Richmond Pharmacology Ltd, R (On the Application Of) v The Health Research Authority [2015] EWHC 2238 (Admin) (28 July 2015)

Richmond Pharmacology Ltd, R (On the Application Of) v The Health Research Authority [2015] EWHC 2238 (Admin) (28 July 2015)

There is no legal requirement under current UK or EU law for sponsors to register or publish phase 1 clinical trials approved before 30 September 2013 unless expressly promised or made a condition of REC approval. The HRA's amended sponsor's declaration introduced in April 2015 unlawfully created a de facto...

Source-derived case information.

Citation
[2015] EWHC 2238 (Admin)
Parties
Claimant: Richmond Pharmacology Ltd; Defendant: Health Research Authority; Interested Party: Sense about Science
Jurisdiction
England and Wales
Judgment Date
28 July 2015
Procedural Posture
Judicial Review / Substantive Hearing and Judgment on Amended Ground
Outcome
Permission granted on amended ground; claim succeeds in part; declaratory relief granted.
Legal Topics
Clinical Trials Regulation, Transparency in Research, Judicial Review, Statutory Interpretation, Ethical Vs Legal Obligations
Administrative Law Health Law Regulatory Law Clinical Trials Regulation Transparency in Research Judicial Review Statutory Interpretation Ethical Vs Legal Obligations

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Parties

Richmond Pharmacology Ltd

Claimant

Health Research Authority

Defendant

Sense about Science

Interested Party

Procedural Posture

Judicial Review / Substantive Hearing and Judgment on Amended Ground

Legal Issues

  1. 1 Whether the Health Research Authority (HRA) unlawfully asserted a legal duty to register and publish phase 1 clinical trials where no such legal duty exists under current law.
  2. 2 Whether HRA's public statements and website materials unlawfully conflated legal requirements with ethical or best practice obligations.

Ratio Decidendi

There is no legal requirement under current UK or EU law for sponsors to register or publish phase 1 clinical trials approved before 30 September 2013 unless expressly promised or made a condition of REC approval. The HRA's amended sponsor's declaration introduced in April 2015 unlawfully created a de facto retroactive legal condition by requiring sponsors to warrant registration of pre-September 2013 trials. The subsequent May 2015 revision cured this defect. However, the HRA failed to provide clear, unambiguous public guidance distinguishing legal from ethical obligations, perpetuating regulatory uncertainty. The HRA must ensure its public statements and guidance accurately reflect the...

Court Disposition

Permission granted on amended ground; claim succeeds in part; declaratory relief granted.

Orders

  • Declaration that there is no legal requirement to register or publish phase 1 clinical trials approved before 30 September 2013 unless expressly promised or made a condition of REC approval.
  • HRA to review and clarify its public guidance and website materials to accurately distinguish between legal requirements and ethical/best practice obligations.