Increasing demand for health economics (HE) means that HE information on pharmaceutical interventions is becoming more widely used in promotion. OBJECTIVES: To identify and assess the current legislative structure relating to the inclusion of HE data in the advertising of medicines in the EU. METHOD: A review of published literature and EU legislation. RESULTS: Advertising and promotion of medicinal products for human use is regulated by the EC directive 92/28/EEC. In addition, member states have their own codes of practice, some regulate pharmaceutical advertising by tribunals e.g. Germany, others by self-regulating bodies e.g. the ABPI in the UK, and some e.g. France, by the health authority (Agence de Medicament). These all embody the principles and standards from 92/28/EEC, whereby advertising should encourage rational use of the product, presenting it objectively, without exaggeration and without being misleading. EFPIA and IFPMA also publish Codes of Practice for the Promotion of Medicines. In these approaches HE data is not explicitly considered - the focus is clinical. Similarly, until recently, legislation for the separate review of HE data did not exist in the US. In addition, a recent cross-functional initiative through ISPOR to develop guidelines for health care economic promotional materials has now been reported CONCLUSION: We have identified no specific guidelines for advertising using HE data in the EU. Given this, key questions are: (i) Do existing codes of practice offer enough scope to review HE data? and (ii) How can we ensure quality assurance of HE information provided to decision makers?