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Judgment
Mr Justice Jay:
Introduction
By this application for judicial review, Richmond Pharmacology Ltd (“the Claimant”) seeks to challenge certain public statements by the Health Research Authority (“the Defendant”) in relation to the latter’s characterisation of the duties of those sponsoring and carrying out clinical trials: specifically, the Claimant contends that the Defendant is wrongly asserting that those in its position are under legal duties to register their trials on publicly available websites and to publish data about the outcome of such trials.
The issue raised in these proceedings is narrow and turns on fine textual analysis. When these proceedings were launched, and permission was subsequently granted by HHJ Pelling QC, the issues were much broader, and arguably of greater public interest. Masses of paper have been spawned by the litigation, most of which is no longer relevant in the light of the issues which have fallen away. However, I was informed by Mr David Lock QC for the Claimant that this judicial review continues to attract keen interest and concern in the pharmacological research world.
The Parties
The Claimant is a leading clinical research company established in 2001. It carries out a wide range of early phase clinical trials of new medicines. The present case is concerned with “phase 1 trials”, namely those which aim to test the safety, as opposed to the efficacy, of medicinal products.
The Defendant was originally established in 2011 as a Special Health Authority. On 1 st January 2015 the Defendant was established as a statutory body corporate under the Care Act 2014 . Its main functions under that statute are adumbrated below, but at this juncture I should state that these include the regulation of the research ethics committees (“RECs”) under its aegis. Under the legislative regime, the HRA is empowered to require RECs to impose conditions on approvals for clinical trials (described as “favourable opinions” in the relevant secondary legislation).
Sense about Science is a UK charity founded in 2002 with the aim of equipping the public with the means of making sense of science and evidence. It runs the AllTrials campaign for clinical trial transparency. Holgate J permitted Sense about Science to intervene in these proceedings by filing written submissions, and I am grateful for Mr Jonathan Price’s detailed contribution. The line his clients were taking diverged from the position of the regulator. Given the potential