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ABPI to tighten up transparency compliance

Hires independent third party to monitor for incidents of non-compliance


The Association of the British Pharmaceutical Industry (ABPI) has introduced measures it says will improve compliance with transparency provisions for clinical trials in the UK.

The announcement, which comes amid growing pressure on the industry to provide greater access to clinical trial data, includes the appointment of an independent third party to monitor compliance of ABPI member companies, with infractions to be reported to UK pharma's self-regulatory body the Prescription Medicines Code of Practice Authority (PMCPA).

“Hiring a third party provider to ensure that companies fulfil their obligations in the ABPI Code of Practice to register clinical trials and publish summary results, is a significant step and illustrates how seriously we take this issue,” said the ABPI's CEO Stephen Whitehead.

The trade body said that these measures will support current transparency requirements in the ABPI Code of Practice, which include an obligation to register clinical trials within 21 days of enrolling the first patients.

Results must also be publicised within one year of marketing authorisation, or one year from completion of the trail for products that already available.

If a company is found to have breached the Code of Practice, it is liable to face sanctions, which in serious cases can include an audit of the company's procedures, a public reprimand or even suspension or expulsion from the ABPI.

In addition to these efforts to improve adherence to the Code, the ABPI said it is bringing out a new toolkit that provides good practice guidelines, compliance checklists and template standard operating procedures for pharmaceutical companies.

There will also be a series of workshops where there will be two main topics of discussion: what disclosure requirements are necessary and what to do about historical data for drugs that have been on the market for several years.

“On the issue of historical data we also want to ensure that we work collaboratively with all health stakeholders and international colleagues to agree a pragmatic approach which is in the interests of patients while protecting the commercial research mode,” said Whitehead.

The announcement comes shortly after Swiss pharma company Roche said it intends to provide greater access to its clinical trial data for all of its licensed medicines on a case-by-case basis.

The company has been at the heart of the ongoing transparency debate after concerns were raised that its flu drug Tamiflu was not as effective as Roche claimed it to be.

However, Roche's attempt to address its critics has been condemned by some, including Peter Gøtzsche of the Nordic Cochrane Centre, for not going far enough.

28th February 2013

From: Research, Regulatory



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