Opinion of Advocate General Medina delivered on 6 October 2022.
Jurisdiction | European Union |
Celex Number | 62021CC0438 |
ECLI | ECLI:EU:C:2022:758 |
Date | 06 October 2022 |
Court | Court of Justice (European Union) |
OPINION OF ADVOCATE GENERAL
MEDINA
delivered on 6 October 2022(1)
Joined Cases C‑438/21 P to C‑440/21 P
European Commission (C‑438/21 P),
Biogen Netherlands BV (C‑439/21 P),
European Medicines Agency (C‑440/21 P)
v
Pharmaceutical Works Polpharma S.A.
(Appeal – Medicinal products for human use – Application seeking to obtain a marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the EMA not to validate the application – Previous decision of the European Commission taking the view that Tecfidera was not covered by the same global marketing authorisation as Fumaderm – Plea of illegality – Directive 2001/83 – Second subparagraph of Article 6(1) – Concept of ‘global marketing authorisation’ and its objectives – Article 10(1) – Regulatory data protection period – Regulation (EC) No 726/2004 – Decentralised application of EU pharmaceutical legislation – Principle of mutual recognition)
I. Introduction
1. This Opinion concerns three appeals brought by the European Commission, Biogen Netherlands BV (‘Biogen’) and the European Medicines Agency (EMA) seeking to have the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241) (‘the judgment under appeal’) set aside. By that judgment, the General Court annulled the decision of the EMA of 30 July 2018 (‘the contested decision’), which refused to validate the application submitted by Pharmaceutical Works Polpharma S.A. (‘Polpharma’) seeking to obtain a marketing authorisation for a generic version of the medicinal product Tecfidera – Dimethyl fumarate (‘Tecfidera’).
2. The Court of Justice has requested that two legal issues be examined, which are, to a large extent, common to the three cases. This Opinion will accordingly focus on the grounds of appeal relating to the concept of ‘global marketing authorisation’ within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83, (2) and to the test set out by the General Court for assessing whether the two medicinal products at issue in the present case belong to the same global marketing authorisation. In essence, that test would have required the Commission, on the basis of the scientific assessment conducted by the EMA, to verify the therapeutic contribution of the components of a medicinal product previously authorised by a national competent authority for the purposes of determining whether a newly developed product fell under that same global marketing authorisation.
3. The appeal in question provides the opportunity for the Court to clarify the requirements that apply, respectively, to the approval of the marketing of a medicinal product in the European Union and to the assessment of whether two medicinal products belong to the same global marketing authorisation. The case also allows the Court to define, within the context of that assessment, the relationship between the competences of the Commission, the EMA and the authorities of the Member State and the degree of (de)centralisation that stems from Directive 2001/83 and Regulation No 726/2004 (3) upon the application of EU pharmaceutical legislation.
II. Legal context
4. Recitals 9 and 12 of Directive 2001/83 state:
‘(9) Experience has shown that it is advisable to stipulate more precisely the cases in which the results of toxicological and pharmacological tests or clinical trials do not have to be provided with a view to obtaining authorisation for a medicinal product which is essentially similar to an authorised product, while ensuring that innovative firms are not placed at a disadvantage.
…
(12) With the exception of those medicinal products which are subject to the centralised Community authorisation procedure established by [Regulation No 2309/93 (4)] a marketing authorisation for a medicinal product granted by a competent authority in one Member State ought to be recognised by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorisation of the medicinal product concerned may present a risk to public health. In the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken according to a Community standard, leading to a single decision on the area of disagreement binding on the Member States concerned. Whereas this decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States.’
5. Article 1 of Directive 2001/83 provides the following definitions of the terms ‘medicinal product’ and ‘active substance’:
‘…
2. Medicinal product:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
…
3a. Active substance:
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;
…’
6. Article 6 of Directive 2001/83 states:
‘1. No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with [Regulation No 726/2004] …
When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1).
…’
7. Article 8 of Directive 2001/83 provides:
‘…
3. The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I:
…
(c) Qualitative and quantitative particulars of all the constituents of the medicinal product, including the reference to its international non-proprietary name (INN) recommended by the [World Health Organisation (WHO)], where an INN for the medicinal product exists, or a reference to the relevant chemical name.
…’
8. Article 10 of Directive 2001/83 states:
‘1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the [European Union].
A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product.
…
The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.
2. For the purposes of this Article:
(a) “reference medicinal product” shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8;
(b) “generic medicinal product” shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.’
9. Article 11 of Directive 2001/83 provides:
‘The summary of the product characteristics shall contain, in the order indicated below, the following information:
…
2. qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used.
…’
10. Article 30 of Directive 2001/83 states:
‘1. If two or more applications submitted in accordance with Articles 8, 10, 10a, 10b, 10c and 11 have been made for marketing authorisation for a particular medicinal product, and if Member States...
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