In the absence of any in-depth studies on this issue, the present study attempted to assess the effectiveness of regulations of pharmaceuticals and medical practice in Sri Lanka. As an economic evaluation the study was undertaken from a societal point of view, encompassing costs and outcomes at organisational and social levels. Thus, prime concern was given to undertake an assessment of the capacity constraints faced by the regulating agencies in performing their duties, first, at organizational level, and then at socio-economic, cultural and political levels. In addition to screening official reports and records of regulating agencies, and discussions with key stakeholders and field officers, field investigations were undertaken in three locations, urban, semi-urban and rural, in the form of discussions and observations at a sample of pharmacies and focus group discussions with public doctors engaged in private practice. Neither pharmaceutical nor medical practice regulations have achieved their social objectives in an effective manner. Highly informal procedures are prominent amongst authorized officers who enforce pharmaceutical regulations, while controlling malpractice by public doctors has lost pace at the central level, with peripheral health authorities playing a highly passive role. The study brings out several organizational, social, cultural and political constraints, which hinder effective implementation of regulations. Lack of human resources and skills, poor allocations, delays at the centre, lack of incentives, team approach and supportive services, legal restrictions and lack of support from consumers are common in the regulation of pharmaceuticals. A limited role played by regulators at the national level, lack of legislative power at central and peripheral levels, lack of organizational/management capacity of regulators, and social, cultural and political influences are common in the regulation of medical practice. A set of policy options and measures addressing these issues was identified to make the enforcement and monitoring of regulations more effective and efficient.
Attanayake, N.; Siyambalagoda, L. An inquiry into the regulation of pharmaceuticals and medical practice in Sri Lanka. London School of Hygiene and Tropical Medicine, London, UK (2003) viii + 70 pp. [HEFP working paper 05/03]