The judgment in the judicial review launched by Richmond Pharmacology against the Health Research Authority (HRA) in response to HRA’s work on clinical trial transparency has been published.
Mr Justice Jay has said that the HRA has a clear legal right to monitor researchers’ compliance with ethical and legal requirements to register and publish clinical trials. He said that it is within the HRA’s remit to sanction researchers who breach these obligations. However, he said that much of the material the HRA has published setting out these obligations is too ambigious to lawfully allow the HRA to sanction researchers for breaching them.
Sense Ab0ut Science points out the judgment is not the end of the matter. Next, both sides will tell the judge the relief they are seeking and the Judge will issue an order, probably very soon.
The important points from the Judgment are set out below comments from the AllTrials campaign. Click here to read the full judgment
Síle Lane, Director of Campaigns at Sense About Science, part of the AllTrials campaign said: “The judge has clearly and comprehensively set out the legal and ethical requirements for clinical trial registration. The HRA has been given a clear mandate to continue its work raising awareness of researchers’ obligations to register trials and to check researchers’ compliance with those obligations. We hope the HRA will start clamping down on breaches of these requirements soon.”
“We’re in a time of legislative change, the new EU clinical trials law is going to be adopted into UK law over the next year, so we need to be alive to the discussions that will go on during that adoption. This case has uncovered the arguments people and organisations like Richmond will be making during those discussions. The Judge has told us today that the AllTrials campaign has a lot of useful expertise on these issues. We know we’ll need to be part of those discussions.”
Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign said: “The judge has stated clearly that people conducting trials have ethical obligations, as well as legal ones, and that research regulators are entitled to hold companies to those ethical standards. It is ridiculous that it has taken five months of intense legal argument and has cost probably hundreds of thousands of pounds to get this statement of the current situation.
“It is saddening that Richmond ever took this case. They claimed that high regulatory standards on trials are making the UK a less competitive place to do research. That is a misunderstanding. Medicine is a knowledge economy.
“There are growing concerns about unreliable data from clinical trials, especially when trials are run at low cost in countries with weaker standards. The UK will never be able to compete with emerging economies on low costs for trials. The UK will, mercifully, never win in a race to the bottom for research regulation. The one thing we can compete on is quality and integrity.
“The judge did a very good service to every UK company working on clinical trials. They should celebrate and capitalise on this success, by telling the world that trials run in this jurisdiction produce reliable evidence, to the highest standards.”
The Judgment:
It was accepted by all parties in the case that public registration of clinical trials is an ethical requirement. The Judge said:
“There are two competing interests in play: the private interests of the sponsors of clinical trials (and of those who carry them out) to preserve commercial confidentiality for as long as possible, and the wider public interest favouring greater openness and transparency. There is certainly a powerful school of thought which holds that it is decidedly in the interest of the public to enable its gaze to be opened onto all clinical trials, since that ensures that as much information as possible enters the public domain as early as possible, with consequent public health benefits.”
The judge said that the HRA is legally entitled to check researchers’ compliance with their ethical requirement to register clinical trials. 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. The judge said that the HRA has up until now been confusing in its published material in relation to whether or not trial registration is a legal or ethical duty or requirement or both. He said:
“An ethical obligation (in this context, being an obligation falling short of amounting to good clinical practice) flows from the application of standards which have national or international backing, including standards which are imposed by the regulator. Furthermore, the regulator would be entitled to set out the consequences of breach of an ethical obligation, although in the present context it has not done so. It is trite law that the entity being regulated is entitled to a clear statement of what those consequences may be.”
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. He said that:
“The Defendant views registration and publication as an ethical or good practice obligation, rather than one which sounds in the strict legal sanctions set out in the Clinical Trials Regulations.”
Mr Justice Jay declined to rule that there is an overarching legal duty to publicly register all trials but he did point out that this will change in 2016 when the new EU clinical trials law is enacted. He said that:
“At this stage, the position may be summarised in this fashion: there is no rule of EU or domestic law which requires phase 1 trials to be registered on a publicly accessible database, or for the results of these trials to be published. There is a European database of clinical trials (“EudraCT”) on which phase 1 trials need to be registered, but only in its “private” section. Since 2004, phase 2-4 clinical trials have to be registered in the public fields of EudraCT. Pursuant to Regulation (EU) No. 536/2014, the registration and transparency requirements in relation to phase 1 trials are likely to change in May 2016. On my understanding, these Regulations will not create an absolute duty to publicise phase 1 trials, but an obligation subject to stated exceptions including commercial confidence.”
The judge said a number of times that he was grateful to Sense About Science for setting out the requirements and obligations on clinical researchers in our “clear and impressive written submission.”
The case which started out with half a dozen broad arguments put forward by Richmond ended up being about the meaning of some wording on some pages of the HRA’s website that were not updated when the Sponsor’s declaration was, and whether those words were significant or not. The Judge said:
“The issue raised in these proceedings is narrow and turns on fine textual analysis. When these proceedings were launched, and permission was subsequently granted by HHJ Pelling QC, the issues were much broader, and arguably of greater public interest. Masses of paper have been spawned by the litigation, most of which is no longer relevant in the light of the issues which have fallen away.”
“A considerable body of evidence has been filed by the parties… Virtually all of this evidence is not strictly relevant to the narrow issues I have to decide, and some of it is somewhat partisan in tone.”
In summary, the judge said: “I am holding that the HRA’s public utterances fail the public law test of certainty and transparency …I would now expect the Defendant as a responsible public body to cast a self-critical eye over the whole of its website material in this domain.”