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. The Proprietary Association of Great Britain (PAGB) regulates over-the-counter medicines. Self-regulation should be the first means of dealing with complaints. The MHRA intervenes where there is a clear case for protection.
The ABPI Code incorporates the principles set out in the international and European codes. In addition it incorporates the principles set out in World Health Organisation (WHO) ethical criteria for medicinal drug promotion.
The PMCPA liaises regularly with the International Federation of Pharmaceutical Manufacturers (IFPMA) which operates the International Code of Pharmaceutical Marketing Practices and the European Federation of Pharmaceutical Industries and Associations (EFPIA) which operates the European Code of Practice on the Promotion of Medicines to ensure that the UK Code us in line with these codes as far as national law permits.
Prescription medicines
The promotion of medicines for prescribing to health professionals is carried out within a robust regulatory framework to maintain patient safety and public health.
There are two complementary systems of control
- self regulation by the pharmaceutical industry by means of the ABPI Code of Practice for the Pharmaceutical Industry, administered by the PMCPA, and
- UK law, administered by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the UK Health Ministers.
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.
A Memorandum of Understanding setting out the relationship has been agreed between the PMCPA, the ABPI and the MHRA.
Click here to view the Memorandum of Understanding in full.
Over-the-counter (OTC) 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. The self-regulatory role of the PAGB is supported by the statutory role of the Medicines and Healthcare products Regulatory Agency (MHRA) which administers UK law.
