Roche Registration Ltd, R (on the application of) v The Secretary of State for Health

Declaratory relief is granted to determine rights and obligations where a proper practical purpose exists. Domestic courts do not give advisory opinions on abstract or hypothetical questions, particularly where an adequate remedy lies before the EU courts.

National pharmacovigilance authorities remain obliged to co-operate with the European Medicines Agency under Directive 2001/83/EC. That obligation is not displaced by the information-gathering powers in the Penalties Regulation. Article 8(3) also permits requests to national competent authorities.

Fairness is contextual. In a highly regulated scheme, no further warning was required where the company knew, or should reasonably have known, that inspection information would be shared and might be used in infringement proceedings, and where extensive procedural safeguards remained available.

Roche challenged the lawfulness of the Medicines and Healthcare Products Regulatory Agency’s re-inspection of its pharmacovigilance systems and the supply of resulting information to the European Medicines Agency.

It sought declarations on three grounds: that the EMA’s requests under Article 8(3) of the Penalties Regulation lacked a lawful basis; that the MHRA had acted unfairly by not explaining the extent and purpose of its co-operation with the EMA; and that the inspection report contained errors concerning Roche’s responsibility for Genentech’s conduct and retrospectivity.

Carr J dismissed the claim and declined references to the CJEU. The central issues on appeal were whether declaratory relief or a reference was appropriate, whether Article 8(3) authorised the requests, and whether the MHRA had breached its duty of fairness.

1. Outcome. The appeal was dismissed on all three grounds. The entirety of Roche’s claim against the MHRA was dismissed and no reference was made to the CJEU.
2. Article 8(3) and declaratory relief. The MHRA was entitled, and in relevant respects obliged, to provide information to the EMA under Article 111 of Directive 2001/83/EC. Article 8 of the Penalties Regulation did not displace that continuing obligation. The MHRA could not impose conditions binding the EMA or the Commission as to the use of information supplied. The claim therefore sought an advisory answer to a hypothetical question about what would have happened if Article 111 had not applied. English courts do not grant such relief. The issue of the EMA’s own lawfulness was also for the EU courts under the Foto-Frost principle, and adequate alternative remedies existed.
3. Article 8(3) was, in any event, clear to the acte clair standard. Article 8(2) concerned requests requiring the exercise of powers specifically vested in national competent authorities. Article 8(3), read with Article 14(2), was apt to include such authorities within the natural or legal persons from whom information could be requested. That interpretation furthered the public-health purpose of the Penalties Regulation and was consistent with its procedural safeguards.
4. Fairness. The duty of fairness was governed by the contextual approach in Doody. The MHRA did not need to disclose the Article 8(3) requests or the full extent of its engagement with the EMA. Roche was a sophisticated and experienced participant in the regime. It knew, or could reasonably be expected to know, that inspection information would be shared with the EMA and could be used in the existing infringement procedure. The opening meetings also expressly referred to that possibility. Roche retained rights to make written and oral representations, obtain access to the file and receive legal representation.
5. Errors of law. The report did not constitute a binding public determination by the MHRA on Roche’s responsibility for Genentech or on retrospectivity. Any implied views would not bind the EMA or Commission and had no independent causative effect. Declarations on those points would therefore also be advisory and premature.
6. Arden LJ agreed with the result and reasoning, save that she did not address paragraph 63. She additionally stressed the importance of procedural guarantees where penalties may be imposed, while recognising that the Penalties Regulation supplied substantial safeguards.

1. Court of Appeal (Civil Division) dismissed Roche’s appeal on Grounds 1 to 3 and refused references to the CJEU.
2. High Court of Justice, Queen’s Bench Division, Administrative Court (Carr J) dismissed the judicial review claim and declined the requested references.