Industry awaits outcome of transparency legal challenge
A judge will today hear arguments from the Health Research Authority and campaigners who are contesting a judicial review of plans for industry transparency.
Richmond Pharmacology, an early-stage clinical research company, will argue at the administrative court in Manchester that the plans by the Health Research Authority (HRA), the ethical approval body for trials, to require the pharma industry to register all clinical trials are unlawful.
The company lodged the legal bid in May, in what campaigners and industry bosses have described as a clear attempt to block the industry’s moves towards greater transparency and full disclosure about clinical trials and pharma-sponsored research.
Mr Justice Jay will hear arguments from barristers representing Richmond Pharmacology, who argue that the HRA “acted unlawfully in respect of the implementation of their transparency policy”.
The requirements state that, as of April 2015, all trials in active recruitment in the UK should be registered before the first participant is recruited, that sponsors should be declared, and that participants have a right to be informed of the outcome of studies.
Richmond Pharmacology contends that by asking trial sponsors to declare that previous or ongoing trials in the UK are registered, the HRA wrongly implied there was a legal requirement and so overstepped its duties as laid down in statute.
The HRA argues that its role in monitoring trial registration comes from its responsibility as the ethical approval body, not from law, and that it never gave any impression of a legal requirement on the part of pharma companies.
The basis of the judicial review has been slammed by an industry body. In a letter published exclusively by Pharmafile, the Ethical Medicines Industry Group (EMIG), a UK research-based trade association that represents the interests of over 200 pharmaceutical, biotech and medtech companies, attacks the ‘erroneous’ judicial review – and calls on others within the industry to speak out against a ‘hugely damaging’ legal challenge.
Dr Mark Edwards, R&D director for EMIG, says it is a ‘puzzle’ why Richmond Pharmacology has chosen to challenge the HRA in the courts, and that a single company cannot act as the industry’s representative voice.
Dr Edwards writes: “Richmond Pharmacology’s action cannot in any way be taken to reflect the views of the research-based biopharmaceutical industry as a whole. Indeed, if left unchallenged, it could be extremely damaging to it. The vast majority of scientists in industry support a balanced and well managed approach to transparency, as it will be of benefit to all stakeholders in health research.
“What makes this action by Richmond Pharmacology even worse is that it is detracting precious resource from the HRA that would otherwise be focussed on the prosecution of its critical work to establish a process for a single ethics and NHS R&D approval for clinical research in England.
“Therefore, I hope that other colleagues in industry will join me in supporting the HRA’s pivotal work, all well-designed transparency initiatives and challenge the basis of this judicial review.”
Sense About Science has submitted evidence and statements to the judge on behalf of fellow member of the ALLTrials campaign and will be present in court today.
Tracey Brown, director at Science About Science, says: “We intervened because Richmond Pharmacology, 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 is 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 about their conduct, and not to threaten trial registration or create loop holes through which more trials could flow, or the new European regulations be nullified.”
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