from [OP – insert the date - one year after the entry into force of this Regulation],
🡻 469/2009 (adapted)
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