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The Who'S Who of International Pharmaceutical organizations
•
THE
1\fH[]'s 1\fH[] []f PHflR~flLELJTH~fll
By ALBERT I. WERTHEIMER
T
he production, research, distribution, promotion, export, and other functions related to the use pharmacologically active substanc Albert I. Wertheimer, PhD, is professor are not simple matters. These fun and head of the department of social and tions are conducted primarily by administrative pharmacy at the Univervate companies or governmen sity of Minnesota, 308 Harvard Street, agencies in many countries throughSE, Minneapolis, MN 55455,. Wertout the world. They are regulated heimer has been actively involved for and monitored by a large number of more than a decade in international national, regional and international pharmacy issues, particularly through agencies in a complex geosociopolthe Federation Internationale Pharmaitical environment. ceutique (FIP). He has held a postdocA number of international organitoral fellowship at St. Thomas' Hospital zations exist to foster health care Medical School, University of London, and research around the world. where he studied the British National Many of these devote considerable Health Service, and a fellowship in money, time, manpower, and other Stockholm, Sweden, at the Apoteksbolaresources primarily to pharmaceuget, the government corporation which - ticals. A large number of them deal operates the pharmacies in that country. directly with the delivery of health He also conducted a comparative study care, but some exist to foster interof the pharmacy systems of Eastern Eunational technical cooperation, to rope under a grant from the National regulate and stimulate the developInstitutes of Health. Wertheimer spent ment of trade, to promote the industhree months early this year studying at trialization of lesser developed World Health Organization headquarcountries, and to provide direction ters in Geneva under a fellowship from to programs and projects that will the American Foundation for Pharmalead to better and cheaper pharmaceutical Education. ceuticals. 18
The principal international health organization is the World Health Organization (WHO) based in Geneva, Switzerland. WHO, which is a United Nations organization, is a giant on the international scene and is concerned with all sorts of health problems. Through two of its major divisions--pharmaceuticals and the Action Program on Essential DrugsWHO undertakes a number of important functions that have a large impact on pharmaceuticals worldwide. Among other things, WHO's pharmaceuticals arm has the responsibility of producing the International Pharmacopoeia. While this compendium does not have official status in any individual country, it finds many uses because its tests for identity use basic procedures that do not require expensive and complex technological apparatus. In addition to the production of the International Pharmacopoeia, the pharmaceuticals division is also re-
American Pharmacy Vol. NS22, No. 11, November 1982/586
sponsible for selecting international generic names and producing a compendium listing those names. (Actually, generic names are selected from names submitted by sponsoring organizations like America's USAN Council [U.S. Adopted Names Council] and the Medicines Commission in the United Kingdom. Specific rules govern the nomenclature of new molecular entities, and when the names are granted, the sponsor is notified. The compilation of these names is published by WHO in a publication referred to as the INN [International Nonproprietary Names for Pharmaceutical Substances] which lists the generic names as well as the major branded names under which the product is available throughout the world.) The pharmaceutical division of WHO also publishes a drug bulletin to inform readers of reports of drug problems, adverse reactions, new uses of drugs and other findings regarding the use of drugs in man that are published in the literature throughout the world.
The WHO Action Program on Essential Drugs fosters the use of safe and effective drugs for the populations of all lesser developed countries. The Action Program sponsors a list of approximately 250 essential drugs selected by its expert consultants. These drugs are recommended to WHO member sovereign states for consideration in their import and licensing policies. The Action Program also assists member countries with drug registration procedures, drug legislation, supply and distribution systems, and training consultation and educational materials. A third arm of WHO deals with the Psychotropic Drug Convention of 1971 and is the international coordinating body for the various campaigns to control use of psychotropic agents. The World Health Organization operates through its regional offices in Alexandria, Egypt; Brazzaville, Congo Brazzaville; Manila, Philippines; Copenhagen, Denmark; New
American Pharmacy Vol. NS22, No. 11, November 1982/587
Delhi, India; and Washington, DC. In Washington, the Pan American Health Organization (PAHO) coordinates WHO health initiatives throughout the Western Hemisphere. It shares knowledge and experience and serves as a coordinating body, with focus on Latin America. Experts are sent to member countries to assist with national formularies, drug control regulations, and a host of health-related projects. A separate international organization within the United Nations family is UNIDO, the United Nations Industrial Development Organization. Essentially, UNIDO acts as a roker for technology in an effort o assist nations in increasing their domestic technological enterprises. This also means increasing the production of trained individuals; and the potential for export ~les, or at the ~ery least, the conservation of fo eign exchange by buying smaller quantities of imports from the developed nations. UNIDO has an active group that assists member nations in making requests for specific production facilities. The United Nations Children's Fund (UNICEF) is still another international organization within the United Nations umbrella. UNICEF supplies aid to children who are victims of catastrophes and serves other needs throughout the world when the health and welfare of children are endangered. UNICEF operates a massive warehouse in Copenhagen which purchases large numbers of pharmaceuticals and health-related items from a very limited list of products on the open market. These drugs and supplies are then repackaged and made available to governments or agencies caring for the needy and displaced throughout the world. UNICEF's drugs are sold at amazingly 19
low costs because of the organization's massive buying power and the ability of this organization to accept products from sources all around the world. UNICEF has offiLes in New York and Geneva as well as in other locations. UNCTAD, the United Nations Conference on Trade and Development, has as its mission the furtherance of trade and development for lesser developed countries. UNCTAD publishes studies and sends consultants to nations to assist them in developing their resources and help them in promoting their products throughout the world. It aids nations in the establishment of priorities and step-by-step procedures for the creation of various industrial enterprises. UNCTAD has assisted a number of nations in the development of rudimentary pharmaceutical industries, even in the production of single chemical items or for the production of certain chemical families. UNCTAD has developed case studies describing the pharmaceutical industry in a number of developing countries. A related agency called UNDP, United Nations Development Program, assists in the development of industrialization among its member states. UNDP is closely related to the other programs and has not had a great deal of direct activity in the pharmaceutical sphere to date. On the other hand, UNDTCD, the United Nations Department of Technical Cooperation for Development (formerly, the Action Program for Economic Cooperation), has been very active in assisting nations when a specific technological problem arises. This office is able to facilitate problem-solving and provide technical assistance to lesser developed countries through the use of consultants and its own reference and resource materials. A number of local or regional banks assist in technological development throughout the world. These organizations lend money to stimulate economic development in their respective areas of the world and in doing so increase the industrial capacity and productivity in virtually any economic sphere. There has been some limited in20
volvement in the pharmaceutical industry with some of these regional development banks, most notably the Caribbean Community Program (Caricom), the African and Asian development banks, and the South Pacific Economic Community (SPEC). The Andean Pact in South America is another organization intended to stimulate economic development through loans and assistance. All these banks and loan organizations, which are funded by their respective member governments, facilitate and cooperate in the exchange of information and programs for the benefit of all their member constituencies.
Pharmaceutical Organizations Closer to working pharmacy is FIP, the Federation Internationale Pharmaceutique, an organization composed of various national pharmaceutical organizations and their respective members, who may be associate members of the FIP. The International Federation of Pharmaceutical Manufacturers Associations (IFPMA), on the other hand, is responsible for representing the international pharmaceutical industry in its various battles and problems throughout the world. IFPMA has published some excellent reviews of the regulations for marketing approval and registration of prescription drugs in various countries and coordinates efforts on the international level for the pharmaceutical industry. There are dozens of other international pharmaceutically related organizations, especially those for pharmacy practitioners, but the last two mentioned organizations are the only ones that are officially recognized as nongovernmental organizations (NGOs) by WHO. These two-FIP and IFPMA-have assigned seats for their delegates and are permitted to speak on the floor at WHO meetings. In the realm of nonprescription drugs, the World Federation of Proprietary Medicine Manufacturers (WFPMM) looks after the interests of its member firms who produce drugs for self-medication and overthe-counter sale. WFPMM sponsors
programs and studies dealing with the use of nonprescribed mecticine. The Council for International Organizations of Medical Sciences (CIOMS) is a Geneva-based organization primarily involved in programs and educational activities dealing with medical ethics and jurisprudence in topics ranging from drug trials to informed consent and the use of human subjects in clinical trials. The World Bank studies health care delivery systems and has sponsored studies intended to produce more efficient and economical health care delivery and distribution systems. Currently the World Bank has researchers studying the pharmaceutical sector. The Council of Europe has stan· dardized a number of parameters dealing with international standards of pharmacy education, products for registration, pharmacy education, reciprocity, etc. The United Nations itself provides certain services in the publication of demographic statistics and summary statistics regarding the use, transfer, exchange, sale, and importation of pharmaceutical agents. The United Nations also has a special interest in the use of narcotic and addicting substances. A major U.N. office in Vienna, Austria, is involved in the international establishment of quotas for production and importation and for the conduct regarding the various international agreements and conventions dealing with the use, advertising and control of narcotic and other controllable substances. There are many more international agencies which have been omitted from this brief review since pharmaceuticals are not their major focus. Each of the organizations above has a specific role in pharma· ceuticals and has current ongoing efforts in this area. Pharmacists and pharmacy leaders should have some understanding of the workings of these groups which affect, either di· rectly or indirectly, their profes· sional prerogatives. D
American Pharmacy Vol. NS22, No. 11, November 198:V58f
THE
1\fH[]'s 1\fH[] []f PHflR~flLELJTH~fll
By ALBERT I. WERTHEIMER
T
he production, research, distribution, promotion, export, and other functions related to the use pharmacologically active substanc Albert I. Wertheimer, PhD, is professor are not simple matters. These fun and head of the department of social and tions are conducted primarily by administrative pharmacy at the Univervate companies or governmen sity of Minnesota, 308 Harvard Street, agencies in many countries throughSE, Minneapolis, MN 55455,. Wertout the world. They are regulated heimer has been actively involved for and monitored by a large number of more than a decade in international national, regional and international pharmacy issues, particularly through agencies in a complex geosociopolthe Federation Internationale Pharmaitical environment. ceutique (FIP). He has held a postdocA number of international organitoral fellowship at St. Thomas' Hospital zations exist to foster health care Medical School, University of London, and research around the world. where he studied the British National Many of these devote considerable Health Service, and a fellowship in money, time, manpower, and other Stockholm, Sweden, at the Apoteksbolaresources primarily to pharmaceuget, the government corporation which - ticals. A large number of them deal operates the pharmacies in that country. directly with the delivery of health He also conducted a comparative study care, but some exist to foster interof the pharmacy systems of Eastern Eunational technical cooperation, to rope under a grant from the National regulate and stimulate the developInstitutes of Health. Wertheimer spent ment of trade, to promote the industhree months early this year studying at trialization of lesser developed World Health Organization headquarcountries, and to provide direction ters in Geneva under a fellowship from to programs and projects that will the American Foundation for Pharmalead to better and cheaper pharmaceutical Education. ceuticals. 18
The principal international health organization is the World Health Organization (WHO) based in Geneva, Switzerland. WHO, which is a United Nations organization, is a giant on the international scene and is concerned with all sorts of health problems. Through two of its major divisions--pharmaceuticals and the Action Program on Essential DrugsWHO undertakes a number of important functions that have a large impact on pharmaceuticals worldwide. Among other things, WHO's pharmaceuticals arm has the responsibility of producing the International Pharmacopoeia. While this compendium does not have official status in any individual country, it finds many uses because its tests for identity use basic procedures that do not require expensive and complex technological apparatus. In addition to the production of the International Pharmacopoeia, the pharmaceuticals division is also re-
American Pharmacy Vol. NS22, No. 11, November 1982/586
sponsible for selecting international generic names and producing a compendium listing those names. (Actually, generic names are selected from names submitted by sponsoring organizations like America's USAN Council [U.S. Adopted Names Council] and the Medicines Commission in the United Kingdom. Specific rules govern the nomenclature of new molecular entities, and when the names are granted, the sponsor is notified. The compilation of these names is published by WHO in a publication referred to as the INN [International Nonproprietary Names for Pharmaceutical Substances] which lists the generic names as well as the major branded names under which the product is available throughout the world.) The pharmaceutical division of WHO also publishes a drug bulletin to inform readers of reports of drug problems, adverse reactions, new uses of drugs and other findings regarding the use of drugs in man that are published in the literature throughout the world.
The WHO Action Program on Essential Drugs fosters the use of safe and effective drugs for the populations of all lesser developed countries. The Action Program sponsors a list of approximately 250 essential drugs selected by its expert consultants. These drugs are recommended to WHO member sovereign states for consideration in their import and licensing policies. The Action Program also assists member countries with drug registration procedures, drug legislation, supply and distribution systems, and training consultation and educational materials. A third arm of WHO deals with the Psychotropic Drug Convention of 1971 and is the international coordinating body for the various campaigns to control use of psychotropic agents. The World Health Organization operates through its regional offices in Alexandria, Egypt; Brazzaville, Congo Brazzaville; Manila, Philippines; Copenhagen, Denmark; New
American Pharmacy Vol. NS22, No. 11, November 1982/587
Delhi, India; and Washington, DC. In Washington, the Pan American Health Organization (PAHO) coordinates WHO health initiatives throughout the Western Hemisphere. It shares knowledge and experience and serves as a coordinating body, with focus on Latin America. Experts are sent to member countries to assist with national formularies, drug control regulations, and a host of health-related projects. A separate international organization within the United Nations family is UNIDO, the United Nations Industrial Development Organization. Essentially, UNIDO acts as a roker for technology in an effort o assist nations in increasing their domestic technological enterprises. This also means increasing the production of trained individuals; and the potential for export ~les, or at the ~ery least, the conservation of fo eign exchange by buying smaller quantities of imports from the developed nations. UNIDO has an active group that assists member nations in making requests for specific production facilities. The United Nations Children's Fund (UNICEF) is still another international organization within the United Nations umbrella. UNICEF supplies aid to children who are victims of catastrophes and serves other needs throughout the world when the health and welfare of children are endangered. UNICEF operates a massive warehouse in Copenhagen which purchases large numbers of pharmaceuticals and health-related items from a very limited list of products on the open market. These drugs and supplies are then repackaged and made available to governments or agencies caring for the needy and displaced throughout the world. UNICEF's drugs are sold at amazingly 19
low costs because of the organization's massive buying power and the ability of this organization to accept products from sources all around the world. UNICEF has offiLes in New York and Geneva as well as in other locations. UNCTAD, the United Nations Conference on Trade and Development, has as its mission the furtherance of trade and development for lesser developed countries. UNCTAD publishes studies and sends consultants to nations to assist them in developing their resources and help them in promoting their products throughout the world. It aids nations in the establishment of priorities and step-by-step procedures for the creation of various industrial enterprises. UNCTAD has assisted a number of nations in the development of rudimentary pharmaceutical industries, even in the production of single chemical items or for the production of certain chemical families. UNCTAD has developed case studies describing the pharmaceutical industry in a number of developing countries. A related agency called UNDP, United Nations Development Program, assists in the development of industrialization among its member states. UNDP is closely related to the other programs and has not had a great deal of direct activity in the pharmaceutical sphere to date. On the other hand, UNDTCD, the United Nations Department of Technical Cooperation for Development (formerly, the Action Program for Economic Cooperation), has been very active in assisting nations when a specific technological problem arises. This office is able to facilitate problem-solving and provide technical assistance to lesser developed countries through the use of consultants and its own reference and resource materials. A number of local or regional banks assist in technological development throughout the world. These organizations lend money to stimulate economic development in their respective areas of the world and in doing so increase the industrial capacity and productivity in virtually any economic sphere. There has been some limited in20
volvement in the pharmaceutical industry with some of these regional development banks, most notably the Caribbean Community Program (Caricom), the African and Asian development banks, and the South Pacific Economic Community (SPEC). The Andean Pact in South America is another organization intended to stimulate economic development through loans and assistance. All these banks and loan organizations, which are funded by their respective member governments, facilitate and cooperate in the exchange of information and programs for the benefit of all their member constituencies.
Pharmaceutical Organizations Closer to working pharmacy is FIP, the Federation Internationale Pharmaceutique, an organization composed of various national pharmaceutical organizations and their respective members, who may be associate members of the FIP. The International Federation of Pharmaceutical Manufacturers Associations (IFPMA), on the other hand, is responsible for representing the international pharmaceutical industry in its various battles and problems throughout the world. IFPMA has published some excellent reviews of the regulations for marketing approval and registration of prescription drugs in various countries and coordinates efforts on the international level for the pharmaceutical industry. There are dozens of other international pharmaceutically related organizations, especially those for pharmacy practitioners, but the last two mentioned organizations are the only ones that are officially recognized as nongovernmental organizations (NGOs) by WHO. These two-FIP and IFPMA-have assigned seats for their delegates and are permitted to speak on the floor at WHO meetings. In the realm of nonprescription drugs, the World Federation of Proprietary Medicine Manufacturers (WFPMM) looks after the interests of its member firms who produce drugs for self-medication and overthe-counter sale. WFPMM sponsors
programs and studies dealing with the use of nonprescribed mecticine. The Council for International Organizations of Medical Sciences (CIOMS) is a Geneva-based organization primarily involved in programs and educational activities dealing with medical ethics and jurisprudence in topics ranging from drug trials to informed consent and the use of human subjects in clinical trials. The World Bank studies health care delivery systems and has sponsored studies intended to produce more efficient and economical health care delivery and distribution systems. Currently the World Bank has researchers studying the pharmaceutical sector. The Council of Europe has stan· dardized a number of parameters dealing with international standards of pharmacy education, products for registration, pharmacy education, reciprocity, etc. The United Nations itself provides certain services in the publication of demographic statistics and summary statistics regarding the use, transfer, exchange, sale, and importation of pharmaceutical agents. The United Nations also has a special interest in the use of narcotic and addicting substances. A major U.N. office in Vienna, Austria, is involved in the international establishment of quotas for production and importation and for the conduct regarding the various international agreements and conventions dealing with the use, advertising and control of narcotic and other controllable substances. There are many more international agencies which have been omitted from this brief review since pharmaceuticals are not their major focus. Each of the organizations above has a specific role in pharma· ceuticals and has current ongoing efforts in this area. Pharmacists and pharmacy leaders should have some understanding of the workings of these groups which affect, either di· rectly or indirectly, their profes· sional prerogatives. D
American Pharmacy Vol. NS22, No. 11, November 198:V58f