Sri Lanka National Pharmaceuticals Policy
Encyclopedia
The Sri Lanka National Pharmaceuticals Policy was established in the 1970s following the submission of a report by Dr S.A. Wickremasinghe and Prof. Seneka Bibile
. It aimed at ensuring that people get good quality drugs
at the lowest possible price and that doctors would prescribe the minimum required drugs to treat the patient's illness. It was a pioneer in the field of rational National pharmaceuticals policy
.
s, giving out biased information about the brand
ed drugs as against those named generically. Doctors often prescribed branded drugs, which were far more expensive than generic drugs, which have the same efficacy.
The United Front
Government of 1970 appointed the Wickremasinghe-Bibile commission of inquiry into this issue and it recommended the establishment a national policy and of a state body to regularise the trade.
In the 1970s Sri Lanka
demonstrated that a state buying agency linked to a national formulary was a viable and powerful instrument for reducing drug costs without compromising quality, for saving foreign exchange, for rationalising drug usage and for supplying essential drugs at reasonable prices to the whole community. This was made possible by the formulation and implementation of an integrated national pharmaceutical policy.
A unique phenomenon about Sri Lanka's pharmaceuticals policy was that the entire programme was conceived, formulated, developed and implemented by Sri Lankan nationals without any form of external aid or assistance.
s. Subsequently the Ministry of Health established a National Formulary Committee (NFC), consisting of representatives from the public and private health sectors and the University Medical Schools, led by Bibile. It published Formulary Notes for doctors, keeping them updated on developments.
(SPC) was established with Bibile as Chairman. The SPC channelled all imports and production of pharmaceuticals, calling for worldwide bulk tenders
which were limited to the approved drugs listed in the CHF. The public and private health sectors had to obtain all their requirements from the SPC.
Hence the stranglehold of the Multinational corporation
s on the drug trade was successfully broken and they were made to compete with each other and with generic drug producers, enabling the country to obtain drugs much cheaper. Branded drugs were replaced by generic drugs in the prescription and sale of medicines.
In 1972 it imported 52 drugs at a third of their previous prices. In 1973, the SPC itself bought the raw material necessary for 14 private processing laboratories established in the island. Some drug prices dropped by half or two-thirds. The SPC bought from an Indian company the raw material necessary for a widely used tranquilliser at a much lower price than that charged by a Swiss multinational.
In Sri Lanka, drug information was provided from official sources. The Prescriber, a quarterly publication edited by the NFC, was published by the SPC and distributed to all medical personnel. The extravagant promotional practices of drugs manufacturers were stopped to remove the dangers and costs inherent in process.
and other United Nations
agencies with enormous benefit to Third World countries. The United Nations Conference on Trade and Development
Secretariat examined the Sri Lankan experience, concluding that an analysis of the Sri Lankan model could give other developing countries an insight into ways of formulating, developing and implementing integrated national pharmaceutical policies. With Bibile’s assistance, it published "Case Studies in the Transfer of Technology: Pharmaceutical Policies in Sri Lanka". http://r0.unctad.org/en/pressref/stdissue.htm This document has proved to be a very valuable guideline for developing countries intending to initiate pharmaceutical reforms. Translated into other languages, it may be found with health planners of almost every Third World country.
in the United States met Sri Lanka's ambassador in Washington, D.C.
and handed him a letter addressed to the Prime Minister of Sri Lanka from the President of the Pharmaceutical Manufacturer's Association (PMA) of the US. The letter concluded with a statement that the PMA believed that the proposed actions would have most serious effects not only on the pharmaceutical industry and on all private industry in Sri Lanka but potentially for the health of its citizens.
The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) issued a statement to UNCTAD strongly criticising the UNCTAD report on the Sri Lankan pharmaceutical policies.
Government of 1977. There was continued government control of the types of drugs imported, but permission was given to the private sector to import multiple brands. The SPC was never dissolved and continued to supply affordable drugs, continuing to be responsible for centralised procurement for the government health sector.
In 1987 the Pharmaceuticals Manufacturing Corporation was established to import raw materials and manufacture generic drugs. This has effectively withstood very strong pressures for privatisation.
The earlier centrally controlled system enabled effective monitoring. However, at present, because of decentralisation of drug supply, while standard treatment guidelines are available, there is no effective monitoring system for prescription practices is in place; there is little quality assessment and no incentive for rational use.
In 2005 the United People's Freedom Alliance
Government promised to establish a National Medicinal Drugs Policy
(NMPD) that would enable Sri Lankans significantly to cut down on drug expenses and get quality drugs at affordable prices while saving billions of rupee
s in foreign exchange for the country. Implementation of the NMDP could reduce the number of drugs imported, prescribed and sold in Sri Lanka to about 350 varieties.
Seneka Bibile
Senaka Bibile was a Sri Lankan pharmacologist. He was the founder of Sri Lanka’s drug policy, which was used as a model for development of policies based on rational pharmaceutical use in other countries as well by the World Health Organization, the United Nations Conference on Trade and...
. It aimed at ensuring that people get good quality drugs
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
at the lowest possible price and that doctors would prescribe the minimum required drugs to treat the patient's illness. It was a pioneer in the field of rational National pharmaceuticals policy
National pharmaceuticals policy
A National Pharmaceuticals Policy is one that aims at ensuring that people get good quality drugs at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patient's illness...
.
Background
At the time, pharmaceutical companies were making considerable money by selling drugs under their trade nameTrade name
A trade name, also known as a trading name or a business name, is the name which a business trades under for commercial purposes, although its registered, legal name, used for contracts and other formal situations, may be another....
s, giving out biased information about the brand
Brand
The American Marketing Association defines a brand as a "Name, term, design, symbol, or any other feature that identifies one seller's good or service as distinct from those of other sellers."...
ed drugs as against those named generically. Doctors often prescribed branded drugs, which were far more expensive than generic drugs, which have the same efficacy.
The United Front
United Front (Sri Lanka)
The United Front was a political alliance in Sri Lanka, formed by the Sri Lanka Freedom Party , the Lanka Sama Samaja Party and the Communist Party of Sri Lanka in 1968...
Government of 1970 appointed the Wickremasinghe-Bibile commission of inquiry into this issue and it recommended the establishment a national policy and of a state body to regularise the trade.
In the 1970s Sri Lanka
Sri Lanka
Sri Lanka, officially the Democratic Socialist Republic of Sri Lanka is a country off the southern coast of the Indian subcontinent. Known until 1972 as Ceylon , Sri Lanka is an island surrounded by the Indian Ocean, the Gulf of Mannar and the Palk Strait, and lies in the vicinity of India and the...
demonstrated that a state buying agency linked to a national formulary was a viable and powerful instrument for reducing drug costs without compromising quality, for saving foreign exchange, for rationalising drug usage and for supplying essential drugs at reasonable prices to the whole community. This was made possible by the formulation and implementation of an integrated national pharmaceutical policy.
A unique phenomenon about Sri Lanka's pharmaceuticals policy was that the entire programme was conceived, formulated, developed and implemented by Sri Lankan nationals without any form of external aid or assistance.
National formulary
A careful selection of drugs is an essential prerequisite of a national pharmaceutical policy. In Sri Lanka, the Ministry of Health requested Prof. Seneka Bibile to look into his matter and he prepared the Ceylon Hospital Formulary (CHF) of about 630 drugs under their generic nameInternational Nonproprietary Name
An International Nonproprietary Name is the official nonproprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization...
s. Subsequently the Ministry of Health established a National Formulary Committee (NFC), consisting of representatives from the public and private health sectors and the University Medical Schools, led by Bibile. It published Formulary Notes for doctors, keeping them updated on developments.
State buying agency
Accordingly, in 1971 the State Pharmaceuticals Corporation of Sri LankaState Pharmaceuticals Corporation of Sri Lanka
The State Pharmaceuticals Corporation is a state-owned enterprise with its headquarters in Colombo, Sri Lanka. It is the largest supplier of drugs in the country, and is tasked with providing quality-assured health care items that are safe and effective, at an affordable price, while educating the...
(SPC) was established with Bibile as Chairman. The SPC channelled all imports and production of pharmaceuticals, calling for worldwide bulk tenders
Request for tender
A request for tender, commonly abbreviated to RFT, is a formal, structured invitation to suppliers for the supply of products or services. In the public sector, such a process may be required and determined in detail by law to ensure that such competition for the use of public money is open, fair...
which were limited to the approved drugs listed in the CHF. The public and private health sectors had to obtain all their requirements from the SPC.
Hence the stranglehold of the Multinational corporation
Multinational corporation
A multi national corporation or enterprise , is a corporation or an enterprise that manages production or delivers services in more than one country. It can also be referred to as an international corporation...
s on the drug trade was successfully broken and they were made to compete with each other and with generic drug producers, enabling the country to obtain drugs much cheaper. Branded drugs were replaced by generic drugs in the prescription and sale of medicines.
In 1972 it imported 52 drugs at a third of their previous prices. In 1973, the SPC itself bought the raw material necessary for 14 private processing laboratories established in the island. Some drug prices dropped by half or two-thirds. The SPC bought from an Indian company the raw material necessary for a widely used tranquilliser at a much lower price than that charged by a Swiss multinational.
Drug information
It is essential that correct information on drugs and therapeutics be given to all medical personnel. The promotional material provided by the drugs manufacturers tends to be distorted in favour of their own products and adds to the costs of supplying drugs.In Sri Lanka, drug information was provided from official sources. The Prescriber, a quarterly publication edited by the NFC, was published by the SPC and distributed to all medical personnel. The extravagant promotional practices of drugs manufacturers were stopped to remove the dangers and costs inherent in process.
International experience
The Sri Lanka experience became a model for the rest of the world. The policy was supported by the World Health OrganizationWorld Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
and other United Nations
United Nations
The United Nations is an international organization whose stated aims are facilitating cooperation in international law, international security, economic development, social progress, human rights, and achievement of world peace...
agencies with enormous benefit to Third World countries. The United Nations Conference on Trade and Development
United Nations Conference on Trade and Development
The United Nations Conference on Trade and Development was established in 1964 as a permanent intergovernmental body. It is the principal organ of the United Nations General Assembly dealing with trade, investment, and development issues....
Secretariat examined the Sri Lankan experience, concluding that an analysis of the Sri Lankan model could give other developing countries an insight into ways of formulating, developing and implementing integrated national pharmaceutical policies. With Bibile’s assistance, it published "Case Studies in the Transfer of Technology: Pharmaceutical Policies in Sri Lanka". http://r0.unctad.org/en/pressref/stdissue.htm This document has proved to be a very valuable guideline for developing countries intending to initiate pharmaceutical reforms. Translated into other languages, it may be found with health planners of almost every Third World country.
Reaction of pharmaceutical companies
The first response from the multi-national corporations came in May 1973. Executives of the major pharmaceutical companiesPharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
in the United States met Sri Lanka's ambassador in Washington, D.C.
Washington, D.C.
Washington, D.C., formally the District of Columbia and commonly referred to as Washington, "the District", or simply D.C., is the capital of the United States. On July 16, 1790, the United States Congress approved the creation of a permanent national capital as permitted by the U.S. Constitution....
and handed him a letter addressed to the Prime Minister of Sri Lanka from the President of the Pharmaceutical Manufacturer's Association (PMA) of the US. The letter concluded with a statement that the PMA believed that the proposed actions would have most serious effects not only on the pharmaceutical industry and on all private industry in Sri Lanka but potentially for the health of its citizens.
The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) issued a statement to UNCTAD strongly criticising the UNCTAD report on the Sri Lankan pharmaceutical policies.
Post-1977 policy
This policy was watered down by the multi-national-friendly United National PartyUnited National Party
The United National Party, often referred to as the UNP ), , is a political party in Sri Lanka. It currently is the main opposition party in Sri Lanka and is headed by Ranil Wickremesinghe...
Government of 1977. There was continued government control of the types of drugs imported, but permission was given to the private sector to import multiple brands. The SPC was never dissolved and continued to supply affordable drugs, continuing to be responsible for centralised procurement for the government health sector.
In 1987 the Pharmaceuticals Manufacturing Corporation was established to import raw materials and manufacture generic drugs. This has effectively withstood very strong pressures for privatisation.
The earlier centrally controlled system enabled effective monitoring. However, at present, because of decentralisation of drug supply, while standard treatment guidelines are available, there is no effective monitoring system for prescription practices is in place; there is little quality assessment and no incentive for rational use.
In 2005 the United People's Freedom Alliance
United People's Freedom Alliance
The United People's Freedom Alliance is a political alliance in Sri Lanka. The current leader of the United People's Freedom Alliance is Mahinda Rajapaksa and Susil Premajayantha is the general secretary of UPFA.The alliance was formed by:...
Government promised to establish a National Medicinal Drugs Policy
National Medicinal Drugs Policy
The National Medicinal Drugs Policy is an essential part of Sri Lanka's Health Policy, aimed at the rational use of pharmaceuticals.By the beginning of the 21st Century, Sri Lanka had approximately 9,000 registered medicinal drugs, hundreds of which were non-essential, unnecessary, highly...
(NMPD) that would enable Sri Lankans significantly to cut down on drug expenses and get quality drugs at affordable prices while saving billions of rupee
Sri Lankan rupee
The rupee is the currency of Sri Lanka, divided into 100 cents. It is issued by the Central Bank of Sri Lanka and is generally written Rs. The rupee (Sinhala: රුපියල , Tamil: ரூபாய்) (sign: ₨; code: LKR) is the currency of Sri Lanka, divided into 100 cents. It is issued by the Central Bank of Sri...
s in foreign exchange for the country. Implementation of the NMDP could reduce the number of drugs imported, prescribed and sold in Sri Lanka to about 350 varieties.
See also
- National pharmaceuticals policyNational pharmaceuticals policyA National Pharmaceuticals Policy is one that aims at ensuring that people get good quality drugs at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patient's illness...
- Chilean pharmaceutical policyChilean pharmaceutical policyThe Chilean Pharmaceutical Policy was an attempt in the 1960s and 1970s to introduce a rational national pharmaceuticals policy. Chile was perhaps the first country in the world to introduce the concept of a limited number of essential drugs....
- Medicare Part DMedicare Part DMedicare Part D is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States. It was enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and went into effect on January 1, 2006.- Eligibility and...
- Medicare Prescription Drug, Improvement, and Modernization ActMedicare Prescription Drug, Improvement, and Modernization ActThe Medicare Prescription Drug, Improvement, and Modernization Act is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history.The MMA was signed by President George W...
- Prescription drug prices in the United StatesPrescription drug prices in the United StatesPrescription drug prices in the United States are the highest in the world. "The prices Americans pay for prescription drugs, which are far higher than those paid by citizens of any other developed country, help explain why the pharmaceutical industry is — and has been for years — the most...
- Seneka BibileSeneka BibileSenaka Bibile was a Sri Lankan pharmacologist. He was the founder of Sri Lanka’s drug policy, which was used as a model for development of policies based on rational pharmaceutical use in other countries as well by the World Health Organization, the United Nations Conference on Trade and...
- State Pharmaceuticals Corporation of Sri LankaState Pharmaceuticals Corporation of Sri LankaThe State Pharmaceuticals Corporation is a state-owned enterprise with its headquarters in Colombo, Sri Lanka. It is the largest supplier of drugs in the country, and is tasked with providing quality-assured health care items that are safe and effective, at an affordable price, while educating the...