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

Published on 26/08/15 at 04:13pm
crossroads
Credit: alphaspirit - Fotolia.com

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.

Clinical Trial Transparency – A Personal View

Published on 24/08/15 at 12:27pm
Clinical research is a collaborative process, says Dr Bina Rawal
Clinical trial research

During the time I worked as research, medical and innovation director at the ABPI, between October 2012 and January 2015, there were dramatic changes in the way in which clinical trial transparency was being discussed throughout the R&D ecosystem, resulting in long-awaited improvements.

Thankfully, this time, there will be no turning back.

Confronting the 'danger' of blocking progress on clinical trial transparency

Published on 19/08/15 at 09:58am
Stem cell research
Trade bodies and transparency campaigners say work on transparency must not be reversed

The Ethical Medicines Industry Group and Sense About Science - a co-founder of the ALLTrials campaign - have written a joint letter, in support of the Health Research Authority's work to bring about greater transparency in clinical trials to the industry. 

In a statement, the two bodies say the recent Court has shown "that there are people who want to reverse its recent attempts to do so."

There is a danger that politicians and others will see this backward-looking view as significant and representative of industry. It isn’t. 

HRA must continue ‘progress towards clinical trial transparency’

Stem cell research
The registration of Phase I trials was under scrutiny during a recent judicial review

Campaigners and industry leaders have urged the Health Research Authority to ensure that its work to bring about full transparency in pharma-sponsored clinical trials is not derailed by its recent legal case.

The groups also urged the Health Research Authority (HRA) to not “let the distraction of the judicial review derail you from achieving key objectives”, and to ‘quickly clarify the wording’ of the contentious Q&A document on its website that was the subject of a High Court challenge wrangle.

Judge rules pharma has ‘ethical' transparency obligation – reaction

Scales of justice
Flickr/Mike Cogh

Both sides of a bitterly contested legal battle over a major part of the industry's transparency drive have reacted to the judge's verdict.

A judge ruled that the Health Research Authority is acting within the law in pushing through plans for companies to register clinical trials in active recruitment in the UK.

Judge backs HRA in transparency legal case

Gavel
The HRA's plans for greater pharma transparency are being challenged in the courts

A judge has ruled that there are likely to be no legal grounds to block the Health Research Authority’s plans for companies to register clinical trials, after the move was challenged in the courts.

The ruling means that the Health Research Authority (HRA) can push on with its requirements for all sponsors of clinical trials in active recruitment in the UK in order to gain ethical approval – a central plank of the industry’s transparency agenda.

Ruling in transparency case ‘due within days’

Sense About Science
Sense About Science outside court in Manchester for the judicial review (Twitter/Bede Constantinides)

A judge is set to rule on a controversial legal challenge to the requirement for the pharma industry to register clinical trials in active recruitment in the UK.

Clinical trials firm Richmond Pharmacology was granted permission to seek the judicial review in May.

It's time the industry spoke out about legal challenge to clinical trial transparency

Published on 16/07/15 at 12:06pm
R&D
Credit: Bristol-Myers Squibb

The judicial review brought by Richmond Pharmacology against the Health Research Authority – erroneous, a waste of public money and if left unchallenged by the biopharmaceutical industry, hugely damaging to it.

Dear Editor,

Industry awaits outcome of transparency legal challenge

R&D
Credit: Bristol-Myers Squibb

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.

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