World Health Organization (WHO) · Technical Documents

Reference document for the technical presentation on "National drug policies and management"

December 31, 1977 World Health Organization

Full text

WORLD HEALTH ORGANIZATION

REGIONAL OFFICE FOR THE WESTERN PACIFIC BUREAU RtGIONAL DU PACIFIQUE OCCIDENTAL

•

ORGANISATION MONDIALE DE LA SANTE

REGIONAL COMMITTEE Twenty-eighth session Tokyo 6-12 September 1977

WPR/RC28/TP/1 Corr.1 9 September 1977 ORIGINAL: ENGLISH

REFERENCE DOCUMENT FOR THE TECHNICAL PRESENTATION ON "NATIONAL DRUG POLICIES AND MANAGEMENT" Corrigendum

Page 17, third paragraph, item (i): insert "Republic of Korea" between Portugal and Sweden.

WORLD HEALTH ORGANIZATION

ORGANISATION MONDIALE " DE LA SANTE

REGIONAL OFFICE FOR THE WESTERN PACIFIC BUREAU RtGIONAL DU PACIFIOUE OCCIDENTAL

REGIONAL COMMITTEE Twenty-eighth session Tokyo 6-12 September 1977

WPR/RC28/TP/l 22 July 1977 ORIGINAL: ENGLISH

REFERENCE DOCUMENT FOR THE TECHNICAL PRESENTATION ON

"NATIONAL DRUG POLICIES AND MANAGEMENT'" This document: Ca) Reviews the overall country and regional situation and identifies programmes related to drug pOlicies and management at national level; (b) considers aspects of the formulation of national drug policies in accordance with the health needs of countries; (c) discusses the technical and administrative components of drug policies and management for establishing pharmaceutical supply systems at country and intercountry levels.

r. II. III. IV. V.

CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . REVIEW OF THE OVERALL COUNTRY AND R~GIONAL

SITUATION.

FORMULATION OF NATIONAL DRUG POLICIES HEALTH NEEDS AND DRUG POLICIES . . . . . TECHNlCAL AND ADMINISTRATIVE COMPONENTS OF DRUG POLICIES AND MANAGEMENT . . . . . . . . . . . • (1) Drug research and development

7 8

10 11

* Prepared by Dr H. Nakajima, Chief, Drug Policies and Management, WHO Headquarters, Geneva.

(2)

Drug legislation and regulatory control Product selection Quality assurance

13 15

(3) (4) (5) (6) (7)

16 18 20

Procurement from multiple sources of supply Local production Distribution. . Control of drug prices Drug information, utilization surveillance, and training of health workers . . . . . . . . . • . . . . . . . . Utilization of locally available natural resources for health care .••• Self-medication

23 24 26

(8) (9) (10)

(11)

...

29 33

ANNEX 1.- THE HEALTH CARE SYSTEM.

WPR/RC28/TP/1 page 1

NATIONAL

DRUGPOJ.ICI~

AND

MA~.GEMENT

INTRODUCTION

"National drug policies and management" was selected by the twenty-seventh session 01' the Rl!gional COlIIDlttee tor the western Pacific in ~eptember 1976 as toe topic tor the Technical Presentation during the twenty-eighth session 01' the Regional Committee. Questions relating to national drug policies and management. have been raised in recent times during discussions 01' the Executive Board and the World Health Assembly, especially at the fitty-tifth session of the Executive Board, and at the twenty-eighth World Health Assembly, when the need was stressed to ~evelop drug policies linking drug research, . production and d~stribution with the real health needs. At the tifty-eighth session 01' the!xecutive Board in May 1976, the subject "Nationalpollctes and practices in regard to aedicinal products; and related.lnternational probleas" was selected tor the Technical Discu,sions to be held during the Thirty-first World Health Assembly in 1978. .. . Problems relating to drugs have been discussed not only1n health toru,.s but recently also 1n political forums, such as the fifth conference of heads 01' state or government of non-aligned countries (Colombo) and the conference on economic cooperation among developing countries (Mexico City), both held in 1976.

There are considerable problems, especially in developing related to the availability of drugs to meet real health needs. these problems at the national level, the multisectoral approach overall development, planning and policies' formulation has been on many occasions.

countries, To solve tor stressed

The selection 01' the topic "National drug policies and management" tor the Technical Presentation during the twenty-eighth session 01' the Regicmal Co_ittee tor the Western Pacitic w11l provide an opportunity to review these problems as they relate to health priorities, and to exchange views and experiences at national and regional levels, especially in tostering technic.al ~ooperation among the countries or areas of the Region.

1977, p. 89.

WHO HandbOok of Resolutions and ~cislons, Vol. II (2nd ed.),

WPR/RC28/TP/1 page 2

II.

REVIEW OF THE OVERALL COUNTRY 'AND REGIONAL SITUATION

The continuing increase in demand for drugs in preventive, curative and rehabilitattvehealth care is creating ever-increasing technical, fin~ncial and social problems in the planning and implementation of comprehensive health services in the countries. To solve these problems, considerable effo~ts have been initiated and success achievediri Member States of the Region in a number of areas as follows: (1) Encouraging the strengthening of national capabilities in research and developmentih respect of: (1)

new, safer and more efficacious drugs of established quality;

(ii) industr-iaJ technology, both in formulation and production of raw materials and In production of vaccines and other biologicals; (HI)

drugs of natural origin, especially Diedlcirial plants;

(i v) drugs of public hea'l th importance, esp~cially for the control of tuber cui os is, leprosy and tropical communicable diseases generally. (2) -. "

Strengthening o'f governmental control in the drug sector through: (1)

·formulatioo and implementation 'of drug legt'slation dealing - licensing of pharmaceutical enterprises, tmporters, manufacturers, marketing agencies, distributors, pharmacies, etc.; _ registration and licensing of individual drug products through evaluation and re-evaluation of quality, efficacy and safety; _ specific control of poisonous and dangerous substances and dependence~producing drugs.

with:

(U)

development of the necessary: ~

_ administrative and technical structures for drug control; _ technical institutions, such as quality control laboratories; _ specifications for pharmaceutical products and national pharmacopoeias; _ pharmaceutical inspection systems; _ procedures for the application of good manufacturing practices.

WPR/RC28/TP/1 page 3

Assuring the provision of·drugs for health services through: (i) procurement of drugs from multiple sources of supply by governments; (ii) encouragement of local production, espeoially of essential drugs, by government oontrolled factories; (iii) preparation and updating of lists of essential or basie drugs or pharmaoeutical benefit lists; (iv) control of market prices and/or prioes to national insurance schemes; hea~th

(4)

(v)

supply of drugs free of oharge or partially so

(benef~ts);

(vi) utilization of locally available drugs, especially medicinal plants and other drugs of natural origin. . Establishing distribution facilities, such as: (i) . central or decentralized government stores for drugs and control laboratories; (ii) adequate transportation systems.

(5) Improving the use of drugs so as to extend health coverage within available resources, for example, through: (i) improvement of drug information to users by: - control of advertising;

- provision of properly evaluated information; (ii) establishment of national formularies or limited lists of drugs for presoription or for self-medication; (iii) continuing education and training of health workers in the proper use of drugs;

(iv) integration of the use of traditional drugs with modern drugs. (6) Providing training to research workers, physiCians, clinical pharmacologists, pharmacists, espeCially industrial pharmacists, anQ dispensers for improvement of national capabilities in pharmaceutical supply and use.

WPR/RC28/TP/1 page 4

However, these efforts have not yet produced satisfactory re,sul ts in many instances for the following reasons: (a) lack of awareness in some countries of the importance of drug policies; (b) the countries differ in their health objectives and economic and industrial policies; c) there are differences among countries in socio-economic development, manpower, financial and technology resources; (d) the demand for drugs is steadily increasing; and

(e} ·most ~rugs move internationally, and the number of drugs is ever increasing. Pharmaceutical sales and per capita consumption for 1976 of some countries in the Region, estimated by a markeUng agency OMS International), are as follows: Sales (US$ million) Australia China: .., Japan Malaysia New Zealand· Philippines Republic of Korea Singapore Per capita 1 consumption (US$) 30.45 3.00 47.85 4.27 19.70 4.25 6.10 7.00

420 2 500 5 360 50

62 185 210 16

If the other countries or areas in the Western Paclfic Region are included, the total pharmaceutical sales in the Region could be estimated roughly at about US$ 9 billion and per capita consumption varies considerably. According to the United Nations' statistics on trade, the value of imports of medicinal products in the Region for the countries or areas listed in Table t, was US$ 805 ~08 000 which represents 16.8 per cent of world :i.mports. The value of exports was US$ 32~ 273 000 which represents 7 per cent of world .imports.

1These figures are rough estimates and need to be adjusted ta~ing into account differences among countries in the prices of pharmaceut1cals, in patterns of distribution and in the use of medicinal plants which are not included in the estimates.

WPR/RC28ITP/1

page 5

I t is clear that the Western Pacific· Region has a tremendous trade deficit in pharmaceuticals, although considerable production capacities exist in some countries.

In most developed countries and in some developing countries of the Region, the pharmaceutical trade is mainly in the hands of the private sector. In some of these countries, a number of private industries are subsidiaries of transnati.onal corporations. In other cases, especially in the developing nations, more than 30 per cent of the drugs may be imported by the government or a public agency and sometimes, the importation of drugs is entirely in the hands of a public or government organization. The proportion of drug expenditure in health expenditure generally varies between 10 and 20 per cent, but in some countries it is more than 30 per cent and in others less than 5 percent. The average drug expenditure is about one pel" cent of GNP, but this also varies from country to country.

WPR/RC28/TP/1 page 6

PHARMACEUTICAL TRADE AND MARKET I~ THE WESTERN PACIFIC REGION (CURRENCY: US DOLLARS) PHA.R.'1ACEUTICAL ~L\RKETS 1976 ESTIMATES SALES PER CAPITA.L ($1000) CO:-lSUMPTION

COUNTRY/AREA

YEAR

IMPORTS ($1000)

EXPORTS ($1000)

AMERICAN SAMOA AUSTRALIA

1973

96 527

43 941

420 000 2 500 000

($)

30.45 3.00

CHINA COOK ISLANDS DEMOCRATIC KAMPUCHEA FIJI FRENCH POLYNESIA GILBERT ISLANDS GUAM HONG KONG JAPAN LAO PEOPLE'S DEMOCRATIC REPUBLIC MALAYSIA NEW HEBRIDES NEW ZEALAND

1973

1 576

1974

...

1974 1974

86 038 455 752

65 973 137 147

5 360 000

47.85

1972 1972 1973 1973/74 1973/74 1971 1974 1974 1974

19 795 261 44 449 17 3 012 22 194 24 801 228 50 759

3 980

50 000

4.27

3 334

62 000

19.70

NIUE PAPUA NEW GUINEA PHILIPPINES REPUBLIC OF KOREA SAMOA SINGAPORE SOCIALIST REPUBLIC OF VIET NAM SOLOMON ISLANDS TONGA TRUST TERRITORY OF THE PACIFIC ISLANDS TUVALU TOTAL - No data available. Sources:

1 491 6 287

185 000 210 000

4.25 6.10

66 120

16 000

7.00

~974

152 152

1974

328 273

805 808

United Nations Yearbook of International Trade Statistics 1974 Report on an examination of the feasibility of collective or bulk purchasing for the South Pacific Bureau for Economic Cooperation (SPEC). IMS Monitor Report. January 1977. -,

1 These figures are rough estimates and need to be adjusted taking into account differences among countries in the prices of pharmaceuticals, in patterns of distribution and in the use of medicinal plants Hhicl! are not included in the estimates.

WPR/RC28/TP/1 Page 7

III.

FORMULATION OF NATIONAL DRUG POLICIES

In any country, the formulation of a particular policy generally takes place in line with the basic national policies which, in principle, aim at self-reliance through social and economic development. It is obvious that health policies should be formulated in the light of the social developments of the country which, however, should also be linked to general econqmic improvement through agricultural, trade and industrial development. National drug policies should be formulated focusing on the social development of the countries. However, in spite of the importance of pharmaceuticals in improving the qualify of life of the population, often drug policies 'are developed mainly for trade and industrial development. Therefore, in many countries, different and contradiotory national drug policies exist independently. Nevertheless, i t is now generally recognized that pharmaceutical products cannot be considered as ordinary commodities floating around freely in a mark~t situation. Thus, when countries are formulating their national, drug policies, priority should be given to their health needs. Pharmaceuticals represent an important part of national assets because of their contribution to the national economy, for example, through foreign exchange earnings and savings and through development of technology in medical, biologioal, chemical and industrial fields, thereby creating new skilled manpower. For this reason, the multlsectoral approach should be imperative in the formulation of national drug policies. According to different political systems in different countries the pharmaceutical sector may belong entirely to either the public sector or to the private sector, or may be shared between these two sectors.

Depending on the national goals, the share of the public sector is more important in most of the developing countries because of the government's or society's responsibility to provide essential health care to the population within the limited financial resources. Even in countries with policies based on a mixed economy concept, the private pharmaceutical sector is more or less under the control of the authorities because of its positive or negative impact on health and the economy. In most countries, the consumers' awareness of pharmaceuticals is also rapidly increasing and influencing public policies. National drug policies could be influenced by those of other countries, international PQlicies and transnational corporate policies owing to the fact that pharmaceutical products are moving internationally and that the volume of international trade is ever increasing. It should be noted that pharmaceutical production is mainly located in developed nations which account for 90 per cent of the world's output. Furthermore, information on drugs, often uncritical and biased, is Circulating freely and rapidly in the world and is stimulating the population's demand for drugs.

WPR/RC/28/TP/1 page 8

IV.

HEALTH NEEDS AND DRUG POLICIES

The definition of "drugs" or "medicines" or "medicinal products" in national legislation varies from country to country. These terms usually mean substances and/or products of synthetic or natural origin used on humans (but, in some countries, it also includes those used on animals) for prophylactic, diagnostic and therapeutic purposes, including pharmaoeutj.oals and biologicals such as antibiotics, vaccines, sera, and hormones. In some cases, blood and its preparations and organs of human origin are also included. About 3000 active substances are contained in the many thousands of pharmaceutical products currently available on the world market. From the point of view of drug policies, it is crucial to determine which products are suitable to meet "health needs" (see Annex I, 3.4) and which other products are required to meet, at least partially, demands not corresponding to real health needs. "Consumer approval" being a commonly aoceptedconcept in health care, national drug policies in developing countries should pay due attention to this distinction, although it is recognized that, in practical terms, it is very difficult to draw the line. In the formulation of drug policies, the following categories should be:considered: (1) Pharmaceuticals suitable to meet health needs, these being defined as scientifically (biologically, epidemio10gioa11y, etc.), determined deficiencies in health of the population. These products contain biologically active SUbstances capable of preventing or influencing a health condition in a predictable fashion (see Annex I, 3.2). The effectiveness of these products is well documented in toxicological, pharmacological and clinical studies. They can be considered as safe and efficacious if properly used because their expected risks and benefits in specific indications have been reasonably assessed. Some of these products. such as chemotherapeutic agents and vaccines. are indispensable tools in the control of the communicable diseases prevalent in developing countries. Other products, such as antibiotics, analgesics, etc., are jndispensable in effective health care. Some of these products are highly specific and can only be used in specialized institutions, e.g., anticancer drugs. Most of the products in this category result from the application of modern science and technology. It is important to remember that not all "modern drugs" fall into this category, or are relevant to the health needs of developing countries. The decreasing level of investment by the pharmaceutical industry in research to develop more effective drugs to meet the priority health needs of developing countries or areas - for example for the control of tropical parasitic diseases, is a matter for concern.

The issue of safety related to the use of pharmaceutical products of this type cannot be ignored and would require an efficient and appropriate transfer of drug information, especially in developing countries. For example, products which have been withdrawn from the market in one or more countries because of severe adverse reactions may still be available in other countries. In some cases, the evaluation of the acceptable risks

WPR/RC28ITP/1 page 9

compare~ with the expected benefits from the use of a product may lead to different conclusions in different countries because of epidemiological, genetic, environmental or other factors.

(2) Pharmaceut1.caJs suitable to meet consumer demands. The demand for drugs beyond the health needs, whether for "modern" pharmaceutical products or for traditional medicines, stems from a deeply-rooted survival instinct. In both developed and developing countries, there are numerous pharmaceutical products which have been widely used for a long time. Well documented toxicological, pharmacological and clinical studies of the effectiveness of these products are lacking or are inconclusive. Most of these products can be considered safe, on the basis that toxic effects are not recorded in widespread use, but their efficacy in influencing specific health conditions in a predictable fashion is dubious. Different policies with regard to this type of pharmaceutical product are evolving in different countries: (i) In some developed countries these products were submitted to systematic revie'-I and, when criteria for proven effecUveness were not met, the products were withdrawn from the market. In other countries, a less stringent approach is being followed and safe products of dubious efficacy are being maintained on the market; but some of them are being withdrawn from the list of products paid for or reimbursed from public funds, move clearly dictated by economic constraints.

(ii) In developing countries, the main policy issue to be discussed is whether 'they should continue to import extenslve products of this type from the industrialized countries when from the health point of view, they could be replaced by cheaper items of local production, particularly herbal remedies. As a substantial proportion of pharmaceutical imports is of this type of product, consideration of this issue is very important. Such unnecessary expenditure drains resources away from the provision of essential drugs to wider segments of the population. The pressure of local physicians trained jn developed countries and the promotion of foreign pharmaceutical industries will probably be the main obstacles to the acceptance of this substitution. Long before the introduction of synthetic products to health care, products of natural origin, such as medicinal plants, were used for many years by people as part of their traditional medicine, which has been well documented in many countries of the Region. Especially in developing countries, drug policies should give adequate priority to the preservation of this cultural heritage and to the promotion of research on medicinal plants, and other drugs of natUral origin, in the Ught of modern medical and scientific knowledge, with a view to making the best use of them in health care. From the economic point of view, as self-reliance is the aim of drug policies in developing countries, it is important to develop technologies for the collection and cultivation of local medicinal plants and for the extraction of known active substances.

WPR/RC28/TP/1 page 10

(3) Pharmaceuticals liable to abuse. Such products contain dependence-producing active sUbstances of value in health care but for which there is also a demand for non-medical use. These products should be ba.nnect or subjected to strict control to avoid their leakage to the illicit trade. One issue regarding drug policies for these products is coordina.tion between the authorities responsible for pharmaceuticals and those responsible for narcotic control, which mayor may not be in the same sector of the government.

TECHNICAL AND ADMINISTRATIVE COMPONENTS OF DRUG POLICIES AND MANAGEMENT

As the main objective of national drug policies is to provide the most effective and safe drugs and vaccines of established quality at reasonable cost for health care of the population countries should rev~ew and plan their pharmaceutical supply system which can be described as a country-wide system of institutions and activities which contribute to the avaHability of pharmeceutical products for health care, ranging from qrug research to industrial production, control, distribution and utilization. Depending on the political and organizational structure of the country, the di,fferenttechnical and administrative components of the .system may be more or less coordinated bv the government. All the components may be under the authority of the health ministry or some components may be un~er its authority, while others are under the authority of different sectors of the government, such as trade, industry, finance, etc. In some countries the whole pharmaceutical system and the health care system (see Annex I) are in the public sector, whereas in others these systems are partly in the pUblic and partly in the private sector. Problems of coordination vary accordingly,. not only between the pharmaceutical supply system and the health care system, but also among the different components of the pharmaceutical supply itself. The aim of developing national drug policies is precisely to achieve better coordination and efficiency. Pharmaceutical supply systems have evolved to some degree in all ranging from the least developed among the developing countries where only some components are present, to the developed countries where all the components are present, although not always coordinated to form a coherent system. Because of conflicting needs that must be met, and because of changing interplay of political, economic and social pressures, the pharmaceutic~l supply system undergoes continuous changes in all countries. Usually the technical and administrative components of a fully developed system are as follows: countries~

drug research and development; drug legislation and regulatory control; product selection; quality assurance; procurement from multiple sources of supply;

WPR/RC28/TP/1 page 11

local production; distribution; control of drug prices; drug information, utilization surveillance, and training of health workers; utilization of locally available natural resources for health care;

self-medication. (1)

Drug research and development

In formulating national drug pOlicies, governments should pay due attention to the main issues of research and development. Policies should be developed giving adequate priority to the real health needs of the country and to its desire for trade and economic .development. Research and development in the field of modern pharmeceuticals is one of the major components of health and industrial technology. These activities are mainly undertaken by the pharmaceutical industry and are also directly or indirectly supported by the public sector in the provision of basic and technical research intelligence and the necessary manpower development. Despite national will to develop research and development capabilities in the area of drugs as part of technological progress, without the necessary infrastructure, manpower and economic resources i t is almost impossible for developing countries to follow the classical type of research and development pattern which has been established in developed countries. In developed countries, the efforts of industry are often concentrated on the development of sophisticated substances and technologies in order to create or maintain leadership in a strong competitive marketing environment. This situation leads to an increase in the number of drugs which may have no relevance to the needs of the general health services and causes economic problems in countries where finances for these services are limited. The patents which are granted for the invention of a new process, new substance and/or a therapeutic innovation, in order to protect the results of successful industrial research and development, are generally considered as industrial property together with the prioprietary (brand) names of products. These two industrial properties account for the main marketing power of modern pharmaceutical concerns. The percentage of research and development cost included in the price of drugs varies considerably from product to product, from 5 per cent to more than.20 per cent of the factory price. However, for brand name products, th:J..s percentage may be higher because of the impact of the name on prescribers and consumers. The research-based pharmaceutical industry,

WPR/RC28/TP/1 page 12

which makes a high contribution to progress in medicine and biology, is willing to continue its endeavours. However, the provision of adequate financing of research and development,as a matter of social responsibility, should be discussed among the health authorities, industry and consumers. In this particular field, the role of the publio sector alone, or in cooperation with industry, needs to be strengthened. There is a trend in the research-based pharmaceutical industry to diminish investments in research and development in the field of some diseases of public health importance, e.g., tropical diseases, which are not a major concern in developed countries. Therefore, promotiqn of collaboration of the research-based pharmaceutical industry with developing countries is urgently needed, duly supported by adequate national policies of the developed countries, in a joint effort to reorient drug research and development so as to bring them more in line with the most pressing health n~eds of developing countries. In this respect, WHO is now developing a special programme for six of the most important diseases in tropical areas, emphasizing technical cooperation among the developing countries for this purpose. In developing countries, the highest priority areas in research and development are (a) concentration of efforts to stimulate research and development of drugs and vaccines most relevant to the countries' health needs, with transfer of appropriately selected technologies from develope<;t countries and intensification of technical cooperation among developing countries, (b) better utilization of 10c8lly available natural reso~rces in health services, especially in primary health care, (c) research in aspects of pharmaceutical supply, particularly logistic aspects such as the technological components of the cold chain (materials and energy sources), (d) development of appropriate technology for packaging and formulating the most essential drugs in the country, whenever possible, and developing technology for long-term pro9uction with raw materials, especially those which are locally available. In developing countries, the quality of research capabilities, especially in clinical medicine, has risen satisfactorily at the central level; clinical trials are carried out, at the request of the industry, of new drugs which are often not related to the priority health needs of the country and which were not subjected to preclinical evaluation. As in developed countries, regulatory control of drug development, especially through clinical trials, is becoming more strict. Often a "new product" is tested in advance in developing countries before approval for clinical trial is given by the authorities of the country ?f 02igin. This practice has been criticized by members of a WHO Consultatl0n.

1WHO Technical Report Series, No. 563, 1975. 2Transfer of information relating to dru s and their re istration. Report of a WHO Meeting, Geneva, 2 September - 2 October 197 (unpublished WHO document DEMI76. 5) .

WPR/RC28ITP/1

page 13

In many cases the locally available natural resources are at the present time often not fully explored and these resources, especially medicinal plants, could be better utilized, particularly in primary health care. Research and development, appropriate to the needs of the country, in identification, collection, specification and processing of these materials could be an appropriate approach to be adopted in developing countries. (2) Drug legislation and regulatory control

Drug legislation is a starting point for the implementation of duly formulated national drug policies. Legislation gives to the government, or a designated public agency, authority and responsibility for control, research and development promotion and services of the pharmaceutical supply system. Current drug legislation generally provides for partial regulatory control through the registration of drugs and licensing of importation, production, distribution and sales to pharmaceutical enterprises, and through inspection and control of various activities, such as production, drug advertising, prescribing and dispensing by pharmacists and the medical profession. Training of the necessary manpower in the pharmaceutical sector, especially pharmacists and dispensers, is also regulated in many countries (through schools of pharmacy and their curricula, licenSing of pharmacists after national examination, for example). The responsibility of the government in promoting the development of national capabilities in the pharmaceutical sector, particularly in relation to production for export and to foreign investment, could be defined by appropriate legislation. The objectives of such legislation should not conflict with the objectives of the health legislation on domestic drug control and pharmaceutical services. 'The service-oriented pharmaceutical legislation sometimes included in regulatory control, e.g. for drug benefits in public health services, price control, proviSion of information for users and consumers, procurement in the public sector, etc., could be in the form of an independent law or regulation enacted by the government. The implementation of drug legislation is the most important and complex matter "lhich confronts the governments, especially in developing countries where only limited and scattered financial, technological and human resources are available. Therefore, the countries should define priority areas, according to their immediate, medium- and long-term planning. In many developing countries the following could be considered as prJority areas for immediate action: (a) Drug control (i) Selection of essential drugs for health needs and strengthening of quality control of these products; (ii) use of generic names whenever possible;

WPR/RC28ITP I 1 page 14

(iii) registration of products according to evaluated information which could be obtained through regional agreements or from international organizations, particularly WHO;

(iv) licenslng, importation, production, distdbution, advertising and sales. (b)

Research and development promotion (i) Adequate regulation of industrial properties, such as patents and brand names; (ii) sector; ( 11]_ ) ,

regulation of foreign investment in the pharmaceutical incentives to research and development in the country;

...

(iv) allocation of priorities to the development of local resources (manpower and natural resources). (c)

Pharmaceutical servi.ces

(i) Establishment of regulations on multisource internati.onal procurement, especially in the public sector; (ii) definition of the distribution of services within the country, giving clear responsibiiity to each level of the network, i.e., central, regional, subregional and peripheral; (iii) provision of information and continuing educatton in the use of drugs.

As pharmaceuticals move internationally, there is need for cooperation among the authori ties of the countries of the Regi_on in the field of drug legislation and information exchange on manufacturing practices, drug prices, and registration of new drugs. Legislation generally allocates responsibilities and includes clauses concerning sanctions for illegal or illicit acts. The determination of state responsibilities for the control of quality, efficacy and safety is a very complicated matter depending on the constitutional defi-nitions and the legal concepts of each country. Recent]y, in many countries. the problem of state responsibility for accidents induced by adverse reactions to drugs has been raised and di.scussed. In this respect, two different legal concepts have been considered, i.e., (a) determination of responsibilities after cause-effect relationshlps have been proved, (b) determination of responsibHities without fault accorMng to the degree of physical, psychological and social damage attributed to the adverse reactions. However, in most current drug legislation, these matters are not mentioned, or the responsibility of the reguJatory authorities is exc'_uderl.

WPRIRC28ITPI1' page 15

Pr.oduct liability generally rests with. the pha.rmaceutical manufacturers, bu.tllere.again, w.hen distributors and retaHers are different ,from th~manu.facturers, :the sharing of the liability raises difficult problems. ,Also;, when the state manufaotul'es and distributes drugs ,should. the st.ate' 8· liabi,l.ity for the products be defined in the same manner as "for the pri va t,e industry. or otllerwise, for example, according to the mode of 'supply, L free t par,tialc;>r at nominal cost?

e.,

Professional liability generally rests with the prescribers and/or dispensers., bu~the same problems can also arise in the case where they are government emploYees. There is no interna~ional1y agreed l,egalviewpoint on the liabilities relating to utilization and control of pharmaceutical products, and each country should carefully consider this matter when establishing or reviewing legislation on the pharmaceutical supply system. (3)

Product selection

As drugs'andvaocines are major strategic components in preventive and curative health action, it is obviously necesssary to draw up a list.or lists of priority drugs which can be available routinely at the different levels ·of.health action. ; 'J,'he country's resources being generally limited, any kind of'.healthactipn necessitates the setting of prioritie~~ When the health needs;·of the country are not., or oannot be, satisfied by private practice or the free market, public health action is required. The other reason for selecting a group of drugs is the limited economic reSOUl"ces and availability of managerial skills when the governmenta'ssumes responsibility in pharmaceutical supply'. The price decreases when large quantities of a limited number of drugs are purchased. tlo individual or instttution can correctly and constantly handle information on more than 1000 products. Physicians in private practice prescribe generally ~Oto 100 products according to the demands of patients, the. local epidemiological pattern, their specialization and product availability. Therefore, in private medical practice, the physician himself selects a limited number of products according to the situation in the particular area where he practises. In organized health care, the selection is based on prevalent health needs of the community, taking into consideration safety, efficacy, quality and economy of products. 1 In.accordanc,e with resolu.tion WHA28. 66 , WHO can advise on the selection· and . ,procurement, at reasonable cost , of essential dru~s of established, qUality corresponding to the national health needs. A group of WHO conSUltants has drawn up a tentative list of about 150 active substances of establish,ed safety" efficacy and economy., This list will be reviewed by an expert committee which will also suggest criteria for the selection of drugs to meet health needs. 1 ' , . , '. WHO Handbook of

Resolutions: and DeCision, Vol. II (2nded. ),

1977, p. 51.

;

WPRIRC281TP /1

page 16

The real drug needs can either be qualitative (the type Of drugs) or quantitative (the amounts) and it is necessary for all countries to be able to identify these needs. Clinical pharmacological expertise, epidemiological surveys and drug utilization surveys at'e essential tools in determin:tngsuch needs and WHO could collaborate wi'th countries, it' t'equired, 1n obtaining such expertise. In ens1;lr1nl that sucntoolS ar~ uaed e'rrectively ,there is an urgent (need for develoPitil countries t6 develop fully, either alone or wfthWHO OOop'f)'ration, a sound hearth inforlbatiOl2 syatet!l. In the context of technical oooperationamoni developing oo,"mtries, the South Pacific Bureau for Economic Cooperation i'sdrawlngup a list of dr'U&s for collect! ve purchasing among the Melliber States and WHO Is proViding the necessary technical support in this r'$spect. (4)

Quality assurance

Ensu!"ing the quality of drugs to be provided to the population is the reat>6nsibili ty of the government and the producers. OUsU ty specification. to which drugs and vacclhesmust conform have been established by national or internation,l organizations and are described in natIonal or Int,ernatlonal pharmacopoeias. ' The responsibilities of the government and the producers to ensure the quality' of drugs -.,bd vaccines vary from country to country. The necessity rot' control both by the government and by the producers theuelVes is generally recognized. Goveri'Hlent re!ponsibility in quality assurance consists .1nly of fa) inspection of manufacturing establishments, stores and phal"liacl~s,(b) sampling and analysis in national control laboratories, (c) verification of analytlcal specifications ,for drugs not included, in official" 1 pharmacopoeias, (d) implementation of the WHO Certification Scheme • Manufacturer's responsibility consists mainly of (a) cond~ctinc self-inspection at all I:Jtages of production, (b) providing adequate analytical facUities, (c) keeping records of all analytical tests performed. The responsibilities of distributors and ph.Mlac~es val', froi country to country and should be defined according to local conditions. Manufacturers' specifications are sometimes more stringen~ than those of official pharmacopoeias. Although there are often legitirlate reasons for this approach, Le., to ensure that druc s meet ott~(l!a~ specifications during their entire shelf';'l1fe, unnecessary requireMents that only increase the cost o,f the drugs should be avoided.

1 For details see WHO Official Records, N<:)., 226, 1975, Annex 12,

section 2 - Certification scheme on tlle quality of pharmaceutical products IIlOving in international commerce, pp. 94-95.

WPR/RC28/TP/1 page 17

The image of drug quality is often linked with the brand name and the name of the producer. Also, the drugs produced in a country-where there.is strict regulatorycqntrol of quality, efficacy and safety are generally believed to be ",better drugs. ' However, exaggerated claims of high quality mayr,tot be related to,better therapeutic performance of the product but maybe used to justify higher prices and to increase market power~ In ~any deyelopil}g countries, the government cannot afford to build up a complete quality contr91 system and producers, when they exist, cannot follow'entirely the same good manufacturing practices as the developed countries. "The extent to which good manufacturing practices are implemented depends on financial and technical resources and on the type of drugs produced. ,In many developing countries, most of the products are imported and the conditions of distribution, storage and utilization differ ft'om those of developed nations. Therefore, it wbuld be worthwhile to adopt certain strategies in the following fields using appropriate technologies to meet the needs of the countries: (1) effective use of the Certification Sche,e as approved by the World Health Assembly in Resolution WHA28.65. At the present time the following' countries have agreed to participate in the Scheme:" '

Australia Cyprus Egypt France Italy Japan New Zealand

Norway Poland , Portugal Sweden Syrian Arab Republic United Kingdom United States of America;

(ii) exchange of information among the countries on pharmaceutical inspection, and agreement on mutual recognition of ~nspection among the, countries; , (ii 1)" sampling :of incoming goods, their analYSis through technicaJ cooperation among the countries, and exchange of "information on products and prices;

(iv) development of "basic tests" for the analysis of the products at the distribution and utilization sites. '

WHO Handbook of Resolutions and Decisions, Vol. II, (2nd ed.), 1977, p. 53.

lfPlf/JfC28/TP / 1

page (5)

Procurement from multiple sources of supply

GeneraJly, when countries become independent. one of their rirst undertakings is to diversify their procurement sources within the context of self-reHance. Thts policy usually gives p'riority to proourelll~nt tor the public sector. As pharmaceuticals are an Impo'rtant part or r>t'Jbl1o purcha~san(j are amongst the most "needed" commodities for the country, the establishment of a multisoui'ce Pr'ocureDi~ht sy'stel'li (domestic or international supply) by government or-public agencies is a priority where economic resources are limi ted. For effective procuremEmt only a relativ'ely ,small qualified staff is needed if the necessary "marketing intelligence" and quality assurance system are available, arid thus substantial sums of public money may be saved. ;

" "Marketing intelligence" is the most neede'd tool for procurement and rep'resents the country's "bargaining power". It is obtained mainly by cOntinuing survey and analysis of: (1)

produoers arid their manufacturing practices and production prj ce trends and speCUlation (early detection);

scale; (ii.) ,

(Ui) reliability of quality assurance, e.g., through batch certificate's; (iv) new drug informa'tion, especially registration status in the countrY of orlgin; (v) information on product iriterchangeabil tty, taking into consldet"ation bioavailability and therapeutic equivalence. In several cOLlntdes, a well organized procurement system, based on worldwide tender, has been established as one of the lllajor acti vi ties of the ministry of health. The system inoludes tacilHies for stor"a'i with cold room, pacldng, repackaging, transport, basic qua 11 ty control and often production of galenicals, such as liquids and SOlids, e.g. i powders, ointments, soluUons and elixirs. The adminiStration us'uaUycons,tsts ot profesSional, genet"al service, accounting and statistioa1 staff. Usually the agency procures not only drugs and vaccines, but alsO othe'r m'fidical equipment and materials, such as X-ray apparatus, fUms, dental chairs, artificial limbs. dressings, etc. Procurement procedures are based on tenders and, tor specific druis, on price negotiation under' the responsibility of an independent committee of otficials from each ministry - hE;!al th, trade, and finance, includinc. ., customs. The speoial allocation of hard currency. the exemption ot cust<)IIIS duty and tax, and collective assurance by the government are also matters of importance when establish} ng a procurement agency. -

WPR/RC28/TP 11 page 19

The first step to be taken in bulldingupaprocurement agency is to draw up a list of drugs to be procured according to the needs of the health services (basic or essential drug 11st) and estimates of the quantities required (annually, bi-annually or quarterly). Ideally, the estimates of items and quantities should be based on the health information available, taking into consideration allocations available from the health budget. Howe'Ver,in many developing countries, this cannot be done in the initial phase owing to incomplete health information and.to particular types of disease patterns, such as mixed infections, plus malnutrition. Therefore, the estimates are usually based on the actual demands of health services, corrected and re-evaluated through inventory control and utilization surveys. Estimates are easier in the case of a specific disease control campaign •. Ideally, in order to reduce the price of drugs, products should be bought in bulk and repackaged in the country with standardized packing and labelling, 'taking into account the necessity for clear distinction between different drugs and their strengths. However, to undertake such activities, the procurement agency requires specialized .technical staff fon packing, stock";k~eping and quality control and premises for storage and packing, 'which might increase the total administrative costs. The unit price. of drugs could be considerably reduced by ordering in large'quantitt.es. Therefore, tenders should be made annually, or at long intervals; for products w:hich have a long shelf life and whose internati,onal price is stable. . the procurement of patented products, or products prOduced by a, few manufacturers, requires price negotiation. Here "marketing intelligence" is very much needed.

In principle, products should be procured under their generiC names. However, procurement methods vary according to the following three major cat;egories of drugs: (a) drugs well protected by patent and produced only by one or by licensed manufac~urers, (b) generic drugs which are produced by only a few manufacturers, and (c) generic drugs which are produced by many manufacturers. The main technical obstacles, other than "marketing intelligence", for the national procurement agency in developing countries are: (a) lack of managerial skills, especially in price/quality evaluation, (b) lack of hard. currencies, (c) trade regulations and trade agreements with particular countries, (d) in tenders, the fact that the appeal may not reach international suppliers, and (e) quality assurance. The problem of quality assurance can be solved partially by requiring product certificates according to the WHO Certification Scheme. Batch certificates are ul!iually issued by the manufacturers, athough some governments deliver such certificates, for example, for antibiotics. However, quality control of goods arriving in developing countries would require technical cooperation with laboratories in other developtng countries as well as with laboratories in the developed countries.

WPRIRC28/TP/1 pa~e

Many of the problems of procurement could .be resolved international cooperation among the developing countries and international organizations, such as WHO, which could playa in coordinating and cooperating in the necessary transfer of information, managerial skills, etc.

by with the greater role technology,

It is noted that the South Pacific Bureau for Economic cooperation has undertaken feasibility studies for collective purchasing. of drugs for Member states and will expect closer cooperation with WHO for possible implementation of bulk purchase arrangements. (6) Local production

The establishment of a national procurement organization is an importqnt and urgent priority in many developing countries. Local facilities for drug and vaccine production could then be set up,. constituting a milestone in the socio-economic development of countries aiming at self-reliance in pharmaceutical supply. l{owever, the feasibility of building up local production depends on many factors, such as (a) population size, (b) available technical manpower and other supporting infrastructure, (c) geographical and climatic conditions, (d) water and energy supplies, (e) road and other transportatIon networks, and (f) the distribution network related to health coverage, for example. These factors are often major constraints and, in many cases, all the drugs needed cannot be produced economically in one country. Ideally, therefore, cooperation is required among the countries themselves. In the long run, the countries will need at least a basic forJ;llUia.tion factory with a view to preventing difficulties of supply due to any unforeseen political and economic events, and to making themselves independent of the influence of transnational marketing power. There are three main types of production in pharmaceuticals: (i) packaging and labelling of imported finished products (tablets, ampoules, etc.) bought in bulk; (ii) formulation (processing) of products from imported and/or locally available raw materials; (iii) production of active and/or inactive raw materials for formulation, including packing materials and containers (bottles, ampoules, etc.). It is obvious that in all facilities for such production an adequate quality control laboratory will be required. Countries, when deciding on local production should carry out long-term planning, step-by-step, corresponding to their health. needs and taking into consideration the available financial and technolog1cal . resources. It should be noted that the production of drugs for publlc health services will be quite different from commercial production. For public health services, the number of items to be produced is often important and sometimes the quantities required are small.

WPR/RC28ITP/1 page 21

Before <;ieciding to bUild up national production of essential drugs for health care, comprehensive feasibility studies should be carried out. As the pharmaceutical production should meet the health needs of the country, preliminary feasibility studies should be conducted in order to identify the health needs before the industrial feasibility studies are undertaken. These preliminary feasibility studies could also be used for fund-rataing purposes when multilateral or bilateral external assistance is required. The following points should be considered in the preliminary studies: (i) demographic situation;

(ii) geographical and climatic situation, such as "land-locked", "tropical", etc. (monthly temperature, humidity, rainfall data, for example) ; (iii) (iv) (v)

existing and planned health infrastructure; . epidemiological and health care utilization surveys; diseases of public health importance and prevalent diseases;

(vi) standard treatment for diseases identified under (v) and evaluation of the cost of treatment (based on the actual figures); (v.it) current prices of drugs, price structure, profit margins and governmental price control policies; (viii) current leglslation on the importation, distribution, sale and advertising of pharmaceuticals;

(ix) current legislation on the registration of drugs and quality control of drugs; (x) current legislation relative to the pharmaceutical industry and type of protection for the industrial properties (patents, trade ... marks, etc.); (xi) availability of technical staff (industrial pharmacists, machine operators, etc.); (xii) acceptability of foreign aid or investment;

(xiii) availability of packing materials and possibility of local production; (xlv) availability of local resources, especially substances of natural origin, for use in industrial production; (xv) possibility of exportation;

(xvi) existing government quality control facilities, including laboratories.

WPR/RC28/TP/1 page 22

Bearing in mind the above-mentioned points, a list of essential drugs should be prepared and from this list drugs should be selected for local production, taking into account: consumption forecasts; (ii) (iii) (iv)

current prices of imported drugs; the possibility of importing raw materials; the cost of investment for each aspect of production, for example: tabletting capsule filling injectable ampoule filling sterile product filling (for antibiottcs and other biologicals) production of intravenous fluids (saline, ringer, etc.), and water production of solid and liquid galenicals (syrups, powders, elixirs, ointments, ear or eye drops, etc.).

The annual specifications (number, weight, volume, etc.) can be estimated for each type of production, e.g. tablets and capsules (number of tablets and mean weight and volume) ampoules (number of ampoules and the mean volume in ml, then total volume to be processed in litres) sterile products (number of vials to be filled and the mean contents) intravenous fluids (number of bottles to be filled and total volume to be processed in litres) galenicals (volume or weight, number of pots or tubes, etc.). When the above-mentioned quantities have been determined, one can estimate the equipment required for production and, consequently, the manpower required (operators and checkers). After analysis of the preliminary feasibility study, the production will be planned on the basis of prelnvestment evaluation and the industrial feasibility study.

WPR/RC28/TP/l page 23

The aspects to be considered in the industrial feasibility study are: (i)

type of buildings and space; type and amount of equipment;

(ii)

(iii) number of consultants/advisers and training of technical staff (in the country and outside the country); (iv) quantity, grade and cost of raw materials including packing materials and estimate of the amount of money necessary for investment and annual running costs. There are various alternatives for financing, both in investment and annual operating costs of production, which vary according to the country's regulations and also the attitude of the financing agencies (domestic, bilateral, mul tilateral) . The study should specify the threshold of profitability, according to the mode of financing. (7) Distribution

The aim of the drug distribution policy is that the "right drugs" are constantly available to and reach the populations who need them. The distribution of drugs is often considered as a separate entity and is therefore handled by independent organizations or agencies having little contaot with other .agencies responsible for procurement, production, etc., and with the health services. The drug distribution system has thus been considered mainly from its "storage" and "transportaion" aspects.

Drug distribution should be an important component of the logistios of health services and an integral part of the pharmaceutical supply system. Drug distribution is generally incorporated in the government health services, although procurement or production are sometimes handled by other national agencies or by the private sector, thus creating an uncoordinated pharmaceutical supply system. Since drug distribution systems differ from country to country according to their respective health policies as well as to geographical, climatic and demographic patterns, the cost of distribution cannot be calculated in a uniform manner. In countries where distribution of drugs is handled by the public sector, the costs for distribution are generally charged to the health budget and are not reflected on the retail price of the drugs. In such cases, the public health services are face with two separate major expenditures, i.e., expenditure for buying drugs and fixed expenditure for their distribution. In other cases, the costs of distribution are included in the retail price of the drugs. In such cases, the distribution costs vary with the volume of drugs.

WPR/RC28ITP 11 page 24

In comparison to other commodities, such as food, drugs - with the exception of vaccines and biologicals - are generally easy to transport and require a limited storage space. However, the number of items and the differences in format of packages create considerable difficulties of handling. This is one of the many reasons why a selection of essential drugs and a standardization of packaging forms and labelling, together with an adequate inventory control, are urgently required. Drugs should be handled with care and may be unstable under extreme temperature and humidity variations. Adequate quality checking, as well as the development of appropriate transportation and storage facilities, such as "cold chains", are therefore needed at each step of distribution to meet local needs. The responsiblity of drug distributors or dispensers for the proper use of drugs, especially at the peripheral level, is extremely important in ensuring education of consumers, utilization monitoring and the provision of useful information to the intermediate and central levels for the review of health logistics. Thus, the end point of the distribution chain is the patient. Distribution systems, including central, intermediate and peripheral storage facilities (taklng into account design, size and required space), mode of transportation, ordering or indenting systems with determination of periods for renewing or recycling stocks, should be considered when" ' countries are planning their health services. The major requirement in establishing successful distribution systems is the education and training of personnel dealing with drug distribution, such as administrative staff, inspectors, accountants, storekeepers,packers, transporters, pharmacists, dispensers, etc. These persons should be conscious of the fact that they are handling the most "needed" goods for the health of the people and that they are participating in the health action of the country. ' ,Such educational activities will prevent waste and leakage of valuable drugs during distribution and will improve the utilization of drugs for health care. Periodical seminars, workshops and meetings on drug management in terms of distribution and continuous supervision activities on the spot, at each level, will be the key factor, not only to save public funds, but also to contribute to efficient and proper utilization of drugs. (8) Control of drug prices

.. ,..

The prices of drugs are generally determined either by cost calculations or by market situations. When determining the prices of drugs by cost calculation, the following expenditures are considered: (i) cost of production, including production of raw materials, formulation, packaging, quality assurance, research and.development (comprising royalties for patents and know-how), market1n~ (comprising advertising, direct and indirect sales promot10n), general administration and returns of investment and interest on credits allocated to wholesalers and retailers;

WPR/RC28/TP 11

page 25

. (11) cost of distribution,·· lncludingstorage , transportation, sales promotion, client services and general administration, as well as interest on credits allocated to retailers; (iii) cost of dispensing, includ1ngtechnical, administrative anA storage expenses, as well as miscellaneous expenses for consumer services. A variable amount of profit and taxes is added to these costs. The main components of the above-mentioned costs could be determined in fixed amounts or as a percentage of the price, within acceptable limits. However, the most difficult components in determining the prices of drugs are the costs of production of raw materials and especially the cost of active ingredients which are generally known only to the producer. The prices of drugs can also be determined according to the market situation, L e., the size of the demand for a particular product ,the prices of competitive products and the therapeutic advantages of a new product over the exist1ng ones. The drug companies determine different prices of their products in each country, or even in each district, taking the above-mentioned factors into considera·tion. As drugs are moving internationally, many transnational companies decide on the transfer of prices according to their own interests. Generally, when a country formulates national policies for drug production, procurement and distribution, and sets up regulations on drug pricing, the prices of drugs tend to decrease. In some countries, the government has no authority to fix the prices of individual drugs but it expects that the prices of drugs will decrease through fair trade practices in free competition among the different companies. However, because of the oligopolistic structure of the pharmaceutical industry, the prices of drugs are not always brought down as expected. Nevertheless, as pharmaceuticals are not considered as ordinary commodities, the governments generally concentrate their efforts mainly on regulating the prices of selected drugs for the public sector, for example, prices of drugs reimbursable by the social security or by governmental health services. In this case, the evaluation of "relative efficacy", "cost-benefit" and "acceptable quality" are the most important technical components for determining such prices. Awareness of the cost of health, especially of the cost of drugs, by health workers, but also by consumers, is rapidly increasing. In response to this situation, governments and public agencies should establish adequate communication on "prescribing costs" as reducing the unit price of drugs is not always enough to achieve savings on drug expenditure. Furthermore, the final objective of reducing drug prices is to increase the access of the population to more useful drugs.

WPR/RC28/TP/1 page 26

(9)

Drug information, utilization surveillance, and training of health workers

Drugs are the outcome of progress in science and technology; they should always be accompanied by up-to-date and objective information on their proper use. The type of information on drugs that is needed varies according to the users: policy makers, decision takers in the regulatory authorities, procurement officers, pharmacists, distributors and, finally, prescribers and consumers. The management of drug information is therefore a very complex' matter and determination of the outputs according to the users requires careful determination of the necessary inputs and adequate processing. For each drug, information on chemical, physical, biological, medical, economic and technological aspects is generally available, setting out detailed research and development results as well as continuous experience obtained during utilization of. the products by physicians, pharmacists and other health workers. For each product, information on the technological and marketing capabilities of the manufacturer and distributor is not always generally available; information about the product of a technological and economic nature is generally considered as industrial and intellectual property and is therefore not released . . Information on the safety of drugs (adverse reactions) is an essential component of drug information for regulatory authorities, prescribers and consumers. Freedom of drug information, particularly on the safety of drugs; has recently been claimed by consumers in some countries .. Because of the complexity and interdependency of information on drugs, its disclosure to public agencies often conflicts with industrial interests. For example, public agencies wishing to evaluate and verify the methods and requirements for the control of the quality of a product proposed by a manufacturer must obtain information on the production procedures, including grade, suppliers, manufacturers of chemicals used, etc., although this information is generally considered as the property of the manufacturer. It is recognized that public agencies should take responsibility in evaluating and controlling the information on drugs for prescribers and consumers, for example, advertising and other promotional materials generated by the pharmaceutical enterprises. In order to do this, a regulatory agency would require quite a sizable qualified staff, a technical infrastructure, as well as investment and operating budgets which, even in the developed countries, are not always available. Furthermore the data available in any single country may not be sufficient to diss~minate timely, objective, evaluated drug information and international collaboration is consequently required.

WPR/RC28ITP/1

page 27

In many develo.ping countries, where there 1s a scarcity of qualified manpower, financial resources and teohnica1 infrastructures, the establishment of drug information systems would be difficult. Furthermore, the type of information needed might be different in developed and developing countries and in different health oare organizations. For this reason, teohnioa1 oooperation among countries in the adequate transfer of drug information, supported by WHO, would be the most appropriate approaoh in order 1;0 provide relevant information to prescribers and consumers. When·oountries deoide to furnish essential drugs to the population, the provision of relevant intormationshould be ensured. Furthermore, the dissemination of suoh information should be combined with educational and training activities on the proper use of drugs for prescribers and consumers. Without suoh a dual effort, the improvement of drug use cannot be achieved. Health authorities shOUld pay greater attention to surveys of drug utilization, studying not only consumption figures but utilization patterns, ino1uding consumers' acceptance of both western and traditional drugs. Such surveys are an important source ot information for formulating and reviewing national drug policies. A continuing drug utilization surveillance, carried out by health workers and coordinated at the central level, would provide the most useful information for drug management and also for the prevention of drug abuse, particularly of dependence-producing drugs (narcotic and psychotropic). Valuable information on drugs is in the hands of the manufaoturers. It is an important social responsibility of the pharmaceutioal industry to collaborate with governments in providing unbiased and accurate drug information to meet the health needs of the populations.

(10)

Utilization of locally available natural resources for health care

Because of the deeply-root survival instinct, people have used locally available drugs of natural origin for centuries. Several countries in the Region have identified useful drugs of natural origin, mainly medicinal plants, and considerable efforts have been made for their standardization. The use of these drugs in traditional medicine has been described in many countries. Chemical, biological and clinical research to identify and isolate active substances which could be applied in western medicine have been carried out extensively and certain important results obtained. National policy on traditional medicine is a matter of concern in many countries. However, policies may be formulated differently for countries where adequate modern health care resources and western-trained health manpower are available. Where resources and manpower are still insufficient, the use of medicinal plants and other natural products available in the country might be very useful in organized health care. Traditional medicine is a cultural heritage of the people and generally has high "consumer approval". A sudden change from traditional to western medicine causes negative attitudes in the population towards the organized health care services. This leads to under-utilization of these services and to competition between them and traditional medicine.

WPR/RC28ITP/1

page 28

Two main alternative approaches have been considered,namely: (i) integration of traditional with western medicine; and

(ii) traditional medicine as parallel or complementary to western medicine. When integrating traditional medicine with western health care, the following problems are encountered: (j) Integration of traditional practitioners into the health services in order to promote cooperation with western-trained health workers. In this case, the role of each type of health worker should be clearly defined at each level of the health services. Examples of this approach in action are education and training of the population in collection, cultivation and use of medicinal plants by traditional practitioners; identification, quality control, processing, preparation and dispensing of traditional drugs by traditional practitioners who act as pharmacists-dispensers. (ii) Education and training of health workers for both western and traditional medicine. This approach has many advantages, especially in the primary health care setting because of its positive effects on consumer approval, thereby increasing the population's participation in community health care. By using this approach, a great deal of progress has been achieved in the primary health care of the population in several countries. In this caSe, however, the development of appropriate technology, as a supporting activity, is.most important. (iii) Integration of traditional drugs with western drugs. Health care started by the use of available natural substances by the population as a means of survival. Experience in the use of traditional drugs has been accumulated and utilized effectively by the people. There are many traditional drugs which could play an equal, or even more advantageous, role than western chemical drugs. Symptomatic treatment is most frequently required in primary health care and, in many cases, the use of traditional drugs may be medically and economically justified. When introducing traditional drugs into health care, two types of activity are required: (i) to identify health conditions which can be treated by traditional drugs as effectively as, or even more effectively than, with western drugs, taking into consideration the pathophysiological and psychosomatic aspects of the symptoms; (ii) to identify useful drugs, either medicinal plants or other natural substances, which can be used to produce traditional drugs.

WPR/RC28/TP/1 page 29

Atter such identification, standardization of the drugs and their raw materials (medicinal plants) should be considered on the basis of pharmacognosy, quality, safety, etc. The appropriate technology for production should be developed in the following areas: collection, selection, cultivation, conservation (washing, drying, sterilization, insect decontamination, etc.), cutting, extraction and processing in the most suitable galenical form for distribution, storage and administration. It should be noted that many medicinal plants are unstable and are effective only under certain conditions of administration. The use of medicinal plants should not be considered only for import substitution, but as an appropriate approach for developing countries to become self-reliant through development of appropriate health technology in accordance with their cultural heritage and natural resources. If a country cannot integrate traditional medicine into health care, for politioal or social reasons, the government generally regulates independently the practice and the substances used in each system, i.e., issuing special requirements for education and training and giving a speCial license for each type of practitioner, along with established lists of apprQved western and traditional drugs using different evaluation systems. Western and traditional medicine should not compete with each other. because both are valuable naUonal health assets. The former is based on the development of science and technology and the latter is based on national -cultural values accumulated by the people over a long period of time. Therefore, in spite of the different policies evolving in this area in various countries, common objectives and goals might be determined for the development of health of the people. Furthermore, the traditional medical systems should be studied in the light of modern science and technology not only by individual countries but also in a collaborative research effort among both developed and developing countries. Through this effort, hidden treasures could more readily be discovered, exploited and developed to a higher degree in order to satisfy the real health needs of the people. (11) Self-medication

Although organized health care is rapidly extending, self-care, especially self-medication, still plays a fairly important role because of easy and quick access to treatment. Self-medication might be considered as a symbol of self-defence against disease when organized health care does not exist or is not available. In developing countries, the health services are operating with lim1.ted resources and manpower which are often not constantly available, espeCially at the peripheral level. In this situation, home medicine and self-care can be given a greater role in community health services through: (1) much greater use within communities of the available health manpower for educational and training activities on self-care, especially in the use of drugs;

WPR/RC28/TP/1 page 30

(ii) improvement of the supply of pharmaceuticals and their utilization; (iii) prOV1S10n of valuable opportunities to the population in order to exchange information and to increase their participation in health activities; (iv) incorporation of useful elements of traditional medicine and drugs into community health services for use in self-care, thereby enabling the community to utilize the most effective methods from both traditional and western medicine. Therefore, the objectives in promoting self-care in developing countries may be formulated in the following way: (a) increasing self-reliance in health care through community participation, (b) optimizing the utilization of health services, (c) increasing availability of health care to the population living in rural and remote areas, and (d) facilitating and increasing nation-wide availability of pharmaceutical supplies. There are several constraints to be considered in implementing these self-medication activities, such as (a) the need to select appropriate drugs, especially safe drugs under various conditions of use, (b) commercial pressures for the introduction of proprietary name specialties. which are usually more expensive, (c) the fact that communities which particularly rely on self-care often have no distribution facilities and very limited resources for purchasing drugs, (d) possible competition between the health workers in the organized health care services and those helping the community in self-care on a voluntary basis, (e) the need for coordination of demand and supply, and hence for training activities and increased availability of supplies, (f) the fact that drugs for self-care are generally paid for by the consumer whose purchasing power is restricted by low income, (g) continued importation of most drugs and raw materials owing to limited technological resources and market. Considering the above objectives and constraints, the policy on self-medication should be formulated according to the situation existing in the most underserved populations. The following approaches can be considered in this respect: (i) Selection of the most appropriate drugs for safe self-care with standardized labelling and instructions for use. (ii) Provision of adequate information and training to the public on the safe and effective use of drugs for self-medication. (iii) Establishment of an adequate distribution system for the continuous supply of essential items, together with control and guidelines for commercial distribution. The training of storekeepers and transporters would also be required. (iv) Price control and surveillance by government authorities.

WPR/RC28/TP/l page 31/32

(v) Encouragement of community participation in the use and distribution of drugs for self-care through community health committees and interested individuals. There is perhaps a need for short training courses for those motivated people to gain some experience to enable them to assist when formally-trained health workers are not available in the community. However, those persons should not be in competition with formally-trained health workers and should work on a voluntary basis and, if offered, should only accept rewards following local traditions. Those persons would play an important role in acting as a link between health workers and the population, particularly in providing useful health information.

It should be stressed, however, that the indiscriminate use of self-medication leads to misuse and abuse of certain drugs, e.g. antibiotics, analgesics and psychoactive drugs. Adequate safeguards are therefore needed when such drugs are made available for self-care.

WPR/RC28ITP /1 page 33 ANNEX I

THE HEALTH CARE SYSTEM (based on a study of the WHO Executive Board)1 1. Health services

Health services can be described as a permanent country-wide system of established institutions, the multiple objective of which is to cope with the various health needs and demands of the population, providing health care to the individual and to the community, including a broad spectrum of preventive and curative activities, and utilizing, to a large extent, multipurpose health workers. According to the country's constitution, organizational and administrative structures, form of government and level of socio~economic development, its health services may be part of the state system, or of another public sector organization, or belong to the private sector or be mixed, coming under all these bodies. Problems of cooperation and coordination vary accordingly, the aim being to obtain a coherent health system. 2. Different levels of the health care system

2.1 Primary care services comprise institutions and persons at the peripheral or local level, at the point of entry into the health care system, concerned with individual patients' care as well as with community health. The services are provided by health workers alone or in units called either dispensary or primary health care centres with satellite subcentres and/or health posts, rural health units, etc. 2.2 Secondary care services include services for referral from the primary care system and are located at the intermediate level (i.e., district, province or regional level). In addition to consultation services, they include inpatient general medical wards and an important administrative component responsible for technical guidance and supervison of the peripheral units. 2.3 Tertiary care services include specialized services and eventually the super-specialities mainly at the teaching hospitals at the central (national) level and at the intermediate (provincial, regional) level, as well as a health administration responsible for planning, technical management and evaluation of the health services.

1 See WHO Official Records, No. 206, 1973, Annex 11 Organizational study on methods of promoting the development of basic health services, pp. 103-115.

WPR/RC28/TP/1 page 34 Annex I

Other terms used in describing health care

3.1 Consumer approval. The health services must really be accepted by the persons they serve. Both the operations of a health service and the statement of goals and priorities require consumer approval; under-utilization or development of parallel health service structures signify disapproval or critictsm and point to a need for re-examination of the existing solutions. 3.2 Health technology. This refers to methods of intervention that can influence a health condition in a predictable fashion. For many health conditions these methods vary in their cost, their effectiveness, their acceptability and their usefulness in different societies and in different health service structures. Public and private sector of health care. The interaction between the pubHc (largely government or tax-supported) segment of heaJth services and the remainder of the health care system (supported by special groups or by tndividual payment) is not properly understood in many countries. The non-public sector includes institutions and persons ranging from the specialized hospital to the private general practitioner, the pharmacist, the village midwife and the local healer. All the services are part of the health care system. Also, it is not widely appreciated that in many countrtes the private sector of health care is the dominant one, as judged both by the expenditure involved and by utilization; this may apply especially to the developing world.

3.3

3.4 Health needs. These may be defined as scientifically (biologically, epidemiologically, etc.) determined deficiencies in health that call for preventive, curative and eventually control or eradication measures. 3.5 Health demands. These are usually measured by the actual utilization of health services. The population's opinion of their needs (usually in curative medicine) mayor may not always correspond to their real needs. 3.6 Cost-benefit analysis. This is the systematic comparison, in monetary terms, of all costs and benefits of proposed alternative schemes with a view to determining: (a) which scheme will contribute most to the achievement of predetermined objectives at a fixed investment, and (b) the magnitude of the benefit that can result from schemes requiring the minimum investment.

Key facts

Organisation World Health Organization (WHO)

Document type Technical Documents

Adoption date December 31, 1977

Source World Health Organization