Scoping the impact of regulation on medicines promotion

Posted on 2 November 2009

By Carole Piriou, Project Officer, Health Action International Global

Medicines play an important role in health care, but the irrational prescribing and use of medicines often result in inappropriate or harmful treatment, a waste of resources and increased  resistance to some medicines, such as antimicrobials. While the interests of medicines manufacturers and public health may coincide, they are often divergent and in the scramble for new and expanding markets for medicines, manufacturers vigorously promote their products. As a result, many countries have introduced a legislative framework to regulate the promotional activities of the pharmaceutical industry,. These frameworks vary widely in content, implementation and enforcement. Indeed, some developing countries still lack any legislative structure to control promotion. This can be for a number of reasons, but budgetary constraint is usually at the centre.

Often in developing countries the only source of information about medicines available to health professionals and consumers is promotional material from the pharmaceutical industry. Elsewhere, the sheer volume of promotion, as well as industry involvement in continuing medical education, clinical research, patient groups and other areas, make persuasive promotional messaging unavoidable, successful and lucrative. Few attempts have been made to map and comprehensively explore the regulatory situation in countries regarding medicines promotion control. This is a crucial first step to determining the outstanding barriers and the best approaches towards a better promotion control framework which promotes the rational use of medicines and safeguards public health.

In 2009, Health Action International (HAI), supported by MeTA and the Dutch Government (DGIS), began work aimed at gathering information on countries’ regulatory practices to control pharmaceutical promotion and their effectiveness in promoting public health as set out in the World Health Organization’s (WHO) Ethical Criteria[1]. To do this, HAI is developing a methodological tool that will help countries gain insight into national regulatory frameworks and their impact and effectiveness on promotional practices; assess key stakeholders’ perceptions of the regulatory situation; and survey outcomes of the regulatory process.

Methodology

HAI’s research tool, now being developed from existing WHO methodologies and with critical opinion from a group of world experts, combines desk research, key informant interviews and sample data collection to provide a picture of national situations. It assesses the provisions on medicines promotion control in countries, but also seeks information on other regulatory aspects such as monitoring and enforcement and inquires about the structure and resources of the institutions involved in promotion regulation. An early version of the methodology was field tested in Kyrgyzstan, Peru, and Uganda. The tool has been reshaped based on the comments and recommendations of the advisory group and the country feedback. Once the full methodology has been refined and pilot tested in countries with different types of regulatory systems, it will be made available to the public as a free-access research and assessment tool.

Value of the findings

The findings will shed light on the efficacy of pharmaceutical promotion regulation, highlight the areas in which regulation needs strengthening and provide an evidence base for recommendations to improve national policies on promotional activities. 

Assessing the impact of promotion is not the goal itself, but rather a means to help achieve better health by identifying the factors that affect rational use and how to act on them. By investigating the strengths and weaknesses of the national system, it should be possible to find causes for shortcomings of the regulatory framework, but also to highlight and disseminate best practices in various areas. The research should clarify the context in which the policies were developed, how transparent the regulatory process is, and who is involved in decision-making. The country profiles obtained through this assessment should, in turn, help inform country-specific policy recommendations to control promotion more efficiently and promote rational use.

[1] Ethical Criteria for Medicinal Drug Promotion, World Health Organization 1988