Solicitors acting for Richmond Pharmacology Limited have succeeded in a landmark judicial review which gives the global pharmaceutical industry certainty and confidence in the UK regulatory process.

In upholding the judicial review brought by Richmond Pharmacology, the court has found that the UK clinical trials regulator, the Health Research Authority (HRA), must be clear about what constitutes ‘guidance’ and what constitutes legal obligations.

The ruling means that companies sponsoring phase one adult clinical trials in the UK retain control over whether and when they wish to make public the registration of previously conducted trials.

Oliver Wright, solicitor at law firm LHS, which acted for Richmond Pharmacology in the case, said:

“Patients and the general public can now continue to have confidence in the way the sector is regulated. The law is now clear and there can be no confusion for the pharmaceutical sector about what constitutes guidance from the regulator and what constitutes legal obligations”. 

“The ruling helps ensure companies can continue to operate in the UK with confidence and on a more level playing field with its international competitors”.

Graham Small, Senior Partner of LHS, added: 

“Challenging a regulator always needs to be carefully considered and respectfully undertaken and it’s not a step taken lightly by any organisation. It’s now up to the Court to determine what is most practical to implement the guidance and recommendations handed down by Mr Justice Jay in this important case. We are pleased that our clients have been vindicated in their pursuit of justice.”

Richmond Pharmacology began Judicial Review proceedings against the Health Research Authority (HRA) following an amendment in April 2015 to the sponsors’ declaration, which companies have to sign before obtaining regulatory approval to begin phase one adult clinical trials in the UK. 

The judge took the view, having heard all the evidence and legal argument, that the HRA has “pursued a strategy which concedes as little as possible in the judicial review, with the aim, no doubt of enhancing its position on costs and, (possibly), avoiding potential embarrassment.”

“While the matter has been lengthy for our clients and HRA anticipate the important matters raised in the judgement can be swiftly addressed and the UK can remain a global leader in clinical trials.”

The effect of the amended sponsors’ declaration was to force sponsors to retrospectively register on a publicly accessible website clinical trials conducted in the UK for which, at the time those clinical trials gained regulatory approval, no such disclosure requirements applied.

Richmond Pharmacology Limited considered this to be unlawful.  When challenged, the HRA refused to seek Counsels' advice and suggested that they would not, unless the matter was taken to Court.  Thereby they forced the issuing of Judicial Review proceedings.

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