CELEX: 62021CJ0469
Reference for a preliminary ruling
Medicinal products for human use
Delegated Regulation (EU) 2016/161
Repositories system containing information on safety features
Creation of an interface integrated into the national repository and managed by the public authorities
Obligation to use a specific application for certain medicinal products

This request for a preliminary ruling concerns the interpretation of Articles 25, 31, 32, 35, 36 and 44 of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ 2016 L 32, p. 1).
The request has been made in proceedings between the Consejo General de Colegios Oficiales de Farmacéuticos de España (CGCOF) (General Council of the pharmaceutical society of Spain) and the Administración General del Estado (General State Administration, Spain) concerning the creation of an interface, owned and managed by the Spanish public health authorities, that must be used by pharmacies when dispensing medicinal products financed by the national health system.

Legal context

European Union law

Directive 2001/83/EC
Under Article 54 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74) (‘Directive 2001/83’):
‘The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
…
(o)      for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:
–        verify the authenticity of the medicinal product, and
–        identify individual packs,
as well as a device allowing verification of whether the outer packaging has been tampered with.’
Article 54a of that directive provides:
‘1.      Medicinal products subject to prescription shall bear the safety features referred to in point (o) of Article 54, unless they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article.
…
2.      The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures supplementing point (o) of Article 54 with the objective of establishing the detailed rules for the safety features referred to in point (o) of Article 54.
Those delegated acts shall set out:
…
(b)      the lists containing the medicinal products or product categories which, in the case of medicinal products subject to prescription shall not bear the safety features, and in the case of medicinal products not subject to prescription shall bear the safety features referred to in point (o) of Article 54. Those lists shall be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products. …
…
(d)      the modalities for the verification of the safety features referred to in point (o) of Article 54 by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public and by the competent authorities. Those modalities shall allow the verification of the authenticity of each supplied pack of the medicinal products bearing the safety features referred to in point (o) of Article 54 and determine the extent of such verification. When establishing those modalities, the particular characteristics of the supply chains in Member States, and the need to ensure that the impact of verification measures on particular actors in the supply chains is proportionate, shall be taken into account;
(e)      provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained. The costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features.
…
5.      Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in point (o) of Article 54 to any medicinal product subject to prescription or subject to reimbursement.
Member States may, for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the repositories system referred to in point (e) of paragraph 2 of this Article.
…’

Delegated Regulation 2016/161
Recital 31 of Delegated Regulation 2016/161 states:
‘The repositories system should comprise the necessary interfaces providing access, either directly or by means of software, to wholesalers, persons authorised or entitled to supply medicinal products to the public and national competent authorities so that they can comply with their obligations under this Regulation.’
Article 25 of that delegated regulation, entitled ‘Obligations of persons authorised or entitled to supply medicinal products to the public’, provides in paragraph 3 thereof:
‘In order to verify the authenticity of the unique identifier of a medicinal product and decommission that unique identifier, persons authorised or entitled to supply medicinal products to the public shall connect to the repositories system referred to in Article 31 through the national or supranational repository serving the territory of the Member State in which they are authorised or entitled.’
Chapter VII of that delegated regulation, entitled ‘Establishment, management and accessibility of the repositories system’, includes Articles 31 to 39 of that regulation.
Article 31 of the delegated regulation, entitled ‘Establishment of the repositories system’, provides in paragraphs 1 and 3 thereof:
‘1.      The repositories system where the information on the safety features shall be contained, pursuant to Article 54a(2)(e) of Directive [2001/83], shall be set up and managed by a non-profit legal entity or non-profit legal entities established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features.
…
3.      Wholesalers and persons authorised or entitled to supply medicinal products to the public are entitled to participate in the legal entity or entities referred to in paragraph 1, on a voluntary basis, at no cost.
…’
Article 32 of Delegated Regulation 2016/161, concerning the ‘structure of the repositories system’, states:
‘1.      The repositories system shall be composed of the following electronic repositories:
(a)      a central information and data router (“hub”);
(b)      repositories which serve the territory of one Member State (“national repositories”) or the territory of multiple Member States (“supranational repositories”). Those repositories shall be connected to the hub.
…
4.      The repositories system shall include the application programming interfaces allowing wholesalers or persons authorised or entitled to supply medicinal products to the public to query the repositories system by means of software, for the purposes of verifying the authenticity of the unique identifiers and of decommissioning them in the repositories system. The application programming interfaces shall also allow national competent authorities to access the repositories system by means of software, in accordance with Article 39.
…’
Article 35 of that delegated regulation, which concerns the ‘characteristics of the repositories system’, states, in paragraph 1 thereof:
‘Each repository in the repositories system shall satisfy all of the following conditions:
…
(b)      it shall be set up and managed by a non-profit legal entity established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features and, where they have chosen to participate, wholesalers and persons authorised or entitled to supply medicinal products to the public;
…
(e)      it shall have application programming interfaces able to transfer and exchange data with the software used by wholesalers, persons authorised or entitled to supply medicinal products to the public and, where applicable, national competent authorities;
…
(g)      it shall maintain a complete record (‘audit trail’) of all operations concerning a unique identifier, of the users performing those operations and the nature of the operations …’
Article 36 of that delegated regulation sets out the list of operations for which the repositories system must provide.
Article 39 of that delegated regulation, entitled ‘Access by national competent authorities’, provides:
‘A legal entity establishing and managing a repository used to verify the authenticity of or decommission the unique identifiers of medicinal products placed on the market in a Member State shall grant access to that repository and to the information contained therein, to competent authorities of that Member State for the following purposes:
(a)      supervising the functioning of the repositories and investigating potential incidents of falsification;
(b)      reimbursement;
(c)      pharmacovigilance or pharmacoepidemiology.’
Article 44 of that delegated regulation, relating to the ‘supervision of the repositories system’, is worded as follows:
‘1.      National competent authorities shall supervise the functioning of any repository physically located in their territory, in order to verify, if necessary by means of inspections, that the repository and the legal entity responsible for the establishment and management of the repository comply with the requirements of this Regulation.
…
5.      National competent authorities may contribute to the management of any repository used to identify medicinal products and verify the authenticity of or decommission the unique identifiers of medicinal products placed on the market in the territory of their Member State.
National competent authorities may participate to the management board of the legal entities managing those repositories to the extent of up to one third of the members of the board.’

Spanish law
Article 84 of Real Decreto 1345/2007 por el que se regula el procedimiento de autorización, registro y condiciones de dispensación de los medicamentos de uso humano fabricados industrialmente (Royal Decree 1345/2007 governing the procedure for authorisation, registration and conditions for the supply of medicinal products for human use manufactured industrially) of 11 October 2007 (BOE No 267 of 7 November 2007, p. 45652), as amended by Real Decreto 717/2019 (Royal Decree 717/2019), of 5 December 2019 (BOE No 293 of 6 December 2019, p. 133741) (‘Royal Decree 1345/2007’), provides:
‘1.      Nodo SNSFarma shall be established as a tool for technological integration and information exchange with the national repository, of which it shall form part; it shall apply to all medicinal products bearing a unique identifier which are supplied at the expense of the Sistema Nacional de Salud [(national health system)].
2.      Nodo SNSFarma shall be integrated into the national repository by means of an agreement … between the Ministry of Health, Consumer Affairs and Social Welfare and the managing body of the Spanish system for the verification of medicinal products, which shall set out the parties’ obligations, the technical requirements and the requirement to meet the interoperability specifications and any other specifications necessary for compliance with [Delegated Regulation 2016/161].
3.      Nodo SNSFarma shall be hosted on the public health administrations’ servers, in accordance with Articles 7 and 11 of Royal Decree 1718/2010 of 17 December 2010 on medical prescriptions and dispensing orders, in order to ensure safe access to and transmission of the information, as well as data confidentiality.’
Article 85(1) of Royal Decree 1345/2007 states:
‘Nodo SNSFarma shall allow the Autonomous Communities and the other managing bodies of the national health system to send the verification data of medicinal products supplied at the expense of the national health system by pharmacies or by the pharmacy services they manage, in order that those data may be anonymised before verification in the national repository, thereby supporting the supervisory and monitoring duties of the competent authorities or bodies, both with regard to verification and management of the national health system’s pharmaceutical provision.’
Article 86 of Royal Decree 1345/2007 provides:
‘1.      In accordance with Article 44(5) [of Delegated Regulation 2016/161], Nodo SNSFarma shall be managed by the Ministry of Health, Consumer Affairs and Social Welfare, through the Dirección General de Cartera Básica de Servicios del Sistema Nacional de Salud y Farmacia [(Directorate-General for the basic portfolio of services in the national health and pharmacy system)], which shall coordinate, with the bodies responsible for managing pharmaceutical provision in the Autonomous Communities and the other management bodies of the national health system, the measures and actions that it is appropriate to adopt regarding the management of pharmaceutical provision.
2.      The bodies responsible for managing pharmaceutical provision in the Autonomous Communities and the other managing bodies of the national health system shall adopt the measures necessary to ensure that information relating to the unique identifiers of medicinal products supplied at the expense of the national health system by pharmacies or by the pharmacy services is transmitted to Nodo SNSFarma.’
Under the sixth additional provision of Royal Decree 1345/2007, in the absence of an agreement as referred to in Article 84(2) concerning the integration of the Nodo SNSFarma into the national repository, and in order to ensure compliance with European legislation on the verification and authentication of medicinal products for human use, the Ministerio de Sanidad (Ministry of Health, Spain) may provide for the functionalities and operations for the implementation of the Nodo SNSFarma by ministerial order.

The dispute in the main proceedings and the questions referred for a preliminary ruling
In July 2016, the Spanish repository, a database seeking to gather all the information necessary for the identification of medicinal products, was created by the incorporation of a legal person, Sistema Español de Verificación de Medicamentos SL (Spanish system for the verification of medicinal products) (SEVEM), the purpose of which is to develop, implement and manage the Spanish system for verifying medicinal products, and of which CGCOF is a partner. When establishing that company, the partners agreed that CGCOF would manage an interface integrated into that repository, called ‘Nodofarma Verificación’.
Following the adoption, on 5 December 2019, of Royal Decree 717/2019 on the creation of a new interface called ‘Nodo SNSFarma’, owned and managed by the Ministry of Health, which is to be used by pharmacies when they dispense medicinal products financed by the national health system, CGCOF brought an action before the Tribunal Supremo (Supreme Court, Spain), the referring court, seeking the annulment of that decree in so far as it inserted into Royal Decree 1345/2007 new Articles 84 to 86 and a sixth additional provision.
In support of its action, CGCOF claims that the contested provisions of Royal Decree 717/2019 are not compatible, in several respects, with Delegated Regulation 2016/161 which establishes detailed rules for the safety features enabling the verification of the authenticity medicinal products for human use. The creation of Nodo SNSFarma goes beyond the powers which that delegated regulation confers on the national authorities and undermines the principle of self-administration of the national repository, according to which the national register is to be managed by market participants. Furthermore, the coexistence of two interfaces in one repository is liable to infringe the obligation laid down by that delegated regulation to maintain a complete record of all operations carried out. Lastly, that coexistence leads to an unnecessary complication for pharmacies.
In its defence, the General State Administration contends, in essence, that Nodo SNSFarma is not a new repository but merely a new interface for accessing the repository, and states that its creation was necessary for the proper functioning of the national health system, not only because it allows medicinal products dispensed to be verified, but also because it facilitates its task as the administrative authority responsible for the funding of medicinal products.
Like CGCOF, the referring court is uncertain whether Royal Decree 717/2019 is compatible with Delegated Regulation 2016/161.
In the first place, the referring court observes, with regard, in particular, to Articles 31 to 35 of Delegated Regulation 2016/161, first, that the management of the verification operations falls to agents in the supply chain, such as manufacturers, distributors and pharmacies. Second, the tool for storing all information relating to the supply of medicinal products takes the form of a mandatory system of national or supranational ‘repositories’. Third, those repositories must be connected to a central hub in such a way as to function like a single system. In this case, that hub took the form of a central router managed by the European Medicines Verification Organisation (EMVO), a non-profit-making legal person governed by Belgian law. Fourth, there is in each Member State, in addition to the repository, one or more ‘interfaces’, that is to say, a management tool enabling verification to be carried out. By means of such an interface, verifiers upload to the repository information regarding medicines supplied.
In the second place, the referring court wonders, referring to the principle of the self-administration of the repository by the supply chain for medicinal products, first, whether the national authorities’ supervisory powers which allow them, within certain limits, to contribute to the management of the repository concerned and which are conferred by Article 44 of Delegated Regulation 2016/161, imply that those national authorities may create an interface, second, whether the national authorities may require pharmacies to use that interface when they supply medicinal products financed by the national health system and, third, whether, in the absence of an agreement between the national authority and the management body of the repository in question regarding the integration of that interface into the repository, it is possible to impose that integration unilaterally and imperatively by ministerial order.
It is in those circumstances that the Tribunal Supremo (Supreme Court) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1)      Is a national provision that creates [an interface] (as a tool for use with the repository), which is owned and managed by the State Administration, compatible with Delegated Regulation [2016/161], in particular Articles 25, 31, 32, 35, 36 and 44 thereof?
(2)      If the answer to the previous question is in the affirmative, is a national provision that requires pharmacies to use that [interface]  when they supply medicinal products financed by the National Health System compatible with Delegated Regulation [2016/161], in particular Articles 25, 31, 32, 35, 36 and 44 thereof?
(3)      If the answer to the previous question is in the affirmative, is a national provision that provides that, where no agreement is reached between the State Administration and the entity managing the national repository in relation to integrating the [interface] concerned into the repository, integration may be required, unilaterally and authoritatively, by ministerial order compatible with Delegated Regulation [2016/161], in particular Articles 25, 31, 32, 35, 36 and 44 thereof?’

Consideration of the questions referred

Preliminary observations
By its questions, the referring court asks the Court to indicate whether and to what extent Delegated Regulation 2016/161 imposes obligations on Member States where the latter intend to create, and then require pharmacies to use, a specific interface to access the national repository when supplying medicinal products financed by the national health system.
In that regard, it should be noted that that delegated regulation was adopted by the Commission pursuant to Article 54a of Directive 2001/83, according to which the Commission is to adopt delegated acts for the purpose of (i) introducing safety features to allow the verification of the authenticity of each pack of medicinal products (point (b) of the second subparagraph of paragraph (2)), (ii) providing for the establishment of the repositories system in which information on the safety features are to be contained (point (e) of the second subparagraph of paragraph (2)) and (iii) enabling the Member States to use the unique identifier of any medicinal product, as well as the information contained in the repositories for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology (paragraph (5)).
Thus, for the purpose of introducing security features, Articles 31 to 39 of Delegated Regulation 2016/161 establish rules relating to the repositories system which must contain the information relevant to the use of those safety features.
However, although Article 32(4) of that delegated regulation provides that the repositories system must include application programming interfaces allowing wholesalers or persons authorised or entitled to supply medicinal products to the public to query the repositories system by means of software, for the purposes of verifying the authenticity of the unique identifiers and of decommissioning them in the repositories system, and also allow national competent authorities to access them, and although those interfaces are also mentioned in Article 35 of that delegated regulation, it does not impose any specific obligation on those authorities with regard to those interfaces, aside from the fact that they must allow actors in the medicinal products chain and the national authorities to access them.
It must be noted that the questions referred for a preliminary by the referring court concern only the introduction of a new interface, which means that the referring court has verified that the Nodo SNSFarma interface is merely a means of accessing the repositories without altering their operation or affecting the audit trail referred to in Article 35(1)(g) of Delegated Regulation 2016/161.

The first question
By its first question, the referring court asks, in essence, whether Delegated Regulation 2016/161, in particular Articles 25, 31, 32, 35, 36 and 44 thereof, must be interpreted as precluding national legislation providing for the creation of an interface, as a tool for accessing the national repository, that is owned and managed by the public authorities.
In the first place, as regards the question whether Delegated Regulation 2016/161 precludes the introduction of a new interface where one already exists, it should be noted that, as stated in paragraphs 29 and 30 above, although that delegated regulation imposes conditions relating to the establishment and use of a system of national repositories, it merely mentions interfaces as tools for accessing those repositories, without laying down specific obligations in that regard.
Consequently, national legislation such as that at issue in the main proceedings, which provides for the use of a specific interface for medicinal products reimbursed under the national health system, is not, in itself, contrary to Delegated Regulation 2016/161.
In the second place, as regards the question whether Article 35(1)(b) of Delegated Regulation 2016/161 precludes national legislation which provides, as in the case in the main proceedings, that the new interface is to be owned and operated by the public authorities, it is true that that provision enshrines a principle of self-administration of the repositories, since it states that each repository ‘shall be set up and managed by a non-profit legal entity established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features and, where they have chosen to participate, wholesalers and persons authorised or entitled to supply medicinal products to the public’.
However, that principle of self-administration is limited to repositories alone and cannot be extended to interfaces. Moreover, such an interpretation is supported by the second subparagraph of Article 54a(5) of Directive 2001/83, according to which a Member State may use the information contained in the repositories system for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology.
Consequently, the mere fact that an interface is owned and managed by the public authorities is not contrary to the obligations laid down in Delegated Regulation 2016/161.
In the light of the preceding considerations, the answer to the first question is that Delegated Regulation 2016/161, in particular Articles 25, 31, 32, 35, 36 and 44 thereof, must be interpreted as not precluding national legislation providing for the creation of an interface, as a tool for accessing the national repository, that is owned and managed by the public authorities.

The second and third questions
By its second and third questions, the referring court asks, in essence, whether Delegated Regulation 2016/161, in particular Articles 25, 31, 32, 35, 36 and 44 thereof, must be interpreted as precluding national legislation which (i) requires pharmacies to use an interface owned and managed by the public authorities when they supply medicinal products financed by the national health system and (ii) obliges the entity managing the national repository to integrate that interface into that repository.
First of all, it is apparent both from the provisions of Article 168(1) and (7) TFEU and from the settled case-law of the Court that the Member States retain the power to organise their own social security systems (judgment of 21 October 2021,
Zakład Ubezpieczeń Społecznych I Oddział w Warszawie
, C‑866/19, EU:C:2021:865, paragraph 25).
Next, Article 39 of Delegated Regulation 2016/161 provides that the legal entity which establishes and manages the national repository is obliged to grant access to that repository and to the information contained therein to the competent authorities for the purposes of, inter alia, reimbursement and pharmacovigilance.
Lastly, the first and second subparagraphs of Article 54a(5) of Directive 2001/83 allow Member States to extend the scope of the application of the unique identifier to any medicinal product subject to prescription or subject to reimbursement and, as is apparent from paragraph 35 above, to use information contained in the repository system for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology.
Consequently, the obligation to use a given interface for certain medicinal products, such as medicinal products supplied at the expense of the national health system, cannot be contrary to the provisions of Delegated Regulation 2016/161. Therefore, the mere possibility, as in the present case, that the establishment of an interface may be decided by regulation in the absence of an agreement between, on the one hand, the entity managing the national repository and, on the other, the public authorities cannot be contrary to EU law.
In the light of the foregoing considerations, the answer to the second and third questions referred for a preliminary ruling is that Delegated Regulation 2016/161, in particular Articles 25, 31, 32, 35, 36 and 44 thereof, must be interpreted as not precluding national legislation which (i) requires pharmacies to use an interface owned and managed by the public authorities when they supply medicinal products financed by the national health system and (ii) requires the entity managing the national repository to integrate that interface into the national repository.

Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.
On those grounds, the Court (Seventh Chamber) hereby rules:
1.
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, in particular Articles 25, 31, 32, 35, 36 and 44 thereof,
must be interpreted as not precluding national legislation providing for the creation of an interface, as a tool for accessing the national repository, that is owned and managed by the public authorities.
2.
Delegated Regulation 2016/161, in particular Articles 25, 31, 32, 35, 36 and 44 thereof,
must be interpreted as not precluding national legislation which (i) requires pharmacies to use an interface owned and managed by the public authorities when they supply medicinal products financed by the national health system and (ii) requires the entity managing the national repository to integrate that interface into the national repository.
[Signatures]
*
Language of the case: Spanish.