By Dr. Ajith Kumara
Consultant Physician
President, All Ceylon Medical Officers Association
Prof. Senaka Bibile is the greatest medical benefactor of humanity that Sri Lanka has hitherto produced. As a student, he was an all-rounder; he excelled in in academic and extracurricular activities including sports and art. He completed his First, Second and Final M.B. Examinations, all with First Class Honours and won the coveted Djunjishaw Dadabhoy Gold Medal in Medicine and the Rockwood Gold Medal in Surgery at the finals.
Both his talent and Marxist ideology motivated him to dedicate the rest of his life to a mission to develop the medical education and also introduce a national drug policy which was overwhelmingly grabbed by many nations and organisations across the world.
Background for National Drug Policy
The capitalist system is full of flaws due to the nature of commodity production. After the world war II, there was a transient progression which was soon followed by economic recessions across the world interpreted as great depression, OPEC oil crisis, Secondary banking crisis of 1973–1975 in the UK, Latin American debt crisis and so on.
Sri Lanka also witnessed a steady deterioration of balance payment from 1960s and economic growth rate progressively declined from 4.6%which was during 1950 and 1960 to 2.6% by 1974. From 1965 to 1970, the foreign exchange allocation for drugs was cut from a total of Rs. 33 million (Rs. 20 million for private and Rs. 13 million for Civil Medical Stores’ imports) to Rs. 24 million (Rp. 14 million and Rs. 10 million, respectively). Those drastic cut downs of health expenses irrespective of growth of population and steadily rise of drug prices resulted in significant drop in per capita pharmaceutical supply compromising health care across the country. Therefore, the prime minister requested Prof Senaka Bibile to cut down expenses without compromising patient care.
By 1970, Sri Lanka had no national health or drug policy like most other countries and drugs were imported for the government sector and for the private sector separately by the civil medical stores and 134 local agents of foreign suppliers respectively. Both the government and the private sector were heavily influenced by propaganda of the transnational companies (TNC).
Major recommendations in National Drug Policy
List of essential drugs
When preparing the drug list, many imitative drugs, which made no contribution to the therapeutic effect of a particular drug that were chosen on the basis of economy, large number of fixed combination drugs and drugs without clear therapeutic value or with high toxicity were left out. Drugs that have got a very slight structural difference to already known drugs, but with the same therapeutic effect (me-too drugs) were also deleted. So, he managed to minimise the drug list from about 4000 preparations to a reasonable number (about 600) without detrimental effect on patient care.
Centralisation of the purchase
The next major recommendation was the centralisation of purchase of both finished drugs according to the rationalised list and pharmaceutical chemicals for local manufacturers. State Pharmaceutical Cooperation (SPC) initiated this task of wholesale import of all drugs and pharmaceutical raw materials and, the purchase of locally processed pharmaceuticals. By the end of 1973, it could take over all imports.
Shopping around the world and accepting low price-bid as bulks rather than finished products helped save a lot of money. To maintain the quality of drugs, the pharmaceutical company should produce certificate of quality plus an independent certificate of quality from a reliable laboratory, an agent or an official body before accepting their bid.
He suggested the following formula to understand the price of a drug to scientifically reduce its price. (See table)
CIF value ( Cost of goods, Insurance and freight) 100Handling charges 05Import duty 25Wholesalers profit 35Retailers profit 35Price to the consumer 200
Prof. Bibile pointed out that the wholesale import of raw materials and bulk pharmaceuticals at the most favourable price (at a lowest possible CIF value) will enable drug to be obtained and sold at the lowest price rather than fighting to limit wholesalers and retailers profit.
Ignore the patent law
The other recommendation was to abolish the patent law. Until that time, Sri Lanka had not been able to purchase patent products from any other manufacturer even though the drug was manufactured in a different process. Therefore, Sri Lanka could not buy cheaper products manufactured by a process different to those used by the original patent holders. Hence, it was suggested to amend the patent law so that only process patents would apply but not the product patents similar to the manner of operating the patent law in many countries such as Japan, Sweden, Denmark, Switzerland and most of the socialist countries.
Drug distribution and advertising
Repacking of bulk imported drugs and distribution of the drugs to the government sector and also to the private sector should be done by the state trading cooperation.
Drug advertising and education of doctors about drugs via brochures from pharmaceutical firms and their representatives should cease and local manufactures too should let the cooperation to advertise on their drugs.
Nomenclature
State Pharmaceutical Industry
Manufacturing pharmaceuticals in the country should also be started under the guidelines set by the government according to the essential drug list using the materials imported by the state, leaving the promotion and distribution to the state. If any manufacturer proved recalcitrant, the government has the authority to nationalise them. With this recommendation, by 1973, Sri Lanka m,anufacuired 47 essential drugs and, by 1974, and it increased to 71 drugs while saving more than 450,000 USD for the country.
Quality control of drugs
It was suggested to establish a quality control laboratory with a trained staff. Initially, he suggested getting consultants for the laboratory and to train staff through the WHO until local counterparts can take over the function.
Pharmacies, Pharmacists and their training
This was one of the most neglected aspect in health system by then. He rec eived assistance from Dr. J. Chilton of the University of Glasgow and a WHO consultant in Pharmacoloy, in training of pharmacists and to recommend the setting up of model pharmacies in the Colombo hospitals. The pharmacology course was later upgraded to a two year university diploma course according to his proposals.
In addition to these, the report has addressed about the research, monitoring and continuous development of human resources and infrastructure too.
Therefore, when analysing the Bibile Policy, it is clear that it is not merely an attempt to control the prices of drugs but, a very comprehensive national strategy for pharmaceutical sector in the health system.
National Drug policy to the world
Prof. Bibile was given the opportunity to present his novel model of pharmaceutical policy at the United Nations Conference on Trade and Development in 1976 and it was soon supported by World Health Organization (WHO) and other United Nations agencies as it would give enormous benefit to the third world countries.
By the year 2,000, over 100 countries had national pharmaceutical policies and 88 countries had introduced the essential drug concept to medical and pharmacy curricula. In 1971, both Chile and Sri Lanka started centralised bulk procurement but, Chile failed due to the power of pharmaceutical companies and the lack of strong political will at their end.
In the early 1980s, Bangladesh ranked as the world’s second poorest country with the average per capita income of US$130. However, they succeeded in national pharmacological policy due to strong political commitment giving a good example to the world that if the vital ingredient of political will and commitment are there, the real progress is possible irrespective of the power of the pharmaceutical giants.
Sri Lankans failure
Signs of failure appeared from the outset of the policy implementation in Sri Lanka. In the report in 1976 written by Prof. Bibile and Dr. Sanjaya Lal, it is clearly mentioned that the government was neither monolithic nor fully consistent with its strategy and, after 1975; government changed its economic strategy and hindered the policy implementation.
By now, Sri Lanka has faced a severe economic crisis with a shortage of foreign currency and an inability to provide basic requirements such as food, education and health of the citizens. Hospitals have run out of drugs including life-saving medications and surgical items.
Nevertheless, there are numerous combinations of various types of vitamins; plenty of medications which have no proven benefits, me-too drug and many counterfeit medications in the market wasting our foreign currency! About 30% of health expenditure is spent for pharmaceuticals.
If Sri Lanka had implemented Bibile drug policy and imported drugs according to an essential medicine list, heath budget could have efficiently be utilised to buy them while avoiding wasting of foreign currency for unnecessary medications. That would be an expeditious solution to the current crisis in essential medicines. As planned earlier, if the pharmaceutical manufacturing industry is commenced, it will be an excellent way of earning the much needed foreign currency in the long term. Therefore, the implementation of Bibile drug policy is much more important today than ever as a comprehensive approach to the crisis in health system to ensure the availability of essential medications.
