Something quite extraordinary has happened in the last couple of weeks which has barely attracted any attention in the media.
I am sure that many of you, like me, were very confused by the High Court action taken by Richmond Pharmacology Ltd against the Health Research Authority (HRA).
It seemed to go on for months (it did), the issues in contention were not clear (they kept changing), and the outcome appeared to be that Richmond won, although the Judge has yet to decide on what actions to recommend.
What was at stake was the transparency of clinical trials. The openness of everything from registration to results. Richmond appeared to have set itself up as a voice for the pharmaceutical industry. However the industry effectively disowned it and made it quite clear that Richmond was on its own.
The Judge made a declaration that the HRA has acted unlawfully because material on its website is “ambiguous and potentially misleading.”
The Judge was heavily critical of Richmond Pharmacology for not being clear about what they were arguing for until their very final submission to Court. He criticized them for introducing new arguments at a very late stage. There were many broad points that were dismissed in 5 months of intense legal argument, in a process that cost hundreds of thousands of pounds. There were continual challenges to the standards which have been developed to create clinical trial transparency.
The main argument Richmond (at the last minute) had asked the Court to rule on was that the HRA is acting unlawfully by asserting that there is an overarching legal requirement for everyone running every clinical trial to register it. The Judge is clear that the HRA never claimed there was such an overarching legal requirement. Phase 1 trials, which is the area where Richmond Pharmacology works, are exempted at present, although EU law may change.
Richmond has ended up with an order which says that the HRA’s website had some ambiguous wording.
Richmond had claimed during the five months of argument that high regulatory standards on trials are making the UK a less competitive place to do research. There are growing concerns about unreliable data from clinical trials, especially when trials are run at low cost in countries with weaker standards. The one thing the UK can compete on is quality and integrity. The Judge’s decision supports that position. We are not in a race to see how far we can compromise standards.
The HRA’s position has been made stronger by the judgement. The Judge says it has a clear legal right to check researchers’ compliance with ethical and legal requirements to register and publish clinical trials. It has a mandate to continue its work raising awareness of researcher’s requirements to register trials and to check researchers’ compliance with those requirements.
Similarly the judge made it clear that people conducting trials have ethical obligations, as well as legal ones. He said the HRA is entitled to apply sanctions where ethical requirements have been breached, as long as it is clear about what those requirements are and what the sanction would be.
Richmond Pharmacology has said little about this case themselves, although their lawyers have inevitably crowed over winning the case on their website. So where were they coming from ? Who are they ?
Richmond Pharmacology Ltd is one of the largest clinical research organizations (CRO) in the UK. They are a commercial provider of the facilities and expertise for Phase 1 clinical trials. They have no investigator led research, their clients are largely pharmaceutical companies. Their facilities are in south London at St George’s University Hospital (Tooting) and Croydon University Hospital. They are therefore a tenant of the NHS and pay substantial fees for the facilities they use.
The Directors of the company own the company and are the doctors who lead the clinical teams, so it is a hands on operation. They turnover about £10m a year and like any small privately owned company have been through ups and downs and have learned how to survive. So what brought about this extraordinary legal case ?
I have never before seen a small company set itself up as the champion for a multi-billion dollar industry, only to find itself dis-owned by that industry. Richmond Pharmacology had nothing to gain from winning any part of the case at all. Misguided altruism? Surely not. What they have won is so easily sorted that it could be called trivial.
Until they actually say something it will remain a mystery. No openness at all, perhaps that’s no surprise. What is no mystery though is that the HRA has massively drawn on public funds to defend itself. An explanation for why that was necessary is the least the public deserves.
Can we, the public, exert any pressure to ensure that happens? Perhaps we should discourage people thinking of joining a Richmond clinical trial.