How we fit with other regulatory bodies

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.

A Memorandum of Understanding setting out the arrangements for the regulation of the promotion of medicines for prescribing has been agreed between the PMCPA, the ABPI and the MHRA.

Serious Fraud Office - Bribery Act 2010

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.

Self-regulation

Efficient, stringent and transparent self-regulation via the ABPI Code enables regulatory requirements to be met by self-regulation. The MHRA will act when there is a clear case for protection or if self regulation fails.

Self-regulation should be the first means of dealing with complaints. Both the PMCPA and the MHRA deal with complaints whatever their source. However, the MHRA focus is on pre-vetting, dealing with complaints other than inter-company complaints and dealing with complaints that are not covered by the ABPI Code or other self-regulatory authority. The MHRA can refer complaints to the PMCPA.

Over-the-counter medicines

The ABPI Code does not cover the advertising or promotion of OTC medicines.

Any queries or complaints about OTC medicines should be directed to the Proprietary Association of Great Britain (PAGB), the UK trade association for the manufacturers of OTC medicines and food supplements.