Manufacturing, Medical (incl. medical device & pharma) - Written by on Wednesday, January 19, 2011 4:57 - 0 Comments

New UK pharma promotion rules now in effect

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Are you a pharmaceutical company? Are you compliant with the new ABPI Code of Practice and ready for the Bribery Act?

In November 2010 we wrote that Richard Alderman, Director of the UK’s Serious Fraud Office told the UK’s Association of the British Pharmaceutical Industry (ABPI) that the UK pharmaceutical industry was on the “high risk register” of the U.S Department of Justice (DoJ) and “will be receiving a considerable amount of attention from the DoJ.”

In a stark warning Mr Alderman signaled that the SFO is also looking closely at the pharmaceutical industry.

We reported Mr. Alderman warned industry not to “underestimate the amount of information sharing that goes on between us and the DOJ and the SEC about all of these issues”.

The warning echoed a similar warning issued a 12 months before when Lanny Breuer warned delegates that the pharmaceutical industry was in the cross hairs of the Department of Justice (DoJ). The DoJ followed through and in the summer of 2010 various pharmaceutical companies reported requests for information they had received from the DoJ.

Against this backdrop the ABPI voted to change the ABPI Code of Practice with the aim of increasing trasparency between the industry and healthcare professionals.

The rules embodied in the new Code of Practice came into effect on 1 Janaury 2011 and all Pharmaceutical companies should now be complying with them.

They are compulsory reading for those in the industry.

There is a four month grace period between 1 January 2011 to 30 April 2011 when no promotional material or activity will be regarded as being in breach of the Code if it fails to comply with its provisions only because of requirements which this edition of the Code newly introduces.

In the meantime, pharmaceutical businesses would be well advised to ensure compliance with the Bribery Act by April 2010.  As we wrote earlier in the week in spite of the various reports of a review of the Bribery Act our view is that material change as a result is wishful thinking – it is coming…

The SFO has already shown that it means business when it comes to the medical sector with the succesful prosecution and imprisonment of Robert Dougall last year on corruption charges relating to sales of medical devices including prosthetic limbs in Greece.

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