Medicines Promotion: Assessing the Nature, Extent and Impact of Regulation. Report and Preliminary Methodology for Pilot-testing
(2011; 38 pages)

Abstract

This report, which precedes the assessment tool itself, outlines the premise and context which has led to the development of a methodology to investigate the regulatory framework of medicines promotion in the context of national settings. The project has developed a methodology to gather information on any given countries' regulatory practice that is aimed at controlling the extent and influence of pharmaceutical promotion. As a tool to gather data on regulation, it complements the World Health Organization's (WHO) Ethical Criteria for Medicinal Drug Promotion1. The project has been conducted by Health Action International (HAI) Global and co-funded by the Medicines Transparency Alliance (MeTA) and the HAI global Programme, under the guidance of an advisory group of international experts...HAI Global in collaboration with MeTA, has developed a methodology (accompanying this report) to help countries gain an overview of the national regulatory framework and assess key stakeholders' perceptions of the regulatory situation regarding medicines promotion.

Although unethical promotional practices and irrational use of medicines are global issues, regulatory practices are usually local (national or regional), and depend on many factors, including the social, political and economic context of regions, countries, and populations. Because of this context-specific nature of regulation, policy recommendations cannot be provided without an extensive understanding of the country's specific situation. It is hence necessary to investigate what the regulatory texts stipulate, but also to map the structure of the drug regulatory authority and related bodies, and to gather testimonies and opinions of the different stakeholders involved in or affected by medicines promotion. The methodology aims to determine: The scope of regulation on pharmaceutical promotion in country settings; The impact and effectiveness of the regulatory framework on promotional practice. For this purpose, HAI developed a methodology to help countries identify: National legal provisions on promotion as well as existing mechanisms to implement and enforce them. This includes assessing the extent of self- regulation by the pharmaceutical companies where relevant; Examples of existing forms of unethical promotion occurring in the country and how they breach legislation or codes of practice; Any gaps in the regulatory framework that need to be addressed...

 
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