1. Whilst the pharmaceutical industry plays a key role in developing and producing medicines, there is a tension between industry’s need to expand product sales and a country’s public health needs. “ There is an inherent conflict of interest between the legitimate business goals of manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way.” 1 Promotional material is often the main or only source of information about medicines for health professionals and consumers. The sheer volume of promotion al activities including industry involvement in continuing medical education, clinical research, patient groups and other areas, make persuasive promotional messages difficult to avoid. Medicines Promotion: Assessing the Nature, Extent and Impact of Regulation Irrational prescribing and use of medicines often results in inappropriate or harmful treatment, a waste of valuable health resources and increased drug resistance. The single most important stimulus behind irrational medicines use is the unethical promotional of medicines Many countries have introduced a legislative framework to regulate the promotional activities of the pharmaceutical industry; these vary widely regarding content, implementation and enforcement. Further information: carole@haiweb.orgcarole@haiweb.org Literature review Key Informants Interview Field analysis Methodology 1988 : WHO Ethical Criteria for Medicinal Drug Promotion. This document remains the gold standard against which promotional activities, and national and regional efforts to regulate promotion, are judged. The project aims to determine: The scope of regulation and/or restrictions on pharmaceutical promotion in countries The impact and effectiveness of regulatory frameworks and/or codes of practice aimed at restricting promotional activities This will help countries to identify: 1) National legal provisions on promotion as well as existing mechanisms to implement and enforce them 2) Existing forms of unethical promotion and best practice 3) Any gaps in the regulatory framework that need to be addressed This research will provide a detailed profile of how promotion is managed within a country’s, including Strengths and weaknesses of the regulatory framework Any outstanding enforcement issues A clearer picture of the political context and stakeholder positions on regulation The research findings will provide valuable insight into the efficacy of pharmaceutical promotion regulation; highlight areas that need strengthening; and inform recommendations to improve policies on medicines promotion. National surveys carried out using the HAI methodology will provide an evidence base, which countries can then use to make policy choices that contribute to the rational use of medicines. Rationale Background Regulation of Promotion: milestones Interview schedules for data collection from representatives from the drug regulatory authorities, WHO, health care professionals, civil society, pharmaceutical industry representatives, insurers and media. Qualitative analysis of insights into the current promotion situation, and observations on best practice. 2007: Resolution WHA 60.16 on rational use of medicines urges Member States “to enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor drug promotion, and to develop and implement programmes that will provide independent, non-promotional information on medicines.” 2 Objectives Results Comprehensive tools for the systematic collection and analysis of relevant laws, guidelines or codes related to the promotion of medicines. Additional tools to assess existing mechanisms that implement and/or enforce restrictions on promotional activity. Monitoring specific promotion outcomes (such as direct- to-consumer advertisements, the impact of sales representatives and the uptake of generic medicines), thus allowing measurement of progress against legislative or code of practice intervention Next steps The methodology now needs to be pilot tested: by assessing a number of countries representing various levels of economic development; these countries will benefit from a comprehensive assessment and will be involved in the finalisation of the methodology. It will then be released as an open access tool. 1 World Health Organization. Clinical Pharmacological Evaluation of Drug Control. WHO, 1993 2 Resolution 60.16 on Rational Use of Medicines. 60 th World Health Assembly, 2007