The new code has just been published in its new yellow livery, its main aim is to set a robust framework of standards for the provision of information to healthcare professionals, prescribers, patients and the public to ensure that the information provided is of high quality and gives a balanced view supported by objective evidence.
The Statutory control of medicine advertising sits with both the (MHRA ) Medicines and Healthcare Products Regulatory Agency and the (SFO) Serious Fraud Office. They support self -regulation and compliance with The Blue Guide and The Memorandum of Understanding.( The agreement set out between the MHRA, The Pharmaceutical Industry and the PMCPA Prescription Medicine Code of Practice Authority.) The PMCPA publishes comprehensive case notes of outcomes from complaints and investigations on its website www.pmcpa.org.uk . PMCPA will review and monitor detail aids, leave pieces and meetings and deliver training on The Code of Practice.
The code has twenty-six clauses which cover the whole area of promotion of medicines from the material and how it is used, the internet and relationships with prescribes and/or patients to the company representative and staff who interface with the prescribers and the public
Clause 2 and 7 covers the materials
Clause 2 which states that no promotional materials should reduce public confidence or discredit the pharmaceutical industry
Or
Clause 7 encouraging rational, non-exaggerated, balanced , accurate, evidences based use of freely available , replicable claims , comparisons and up to date literature on the medicines in question.
Clause 15, 16, 17, 18 and 26 covers the company representative and how they are to be trained to both promote their products and use the materials they are given safely and effectively in a compliant manner.
Clause 15 Representatives & Clause 16 Training
Clause 17 Samples &
Clause 18 Gifts and Inducements &
Clause 19 Hospitality and meetings
Clause 26 Compliance with undertakings
The code contains valuable information and is available both on line or in hard copy and can be ordered for free from ABPI.