Roche Registration Ltd, R (On the Application Of) v Secretary of State for Health (Rev 2)

A national court may review the lawfulness of conduct by a domestic regulator exercising national powers, even where that conduct supports an EU infringement procedure. However, it may not declare an act of an EU institution invalid. A challenge that necessarily depends on invalidity falls within the Foto-Frost limitation.

Where EU proceedings concerning the same issues remain pending, the national court should avoid substantive rulings or references which may pre-empt the EU institution’s decision or produce inconsistent conclusions. Fairness is context-specific. A sophisticated marketing authorisation holder aware of the regulatory framework and told that inspection results might be used in infringement proceedings was not entitled to further disclosure of the regulator’s internal co-operation arrangements.

Roche, the marketing authorisation holder for centrally authorised medicinal products, sought judicial review of the MHRA’s pharmacovigilance re-inspection and its communications with the EMA. Roche challenged the legal basis for requests made under article 8(3) of the Penalties Regulation, alleged procedural unfairness because the re-inspection material might be used in quasi-criminal infringement proceedings, and alleged errors concerning the identity of the responsible marketing authorisation holder and the retrospective application of later regulatory standards.

The EMA’s infringement inquiry was ongoing. The central issues were whether the Administrative Court had jurisdiction, whether the MHRA had acted fairly, and whether the court should determine or refer the EU-law questions while the Commission’s proceedings remained pending.

1. Jurisdiction. The Court had jurisdiction to review acts and decisions of the MHRA, a domestic authority exercising powers under the Human Medicines Regulations 2012. The EU courts’ exclusive competence to declare EU institutional acts invalid did not deprive the national court of jurisdiction over domestic conduct.
2. That jurisdiction did not permit the Court to declare the MHRA’s responses to the EMA’s article 8(3) requests unlawful where the challenge necessarily depended on holding that the EMA lacked power to issue those requests. Under Foto-Frost v Hauptzollamt Lubeck-Ost Case 314/85 [1987] ECR 4199, the Court could not itself declare the EU measure invalid.
3. The article 8(3) issue was properly arguable, but no reference was warranted. The alleged defect was technical and immaterial. The information would have been obtained and supplied lawfully under the MHRA’s continuing duties of co-operation, including under article 111 of the 2001 Directive and article 3(1) of the Penalties Regulation.
4. Fairness. The common-law duty to act fairly applied. Its content depended on all the circumstances. Roche was a sophisticated and well-resourced organisation, knew that infringement proceedings were underway, knew or should have known of the MHRA’s duties to share inspection information, and was told at the outset that the inspection report would or might be used in those proceedings. The MHRA was not required to disclose the detail of its prior co-operation with the EMA or the Article 8(3) requests.
5. Ground 3. The arguments concerning responsibility for acts of service providers and the possible retrospective use of later standards were properly arguable. Nevertheless, applying Masterfoods Case C-344/98 [2000] ECR I-11369 and Conex Banninger Ltd v The European Commission [2010] EWHC 1978 (Ch), it would be wrong to pre-empt the Commission’s pending decision or risk inconsistent conclusions. Roche could advance its arguments in the infringement procedure and on any appeal.
6. Permission to apply for judicial review was granted, but the claim was dismissed on all three grounds. The parties were invited to agree the consequential order and costs.