Case T‑611/18
Pharmaceutical Works Polpharma S.A.
v
European Medicines Agency
Judgment of the General Court (Seventh Chamber, Extended Composition), 5 May 2021
(Medicinal products for human use – Application for marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the EMA not to validate the application for marketing authorisation – Previous decision of the Commission taking the view that Tecfidera – Dimethyl fumarate was not covered by the same global marketing authorisation as Fumaderm – Plea of illegality – Admissibility – Previously authorised combination medicinal product – Subsequent marketing authorisation for a component of the combination medicinal product – Assessment of the existence of two different global marketing authorisations – Manifest error of assessment)
1. Plea of illegality – Scope – Measures the illegality of which may be pleaded – Measure of a general nature – Concept – Commission decision granting marketing authorisation for a component of a previously authorised combination medicinal product – Finding that there are two different global marketing authorisations – Applicability of a period of data protection to the component of the combination medicinal product – Included
(Art. 277 TFEU; European Parliament and Council Regulation No 726/2004, Art. 14(11); European Parliament and Council Directive 2001/83, Arts 6(1) and 8(3))
(see paragraphs 90-96)
2. Plea of illegality – Scope – Measures the illegality of which may be pleaded – General measure providing the basis of the contested decision – Need for a legal connection between the contested measure and the contested general measure – Plea of illegality raised in respect of a Commission decision based on the opinions of a scientific authority – Opinion forming an integral part of the decision – Admissibility
(Art. 277 TFEU)
(see paragraphs 98, 99, 101-105)
3. Plea of illegality – Measures the illegality of which may be pleaded – General measure providing the basis of the contested decision – Admissibility of an action for annulment brought against the general measure – Not time-barred
(Arts 263 and 277 TFEU)
(see paragraphs 107-109)
4. Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – Commission decision granting marketing authorisation for a component of a previously authorised combination medicinal product – Finding that there are two different global marketing authorisations – Action brought by the manufacturer of a generic medicinal product – Not individually concerned – Inadmissibility
(Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 726/2004; European Parliament and Council Directive 2001/83)
(see paragraphs 110-115, 117-121)
5. Action for annulment – Natural or legal persons – Concept of a regulatory act – Any measure of general application other than legislative acts – Commission decision granting marketing authorisation for a component of a previously authorised combination medicinal product – Finding that there are two different global marketing authorisations – Included
(Art. 263, fourth para., TFEU; European Parliament and Council Directive 2001/83, Art. 6(1))
(see paragraphs 122-124)
6. Action for annulment – Natural or legal persons – Regulatory acts entailing implementing measures – Concept – Commission decision granting marketing authorisation for a component of a previously authorised combination medicinal product – Finding that there are two different global marketing authorisations – Included – Concept of an implementing measure – Decision of the European Medicines Agency not to validate the application for marketing authorisation for a generic version of that component – Included
(Art. 263, fourth para., TFEU; European Parliament and Council Directive 2001/83)
(see paragraphs 125-131, 134, 136, 137)
7. Action for annulment – Natural or legal persons – Interest in bringing proceedings – Need for a vested and present interest – Assessment at the time when the action was brought – Action capable of securing a benefit for the applicant – Interest relating to future and uncertain situations – Inadmissibility
(Art. 263, fourth para., TFEU)
(see paragraphs 138-142, 145-148)
8. Approximation of laws – Medicinal products for human use – Marketing authorisation – National authorisation for a combination medicinal product and subsequent authorisation at EU level for a component of that combination – Assessment of the existence of two different global marketing authorisations – Criteria for assessment – Taking into account the law and scientific knowledge on the date the marketing authorisation was granted
(European Parliament and Council Directive 2001/83, Arts 6(1) and 8(3))
(see paragraphs 187, 204, 208, 214, 215, 217)
9. Approximation of laws – Medicinal products for human use – Marketing authorisation – National authorisation for a combination medicinal product and subsequent authorisation at EU level for a component of that combination – Power of the European authorities – Power of the Commission to request a scientific authority to carry out a new scientific assessment of a combination medicinal product previously authorised by a national authority – Infringement of the principle of mutual recognition – None
(European Parliament and Council Regulation No 726/2004; European Parliament and Council Directive 2001/83)
(see paragraphs 227-236)
10. Approximation of laws – Medicinal products for human use – Marketing authorisation – National authorisation for a combination medicinal product and subsequent authorisation at EU level for a component of that combination – Commission decision finding that there were two different global marketing authorisations – Failure to analyse all of the data relevant to the taking of that decision – Manifest error of assessment
(European Parliament and Council Regulation No 726/2004, Art. 14(11); European Parliament and Council Directive 2001/83, Arts 6(1) and 8(3))
(see paragraphs 273-275, 282, 289, 293)
Résumé
The applicant, Pharmaceutical Works Polpharma S.A., is a pharmaceutical company that develops and markets various medicinal products, including generic medicinal products. In June 2018, the applicant submitted to the European Medicines Agency (EMA) an application for marketing authorisation for a generic version of the medicinal product Tecfidera, composed of a single active substance. (1)
By its decision of 30 July 2018 (‘the contested decision’), the EMA refused that application on the basis of the assessments that appeared in the Commission’s implementing decision of 2014 (‘the implementing decision’), by which the Commission had granted the company Biogen Idec marketing authorisation for the medicinal product Tecfidera. (2) The EMA stated, inter alia, that, given that that reference medicinal product benefited from an eight-year period of data protection as from the date on which that authorisation was granted, (3) the applicant’s application for authorisation would be accepted only when that period expired. In addition, the EMA noted that, in the implementing decision, the Commission had taken the view that Tecfidera was not covered by the same global marketing authorisation (4) as another medicinal product, Fumaderm, which had been authorised and placed on the market in Germany and which was composed of, inter alia, the same active substance as Tecfidera. The authorisation for Fumaderm was granted in 1994 and transferred to the same company Biogen Idec.
By its action brought before the General Court, the applicant raised a plea of illegality in respect of the implementing decision in so far as, in that decision, the Commission had taken the view that Tecfidera was not covered by the same global marketing authorisation as Fumaderm. In addition, the applicant sought annulment of the contested decision.
The General Court annuls the contested decision, while ruling, first, on the admissibility of the plea of illegality and, second, on the conditions under which the Commission may consider that a marketing authorisation for a medicinal product composed of a single active substance which forms part of the composition of a previously authorised combination medicinal product is not covered by the same global marketing authorisation as that combination.
Findings of the Court
In the first place, the Court finds that the plea of illegality raised by the applicant in respect of the implementing decision is admissible.
First of all, the Court classifies the implementing decision as an ‘act of general application’, (5) inasmuch as the implementing decision finds that Tecfidera does not belong to the same global marketing authorisation as Fumaderm, which had previously been authorised. That decision applies to objectively determined situations on account of the finding as to the characteristics of those two medicinal products. Moreover, that decision, in so far as it implies that a period of regulatory protection of the data relating to Tecfidera is applicable, is capable of producing legal effects with respect to any operator whose activities are linked to Tecfidera and, in particular, any operator that is capable of manufacturing a generic medicinal product derived from Tecfidera.
Next, the Court notes that, in order to demonstrate the unlawfulness of the implementing decision, the applicant is entitled to challenge the assessments that appear in the documents of the Committee for Medicinal Products for Human Use (‘the CHMP’) (6) relating to Tecfidera, which form the basis of, and are an integral part of the statement of reasons for, that decision. The Commission expressly relied on the CHMP’s assessments in order to infer that Tecfidera and Fumaderm did not belong to the same global marketing authorisation.
Lastly, after carrying out a detailed analysis of the information in the file, the Court concludes that the applicant would not have been entitled to bring a direct action for annulment of the implementing decision because it did not satisfy the relevant criteria. In that regard, first, the Court states that that decision was not of individual concern to the applicant in so far as it concerned the applicant solely by reason of its objective capacity as a manufacturer of generic medicinal products, in the same way as any other economic operator in an identical situation. Second, the Court considers that the implementing decision entails implementing measures, in so far as that decision finds that Tecfidera does not belong to the same global marketing authorisation as Fumaderm, and that the contested decision, addressed to the applicant, constitutes one of those measures. In any event, the Court notes that the applicant’s interest in seeking annulment of the implementing decision was not vested and current, but future and uncertain on the date on which it would have been entitled to bring an action for annulment of that implementing decision, in so far as it was not conceivable that it would submit an application for marketing authorisation for a generic medicinal product derived from Tecfidera on that date.
In the second place, the Court upholds the plea of illegality and finds that the contested decision, which is based on the implementing decision, is unfounded and must be annulled.
First of all, the Court observes that, in adopting the implementing decision, the Commission was faced, for the first time at EU level, with the question of whether or not an authorised combination medicinal product, on the one hand, and a component of that combination, on the other, belonged to the same global marketing authorisation. Furthermore, in answering the question of whether or not the marketing authorisation for Tecfidera, the only active substance of which was a component of Fumaderm, belonged to the same global marketing authorisation, the Commission had to take account of the fact that the EU law relating to combination medicinal products and the scientific knowledge available were significantly different from those applicable in 1994 when the national authority had granted authorisation for Fumaderm. The Commission was therefore fully entitled to request the CHMP to assess whether the only active substance in Tecfidera differed from Fumaderm, which contained, inter alia, that substance.
Next, the Court notes that, in particular cases of interest to the European Union, the Member States, the Commission, the applicant or the marketing authorisation holder may refer the matter to the CHMP, which is responsible for carrying out, at EU level, its own assessment of the medicinal product concerned, independent of that carried out by the national authorities. Thus, in the context of marketing-authorisation procedures for medicinal products, in particular at EU level, the EMA and the Commission have a particular function that differs from that of the national authorities. In that sense, the principle of mutual recognition does not preclude the CHMP from examining the assessments previously carried out by a national authority or from carrying out an independent assessment. That is the case where an application for marketing authorisation is submitted at EU level for a substance that forms part of the composition of a combination medicinal product authorised 15 years previously at national level. That is all the more true since the question of whether Tecfidera was covered by the same global marketing authorisation as Fumaderm, on which the EMA, through the CHMP, and then the Commission, took a decision, constituted a particular case of interest to the European Union in the light of the objectives pursued by Directive 2001/83, in general, and by the concept of global marketing authorisation, in particular.
Lastly, the Court notes that, when the implementing decision was adopted, the EMA and the Commission had, or could have had, data capable of rendering implausible the theory that the other active substance forming part of Fumaderm, but not of Tecfidera, played a role within Fumaderm. Thus, the Commission was not entitled to conclude that Tecfidera was covered by a different global marketing authorisation than Fumaderm, which had previously been authorised, without verifying or requesting the CHMP to verify the role played by that other active substance. Therefore, in the absence of such verification and in view of the fact that the Commission did not analyse all the relevant data which had to be taken into consideration in order to conclude that Tecfidera and Fumaderm were covered by separate global marketing authorisations, the implementing decision is vitiated by a manifest error of assessment.