12.1 Promotional material and activities must not be disguised.
12.2 Market research activities, clinical assessments, post-marketing surveillance and experience programmes, post-authorization studies (including those that are retrospective in nature) and the like must not be disguised promotion. They must be conducted with a primarily scientific or educational purpose.
Clause 12.1 Disguised Promotional Material
Promotional material sent in the guise of personal communications, for example by using envelopes or postcards addressed in real or facsimile handwriting, is inappropriate. Envelopes must not be used for the dispatch of promotional material if they bear words implying that the contents are non-promotional, for example that the contents provide information relating to safety.
When a company pays for, or otherwise secures or arranges the publication of promotional material in journals, such material must not resemble independent editorial matter. Care must be taken with company sponsored reports of meetings and the like to ensure that they are not disguised promotion. Sponsorship must be declared in accordance with Clause 9.10.
Clause 12.2 Non-Interventional Studies of Marketed Medicines
The conduct of non-interventional studies of marketed medicines is dealt with in Clause 13.
Clause 12.2 Market Research
Market research is the collection and analysis of information and must be unbiased and non-promotional. The use to which the statistics or information is put may be promotional. The two phases must be kept distinct.
Attention is drawn to the Legal & Ethical Guidelines for Healthcare Market Research produced by the British Healthcare Business Intelligence Association in consultation with the ABPI.
Market research material should be examined to ensure that it does not contravene the Code.
Where market research is carried out by an agency on behalf of a pharmaceutical company, the agency must reveal the name of its client to the Prescription Medicines Code of Practice Authority when the Authority requests it to do so. When commissioning market research, a company must take steps to ensure that its identity would be so made known to the Authority should a request for that information be made.