Pharmaceutical regulation in context: the case of Lao People's Democratic Republic.

An explosive development of private pharmacies in the Lao People's Democratic Republic (Lao P.D.R.) has led to 80% of pharmaceuticals being provided by the private sector. In order to achieve the goal of access to good quality health care for all citizens, the Lao government is making an effort to regulate the private pharmaceutical sector using the emerging legal system of laws, decrees, and regulations. The aim of this paper is to describe and analyze the system of drug regulation in Lao P.D.R. in relation to the public social goals. Relevant official documents at the central, provincial and district levels have been reviewed, interviews were held with 30 key informants and 15 pharmacies were surveyed. The public social goals have been expressed in terms of equity and quality of care. However, total drug expenditure may be as low as US$1 per person per year which is far below any minimum standard and does not make it possible to achieve reasonable access to drugs for all. The regulatory system has so far been focused on entry into the pharmaceutical retail market and dealing with basic issues of product quality and conditions of sale. An enforcement system including sanctions is being developed; other policy instruments such as information and economic means are hardly being used at all. The government presently faces a trade-off between quality of pharmaceutical services and geographical equity of access. The study shows that regulation is strongly influenced by the general socioeconomic context.