Judge backs HRA in transparency legal case

pharmafile | July 28, 2015 | News story | Research and Development EU Clinical Trial Regulation, Richmond Pharmacology, alltrials, clinical trial regulation, clinical trials, health research authority, sense about science, transparency 

A judge has ruled that there are likely to be no legal grounds to block the Health Research Authority’s plans for companies to register clinical trials, after the move was challenged in the courts.

The ruling means that the Health Research Authority (HRA) can push on with its requirements for all sponsors of clinical trials in active recruitment in the UK in order to gain ethical approval – a central plank of the industry’s transparency agenda.

The judge ruled the HRA had not acted unlawfully in bringing in the requirements – although he did suggest the body reviews its information materials to make it clear to companies exactly what is required.

At a High Court hearing earlier in July Richmond Pharmacology, which carries out early-phase clinical trials of new medicines, requested a judicial review of the plans. It argued that the HRA had overstepped its boundaries by implying that registering clinical trials is a legal, and not just an ethical requirement.

Mr Justice Jay found that Richmond’s grounds for seeking a review – which contends that “the HRA acted unlawfully by asserting that sponsors and those conducting clinical trials are under a legal duty to register their trials… and by regulating or seeking to regulate sponsors and those conducting clinical trials against this supposed legal duty” – were worth being heard.

The full ruling sets out the case between Richmond Pharmacology and the HRA, as well as Sense About Science – part of the ALLTrials campaign for industry transparency – whose lawyers were permitted to attend and argue in court as an ‘interested party’. The judge also heard witness statements from the Ethical Medicines Industry Group (EMIG), whose open letter backing the HRA and the transparency agenda was seen in court.

The court papers, seen by Pharmafile, show much of the argument centres on the precise wording of a Q&A document on registering trials on the HRA website. The judge considered whether the document is worded in a way that implies companies have a legal obligation – and if it applies between September 2013 and April 2015.

He continues: “My starting-point is that the [HRA’s] readership is knowledgeable and sophisticated, and may reasonably be expected to have recourse to legal advice.

“Furthermore, the Defendant’s internet materials need to be read in context and of a piece. It is not right to cherry-pick a narrow pathway through these documents and to seek to construe them as if they were statutes. On the other hand, the informed reader is entitled to a reasonably clear set of explanations which are free from internal contradiction and ambiguity.”

The judge agreed with the HRA’s lawyer “that nowhere has the [HRA] stated in unequivocal terms that sponsors are under legal duties to register and publish phase 1 trials”. But he still found that the Q&A document contains “defective, confusing wording which falls well short of the certainty and transparency obligations which are incidental to the rule of law.”

Overall he ruled any misleading statements are not so unclear or serious as to warrant judicial action, intervention or review. In summary, Mr Justice Jay ruled: “I am not holding that the HRA has expressly stated that there is a legal obligation in relation to the pre-September 2013 approvals, or that this is clearly to be inferred from what the HRA has said. I am holding that the HRA’s public utterances fail the public law test of certainty and transparency.”

As a result, he recommended that the HRA should “cast a self-critical eye over the whole of its website material in this domain” –  and may have to pay legal costs arising from the judicial review.

Lilian Anekwe

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