The pharmaceutical industry is in the global media spotlight and has received heavy criticism from politicians, and the lay and medical press for the way that it commercialises its products.1–3 It is mainly as a result of this criticism that regulatory and self-regulatory controls for the promotion of prescription medicines have been or are being revised in many countries around the world. In most countries both legal regulation and self-regulation (i.e. codes of practice of trade associations) operate but the balance between the two can differ; in the best national models they work synergistically.4 In some countries the national regulatory authorities vet promotional materials as well as dealing with complaints; in others the primary route is self-regulatory codes of practice. This information is summarised in Table 5.1 in Section 5.5 (p. 33).
Many pharmaceutical companies have realised that they must improve their public image, and business reports, such as the one from Price Waterhouse Coopers,5 have reinforced this making sound business sense, with the result that companies are producing internal guidance on promotional activities, additional compliance officers are being appointed, there are more internal audits and there is generally a tightening of company procedures for approval of promotion.
This, in turn, has placed increasing pressure on those involved in the promotion of pharmaceuticals in terms of both the sales and marketing departments and the medical and regulatory departments, which have to approve promotion to ensure compliance. There has been further intensification within the market place for pharmaceuticals becoming more and more global; this has resulted in sales and marketing campaigns often being prepared at a global or at least a pan-European level. Therefore sales, marketing, medical and regulatory departments within regional or international pharmaceutical company offices need to be aware of the plethora of regulations and self-regulatory codes that exist.
This does not mean that those working at a national level need be aware only of their national code; there are many examples where referral to the codes of other countries is important. An example of this would be international or company meetings held overseas.
Whilst working within the pharmaceutical industry as European and later as International medical information manager, with responsibility for compliance of promotional materials across the region, I was regularly required to approve the use of promotional materials such as stand panels and giveaways for use at international meetings, or to approve marketing campaigns for pan-European or international use. This involved finding the relevant code of conduct or, if it was for an international campaign, numerous codes of conduct.