British contract research organisation (CRO) Richmond Pharmacology brought a judicial review against the country’s Health Research Authority (HRA), claiming the institution cannot require researchers to register clinical trials begun before September 2013.
Since 2013, drug companies have had to register UK clinical studies as a condition of HRA approval to run them. More recently, HRA has also asked sponsors to confirm they have registered all UK trials in active recruitment – including those which began before September 2013.
Richmond Pharmacology claimed HRA was illegally imposing a retrospective legal obligation on researchers for trials preceding the 2013 cut-off.
Legal vs ethical duties
The HRA conceded it lacks the authority to enforce registration before this date, and Mr Justice Jay confirmed in his judgment "registration and publication is not a legal requirement in relation to pre-September 2013 approvals, because [...] such were not promised or made a condition of such approvals, and there is no power under the Clinical Trials Regulations to amend conditions or impose them retroactively."
The judge also ruled a “Question and Answer” section of the HRA website was unclear about whether researchers’ obligations to register were a legal duty or only an ethical one and part of scientific best practice. The wording was therefore “unlawful” and unenforceable, he found.
The judgement means sponsors cannot be required to publicly register UK Phase I adult trials from before September 2013. Both parties are now waiting for the judge’s order for what will happen in future and payment of costs.
But campaign group AllTrials, which gave evidence in the judicial review, insisted researchers have always had a legal obligation to register trials in Europe.
“HRA is not applying new rules out of nowhere. These trials should have been registered all along if the researchers were running them according to European law and best ethical practice and HRA is completely within its remit to check those things,” AllTrials director Síle Lane told Outsourcing-Pharma.com.
Lawyers for Richmond Pharmacology said the judicial review had made the law clearer for pharmaceutical companies. While industry insiders have speculated on why the case was brought by a CRO when trial sponsors are responsible for registration, Richmond's legal team told us over-regulation in the UK could create an uneven playing field which will send trials abroad to foreign competitors. It declined to name pharma companies which had expressed these worries.