Regulating the pharmaceutical sector: Coping with low capacity while maintaining regulatory independence
Ensuring medicines available to the public are both safe and effective is a key role of national Departments of Health, in their regulation of the private health industry. Commonly, statutory bodies are tasked with the responsibility of evaluating the claims of safety and effectiveness of a drug put forward by the pharmaceutical industry. Drug approval requires sufficient organizational and personnel capacity to ensure a thorough and timeously process. In many low and middle-income countries, the responsible organizations have neither adequate capacity nor sufficient funds. As a result various mechanisms are used to try to ensure an appropriate drug approval process - such as reliance on decisions taken by international conventions or other countries, part-time evaluators, and charging drug registration fees from the industry. Yet these mechanisms may weaken the independence of the regulating authority, leading to 'regulatory capture'
South Africa has been at the forefront of recent debates about pharmaceutical regulation, particularly with respect to the changes to its legislative framework allowing both parallel importation and compulsory licensing to manufacture drugs still under patent under certain conditions. This paper looks at how the South African Drug Regulatory Agency has responded to capacity problems while trying to ensure the independence of its decisions. It examines how commonly suggested measures to deal with poor capacity might jeopardize the objectives of the regulator. Reflection on the South African experience has relevance for other low and middle-income countries struggling with similar issues. This paper contributes to the small existing literature on drug regulation in developing countries, and the even smaller literature on capacity issues within regulation.
Matsebula, T.; Goudge, J.; Gilson, L. Regulating the pharmaceutical sector: Coping with low capacity while maintaining regulatory independence. HEFP working paper 01/05, LSHTM (2005)