National pharmaceuticals policy
Encyclopedia
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. The pioneers in this field were Chile
and Sri Lanka
.
s, promoting the brand
ed drugs as against those named generically. Doctors often prescribe branded drugs which are more expensive than generic drugs which have the same efficacy.
In the 1960s and 1970s Chile attempted to introduce a rational policy, based on a limited number of essential drugs. The Chilean pharmaceutical policy
failed due to pressure from the pharmaceutical industry. 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.
The Sri Lanka experience
became a model for the rest of the world.
which are limited to the approved drugs listed in the national formulary. The public and private health sectors must obtain all their requirements from the central buying agency.
In Chile
in 1971, the government of Dr Salvador Allende
organised centralised bulk procurement and the first international tender for raw materials was called. However, the pharmaceutical industry struck back and, in the three months following the call for tender, widely used drugs disappeared from the market, including analgesics and antibiotics. The manufacturers had cut their production. They agreed to replenish the market within one week only if the international tenders were called off. In 1972, the government was forced to succumb and called off the tenders.
In Sri Lanka the Sri Lanka State Pharmaceuticals Corporation
(SPC) was established in 1972 with Bibile as Chairman. Hence the stranglehold of the Multi National Corporations 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 India
n 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.
(WHO) 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.
The "Guide to Good Prescribing" has been translated into 18 languages and adopted by teaching institutions throughout the world.
The WHO took Sri Lanka's experience to the rest of the World, with the result that by 2000:
Bangladesh
is a least developed country which has confirmed and reiterated that it is within the capabilities countries with limited resources to successfully introduce an integrated national pharmaceutical policy.
The Chilean experience showed the power of the pharmaceuticals giants. The successful implementation of pharmaceutical reforms in Sri Lanka and Bangladesh was due to the presence of the vital ingredient of political will with which real progress is possible.
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 prescribe the minimum of required drugs in order to treat the patient's illness. The pioneers in this field were Chile
Chile
Chile ,officially the Republic of Chile , is a country in South America occupying a long, narrow coastal strip between the Andes mountains to the east and the Pacific Ocean to the west. It borders Peru to the north, Bolivia to the northeast, Argentina to the east, and the Drake Passage in the far...
and 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...
.
Background
A rational drug policy is one based on drug use in which patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community. Pharmaceutical companies make 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, promoting 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 prescribe branded drugs which are more expensive than generic drugs which have the same efficacy.
In the 1960s and 1970s Chile attempted to introduce a rational policy, based on a limited number of essential drugs. The Chilean pharmaceutical policy
Chilean pharmaceutical policy
The 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....
failed due to pressure from the pharmaceutical industry. 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.
The Sri Lanka experience
Sri Lanka National Pharmaceuticals Policy
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...
became a model for the rest of the world.
Causes of irrational drug use
- Irrational prescribing practices of doctors
- Dispensing by pharmacists and drug sellers
- Drug pricing policies and promotional activities of the pharmaceutical industry
- Lack of information, education and communication on rational drug use to providers and consumers
- Lack of effective control and regulatory mechanisms on drug use and
- Lack of political will and leadership to promote rational use.
Centralised buying agency
Under an integrated national pharmaceutical policy, the central buying agency channells all imports and production of pharmaceuticals, calling for worldwide bulk tendersRequest 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 are limited to the approved drugs listed in the national formulary. The public and private health sectors must obtain all their requirements from the central buying agency.
In Chile
Chile
Chile ,officially the Republic of Chile , is a country in South America occupying a long, narrow coastal strip between the Andes mountains to the east and the Pacific Ocean to the west. It borders Peru to the north, Bolivia to the northeast, Argentina to the east, and the Drake Passage in the far...
in 1971, the government of Dr Salvador Allende
Salvador Allende
Salvador Allende Gossens was a Chilean physician and politician who is generally considered the first democratically elected Marxist to become president of a country in Latin America....
organised centralised bulk procurement and the first international tender for raw materials was called. However, the pharmaceutical industry struck back and, in the three months following the call for tender, widely used drugs disappeared from the market, including analgesics and antibiotics. The manufacturers had cut their production. They agreed to replenish the market within one week only if the international tenders were called off. In 1972, the government was forced to succumb and called off the tenders.
In Sri Lanka the Sri Lanka State Pharmaceuticals Corporation
State 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 in 1972 with Bibile as Chairman. Hence the stranglehold of the Multi National Corporations 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 India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
n 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 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 Lankan policy was supported by 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...
(WHO) 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
Third World
The term Third World arose during the Cold War to define countries that remained non-aligned with either capitalism and NATO , or communism and the Soviet Union...
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.
The "Guide to Good Prescribing" has been translated into 18 languages and adopted by teaching institutions throughout the world.
The WHO took Sri Lanka's experience to the rest of the World, with the result that by 2000:
- over 100 countries had national pharmaceuticals policies,
- 156 countries had national or provincial essential medicinesEssential medicinesEssential medicines, as defined by the World Health Organization are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford."The WHO...
lists
- 135 countries had national treatment guidelines/formulary manuals
- 88 countries had introduced the essential drug concept into medical and pharmacy curricula.
Bangladesh
Bangladesh
Bangladesh , officially the People's Republic of Bangladesh is a sovereign state located in South Asia. It is bordered by India on all sides except for a small border with Burma to the far southeast and by the Bay of Bengal to the south...
is a least developed country which has confirmed and reiterated that it is within the capabilities countries with limited resources to successfully introduce an integrated national pharmaceutical policy.
The Chilean experience showed the power of the pharmaceuticals giants. The successful implementation of pharmaceutical reforms in Sri Lanka and Bangladesh was due to the presence of the vital ingredient of political will with which real progress is possible.
See also
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- pharmaceutical policyPharmaceutical policyPharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs , biologics , vaccines and natural health products...
- 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...
- National Medicinal Drugs PolicyNational Medicinal Drugs PolicyThe 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...
- Pharmaceutical companyPharmaceutical companyThe 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...
- 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...
- Sri Lanka National Pharmaceuticals PolicySri Lanka National Pharmaceuticals PolicyThe 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...
- 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...
- National Drug Code SystemNational Drug Code SystemThe National Drug Code System is a system that is designed to provide drugs in the United States with a specific 11-digit number that describes the product...