In March 2015 Richmond Pharmacology launched a judicial review against the Health Research Authority over its work to further clinical trial transparency.
28th July 2015
The Judgment in Richmond Pharmacology’s judicial review against the HRA 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.
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.”
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.
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 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. 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.
17th July 2015
The court hearing happened yesterday. Judgment is expected next week. Here’s a summary of what happened.
The judge grasped the importance of trial registration and when he took into account our and the HRA’s evidence on legal and ethical obligations to register trials he found that Richmond was left with an extraordinarily narrow argument. It seems the case will come down to some words in a Q&A on HRA’s website that wasn’t amended at the same time as the sponsors’ declaration was. And then whether the ambiguity was significant.
We are so pleased we decided to intervene in the case. The court could find for Richmond on this very narrow point but it ended up exactly where we thought it should be: a principled discussion in which the judge seemed to grasp the issues well, the removal of Richmond’s broad claims that no registration was legally required and that the HRA was acting unlawfully, and alighting on a narrow matter for decision that will not impact on how trials are run or on the EU rules coming into force next year. Of course we would have liked the case refused altogether instead of it wasting public funds, which will be a lot if HRA has to pay Richmond’s costs.
Based on what was said in court, we are hopeful too that the court will find that the HRA has been going about its proper business promoting clinical trial registration. We are pleased that the judge ignored Richmond’s attempts to discredit AllTrials, and in fact that these appeared to backfire.
We will share the transcript of the hearing as soon as we have it. I think you’ll enjoy reading it!
When the judge heard that the HRA does not impose any sanctions on trial sponsors who don’t register their trials properly he said, “well, they should.”
Our legal team was amazing – solicitor Robert Dougans and barrister Jonathan Price – before during and after. If any of you read L Phillips’ recent speech asking where are the lawyers who are motivated above all by the pursuit of justice, well we know them.
(Tracey Brown is especially grateful for their patience with her unceasing flow of notes and questions)
Also yesterday, the pharmaceutical industry body EMIG said that Richmond’s actions do not represent the views of the rest of industry. Mark Edwards, EMIG’s R&D Director, said that the case could have a disastrous effect on the industry. Read EMIGs letter here. It contradicts Richmond’s claim to the court that its concerns are representative. Some of you have told us that but EMIG said it publicly, which matters.
Thank you so much to those who came to court and sent messages of support. As well as the judgment, look out for some other big news stories from AllTrials this week: we can’t wait to tell you what your support has helped to achieve.
15th July 2015
Tomorrow is the court hearing in the judicial review between Richmond Pharmacology and the Health Research Authority, in Manchester at 10:30am. I know we’ll see some of you there tomorrow. We hope to be able to tweet in the breaks in proceedings so please follow #AllTrials and @senseaboutsci for updates. We’ll update you all with news from the day as soon as possible after the hearing is over. Here’s our statement ahead of the hearing:
Richmond contends that the ethical approval body for trials, the HRA, acted illegally in asking trial sponsors to declare that previous or ongoing trials in the UK had been registered; that by doing this HRA wrongly implied there was a legal requirement and so overstepped its duties as laid down in statute. HRA responds that it did not say that and did not intend that impression, and that its role in monitoring trial registration springs from its responsibility as the ethical approval body not from law. We intervened to set out the legal and moral case for trial registration and reporting. The judged permitted us to make written legal arguments. Richmond changed its case four times from narrow to broad to narrow etc. It contends that HRA accepted some of its earlier points. HRA argues that those points were mostly pointless.
We intervened because Richmond, whether intentionally or not, said it would be asking the court to decide a major point of principle about clinical trial registration. We, and our lawyers who alerted us immediately, saw a serious risk that the public’s expectations of transparency, the hard won progress of two decades and new advances in patient safety would be unwittingly sacrificed in a squabble between a company and the regulator. Our aim was to put to the court and to HRA the broader demand for transparency and monitoring of trials, and to challenge Richmond’s and HRA’s accounts of the basis for the registration and reporting. This is a matter that is far too significant to be negotiated as part of parties’ settlement of a court case. We sought to get the arguments between the parties to narrow, about their conduct to one another, and not to threaten trial registration or create loop holes through which more trials could flow, or the new European regulations be nullified.
On the eve of the case it looks to us hopeful that this may happen, but we have been surprised by argument switches all along and so we cannot make any assumptions.
7th July 2015
Yesterday we sent our submission to the court in the judicial review brought against the HRA by Richmond Pharmacology.
We have spent the last few weeks ploughing through the hundreds of pages of documents. Richmond is currently asking the judge to rule that there is no overriding legal requirement to publicly register any trial. That’s not correct. Since 2011 all trials except for adult phase 1 have been publicly registered through the EU Clinical Trials Register. And by next year this legal requirement will extend to all clinical trials unless exempted according to some very tight criteria. Richmond is effectively asking the judge to set the clock back 10 years and wipe out the careful progress that has been made in relation to trials registration at national and EU level. We have set out in detail the legal frameworks related to this, and put forward legal arguments as to why HRA has a duty to monitor compliance with both legal requirements and sound practice for running a trial. However, Richmond has changed its case three times and may yet change it again.
The hearing will be in open court in Manchester on Thursday 16th July. We will be there. It would be lovely to see any of you who’d like to come along too; we could do with some help capturing what is discussed in Court. We are unlikely to know the result on the 16th, we hope the Judge will make his decision by the end of July but it could be October.We and our barrister Jonathan Price and solicitor Robert Dougans knew that we faced a demanding timetable and it meant that two of us here at Sense About Science have been almost completely absorbed by reading and writing legal arguments (it’s why I don’t have a suntan, when most of London does!).
We have managed to keep the rest of the AllTrials campaign going only in the face of that because many of you have given us help and topped up our fundraising appeal. Thank you! In a couple of weeks I will be able to show you just how significant that is. We are about to break a story about a new group coming on board for all trials registered and all results reported, in a way that should change part of the international scene, for good. We are also reaching the critical mass to be able to launch a US campaign. I can see from the comments on the Just Giving site how determined you are that the challenge of the Richmond/HRA case is not going to stop this. And if you have been thinking about giving something, however small, could I urge you to do it now?
Let us know if you can join us in court on 16th.
Síle and James
We have just received the judge’s orders in respect of Richmond Pharmacology v HRA. As some of you know, Richmond Pharmacology wrote directly to the judge to try to stop us being heard. So we are very pleased to tell you that the judge has ruled that Sense About Science can intervene to represent AllTrials.
We are relieved too, because the Judge has also decided to allow Richmond to take forward a broad argument it introduced at the last minute, asking the Court to declare that no trial sponsor or person running a trial has any legal requirement to publicly register any clinical trial unless the sponsor has given a legally binding commitment to do so, or an ethics committee has asked them to do so for every trial. That makes the issues at trial potentially very serious indeed.
We now have to write a submission for the Court by 10 am on Monday 6th July. It’s not much time. We and our legal team of Robert Dougans and Jonathan Price are working flat out on it. James is coordinating volunteers and drafting in other staff help, assisted by your great offers and donations, to keep the rest of the AllTrials activity on track during this tricky time. You may have seen that while all this has been going on, the number of organizations committing to AllTrials across the USA is growing every day! And we have more announcements to come. Your marvellous support means a great deal.
The hearing in Manchester is not going to be on Monday, we hope to hear about a rescheduled date soon.
We hoped to tell you more about the case Richmond Pharmacology is bringing against the Health Research Authority (HRA). That’s not been straightforward. Richmond has now changed their argument three times and has altogether abandoned some arguments it relied upon earlier, so getting to grips with what is at stake has been difficult and time consuming for us and for our lawyers.
At the beginning of this week it looked as though Richmond had narrowed the case down to a technical argument about the wording of HRA’s guidelines which only applied for a period of 10 days earlier this year.
Just as the issues seemed to be narrowing, Richmond then asked the Court not to allow AllTrials to be heard. We had written to Richmond and the HRA outlining our planned argument to the court and inviting their response. HRA replied to us, Richmond did not. Instead they went straight to the Judge and asked him not to hear us.
And then yesterday we saw that Richmond has asked the Court at the very last minute to rule on something huge. They want the Court to declare that no trial sponsor or person running a trial has any legal requirement to publicly register any clinical trial unless the sponsor has given a legally binding commitment to do so, or an ethics committee has asked them to do so for every trial. So now the Court is being asked to rule not on the specifics of the case but on a much broader point.
Richmond has asked the Court for a hastily arranged hearing in Manchester on Monday where they will ask to seek that declaration as part of the case. This is after they have warned the court that AllTrials’ references to international rules and protocols are irrelevant and will only add to their costs!
We need to be there on Monday to make it clear to the Court that it is being asked to rule on something that has real ramifications beyond this case. If Richmond win, this would go in the face of international laws, regulations, professional standards and the ethical rules of research. If such a declaration was made it would shatter the progress towards transparency made by AllTrials and the progress made internationally before AllTrials even started.
Today we are writing our submission to the Court to be allowed to speak on Monday. We’ll tell you more as soon as we know it. We have only been able to do this because hundreds of you have sent support, encouragement and donations. Thank you.
This morning our director has instructed lawyers to apply to the Administrative Court to intervene in the judicial review brought by Richmond Pharmacology against the Health Research Authority in respect of clinical trial registration.
This has been a difficult decision for us. Sense About Science is a very small charity, and we intervene with a small but real risk of financial devastation. However, our Board of Trustees and the AllTrials steering group agree that this is our duty. Your letters of support, offers of help and kind donations have played a significant role in our decision to take on this struggle for clinical trials transparency.
The next step is to write to both the HRA and Richmond Pharmacology, and detail our planned intervention to the court. Síle Lane and Ben Goldacre are working hard to produce a summary of the issues, which we look forward to sharing with you as soon as possible next week.
What happens then remains to be seen, but we will keep you updated every step of the way. Thank you for your support.
This is a quick note to let you know that we have obtained the court papers (hundreds of them!), we are looking urgently with lawyers at what can be done and we will be in touch next week to tell you. In the meantime, if you have been meaning to help with our campaign fund, now would be a great time…
We’ve just learned that progress on clinical trial transparency could be at risk. A company which conducts clinical trials on behalf of industry, Richmond Pharmacology Ltd, is launching a judicial review against the UK’s Health Research Authority (HRA), challenging the HRA’s world leading efforts to reform trial registration.
The HRA is the body set up to protect and promote the interests of patients and the public in health research in the UK. It has been working hard to make clinical trials more transparent, supported by thousands of patients, doctors, pharmacists, researchers and the public. It has made trial registration a condition of running a trial in the UK and has asked researchers who want to run trials to ensure that all trials they’ve run in the past have been registered. If the decision in the judicial review goes against the HRA, this fantastic work and all our efforts to break through the era of secrecy on clinical trials could come to an abrupt stop.
Síle Lane, Director of Campaigns, Sense About Science, co-founding organisation of the AllTrials campaign said: “It is shocking that a company is using court action to try to stop transparency. We want the HRA to help right the injustice done to the thousands of patients who have taken part in clinical trials that have been kept hidden. I find it deplorable that one company is trying to stop that.”