A judicial review brought by Richmond Pharmacology against the Health Research Authority (HRA), has been upheld by a High Court Judge. The company argued that the HRA had overstepped the law by requiring researchers applying to run clinical trials to declare that all past trials had been registered, including those approved before September 2013.
Lawyers representing the pharmaceutical company, Richmond Pharmacology, argued that the retrospective change was unlawful. The company believes that the ruling means that companies sponsoring phase I clinical trials in the UK will retain control over whether and when they make public the registration of previously conducted trials.
In upholding the judicial review, Mr Justice Jay said that the HRA must be clear about what constitutes guidance and what constitutes legal obligations. “A legal obligation flows from the imposition of a specific requirement of the clinical trials regulations,” he explained.
The HRA was understandably disappointed, saying that the ruling is in effect a challenge to research transparency in the UK.
However, not everything went Richmond’s way. The Judge, was critical of the company’s approach, saying that it had only made clear what it was arguing in its very final submission to Court and that it introduced new arguments at a very late stage.
This judgment is not the end of the story. Both sides will tell the Judge what they want him to declare or to rule. The Judge will then review the arguments and will issue an order, probably very soon…
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