National pharmaceuticals policy

A National Pharmaceuticals Policy is one that aims 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 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 is a country off the southern coast of the Indian subcontinent. The South Asian island nation was known as Ceylon until 1972... .

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 name Trade 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 A brand is the identity of a specific product, service, or business.A brand can take many forms, including a name, sign, symbol, color combination or slogan. The word branding began simply as a way to tell one person's cattle from another by means of a hot iron stamp. A legally protected 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 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 tenders Request for tender A request for tender, commonly abbreviated to RFT, is a structured invitation to suppliers for the supply of products and/or services.As a consequence of the scale and of the tender process the majority of RFTs are published by government sector agencies at the local, state and federal levels... 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 Isabelino del Sagrado Corazn de Jess Allende Gossens was a Chilean physician and 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 (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 , conventional long name Republic of India , is a state located 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 WHO and other UN agencies with enormous benefit to Third World Third World The term "Third World" arose during the Cold War to define countries that remained nonaligned with either capitalism and NATO , or communism and the Soviet Union... countries. The UNCTAD 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 Bibiles 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 World Health Organisation (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 medicines Essential medicines Essential 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

ICH pharmaceutical policy Pharmaceutical policy Pharmaceutical 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 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....

Medicare Part D Medicare Part D Medicare 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 Act Medicare Prescription Drug, Improvement, and Modernization Act The 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 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 nonessential, unnecessary, highly...

Pharmaceutical company Prescription drug prices in the United States Seneka Bibile Seneka Bibile Senaka Bibile was a Sri Lankan pharmacologist. He was the founder of Sri Lankas drug policy , which was used as a model for development of policies based on rational

pharmaceutical use in other countries as well by the WHO, UNCTAD and the NonAligned Movement...

Sri Lanka National Pharmaceuticals Policy State Pharmaceuticals Corporation of Sri Lanka National Drug Code System National Drug Code System The 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...

The Sri Lanka Sri Lanka Sri Lanka is a country off the southern coast of the Indian subcontinent. The South Asian island nation was known as Ceylon until 1972... National Pharmaceuticals Policy was established in the 1970s following the submission of a report by Dr S.A. Wickremasinghe and Prof. Seneka Bibile Seneka Bibile Senaka Bibile was a Sri Lankan pharmacologist. He was the founder of Sri Lankas drug policy , which was used as a model for development of policies based on rational pharmaceutical use in other countries as well by the WHO, UNCTAD and the Non-Aligned Movement... . 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 .

Background

At the time, pharmaceutical companies were making considerable money by selling drugs under their trade name Trade 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 A brand is the identity of a specific product, service, or business.A brand can take many forms, including a name, sign, symbol, color combination or slogan. The word branding began simply as a way to tell one person's cattle from another by means of a hot iron stamp. A legally protected 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 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 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 Seneka Bibile Senaka Bibile was a Sri Lankan pharmacologist. He was the founder of Sri Lankas drug policy , which was used as a model for development of policies based on rational pharmaceutical use in other countries as well by the WHO, UNCTAD and the Non-Aligned Movement...

to look into his matter and he prepared the Ceylon Hospital Formulary (CHF) of about 630 drugs under their generic name International Nonproprietary Name An International Nonproprietary Name is the official non-proprietary 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 Lanka 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 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 structured invitation to suppliers for the supply of products and/or services.As a consequence of the scale and of the tender process the majority of RFTs are published by government sector agencies at the local, state and federal levels... 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 multinational 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 WHO and other UN agencies with enormous benefit to Third World countries. The UNCTAD 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 Bibiles 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 Giants

The first response from the Multi-National Corporations came in May 1973. Executives of the major pharmaceutical companies Pharmaceutical 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 Ambassador An ambassador is the highest ranking diplomat who represents a nation and is usually accredited to a foreign sovereign or government, or to an international organization.... in Washington DC 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 IFPMA The International Federation of Pharmaceutical Manufacturers & Associations is the global nonprofit NGO representing the research-based pharmaceutical industry, including the biotech and vaccine sectors. Its members comprise 25 leading international companies and 45 national and regional industry... ) 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 Party United 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 Rupee The rupee is the common name for the monetary unit of account in India, Sri Lanka, Nepal, Pakistan, Mauritius, Seychelles, Indonesia, Maldives and formerly in Burma, and Afghanistan.In the Maldives, the unit of currency is known as the rufiyah, which is a cognate word of Hindi rupiya... 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

Seneka Bibile (February 13 1920 - September 29 1977) pharmacologist, 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 WHO,UNCTAD and the Non Aligned Movement.

He has been called the `greatest medical benefactor of humanity that Sri Lanka has hitherto produced`. This trail blazing legend in his own time, was born at Kathaluwa near Galle. His father was Charles Bibile, a Rate Mahathmaya or Chief Native Feudal Official, his mother Sylvia Jayawardana of Kathaluwa Walauwa, the manor house of the Jayawardana Native Feudal family. The Bibile family

The Bibile family claimed descent from a 16th century Vedda chieftain. He received his primary and secondary education at Trinity College, Kandy, and later entered the Medical College in Colombo, where he had a brilliant career, winning the gold medals for medicine and surgery, and obtained a first class honours degree in 1945. In 1949, he began post-graduate studies at the University of Edinburgh, returning to Sri Lanka in 1952 with a PhD. His early career in research was indicative of great promise. .He joined the University of Ceylon in 1947, net 1947-49 he led a research team of doctors under the guidance of Prof. Cullumbine, Professor of Physiology. In 1958 he was selected as the first Professor of Pharmacology and became the head of a new department. He was the first dean of the faculty of medicine at the University of Peradeniya from 1967 to 1977. There he started the first medical education unit in Sri Lanka. He is best known for his advocacy of the government-controlled pharmaceutical purchasing plans often referred to as `rationalisation` of pharmaceuticals and the development of a national pharmaceuticals policy. He played the leading role in developing such a pharmaceutical policy aimed at ensuring that impoverished people would get reasonable drugs at a low price. A pharmaceutical patenting law is now threatening to disturb this drugs policy. Further, the programs begun by Bibile are aimed towards ensuring that doctors prescribe the minimum required drugs to treat the patient`s illness. A careful selection of drugs was an essential component of the policies he advocated. He was called up by the Minister of Health to address this issue, and prepared the Ceylon Hospital Formulary of about 630 drugs under their generic names almost singlehandedly. Subsequently the National Formulary Committee (NFC), consisting of representatives from the public and private health sectors and the University Medical Schools, was set up with him as its first chairman. The NFC published Formulary Notes for the use of doctors, which later became The Prescriber. At the time, it was alleged and widely believed that Pharmaceutical companies in the country made considerable money by selling drugs under their trade names, giving out biased information about the branded drugs as against those named generically. The United Front Government of 1970 appointed Dr. S. A. Wickremasinghe and Dr. Bibile to lead a commission of inquiry to investigate this issue and they recommended the establishment of a national policy and of a state body to regularise the trade.

Accordingly, in 1971 T. B. Subasinghe, the Minister of Industries, appointed Dr Bibile as founder chairman of the Sri Lanka State Pharmaceuticals Corporation (SPC). The SPC channelled all imports of pharmaceuticals. The SPC also called for worldwide bulk tenders which were limited to the approved drugs listed in the national formulary. The public and private health sectors obtained all their requirements from the SPC. Hence the drug trade was regulated by this body and vendors were forced to compete with each other and with generic drug producers on a cost basis only. This program is generally perceived to have resulted in a cheaper drug supply for poor countries. This trail blazing policy was supported later by WHO and other UN agencies with enormous benefit to Third World countries. The UNCTAD 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, UNCTAD published `Case Studies in the Transfer of Technology: Pharmaceutical Policies in Sri Lanka`. 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. Although his policy was watered down by the United National Party Government of 1977, which re-opened the doors to unrestricted imports, the SPC was never dissolved and continued to supply affordable drugs. NMPD 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 Rupees 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. Bibile`s contribution to development in the area of drugs was acknowledged publicly during the 35th World Health Assembly, in Geneva in May 1982. It has been alleged by some conspiracy theorists that it is possible that the threat he posed to the powerful drugs Multi-nationals may have had some bearing on his premature death in 1977 while on a UN assignment in Guyana to introduce these policies there. It`s not known very much that Bibile was a Trotskyist, a member of the Lanka Sama Samaja Party becoming Treasurer of its Youth Leagues in his early years. He conducted study classes on Marxism at his house in Castle Street, Colombo. At the height of the language issue crisis, when the LSSP stood for both Sinhala and Tamil being state languages, he agreed to contest a by-election seat in the Colombo Municipal Council as the LSSP candidate, to fight for that principle, risking his life in the process and facing certain defeat

in

an

atmosphere

of

ethnic

animosity.

Dr. Bibile was the author of over 45 publications, including: Bibile, S, and Lall, S, `The Political Economy of Controlling Transnationals: The Pharmaceutical Industry in Sri Lanka (1972-76)`, World Development, August 1977. An oration is held every year in commemoration of Seneka Bibile, under the auspices of the Kandy Society of Medicine.