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Meeting of Working Group on the Regional Aspects of Drug Policies and Management, Manila, Philippines, 6-10 March 1978 : report

December 31, 1978 World Health Organization

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ICP/DPM/002

25 July 1973

ORIGnIAL:

ENGl. ISH

MEETING OF WORKING GROUP ON THE REGIONAL ASPECTS OF DRUG POLICIES AND MANAGEMENT

Convened by the

WORLD HSALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC

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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

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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.

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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.

CONTENTS

INTRODUCTION

...................................... , ..... . " " " " " . " " " " " , " " " " " " " " " " .... " .. " " " " " " ....

Pac· 1

2. QBNERAL CONSIDERATIONS 3.

PROBLEM AREAS IN DRUG POl.ICIU AID MAIIAOIMINT 3.1 Legislation and regulatory oontrol Produotlon

" " " " " " " .... " "

3.2 Rea •• roh and develoPlMH"t " " " " " " " " " " " " .. " " " " .. " " " " " " " " " " 3.3 Prooure.ent and distribution ..•••.•.••.•••.••••••• ,' 3./1

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3.6 3.7

3.5 Quality ••• urance

". """"""""""""""""". """"""""", """.. """"""". .... , .... ,....•..•...........•....•. Intorutlon a.,d ut111aatlon """""""""""" Human resource. and development .•... t " " "" " " " , " .. " " 1 •••••••••••••••

" '5 5 6

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II • OBJECTIVES OF A PROGRAMH! ON DRUG POLICIES AND MAHAOD4Btrf " " " " " " " " " "" " " " " " " " " " .. " "',, " .. " " " " " " " " " .. " " " " " " , " " " .. " " " " " " " " " . " , , , " "" " """" " " "" "", , ", " "" "

5. GUIDELINES FOR AN ACTION PROGRAMME 6. 7. CONCLUSIONS AND RECOHMSNDATIONS

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ACTIVITIES IN IMPLEMENTING ACTION PROGRAMMES

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ANIIEX 1 - OPENING ADDRESS BY DR FRANCISCO J. DY, REGIONAL DIRECTOR, WHO RIOIONAL orr ICE FOR THB WISTER. PACIPIC • I I •• I I I . I, • • • • • , . , • • • I •••• "

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ANNEX 2 - ADDRESS BY DR CH'EN WlN-CHIEH, ASSISTANT DIRECTORGENBRAL , WHO H!ADQUARftRS

ANNEX 3

AGENDA

...................................... ,., .... •••••• I ••••••••••••••••••• I •• I ••••••• I •••• ••••••••••••••••••••• I ••••••••••••••

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ANNEX " - TIMETABLE

ANNEX 5 - LIST or TEMPORARY ADVISERS, PARTICIPANT, REPRESENTATIVE OF THE WHO EXECUTIVE BOARD A ....D SECRETARIAT ANNEX 6 ANNEX 7 LIST 01' DOCUHINTS • I •••••••••••• I

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25 27

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

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ANNEX 8 - WPR/DPM/78.2 - POLICY BASIS AND BACKGROUND ANNEX 9 - WPR/DPM/78.3 - RESEARCH AND DlYlLOPMINT

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Contl!nta

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

ANNEX 11 -WPR/DPMI78.5 - QUALITY ASSURANCE ANNEX 12 - WPR/DPHI78.6 - PROCUREMENT ANNEX 13 - WPR/DPH/78.7 - DISTRIBUTION ANNEX 14 - WPR/DPH/78.8 - PRODUCTION

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73 77 79 81

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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. now In his add..... , Dr OJ str.aaed thlt oountrlea In the Rellon 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. t

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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;

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'TRS 615, The selection or essential drugs. Commit tee.

Report of a WHO Expert

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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) (b) (c) problem definition; proposed objectives and targets; 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) (b) •

Legislation and regulatory control Research and development Procurement and distribution Production Quality assurance Information and utililation Human resources development

(g)

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) (e) the provision of specifications for the Quality of drugs; 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. Committee. Report of a WHO Expert

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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 the following areas: requi~~ents

of suoh systeas oovered

(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) (b) .

repacking of bulk products; production of syrups, linctuses, ointments and creams; production of tablets and capsules; production of small and large volume injections; and 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<1 pl"ovirje a usefu) index of improvements of health l1ar8 delivery. 3.7 ~uman

resources development

For the effective implementation of national drug polioies and management sufficient and adequately trained personnel are requil"ed. The Working Group noted that in some countries of the Region there ill a 'leed to develop human resources both 1n the peripheral level, e.g., the dispenser, and the central level, e.g., the staff working in a national control labol"atol"Y or staff opel"ating in the central procurement and distribution systems. Furthermore, it was noted that whilst thel"e are a).I"eady countr! ... " in the Region which have their own national training prop,rammes for auxiliary health personnel the hIgher level of staff training hAS not yet been embarked upon by some countries. Some countries which offered training facilities have found thAt the experience and knowledge gained by the trainees were sometimes not properly utilized. It would therefore be a step 1n the rIght directIon to identir., precisely the types of training neeried. The Working Group also "ecognize.~ that human resources development should be concentratpn in "reA~ of pharmaceutical production, distribution inclurling the peripheral level 'Inn quali ty control. 4. OBJECTIVES OF A PROGRAMME ON DRUG POLICIES AtiD MANAGEMENT

After careful consideration of the above problem areas, t twas Ao:repd that the objectives of " WHO programme on rlrug policies and m'lnagement could be specified as follows: (a) General objective

- to promote a more rationAl procurement, distributlnn And utilization of safe and effective drugs 'msuri-ng that ~unh drup;s OIl"" made accessible at reasonable costs to meet the health needs of the whole population. (b) •

Specific objpctives

(i) to co'.laborate with countries in the Region in formu;atlno: national pol tni.es for the production, di.strlbution and IJtniz~ •. ion and control of safe and effjcacious drugs; (ii) to collaborate with countries in the Region In the development and establishment of national, regional or sub-reglonal services needed for the implementation of these policies;

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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 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. ~rug

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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.

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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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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ANNEX 1 OPENING ADDRESS BY DR FRANCISCO J. DY, REGIONAL DIRECTOR WHO REGIONAL OFFICE FOR THE WESTERN PACIFIC 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.

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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ANNEX 2 ADDRESS BY DR CH'EN WEN-CHIEH, ASSISTANT DIRECTORGENERAL, WHO HEADQUARTERS Mr Chairman, dear colleagues, ladies and gentlemen: 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 3 4.1 4.2 Election of Chairman and designation of Rapporteurs Introductory remarks by Dr Ch'en Wen-chieh, Assistant DirectorGeneral, WHO Headquarters, Geneva Regional situation on drug policies and management Specific issues in drug policies and management in the Region 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 5 6 Research and development Procurement and distribution Production Quality assurance Information and utilization Human resources and development Legislation and regulatory control

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

TIMETABLE

Time ~ 0830 - 0930

Monday, 6 March

Tuesday, 7 March Agenda item 4.2

Wednesday, 8 March Drafting group Agenda item 4

Thursday, 9 March Agenda item 5

Friday, 10 March

Drafting group Agenda it em 6

0930 - 1000

Opening, Agenda item 1 Election, Agenda item 2

1000 - 1030 1030 - 1200

- - -

- -

- - -

- -

- - - - - - - Agenda item 6 (Adoption)

Agenda item 3 Agenda item 4.1

Agenda item 4. 2

Agenda item 5

Drafting group Agenda item 5

"" '" -~

1200 - 1300 1300 - 1430 1430 - 1445

---------Agenda item 4.1

- -

-- -

- - - - -

Closing

Agenda item 4.2

Agenda item 5 0 F F E

Agenda item 6

- - - -

- -

- - - - -

1445 - 1600

Agenda item 4.1

Agenda item 4.2

Agenda item 5

Agenda item 6

~ ~

'" "

- 21 -

ANNEX 5 ~IST OF TEMPORARY ADVISERS, PARTICIPANT, REPRESENTATIVE OF THE WHO EXECUTIVE BOARD AND SECRETARIAT

1. AUSTRA~IA

TEMPORARY ADVISERS

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

~aboratory

PEOP~E'S REPUB~IC

OF CHINA

Dr Chou Hai-chun 1 Vice-Chairman Peking Institute for Control of Pharmaceuticals Peking Dr Y. Yamada Director Division of Narcotics Pharmaceutical Affairs Bureau Ministry of Health and Welfare Tokyo Mr Yeap Boon Chye Director of Pharmaceutical Services Ministry of Health Kuala ~umpur Dr Jack Onno First Assistant Secretary (Health Care) Department of Health P.O. Box 3084 Konedobu

JAPAN

MA~AYSIA

PAPUA NEW GUINEA

1Unable to attend.

- 22 -

Annex 5 PHIloI PPINES 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

SINGAPORE

Mr Kun-Ho Yong 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

SOCIALIST REPUBLIC OF VIET NAM

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 -

Annex? 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 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

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

- 24 -

Annex 5 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 WPR/DPM/78.2 WPR/DPM/78.3 WPR/DPM/78.4 WPR/DPH/78.5 WPR/DPM/78.6 WPR/DPM/78.7 WPR/DPM/78.8 WPR/DPM/78.9 WPR/DPM/78.10 Annex 13, Official Rec. 226 Resolution WHA28.66 WHO Tech. Report Ser. 615 EB61/WP/2 National Drug Policies and Management Policy Basis and Background Research and Development Legislation and Regulatory Control Quality Assurance Procurement Distribution Production Information and Utilization Human Resources and Development Prophylactic and Therapeutic Substances Prophylactic and Therapeutic Substances The Selection of Essential Drugs Proposed Programme Bu~get for 1978 and 1979 (Financial Year 1979) - Drug Policies and Management Drug Policies and Management - F.ssential DruRs Pro~uct8

EB61.R17

Certification Scheme on the Quality of Pharmaceutical International Commerce

Moving in

- 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 twentyeighth session of the Regional Committee for the Western Paoiflo. Tokvo, 6-12 September 1977.

- 28 -

Annex 7 CONTENTS

I. INTRODUCTION. . • . • • . • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • REVIEW OF THE OVERALL COUNTRY AND REGIONAL SITUATION '" FORMULATION OF NATIONAL DRUG POLICIES •••••••••••••••••• HEALTH NEEDS AND DRUG POLICIES ......................... TECHNICAL AND ADMINISTRATIVE COMPONENTS OF DRUG POLICIES AND MANAGEMENT ••••••••••••••••••••••••••••••••

Page 29 30 35 36 38

It. III. IV. V.

(1) (2) (3) (4)

Drug research and development ••.•••.•••••••.•.••••

39 111

Drug legislation and regulatory control........... Product selection Quality assurance 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.... . . • . . . . . • . . . . . . . . . . . . . • . • • . . • . •

.................................

43 44 46 48 51 52 54 55 57 61

(5) (6) (7) (8) (9) (10) ( 11)

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

- 29 -

Annex 7 NATIONAL DRUG POLICIES AND MANAGEMENT I. INTRODUCTION

"National drug policies and management" was selected by the twentyseventh 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.

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 (US$ million) Australia China Japan Malaysia New Zealand Philippines Republic of Korea Singapore 420 2 500 5 360 50 62 lB5 210 16 Per capita consumption 1 (US$) 30.45 3.00 117.85 4.27 19.70 4.25 6.10 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.

jll

Ar.rl"x "

(CURRENCY:

U,'j DOLLAns)

IMPORTS mUNTIl'{ IAHI':I'\

~;XPOkT.';

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

'tEAH

($1000)

(tlOO!))

.":ALF::l ($1000) (I)

11:11':11 I CAN !,AMOA

AIJ:iTHALT A

1')1 J

JI?O 000

W.ljI,

CIlINA , 'f('~

II',

/II-:WX:HATIC KAMl'llcllEA

1911 ~'IIF.Nr;1i

1 ')1(,

POI.YNF'..stA

GII.BEHT 1SLANDS

GUAM IIONG KON(; .JAPAN 19'(4 ()~Ot:HAT Ie

Ina 1 37 111'1 ') 360 OIlU

11'>5 1'>2

I.AO PEOPl.E I S RF:PUBJ.IC "1A1.AYSIA NEW HEBRIDES NEW ZEALAND NlIJE

1972 1972

19 '19'1 261 •• "9 17

3 'J80

1)0 000

1973 1973/'" 1973114

3 ll'

62 000

19·10

PAPUA NEW GU (HEA PHILIPf'INES

3 012 22 194

1911

.., 6 287 66 ll0

185 000 210 000 6.10

HEPUBLIC OF KOREA SAMOA

197' 197' 1974

2' 801 228 50 759

SINGAPORE

16 000

7.00

SOCIALIST REPunLIC OF VIET NAM

:)OI.OMON ISLANDS TONGA TRUST TERRITORY OF THE

1971.1 1974

152 152

PACIFIC ISLANDS

TUVALU

TOTAL ,"10 :;O'wr~e:l: d:~ta

805 808 HV2i

328 273

lable. Tn:l.t~

Un i ted Nat i ons Ycarbook of Internall ana 1 "(~port

Sta t l:lt It):..! 11 J7'1

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

IM:i M· In Itor' Report

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 dependenceproducing 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.

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;

- 39 -

Annex 7 - 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,

Annex 7

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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Annex 7 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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Annex 7 (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) (iii) regulation of foreign investment in the pharmaceutical sector; 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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Annex 7 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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Annex 1 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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Annex 7 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 at the distribution and utilization sites. pro~ucts

_ ... --1WHO Handbook of Resolutions and Decisions, Vol. II (2nd ed.), 1977, p. 53.

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Annex 7 (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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Annex 7 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 services (basic or essential drug list) 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. However, 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 for packing, stock-keeping 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 quantities. Therefore, tenders should be made annually, or at long intervals, for products which have a long shelf life and whose international price is stable. The procurement of patended 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 categories of drugs: (a) drugs well protected by patent and produced only by one or by licensed manufacturers, (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) 1n 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 usually issued by the manufacturers, although 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 developing countries as well as with laboratories in the developed countries.

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Annex 1 Many of the problems of procurement could be resolved by international cooperation among the developing countries and with the international organizations, such as WHO, which could playa greater role in coordinatln~ and cooperating in the necessary transfer of technology, information, managerial skills, etc. It is noted that the South Pacific Bureau for Economic Cooperation undertaken feasibility studies for collective purchasing of drugs fnr Member States and will expect closer cooperation with WHO for possible implementation of bulk purchase arrangements. (6) ~ocal

ha~

production

The establishment of a national procurement organization is an important 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. However, the feasibility of building up local production depen~s 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 covera~e, for example. These factors are often major constraints and, in many ca~eA, 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 formulation factory with a view to preventing difficulties of supply due t.o any unforseen 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 quality control laboratory will be required. ~dequate

•

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 technological resources. It should be noted that the production of drugs for public 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.

Annex 7 Before deciding to build up national production of essential drugs for health aare, 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-raising purposes when multilateral or bilateral external assistance is required. The following points should be considered in the preliminary studies: (i) demographic situation;

(11) geographical and climatic situation, such as "land-locked", "tropical", etc. (monthly temperature, humidi ty, 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 disea~es;

(vi) standard treatment for diseases identified under (v) and evaluation of the cost of treatment (based on the actual figures); (vii) current prices of drugs, price structure, profit margins and governmental price control policies; (viii) current legislation 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 produc tion; (xiv) 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.

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Annex 7

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: (i) (ii) (iii) (iv) consumption forecasts; current prices of imported drugs; the possibility of importing raw materials; the cost of investment for each aspect of production, for example: - tab let t ing - capsule filling - injectable ampoule filling - sterile product filling (for antibiotics 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 feasibiUty study, the production will be planned on the basis of preinvestment evaluation and the industrial feasibility study.

•

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Annex 7 The aspects to be considered in the industrial feasibility (1) (t1) type of buildings and space; type and amount of equipment; stu~y a~e:

(1i1) number of consultants/advisers and training of techn1cal 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 anrl 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 attitu~e of the financing agenCies (domestiC, bilateral, multilateral). 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 contact 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 "transportation" aspects. Drug distribution sbould be an important component of the logistiCS of health services and an integral part of the pharmaceutical supply system. Drug distribution is generally incorporated in the government helllth services, although procurement or production are sometimes han~led by other national agencies or by the private sector, thus creating an uncoor~inate1 pharmaceutical supply system. Since drug distribution systems differ from country to country according to their respective health policies as well as to geographlcal, climatiC and demographic patterns, the cost of distribution cannot be calculated in a uniform manner. In countries where distribution of drugs is handlecl 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. Tn such cases, the public health services are faced with two separate major expenditures, i.e., expenditure for buying drugs and fixed expenrliture for their distribution. In other cases, the costs of distribution are included in the retA! 1 price of the drugs. In such cases, the distributIon costs vary with the volume of drugs.

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Annex 7 In comparison to other commodities, such as food, drugs - with the exception of vaccines and biologicals - are generally easy to transport An~ 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 facil i ties, such as "cold chains", are therefore needed at each step of distribution to meet local needs. The responsibility 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 (taking 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 ror 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 terof distribution and continuous superVision activities on the spot, at eac·, 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), marketing (comprising advertising, direct and indirect sales promotion), general administration and returns of investment and interest on credits allocated to wholesalers and retailers;

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Annex 7 (ii) cost of distribution, including storage, tr~nsportatlon, ~ales promotion, client services and general admin~stration, as we,l a~ interest on credits allocated to retailers; (iii) cost of dispensing, includ1ng technical, adminl~tratlve ann storagf' expenses, as well as miscellaneous expenses for consumer ~ervlcps. A variable amount of profit and taxes is added to these costs. The main components of the above-mentioned costs could he deter-mi"en. ]n fixed amounts or as a percentage of the price, within acceptahle lI.mtts. However, the most difficult components 1n determining the prices of dru~~ are the costs of production of raw materials and espeCially the cost of active ingredients which are generally known only to the pr'oducer'. The prices of drugs can also be determined according to the mar'ket situation, i.e., the size of the demand for a particular pr'oduct, the prices of competitive products and the therapeutic advantages of a new product over the existing ones. The drug companies determine different prices of thetr products in eac~ country, or even in each district, taking the above-mentioned factors into consideration. As drugs are moving internationally, many tr'ansnational companies decide on the transfer of prices according to their own interests. Generally, when a country formulates national pol1ci!>s for rlrup; production, procurement and distrihution, and sets up regulRtion~ 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 diffcr'ent companies. However, because of the oligopolistic structure of the pharmaceutical industry, the prices of drugs are not always brought dow~ as expected • Nevertheless, as pharmaceuticals are not considered as ordina~v commodities, the governments generally concentrate their effort" malr.ly on regulating the prices of selected drugs for the public sector, for example, prices of drugs reimbursable by the social security or by ~overnmental health services. In this case, the evaluat.ion of "relative "rfl"'lCY", "cost-benefit" lind "acceptable qUlll1ty" lire the most important techni.cRl oomponents for determining such prIces. Awareness of the cost of health, especially of the co~t of <ir,,",", pv health workers, but also by consumers, is rapidly increa:'linp. Ir "'''spon"" to this situation, governments and public agencies shoul" est~t>li"., adequate communication on "prescribing costs" as reduf.!inp; th .. "nit pdc!> ,," drugs is not always enough to achieve savings on dru~ e:<peno f ·,,,re. Furthermore, the final objective of redUCing drug pl"'if.!es the access of the population to more useful drugs. j~

to lncre.ose

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Annex 7 (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 ~nd 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 1s therefore not released. Information on the safety of drugs (adverse reactions) is an essentiRl 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 budget~ which, even in the developed countries, are not always available. Furthermore, the data available in any single country may not be sufficient to disseminate timely, objective, evaluated drug information and international collaboration is consequently required.

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Annex 7 In many developing countries, where there is a scarcity of qualirle~ manpower, financial resources and technical infrastructures, the establishment of drug information systems would be difficult. Furthermore, the type of information needed might be different 111. developed and developing countries and in different health care organizations. For this reason, technical cooperation among countries in the adequate transfer of drug information, supported by WHO, would be the ~ost appropriate approach in order to provide relevant information to prescribers and consumers. When countries decide to. furnish essential drugs to the population, the provision of relevant information should be ensured. Furthermore, the dissemination of such information should be combined with educational and training activities on the proper use of drUjs for prescribers and consumers. Without such 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, including consumers' acceptance of both western and traditional drugs. Such surveys are all. important source of information for formulating and reviewing national drug policies. A continuing drug utiHzation 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 manufacturers. is all. important social responsibility of the pharmaceutical tndustrv to

•

collaborate with governments in providing unbiased and accurate drug information to meet the health needs of the populations. (10)

Utilization of locally available

~tur~_!. r!s..~22~_for__~!21~h.• ~!,_~!,

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 use.ful 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 result:'! obtBined. National policy on traditional medicine is a matter of concern in mAny countries. However, policies MY be formulated differently for countrie" where adequate modern health care resources and western-trained health manpower are available. Where resources Bnd manpower are still insufficient, the use of medicinal plants an~ other natural pro~u~t~ available in the country might be very useful in organized health care. Traditional medicine is. a cultural heritage of the people Bnd generally h~~ high "conaumer approval". A sudden change from t~aditional to weRtern 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.

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Annex 7 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: (i) 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 partlcipation 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.

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Annex 7 After suoh identiFication, standardization of the drugs and their raw materials (medicinal plants) should be oonsidered on the basis of pharmacognosy, quality, safety, etc. The appropriate technology for produotion should be developed in the following areas: oolleotion, seleotion, oultivation, conservation (washing, drying, sterilization, inseot deoontamination, eto.), outting, extraotion and processing in the most sUitable galenioal form for distribution, storage and administratlon. It should be noted that many medioinal plants are unstable and are effective only under certain conditions of administration. The use of medioinal plants should not be oonsidered only for import substitution, but as an appropriate approach for developing oountries to beoome selF-reliant through development of appropriate health technology in accordanoe with their cultural heritage and natural resouroes. If a oountry oannot integrate traditional medicine into health care, for political or sooial reasons, the government generally regulates independently the practice and the sUbstances used in eaoh system, i.e., issuing special requirements for eduoation and training and giving a special lioense for eaoh type of practitioner, along with established lists of approved western and traditional drugs using different evaluation systems. Western and traditional medicine should not compete with eaoh other because both are valuable national health assets. The former is hased on the development of science and teohnology and the latter is based on national cultural values aooumulated by the people over a long period of time. Therefore, in spite of the different poliCies evolving in this area in various oountries, common objeotives and goals might be determined for the development of health of the people. Furthermore, the traditional medioal systems should be studied in the light of modern sOience and teohnology not only by individual oountries but also in a oollaborative researoh effort among both developed and developing oountries. Through this effort, hidden treasures oould more readily be disoovered, 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, espeoially self-medioation, still plays a fairly important role beoause of easy and quiok aooess to treatment. Self-medioation might be considered as a symbol of self-defenoe against disease when organized health care does not exist or is not available. In developing oountries, the health servioes are operating with limited resources and manpower whioh are often not oonstantly available, especially at the peripheral level. In th1s s1tuation, home medioine and selr-cara can be given a greater role in community health serv10es through: (1) much greater use within communities of the available health manpower for educational and training aotivities on self-care, espeoially in the use of drugsj

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Annex 1 (11) improvement of the supply of pharmaceuticals and their utilization; (iii) provision 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 ~eveloping 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 faciltties 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 coordinat10n of demand and supply, and hence for training activities and 1ncreased 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 lim1ted technological resources and market. ConSidering the above objectives and constraints, the pollcy on selfmedication should be formulated according to the situation existing in the most underserved populations. The following approaches can be considered in this respect: (1) 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 safe and effective use of drugs for self-medication. ~~~

(11i) 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 oontrol and surveillance by government authorities.

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Annex 7 (v) Encouragement of community participation in the use ~nn distribution of drugs for self-care through community health committees and interested individuals. There is perhaps a need for short tra:.ning courses for those motivated people to gain some experience to enable them to assist when formally-trained health workers are not availahle 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 selfmedication 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 .

•

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Ann'!x 7 APPP.NDIX 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 cooperatton 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 patient's 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 supervision of the peripheral units.

2.3 Tertiary care services include specialized services and event'.lally the super-specialities mainly at the teaching hospitals at the central (national) level and at the intermeoiate (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.

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Annex 7 Ap£!,~

Other terms used in describing health care

3.1 Consumer approval. The health services must really be accepted by the persons they serve. Roth the operations of a health ~ervice and t~" statement of goals and priorities require consump.r approval; 11nd"rutilization or development of parallel health service structures sign; ry disapproval or criticism and point to a need for re-examinatIon of the existing solutions.

3.2 Health technology. This refers to methods of intervention that can inf' 'nee 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 public (largely government or tax-supported) segment of health services and the remainder of the health care system (supported by speCial groups or by individual payment) is not properly understood in many countries. The nonpublic sector includes institutions and persons ranging from the specialized hospital to the private general practitioner, the pharmacist, t~e village midwife and the local healer. All the services are part of t~e health c~rp' system. Also, it is not widely appreciated that in many countries the private sector of health care is the dominant one, as ,judged both by t~e expenditure involved and by utilization; this may apply espeCially t.o 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, tn monatl'lry 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, 3nd (b) the m3gnitude of the benefit that can result from schemes requiring the min!mum investment.

ANNEX b

1. 1.1

POLICY BASIS AND BACKGROUND

Overall Mandate (World Health Assembly Resolution) WHA 28.66

..............

RECOGNIZING the importance of further development of international standards and requirements for prophylactic and therapeutic substances, CONVINCED of necessity of developing drug policies linking drug research, production and distribution with the real health needs,

·................. . · ................. . 3. REQUESTS the Director-General:

·................. .

(ii) to develop means by which the Organization can be of greater direct assistance to Member States in: (a) the implementation of national programmes in research, regulatory control, management and monitoring of drugs and, in so doing, also in the formulation of national drug policies;

•

(b) advising on the selection and procurement, at reasonable cost, of essential drugs of established quality corresponding to their national health needs;

" 1.2 Sixth General protramme of Work Covering a Specific Period

(1918-1983. page 2)

"10.9.2 To collaborate with countries in developing and executing actual drug policies and programmes based on such policies.

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Annex 8

WHO will cooperate with Member States in the development of national drug policies to solve such problems as the production or procurement anrt the distribution of drugs and the control of nomenclature, registration, qual! ty and distribution." 1.3 Resolution of the Executive Board of the WHO EB 61.R17

"Realizing that large segments of the world's population do not have access to the most essential drugs and vaccines that are indispensable to ensure effective health care; Recognizing the importance of an adequate supply of essential drugs and vaccines to meet the real health needs of people, particularly in developing countries, through the implementation of national programmes of health care; Deeply concerned by the high proportion of health budgets spent on pharmaceuticals by governments of developing countries, thereby limitin~ the remaining funds available for the prOVision of adequate health care to the whole population; . Stressing the need to provide essential drugs of adequate quality, in sufficient quantity and at reasonable costs to meet the health needs of these countries; Considering that local production of essential drugs and vaccines h a legitimate aspiration which developing countries have expressed on many occasions, and that considerable progress has been achieved in some countries; Convinced that urgent international action is required to alleviate this situation through the establishment of an action programme of technical cooperation on essential drugs aimed at strengthening the national capabilities of developing countries in the field of selection and proper use of essential drugs to meet their real needs, and in local production and quality control, wherever feasible, of such drugs; 1. REQUESTS the Director~General:

(1) to continue to identify the drugs and vaccines which, i.n the· light of scientific knowledge, are indispensable for basic health care and disease control in the vast majority of the population, and to update periodically this aspect of the report of the Expert Committee on Essent.1al Drugs; (2) to cooperate with Member States in formulating drugs policies and programmes that are relevant to the real health needs of populations, aimed at ensuring access of the whole population to essential drugs at a cost the country can afford; (3) to foster technical cooperation among developing countries for the formulation and implementation of appropriate programmes on drugs, including the local production of essential drugs and vaccines;

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Annex 8 (4) to stimulate bilateral and multilateral cooperation in order to provide generous support to countries for the implementation of their programmes on drugs, including the local production of essential drugs and vaccines; (5) to maintain a dialogue with the pharmaceutical industry in order to assure its collaboration in meeting the health neeris or large unrierserved segments of the world's population; (6) to appeal to governments and the pharmaceutical industry to participate in WHO's action programme of technical cooperation aimed at making available to governments of the less developed countries essential drugs and vaccines under favourable condltions in order to exten~ population coverage; (1) to assiRt in the development or a system of qualIty cont.rol of the products provided under such a programme of technical cooperation."

1.4 Technical resentation on national dru policies and mana ement at 28th Regional Committee or the Western Pacific Region 2. PROBLEM DEFINITION

2.1 For effective health care, pharmaceuticals constitute one of the mo~t important elements. The present situation in the field of drUR policies and management within the countries and areas of the Western Pacific Region could be characterized as follows:

Many countries in the Western Pacific Region are heavily dependent on imported drugs; (1)

(2) Most developing countries have not yet formulated their own rirug policies within an overall national health development programme. (3) Most developing countries in the Western Pacific Region lack: (a) appropriate legislation to implement improved drug policies; (b) infrastructure for an effective procurement and distribution system; (c) qualified manpower required for management and execution of procurement, production, distribution and quality control of drugs; (4) drugs; Most countries have not yet identified their needs of essnntial

(5) Some developing COUntries have established local production; mainly processing, but few have established a comprehensive local dru,. produC'tion based on a comprehensive policy and programme to meet theIr health needs; (6) Only a few countries have initiated drug utilization and production from local resources (especially medicinal pl'lnts) as tntegl"ate<1 part of health care;

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Annex 8 (1) Industrial property systems, which sustain monopolistic or oligopolistic mechanisms, are hampering efforts of some developing countries in establishing rational procurement and production system; (8) In many countries there is improper utilization of drugs from lack of unbiased information. ari~in~

2.2 Some important problem areas are as follows: (1) research and development; (2) legislation and regulatory control: (3) quality assurance; (4) procurement and distribution; (5) production: (6) information and utilization: (1) human resources development.

2.3 Consequently the programme area will cover the following aspects related to drug policies and management: (1) Promotion of national drug policies including appropriate legislation relating to procurement, distribution, production and quality control of drugs.

(2) Promotion of national production· of essential drugs in developing countries according to their needs. (3) Research and surveys leading to: - identification of country needs of essential drugs: - identification of local resources for drug production: - identification, development and utilization of traditional drugs especially in primary health care. (4) Development of drug information systems leading to rational drug utilization. (5) Development of manpower, services and facilities required for national drug production, procurement, distribution and quality control as well as for research. 3. 3. 1 ~~2.~ obje~e..:!.

PROPOSED OBJECTIVES AND TARGETS

3.1.1 To promote a more rational procurement production, distribution and utilization of safe and effective drugs.

3.2

~pecific

objectives

3.2.1 To promote the development and implementation of national policies in production, distribution and utilization for ensuring availability of safe and efficacious drugs of quality.

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Annex 8 3.2.2 To promote the development and establishment of national, re~ional or subregional services required for the control of qual1ty, safety and efficacy of drugs and their procurement, production, distribution and utilization 1n accord.ance with country needs and policies. 3.2.3 To establish international requirements and standar~s for the quality, safety and efficacy of drugs (1nclu~ing medicinal plants). 3.3 Targets by 1983 - to be formulated by working group.

4. 4.1 Approaches

DESCRIPTION OF THE PROGRAMME

In relation to the general objectives mentioned above, collaboration will be provided through: (a) exchange of information on the drug policies and legislation existing in other countries or areas for government regulatory control; (b) formulation of national drug policies for production, distribution, control and management, including establishment of national lists of essential drugs; (c) organization of regional, intercountry or national seminars, workshops or courses on drug policies; (d) provision of expertise (consultants' services).

In relation to the specific objectives, collaboration will be provided through: (a) programming, planning and organizing the production or procurement of drugs; (b) undertaking of feasibility stUdies on procurement, productlon and distribution of drugs for health needs of countries in order to stimulate bilateral and multilateral cooperation; (c) organization of national or intercountry training courses, seminars or workshops; (d) provision of fellowships;

(e) WHO country or intercountry programmes for the development of services required for drug quality control;

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Annex 8 (fl the establishment of WHO Regional Collaborating Centres in relevant disciplines; (g) e~pecial1y

promotion of better utilization of locally available resources medicinal plants;

(hl conducting drug utilization studies to improve rational utilization of drugs at all levels of health care.

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ANNF.X 9

RESEARCH AND DEVELOPMENT

The research and development of modern pharmaceuticals is one of the major components of development of health and industrial technology. These activities are mainly undertaken by the pharmaceutical industry and often concentrated on the development of sophisticated substances and technologies and are directly or indirectly supported by the public sector, for example through inputs from universities {research, human resources development), or in the price of the final product (which includ..,s a research and development component) which has to be borne by purchasers in both developed and developing countries. As this classical approach for research and development in the pharmaceutical field requires a sophisticated infrastructure, availability of highly qualified human resources and other important economic r..,sources, it is neither feasible nor economical that the same pattern will be followed in the developing countries in the near future. When country lists of essential drugs are established, intended to cover the baSic health needs of large populations, there is however a wide scope for cooperation in .the field of research and development between countries. Essential drugs will be needed in large quantities, they will be designated in generiC terms, they may be purchased either as finished dosage forms or formulated from imported raw materials. Finished dosage forms may be purchased prepacked or in bulk. In the latter case, the bulk products will have to be repacked and labelled to meet local requirements. In many developing countries, the distribution system of drugs needed for basic health services is often not capable of handlIng the flow nf required quantities of safe and efficacious drugs from central to peripheral levels.

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Annex 9 Priorities for collaboration in research and development between countries 1n this context are: (a) (b)

development of essential drugs most relevant to the countrtrs' health needs; establishment of the most appropriate dosage forms of essential drugs to be selected and developed from the point of view of (1) stability, (Ii) qua 11 ty, (11 i) price, (1 v) consumern' acceptance; development of suitable technology for the processing and packaging of drugs to withstand adverse climat ic condl tionll lind rough handling; definition of storage and distr1bution facilities required to guarantee the integrity of drugs dur1ng storllge and distribuUon as well as an adequate supply system for normal use and for emergencies; resesrch in logistiCS systems, for example technological oaeponents in the oold ohain and requirements for basic logistiCS infrastructure and trained human resources.

(c)

(d)

(e)

In the context of t~e wider utilization of medicinal plants in basic health serVices, there is a need of coordinating research (especially applied) on methods of evaluation, collection, cultivation, processing lind use of medicinal plants in the various countries and exploring the feasibIlity of creating regional centres in order to aocelerate efforts .1n better utilization of medicinal plants in health care.

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ANNEX 10

LEGISLATION AND REGULATORY CONTROL

A wide variation is found in national legislations which ~irectly determines the form and content of modern drug control. It is essential that all the technical policy and enforcement elements have statutory basis which provides the authority to undertake these activities and to prescribe norms, standards and specifications. The executive branch of government requires this authority to ensure that all drugs used in a particular country are safe and efficacious. Regulations are required to provide the necessary authority to control the production, distributIon, advertising and permissible therapeutic claims for all drugs. Review of existing national drug legislations, followed by drafting and then promulgation and enforcement are the phases necessary for developing effective legislation and these are rendered more complex in developing countries where only limited financial, technological and human resources are available. Therefore, the countries should concentrate on the following priority areas: (1) in the field of drug control, licensing and registration of importation, production, distribution, advertisement, and sales of drugs and further, the use of non-proprietary (generic) na~es; (2) in the field of drug research and development, adequate and satisfactory regulation of industrial property system; (3) product liability and professional liabili ty in the prorluction, distribution, prescription and dispensing of drugs.

Exchange of information and close cooperation among authorities in the various above-mentioned fields as well as intercountry studies of particular aspects which could include regulatory aspects of use of medicinal plants is therefore important.

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ANNEX 11

QUALITY ASSURANCE 1

Introduction

In order to obtain maximum benefits from drugs it is necessary to ensure: (a) that the drugs are produced using correct manlJfacturinR procedur~s, in order to make sure that the finished product meets established quality requirements; (b) that none of the quality attributes which are built into the product by. the producer are lost before the product reaches the consumer. It is generally accepted that the manufacturer should be responsible for the quality of their product. It is equally important that legislation should provide authority for pharmaceutical inspections and random sampling of drugs for analytical control. It is essential that health authorities have the necessary personnel and facilities for both manufacturing plant inspections and analytical control in order to be in a position to ensure that manufacturers are meeting their responsibilities. 2. Good manufacturing practice requirements

•

The quality of drugs depends on the correct performance of all manufacturing operations and must be "built-in" from the beginning of the manufacturing process. The main approach to maintain desired quality levels in intermediate and final products is production control. The principles for quality control procedures that should be applied to drug manufacturing practices are designated as "Good Practices in the Manufacture and Quality Control of Drugs", adopted by the World Health Assembly in its resolution WHA 28.65. 2 These principles are general guides which, whenever necessary, may be adapted to meet local needs, provided the established standards of drug quality are still achieved. Manufacturers with a limited range of products need only utilize rel~vant parts of the requirements.

lThis section is restricted to the pharmRceutical aspects or dru~ quality control. 2published as a supplement to the WHO Chronicle, Vol. 31, No. 12 (1977).

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Annex 11 3. WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce

For many years, WHO has been concerned with the fact that ~rugs n~p sometimes exported without having been subjected to the same quality control as those produced for the home market. The quality of such drugs cannot be then properly allsured, parti<'ularlv in developing countries lacking easy access to laboratory ra~llitje~ ror drug analysis. A Certification Scheme on the quality of pharmaceutic'll products moving in international commerce was adopted by the.World Health Assembly in its resolution WHA 28.65. So far, 26 countries have agreed to participate in the Scheme and designated the competent authority responsible for its implementation. 1 According to the text of the Certification Scheme, control authoritlp~ in the exporting countries will issue, at the request of the importing country, a product certificate stating whether a given drug produced by a specified manufacturer is permitted to be marketed in the country where tt is being manufactured. Each product certificate should state that the manufacturer is inspected by the control authorities and complies with t.he requirements of the "Good Practices in the Manufacture and Quality Control of Drugs". If the product is not authorized for sale or distribution in the exporting country the reasons should be stated on the certificate. The most important point is, of course, that the product has not been refuse~ for sale in the exporting country. Batch certificates, if reqUired, can be issued under the Scheme either by the manufacturer or by the competent governmental authority. It is expected that batch certificates will normally be issued by the manufacturer. However, in some countries quality certification of individual batches, at least for certain types of drugs, is carried out. by the control authorities, and this fact has been taken into consideration !n the Scheme. The Scheme envisages, furthermore, an exchange of information between exporting and importing countries. Information that could be exchanged concerns the implementation of inspection and controls exercised by the authorities in the exporting country. In the case of serious quality defects being found in specific drugs in the exporting or the importinr. country, such information and requests for enquiries may also be exch'lnv.p.~.

, 1The text of the Scheme, the designated authorities as well as the individual replies of the countries, containing comments and reservations, are published in the above-mentioned supplement to the WHO Chronicle, Vol. 31, No. 12 (1977).

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Annex 11 The WHO Certification Scheme is primarily intended to define the statu~ of a pharmaceutical product and its manufacturer in t.he exporting count.ry. The main purpose of the Scheme is to assist countries which ~Rve not yet established syst ••s of drug quality assessment, or which have no fRClli tt .. " for drug control to ensure that imported drugs are of satisfactory quality. Two types of partiCipating countries are ther .. fore envisaged un~er the Scheme: those countries that agree to issue certificates for drugs they export, and those that only wish to receive such certificates, and if necessary, additional information. Countries which do not expect to provide export certificates could indicate this clearly when accepti"~ to participate in the Scheme. Any Member State of WHO can join the Scheme by addressing a formal notification to the Director-General of the World Health Organization, giving the name and address of the component authority. The designa.tlonof this authority is also important for importing countries, a~ the exchange of information under the Scheme will take place between the competent authorities of exporting and importing countries, and the de8ignation Qf such an authority is necessary for the importing country wishing to u~eth .. Scheme. 4. Government drug control agencies 1

To facilitate adequate national control a pharmaceutical supply systeme authority should be vested in a ministry which is responsible ror health matters. This will permit the establishment of a drug control agency and the development of administrative and regulatory procedures for the quality control of drugs. In some instances, collaboration between countries which individually do not have the possibilities to establish adequate quality oontrol mechanisms, could be explored. 4.1 Inspection services

The inspection service acts as the field arm of an agency, by verifying that all elements within the pharmaceutical supply system comply with the regulations, and that data submitted to the agency are factual. Verification by inspeotion includes assessment of manufacturing and dtstl"ibuting establishments and dispensing outlets. It is essential that inspectors espectally those inspecting manufacturing establishments howe II soientific education that includes a general knowledge of chemistry, bacteriology and the pharmaceutical sciences in view of the scope of their activities which may be highly technical.

1A comprehensive document "Quality Assessment and Assurance in Pharmaceutical Supply Systems" including details of the organization, activities and equipment needed for various types of drug control laboratories, is at present being elaborated by WHO I.n collaboration wi th experts from WHO regions. It is expected to be finalized by a WHO F.lCpert Committee in 1979.

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Annex 11 4.2 Quality control laboratory services

A governmental analytical drug control labor3tory carries out tests and assays on drug samples to establish whether the products in question conform to the claimed specifications. The type and size or the dru~ control laboratory has to be adapted to the needs or the country, ta~tng into account the nature or the pharmaceutical supply system Rnd the extent of ~ocal production and importation of drugs.

4.3 Basic test laboratories A basic test laboratory at a peripheral level of the distribution chain would carry out only simple analytical teats which serve to ensure the identity and the absence of gross degradation of drugs used 1n hasic health services. By using simplified analytical methods, 3dverse results should serve as a warning of potenti3l unsuitability of a drug. Fin31 conclusions would have to be referred to a laboratory equiPped for full 3nalytical examination. WHO has recently initiated a project to investigate the feasibility of using such simplified techniques. Experts from the European and African Regions are at present involved, and participation rrom other regions is envisaged. In conclUSion, the rollowing procedures could reduce considerably the costs for ensuring the quality or essential drugs used in b3Sic health services. They might also contribute to the establishment of a more effeotive and economical storage and distribution system. (1) Establishment of quality requirement for essenti3l drugs at oountry, intercountry or sub-regional level. (2) Establishment of an effective inspection system covering national drug manufacturing establishments as well as the entire distribution chain. (3) Effective utilization of the WHO Certlfication Scheme for imported drugs.

If such procedures were followed it should be possible even for a small sized laboratory (annual amount 500 - 1000 analyzed samples) complemented with basic test laboratories at peripheral level to cope with the analytical work required to assure the quality of essential druAs through the distribution chain.

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ANNEX 12

PROCUREMENT

Most developing countries are operating systems of central procurement and distribution of drugs and the level of "centralization" varies from those where an organization set up by Government has a procurement and distribution monopoly covering both private and public sectors to those where there is central procurement covering only the public sector and at the other end, countries where there is no central national procurement system at all. From experience in some developing countries such central system have resulted in a diversification of procurement sources leading to more economical prices for drugs and savings of substantial sums of public money. For effective operations of such systems, only a relatively small number of qualified manpower is needed but information on prices, etc., as well as quality assurance aspects of the system which are covered in greater detail in separate paragraphs are important considerations. One of the basic things required for efficient operation of such system is the use of a standardized list of drugs. A WHO Expert Committee' on selection of essential drugs has now drawn up a model list which could be used as a basis by countries in establishing their own lists for the purpose of central procurement. Procedures operated in such system should be simple and should not contribute to unnecessary and expensive bureaucratic systems, which would be counter productive. Further development of systems from their different existing levels in various countries is generally agreed as being necessary and an approach could be through feasibility studies on pooled purchasing by groups of countries. This approach is a logical extension of central procurement and has many advantages, but, nevertheless, is one in which other extraneous factors come into play. There are political considerations, e.g., where the operations should be based and who should head it. Also, other factors concerning procedures, accountability and quality assurance have to be considered in detail during the stage of feasibility studies.

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. I

ANNEX 13

DTSTRIBlITION

The requirement for an efficient distribution system are adequate and proper storage space, manpower, transportation as well as effective inventory controls. Whilst experience from some countries can be used to determine the minimum requirements for such systems, these cannot be applied without consideration of the communication network in the individual country or area and the development of that sector will greatly influence the planning and design of distribution systems. Another factor which directly influences the design is the level of stock that is necessary to be maintained at all times at the central and peripheral receipt and distribution points. Manpower required for the operation of the different levels of the system should have the necessary basic training, for example, application of quality assurance (basic tests) may require personnel with elementary training in pharmaceutical analysis (this subject is covered in greater detail in a separate paragraph) .

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ANNEX 15

INFORMATION AND UTILIZATION Scientific information on drugs that are available or are supplied to the medical professions has been rightly an area of concern to many developed and developing countries because of the influence of such information on the proper utilization and the rational prescriblng of drugs. The information supplied by the manufacturers is sometimes biased. The dissemination of such accurate and objective information on drugs used in any country is therefore the first objective and the ta~k is made more difficult in developing countries if there is a lack of adequate professional manpower and if lists of essential drugs are not being established. Information to be disseminated to the personnel in the various health care levels may be slightly varied in a manner which is understandable to each level of prescriber. Discussion on drug information systems in this context does not cover information In the area of marketin/!: intelligence, including prices, availability, etc., which is more relevant in procurement procedures. Education of health professionals in their formal training period as well as throughout their entire professional life is an area in which information on drugs is an integral part. Exchange of .information on use of medIcinal plants in health care systems would form an important basis for countries to further develop this aspect of national drug policy. The proper utilization of drugs is important for therapeutic and economic reasons and is influenced by education and information activities. Utilization surveys could be undertaken in order to ensure proper usage and depending on the availability of resources, the type and coverage of such surveys can be phased. Data obtained from such surveys could be of value also for the purpose of education of health professionals as well as for revision of lists of essential drugs.

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ANNEX 16

•

HUMAN RESOURCES AND DEVELOPMENT

Proper and adequate national drug policies can be laid ~own based on country experiences and intercountry studies of different systems but cannot be of any value to particular countries if there is inadequate or inadequately trained human resources. Its development in countries is therefore of highest priority and would cover the peripheral level worker, e.g., the dispenser or the central national level worker, e.g., the staff in a national control laboratory or the staff operating the central procurement and distribution systems. Whilst there are already countries in the Region who have their own national training programmes for the paramedical personnel, the training of the higher level of staff has not been embarked upon by many countries and more and more specialized skills are required of the personnel carrying out national programmes of quality control, production and management of drugs. To promote self reliance and technical cooperation between countries training of human resources should as far as possible be carried out in the Region. Drug management and delivery in the health care system varies with each country but it is useful to collaborate in an intercountry programme which would identify the personnel required so that suitable training in the form of national, regional and interregional seminars or workshops can be organized and fellowships provided. Concern has been voiced by some countries which offered training facilities that from their experience, it was found that the knowledge gained by officers trained under fellowship schemes were sometimes not properly utilized after such training. It would therefore be a step in the right direction if identification of personnel required mentioned above could be used as a guide to countries in the choice of fellows. Another approach in human resources development ~hich has been found to be very meaningful in other programmes is collaboration in the setting up of WHO regional or ~ub-regional centres in specifiC disciplines. Thi.s approach should also be conSidered for the Drug Policies and Management Programme, for example in the fields of quality control and medici"",l plants research .

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ANNEX 17

• ....

• 1.

PROPOSED GUIDELINES FOR COUNTRY STUDIES OF PHARMACEUTICAL SUPPLY SYSTEMS The Report of a Country Study should include at least the following Baokground information on: - geographical, climatio and demographic aspects of the oountry - the economio faotors relevant to the study - health polioies 2. An analysis of the pharmaoeutioal supply systems inoluding: - legislation and regulatory oontrol - researoh and development - procurement system - produotion of drugs - quality assuranoe in all its aspeots

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~..

- distribution of drugs - drug information systems

I I

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- drug utilization - utilization of looally available resources - self medication - drug prices and control meohanisms - training

3. 4. 5. 6. •

Analysis of the health needs. General outline of programmes and their priority. Description of specific programmes and the timing of the objectives. achieve~ent

The overall costing for individual programmes inoluding such element~ as buildings, eqUipment, etc., consultant services requested, human resources development and training. The resources which might be drawn on, such as WHO multilateral Bnd bilateral aid programmes.

Key facts

Organisation World Health Organization (WHO)

Document type Technical Documents

Adoption date December 31, 1978

Source World Health Organization