Roche Registration Ltd, R (on the application of) v The Secretary of State for Health [2015] EWCA Civ 1311 (21 December 2015)

Roche Registration Ltd, R (on the application of) v The Secretary of State for Health [2015] EWCA Civ 1311 (21 December 2015)

The Court held that MHRA acted within its statutory and regulatory powers in cooperating with EMA requests and conducting the re-inspection. Roche's procedural rights were not breached, as full protection is afforded during the EU infringement procedure. The MHRA's conduct was not ultra vires, and no unlawful deprivation of rights occurred. Declaratory relief was refused as no illegality was established.

Citation
[2015] EWCA Civ 1311
Parties
Claimant/appellant: Roche Registration Limited; Defendant/respondent: Secretary of State for Health (acting through the Medicines and Healthcare Products Regulatory Agency)
Jurisdiction
England and Wales
Judgment Date
21 December 2015
Procedural Posture
Judicial Review Appeal / Court of Appeal Judgment
Outcome
Appeal dismissed
Legal Topics
Pharmacovigilance, Procedural Fairness, Ultra Vires, Declaratory Relief, Penalties Regulation
Administrative Law EU Law Pharmaceutical Regulation Pharmacovigilance Procedural Fairness Ultra Vires Declaratory Relief Penalties Regulation

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Parties

Roche Registration Limited

Claimant/appellant

Secretary of State for Health (acting through the Medicines and Healthcare Products Regulatory Agency)

Defendant/respondent

Procedural Posture

Judicial Review Appeal / Court of Appeal Judgment

Legal Issues

  1. 1 Whether MHRA's compliance with EMA Article 8(3) requests was ultra vires
  2. 2 Whether MHRA failed to provide procedural protections to Roche during re-inspection
  3. 3 Whether MHRA's reports to EMA contained fundamental errors of law

Ratio Decidendi

The Court held that MHRA acted within its statutory and regulatory powers in cooperating with EMA requests and conducting the re-inspection. Roche's procedural rights were not breached, as full protection is afforded during the EU infringement procedure. The MHRA's conduct was not ultra vires, and no unlawful deprivation of rights occurred. Declaratory relief was refused as no illegality was established.

Court Disposition

Appeal dismissed

Orders

  • No declaration granted
  • Confidentiality order maintained for certain documents