By Dr. Ajith Kumara
President, All Ceylon Medical Officers Association
Professor Senaka Bibile is the greatest medical benefactor to mankind that Sri Lanka has produced so far. As a student, he was versatile; he excelled in academic and extracurricular activities, including sports and art. He completed his first, second and final MB exams all with first class honors and won the coveted Djunjishaw Dadabhoy Gold Medal in Medicine and Rockwood Gold Medal in Surgery in the final.
His talent and his Marxist ideology motivated him to dedicate the rest of his life to a mission of developing medical education and introducing a national drug policy that was overwhelmingly adopted by many nations and organizations around the world.
Context of national drug policy
The capitalist system is full of defects due to the nature of commodity production. After World War II there was a transient progression which was soon followed by economic recessions across the world interpreted as a Great Depression, the OPEC oil crisis, the secondary banking crisis of 1973-1975 in the UK United, the Latin American debt crisis, etc.
Sri Lanka also experienced a steady deterioration in the balance of payments from the 1960s and the economic growth rate gradually declined from 4.6% in 1950 and 1960 to 2.6% in 1974. From 1965 to 1970, the foreign exchange allocation for medicines has been reduced from a total of Rs. 33 million (Rs. 20 million for private imports and Rs. 13 million for imports from civilian medical stores) to Rs. 24 million (Rp. 14 million and Rs. 10 million, respectively). These drastic cuts in healthcare spending regardless of population growth and ever-increasing drug prices have resulted in a significant drop in the per capita pharmaceutical supply, compromising healthcare across the country. Therefore, the Prime Minister has asked Professor Senaka Bibile to cut spending without compromising patient care.
In 1970, Sri Lanka did not have a national health or drug policy like most other countries and drugs were imported separately for the public sector and for the private sector by civilian medical stores and 134 local supplier agents foreigners respectively. Both the government and the private sector have been heavily influenced by the propaganda of transnational corporations (TNCs).
Key National Medicines Policy Recommendations
List of essential medicines
Professor Senaka Bibile pioneered the publication of the Ceylon Hospital Formulary from 1957 to identify essential medicines for hospitals and introduced the concept of Essential Medicines List in 1958 in Sri Lanka; it was new to the world and later taken up by the WHO and other countries to ensure a continuous supply of essential drugs at the lowest possible cost.
When preparing the list of drugs, many imitative drugs, which made no contribution to the therapeutic effect of a particular drug which were chosen on the basis of economy, a large number of drugs to fixed combination and drugs with no clear therapeutic value or with high toxicity were left out. Drugs with a very slight structural difference from already known drugs, but with the same therapeutic effect (me-too drugs) have also been removed. Thus, he managed to reduce the list of drugs from about 4000 preparations to a manageable number (about 600) without any adverse effect on patient care.
The next major recommendation was the centralization of the purchase of finished drugs according to the rationalized list and pharmaceutical chemicals for local manufacturers. The State Pharmaceutical Cooperation (SPC) initiated this task of wholesale importation of all medicines and pharmaceutical raw materials and the purchase of locally processed pharmaceutical products. By the end of 1973, it could handle all imports.
Shopping around the world and accepting cheap wholesale offers rather than finished goods has saved a lot of money. To maintain the quality of the drugs, the pharmaceutical company must produce a quality certificate as well as an independent quality certificate from a reliable laboratory, agent or official body before accepting their offer.
He suggested the following formula to figure out the price of a medicine in order to scientifically lower its price. (See table)
CIF Value (Cost of Goods Insurance and Freight) 100Handling Charge 05Import Duty 25Wholesalers Profit 35Retailers Profit 35Consumer Price 200
Professor Bibile pointed out that the wholesale importation of bulk raw materials and pharmaceuticals at the most favorable price (at the lowest possible CIF value) will enable medicines to be obtained and sold at the lowest price rather than fighting to limit the profits of wholesalers and retailers.
Ignore patent law
The other recommendation was to abolish the patent law. Until then, Sri Lanka had not been able to purchase patented products from another manufacturer, even if the drug was manufactured using a different process. Therefore, Sri Lanka could not buy cheaper products made by a process different from those used by the original patent holders. Therefore, it was suggested to change the patent law so that only process patents apply, but not product patents, as the patent law does in many countries such as Japan, Sweden, Denmark, Switzerland and most socialist countries.
Drug distribution and advertising
The repackaging of bulk imported drugs and the distribution of drugs to the government sector as well as the private sector should be carried out by the State Trade Cooperation.
Advertising of drugs and educating doctors about drugs through pamphlets from pharmaceutical companies and their representatives should stop and local manufacturers should also let cooperation to advertise their drugs.
The report strongly recommended using generic drug names instead of trade names in prescriptions.
State pharmaceutical industry
The manufacturing of pharmaceuticals in the country is also expected to be started as per the guidelines set by the government according to the Essential Medicines List using the materials imported by the state, leaving the promotion and distribution to the state. If a manufacturer proves recalcitrant, the government has the power to nationalize it. With this recommendation, in 1973, Sri Lanka manufactured 47 essential drugs, and in 1974, it increased to 71 drugs while saving over US$450,000 for the country.
Drug quality control
It was suggested to establish a quality control laboratory with qualified personnel. Initially, he suggested hiring consultants for the laboratory and training staff through WHO until local counterparts could take over.
Pharmacies, pharmacists and their training
It was one of the most neglected aspects of the healthcare system at the time. He received help from Dr J. Chilton of the University of Glasgow and a WHO consultant in pharmacology, for the training of pharmacists and for recommending the establishment of model pharmacies in Colombo hospitals. The pharmacology course was later transformed into a two-year university degree course according to his proposals.
In addition to these, the report also addressed the research, monitoring and continuous development of human resources and infrastructure.
Therefore, when analyzing the biblical policy, it is clear that it is not just an attempt to control drug prices, but a very comprehensive national strategy for the pharmaceutical sector in the health system..
National drug policy around the world
Professor Bibile had the opportunity to present his new drug policy model at the United Nations Conference on Trade and Development in 1976 and it was quickly supported by the World Health Organization (WHO) and other United Nations agencies because it would bring enormous benefits to third world countries.
By the year 2000, more than 100 countries had national drug policies and 88 countries had introduced the concept of essential drugs into medicine and pharmacy curricula. In 1971, Chile and Sri Lanka started centralized bulk purchasing, but Chile failed due to the power of pharmaceutical companies and lack of strong political will on their side.
In the early 1980s, Bangladesh was the second poorest country in the world with an average per capita income of US$130. However, they have achieved a national drug policy through strong political commitment setting a good example to the world that if the vital ingredient of political will and commitment is there, real progress is possible no matter how powerful the pharmaceutical giants.
The failure of the Sri Lankans
Signs of failure appeared early in the implementation of the policy in Sri Lanka. In the 1976 report written by Prof. Bibile and Dr. Sanjaya Lal, it is clearly mentioned that the government was neither monolithic nor fully coherent with its strategy and after 1975; government changed its economic strategy and hindered policy implementation.
At present, Sri Lanka is facing a severe economic crisis with a shortage of foreign currency and an inability to meet basic needs such as food, education and health for the citizens. Hospitals are running out of medicines, including life-saving drugs and surgical items.
Nevertheless, there are many combinations of different types of vitamins; lots of drugs that have no proven benefit, me-too drugs and many counterfeit drugs in the market that waste our foreign currency! About 30% of health expenditure is spent on pharmaceuticals.
If Sri Lanka had implemented the Bibile drug policy and imported drugs according to an essential drug list, the health budget could have been used efficiently to procure them while avoiding wastage of foreign exchange on drugs. unnecessary. This would be a quick fix to the current essential drugs crisis. As predicted earlier, if the pharmaceutical manufacturing industry gets started, it will be a great way to earn the much-needed foreign currency in the long run. Therefore, the implementation of the Bibile Medicines Policy is now much more important than ever as a comprehensive approach to the health system crisis to ensure the availability of essential medicines.