Update: 30th July 2015

The Judge published his order today. He has made a declaration that the HRA has acted unlawfully because material on its website is “ambiguous and potentially misleading … in the specific respects and to the extent set out in the judgment.”

The Judge slammed Richmond for not being clear about what they were arguing for until its very final submission to Court and for introducing new arguments at a very late stage.

Síle Lane, Director of Campaigns at Sense About Science said: “After starting out making broad points that were dismissed, through 5 months of intense legal argument, in a process that cost hundreds of thousands of pounds, and after putting clinical trial transparency in peril, Richmond has ended up with an order which says that the HRA’s website is unclear.”

29th July 2015

The Judgment in Richmond Pharmacology’s judicial review against the Health Research Authority has been published. The Judge Mr Justice Jay has said that the HRA has a clear legal right to check researchers’ compliance with ethical and legal requirements to register and publish clinical trials. However, he said that much of the material the HRA has published on these requirements is too confusing to allow them to do that now.

Today’s judgment is not the end of the matter. Next, both sides will tell the Judge what relief they are seeking (ie what they want him to declare or to rule), the Judge will review those arguments and will issue an order, probably very soon.

On the publication of the Judgment, Sile Lane 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 researcher’s requirements to register trials and to check researchers’ compliance with those requirements. 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 AllTrials:

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 5 months of intense legal argument and cost probably hundreds of thousands of pounds to get this statement of the status quo.

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. Today 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.

We’ve set out some of the important points from the Judgment below and you can read the entire Judgment here: http://www.bailii.org/ew/cases/EWHC/Admin/2015/2238.html

It was accepted by all parties in the case that public registration of clinical trials is an ethical requirement. The Judge said about the case:

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.

The Judge 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.

This is just as we set out in our submission to the Court. The Judge said a number of times that he was grateful to us for setting out the requirements and obligations on clinical researchers now in our “clear and impressive written submission.”

We know that we helped to narrow things down for the Court. 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 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.

We are glad that we intervened in the case. Síle Lane, Director of Campaigns at Sense About Science 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 researcher’s requirements to register trials and to check researchers’ compliance with those requirements. 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 AllTrials:

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 5 months of intense legal argument and cost probably hundreds of thousands of pounds to get this statement of the status quo.

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. Today 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.

Janet Wisely, Chief Executive of HRA, said:

It is a matter of great regret that there has been a public challenge to research transparency in the UK. We are mindful that the vast majority of our colleagues working within commercial clinical research share our ambitions and commitment to greater research transparency. We are grateful that Sense About Science participated in the claim. We are also grateful that the Ethical Medicines Industry Group supported the HRA in the case and made clear that the claimant was not representative of the wider clinical research community.

We note the judgment of the Court and are disappointed that on a very narrow issue introduced late in the day, we have been found wanting on a point of ambiguity regarding the source of duties to register. However, the Court has recognised that it is appropriate for the HRA to take account of both legal and ethical obligations in its work. We will review the material identified by the judge to ensure that it is lawful.

Read the HRA’s full statement here.