Oliver Wright, solicitor at law firm LHS, says a new high court ruling means improved transparency and a clearer framework for companies operating under regulation by the Health Research Authority
The clinical trials industry needs a strong regulator. The public demands it and the organisations operating under its remit expect it. Being clear and transparent with its subjects is of fundamental importance for all regulators in the health and pharmaceutical sectors.
That’s why the recent judgement by Mr Justice Jay, following a judicial review brought by Richmond Pharmacology Limited, a UK-based clinical research organisation, is so important for European pharmaceutical manufacturers.
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 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 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.
Challenging a regulator always needs to be carefully considered and respectfully undertaken and it’s not a step taken lightly by any organisation but in this case the decision was vindicated.
In the case the judge ruled that the HRA acted unlawfully in giving ‘misleading’ and ‘confusing’ messages to companies carrying out early stage clinical trials about new rules on publicly registering trials.
Stinging criticism from Mr Justice Jay asserted that the authority’s public utterances fail the public law test of certainty and transparency which ensures that those who are required to comply with the rules can be sure of exactly what requirements they must meet.
The judge was particularly critical of the HRA’s website which he deemed to be using ‘defective, confusing wording’ which fell well short of the certainty and transparency obligations which are incidental to the rule of law and would mislead readers.
Ultimately, 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.
As a result of the judicial review brought by Richmond Pharmacology, 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 competitor which is vitally important not only for the UK but the entire European industry.
We live in interesting times as the new EU clinical trials law will be assimilated into UK law over the next year. It will be worth keeping a close eye on developments to see how the law unfolds during this time.
Oliver Wright is a solicitor at law firm
LHS which acted for Richmond Pharmacology in the case.