After the legal case – where next for pharma industry transparency?

pharmafile | August 26, 2015 | Feature | Research and Development clinical trial transparency, clinical trials, health research authority, transparency 

Even in an industry as litigious as pharma can sometimes be, the recent legal drama that has played out in the High Court has been unprecedented.

And in an industry used to changes in guidelines and demands from watchdogs, it’s unusual for a company to take a regulator to court, and publically accuse it of acting unlawfully in introducing new obligations for firms in the industry to adhere to.

When this did happen, as was the case in The Queen (on the application of Richmond Pharmacology Ltd) and the Health Research Authority, it sent shockwaves throughout the industry and beyond. It has been painted as a classic, ‘David and Goliath’ battle, although as the fall-out from the case settles it’s far from clear who will be the winner in the long run.

The clinical research organisation, Richmond Pharmacology, based in Croydon and St George’s University in London, sought and gained permission for a judicial review of the Health Research Authority’s (HRA) demands for clinical trials to be registered in a publicly accessible database.

For some, the transparency requirement seems straightforward and innocuous enough. The HRA, as the UK’s ethics approval body which grants – or denies – ethical approval for all clinical trials conducted in the UK, says it is an organisation that is “committed to improving the transparency of health research in the UK.” And as part of this it published plans and implemented specific requirements as a condition of a company gaining permission from its Research Ethics Committee (REC).

No trial can begin without ethical approval, so registration is effectively required for permission to conduct a clinical trial. No favourable HRA opinion, no trial – and millions of pounds in R&D costs are lost.

Transparency in the industry

People within the industry will recognise this requirement as being in line with a general shift towards greater transparency and openness about pharma-sponsored clinical trials.

The ALLTrials campaign, a coalition of charities, doctors and latterly the investors behind $3.5 trillion-worth of pension funds and assets, began the movement in 2013. Their campaign calls on pharma companies to set out plans to ensure that all of their clinical trials – past, present and future – are registered, and all available results are reported in full and in a timely manner.

However, so far only one big pharma company – notably the UK firm GSK – has publicly backed and signed up to the campaign, as well as the World Health Organisation and the Institute of Medicine in the US. The UK is no different, and indeed has been held up as a model early adopter of the requirements, which are also inscribed in the EU Clinical Trial Regulation, which comes into force in April 2017.

It seemed as though the requirement was an uncontentious one – until news broke of a looming legal challenge, brought by Richmond Pharmacology.

To bring in the requirements in April 2015 the HRA needed to change their trial sponsor’s declaration, to stipulate that all trials, including the Phase I human trials Richmond conducts, that commenced before September 2013, had to be registered and published on the HRA’s database. However Richmond and its lawyers argued that this was a ‘retrospective rule’, and therefore, constituted unlawful practice on the HRA’s part. This disagreement spiralled into a lengthy and controversial judicial review, with the two sides becoming increasingly combative and others within and without the industry being drawn into the legal war of attrition.

Dr Bina Rawal, former director of research, medical and innovation at the ABPI, told Pharmafocus: “Given that the HRA does consider requests for registration deferral for a Phase I healthy volunteer trial when justified, it is disappointing that it has found itself the subject of a judicial review.”

Could a legal case have been avoided?

Many observers wondered how a judicial review came about. Why, they asked, couldn’t the dispute have been resolved by discussion, or through consultation – particularly as the HRA had held several events where the proposals were put to the industry? However these were held between CROs and the HRA – so the wider pharma industry may not have been aware they took place, and of course the general public would not be cognisant of them.

Yet Dr Mark Edwards, R&D director at the Ethical Medicines Industry Group, comments: “It’s still a great shame that it came to this, rather than something that Richmond Pharmacology could have sorted out with the HRA behind closed doors.” While ALLTrials campaign founder Dr Ben Goldacre says: “It is saddening that Richmond ever took this case”.

In their defence – both figuratively and literally – is Oliver Wright, a solicitor at law firm Lewis Hymanson Small, who represented Richmond Pharmacology in the case. He told Pharmafocus that Richmond had tried on several occasions to ‘engage’ with the HRA and had been ‘loath’ to go to the courts. He commends Richmond Pharmacology for bringing the issue to the wider industry’s attention and provoking public debate – for better or for worse.

“It’s not possible that someone can land in court out of the blue; from a legal standpoint there needs to be evidence of engagement,” Wright says. The meetings Richmond attended, where they raised their concerns, are a matter of public record. Richmond did challenge the HRA at a number of meetings and in letters between the two of them in February and in March. The HRA refused to change their rule and refused to take legal advice.”

Wright says Richmond followed a ‘pre-action protocol process’ by issuing a letter warning the HRA of the consequences in March and April, before moving to formally begin the judicial review process in May. But “the HRA resisted all the way and only started to give in when they had to,” he says.

Janet Wisely, who is chief executive of HRA, says: “It is a matter of great regret that there has been a public challenge to research transparency in the UK. We are extremely disappointed that in bringing this case there has been broader criticism of the regulatory environment for Phase I research in the UK. The HRA works tirelessly to provide a responsive and efficient service, as is evidenced by the competitive timelines for Phase I research in the UK.”

The CRO also objected to way a Q&A document on the HRA website that explained trial sponsors obligations was worded to imply a legal obligation, that it claimed would put off foreign companies looking to conduct clinical trials in the UK.

There’s little evidence that foreign companies were dissuaded from locating trials in the UK – this would be difficult to prove as one can’t measure trials that were never registered to begin with. But the judge did instruct the HRA to carefully review the materials on its website, and the HRA admits it was “found wanting on a point of ambiguity regarding the source of duties to register”.

Oliver Wright says: “Richmond Pharmacology were concerned that if I’m sitting in the US deciding where to spend my money and am looking at regulatory websites, if it appears that I have to do very onerous things in one jurisdiction, I’m not going to do my Phase I trial in that country. Now – as a direct result of the judicial review and the judge’s ruling – I can see exactly what the requirements are.”

Negative public perceptions

Richmond would argue they have done the industry a favour by making sure international colleagues can stay in the UK and don’t switch their trials to another European Country. But there is still the perception that it is trying to – at least to the man on the street – find a loophole to avoid having to register the Phase I trials it conducts. Or that by splitting hairs on the wording of the requirements they were seeking to exempt themselves from the need to register their trials, and sidestep a key transparency commitment. It’s an accusation that the CRO has yet to be able to shake.

Wright insists: “There are good reasons why companies don’t want to publish this trial data, because it’s so early. People think of clinical trials and think of drugs, but these are very early studies into chemicals, active ingredients – the possible component parts of potential new drugs.”

This is yet to convince others in the industry, however. Sense About Science, another member of the ALLTrials campaign group, says the judicial review risked “putting clinical trial transparency in peril.” While Mark Edwards says: “Thank goodness it is not similarly possible to move the goalposts of a clinical trial itself with such apparent ease and alacrity to achieve a desired outcome.”

Another question that arose repeatedly during the court case is how widely Richmond’s views are shared across the pharma industry, and how many people in the industry it may have been representing while contesting the legal challenge.

EMIG’s Mark Edwards says the vast majority of the industry stands behind the HRA. “The HRA can rest assured that it has support in the biopharmaceutical industry for a positive and well-managed transparency policy. As a small organisation with limited resource, it will, no doubt, have been distracted by this court case. But I hope under no circumstances does it let these events derail the organisation from achieving all of its key objectives.”

However Wright is adamant that Richmond Pharmacology did not bring the legal action on behalf of a silent actor, and was not a front for a larger company, as has been speculated by industry insiders. 

“If my clients have had discussions with others in the industry then these would be privileged and I would not tell you about them – if they happened at all”, Wright says. “It’s not a nice thing to have to do – to stick your head above the parapet. Only one person stood up and had the courage to do it and say something is unlawful – I don’t understand why people are making that a criticism. The regulator must regulate in a lawful way. Transparency may be very laudable, but it has to stand for something.”

What needs to happens now?

What transparency stands for now is down to the industry to prove. The ABPI – which avoided commenting on the case until its conclusion – is now attempting to be more proactive in pushing the transparency agenda. 

It may well have its own battles to fight with regards to industry transparency – on payments to doctors. This is a result of the fallout from damaging allegations in the national press about cash and other inducements paid by pharma to influence healthcare professionals’ prescribing decisions.

The trade body is planning a publically accessible and searchable database for pharma companies to register every payment made to named, individual healthcare professionals, in another, similar industry transparency initiative. It has sought legal advice about how to implement its plans from the Information Commission, to avoid legal challenges brought under the Data Protection Act.

So the ABPI has been forced to adapt to the push for more transparency, and it’s likely the HRA will have to, as well. Dr Rawal says that though the changes may not be ‘comfortable’, they will improve the industry for the better.

“It may seem that many, if not all of the recent strong statements on clinical trial transparency from several quarters, including the pharmaceutical industry, have been precipitated by the conscience-pricking effect of public campaigns. In raising awareness of the importance of clinical trial transparency, campaign groups have undoubtedly galvanised disparate organisations to act decisively.

“The campaigners have asked the difficult questions and confronted those who had the power to have changed things for the better before now. Although it was not comfortable, I was happy to be challenged and in turn challenged the member companies of the ABPI.

“In bringing together the campaigners and the research community, attempts were made to address thorny issues such as how best to achieve disclosure of the vast number of historic trials on older products. To their credit, the medical, statistical and compliance functions in the companies responded positively and gave their full assistance.”

In the HRA case, the judge ordered the HRA to pay both its own and Richmond’s costs. This is expected to be in the tens of thousands, and is likely to be negotiated between the two parties – or decided by a judge if they can’t agree. The financial costs of the judicial review are yet to be settled, and the cost of the case to the industry is yet to be seen.

Observers hope the steps already taken in the industry towards becoming more open and transparent about clinical trials will not be affected, and that the ultimate outcome of the review is to promote greater debate and dialogue about the vast scale of clinical research the industry takes part in. This will, ultimately, change the industry for the better.

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