Generics (UK) Ltd (t/a Mylan), R (On the Application Of) v Secretary Of State For Health (acting as The Licensing Authority)

Permission to bring judicial review may be refused where the claimant had, or still has, an effective alternative remedy, including a direct challenge to the relevant European Union act. Delay is a separate ground for refusal where an earlier decision was not challenged promptly and later evidence could have been obtained earlier.

A national licensing authority operating within a harmonised regulatory regime must follow a binding Commission decision unless it is set aside. It cannot reopen or independently reassess the scientific conclusions of the competent European authorities. Alleged disagreement between experts does not, without more, establish an arguable error of law or justify a preliminary reference.

The claimant sought permission to challenge the MHRA’s refusal to validate or revisit its application for a generic marketing authorisation referring to Tecfidera as the reference medicinal product. The Commission had decided that Tecfidera and Fumaderm did not fall within the same global marketing authorisation because dimethyl fumarate and the fumarate salts were different active substances.

The claimant relied on later expert evidence and argued that the Commission decision was legally and scientifically flawed. The central issues were whether the claimant had an effective alternative remedy, whether the claim was delayed, whether the MHRA had applied the correct test and whether it was required to consider the new evidence or seek a preliminary ruling.

1. Permission refused. The claim was refused on the grounds of alternative remedies, delay and failure to disclose an arguable ground of challenge.
2. Under Article 263(4) TFEU, the Commission decision was a regulatory act of general application and was of direct concern to the claimant. The claimant could have challenged it directly within the prescribed period. It could also have challenged the EMA’s refusal to review the CHMP opinion, sought a centralised authorisation and challenged any resulting refusal, or invoked the procedure under Article 31 of Directive 2001/83. Those were effective avenues for challenging the data-exclusivity consequences of the Commission decision.
3. The claim was also delayed. The claimant had withdrawn its earlier application instead of promptly challenging the MHRA’s January 2017 decision. The expert evidence obtained later could have been commissioned and obtained earlier.
4. The MHRA was bound by the Commission decision and could not question the scientific evaluation of the CHMP, the Standing Committee or the Commission. The centralised procedure depended on a harmonised and uniform outcome. The allegedly new expert evidence therefore could not establish a legal failure to take relevant considerations into account.
5. The applicable legal question was whether the active substances were the same or different for the purposes of the global marketing authorisation. Substances were different where they had different therapeutic moieties. The conclusion that dimethyl fumarate and the fumarate salts were independently pharmacologically active and had different therapeutic moieties was not shown to involve an error of law. Scientific disagreement did not make the issue justiciable in judicial review.
6. Neither ground was arguably well founded within the meaning of Case C-344/04. There was consequently no basis for a preliminary reference. The permission application was refused.