Best tribute to Prof. Senaka Bibile:

Quality medicines in State and private hospitals

by Prof. Tissa Vitarana

Senaka Bibile was born on February 13, 1920, the son of the Ratte Mahaththaya of Bibile, and grew up in a privileged environment, but was deeply affected by the poverty around him in the Moneragala district.

A variety of medicines available in the market

After his education at Trinity College, Kandy (1928-1939), he entered the Medical College of the University of Ceylon in Colombo from 1940 to 1945, where he excelled, obtaining a First Class at the final MBBS, with distinctions and gold medals for Medicine and Surgery. But rather than earning money in one of these lucrative fields, he opted to do research and teaching, and joined the Faculty of Medicine, University of Ceylon as a Lecturer in Pharmacology. Typically, he repaid his scholarship funds so that another student would benefit.

After completing his PhD in Edinburgh, he became the first Professor of Pharmacology in Sri Lanka, in 1958. In 1962 he moved to Peradeniya where he established the Pharmacology Department, and played an innovative role as the Dean of the Medical Faculty, from 1967-70, giving it a unique character. He was popular with both students and staff. He was an excellent lecturer who often spoke without notes.

But he is best known and remembered for his pharmaceutical reforms, which had a global impact. He established the State Pharmaceutical Corporation (SPC) in September 1971 and became its first Chairman. After the Lanka Sama Samaja Party (LSSP) was thrown out of the Coalition Government in 1975, lacking the support required to carry forward his reforms, he left the SPC. He joined UNCTAD as a Senior Advisor and Consultant on Pharmaceutical Policy in March 1977.

This great visionary was my teacher, my friend, my fellow medical scientist and researcher, and most of all, my comrade in the Socialist party, the Lanka Sama Samaja Party. It was this broad scientific socialist outlook and commitment that was at the root of his revolutionary drug reforms. His commitment was evident when he agreed to contest an ugly Municipal by-election, for Kuppiawatte, at the height of the language crisis, at the request of the Party. It was this fighting spirit that enabled him to face and fight the might of the TNCs, to carry through his drug reforms.

But they eventually got him. He died under very suspicious circumstances (was killed, in my opinion) on September 29, 1977 in Guyana, while on a mission to introduce his drug reforms, for UNCTAD. But they could not kill his ideas which are being implemented successfully in many Third World countries, like Bangladesh, though unfortunately, not properly in Sri Lanka.

Senaka Bibile’s legacy

The aim of Senaka Bibile’s pharmaceutical policy could be summarised as follows: “Effective safe medicines for all. Affordable to those able to pay, free for those who cannot”. What has prevented this very desirable policy being achieved?

1. Sri Lanka is part of an international market for pharmaceuticals. In the 1970s, this market was dominated by the Transnational Corporations (TNCs or MNCs).

Seventy percent of this market was controlled by a few huge drug companies or TNCs from just six countries (USA, UK, France, Germany, Switzerland and Japan). Since then, Indian drug giants such as CIPLA and Ranbaxy have also come up and in countries such as Sri Lanka, they are directly supplying the market and tending to play a similar dominating role.

2.The financial strength of these TNC pharmaceutical companies is evident from their revenue in 2012.

3. Among global industries, the pharmaceutical industry is only second to the armaments industry in size, profits and power, both financial and political. The current attempt by the US Congress to shoot down Obama’s health care proposals is a case in point.

4. Promotion of brand names as against generic names of medicines. Every pharmaceutical preparation or drug has only one scientific or generic name e.g. Paracetamol. But the different pharmaceutical manufacturers can produce and sell it under several brand names e.g. Panadol, Calpol etc. Sometimes 20 or more products.

But there are companies that produce one generic product alone at well below the price of brand products. According to the USA Food and Drug Authority (FDA), “on average the cost of a generic drug is 80 to 85 percent lower than the brand name product. In 2010 alone, the use of FDA-approved generics (in the USA) saved $ 158 billion.”

5. A comparison of the current price of a few commonly used generic drugs in the Sri Lankan market with the highest price branded product (within brackets) gives an idea of the difference in price .

6. How do TNC drug companies make huge profits?

(a) Retaining monopoly control of the generic product that they develop by obtaining a product patent from the Government Patent Office. This is sold under a variety of brand names, and by claiming that these are more effective and safe, boost the prices as indicated above. But this claim is not justified. For example, “in 1966 the Deputy Commissioner of the FDA,USA, declared that 7.8 percent of generic drugs and 8.8 percent of branded drugs were not up to acceptable potency” (quoted by Prof. Colvin Guneratne).

(b) Boost brand names through advertisements and promotions among doctors, pharmacies, hospital managers and government administrators, policy makers and drug regulators.

(c) Through misinformation and perks, influence doctors to prescribe, pharmacists to sell, and regulators and administrators to register and promote more expensive brands.

Senaka Bibile reforms

What Senaka Bibile achieved can be summarised as follows:

He showed that there were innumerable brands of a particular medicine imported into Sri Lanka and that the more expensive ones dominated the market. For example, there were 23 brands of tetracycline. What Senaka achieved was to ensure that only one generic tetracycline of good quality was imported to Sri Lanka at the lowest price.

He did the same for all other medicines and in 1972 there was an overall saving of more than 40 percent in the drug import bill to the country. All the low cost essential medicines were available throughout the year in government hospitals and in private pharmacies. By insisting on certificates of good manufacturing practice and regular sample testing, he ensured their quality. Every patient got the medicines he needed at all times.

How did Senaka Bibile achieve this?

Senaka Bibile and Dr. S.A. Wickremasinghe presented a detailed report of their proposals to the Prime Minister Sirimavo Bandaranaike. What he did follows:

(1) Established the State Pharmaceuticals Corporation (SPC) in 1971. All imports of drugs to Sri Lanka (for both public and private sectors) were by the SPC. After estimating our national requirements, the SPC called for bulk tenders worldwide on the basis of generic names, so that TNCs were forced to compete with each other and also with producers of generic drugs. The immense benefit to the country can be seen through this example of the purchase of our requirement of Diazepam.

The TNC of Switzerland, reduced the price of their Valium from 91 cents per tablet to 51 cents. But Ranbaxy of India offered Diazepam at 2 cents per tablet. After obtaining Certificates of Good Manufacturing Practice (CGMP), and getting adequate samples tested, to ensure the quality, the SPC purchased the diazepam from Ranbaxy, with a great saving to the country and the patient.

(2) While stressing the need for quality assurance, Senaka mooted the need for a national laboratory that would ensure the quality of drugs. The National Drug Quality Assurance Laboratory (NDQAL) was a later outcome. Pending this, Senaka prevailed on Dr. H.R. Wickremasinghe, the Pathologist at the General Hospital, Colombo to provide the services of a quality control laboratory. He also ensured quality, by insisting on CGMP when registering a drug supplier, and valid sample test reports at registration, awarding tenders, and delivery, backed by random testing of samples.

(3) Compiling an essential drug list to greatly reduce the number of drugs imported to the country, particularly those that were of no real benefit to patients. He proposed amending the patent to break the monopoly control of the TNCs. Though it was not implemented, he purchased drugs from the Eastern European communist countries that did not observe patent rights. He insisted on replacing brand names by generic names when tendering, prescribing and selling medicines.

(4) Senaka promoted the development of a local pharmaceutical industry regulated by the Government and with a State institution to compliment the activities of the SPC. This idea came into fruition later with the establishment of the State Pharmaceutical Manufacturing Corporation (SPMC). The importance of the SPMC is evident – it manufactures and sells a 500mg amoxycillin capsule at Rs.1.85, while the private brand product sells at Rs. 12.50.

(5) Senaka stressed the need to train pharmacists, for both the State and private sectors, and the need for proper storage and distribution of drugs.

Open economy and undermining of Bibile’s policies

Major changes included the progressive taking away of private sector import of medicines from the SPC and handing it back to the private importers. This enabled the TNCs once again to influence and even control the sector, so that high cost brands have come to dominate the market, and the import cost to the nation has also gone up (the private sector import cost was less than the State sector during Senaka’s time, but today while the State sector import bill is about Rs. 15 billion, the private sector import bill exceeds Rs. 50 billion). The limitation of the essential drug list no longer applies and over 13,000 brands are now imported with many unsuitable combinations, as well as high priced and poor quality medicines. The price control that was in place (c.i.f. cost +65 percent) was also totally removed so that fancy prices are charged.

But while the SPC continues to import for the State sector, it is regrettable that the levels of honesty and efficiency of the Senaka Bibile era is lacking today among some sections. Failure to order the actual requirement for the State sector in time, and the lack of quality control, leading to the rejection and destruction of poor quality medicines, leads to perpetual shortages. The limited budget of the State hospitals is exhausted on local purchase of high cost brands. This leads to further shortages, forcing patients to take prescriptions to private pharmacies for many of the medicines.

When the poor patients are unable to take the full course of medicine due to lack of money, the illness persists, and drug resistance among the infectious agents in the community arises. The need for more expensive and more powerful antibiotics arises in the community thereafter.

The SPMC ensured the regular manufacture and supply of over 50 of the most commonly required medicines for the State sector, so that there were no shortages, and by frequent testing, the quality was ensured. But as the policy of the SPMC has been changed to one of generating a profit, the SPMC is also selling to private pharmacies so that less is available for the State sector.

Unlike in Senaka Bibile’s time, today’s situation can be summarised as being one of “chronic shortages of medicines in the State health sector aggravated by frequent quality failures, and unaffordable or poor quality medicines in the private sector”.

Rectifying the situation

1. The National Medicinal Drug Policy, which is long overdue from the legal draftsman, should be made public forthwith.

2. The establishment of an Autonomous Drug Regulatory Authority (ADRA) with the necessary expertise answerable to the Minister of Health. This body should regulate the purchase, supply and prescribing of drugs in both the State and private sectors. It should regulate the imports to both State and private sectors by a strict process of registration of suppliers, with defaulters being blacklisted. Imports should be restricted to generics from the essential drug list for the State sector, and the private sector should be allowed in addition a limited number of good quality branded drugs (say five), as in some countries such as Australia.

3. In the registration of suppliers, Pre-qualification is essential to ensure good quality, and I am happy that the SPC has issued a newspaper notice a few days ago. It must insist on CGMP and adequate testing of samples by the NDQAL or other accredited laboratories.

4. Import and Supply of drugs to the State health sector -

*The SPC must call for global tenders, strictly following documented transparent procedures; give preference when purchasing to (a) the SPMC,(b) Registered local manufacturers, (c) Global suppliers of generic drugs, in that order; and adhere as far as possible to the Essential Drug List.

* The SPC and SPMC having one Board of Management would maximise coordination.
* The SPMC should serve the State health sector and Osu Salas, and not profits.

5. A Confidential Inventory Control System (as in the Bibile era) with an efficient computerised Drug Management Information System would ensure timely supply of drugs to the State sector. The MSD must maintain adequate buffer stocks with proper regional storage facilities.

6. Promote the local pharmaceutical industry (to meet national needs and as an export industry, as Bangladesh has done). The SPMC can be expanded, and branches should be established at suitable locations e.g. in the proposed pharmaceutical manufacturing zone in Chilaw. These measures would ensure that good quality low cost medicines are available in the SPC and pharmacies at all times.

7. Take action to reduce the price of medicinal drugs - (a) Re-introduce price control (b) Increase local manufacture (c) Professional bodies (SLMA, GMOA) and Medical Faculties must ensure that doctors use generic names when prescribing (d) Make it mandatory for pharmacists to stock and offer the cheapest registered generic drugs to the customers (e) The media should educate the public accordingly.

The best tribute to Senaka Bibile is to ensure that every patient receives good quality medicines free for all illnesses in State hospitals, and at affordable prices in the private sector. I am sure the Minister of Health will do all he can to achieve this objective, overcoming the many obstacles. We offer him all our support.

Excerpts from the Senaka Bibile memorial lecture delivered by Minister Tissa Vitarana recently.