Medicines and healthcare products Regulatory Agency
In the UK the control of medicines advertising is based on the long established system of self-regulation supported by the statutory role of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA administers UK law on behalf of the Health Ministers. UK law is based on a European Directive.
The ABPI Code of Practice for the Pharmaceutical Industry, administered by the PMCPA, is the self-regulatory system covering prescription medicines. The ABPI Code reflects and extends beyond UK law. Self-regulation should be the first means of dealing with complaints. The MHRA intervenes where there is a clear case for protection.
The Bribery Act came into effect on 1 July 2011. The ABPI and the PMCPA liaised with the Serious Fraud Office (SFO) to present the perspective of the pharmaceutical industry and its self regulatory body.
A Memorandum of Understanding has been developed between the ABPI, PMCPA and SFO which provides some clarity around which agency is likely to lead on enforcement for breaches of the ABPI Code in cases where a Code breach is also a potential breach of The Bribery Act. The Memorandum of Understanding states that self regulation should be the first means of dealing with complaints.
The SFO considers that the ABPI Code of Practice for the Pharmaceutical Industry will help companies governed by it in responding to the requirements of the Act, particularly in areas such as hospitality, gifts and inducements to prescribe to healthcare professionals.