(1995; 44 pages)
Sri Lanka’s pharmaceutical policy represents a classical case of a far-sighted National Drug Policy, even if it is not set out in a single comprehensive government document. Instead it is based on a number of laws, reports and recommendations which have evolved over time and been adjusted and balanced by the political, scientific and administrative process that has been going on since the 1950s and continues today. As the author of this study points out, even if "much of it is unwritten, a lot of it is in place".
The basis of this pharmaceutical policy is to be found in the democratic traditions of Sri Lanka characterising the early decades of this century, long before the country became independent in 1948, and in its advanced social policies. These provided education and health services free or at low cost to the broad mass of the population earlier than in most countries in the South and, for that matter, than some countries in the North.
A democratic and socially responsible policy does not, however, come about by itself. It requires a person who has both a strong vision and the capacity to make this vision come true. Such a person was the brilliant and charismatic physician and pharmacologist, the late Professor Senaka Bibile who was able to implement step by step Sri Lanka’s comprehensive pharmaceutical policy. Important parts of this development were the creation of the National Formulary Committee in 1962, which reduced the number of drugs in the country to about 2,100, and, above all, Bibile’s report on "Management of Pharmaceuticals in Ceylon" (1971), which, inter alia, proposed the creation o f a centralised purchasing authority (called the State Pharmaceuticals Corporation, SPC), the development of an indigenous pharmaceutical industry, the increased use of generic names instead of brand names, and a functioning quality control system. Although his early death in 1977 prevented Professor Bibile from carrying through all his ideas, his work has been continued—despite a more market-oriented government coming to power—by his many colleagues and students, and important reforms have been introduced in the 1980s and 1990s. Examples of such reforms are a strict and formal system f o r the registration of drugs, which was based on drugs relevant to the health care needs of the country, strong requirements for evidence from clinical trials before the approval of new pharmaceuticals, and an increased emphasis on unbiased drug information.
The article published here shows how the legacy of Professor Bibile has been preserved, developed and adjusted to prevailing political, social and economic circumstances during the past two decades. In summing up his study, the author writes: "Perhaps the future of pharmaceuticals will reflect the fabric of the nation itself. Democracy has survived despite severe economic, social and political threats; the concept of pharmaceuticals as a part of health and not as an item to be exploited will also survive, despite similar tensions. Like democracy, this concept of pharmaceuticals is not perfect or acceptable to all, but will triumph simply by prevailing."
Dr Krisantha Weerasuriya was educated as a physician in Sri Lanka and trained in Clinical Pharmacology in London. He is currently the Professor of Pharmacology at the Faculty of Medicine, University of Colombo, a position first held by Professor Bibile.