Richmond Pharmacology Ltd, R (On the Application Of) v The Health Research Authority

Public bodies must distinguish clearly between legal requirements and ethical or good-practice obligations. Where breach of a requirement carries criminal or other legal consequences, the governing framework must provide clarity and precision. A regulator’s public guidance must be sufficiently clear, consistent and transparent for an informed reader to understand the nature of the obligation and its consequences.

Although no legal duty required registration or publication of phase 1 clinical trials approved before 30 September 2013 where registration had not been promised or imposed as a condition, the regulator’s published materials were unlawful to the extent that they blurred that distinction and were so ambiguous as to mislead.

Richmond Pharmacology Ltd sought judicial review of statements and online guidance published by the Health Research Authority concerning the registration and publication of clinical trials. The dispute ultimately concerned phase 1 trials approved before 30 September 2013, for which registration had not been promised in the application or imposed as a condition of the favourable Research Ethics Committee opinion.

The April 2015 sponsor declaration appeared to make current applications contingent on the registration of earlier trials. It was withdrawn and revised on 22 May 2015. The central issues were whether registration and publication were legal requirements, and whether the HRA’s remaining public materials communicated the distinction between legal and ethical obligations with the certainty and transparency required by public law.

1. Permission and substantive issue. Permission was granted on the amended ground. The court held that registration and publication were not legal requirements for pre-September 2013 approvals where they had neither been promised nor made a condition of REC approval. Regulation 15(3A) of the Medicines for Human Use (Clinical Trials) Regulations 2004 did not permit conditions to be imposed retrospectively.
2. The reference in the Regulations to the Declaration of Helsinki meant the 1996 version identified in Schedule 1. Later versions could not be introduced by interpretation. The general reference to ethical principles in Schedule 1 did not create a specific legal duty to register and publish phase 1 trials. Nor could an alleged incorrect transposition of EU directives convert an obligation into good clinical practice under domestic law.
3. The court distinguished a legal obligation, arising from a specific requirement of the Regulations and carrying consequences including notification duties and criminal sanctions, from an ethical obligation based on nationally or internationally supported standards or regulatory requirements. A regulated person was entitled to know clearly what consequences followed from breach.
4. The April 2015 sponsor declaration was unlawful in effect. Although it did not expressly state that a legal duty existed, a sponsor could not properly sign it unless earlier trials had been registered or otherwise dealt with. The current application was therefore made contingent on past registration. The May revisions removed that de facto condition.
5. Nevertheless, the HRA’s webpages and key messages continued to use language which blurred legal requirements and ethical responsibilities, including by referring to an existing responsibility, compliance requirements and deferrals without adequate differentiation. Applying the public-law principles of certainty and transparency, the materials were so ambiguous as to mislead an informed reader. The HRA was invited to make submissions on the appropriate relief.