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

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

MHRA acted lawfully in providing information to EMA under its general cooperation obligations; Roche was on notice of potential use of inspection information in infringement proceedings; no breach of duty of fairness occurred; errors of law alleged in inspection report do not warrant declaratory relief as they are immaterial and advisory; no reference to CJEU required.

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 From High Court Judgment
Outcome
Appeal dismissed; claim dismissed; no reference to CJEU.
Legal Topics
Pharmacovigilance, Procedural Fairness, Declaratory Relief, Jurisdiction, Penalties Regulation, Cooperation Obligations
Administrative Law EU Law Pharmaceutical Regulation Pharmacovigilance Procedural Fairness Declaratory Relief Jurisdiction Penalties Regulation +1 more

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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 From High Court Judgment

Legal Issues

  1. 1 Whether MHRA acted unlawfully in providing information to EMA under Article 8(3) Penalties Regulation
  2. 2 Whether MHRA breached duty of fairness to Roche during re-inspection
  3. 3 Whether errors of law in MHRA's Re-Inspection Report warrant declaratory relief

Ratio Decidendi

MHRA acted lawfully in providing information to EMA under its general cooperation obligations; Roche was on notice of potential use of inspection information in infringement proceedings; no breach of duty of fairness occurred; errors of law alleged in inspection report do not warrant declaratory relief as they are immaterial and advisory; no reference to CJEU required.

Court Disposition

Appeal dismissed; claim dismissed; no reference to CJEU.

Orders

  • No declaratory relief granted.
  • No reference to CJEU.