AND 4

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INTERCOUNTRY

SYRIAN ARAB REPUBLIC

Damascus, Syrian Arab Republic, 18-22 October 1986

( ~ e e t i n g Reference: $M/~NC.MTG.DPM/~)

WOH1,L) HEALTH ORGAN I ZATPON

REGIONAL QFE'1CE FOR THE EASTERN ME[)1'VERRANEAN 1987

~ h s i s s u e of: thfr document does not constitute formal publication.

The manuscript bas only been modified to the extent necessary for _proper comprehension. The views expressed, however, do not necessarily reflect the o f f i c i a l policy of the World Health Organization.

The designations employed and the presentation of the material in thifs documetlt do nat imply the oxpressian of any opinion whatcroever an the pert of the Secretariat of the Organization concerning the legal status of any country, territory, chky or srea or of its suthosities, or concerning the delimitation of its frontiers or boundaries.

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A N N E X 1 L I S T O P P A R T L C L P A N T S

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ANNEX 2 AGENDA

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A N N E X 3 PROGRAMME 26

1. OPPNXNG SESSION

The message of Dr Hussein A . Gezairy, Regional Director for the Eastern Mediterranean Region of the World Health Organizat..ion, was read by Dr A.M. Abdul ELadi, WHO H e p t - o s o n t a t i v n i n tho Syrian Arab Ropublic. I n this messagc: Dr Gcxairy expressed his gratitude to the Goverrlment of the 'yrian

Arab Republic for hosting the meeting and for providing the cxc~llent facilities. He then referred to the pcevior~s lntercountry Meeting on Drug Policies and Management which was held in Bahrain in November 1983 and compared the situation in the countries of the Region at that time with their present status in Lhc field of essential drugs and pharmaceuticals. In many

wayc, h i e improvements had bsun made. S n recent years the number of drugs i n u s e in the public health sector has decreased dramatically in most countries.

Eighteen counCcics now have faci.lities for drug quality control, many of which are being supported by WHO. Several important Regional publications on drugs have been issued by WHO, of which special mention may be made of the Drug Znf ormation Sheets for Conununity Health Workers in English and Arabic, the bilingual Drugs D i g e s t and thc most recent Drug Information Sheets for

D o c t o r c in Primary Hca1t.h Care.

Dr Gczaitay went on to say that t h e aim of the present meeting was to discuss the progress trrade in the essential drugs programmes i n all the countries as well as in WHO in general. Based on these discussions, priorities would be identified for future action.

I 4 . E . Thc N i n i ~ t e r of Hcnlth, Dr Ghasoub A l - ~ i f a i , then welcomed the guests who had come to Damascus to participate in tho meeting. He thanked the WHO OCfice for the Eastern Mediterranean Region for its sustained efforts in order to tighten links of cooperation and coordination wi.th the Syrian Ministry of Health, and for having chosen Damascus as the site of the meeting.

His Exccli.~ney t h e n spoke about the aims of the meeting and about the drug policy i n Syria11 Arab Ropublic. 1 1 1 t h i s c u l ~ ~ i t : c l i u r ~ 11e p u i ~ l t e d uud, that the Technical Committee for Drugs in Syrian Arab Republic is the sole authority in the country for locally manufactured and imported drugs available on the Syrian market, and that this Technical Committee carries out the technical evaluation of these drugs and takes their prices into account when comparing them with s i n l i l a c medical substances. His Excellency added that the Technical Committee has recently classified medicines in Syrian Arab Republic into hherapeutic groups, and that this has reduced the medical substances necessary for thc national health institutiorla to the minimum level; at prcccnt the nunibor of medical subst.ances in the country does not exceed 600.

2 . SELKCT10N QF UYC'XCEKS

Dr Mohamed El Bayoumi (Egypt) proposed that Professor Abdul Raouf Abbas (Syrian Arab Republic) be appointrd Chairnan of the meeting. This motian was seconded by Dr Y . Y , A l Mazrou (Saudj Arabia) and was passed i ~ n n n i m n ~ ~ s f y D r T.M. S a l c h (Bahrain) then proposed Mr E. KkoLos (Cyprus) as Vice- Chairman, and r K. AL Mousa (Jordan) proposed Dr K.K. Kheirallah (Sudan) as

Kapprrrf eur. 80th motior~s wore also passed unanimously.

3. ADOPTlON OF AGENDA

The Agenda was adopted without amendment (See Annex 2 ) .

4, GLQBAL PERSPECTIVES OF THE ACTION PROGRAMME ON ESSENTIAL UKUGS

Dr R.B. Ghaudhury (then Regional Adviser, Pharmaceutical, Diagnostic and Thefapeut ic Substances) p r e s e n t - e d a d e s c r i p t i o n of WHO'S collaborative programme in the field of essential drugs and pharmaceuticals, delineated the problems still facing countries in this difficult area and described steps taken by countries, both within and outside the Region, to overcome these problems. The objective of the collaborative enaeavour between WHO and the countries is to ensure that a carefully selected number of safe and effective drugs are always available at the primary health care and referral levels, that these drues are prescrihert properly and a r e taken as r a q t i i r e d by

patients. Although the cornerstone of the WHO programme with countries has been the selection of a number of essential drugs, this list of essential drugs pubtished by WHO from time to time had often not been understood or appreciated in its proper perspective. ur chaudhury stated that this is only a model list and each country would need to develop not only its national list of drugs but also separate lists of drugs for different levels of health cars. These lists w o u l d need t o he r e v i s e d frnm t i m e t o t i m e . I t was a l s o not often appreciated that there would always be need for some additional drugs that were not on the list, for treatment of illnesses which may occur in about 2% of the population, A short list of such drugs should be available for special u s e . A limited list of about 250 drugs should suffice to treat almost all symptoms and diseases seen at the primary health care and first- referral levels.

Dr Chaudhury then stressed that the use of a limited number of drugs did not mean inferior medical care and stated that with use of such a list there could be considerable cost reduction for the country concerned with no change in the quality of health care. The other advantages of using a limited list were then described in detail. These were:

(a) easier procurement, storage and distribution of d r u g c ; (b) fewer drugs for quality control;

(c) easier bulk procurement at good prices;

( d l easier training for all categories of personnel in the rational use of drugs ;

(el easier dissemination of objective information about drugs, and

(f) easier monitoring of drug use and adverse reactions with the use of fewer drugs.

Countries in khe Eastern Mediterranean Region of the World Health Organization had already begun reducing the number of drugs in their public health services before the initiation of the WHO programme in this field; and there had been drastic reduction in most countries. However, this had not been paralleled by a similar decrease in the number of drugs available in the privaLe sector in the countries. The availability of a large number of unnecessary brand-name drugs led to indiscriminate use and irrational prescribing.

Dr Chaudhury dosrt-ibed steps taker1 liy the Govcrnrncnts of Norway, the United Kingdoru and Bangladesh to solvc:: sortic of the problems associated wikh the use of a large numhar of drtlgs, by tedricing the number of drugs for use in the h e a l t h services o f these c o ~ a i ~ t v i c : ~ .

k:xan~ples of some o f the s t e p s l a k e n by countries in the Region and a description of a few ac:tivitics of t h e WHO KegionaL collaborative programme with countries was discussed in brief. Thcsc activities included:

holding of National Workshops on t h e K a t i o n a l U s e of Essential Drugs;

pataEed procurement of drugs by courltries in the Gulf area;

use of drugs by their generic names;

cstabl istunent of Drug Information Ccnt res;

development of a complementing network of drug quality control centres;

development of clinical pharmacology centres in the Region;

use o f herbal remedies for primary health care;

deirolopment of comprehensive essential drug programlmcs in countries, and p u b l i c a t i o n of EMHO documents.

5 , PRESk;NT STATUS I N COUNTRIES OF T H E HEGLON

Each participant presented a sunrnary of t h e current status of essential d m g s and phar.n~aceutical progranunes in his respective country. Those sununaries are given below in alphabetical order.

5.1. Bahrain

Bahrain has a Pharmacy Law (1975) with amendments from 1.987 which contains chapLers on the regulation of import and export of drugs, registration of drugs, firms, drug advertisements, pricing and the organization o f pharmacies in the private sector. Xn 1985 the equivalent of about ( I ~ $ 3 . 5 r n i l l i o r l was aspent on d r u g s , which represents 5% of the total health expenditure. Procurement of medicines i s usual-ly done by the private sector and limited tc licensed pharmacies. All the drugs must be registered and priced w i t h the Ministry of Health before marketing. A tender committee is responsible for the selection of drugs for the public sector. To achieve good quality o f d c u g s at econon~ic cost the following factors are taken into considerahiorl:

(1) The use of generic nanzes in tenders;

(2) Combined purchasing Lhrough the Secretariat General of Health for the Arab Countcie:; of t h e Culf At-ea. About. 100 itcms were purchased in this way for the year 2 9 8 5 .

About 370 dr-lrgs are available in primary health care, 40 of which can be

~ ~ s a r l by curtunurlily heiillbt rJur ses. The e s s c ~ l t i a l drugs reconmended by WHO are all included. Besides these there are 900 items available at the secondary health care level. A Central Store is responsible for storage and distribtrtion o f d r u ~ s Lo various sections of the Ministry of Health. A l l

t h e s e processes are conputerized. There is no drug quality control

laboratory, but at present t't~er-e is an agrc~ement between Bahrain, Kuwait and

S a u d i Arabia t o send samples for analysis when deemed necessary. The Health

Arr1.hor.i ty i s providing independent. inf orm~ation on drugs to a l l doctors and phar.m,jc.ists. This information usually comes from Lhe WHO Bulletin, Food and Drug Adminiskc-ation b u l l e t i n or ^othcr scientific sources.

All drugs imported into Bahrain must be registered by a registration

cnmmit-t--en b e f o r e m a r k e t i n g . S i n c e May 1 9 8 1 , 8575 drugs have been submitted for registration, of which 2850 have been approved by the committee; the rest are still pending. Same drugs, such as aspirin and paracetamol, may be sold in cold stores rather than pharmacies, if they have a licence to sell such drugs. For certain drugs such as diazepam and codeine, sales are recorded in a special record so that abuse can easily be detected.

A population of 541 000 lives in the Government-controlled area of Cyprus. The public services provide medical. care, including drugs, to about

bOX of the population; the remaining 40% are coveced by the private sector.

There are 32 pharmacies in the public health sector and 320 in the private sector. Drugs used in the public health services are purchased by their generic n e e through international tenders according to the limited drug list established by the Drug Committee. This list contains about 425 drug substances in about 500 dosage forms. Of these, about 170 are available for use at the health centre level.

Drugs purchased have to be registered in Cyprus and/or been marketed in the country nf m a n u f n r t ~ ~ r e . Prioc t o their d i s t r i b u t i o n they have t o be analysed by the State General Laboratory. The government pharmaceutical laboratory produces a l l large- volume parenteral solutions needed for the public health services and a range of about 30 conunonly used pharmaceutical preparations. Government expenditure on drugs and medical supplies In 1984 was US$5 792 045 (CIF prices), representing 13.3% of total expenditure on health services. About 12% of drugs used in the public health services are locally produced. The G o v e r n m e n t ~ s p o l i c y is t o increase p o p ~ r l a t i n n coverage.

In the private sector import, storage, supply and prices of drugs are controlled in accordance with the provisions of the existing legislation. The number of drugs circulating in the private sector is about 4000 containing 1000 different substances, although at present 10 795 are registered by the Drugs Council. About 450 drug formulations are locally manufactured, covering about 5% of local needs. Private oxpenditure on health services in 1984 was

~ ~ $ 5 1 043 600 of which ~ ~ $ 3 1 753 800 was spent on drugs and other medical supplies, representing 62.2% of the total expenditure; this include wholesalers' and pharmacists' profit.

An increasing effort is made to disseminate information to both health providers and the public for more rational use of drugs. By the end of 1986 computerizntiozl of t h e pharmaceutical services of the Ministry of Health was

to commence; and this will influence procurement, monitoring, registration and pricing of drugs. A number of pharmacists have been trained .in pharmaceutical technology, phamaceutisak analysis and hospital pharmacy.

Training of pharmacists in clinical pharmacy or pharmacology and drug monitoring is planned. Some research on drug use has been carried out. A drug information and poisoning centre will be established in the near future and a

two-year research p r o j e c t on thc public's p c r c c p t i o n a n d use of drugs has been undertaken.

5.3. Egypt

Zn1plc'nwntat i o n o f I he I<gypti.ir: dr-ug p o l i c y i s c a r r i e d o u t t h r o u g h :

( a ) 'rho tptvttraE A t l m f n l s t r a t f o t l of Pharwacy aticl P t o f o u r m i l n depar-tments f o r i n s p e c t - i o n , 1 i c e n s i n g , r c g i st r a t i o n a ~ d drug c o n t r n f ;

( b l l'he p h a r n ~ s c c u t i c a P d e p a r t r l ~ e n t s i n t h e g o v f 3 ~ . n o r d t e s ;

(c) T h c Drug O r g a n i z a t i o n f o r Chemical s

,

( e l Tho T e c h n i c a l and S c i e n t i f i c Cormuittet.

The a c t i v i t i e s o f t h e a b o v c a g e n c i e s a r e r e g u l a t e d t h r o u g h t h e ~ a t i o n a l P h a r m a c e u t i c a l Law 1 2 7 ( 1 9 5 5 1 , t h e N a r c o t i c s L a w 187 (1960) and t h e d i f f e r e n t m i n i s t e r i a l d e c r e e s which r e g u l a t e and cant-rol new a c t i v i t i e s which may a r i s e . T h e r e a r e 250 a p p l i c a b l e e s s e n k i a l d r u g s ( d o s a g e f o t m s ) f o r t h e p u b l i c s e c t o r s ; a l l . are p r o d u c e d l o c a l l y . There i s no e s s e n t i a l d r u g l i s t f o r t h e p r i v a t e s e c t o r P r i m a r y h e a l t h c a r e i s d e l i v e r e d by d o c t o r s . The t o t a l consuraptian oE d r u g s is a b o u t 800 m i l l i o n E g y p t i a n pounds p e r y e a r (consumer p r i c e s ) , 15% i m p o r t e d and t h e rest L o c a l l y m a n u f a c t u r e d .

Thc govornment/pubLlc s e c t o r budget f o r d r u g s p e r y e a r i s a b o u t 1 6 0 m i l l i o n E g y p t i a n pounds (20% of t h o t o t a l e x p e n d i t u r e on h e a l t h s e r v i c e s ) ; 90% of t h i s i s f o r l o c a l l y m a n u f a c t u r e d and 10% f o r imported

drirgc: Thp p r i v n v e s o r t o r a c c o r ~ n t s F a r about f i b 0 mi 1 1 ion Egyptian pnrlndn, a b o u t 83% l o c a l l y l n a n u f a c t u r e d and t h e r e s t i m p o r t e d . G e n e r i c names are u s e d f o r p u b l i c s e c t o r t e n d e r i n g and d i s t r i b u t i o n b u t n o t f o r t h e p r i v a t e s e c t o r .

I n t h e f u t u r e i t i s p l a n n e d t o p r o d u c e more raw m a t e r i a l s , a s a t p r e s e n t o n l y a b o u t 15% a r e p r o d u c e d i n t h e c o ~ l n t . r y . Export: of d r u g s is t o be i n c r e a s e d . F ; f T o r t s w i l l b e made t o e x p o r t 15% of p r o d u c t i o n . C u r r e n t l y export acccunt:: f o r 5 million eeyptian pounds out of the total production of 800 m i l l i o n .

The int-reduction of a new Drug A c t and Medicel Plant; Act is u n d e r c o n s i d e r a t i o n .

5 . 4 . Jordan

I n 1977 i h ~ Mlr1i::tcy of H e a l t h i s s u e d t h e J o r d a n F o r - a ~ u l a r y which was p r e p a r e d b y +.he 12or'1rn~lar'y Cornmittre representing m e d i c a l and p h a r m a c e u t i c a l professions, a n d which c o n t a i n e d b a s i c i n f o r m a t - i o n on a p p r o x i m a t e l y 300 drugs i n 5 5 8 d o s a g e f o t m s . It has bt:cn updatcd a t r e g u l a r i n t e r v a l s .

I n 1984 the Mini:*try i s s u e d a list, of d r u g s for. p r i m a r y h e a l t h c a r e c c n t r c a which con+ a i n s 6 7 d r u g s i n 92 d o s n g n foxms. Tn 1905 w o r k wnc started

4 - 0 preparc? n f u l l l i s t O F d r u g s f o r a l l c l i n i c s , h e a l t h c e n t r e s and d i s t r i c t

h n s p i t a l s , wl t 11 360 dritgs i n 600 d o s a g e f o r m s .

A t present there are 2054 registered drugs in Jordan, in 350Q dosage forms. The total annual drug budget is 12 6 / U UUV Ju for imported drugs and 11 600 000 JD for locally produced drugs; the total value of exported drugs is JD 3 576 000. Import for the public sector is tendered for by generic and received by brand and/or eeneric names. Tmpnrt for the private sector is solely by brand name.

5 . 5 . Islamic Republic of Iran

The basic aim of the drug policy in Islamic Republic of Iran is to ensure that effective and safe drugs of good quality are available to cover Chc hcoXth needs _{o f} tho c o u n t r y . T h i s policy w a s fnrmulat-nd after khe Islamic Revolution. Previously there were about 4000 brand-name drugs on the market, including many expensive and luxury combination drugs; 75% were imported, mainly from multinational companies. Local production was mainly by

subsidiaries of these multinationals.

The new policy closely followed the WHO guidelines. The number of drugs

w a s rcdrtced t o 7 6 0 drugo i n 1164 dosage farms. T h e list o f drugs f n r t h e

primary health care workers consists of 26 drugs in 38 dosage forms; the list for physjciat~s in health centres contains 84-121 drugs in 124-161. dosage forms, according to needs. There is no difference between the lists for the public and private sector.

A Drugs Council was established, representing all parties concerned.

Selection criteria for drugs follow WHO recommendations. The policy of self-sufficiency in drug formulation has been successful. About 50 nationalized factories, government plants and a few private companies now formulate 82 per cent of total consumption. The total annual budget for drugs was uS$I 163 000 000* in 1985-86, of which 32% was spent in the public health services. Tenders were solicited in generic names; only combination products (10%) are being distributed under specific, sometimes non-generic, names.

G u u d quality r a w materials are importcd a t rcoconable c o s t ; t r a n s f e r p r i c i n e

is no longer possible. Prices for drugs are the same even if manufacturers differ. There is a quality control laboratory as part of the Food and Drug Laboratory of the Ministry o f Health and Medical Education. Sales representatives are no longer permitted and dissemination of information on drugs to doctors has become the responsibility of the Government. A monthly medical magazine and a drug information publication have been issued. A new pharmaceutical research centre has been established t o study &ability, availability and process development.

5 . 6

.

There are 70 health centres in the country in all of which drugs are prescribed by doctors and dispensed by qualified pharmacists. For the private sector new rules have recently bee11 illtroduced to l i m i t the use of drugs without prescription, e.g. antibiotics. The number of drugs for the primary health care centres is approximately 250.

*

KM/PHARM/ 11 7 E page 7

Tho n r u g Quality Control and Re~istration Centre is the only body

authorized to certify and register pharmaceutical products. In 1984 the numhnc of markct,ed drugs was reduced from approximately 12 000 to only 2000.

Since 1985 a newly built central medical store has been in operation with a computer connection to a1 1 health cerrtres

.

factory has bcon in operation which produces about 30 commotr drugs and preparations. This facility is being expanded. In this field of expanding p h ~ r m n r ~ i t t i r a l manufackure there is close coordination with other Gulf States. Several publications are issued to provide information for doctors and other health workers, e.g. the Kuwait Drug Index, the Kuwait National Formulary (both are revised regularly). There is also a drug infomation centre, a poison centre, and several drug bulletins.

Bulk purchasing is successfully combined with that of other Gulf

s t a f e r ; . Most. tenders are issued in generic names. Plans for the future include the increased use of generic names, the involvement of local connittees and a better estimation of drug needs.

5.7. Lebanon

The aim o f the Ministry of Public Health and Social Affairs in Lebanon is to provide pharmaceuticals of good quality at relatively low prices and to control and regulate pharmaceuticals, both imparted and locally manufactured.

In 1985 a "Technical Conunittee for Drug Registration'' was established, It collects special intormati on and documents from foreign manufacturer.^ uf

pharmaceutical specialities. A pricing committee operates with the general rule that the margin for the importer is 10% and for the pharmacist 30%.

There is a quality control laboratory and an inspection department.

A list of essential drugs was prepared and adopted; it includes drugs in 301 dosage forms. The list is divided into the following 5 levels:

( a ) drugs dispensed wikhout prescription;

(b) d m g s for dispensary use;

( c ) drugs for hoepitai use;

(dl drugs for specialized unit use;

(el drugs for specialized hospital use.

There is a classified list of local manufacturers that follow Gooa Nanufackuring Practices rules. A planning unit has been establised for the national computerization of pharmaceuticals; a supplier List of " 4 5 0 foreign manufacturers" was prepared, including country o f o r i g i n , laborat-ary, code number, eurcency and agent. Similarly, a n d a pharmaceutical index of 4600 drugs was made which includes: product name, form, dosage presentation, manufacturer, country of origin, retail price in country of origin, and

export price CIF or FOB.

Therc arc 9 local manufacturers, which produce about 10% of the local

~ ~ e * : . . d v uf L h e countcry; approximately 7000 d r u g s arc, available produced by 502

foreign manufacturers. The tot.al amount spent on imported drugs is

~ ~ $ 3 8 million per year. The governn~ent budgct for drugs is approximately US$16 million. Tenders f o r the public sector arc? issued in generic names, but o n l y 10% are a c t u a l i y distributed as generic products.

5.8. Saudi Arabia

The National Drug Policy of Saudi Arabia concentrates mainly on the control o f drug inports, as this constitutes the major part of drug use in the country, The intention is to have the best drugs as regards quality, efficacy and safety. Regulations, for the P r a c t i c e of Pharnlacy Occupation

and its Fxccutive Status wet-e announced by Royal Decree No. M/18 of 18.3.1398 AH (2986-1987). On implementation of these regulations the number

of rnrnpanies registered dropped from 672 in 1978 to 193 at present and their

prodarcts from approximately 12 000 to 3500 dosage forms.

The Ministry of Public Health has adopted the Drug Directory for Essential Drugs Which was prepared w i t 1 1 the help o f personnel of the medical

and pharmacy colleges and specialists in different fields of medicine. It contains 570 drugs in 671 dosage forms and this list is compulsory for all Ministry of Public Health facilities; no drugs are ordered which are not on this list. Coordination with other government ag,encies providing health services to adapt the lists is under way. For primary health care centres another list of essential drugs was prepared in 1985 and revised in 1986;

this contains 1 1 0 d r u g s in 135 dosage forms.

The budget spent on drugs by the Ninistcy of public Health amounts to 450 million Saudi Riyals (IJS$120 million) each year; out of this only 10% is locally manufactured (mainly intravenous fluids) and the rest imported.

Generic names are used in preparing and announcing the drug tenders; the drugs are received by brand name.

Future plans include increasing the share of local manufacture of drugs, improving the application of registration regulations and improving storage procedures and facilities.

Primary health care (PHC) has been adopted by the Government of Somalia as the most appropriate approach for meeting the basic health needs

of

e r c ~ n t i a l drugs among the population which cannot be sustained from national resources.

'on the basis of consultations, an Action Programme on Essential Drugs has been developed in Sor~talia to establish a national intcgroted d r u g and medical supply system. The programme is being implemented through UNICEF with financial support from the Government of Italy. The general objectives

nf the programme in Somalia are: to improve the availability of essential drugs to the population through primary health care; to improve the utilization of drugs; to establish a supplies management system and to

improve legislation on a national drug policy.

The programme started in August 1986 and will be implemented over a period of four years. The following activities will be carried out:

(a) Steps have already been taken to prepare standard lists of drugs, dressings an& medical equipment for use in primary health care facilities.

Thesc lists have been agreed and approved at governmentiagency workshops oc.ganixed in 1985.

EM/PHARM/ 117--E

page 9

(b) The Ministry of Health ~ x p e c t s that all agencies will strictly adhere to the cssent-ial drugs list and not import or introduce othor drugs into health facilities. However, some regional flexibility will be allowed.

( c ) A d r u g supply system has been proposed fur the p r u v i s i u r l oC d r u g s , dressings, syringes and sutures far the primary health care system.

Standard baseline drug supplics for health p a s l s , primary health care units, maternal and child health centres and District Health Centres have been established which will soon serve as guidelines f o r the ordering and distribution of drugs. All drugs to be used for primary health care in Somalia are to be procured through one cornrlron procuremerit s y s t e m . For- ttre initial phase, the Ministry of Health intends to use the UNlCEF procurement centre in Denmark (UNLPAC) as the source of all supplies. Eventually it will be possible to purchase certain drugs trom the new pharmaceutical factory in Mogadishu. The prograrimc? further envisages the development of central and zonal storage facilities, and transport and logistical supporl;, as well as training in the use of essential d m g s . Funds in suppart of the Action Programme on Essential Drugs in Somalia have been provided by the Government of Italy. The total cont,ribution allocated for somalia is approximately US$1.6 million. This figure was based on an assessment of needs undertaken by a WHO technical missiorl (2983).

5.10. Sudan

The national drug poltcy was drawn up in 1981 in response to tne rising expenditure on drugs for both the private and the public sector, as well as drastic shortages in drug supplies. The basic objectives of the policy c l o s ~ l y follow WHO g r l i t l a l i n e s . So far, the following has been achieved: A National List of Essential Drugs was prepared in 1982 and revised in 1985. It contains 233 drugs f o r general use and 64 complementary drugs. Procurement of essential drugs now follows this list. In 1985 all brand-name drugs were reviewed and the registered number was reduced trom ¹⁴ UUO to JbOU; a further reduction is expected. Drug inforn~ation sheets are being prepared. The quality control laboratory is being developed with assistance from WHO to include phorruacological drug q u a l i t y r o n t r o l i n a d d i t inn t o chemical and

microbiological quality control which are already operational. A ministerial decree was in 2986 to upgrade pharmacy administration. The Central Medical Stores are being reorganized and renovated.

Plans for the future include the est.ablishment of regional drug quality control services. The local pharmaceutial industry is to be promoted. A very important f u t u r c a c t i v i t y will ba tho astablishment of a training programme f o r all health workers on the rational use of essential dtugs. A comprehensivr, p l a n hils been drawn up by W1.10 consultants and has now received external funding. Under. this plan the concept of essential drugs will be introduced in a l l . formal and in service training in medicine, pharmacy and other schools; tcainir~g needs will be assessed and training materials prepared; a nat.ional training team will be established. It is proposed to

start a comtiricd t r a i n i n g orld drug distribution programme in o n e province, _{a s} a pilot project.

KN/PHARM/117-E page 10

5.11. Syrian Arab Republic

For more than twenty years the Government of Syrian Arab ~epublic has been in sole charge of import, manufacture and distribution of drugs all over the country, through a State owned concern (PHAHMKX). The nurnbbsr of pharmaceutical products imported into Syrian Arabic Republic has decreased from 15 000 to nearly 3000, drugs being selected from companies known for their high level of technology. _The capacity for local manufacture of drugs

ha- i n r r ~ a c ~ r l r;n n e t n p r n d ~ ~ r ~ m o s t d r u g s t o r p p l a r p i m p o r t e d n n p s ; i n this connection a coordinating conunittee was established. A technical and specj.alized committee was set up to study and research both imported and locally manufactured drugs including monitoring of any adverse cffects. A drug control laboratory has been developed wlth assistance of WHO.

Drugs are only prescribed by doctors and sold by pharmacists. Drugs

i m p o r t e d into Syrian Arab Republic account for about ~ ~ $ 1 5 0 million i n

addition to ~ ~ $ 5 0 million for locally manufactured drugs. The value of drugs consumed in governmental health institutions reaches almost US$70 million per year, while US$130 million are spent in the private sector.

Drugs imported into Syrian Arab Republic are known by their brand-name but in tenders generic names are used. In training in clinical pharmacology

it is planned to promote the rational use of d r u g s .

5.12. Tunisia

The Tunisian Government encourages drug production by private industry (Law of November 1985) and by the Central Pharmacy (under licence). Since 1985 a Drug Committee of doctors, pharmacists and dentists has met monthly to

discuss and approve n e w drugs for registration, and to review drugs currently

in use. Several drugs have been withdrawn. Drug quality control is performed at the Central Pharmacy or the National Institute of Nutrition. Procurement of drugs is done by the Central Pharmacy; several modern air conditioned stores f o r drugs have been built during the last two years. ~istribution of drugs is done by the Central Pharmacy and by an increasing number of wholesalers, Use of drugs in the public sector is reviewed annually,

according to a budget. Bioavailability studies are perEormcd in Tunis and Monastir. Since 1986, a new centre for drug information and drug monitoring has been in operation.

At present the essential drugs list for the public sector contains 479 drugs in 587 dosage forms, out of which 21% are locally produced. In the private sector 570 drugs in 1710 dosage forms are available (14% produced

l u c d l L y ) . Thc L o L a l a n ~ ~ u a l budget for drugs is estimated t o b e ~ ~ $ 5 7 million,

out of which 12% is spent in the public health service and 88% in the private sector. Tenders for drugs in the public sector a r e issued by generic name;

such drugs are also received and distributed by generic name.

5.13. Yemen

It i s the objective of the Guvernmerlt of Yenlerl to i r n ~ p u r l a r ~ d produce drugs at economic prices. In April 1986, a National Workshop, organized

in

T o t a l kxxpendiCure : O r 3 d r u g s i n 1 9 8 5 w ; ~ : 1 7 million Yemeni riyals f o r t h e p u b l i c s e c t o r ^(j.SEj, I b mi ZlEon Ycmenl r i y a l s l o r the A r m y m e d i c a l s e r v i c e s (byb), 4 7 r n i l l i o r ~ f o r A l Thawr-a H o s p i t a l ( 1 3 . 5 % ) ar,d 210 m i l l i o r \ f o r the p r i v a t e s e c t o r ( 7 8 % ) .

Tenders for the: p i t h l i c r:cct*or arc? m a d e out in generic. names. M o u t 7%

i s produce6 w i t h i n thr rorin2.ry. I t I s plarlrled t o d i s s e m i n a t e t h e c c s e r ~ t i a l d r u g l i s t t o a l l doct..or.t; and p h a r m a c i s t s , to l i m i t t h e procurcnient o f d r u g s f o r thc p t i h l h r ~ c c t o r Lo cccontinf drugc on t,his lick, t o int.roduca tha c:oncept of csscntial d r u g s i n m e d i c a l cdl.lcation and t o s t a r t a d r u g q u a l i t y c o n t r o l l a b o r a t o r y .

The Medical Department of UNRWA s u p p o r t s h e a l t h c a r e i n f i v e c o u n t r i e s and a r e a s : J o r d a n , Lebanon, Syrian Arab H e p u b l i c , Gaza and West Bank. I n Syriari Arab Kepr~blic a l o n e there arc. 2 1 w e l l e q u i p p e d a n d well-staf f e d health c e n t r e s in operation. T w o lists u f e s s e n t i a l . d r u g s are i n u s e , ^one s h o r t l i s t of c s s c n C i a E d r u g s f o r p r i m a r y h e a l t h care, and a l i m i t e d l i s t of s p o r r i a k i n c d d r u g s A 1 1 ; ~ r d o z - c ^{a t - n} p l a r r . 8 with q i r n n t i t i o r h a q d slpnn a n n l ~ a l c o n s u r i ~ p t j o n . F o r many d r u g s , lrsc i s m o n i t o r e d on n monthly b a s i s . In g e n e r a l , h e a l t h c a r e of an e x c e l l e n t s t a n d a r d i s a c h i e v e d w i t h o n l y a v e r y l i m i t e d number of e s s e n t i a l d r u g s .

The question o f s u p p l i e s t h r o u g h L e n d e r s was t h e main t o p i c of d i s c u s . ; i o n with e m p h a s i s on: ( i ) how to g u a r a n t e e t h e s u p p l y of s a f e , e f f e c t i v c d r i i g s u n d e r t h e i r g e n e r i c names and (ii) what measures a r e t o be t a k e n t o c o n v i n c e p r e s c r i b e r s t h a t generically named p r o d u c t s a r e a s good and s a f e ;s brartd nmw ornec knother quostion was r a i s e d , i e measures t o be t a k e n t o a s s u r e do3ilrer.y o f d r u g s i n g e n e r i c names and n o t i n brand rlames and whetiicr it. i s possible t o con~pel. i n t e r n a t i o n a l m a n u f a c t u r e r s t o s u p p l y d r u g s i n generic. n~mmes, I t was a g r e e d t h a t i f . i s mare e a s y t o implement the c o n c e p t of prescribtfig iil g w ~ e r i c names I n t:rc p u b l i c s e c t o r t h a n t n the p r i v a t e s e c t o r ; more a c t i o n h a s t o b e t a k e n t o a c h i e v e t h e latter aim.

Thc experience of l s l a m i c R e p u b l i c of I r a n w a s a p p r e c i a t e d s i n c e t h a t c o u n t r y h a s succeeded i n e n f o r c i n g t h e s u p p l y and p r e s c r i b i n g o f d r u g s i n g e n e t i c names. A f a c i L i t a t . i n g f a c t o r ^is t h a t o v e r 80% of d r u g s i n Islamic R e p u b l i c of I r a n a r e produced l o c a l l y ; t h e tender f o r d r u g s f o r b o t h p u b l i c

and n r i v a t P < : o r t o r c r a n t h ~ r c f n s ~ ho e a q i ly specified f o r generic drugs o n l y . Also- i n Egypt

most l o c a l l y produced drugs are lcnCered for ^1st [he aiblic

s e c t o r as generic

p r o d u f i ~

In C y p r u s , t h e u s e o f g e n e r i c rivmrs is a c h i e v e d t h r o u g h r e p a c k i n g of d r u g s I i-el ahel ling them with geiicrie names artd t h u s o b l i g i n g b o t h p r e s c r i b e r and d i s p c n r ~ r t o u s e g r n e r i c names. _{I t was} n o t e d t h a t r e p u t a b l e cornponies can a l s o b.r ~ ~ ~ k e d t o uppl ply t h e i r p r o d u c t s i r l g e r l e r i c names, i f s u f f i c i e n t quaat i t i e a s r . ~ o r d e r e d . I t was a l s o mentioned t h a t , b e f o r e j mposing t h e use of g e n e r i c namShs, t h e prcseribcrs have to b e c o n v i n c e d t h a t g s o a r i c p r o d u c t s am e q u a l l y s a f e , sffcctivn and of t h e same good q u a l i t y a s brand-name

gu-ndu,-+ ^{S .} T ~ w m e c h s n l s n ~ s t o c o n v i n c e d o e t o r s a r e : ( a ) t h e presence of an . t ~ i t h o r i k a t i v a druy, quality c o n t r o l l a b o r a t o r - y t o p r o v e t h a t t h e

genfsr i c a l ly rlaaned d r u g j s

EM/PHARM/117- B page 12

(b) the presence of a few experts, e.g. c-linical pharmncofogists, t o present convincing evidencte to doctors; and ( c ) continuous pressure by means of in-service training, workshops, seminars etc.

In reply t o a comment raised about the poor distribution of the relevant

WHU publications, Dr- F;lraudhu~-y mentioned that measure= will be taken t o secure the regular supply of WHO publications t.o all countries in the Region. However, in most countries WHO is not authorized to send any publication direct to individuals; as a consequence the full burden of distribution falls upon the Ministry of Health.

Participants were then asked to specify their national priorities for the coming years. Some c o u n t r i e s presented their p r i o r i t i e s wi.thLn the

essential drugs progr'ame; most, however, felt that they were not yet. in a position to do so and that it would be preferable to have further discussior~s rat the national level first. It was therefore concluded that this intercountry meeting was not the right place to discuss such national priorities, as other mechanisms exist for this purpose (e.g. the Joint Programme Review Missions scheduled for early 1487). In general, the priorit,ies f o r the Regional programme 8s identified by f>r Chaudhury were accepted.

In answering a question about the possibility of making use of the available facilities in some countries in the Region by other countries which lack these facilities, Dr Chaudhury mentioned that this could be arranged by mutual. agreements. He used the examples of the Draft Guidelines for Registcdtiun oC Drugs and the Draft Hcrbal R c m e d i e ~ Act, the testing of d n i g

samples from countries in the Region in the laboratories of Cyprus and Egypt and thc proposed training centres in clinical pharmacology in Jordan, Pakistan and Sudan.

7 . DRAFT GLiZLIEr,lNES ON THE REQllIREMENTS FOK REGISTHATION OF DRUGS

The objective of the Draft Guide1inc.s is to provide drug regulatory authorities of the Region with information concerning documentation to be submitted for approval and registration of a drug, taking into consideration the guidelines already followed in a numher of other countries for drug approval and registration. The guidelines indicate, firstly, the t y p e of the material to be> submitted and, secondly, the requirements for registration. A

further pur-pose of the document i.s to i n d i c a t c the exact cont~nts o f a synopsis (summary) st all the documentation that is to be submitted. This synopsis could be the main tool in acceptir~g a d m g for registration, Should more infor~~alion be required, the full set of material could be consulted.

The general ides hehind a standardized format of registration of drugs was that in this way registration in one country could more casily lead to acceptance fur registration in another country, thus avoiding unnecessary duplicatiorl of effock.

In the discl~ssior~s that £01 l.oweQ the presentation, several suggestions

f o r improving the document were made. It was suggested to include informat~on

on t h c manufacturers, t h e price in the country of origin and other countrics

anti tht: expectetl sales price, as well as information on registration of the

d r u g i . r ~ t h e c o u n t r y of o r i s i n . It _{w a s} s t r e s s o d t h a t over- t h e - c o u n t e r d r u g s

EH/kJHAKM/ I 17 - E p a g e 13

s t l o u l d be ~ c b i s t e r u d i d 1 the same m o n n c c a c p r a c c r i p t i o n drugs, as tho criteria for* r-cgistcation wocrld be the same. This would apply for both brand name and generic drugs. Many countries experience difficulties in assessing t h e quality o f the clinical trials that are usually quoted to indicate the efficacy o f the drugs. T t i sueh cases consideration of the quality of t h r journal i n which Che trial is published might be of help, In this field the rxpertisc of a clinical phatmacologist may also be necessary.

1 r 1 i ~ ~ d i v i d u a l . cases WIIO hoo r ~ o s i s t e d in a s c o s n i n g t h o quality of c l i n i c s 1 trials on drug:; submitted for registration. WIic), however, is not and cannot be a regulatory body; WHO can ollly advise on the quality of documentation {,hat has been submitted, and can supply documentation or1 standardization, e. g. standard reyuircments for packing material.

Some countries are willing to publish registration applications that

t ~ d v a b e c ~ a r e j ccted; t h i n inf o r m o t i o n is prcccntcd i n certain United Nations documenLs. WHO issues a bulletin giving drug rcgulatory decisions around the world; the effectiveness of this bulletin depends largely on the information boirlg sent to WHO by individual countries regarding their regulatory decisions.

The possibilities were discussed of establishing a simple drug data base for drug L egistration p u r p o s e s , using a microcomputer with standard software (e.g. D Base 111 Plus). This could greatly facilitate the work of registration departments, although it should be realized that a l l procedures within departments would have to be adapted and standardized. T h i s would imply big initial efforts and continuous care by the staff concerned. In the ensuing d i s c u s s i o n s it beca~ne clear that in Saudi Arabia such a system has been in operation for a year, that Syrian Arabic Republic is planning for the

same, that Lebanort has recently completed the computerization of the regislec

of a l l drugs available on the market, that UNRWA uses a microcomputer for stockkecping and drug infomat-ion and that Cyprus, Democratic Yemen and Sudan

arc. in the process of start-inp, a computerized system of drug registration with WHO assistance.

The meeti.ng then concluded that. it would be useful to develop a conunon format tor s u e h regist catton systrtns based or1 cxperierlce i i n those countries that have established such a system.

8. CONSZDEKATlON OF A D R A F T ACT AND NOTE !!OH CXJIDANCE APMLNG AT ENSUHlNG THE SAY ETY AND QUA1,I 'L'Y OF HERBAL KKMEDI ES

The drar t A c t and Note for Guidance alming at ensuring the S a f e t y and Quality of Herbal Remedies followed an earlier docuinent in which 54 essential herbal remedics were identified far possible use in primary health care in the E a s t ~ r n M ~ d i t e r r a n e a n Region. and was nteant t o identifv those requirements that are usofut and rcsalSstjcally feasible for regist-ration of herbal remedies.

There is a principal d i t t c r t l n c c bctwecn the practlce of individual herbal ists preparing, prescribing and di spensir~g herbal remedies, and the production and sale o f herbal remedies through the national market, or

t-lil:-nti~h lntocnatkonal t r a d e . Thp f i rsl:

.

har.dl.y c v e r ^bc regulated by law, but national or international trade in

herbel remed i p s c o u l d .

EM/PHARM/117- E page 14

The basic difference between the proposed requirements for registration of herbal remedies and those for allopathic drugs are that in the case of herbal remedies efficacy would not need to be proved, as assessment of efficacy, e.g. by clinical trials, is very difficult. For example, in the case of a herbal remedy that has been used for years, the most important criteria for registration would be that i t , should not be toxic, and that it should be well packed.

The adoption of Lhese guidelines was left for each country to decide upon as' the document was only meant to be a preliminary guideline. It might be especially useful for those countries in which herbal remedies are manufactured and/or imported on a semi-.industrial scale.

9 . COMPLEMENTARY NETWORK OF DRUG Q I I A l . f T Y CONTROI. 1.ARORATORIF:S

Dr Chaudhury described first the status of the WHO collaborative programme with countries for developing or further strengthening national drug r@gulatory laboratories. There were ongoing programmes in the following countries: Afghanistan, Cyprus, Democratic Yemen, Egypt, lslamic Republic of Tran, Iraq, Jordan, Lebanon, Oman, Pakistan, Sudan, Syrian Arab Republic and

Yemen.

Some of the activities that had been initiated were described. New drug quality control laboratories were to be establised in Democratic Yemen and Yemen. The chemical quality control sections in the laboratories of the other countries had been strengthened. Microbiological sections are being established at Amman and Khartoum and pharmacological units are being strengthened at Baghdad, Islamabad and Cairo. Bioavailability centres are being established at Cairo and Teheran while a vaccine quality control section is being supported at both Baghdad and Amman. Preparation of reference substances is an ongoing WHO-supported activity in the Cairo laboratories. In Pakistan WHO is working with the Government in establishing a network of quality control laboratories at Islamabad, Karachi, Lahore, Peshawar and Quetta. A workshop on standardized methodology to be used at these laboratociee for chemical and m k c r o b i o l o g i c a l quality control analysis is scheduled to be held in 1987.

Dr Chaudhury then discussed the concept of the WHO Network of Complementirlg Laboratories. Since it will not be immediately possible, or necessary, for every country to develop its own chemical, microbiological, pharmacological quality control units or units for vaccine quality control and bioavailability studies, it was Eclt that the l i m 2 t e d manpower, expertise

and facilities in the Region could be shared by the countries. The WHO programme envisages a network in which facilities in different countries would be complementary so that samples could be sent from one country'to another for testing. Training of Regional staff could also be carried out at these laboratories. It is planned that all twenty- three countries in the Region would have sections for chemical analysis of drugs, while microbiological analysis would bc c a r r i e d o u t at six, bionvsilability research at two and pharmacological analysis at four of the laboratories.

Already samples from some countries had been tested at other national laboratories in the Region while training of scientists in different aspects of quality control analysis of drugs had been undertaken at other Regional laboratories. The network concept would make maximal use of existing resources and available manpower and avoid unnecessary duplication of effort.