A policy has been published on our approach to handling potential conflicts of interest (COI) arising out of the merger with the Medicines and Healthcare Products Regulatory Agency (MHRA) of the National Institute of Biological Standards and Control (NIBSC), and the separate launch within the MHRA of the Clinical Practice Research Datalink (CPRD). This policy sits alongside the MHRA staff COI policy.

 

On 1 April 2013, NIBSC, formerly part of the Health Protection Agency (HPA), became a new centre of the Medicines and Healthcare Products Regulatory Agency. CPRD, formerly the General Practice Research Database, was launched as a centre of the Medicines and Healthcare Products Regulatory Agency in April 2012. These two developments have resulted in a significant expansion of the Agency’s responsibilities. The ‘Regulatory Centre’ (ie the MHRA’s regulatory divisions relating to medicines and devices), NIBSC Centre and CPRD Centre constitute the three operational ‘pillars’ of the Agency from 1 April 2013 – together with the supporting corporate divisions already in existence in the MHRA.

 

NIBSC and CPRD currently, or may in the future, undertake a variety of work that potentially falls within the remit of the MHRA regulatory responsibilities in relation to medicines and devices. This creates the risk of COI – that is, the MHRA being in a position where its regulatory decisions might be influenced by its other interests. While much of the work undertaken would be for third parties, and not via direct contact, nevertheless, in order to manage this risk and ensure the MHRA’s regulatory integrity and impartiality is maintained, a transparent policy for handling potential COI has been developed. This policy has been developed taking account of all of the activities carried out by NIBSC and CPRD and will be reviewed on a regular basis. Any queries about the policy or specific COI concerns can be directed to info@mhra.gsi.gov.uk

 

Policy for handling conflicts of interestPDF file (opens in new window)

 

Conflicts of interest flowchartPDF file (opens in new window)

 

Conflicts of interest

 

Posted on the UK MHRA website on 21 May 2013