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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.

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.

NICE rejects ‘benefit’ test

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NICE has refused to include a ‘wider societal benefit’ test into its deliberations about which drugs should be available on the NHS, saying that it would have a disproportionate impact on elderly patients.

Notes from a NICE board meeting published by The Guardian, say: “However broadly the concept is drawn, our age has an impact on what we are able to contribute and what we take from society.”

PPRS deal ‘dreadful’, says EMIG

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The Ethical Medicines Industry Group (EMIG) has slammed the new PPRS plan, calling it a ‘dreadful deal’ for its members.

The UK research-based trade association represents small and medium-sized (SME) pharma and biotech firms, and it says the new PPRS is in danger of driving away investment from the UK.

EMIG chairman Leslie Galloway told Pharmafile: “The more you get into the detail, the more concerned I am about this dreadful deal.”

NICE to assess drug value

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NICE will be responsible for assessing the full value of medicines - taking into account their benefit to patients and to society as a whole - when Value-Based Pricing (VBP) comes into force next year.

The government made the announcement in its response to the House of Commons health select committee’s report on the changing role of NICE.

“The move will give NICE a crucial role in the future VBP arrangements for branded medicines,” the Department of Health said.

VBP negotiations ‘opened up’

Patient views will for the first time be heard in negotiations between the Department of Health and ABPI about Value-Based Pricing (VBP).

In a joint announcement, the two bodies have said that they will hold separate meetings with other parties on VBP rather than keeping discussions - as they are now - behind closed doors. 

“The content of these meetings will be reported back to meetings of the negotiating teams for their information to ensure an holistic basis of common understanding for a new scheme,” the statement said.

Cancer Drugs Fund must not be forerunner to value-based pricing - EMIG

The association representing small to medium UK pharma companies says the forthcoming Cancer Drugs Fund is welcome – but must not distort NHS priorities or be a pilot for a new pricing system for all drugs.

The Ethical Medicines Industry Group (EMIG) has made the remarks in response to the government’s consultation on the Cancer Drugs Fund, the full version of which is set for launch in April this year.

Generic substitution will not deliver significant NHS savings, says EMIG

The Department of Health’s plans for automatic generic substitution will not result in significant savings for the NHS and should be abandoned.

That’s the message from the Ethical Medicines Industry Group (EMIG), which represents small to medium pharma firms.

It says proposals to allow pharmacists to swap a doctor prescribed branded medicine with a generic substitute could even have the opposite effect of its intended cost-saving aim.

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