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ICP/DPM/002

MEETING OF WORKING GROUP ON THE REGIONAL

ASPECTS OF DRUG POLICIES AND MANAGEMENT

Convened by the

25 July 1973

ORIGnIAL: ENGl. ISH

WORLD HSALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC

Manila, Philippines 6 - 10 Maroh 1978

FINAL REPORT

Not ror Sale

Printed and distributed

by the

Rea10nal Orfice fOr the Western Paoifio ot' .. ,the World Health Orl!llI'Ilzation

ManUa,PhUippines

NOTE

The views expressed 1n \J'Ils report. are \J'IoBe of' t.he members of t.he work1ng group anQ ao not. neaessarily refleot. t.he polioies of t.he Organizat.ion.

Thl. report hll bt.n prepared bJ t.h. W •• t.rn PaoJfl0 R.,lonal orrioe or the WorLd H.aJ.th Or.pn1 •• tlon for OoY.rns.nt. or Membtr St,&t.e. ·In th. Re,lon an~ ror tho .. who pel't.101pewa ln the Workln, oroup on ~h. R.,lonal A.peot.. or DrY, Poll01 ••• nd Mana .... nt whioh WII held ln Manll., Phillpplne., rrom 6 to 10 Maron 1978.

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CONTENTS

1. INTRODUCTION ...................................... , ..... . 2. QBNERAL CONSIDERATIONS " " " " " .. " " . " " " , " " " " " " " " " " .... " .. " " " " " " .... 3. PROBLEM AREAS IN DRUG POl.ICIU AID MAIIAOIMINT . " " " " " " " .... " "

3.1 3.2 3.3 3./1 3.5 3.6 3.7

Legislation and regulatory oontrol •••••••••••••••••• Rea •• roh and develoPlMH"t " " " " " " " " " " " " .. " " " " .. " " " " " " " " " " Prooure.ent and distribution ..•••.•.••.•••.••••••• ,' Produotlon " .. " " " " " " " " " " " " " " " " " .. " " " " " " " " " , " " " .. " " " " " " " .. Quality ••• urance .... , .... , ....•..•...........•....•. Intorutlon a.,d ut111aatlon " " " " " " " " " " " " t " " "" " " " , " .. " " Human resource. and development .•... 1 •••••••••••••••

II • OBJECTIVES OF A PROGRAMH! ON DRUG POLICIES AND

Pac· -1

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" '5 5 6 6 7

MAHAOD4Btrf " " " " " " " " " " " " " " " " " " " " .. " "',, " .. " " " " " " " " " .. " " " " " " , " " " .. 1

5. GUIDELINES FOR AN ACTION PROGRAMME " " " " " " " " " .. " , , , " " " " " " " " "

6. ACTIVITIES IN IMPLEMENTING ACTION PROGRAMMES " " " " " , , " , " " " "

7. CONCLUSIONS AND RECOHMSNDATIONS ••••••••••••••••••••••••••

ANIIEX 1 - OPENING ADDRESS BY DR FRANCISCO J. DY, REGIONAL DIRECTOR, WHO RIOIONAL orr ICE

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FOR THB WISTER. PACIPIC • I I •• I I I. I, ••••• ,., ••• I •••• " 13

ANNEX 2 - ADDRESS BY DR CH'EN WlN-CHIEH, ASSISTANT DIRECTOR-GENBRAL , WHO H!ADQUARftRS ••••••• I •• I •••••• I ••••• " I • , 5

ANNEX 3 AGENDA ...................................... ,., .... ANNEX " - TIMETABLE •••••• I ••••••••••••••••••• I •• I ••••••• I ••••

ANNEX 5

ANNEX 6

ANNEX 7

- LIST or TEMPORARY ADVISERS, PARTICIPANT, REPRESENTATIVE OF THE WHO EXECUTIVE BOARD A .... D SECRETARIAT ••••••••••••••••••••• I ••••••••••••••

LIST 01' DOCUHINTS • I •••••••••••• I •••••• I ••••• I ••••••

WPR/DPMI78. 1 - NATIONAL DRUG POLICIES AIID MANAGBMENT ......... , ........ , ..................... .

ANNEX 8 - WPR/DPM/78.2 - POLICY BASIS AND BACKGROUND •••••••••

ANNEX 9 - WPR/DPM/78.3 - RESEARCH AND DlYlLOPMINT I • I •••••••••

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Contl!nta

ANNEX 10 - WPR/DPJoII78.4 -'LEGISLATION AND REGULATORY CONTROL ••••• oooooooo ........ oo .. oo ................. oo ........................ e,_"" 7'

ANNEX 11 -WPR/DPMI78.5 - QUALITY ASSURANCE •.•••.•.••••••••.• 73

ANNEX 12 - WPR/DPHI78.6 - PROCUREMENT •••....•••••••.••••..••• 77

ANNEX 13 - WPR/DPH/78.7 - DISTRIBUTION ••••••.•••••••••••••••• 79

ANNEX 14 - WPR/DPH/78.8 - PRODUCTION ••••••••••••..••• , •..•••• 81

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. 1. INTRODUCTION

The Working Group on the Regional Aapecta of Drua Polici.a and Management for the Western Pacific Region met in Manila from 6 to 10 March 1978. The meeting was opened by Dr Franclaoo J. Dy, Rel10nal Director, World Health Organization (WHO) Resionsl Office for the West.rn Pacific.

The objectivea of the meeting were:

(a) to review and analyae various aap.cta of drue polici.a and management in eaoh country and in th.R.,ion;

(b) to identify the priority .re. in t.ohnio.l ooop.ration In drul policl.a and man .... ant at oountry and int.roountry l.vell;

(c) to propoa. and recoaaand an aotion pro'r .... for technioal cooperation 1n dr"" pollote. and un., .. ant wUhin eaoh country .nd amonc the ~untri.a in the leClon. In his add ..... , Dr OJ str.aaed thlt oountrlea In the Rellon .1". now

confront.d with rapidly rlalng ooatl 1n the provilion of ph ..... c.utio.lI for he.lth car.. There.re probleaa of loaletioa in the diltribution ot druas in some countriel particul.rly to r..ate rur.l .real. There .r. likewia. problema aaaooiat.d with drUi produotion .nd !eport.tion .a well as with monitoring, quality control, .nd product r.,iltr.tion .nd certitioation. He exprelled confidanoe thlt the Group will produoe prectical and meaningful r80OIIIMndationl whiohwUl enable WHO to l.y the Iroundwork and basis not only for technic.l cooper.tion In drUi polict •• and managem.nt at country and intercountry lev.ls, but .lao tor the collaborativ. action WHO and other int.rnation.l Blancie. oould undert.ke in this important field.

Dr Ch'en Wen-chieh, Alailtant Director-General, WHO " .. dquarterl, Geneva, recalling reaolution WHA 29._8, lald that the ..-tina ot the Working Group provided a good opportunity for dilcu •• ion. on oonorete propoaals for technical cooper.tion .. ana the oountriel ot the R.,lon in the drug field. He hoped that after a revlew of the .ituation in the Region,the Group could Identify aOlie prioritY .rea. for technio.l cooperation which, in the spirit of the above .. entioned resolution, would lead to the formulation of .n action pro"'.... in the i~rtant field of drug policies and management. He also drew attention to re.olut1on £861.RI7 1n which the Executive Board expr.ll.d itl Itroh, lupport to the n.w ori.ntation of the proara-- on •• aanti.l drup and v.coinaa to •• et the balio health needl of the _jQr1ty Of the population.

Hr Yeap Boon Chye was .lected Ch.irman of the Worklnl Group; Dr L.F. Dodson and Hr Tan KiOk K'nl were deli,nated al R.pport.url.

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2. GENERAL CONSIDERATIONS

The meeting then considered a working paper on national drug policies and management and the three main areas covered in the discussions were:

(a) a review of overall country and regional situation;

(b) matters affecting the formulation of national drug policies to meet the health needs of countries; and

(c) technical and administrative components of drug policies and management.

A regional overview was presented and certain country situations were clarified. The need for a more precise method for compiling statistics covering import and export of pharmaceuticals was expressed. The value of using medicinal plants for health care was emphasized. In some instances, these products· could be locally prepared and utilized thus reducing the load on the distribution system and saving currency required for imported synthetic products. It was strongly recommended that product selection which contributes to rational drug policfes should be based on the list of essential drugs prepared by the WHO Expert Committee.' Furthermore, the formulation of drug policies and management is multi-sectoral and involves such public and private sectors as health, finance and industry.

The Group noted the recent resolutions of the Executive Board meetin,. which requests the Director-General to, ~!!.!!:

(a) continue to identify the drugs and vaccines which, in the light of scientific knowledge, are indispensable for basic health care and disease control in the vast majority of the population, and to update periodioally this aspect of the report of the Expert Committee on Essential Drugsl;

(b) cooperate with Member States in formulating drug policies and programmes that are relevant to the real health needs of populations, aimed at ensuring acoess of the whole population to essential drugs at a cost the country can afford;

(c) foster technical cooperation among developing countries for the formulation and implementation of appropriate programmes on drugs, including the local production or essential drugs and vaccines;

'TRS 615, The selection or essential drugs. Report of a WHO Expert Commit tee.

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(d) stimulate bilateral and multilateral cooperation in order to provide generous support to countries for the implementation of their procre ... on druce. inolvdi'lll'tlle looal produotion of eseenUal drlCs and vaccines; and

(e) to assist in the development of a system of , quality control of the products provided under such a programme of technical cooperation.

These policies were considered in terms of:

(a) problem definition;

(b) proposed objectives and targets;

(c) description of the programme.

3. PIIOBLIM lJllAa 1 .... 00 POLICIES Aln MANAGEMENT

In the .. neral dleouaalon en the p .. oblelll areas enoounterad in the field of natioM.l drlC polioies and management in the countries of the Western Pacific Region, the meeting noted that the solutions to most of the problems arising are inhibited by a lack of olear national drlC policies based on rational drug management. The Working Group emphasized that because the prices of drugs are riSing rapidly, a high proportion of health budgets are spent on pharmaoeuticals in developing oountries. In addition there is frequently an inadequate supply of essential drugs relative to the health needs of the population. There is insufficient awareness of the.e facts. Seven important problem areas were then identified and the meeting agreed that disoussions in depth of these issues should be done in the following order:

(a) Legislation and regulatory control

(b) Research and development

(c) Procurement and distribution

(d) Production

(e) Quality assurance

(f) Information and utililation

(g) Human resources development

3.1 Lelislation and relulatorl control

A wide variation is found in the national legislations amongst oountries of the Region. Furthermore, in some newly independent countries there is as yet no adequate legislative basis for the implementation of drug policies. Confusion results from the use of common terms for allied but not identical activities en the part of national control authoritiea. For exuple, the terms "registration" and "Ucensing" frequently have different meanings in some oountries.

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The Working Group agreed that whatever the framework of the legislation used or the term applied to various control activities, national legislation should supply powers for the following:

(a) the drugs made available should be only those approved by the government (for example, by registration or the provision of lists of essential drugs);

(b) government approval should be based on an asses~ment of the health needs of the populati.on and the evaluation of scientific nat", provided about the drug by the manufacturer;

(c) the establishment of national control authorities And laboratories;

(d) the provision of specifications for the Quality of drugs;

(e) the sampling and testIng of drugs to accepted specifications;

(f) the inspection of manufacturing establishments to enSUre that good manufacturing practices are observed;

(g) controls over labelling and advertising of drugs;

(h) the recall of batches of sub-standard drugs and the prompt removal of dangerous drugs from use.

The Working Group considered that these powers should be acquired by governments even before the resources and facilities to implement programmes are developed.

3.2 Research and develEpment

The Working Group considered that the classical approach to research and development in the pharmaceutical fIeld with its reQuiremo>nts of a sophisticated infrastructure and availability of highly Qualified human resources was inappropriate for the developing countries of the Region.

A high priority should be accorded to research which would permit the collation of elata on the patterns and incidence of disease in the Region. If, as it is believed, that a number of countries have common needs, this would provide the basis of collaboration. In particular, the Group will assist in the pre,paration of national lists of essential drugs whIch are reasonably uniform and which are based upon the list prepared by a WHO Expert Committee'.

ClinIcal research on problems common to the Region also appeared necessary. The varietIes of some parasites (e.g., SchistOSomA japonicum) appeared to be relatively resistant to current therapeutic agents.

The dosage and information on side-effects of drugs rleveloped for other regions were not always applicable to peoples of the Region. The capability to carry out therapeutic trials should therefore he developed to determine the relative efficacy of drugs included in nationAl lists and the effects of such factors as stature, malnutrition and gp.netic differences 1f there is reason to believe that these factors may be operative.

'TRS6'5, The selection of essential drugs. Report of a WHO Expert Committee.

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The Region is rich in ~edicinally valuable plants which received considerable acceptance under traditional medical systems. These remedies were relatively cheap, saved currency otherwise required for importa and were generally free from slde-effects. In so~e cases, the re~edies could be locally prepared at the village level thus relieving the distribution system. It was agreed that such products required appropriate standardlzation particularly ldentification of the starting material and method of preparation rather than the analysis of finished products which was difflcult with co~lex mixtures. Reglonal collaboratlon should be encouraged to assist in standardization.

It was also recommended that consideration be given to the development within countries of the Region of sources of supply of common materlals such as glucose whlch were not available in forms suitable for pharmaoeutioal use.

3.3 Proourement and di.tribution

The ooncept of central procurement by government agenoies for distribution was generally agreed to be advantageous from· the econo~ic and therapeutio viewpoints.

Disoussions on the operational requi~~ents of suoh systeas oovered the following areas:

(s) the use of national lists of essential drugs - international non-proprietary (generiC) na~s should be used:

(b) basic distribution infrastructure with proper facilities for transport and storage;

(0) a sound system to ensure sufficient quantities of drugs for distribution throughout the oountry;

(d) the neoessary personnel with basic training who are supervised by professionals;

(e) improvement of the existing purohasing procedures in the oountry,

The possible i~ple~entation of suoh systems would be a national polioy decision. The advantages of such systeM and information on price trends and sou roes of supply should be .. de available and technioal oooperation a~ong the oountries of the Region should form the astn thrust of WHO regional aotivities.

3.4 Produotion

The ooncept of establishing plants for looal pharmaoeutioal formulation to ~eet health needs of populations in developing oountries was deliberated, The meeting noted that experienoe in so.e oountries ha. shown that development of looal formulation of limited range of drugs needed in large quantities has not only benefitted health care of populations but has brousht economic advantages as well. In taot, oonsiderable progress has been aohieved 1n sOllie oountries in meeting the legitimate asp1raUons of

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developing countries in local production of essential drugs and vaccines. These advantages could be further enhanced by central purchasing of bulk raw materials. The rationale for local formulation should be such that it has economiC advantages so as to ensure that the objectives of supplying sufficient drugs for wider population coverage is achieved. The possible step-by-step approach to local formulation of pharmaceuticals could be as follows:

(a) repacking of bulk products;

(b) . production of syrups, linctuses, ointments and creams;

(c) production of tablets and capsules;

(d) production of small and large volume injections; and

(e) production by dilution and local packaging of bulk vaccines.

The meeting also stressed that quality control facilities for the above activities should be developed in phased-stages in accordance with the range of products to be formulated.

3.5 Quality assurance

The Working Group examined the place of quality assurance in the development of drug poliCies in the Region. It is necessary to ensure that drugs are produced using correct manufacturing practices to meet established quality specifications including stability and bio-availability when necessary. The formulation and packaging must be designed so as to ensure that the product does not deteriorate before use.

Past WHO programmes have dealt comprehensively with quality assurance and form a firm basis upon which policies can be formulated. WHO documents relating to Good Practices in the Manufacture and Quality Control of Drugs, the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, Quality Assessment and Assurance in Pharmaceutical Supply Systems (at present being developed) form comprehensive guidelines for planning and development.. The need for inspection services to verify compliance by manufacturers with good practices and specifioations was endorsed as was the role of government quality control laboratory services.

One recent WHO initiative which appears to be particularly relevant to the needs of the Region is the development of a series of simple analytical tests to ensure the identity and absenoe of gross degradation of drugs used in basic health services. The establishment of a capacity to utilize such tests at the periphery of distribution systems was considered important.

3.6 Information and utilization

Limitations of skilled manpower and resources in developing countries of the Region results in self-medication assuming a greater importance. Accordingly, in aome oases the provision of information to the population generally on the use and properties of drugs needs to be thorough and well-controlled.

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The data supplied to heaJ th professionals on the :nore cO!'lplex drup:n need to be more accurate and objective. The data provided in the Model Information Sheet discussed in WHO Technical Report Series 615 were considered vcry suitable for this purpose.

If surveys of drug utilization in the countries of the Re~'on, even if not very detailed, were periodically made they wOllI

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(111) to collaborate with countries in the Region in the establishment of national lists of essential drugs and if necessary specifications for them.

5. GUIDELINES FOR AN ACTION PROGRAMME

The meeting noted that in other WHO programmes, specific targets within a time frame were normally elaborated after due consideration of problems areas and objectives. However, in the case of this particular programme, activities both by WHO and countries of the Region had only been initiated within the past few years and more collaborative work would be needed in identifying problem areas in certain country'situations and the resources available in the Region. National health administrations are increasingly realizing that drug policies and management is an important component of national programmes of health care.

The meeting therefore did not attempt to lay down targets within a time frame. However, for countries which have indicated such targets in the national programmes, WHO should collaborate with them to achieve the targets, if these are feasible.

As far as the guidelines of an action programme are concerned, the following are the recommendations of the Working Group:

5.1 Legislation and regulatory control

The Group recommended that in the case of countries whose legislation is not fully developed WHO should collaborate in the development of suitable legislation. This could be achieved through an interchange of information on existing national legislation in the countries of the Region. WHO should convene meetings amongst countries who wish to develop their legislation further.

The existing WHO programmes which assist in regulatory oontrol suoh as good manufaoturing praotioes and international speoifioations for drugs should be maintained and if necessary strengthened.

5.2 Researoh and development

The Working Group oonsidered that teonnology transfer was an important oonstraint in building up national oapabilities and that teohnioal cooperation with and among developing oountries should be fostered through WHO in developing appropriate methods for:

(a) formulating and paokaging of stable and effeotive dosage forms for local oonditions;

(b) clinical, ohemioa1 and biological researoh on the therapeutio properties of looally available resouroes of natural origin;

(0) produotion of raw materials for essential drugs.

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5.3 Procurement and distribution

The Working Group recognized the role of WHO in collaborating with countries and in stimulating technical cooperation among developing countries of the Region in:

(a) examining the possibility of bulk procurement and distribution of pharmaceuticals to ensure that more of the essential drugs can be made available to more people at the lowest cost;

(b) encouraging the production of suitable packaging materials whe~e local resources are available and their utilization in the countries of the Region, e.g., production of suitable glass containers for injectables.

5.4 Production

The Working Group recommended that for the encouragement of local pharmaceutical production, priority should be given to:

(a) foster technioal ooeperation among the oountries for formulation and implementation of appropriate programmes on drugs including the looal production of essential drugs' and vaccines;

(b) stimulate bilateral and multilateral cooperation in order to provide generous support to oountries for the implementation of their programmes on drugs, including looal production of essential drugs and vaccines;

(c) establish WHO regional collaborating centres to facilitate the transfer of pharmaceutical production technology.

5.5 Quality assuranoe

The Working Group recommended that amongst the various methods of quality assurance priority should be given to:

(a) the establishment of quality reqUirements for essential drugs at the country, intercountry and sub-regional levels;

(b) the establishment of inspection services covering national ~rug manufaoturing establishments and the entire distribution ohain;

(c) effeotive utilization of the WHO Certification Soheme for imported drugs;

(d) the establishment of laboratory facilities both for national control activities and for basic tests applied at the periphery or the distribution system.

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5.6 Information and utilization

The Working Group recommended:

(a) establishing mechanism for exchange of information on price trends and sources of supply of drugs and encouraging governments to participate in this exchange mechanism;

(b) fostering the exchange of information on safety and efficacy of drugs in order to provide early accurate and objective information;

(c) promoting drug utiltzation studies especially in peripheral areas to ensure a constant and sufficient supply of drugs and their rational use;

(d) providing information and technical support to countries who require effective control in advertisement of medicine.

5.7 Humsn resources development

The Working Group recommended that WHO:

(a) collaborates with countries in the identification of personnel required in all aspects related to drug policies and management;

(b) collaborates in providing appropriate training in national, regional and inter-regional seminars and workshops;

(c) collaborates in providing postgraduate training including fellowships in the fields of pharmaceutical technology, quality control and mediCinal plants;

(d) assists in national efforts in establishing training faciltties for humsn resources development;

(e) collaborates in providing appropriate training in pharmaceutical management, in particular, economics and marketing; and

(f) establishes regional or sub-regional centres for the above activities.

5.8 Use -of medicinal plants in health care

It was strongly felt that WHO has a very important role to play in the following areas of technical cooperation:

(a) collaborating with countries desirous of improving the use of medicinal plants in health care;

(b) coordinating regional efforts 1n increasing and improving utilization of medicinal plants in health care;

(c) collecting and disseminating information on methods of evaluation, collection, cultivation, processing and use of medic ina} plants in different countries;

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(d) coordinating ongoing research on methods of evaluation, co11eotion, oultivation, processing and use of medicinal plants in the various oountries and exploring the feasibility of creating regional centres in order to accelerate efforts in better utilization of medioina1 plants in health care. In the early development of these activities, stress should be laid more on aspects pertaining to applied research than to basic researoh.

6. ACTIVITIES IN IMPLEMENTING ACTION PROGRAMMES

The Working Group oonsidered the timing and priority for aotions by WHO to implement their reoommendations.

It is recommended that the first steps should be the initiation of country studies by nationals of the country in oollaboration with WHO to provide the detailed inforwation necessary for the formulation of clearly defined projects. These studies would provide general background data and Information on the development of the various elements of the pharmaoeutioalaupply ..,at... On the baais of this information detailed prograDllles and priorities could be proposed including such I118ttera aa physical and training needs, oosts and resource souroea. A more detailed guideline for these studies is provided in Annex 17.

Following country studies there should be two sub-regional meetings of countries selected on the basis of common problems and community of interests.

These meetings should examine ways and means of further advancing the programme of drug policies and management.

Some of the outcomes could be:

- the formulation of national lists of essential drugs;

- the definition of specific areas for further research and development;

- specific activities relating to quality assurance;

- an_ination of the feasibility of oulk-purchasing schemea;

- a clearer appreciation of training needs both basic and post-basic;

- the feasibility of establishing local production in various countries.

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7. CONCLUSIONS AND RECOMMENDATIONS

The Working Group recommended that:

(a) the Action Programme on Technical Cooperation in Drug Policies and Management be urgently implemented with a view to strengthening the national capabilities of developing countries in meeting the needs of the whole population for essential drugs and vaccines;

(b) attention of all countries be drawn to the Report of the WHO Expert Committee on the selection of essential drugs, Technical Report Series (TRS) 615;

(c) a Regional Advisory Committee on Drug Policies and Management be established to advise the Regional Director on planning, implementing and evaluating the Action Programme of Technioal Cooperation with and amongat the oountries;

(d) in the course of country health programming due attention be paid to the multi-sectoral approach in country drug programming;

(e) high priority be accorded to training of manpower at all levels with WHO collaboration;

(f) in order to implement the proposed action programme effeotively, WHO stimulate contributions from extra-budgetary resources;

(g) ap'opriate mechanisms be established for cooperation with other international organizations at regional and country levels. In this connexion. t~e role of the WHO representative would be of particular importance and should be backed by technical support, if necessary.

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OPENING ADDRESS BY DR FRANCISCO J. DY, REGIONAL DIRECTOR

WHO REGIONAL OFFICE FOR THE WESTERN PACIFIC

ANNEX 1

It is with sreat pleasure that I welcome you to this meetina of the Workins Group on the Resional Aspects of DruS Poltcies and Hanasement. The meetina is the first of its kind in the Western Pacific Resion.

The convenins of this Workins Group is opportune at this ttme when countries in the Region are confronted with rapidly rislna oosts in the provision of pharmaceuticals for health care. There are probleas of logistics tn the distribution of drugs in some countries particularly to reaote rural areas. There are Ukewise problellS associated with drug production and illlportation as well as with IIIOnitoring, quality control, and product resistration and certification. It was therefore felt that a satherins of experts in the ReSion, to exchange views, share experiences

. .... ", ... ~Mt10111Pl'01I'" e _s called tor.

The objectives of this meetina are to review and analyse various aspects of drug policies and manasement, to identity the priority area for technical oooperation, and to prepare and recommend an action programme for SUCh cooperetion within and among the countries of the Region.

We have with us today 10 temporary advisers, each one of whom has been selected on the basis of his knowledge and expertise in current policies of governments and international cooperation in the pharmaceutical sector, and not as a representative of his government. We have also a participant froll UNICEF. We invite him to take an active part in the diacussions particularly in areas relevant and ot special interest to his asency. For example, international cooperation in bulk purchasina of pharmaceuticals may be of particular interest to UNICEF.

We are fortunate to have with us two consultants who are staff lIIembers in WHO Headquarters, namely, Dr H. Nakajima, Chief of Drug Policies and Hanaselllent and Hr r.o. Wallen, Chief of Pharmaceuticals Section. Both have been very active in this field and have played a key role in initiating and plannina for the lIIeetina. Other members of the Secretariat who are on the Begtonal Office staff are here to aSSist you in any way they can.

We a"e especially honoured at.thh gathering by the presence of Dr Ch'en Wen-chieh, Assistant Director-General, WHO Headquarters, and Dr V. 'attorusso, Director, Division of Prophylactic, Diagnostic, and Therapeutic Substances, WHO Headquarters. Their presenoe here underlines the importance WHO attaches to this crucial component in the health care system, the area of drug policies and managelllent.

We are also deeply honoured by the presence with us here today of Professor Jakovljevic, Chairman of the Ad Hoc Committee on Drug Policies and Hanasement of the Executive Board of WHO.

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Annex'

I have no doubt that a gathering such as we haVe here will produce practioal and meaningful reoommendations whioh will enable us to lay the groundwork and basis not only for teohnioal oooperation in drug polioies and management at oountry and intercountry levels, but also for the collaborative action WHO and other international agencies could undertake in this important field.

It only remains for me to wish you sucoess in your deliberations, and for those of you who have come from abroad, may you have a pleasant stay in Manila.

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ADDRESS BY DR CH'EN WEN-CHIEH, ASSISTANT DIRECTOR-GENERAL, WHO HEADQUARTERS

Mr Chairman, dear colleagues, ladies and gentlemen:

ANNEX 2

First of all, I would like, on behalf of the Director-General, Dr Mahler, to transmit his warm greetings to all of you. As you are aware the programme of drugs in WHO Headquarters has been reoriented towards technical cooperation with countries in the spirit of resolution WHA 29.48 in which the Director-General was requested to "reorient the working of the Organization with a view of ensuring that allocations of the regular programme budget reach the level of at least 60% in real terms towa~ds technical cooperation and the provision of services by 1980 •.•. ".

I think this meeting provides a good opportunity to translate into action the reorientation of the WHO programme on drugs. This requires, as suggested in the draft agenda, a review of the situation on drug policies and management in the Region and then an analysis of the main components of the pharmaceutical supply system. Thi~ would hopefully permit the identification of some of the key problems on the basis of the experience of the temporary advisers coming from the countries of the Region. To m~ke progress towards the solution of these problems technical cooperation among the countries themselves may be required and we hope that, by the end of the meeting, you will agree on proposed guidelines for the development or new activities to stimulate, through WHO, such technical cooperation in the drug field. Then we could be sure that, as stated in resolution WHA 29.48, the services provided by WHO in this field, correspond to the real needs of the countries.

At the 61st session of the Executive Board in January this year, the problem of drugs was extensively discussed in connexion with the presentation of a report of a WHO Expert Committee on the Selection of Essential Drugs and· a progress report on drug policies and management of which you will find copies in your files. The Executive Board adopted resolution EB61.R17 which also is included in your files in which the Board expressed its strong support to the programme and established an Ad Hoc Committee on Drug Policies and Management and the committee has expressed its deep interest in this working group and deCided that the chairman of the committee, Professor Jakovljevic, should participate.

This is the first time a working group on drug policies and management has been convened by a WHO region, and it is hoped that your deliberations will give guidelines for the formulation of a concrete action programme in the important field of drug policies and management of this Region.

It is also expected that the experience gained during the meeting will contribute to the development of other regional as well as global programmes. I deeply appreCiate the initiative of the Regional Director, Dr Dy, to rapidly develop a programme in this field.

Thank you, Mr Chairman.

- 17/18 -

ANNEX 3

AGENDA

Opening address by Dr F.J. Dy, Regional Director, WHO Regional Office for the Western Pacific

2 Election of Chairman and designation of Rapporteurs

3 Introductory remarks by Dr Ch'en Wen-chieh, Assistant Director-General, WHO Headquarters, Geneva

4.1 Regional situation on drug policies and management

4.2 Specific issues in drug policies and management in the Region

4.2.1 Research and development

4.2.2 Procurement and distribution

4.2.3 Production

4.2.4 Quality assurance

4.2.5 Information and utilization

4.2.6 Human resources and development

4.2.7 Legislation and regulatory control

5 Proposed guidelines for medium-term programming in drug pol1ctes and management through technical cooperation 1n the Region

6 Recommendations

~ Time Monday, 6 March Tuesday, 7 March Agenda item 4.2

0830 - 0930

0930 - 1000 Opening, Agenda item 1 Election, Agenda item 2

1000 - 1030 - - - - - - - - - - C 0 F 1030 - 1200 Agenda item 3 Agenda item 4. 2

Agenda item 4.1

1200 - 1300 ---------- L U N

1300 - 1430 Agenda item 4.1 Agenda item 4.2

1430 - 1445 - - - - - - - - - - C 0 F

1445 - 1600 Agenda item 4.1 Agenda item 4.2

TIMETABLE

Wednesday, 8 March

Drafting group

Agenda item 4

F E E

Agenda item 5

C H

Agenda item 5

F E E

Agenda item 5

Thursday, 9 March Friday, 10 March

Agenda item 5 Drafting group

Agenda it em 6

- - - - - - - - - - - - - - - - -Drafting group Agenda item 6 Agenda item 5 (Adoption)

- - - - - - - - - - - Closing Agenda item 6

- - - - - - - - - - - -

Agenda item 6

~ ~ '" " "

"" '" --~

- 21 -

ANNEX 5

~IST OF TEMPORARY ADVISERS, PARTICIPANT, REPRESENTATIVE OF THE WHO EXECUTIVE BOARD AND SECRETARIAT

AUSTRA~IA

1. TEMPORARY ADVISERS

Dr ~.F. Dodson Director National Biological Standards ~aboratory Department of Health P.O. Box 462, City Canberra, A.C.T. 2601

PEOP~E'S REPUB~IC Dr Chou Hai-chun 1 OF CHINA Vice-Chairman

JAPAN

Peking Institute for Control of Pharmaceuticals Peking

Dr Y. Yamada Director Division of Narcotics Pharmaceutical Affairs Bureau Ministry of Health and Welfare Tokyo

MA~AYSIA Mr Yeap Boon Chye Director of Pharmaceutical Services Ministry of Health Kuala ~umpur

PAPUA NEW GUINEA Dr Jack Onno First Assistant Secretary (Health Care) Department of Health P.O. Box 3084 Konedobu

1Unable to attend.

Annex 5

PHIloI PPINES

- 22 -

Dr Wilfredo A. Clemente Director Technology Resource Center TRC Building Buendia Avenue Extension Makati Metro Manila

Mr Arsenio M. Regala Administrator Food and Drug Administration Department of Health Manila

REPUBLIC OF KOREA Mr Kun-Ho Yong

SINGAPORE

SOCIALIST REPUBLIC OF VIET NAM

Chief, Office of Drug Safety Research National Institute of Health Seoul -Mr Tan Kiok K'ng Acting Chief PharmaCist Pharmaceutical Department Ministry of Health No. 1 Jalan Bukit Herah Singapore 3

M. Nguyen Ouy Cuong Vice-Minister Director-General of Health Ho Chin Minh Ville

2. PARTICIPANT

Mr Wah Wong UNICEF Representative P.O. Box 883 Manila

3. REPRESENTATIVE OF THE WHO EXECUTIVE BOARD

Professor D. Jakovljevic Chairman Ad Hoc Committee of Executive Board on Drug Policies and Management WHO Headquarters Geneva

- 23 -

4. SECRETARIAT

Dr Francisco J. Dy Regional Director WHO Regional Orrice ror the Western Paotrlc Manila

Dr Ch'en Wen-chieh Assistant Direotor-General WHO Headquarters aeneva

Dr V. Fattorusso

Annex?

Director, Division of Prophylaotio, DiaRnostic and Therapeutic Substances WHO Headquarters Geneva

Dr H. Nakajima Chier, Drug Policies and Management Unit WHO Headquarters Geneva

Mr K.O. Wallen Chier, Pharmaoeuticals WHO Headquarters Geneva

Dr a.J.A. Ferrand Assistant Direotor of Health Services WHO Regional Orrice for the Western Pacific Manila

Dr C.J. Ross-Smith WHO Representative Suva mr Dr Wan Fook Kee Regional Adviser on Health Services Development WHO Regional Orfice for the Westsrn Pacirlc ManUa

Dr a.M. !mery Relional Adviser on Health Services Development WHO Regional Orrioe ror the Western Paotftc Manila

Annex 5

- 24 -

Dr R.D. Mercado Regional Adviser on Health Services Development WHO Regional Office for the Western Pacific Manila

Mr J. Abcede Public Information Officer WHO Regional Office for the Western Pacific Manila

Miss Genevieve Clement Interpreter WHO Regional Office for the Western Pacific Manila

Mr Jean-Daniel Katz Interpreter

Mrs Nad1ne Kieffer Interpreter

Mrs Nicole Ongp1n Translator WHO Regional Office for the Western Pacific Manila

Mrs Aurora C. Paz Secretary Health Services Development WHO Regional Office for the Western Pacific Manila

- 25/26 -

ANNEX 6

LIST OF DOCUMENTS

Agenda

Timetable

List of Temporary Advisers, Participant, Representative of WHO Executive Board and Secretariat

WPR/DPM/78.1 National Drug Policies and Management

WPR/DPM/78.2 Policy Basis and Background

WPR/DPM/78.3 Research and Development

WPR/DPM/78.4 Legislation and Regulatory Control

WPR/DPH/78.5 Quality Assurance

WPR/DPM/78.6 Procurement

WPR/DPM/78.7 Distribution

WPR/DPM/78.8 Production

WPR/DPM/78.9 Information and Utilization

WPR/DPM/78.10 Human Resources and Development

Annex 13, Official Rec. 226 Prophylactic and Therapeutic Substances

Resolution WHA28.66 Prophylactic and Therapeutic Substances

WHO Tech. Report Ser. 615 The Selection of Essential Drugs

EB61/WP/2 Proposed Programme Bu~get for 1978 and 1979 (Financial Year 1979) - Drug Policies and Management

EB61.R17 Drug Policies and Management - F.ssential DruRs

Certification Scheme on the Quality of Pharmaceutical Pro~uct8 Moving in International Commerce

- 27 -

ANNEX 7

NATIONAL DRUG POLICIES AND MANAGEMENT'

Thill document:

(a) reviews the overall country and regional situation and identifies programmes related to drug policies and mana~ement at national level;

(b) considers aspects of the formulation of national drug policiea in accordance with the health needs of oountries;

(c) discusses the teohnical and administrative oomponents of drug policies and management for establishing pharmaceutical supply systems at country and intercountry levels.

1 Originally dooument WPR/RC28/TP/1 presented at the twenty-eighth session of the Regional Committee for the Western Paoiflo. Tokvo, 6-12 September 1977.

- 28 -

Annex 7

CONTENTS

Page -I. INTRODUCTION. . • . • • . • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 29

It. REVIEW OF THE OVERALL COUNTRY AND REGIONAL SITUATION '" 30

III. FORMULATION OF NATIONAL DRUG POLICIES •••••••••••••••••• 35

IV. HEALTH NEEDS AND DRUG POLICIES ......................... 36

V. TECHNICAL AND ADMINISTRATIVE COMPONENTS OF DRUG POLICIES AND MANAGEMENT •••••••••••••••••••••••••••••••• 38

(1) Drug research and development ••.•••.•••••••.•.•••• 39

(2) Drug legislation and regulatory control........... 111

(3)

(4)

Product selection

Quality assurance

................................. 43 44

(5) Procurement from multiple sources of supply....... 46

(6) Local production ..........................•..•.•.. 48

(7) Distribution...................................... 51

(8) Control of drug prices •......•...•........•......• 52

(9) Drug information, utilization surveillance, and training of health workers ..•...........•....• 54

(10) Utilization of locally available natural resources for health care ......................... 55

( 11) Self-medication.... . . • . . . . . • . . . . . . . . . . . . . • . • • . . • . • 57

APPENDIX - THE HEALTH CARE SySTEM............................ 61

•

- 29 -

Annex 7

NATIONAL DRUG POLICIES AND MANAGEMENT

I. INTRODUCTION

"National drug policies and management" was selected by the twenty-seventh session of the Regional Committee for the Western Pacific in September 1976 as the topic for the Technical Presentation during the twenty-eighth session of the Regional Committee.

Questions relating to national drug policies and management have been raised in recent times during discussions· of the Executive Board and the World Health Assembly, especially at the fifty-fifth session of the Executive Board, and at the twenty-eighth World Health Assembly, when the need was stressed to develop drug policies linking drug research, production and distribution with the real health needs.

At the fifty-eighth session of the Executive Board in May 1Q76, thp. subject "National policies and practices in regard to medicinal prooucts; and related international problems" was selected for the Teohnical Discussions to be held during the Thirty-first World Health Assembly in 1978. 1

Problems relating to drugs have been discussed not only 1n heslth forums but recently also in political forums, such as the fifth conference of heaos of state or government of non-altgned countries (Colombo) and the conference on economic cooperation among developing countries (Mexico City), both held in 1976.

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

The selection of the topic "National drug policies and management" for the Technical Presentation during the twenty-eighth session of the Regional Committee for the Western Pacific will 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 1n fostering technical cooperetion among the countries or areas of the Region.

1 WHO Handbook of Resolutions and Decisions, Vol. It (2nd ed.), 1977, p. 89.

- 30 -

Annex 7

II. REVIEW OF THE OVERALL COUNTRY AND REGIONAL SITUATION

The continuing increase in demand for drugs in preventive, curative and rehabilitative health care is creating ever-increasing technical, financial and social problems in the planning and implementation of comprehensive health services in the countries.

To solve these problems, considerable efforts have been initiated and success achieved in Member States of the Region in a number of areas as follows:

(1) Encouraging the strengthening of national capabilities in res.arch and development in respect of:

(1) new, safer and more efficacious drugs of establlshed quality;

(11) industrial technology, both In formulation and production of raw materials and in production of vaccines and other biologicats;

(iil) drugs of natural origin, espeCially medicinal plants;

(iv) drugs of public health importance, especially for the oontrol of tuberculosis, leprosy and tropical communicable diseases generally;

(2) Strengthening of governmental control in the drug sector through:

(i) formulation and implementation of drug legislation dealing with:

- licensing of pharmaceutical enterprises, importers, manufacturers, marketing agencies, distributors, pharmacies, eto.

- registration and lioensing of individual drug products throuRh evaluation and re-evaluation of quality, efficacy and safety; .

- speoific control of poisonous and dangerous substances and dependence-producing drugs.

(ii) development of the necessary:

- administrative and technioal struotures for drug control;

- technical institutions, such as quality control laboratories;

- specifications for pharmaceutical produots and nat tonal pharmacopoeias;

- pharmaceutioal inspection sYstems;

- prooedures for the applioation of good manufacturing practices.

•

- 31 -

Annex 7

(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, especially of essential drugs, by government controlled factories;

(iil) preparation and updating of lists of essential or basis drugs or pharmaceutical benefit lists;

(iv) control of market prices and/or prices to national health insurance schemes;

(v) supply of drugs free of charge or partially so (benefits);

(vi) utilization of locally available drugs, especially medicinal plants and other drugs of natural origin.

(4) 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 prescription 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, and dispensers for improvement of national capabilities in pharmaceutical supply and use.

- 32 -

Annex 7

However, these efforts have not yet produced satisfactory results 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 drugs 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 marketing agency (IMS International), are as follows:

Sales Per capita (US$ million) consumption 1

(US$)

Australia 420 30.45 China 2 500 3.00 Japan 5 360 117.85 Malaysia 50 4.27 New Zealand 62 19.70 Philippines lB5 4.25 Republic of Korea 210 6.10 Singapore 16 7.00

If the other countries or areas in the Western Pacific 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 1 was US$ 805 B08 000 which represents 16.8 per cent of world imports.

The value of exports was US$ 32B 273 000 which represents 7 per cent of world imports.

lThese 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 which are not included in the estimates.

..

•

. ,

- 33 -

Annex 7

It is olear that the Western Paoifio Region has a tremendous trade defioit in pharmaoeuticals, although oonsiderable produotion oapaoities exist in some oountries.

In most developed countries and in some developing oountries or the Region, the pharmaoeutioal trade ia mainly in the hands of the private sector. In some of these oountries, a number of private industries are subsidiaries of transnational oorporations.

In other oases, especially in the developing nations, more than 30 per cent of the drugs may be imported by the government or a publio agenoy and sometimes, the importation of drugs is entirely 1n the handa of a publio or government organization. The proportion of drug expenditure 1n health expenditure generally varies between 10 and 20 per oent, but in some oountries it is more than 30 per cent and in others leas than 5 per cent. The average drug expenditure is about one per cent of GNP, but th1s also varies from oountry to oountry.

Ar.rl"x "

mUNTIl'{ IAHI':I'\

11:11':11 I CAN !,AMOA

AIJ:iTHALT A

CIlINA

/II-:WX:HATIC KAMl'llcllEA

~'IIF.Nr;1i POI.YNF'..stA

GII.BEHT 1 SLANDS

GUAM

IIONG KON(;

_ jll -

(CURRENCY: U,'j DOLLAns)

IMPORTS ~;XPOkT.'; 'tEAH ($1000) (tlOO!))

1')1 J

, 'f('~ II',

1911 1 ')1(,

86 Ina

PI!ARMAf':F:UTrr:AI. MAHKf.:T~ 19'(1, E:1TIMAn:;l

.":ALF::l ($1000)

JI?O 000

(I)

W.ljI,

.JAPAN 19'(4 11'>5 1'>2 1 37 111'1 ') 360 OIlU

I.AO PEOPl.E I S ()~Ot:HAT Ie RF:PUBJ.IC

"1A1.AYSIA

NEW HEBRIDES

NEW ZEALAND

NlIJE

PAPUA NEW GU (HEA

PHILIPf'INES

HEPUBLIC OF KOREA

SAMOA

SINGAPORE

SOCIALIST REPunLIC OF VIET NAM

:)OI.OMON ISLANDS

TONGA

TRUST TERRITORY OF THE PACIFIC ISLANDS

TUVALU

TOTAL

,"10 d:~ta HV2i lable.

1972

1972

1973

1973/'"

1973114

1911

197'

197'

1974

1971.1

1974

19 '19'1 3 'J80 1)0 000

261

•• "9 3 ll' 62 000 19·10

17

3 012

22 194 . ., 185 000 2' 801 6 287 210 000 6.10

228

50 759 66 ll0 16 000 7.00

152

152

805 808 328 273

:;O'wr~e:l: Un i ted Nat i ons Ycarbook of Internall ana 1 Tn:l.t~ Sta t l:lt It):..! 11J7'1

"(~port on an exa.minatlon of the feasibility of (!oll~ctlvt! or bulk purch:ssing for the Sout.h Pacific BureHIl for Economic Coopuriltlon (SPECl.

IM:i M· In Itor' Report I JanIJrH'Y 1971,

'Tht!st! figl.irc:I .lre rough estimatea and need to b~ ,:ldjusled LioIklng into (lcc()lmL dlfft1rences among countries 1n the prices of pharmaceutlcal~, In pattern!l of (iistrlbution and 1n the use or medicinal plants which are not incllJuQd tn the estimates,

. .

- 35 -

Annex 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 throu h social and economic development. It is obvious that hea th po icies should be formulated in the light 0 the social developments of the country which, however, should also be linked to general economic 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 quality of life of the population, often drug policles,are developed mainly for trade and industrial development. Therefore, in many countries, different and contradictory national drug policies exist independently. Nevertheless, it is now generally recognized that pharmaceutical products cannot be considered as ordinary commodities floating around freely in a aarket 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, biological, chemical and industrial fields, thereby creating new skilled manpower. For this reason, the multisectoral approach should'be imperative in the formulation of natIonal drug policies.

According to different political systems in different countries th& 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 goa"". 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 'Oft 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 policies and transnational corporate policies owing to the fact that pharmaceutical products are moving internationally and that the volume or 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, inrormation on drugs, often uncritical and biased, is circulating freely and rapidly 1n the world and 18 st1mulating the population's demand for drugs.

- 36 -

Annex 7

IV. HEALTH NEEDS AND DRUG POLICIES

The definition of "drug~" or "medicines" or "medicinal products" in national leSislation varies from country to country. Thes. te~s usually maens subatances and/or products of synthetic or national orisin used on humana (but, in some countriea, it also includes those used on ani .. ls) fo~ prophylactic, diasnostic and therapeutic purpoaea, inoludinc pharmao.utioals and biolOlioals such as antibiotios, vaocines, s.ra, and horaon.s. In some oaaes, blood and its prepsrstions and orsans of human ori,in sr. also inolu~ed.

About 3000 active substances ar. contained in the many thous.nds or pharaaceutioal prOducts ourrently aV.ilable on the world mark.t.

to

~~~~~~~ th ; drug polioies 1n developine oountri.s should p.y due .ttention di.tinotion, although it is recoan1 •• d that, in praotioal t.r .. , it ia

very difficult to draw the line.

In the formulation of drug polici.s, the following o.t.,orie. should b. conaidered:

(1) Pharmaceutioals suitable to meet-heslth needs, the.e b.in& d.fin.d as aci.ntirloally (biolosioally, epidemioloSioally, .to.), d.termined def10ienoies in health of the population. Th.s. produota oontain biolo,loally aotiv. aUbstanoes oapsble of prevent ins or influenoin& a h.alth oondition in a predIotabie feahion (see Appendix, 3.2). The effeetivene .. of these produots ia w.ll documented in toxicol08ical, pharmaoolo,ioal .nd olinioal .tudtes. They oan be oonsidered as aafe and effioaoious if prop.rly used b.oaua. their .xp.ot.d riska and b.nefita in sp.oific indioations have b •• n reasonably aas.as.d. Some of these producta, suoh as ohemotherapeutio asents and vaooines, are indispensable tools in the oontrol of the ooamun10able dia •••• s prav.lent 1n d.velopin, oountri.s. Oth.r produota, auoh aa antibiotioa, ana1&esioa, .to., .r. ind1ap.naabl. in .ff.otiv. health oare. Some of the.e produot. ar. hiShly apecific and oan only be u.ed 1n apeo1ali •• d inatltutions, a.,., antioano.r dru,a. Moat of the produots in thia oat.,ory r.lult rrom the applioation of mod.rn soience and technology. It is l~ortant to r .... b.r that not all "mod.rn druss" fsll into this oat.,ory, or are r.l.vant to the h .. lth n •• dl of d.v.lopins countries. Th. deoreasinc l.v.l of inv.atment by the pharmao.utio.l industry in reaearoh to d.velop aor. .rreotiv. dru,a to m •• t the priority h.alth n.eds of .d.velopi", oountri.s or .r.aa - for exa.ple for the oontrol of tropioal parasitio diseases, is a matt.r for oono.rn.

Th. issue or safaty related to the use or pharmao.utioal produots of this type oannot be 1&nore and would require an .rfioi.nt and appropriate transfer of drua information, .specially in d.v.lopi", countri.s. For .xampl., produots whloh have b •• n withdrawn from the mark.t in on. or mor. oountri.a because of levere adv.rse relotions may stll1 be .vlilabl. in oth.r oountri.s. In som. oas.s, the .valuation of the aooeptable risk. oa.par.d with the .XPected benefits from the us. of I produot may l.ad to dirterant oonolusions in different oountries beoaus. of .pidamiolOlioal, s.netio, enVironmental or other tectors.

- 37 -

Annex 7

(2) Pharmaceuticals sUitable to meet consumer demands. The demand fnr rtrlJl!;.~ beyond"the health needs, whether for "modern" pharmaceutical produ~t~ nr rnr traditional medicines, stems from a deeply-rooted survival instinct. Tn hoth developed and developing countries, there are numerous pharmaceutical pronuct~ which have been widely used for a long time. Well documented toxicoloF,ical, pharmacological and clinical studies of the effectiveness of these product~ are lacking or are inconclusive. Most of these products can he considered safe, on the basis that toxic effects are not recorded in widespread usc, bu~ their efficary 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 review and, when criteria for proven effectiveness were not met, the products were withdrawn from the market. In other countries, R less stringent approach is being followed and safe product~ of dubiou~ efficacy are being maintained on the market; but some of them are being withdrawn from the lilt of producta Paid for or reimbursed from public funds, a move clearly dictated by economic constraints.

(11) In developing countries, the main policy issue to be discu~sed is whether they should continue to import extensive 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 in 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 fnr many years by people as part of their traditional medicine, which has been well. documented in many countries of the Region. ~specially in developing countries, drug policies should give adequate priority to the preservation of this cultural heritage and to the promotion of research on medicinal pl~nt9, and other drugs of natural origin, in the light of modern medical and scientific knowledge, with a view to making the best use of them 1n health care. From the economic point of view, as self-reliance is the aim or drug policies in developing countries, it is important to develop technologies for the collection and cultivation of local medicinal plant!! and for the extraction of known active SUbstances.

- 38 -

Annex 7

(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 banned or subjected to strict control to avoid their leakage to the illicit trade. One issue regarding drug policies for these products is coordination between the authorities responsible for pharmaceuticals and those responsibile for narcotic control, which mayor may not be in the same sector of the government.

V. 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 review and plan their p~armaceutical_supply system which can be described as a oountry-wide system of institutions and activities which contribute to the availability of pharmaceutioal products for health oare, ranging from drug research to industrial produotion, oontrol, distribution and utilization. Depending on the politioal and organizational structure of the country, the different technical and administrative components of the system may be more or less coordinated by the government. All the components may be under the authority of the health ministry or some components may be under its authority, while others are under the authority of different sectors of the government, such as trade, industry, finanoe, etc. In some countries the whole pharmaceutical system and the health care system (see Annex Il are in the public sector, whereas in others these systems are partly in the public and partly in the private seotor. Problems of coordination vary acoordingly, not only between the pharmaceutical supply system and the health oare system, but also among the different components of the pharmaoeutical supply itself. The aim of developing national drug policIes is preoisely to achieve better coordination and efficiency.

Pharmaceutical supply systems have evolved to some degree in all countries, ranging from the least developed among the developing countries where only some oomponents are present, to the developed countries where all the components are present, although not always coordinated for form a coherent system. Because of conflioting needs that must be met, and because of changing interplay of political, economic and social pressures, the pharmaoeutical supply system undergoes continuous changes in all countries. Usually the technical and administrative oomponents of a fully deVeloped system are as follows:

- drug research and development;

_ drug legislation and regulatory control;

- produot selection;

- quality assurance;

- procurement from multiple sources of supply;

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- local productionj

- distributionj

- control of drug prices;

- drug information, utilization surveillance, and training of health workers;

- utilization of locally available natural resources for health carej

- self-medication.

(1) pr~ rese~h and development

In formulating national drug policies, governments should pay due attention to the main issues of research and development. Policies should be dey.loped giYing 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 pharmaceuticals 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 techonological progress, without the necessary infrastructure, manpower and economic resources it 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 substances and/or a therapeutic innovation, 1n order to protect the results of successful industrial research and development, are generally considered as industrial property together with the proprietary (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, this percentage may be higher because of the impact of the name on prescribers and consumers. The research-based pharmaceutical industry,

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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 public 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, promotion 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 needs 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 amon, 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 developed countries and intensification of technical cooperation among developing countries, (b) better utilization of locally available natural resources 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 production with raw materials, especially those which are locally available. 1

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 oountry 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 of origin. This practice has been criticized by members of a WHO consu1tation. 2

1WHO Technical Report Series, No. 563, 1975.

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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 nee~s of the country, in identification, collection, specification and processing of these materials could be an appropriate approach to be adopted in clevelopin~ 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 pharm~ceutical supply system.

Current drug legislation generally provides for partial regulatory control through the regist1"lltion 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 aector, especially pharmaCists and dispensers, is also regulated in many countries (through schools of pharmacy and their curricula, licensing of pharmacists after nati) rl 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 inclucled in regulatory control, e.g., for drug benefits in public health serVices, price control, provision of information for users and consumers, procu.rement 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 which 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, medlum- and long-term planning. In many developing countries the following could be considered as priority areas for immediate action:

(a) Drug control

(i) Selection of essential drugs for health needs and strengthening or quality control of these products;

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(ii) use of generic names whenever possible;

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

(iv) licensing, importation, production, distribution, advertising, and sales.

(b) Research and development promotion

(i) adequate regulation of industrial properties, such as patents and brand names;

(ii) regulation of foreign investment in the pharmaceutical sector;

(iii) incentives to research and development in the country;

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

(c) Pharmaceutical services

(i) establishment of regulations on multisource international procurement, especially in the public sector;

(ii) definition of the distribution of services within the country, giving clear responsibility to each level of the network, i.e., central, regional, subregional and peripheral;

(iil) provision of information and continuing education in the use of drugs.

As pharmaceuticals move internationally, there is need for cooperation among the authorities of the countries of the Region 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 definitions and the legal concepts of each country. Recently, in many countries, the problem of state responsibility for accidents induced by adverse reactions to drugs has been raised and discussed. In this respect, two different legal concepts have been considered, i.e., (a) determination of responsibilities after cause-effect relationships have been proved, (b) determination of responsibilities without fault according to the degree of physical, psychological and social damage attributed to the adverse reactions.

However, in most ourrent drug legislation, these matters are not mentioned, or the responsibility of the regulatory authorities is excluded.

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Product liability generally rests with the pharmaceutical manufacturers, but here again, when distributors and retailers are different from the manufacturers, the sharing of the liability raises difficult problems. Also, when the state manufacturers and ~istributes drugs, should the state's liability for the products be defined in the ~ame manner as for the private industry or otherwise, for example, according to the mode of supply, i.e., free, partial or at nominal cost?

Professional liability generally rests with the prescribers and/or dispensers, but the same problems can also arise in the case where they are government employees.

There is no internationally agreed legal viewpoint 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 and vaccines are major strategiC components in preventive and curative health action, it is obviously necessary to draw up a list or lists of priority drugs . ·,ich can be available routinely at the different levels of health action. The country's resources being generally limited, any kind of health action necessitates the setting of priorities. When the health needs of the country are not, or cannot be, ~at1.sfled 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 resources and availability of managerial skills when the government assumes responsibility in pharmaceutical supply. The price decreases when large quantities of a limited number of drugs are purchased. No individual or institution can correctly and constantly handle information on more than 1000 products. Physicians in private practice prescribe generally 50 to 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 or products.

In accordance with resolution WHA28.66 1, WHO can advise on the selection and procurement, at reasonable cost, of essential drugs 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 established safety, erficacy and economy. This li~t will be reviewed by an expert committee which will also suggest criteria for th~ selection of drugs to meet health needs.

1WHO Handbook of Resolutions and DeciSion, Vol. II (2nd ed.), 1977, p. 51.

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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 are essential tools 1n determining such needs and WHO could collaborate with countries, if required, in obtaining such expertise. In ensuring that such tools are used effectively, there is an urgent need for developing countries to develop fully, either alone or with WHO cooperation, a sound health information system.

In the context of technical cooperation among developing countries, the South Pacific Bureau for Economic Cooperation is drawing up a list of drugs for collective purchasing among the Member States and WHO is providing the necessary technical support in this respect.

(4) Quality assurance

Ensuring the quality of drugs to be provided to the population is the responsibility of the government and the producers. Quality specifications to which drugs and vaccines must conform· have been established by national or international organizations and are described in national or international pharmacopoeias.

The responsibilities of the government and the producers to ensure the quality of drugs and vaccines vary from country to country. The necessity for control both by the government and by the producers themselves is generally recognized.

Government responsibility in quality assurance consists mainly of (a) inspection of manufacturing establishments, stores and pharmacies, (b) sampling and analysis in national control laboratories, (c) verification of analytical specifications for drugs not included in official pharmacopoeias, (d) implementation of the WHO Certification Schemel.

Manufacturer's responsibility consists mainly of (a) conducting self inspection at all stages of production, (b) providing adequate analytical facilities, (c) keeping records of all analytical tests performed.

The responsibilities of distributors and pharmacies vary from country to country and should be defined according to local conditions.

Manufacturer's specifications are sometimes more stringent than those of official pharmacopoeias. AlthOugh there are often legitimate reasons for this approach, i.e., to ensure that drugs meet official specifications during their entire shelf-life, unnecessary requirements that only increase the cost of the drugs should be avoided.

lFor details see WHO Official Records No. 226, 1915, Annex 12, section 2 - Certification scheme on the quality of pharmaceutioal products moving in international oommerce, pp. 94-95.

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The image of drug quality is often linked with the brand name an~ the name of the producer. Also, the drugs produced in a country where there is strict regulatory control of quality, efficacy and safety are generally believed to be better drugs. However, exaggerated claims of high quality may not be related to better therapeutic performance of the product but may be used to justify higher prices and to increase market power.

In many developing countries, the government cannot afford to buil~ up a complete quality control 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 ~iffer from those of developed nations. Therefore, it would be worthwhile to adopt certain strategies in the following fields using appropriate technologies to meet the needs of the countries:

(i) effective use of the Certification Scheme 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 Republic of Korea 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 inspection among the countries;

(iii) sampling of incoming goods, their analysis through technical cooperation among the countries, and exchange of information on products and prices;

(tv) development of "basic tests" for the analysis of the pro~ucts at the distribution and utilization sites.

_ ... ---1WHO Handbook of Resolutions and Decisions, Vol. II (2nd ed.),

1977, p. 53.

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(5) Procurement from multiple sources of supply

Generally, when countries become independent, one of their first undertakings is to diversify their procurement sources within the context of self-reliance. This policy usually gives priority to procurement for the public sector. As pharmaceuticals are an important part of public purchases and are amongst the most "needed" commodities for the country, the establishment of a multisource procurement system (domestic or international suPply) by government or public agencies is a priority where economic resources are limited. For effective procurement only a relatively small qualified staff is needed if the necessary "marketing intelligence" and quality assurance system are available, and thus substantial sums of public money may be saved.

"Marketing intelligence" is the most needed tool for procurement and represents the country's. "bargaining power". It is obtained mainly by continuing survey and analysis of:

(1) producers and their manufacturing practices and production scale;

(it) price trends and speculation (early detection);

(iii) reliability of quality assurance, e.g., through batch certificates;

(iv) new drug information, especially registration status in the country of origin;

(v) information on product interchangeability, taking into consideration bioavailability and therapeutic equivalence.

In several countries, a well organized procurement system, based on worldwide tender, has been established as one of the major activities of the Ministry of Health. The system includes facilities for storage with cold room, packing, repackaging, transport, basic quality control and often production of galenicals, such as liquids and solids, e.g., powders, ointments, solutions and elixirs. The administration usually consists of professional, general service, accounting and statistical staff. Usually the agency procures not only drugs and vaccines, but also other medical equipment and materials, such as X-ray apparatus, filma, dental chairs, artificial limbs, dressings, etc.

Procurement procedures are based on tenders and, for specific drug~, on price negotiation under the responsibility of an independent committee of officials from each ministry - health, trade, and finance, including customs. The speCial allocation of hard currency, the exemption of custom~ duty and tax, and collective assurance by the government are also matters of importance when establishing a procurement agency.

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The first step to be taken in building up a procurement agency is to draw up a list of drugs to be procured according to the needs of the health