Pharma firm seeks judicial review against transparency
The battle for greater transparency in the pharma industry is to take another twist after a company lodged a legal challenge in an attempt to block a major part of the transparency agenda.
Richmond Pharmacology, a clinical research organisation that conducts Phase I clinical trials on behalf of pharma firms and had a £7.4 million turnover in 2013, has been given permission to bring a judicial review of plans brought in under the EU Clinical Trial Regulation to force companies to register details of studies that take place in the UK.
The review will challenge the Health Research Authority (HRA), the body which approves clinical trials in the UK and promotes access to and dissemination and publication of data from clinical trials.
The HRA promotes the transparency agenda and from April 2015 extended its requirements to include all trials in active recruitment in the UK. Pharma companies and clinical research organisations in the UK are expected to participate by registering all clinical trials before the first participant is recruited, declaring sponsors, and inform participants of the outcome of studies.
The legal proceedings are set to ignite the row over publishing clinical trial results once again and could be a major setback to the AllTrials campaign, which calls for full clinical trial transparency. One of the founders, Dr Ben Goldacre, called the judicial review ‘shameful’.
Síle Lane, from Sense About Science, one of the organisations behind AllTrials, says: “It is shocking that a company is using court action to try to stop transparency. Hidden and unregistered trials are compromising patient care, and, rightly, causing public outrage.
“The HRA has really led the way with its proposals to check that clinical trials aren’t kept hidden during the trial approval process. I find it deplorable that one company is trying to stop that.”
The HRA confirmed in a statement that the judicial review is to go ahead. “We confirm that the claimant has been granted permission to proceed in its application for judicial review, although not in respect of all its grounds of claim.
“We would point out that the merits of the claim are not considered at permission stage. The issue of merit will be considered at the substantive hearing. The HRA is due to file detailed grounds of defence shortly, and will continue to act in line with its statutory duties and responsibility to protect and promote the interests of patients and the public in health research.”
Richmond Pharmacology told Pharmafile: "Clinical research is conducted worldwide, therefore it's important to design a set of rules that are acceptable and enforceable across most areas where research is performed."
It says it strongly believes the HRA has acted unlawfully in respect of the implementation of their transparency policy, and that it has been forced to bring this Judicial Review because the HRA "persistently refused to consider its legal position making this stance clear in public meetings".
The firm concluded: "Richmond Pharmacology welcomes the Court’s recent decision to grant permission to bring this Judicial Review and looks forward to the Court’s decision in July."
Embracing full disclosure
Some companies are embracing the move towards full disclosure, which has been backed by the World Health Organization in a new position statement on the issue, and the US Institute of Medicine. This week the Japanese firm Eisai announced it is making clinical trial data for products submitted and approved after 1 January 2014 publically available on request via an external website.
“By making clinical trial related information and results more widely available, Eisai believes that this will lead to the advancement of science and medicine, and contribute to the improvement of public health,” the company says.
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