Regulating the pharmaceutical sector: Coping with low capacity while maintaining regulatory independence
Drug regulatory agencies play a key role in ensuring that medicines available for use are safe and effective. South Africa has been at the forefront of recent debates about pharmaceutical regulation, adopting wide-ranging changes to its legislative frameworks, in order to ensure cheaper access to quality drugs through parallel importation and compulsory licensing. At the same time the drug regulatory agency has sought to improve its effectiveness while dealing with a substantial capacity shortage. As with all regulation, agencies have to maintain independence from private sector interests – in this case the powerful pharmaceutical industry. In many low and middle-income countries there is insufficient individual and organizational capacity to ensure that regulation is effective. Steps often taken to deal with the capacity shortages can lead to agency independence being compromised. This paper describes: firstly, the capacity problems experienced in South African drug regulation over the period 1997-2003; secondly, steps taken to remedy some of the problems; thirdly, the ways in which possible solutions, suggested by various stakeholders, are likely to affect the independence of the agency. Finally, the paper concludes with recommendations, drawing on the lessons from the South African experience for other low and middle-income countries struggling with similar issues.
Matsebula, T.; Goudge, J.; Gilson, J. Regulating the pharmaceutical sector: Coping with low capacity while maintaining regulatory independence. London School of Hygiene and Tropical Medicine, London, UK (2005) 22 pp. [HEFP working paper 01/05]