Essential Drugs and Medicines Policy: W H O …whqlibdoc.who.int/hq/2003/WHO_EDM_2003.1.pdfEssential Drugs and Medicines Policy: Supporting countries to close the ... ESSENTIAL DRUGS

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Annual Report 2002Essential Drugs and Medicines Policy:Supporting countries to close the access gap

In each WHO region, areas of support aretailored to specific country needs

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Policy:implementation and monitoring

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41 countries supported

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Access:public sector drug supply

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Quality:medicines regulation, quality assurance andactivities to fight anti-counterfeit medicines

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Rational use:essential medicines lists, treatment guidelines

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W H O

The year 2002 marked the 25th anniversary of the first WHO Model List of Essen-tial Medicines. It also marked the 25th annual meeting of the WHO InternationalMonitoring Network for Medicines Safety. In 25 years, much has been achieved:100 countries have national drug policies in place or under development; 156countries have national or provincial essential medicines lists; 135 countries have

turned the essential medicines concept into clinical practicewith national treatment guidelines and/or formularymanuals; over 90 countries have introduced the essen-tial drugs concept into curricula for medicine andpharmacy students; the WHO Programme for Interna-

tional Drug Monitoring now includes 76 member andassociate member countries; and a major global effort hasbeen launched to assure medicines quality. Most signifi-

cantly, the number of people estimated to have regular access to essential drugshas risen from 2.1 billion in 1977 to over 4 billion today.

But despite these gains, a huge unfinished agenda remains. Roughly two billionpeople – one-third of the world’s population – still lacks regular access to essentialmedicines of affordable price and assured quality. Irrational use of medicines,unfair financing, unreliable delivery systems, inadequate regulatory systems andhigh medicines prices are critical factors in this access gap.

This report focuses on WHO country support activities aimed at closing the accessgap. In line with the WHO Medicines Strategy, WHO provided support to countrieson: medicines regulation, quality assurance and anti-counterfeit activities (69countries); rational use of medicines by health professionals (54); public sectordrug supply (54); overall national drug policy development and monitoring (41);medicines financing and pricing (27); improving medicines use by consumers(25); and setting of pharmaceutical norms and standards (21). This supportincluded training in these areas to nearly 900 health professionals.

WHO supported comprehensive medicines programmes in 22 countries, specifictechnical support in 85 countries and situation analysis in 6 countries. Afghanistan,Bangladesh, Bolivia, Brazil, Cape Verde, China, the Democratic People’s Republicof Korea, Ethiopia, Haiti, India, Indonesia, the Islamic Republic of Iran, Myanmar,Nepal, Nicaragua, Nigeria, South Africa and Sudan received the most intensivesupport in financial terms.

Country experiences reported here confirm that when sound policies and guide-lines are actively implemented, substantial improvements can be achieved inaffordability, availability, quality and rational use of medicines. Progress is oftengreatest when local officials and development partners work closely together.

Dr Anarfi Asamoa-Baah, Executive DirectorHealth Technology and PharmaceuticalsDr Jonathan Quick, DirectorEssential Drugs and Medicines Policy

ANNUAL REPORT 2002 – ESSENTIAL DRUGS AND MEDICINES POLICY: SUPPORTING COUNTRIES TO CLOSE THE ACCESS GAP| 2 |

WHO provided direct support on essential drugs and medicines policy to 113 countries, of which 22 benefited from comprehensiveprogrammes

Nearly 900 health professionals around the world received training in medicines areas through 28 regional and international coursesand workshops, covering all six official UN languages

Access to essential medicinesMedicines managementMedicines policy issuesPharmacoeconomics

Medicines qualityEvaluation of dossiers of generic medicinesEvaluation of multisource productsGood manufacturing practice

Medicines regulationBasic trainingGood clinical practiceRegulation of herbal medicines

Monitoring medicines safety and useAnatomical therapeutic chemical classification system/defined daily dosePharmacogivilance

Rational use of medicinesDrugs and therapeutics committeesPharmaceutical educationPromoting rational medicines usePromoting rational medicines use in the communityUse of opioid analgesics

Situation analysis (6 countries) todetermine priority needs and what furthersupport would be most appropriate

Specific technical support (85 countries)in form of interventions focused on: policy;access; quality, safety and efficacy; and/orrational use

Comprehensive programme support(22 countries) covering most or all of thefollowing: policy; access; quality, safetyand efficacy; and/or rational use; generallycovering two or more biennia andnecessitating a full-time pharmaceuticaladviser in the country concerned

ANNUAL REPORT 2002 – ESSENTIAL DRUGS AND MEDICINES POLICY: SUPPORTING COUNTRIES TO CLOSE THE ACCESS GAP | 3 |

P O L I C Y

A WHO survey package to facilitatemonitoring and assessment ofcountry pharmaceutical situationswas further developed in 2002. Itprovides a cost-effective means ofdetermining availability of essentialmedicines, the safety, efficacy andquality of those medicines, andwhether they are used rationally. Soit can help countries pinpoint thestrengths and weaknesses of theirpharmaceutical sector and prioritizeareas for intervention. Follow-upsurveys can be undertaken to assessthe impact of interventions and tomonitor pharmaceutical trends overtime. Common use of the packagewill facilitate comparisons betweenfacilities, districts/regions and coun-tries. By the end of 2002, the packagehad been field-tested in 16 countries,representing all six WHO regions.

Looking at access and rational useUse of the package in Bulgaria andthe Philippines not surprisinglyyielded different performances forthe key indicators. Although Bulgariadoes not yet have a national drugpolicy (NDP) in place, a pharmaceu-tical programme is included in itsnational health plan. This is reflectedin the availability of key essentialmedicines, which is high, and which

Developing a monitoring culture to improve impact

Comparing 1995 and 2002 indicators for Bulgaria and the Philippines shows progress in some areas but that enhanced efforts neededin others

has increased since 1995. However,further efforts are required inrational medicines use, given thatless than 50% of medicines pre-scribed are on Bulgaria’s essentialmedicines list.

In the Philippines, availability of keymedicines in rural health facilitieshas gone down – possibly due todecentralization of health services.Prescription of medicines on theessential medicines list has alsodeclined. Worryingly, the percentageof patients being prescribed anti-biotics has increased to over 50%,although other prescribing practices

have improved. Training and con-tinuing education in rational medi-cines should therefore remain afocus of support provided bygovernment to provinces and towns.

Looking at access indicators for fourcountries – Bulgaria, Guatemala, Iranand the Philippines – it can be seenthat availability of key medicines anddispensing do not concur. Thissuggests that prescribing of non-essential medicines may be occurring.

Field-testing in AfricaIn Africa, field-testing of the moni-toring package was carried out in

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EML = essential medicines list

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The affordability of essential medicines varies widely in the four countries surveyed,while prescribing data indicate that key medicines are not available in sufficientquantity


Ghana, Mali, Nigeria, Tanzania andUganda by newly-appointed nationalprogramme officers (NPOs) workingwith their Ministry of Health (MoH)counterparts. The package wasparticularly welcomed by MoH staffgiven that previous pharmaceuticalsituation surveys had generally beencarried out by external consultants.In carrying out the surveys with theNPOs, MoH policy-makers andhealth officials could appreciate first-hand the impacts – good or bad – ofpharmaceutical decisions they havemade. Results of these surveys arenow guiding implementation and ormodification of NDPs.

For most of the countries, the role ofthe private sector in providing healthcare and medicines is increasing. Soincluding private pharmacies anddrugs outlets in the surveys was veryimportant. In so doing, the surveysmade possible the comparison ofthe availability and affordability ofmedicines in the public and privatesectors.

Household surveysThe monitoring package includes aone-page questionnaire for carryingout a household survey. The ques-tionnaire covers: health-seekingbehaviour and whether it leadsto use or non-use of medicines;whether needed medicines areavailable and affordable; and, if used,whether they are used rationally.Household surveys are key tomeasuring access to medicines sinceit is only through these that we canobtain information to determine

Tanzania 2002: what percentage of the medicine prescribedwas obtained by households within 5 kilometre radius ofpublic facilities and public private pharmacies

Tanzania 2002: why households – within 5 kilometre radius ofpublic facilities and public private pharmacies – did not obtainall the medicines they required

P O L I C Y

whether households canobtain all the medicinesthey need and how muchthey can afford to pay forthem.

In Tanzania, use ofthe household surveyshowed that householdsare most likely to self-medicate and use publichealth facilities, and thatuse of public healthfacilities is not confinedto lower economicgroups. Nevertheless,it was seen that manyhouseholds, especiallythose in the lowesteconomic groups, areunable to obtain all theprescribed medicinesthat they need. Morethan 50% of the lowesteconomic group couldnot obtain all the medi-cines that it needed.Access to medicines wasobserved to be limitedprimarily by lack ofincome for purchasingmedicines, high pricesof medicines and/orunavailability.

Such information can beused by policy-makers to

The WHO Traditional MedicineStrategy 2002–2005 was launched atthe World Health Assembly, receivingwide coverage in the internationalpress. It aims to promote develop-ment of national traditional and

Traditional and complementary medicine: puttingpolicy into action

complementary medicine (TM/CM)policies and programmes, improve thesafety, efficacy and quality of TM/CMby expanding the knowledge base onTM/CM, and provide guidance onregulatory and quality assurance

standards. Traditional Medicine in Asia(SEARO Regional Publication No.39), published in 2002, comple-ments the WHO Traditional Medi-cine Strategy by exploring policyissues such as harmonization of

design policies, programmes and interventions to meet essential mediciinesneeds.

Copies of the monitoring package can be requested from: [email protected] package will also be posted on the WHO Essential Drugs and Medicines Policywebsite at: http://www.who.int/medicines/strategy/policy/indicators_op.shtml ■

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P O L I C Y

traditional and modern medicine,the role of TM in national health caresystems, cost-benefit analysis andtraining programmes.

In the African and Western PacificRegions, regional TM strategies arealready guiding Member States onregional TM issues. In the EasternMediterranean Region, a WHORegional Committee resolution waspassed in 2002, calling on MemberStates to adopt the WHO TraditionalMedicine Strategy 2002–2005 as aframework for developing nationalTM programmes.

Tools for institutionalizing traditionalmedicineIn the African Region, several toolsfor institutionalizing TM weredeveloped, including:

• guidelines for formulating anational master plan for develop-ing TM

• a tool to help countries documentthe status of African TM

• guidelines for documentingethnomedical evidence data

• guidelines for registering tradi-tional medicines in the AfricanRegion, as part of an effort toaccelerate the registration andcirculation of standardized Africantraditional medicines within theAfrican Region.

Regulating herbal medicinesThe global WHO Traditional Medi-cine Strategy indicates that rapidlyincreasing use of herbal medicinesthroughout the world has maderegulation of herbal medicines anurgent issue. A series of workshops –for Africa, the Americas, the EasternMediterranean, Europe and South-East Asia – was therefore launched tohelp drug regulatory authoritiesdevelop the expertise required forregulating herbal medicines. Thefirst workshop was held in Teheranin December, for Eastern Mediterra-nean countries. The aim is tofamiliarize national drug regulatory

authorities with the principal policy,safety and quality control issuesregarding regulation and registrationof herbal products, includingdevelopment and implementation ofnational regulations. The workshopswill also work towards developmentof common regional requirementsfor registration of herbal medicines.

In the Western Pacific Region, suchharmonization is in fact alreadyunder way. The first meeting of the

Even in China, the number of traditional Chinese medicine (TCM) hospitals, beds and researchinstitutions is soaring

Source: Traditional Medicine in Asia. New Delhi, WHO, 2002 (SEARO Regional Publication No. 39).

1952 1957 1963 1975 1980 1985 1990 1995

Number of TCM hospitals 19 257 124 160 647 1414 2037 2371

Number of beds 224 5684 9254 13 675 49 151 101 418 160 899 206 812in TCM hospitals

Number of TCM – 16 33 29 47 54 55 65research institutions

In 2002 WHO supported a range of countries on numerous traditionalmedicine (TM) issues

China: to set up a computerized database on endangered medicinal plants in China;to establish a clinical research centre in the Chinese Academy of Traditional ChineseMedicine; to assess the role of Chinese medicines and its use within a market economyand reformed health service system; to prepare guidelines on safe use of Chineseherbal medicines.

Burkina Faso and Zimbabwe: to evaluate medicines for treating HIV/AIDS.

China and Korea: to collect and analyse data on effectiveness of acupuncture throughreview of existing literature in Chinese and Korean.

China, Mongolia and Viet Nam: to organize training courses on use of TM fortreatment of selected diseases.

Ghana, Kenya and Nigeria: to review results of clinical trials for antimalarial herbalmedicines.

Guinea, Philippines, Sao Tome and Principe, Tanzania, Uganda and Viet Nam: todevelop national policies/masterplans and programmes for TM.

Papua New Guinea: to collect local information on use of medicinal plants.

Philippines: to develop a curriculum on traditional and alternative health care forseven health science disciplines.

Uganda: to develop a national code of ethics for traditional health practitioners.

Viet Nam: to advise on methodology of clinical research, and development of TMcurricula in universities; to assess quality control of herbal medicines and standardiza-tion of plant materials; to organize a training course and lectures on quality control ofherbal medicines.

Western Pacific Region Forum forthe Harmonization of Herbal Medi-cine was held in March 2002. Itdrew up a work plan to deal with:harmonization of nomenclature forherbal medicines; harmonization ofmethods and guidelines for theregistration and regulation of herbalmedicines; harmonization of agricul-tural and field collection practiceprocedures; and communication ofinformation on herbal medicineregulation. ■


Countries receiving substantial WHOsupport in 2002 included Afghani-stan, Somalia, South Africa andUganda. In both Afghanistan andSomalia, pharmaceutical supportwas an important element of healthsystem reconstruction. In SouthAfrica, intensive WHO supportfacilitated sound implementationof the country’s national drug policy.In Uganda, the results of a WHO-assisted pharmaceutical situationanalysis were used to reorient accessand rational use activities.

Afghanistan: rebuilding thepharmaceutical sectorThe arduous process of reconstruct-ing Afghanistan’s health system isnow under way. WHO made apreliminary assessment of the phar-maceutical sector in early 2002.Shortly afterwards, it recruited anational programme officer toassist the Ministry of Public Health(MoPH) on pharmaceutical issues.

Key activitiesKey MoPH/WHO activities in 2002included:• creation of a department of

pharmaceuticals within MoPH• staffing of the department of

pharmaceuticals• selection of essential medicines

focal points in 20 provinces ofAfghanistan

• creation of a national drugs andtherapeutics committee

• adaptation and adoption of WHOGuidelines for Drug Donations

• process of updating and revisingnational essential medicines liststarted, via consultation withhealth professionals in Kabul, theregions, provincial hospitals andhealth centres

• review of Afghanistan’s genericmedicines law

• further development of standardtreatment guidelines.

Key country support in Africa and EasternMediterranean

Framework agreement with IranEvidently, building national pharma-ceutical capacity is a long-termprocess, but collaboration with Iranwill greatly facilitate it. A frameworkagreement between Afghanistan’sMinistry of Public Health and Iran’sMinistry of Health was signed in2002, under which Iran will providea training programme for staff of theAfghan drug regulatory authority, thenational quality control laboratoryand the faculty of pharmacy.

Somalia: long-term developmentfollows emergencyConstant civil war in Somaliadestroyed almost all the country’spublic health services. A WHOsituation analysis was carried out in2001. It described the lack of anational drug policy, the poorcondition of the country’s medicalstores, overuse of antibiotics andinjections, and a pharmaceuticalsupply system that was completelydependent on donations. But WHOnow has an office in Hargeisa andin 2002 started to work with thenational authorities to lay the ground-work for health sector development.

A national drug policy (NDP)workshop was held and a strategyfor NDP implementation was agreedupon. This includes setting up anational steering committee andNDP secretariat, establishing anational medicines regulatoryauthority, and publishing anddisseminating national donor guide-lines and an updated nationalessential medicines list.

WHO also worked closely withnational authorities to re-establishSomalia’s medicines distributionsystem. The immediate goal wasdefined as creating a unified phar-maceutical policy among the manyNGOs and international organizations

currently providing health care inSomalia. The long-term goal will beto create an integrated essential medi-cines system for the whole country,responsibility for which can later bepassed to the national government.

South Africa: comprehensivesupport sees resultsIn December 2002, the South AfricaDrug Action Programme (SADAP)concluded six years of intensivesupport for implementation of SouthAfrica’s National Drug Policy. SADAPwas a project attached to the SouthAfrican Department of Health,funded by the South African Depart-ment of Health and the UnitedKingdom Department for Interna-tional Development.

Much was achieved during the sixyears. SADAP supported the SouthAfrican Government throughout itsinvolvement in the highly conten-tious international debate surround-ing essential medicines, patents andaffordability of medicines. SADAPalso generated widespread under-standing of the rationale and opera-tion of an essential medicines list interms of health policy-making andmanagement, and contributed to thesuccessful production and dissemi-nation of standard treatment guide-lines, particularly at primary healthcare level. Additionally, a number ofworkshops on medicines supplymanagement – which trained over700 pharmaceutical assistants –were held. These were an importantcontribution towards developingnorms and standards for procure-ment, stock control, distribution,financing and staffing.

In late 2002, the Department ofHealth created the Pricing WorkingGroup, preparatory to establishingthe Pricing Committee, mandatedby the 1997 Medicines Act 90. WHO

P O L I C Y


will provide technical advice to thePricing Working Group during 2003.

Uganda: from assessmentto actionMedicines advisers are nationalprofessional officers with specializedpharmaceuticals expertise. Theirbrief is to help monitor countrypharmaceutical sectors, assistcountries in identifying priorities,and coordinate WHO pharmaceuti-cal assistance. In 2002, medicinesadvisers began work in 11 WHOCountry Offices in the AfricanRegion, including Uganda.

The medicines adviser in Uganda,WHO’s Regional Office for Africaand WHO Headquarters assisted theUgandan Ministry of Health (MoH)in carrying out a baseline survey toassess Uganda’s pharmaceutical

situation. The assessment helpedbuild capacity in monitoring andalso created an evidence base fordeveloping collaborative work plans.Collaboration between the MoH andthe WHO Country Office for Ugandaled to significant achievements in thepharmaceutical sector in three ofWHO’s key medicines areas: access,rational use, and quality and safety.

In terms of access, the situationassessment revealed that availabilityof key medicines varied nearly two-fold among public health facilitiesand five-fold among district ware-houses. To improve this situation,district drug managers were trainedin drug information management,and National Medical Stores person-nel and district drug managers weretrained in the selection and procure-ment of essential medicines and

medical supplies. Under Uganda’sdecentralization policy, districts arerequired to procure medicinesaccording to their local needs. TheWHO Country Office and MoHtherefore supported districts inswitching to a needs-based systemfor essential medicines procurement.Outstanding success has beenachieved in this area, with 53 out ofthe 56 districts (95%) placing ordersfor essential medicines and suppliesaccording to their local quantifiedneeds for the first quarter of 2003.

In the area of rational use, the WHOCountry Office supported the MoHto develop the National HIV-ARTTreatment & Care & ImplementationPlanning Guidelines for scaling upHIV/AIDS care and support in thecountry. Support was also providedfor dissemination of HIV/AIDSinformation and the setting upof the National Drug InformationCentre. One of the major findingsof the national assessment of thepharmaceutical sector was high useof antibiotics and injections in healthfacilities. Accordingly, the MoH/WHO work plan includes strategiesfor promoting rational use of drugsto reverse this trend.

To help ensure the quality andsafety of medicines, WHO providedsupport for setting up a databasesystem at the National Drug QualityLaboratory (NDQCL). This was inaddition to procuring chemicals foruse by NDQCL in analysing medicinessamples. ■

The 2002 pharmaceutical situation assessment in Uganda revealed that availability ofkey medicines varied two-fold among public health facilities and five-fold amongmedicines warehouses

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P O L I C Y

More than 40 WHO CollaboratingCentres (CCs) now work with WHOon medicines priorities. Threeexamples of CCs working withWHO on WHO Medicines Strategyobjectives are based in Chicago,Tunis and Rio de Janeiro.

WHO Collaborating Centres: supplying active supportfor medicines work

WHO Collaborating Centre for DrugRegulationDirection de la Pharmacie et duMédicament, Tunis

WHO’s collaboration with Tunisia’sDirection de la Pharmacie et du Médi-cament (Pharmacy and Medicines

Directorate – DPM) started in theearly 1990s, when it helped DPM toimprove its capacity to carry outmedicines regulation activities, andto provide training and support toother countries. This included trainingDPM staff, providing reference


P O L I C Y

books, and developing operatingprocedures and a comprehensivecomputer-based drug registrationsystem. In 1995, DPM started totrain regulatory officials from franco-phone African countries in technicaland administrative measures foreffective medicines regulation.

In 1998, the German Foundation forInternational Development joinedforces with WHO and organized atraining course on medicinesregistration in collaboration withDPM. External experts and DPM stafftaught the course, attended by 17participants, representing 13 coun-tries. That same year, DPM became aWHO Collaborating Centre for DrugRegulation. By the end of 2002,23 drug regulation officers from 10countries had received training fromDPM in medicines registration.

DPM is now an established referenceand technical support centre forcountries that have adopted orintend to adopt WHO’s modelsystem for computer-assisted drugregistration (SIAMED). DPM staffinstall the system, train users,undertake remote maintenance ofthe system and make follow-upvisits. During the period 1996 to

Data sourcing in traditional medicine: over halfa million accessions to the NAPRALERT* databasewere made by developing countries in 2002

Number of accessions

Africa 115 795Europe 226Mediterranean 12 699Americas 146 172South-East Asia 205 026Western Pacific 21 620

2002, 12 African countries benefitedfrom DPM assistance in installingand using SIAMED.

South-North-South interchange andcollaborationIn 1999, the European MedicinesEvaluation Agency decided to useDPM’s computer system for medi-cines registration (developed incollaboration with WHO) as a modelfor developing its own computersystem. EMEA’s new system becameavailable for wider distribution in2002. Tunisia has itself adopted thisnew system, the end result of a rareinstance of South-North-Southinterchange and collaboration.

Also in 2002, DPM pioneered astandardized evaluation method forassessing the safety and efficacy ofnew chemical entities in developingcountries. It will be more broadlytested in 2003 and the subject of atraining course.

WHO Collaborating Centre forTraditional MedicineCollege of Pharmacy,University of Illinois at ChicagoIn 2002, the College of Pharmacy –designated a WHO CC for Traditional

WHO Collaborating Centres provide valuable technical support in: policy, access and rational use of medicines; regulation, qualityand safety of medicines; and traditional medicine

Medicine in 1981 – enhanceddeveloping country research capacityin traditional medicine in two ways.It enrolled 22 graduate developingcountry students in its PharmacognosyGraduate Program, and providedpost-doctoral research training onmedicinal plants for 15 developingcountry visiting scientists.

The College of Pharmacy alsoimproved information exchange ontraditional medicine by providinginformation free of charge to scien-tists and non-profit organizations indeveloping countries through itsNAPRALERT (NAtural PRoductsALERT) database. NAPRALERT con-tains nearly 170 000 bibliographicrecords with information on over140 000 natural products and over

policy, access andrational use of medicines

regulation, qualityand safety of medicines

traditionalmedicine

* NAtural PRoducts ALERT database

Countries with multiple Collaborating Centres are: UK (in policy, accessand rational use of medicines); South Africa and Sweden (in regulation,quality and safety of medicines); and China, Democratic People’s Republicof Korea, Japan and USA (in traditional medicine).


160 000 organisms. This CC alsomade the final revisions to Volume 3and initiated preparation of Volume4 of the WHO Monographs onSelected Medicinal Plants. It alsoconstructed a website capable ofbeing hot-linked to WHO head-quarters, WHO Regional Offices,and other CCs, to further facilitateinformation exchange.

WHO Collaborating Centre forPharmaceutical PoliciesNucleus of Pharmaceutical Assistance,National School of Public Health,Rio de JaneiroPart of Brazil’s National School ofPublic Health, the Nucleus forPharmaceutical Assistance (NAF) hasbeen a designated WHO Collabo-rating Centre for PharmaceuticalPolicies since 1988. Its mandatederives from the Brazilian NationalDrug Policy and the WHO Medi-cines Strategy. In partnership withall levels of government in Brazil, aswell as nongovernmental organiza-tions, bilateral and multilateralagencies, and donors, NAF contri-butes to important national andinternational initiatives to improveaccess to health care.

In 2002, NAF activities includedsetting the pharmacological andclinical basis for medicines in Brazil,advising ANVISA (the drug regula-tory authority) on generic medicinesissues, seminars and educationalactivities, translation of WHOguidelines into Portuguese, researchand evaluation. National elementsof this work included evaluatinghospital pharmacy and pharmaceuti-cal services within primary healthcare, making a pharmacoeconomicassessment of drug selection, andassessing indicators for measuringaccess to essential medicines. Otheractivities had an international focus– such as examination, for LatinAmerican and Caribbean countries,of financing for HIV/AIDS medi-cines, and the impact of patentprotection and the TRIPS Agreementon access to medicines. ■

The Network for Monitoring theImpact of Globalization and TRIPS(the Agreement on Trade-RelatedAspects of Intellectual PropertyRights) on Access to Medicinesconsists of four WHO CollaboratingCentres in Brazil, Spain, Thailandand the United Kingdom. Additionalinput is provided from experts inappropriate pharmaceutical selec-tion, intellectual property andeconomics.

The Network has developed indicatorsand an assessment tool to conductbaseline surveys and ongoing monitor-ing of: national intellectual propertylaws; pharmaceutical consumption;pharmaceutical pricing; medicinesregulatory systems; and investmentin pharmaceutical research, develop-ment and manufacturing. The toolis currently being revised based onresults from field tests and will bepublished in 2003.

To date, assessment has been carriedout in 11 countries in East Asia,

How is TRIPS affecting access tomedicines?

Eastern Europe and Latin America.It provides valuable information oncountry situations as well as a meansof comparative analysis. The datashed light on key policy questions,including: whether country relianceon quality generics is increasing ordecreasing; the extent to whichcountries are making use of flexibil-ity built into the TRIPS Agreement;the extent to which TRIPS andglobalization is spurring foreigninvestment and technology transferin developing countries; and theextent of pharmaceutical patentingin particular countries. As it accumu-lates, the data will become increas-ingly important in monitoring theimpact of the TRIPS Agreement onaccess to medicines, making itpossible to analyse changes inpolicies, prices and consumptionover time.

Further data will be collected inadditional countries, including inAfrica, in 2003 and 2004. ■

Illustrative data for Eastern Europe from the Network for Monitoring the Impact ofGlobalization and TRIPS

Bulgaria Croatia Turkey

Has legislation been modified Yes Yes Yesto conform with TRIPS?

Did or will the country use No, modified No, modified IP Yes, until 1999the transition period? IP law before law before WTO

WTO accession accession

Does the Ministry of Health inter- No No Novene in the patent review process?

Have compulsory licenses been No No Nogranted for pharmaceuticals

Can the drug regulatory authority — Yes Noapprove or register a pharmaceuticalfrom a person, company or otherentity that is not the patent holder?

Can the health authority rely on Yes Yes Yesinformation submitted by a priorregistrant to approve a subsequentapplication to make a generic product?

IP = intellectual property WTO = World Trade Organization

P O L I C Y

Pharmaceutical promiseand dangers

1970sThe concept of essentialdrugs emerges

Before and into the

Developmentof the essentialdrugs conceptover the past25 years

New and powerful drugs emerge1899• Aspirin first marketed

1941• Penicillin isolated – first clinical use

1943• Chloroquine trial against malaria

1944• Streptomycin first effective TB drug

1948• Antiobiotics tetracyline and

chloramphenicol introduced

1951• Isoniazid introduced against TB

1952• Erythromycin introduced for patients with

penicillin allergy

1954• Sulfonylureas introduced as first oral anti-

diabetic and nystatin as first antifungalagent

1955• Field trials of oral contraceptives

A powerful pharmaceutical industrydevelops• Automated high-volume manufacturing

processes create large profits• Patent protection creates long periods of

market exclusivity• Mergers create large companies

Significantly increased and widespreadconcern about safety: thalidomide1961• Thalidomide withdrawn from US and

European markets after association withserious birth defects observed, leading toglobal recognition of need for drugregulation and safety assessment

Growing recognition that medicines canbring dangers as well as great promise

General picture• Few countries have essential drugs lists• Very little independent information on drugs

and prices publicly available• Few countries allow generic substitution• No systematic teaching on prescribing• No regulation of drug promotion• Early start of safety monitoring

Early 1970s• Developing countries complain that up to

40% of health budgets is spent on drugs• Public protest at promotional practices of

pharmaceutical industry

1975 First definition of essential drugs• WHO Director-General Dr Halfden Mahler

puts drugs issues on international develop-ment agenda by defining essential drugs as“those considered to be of utmost impor-tance and hence basic, indispensable andnecessary for the health needs of thepopulation”

1976• WHO collects drug lists from Member States,

prepares criteria for drug selection andproduces first draft list of essential drugs

1977 WHO Model List of EssentialDrugs

• First Model List includes 206 activesubstances – Model List revised everytwo years thereafter

1978• 31st World Health Assembly urges Member

States to establish essential drugs lists anddemands creation of Action Programme onEssential Drugs

1978 WHO/UNICEF Conference inAlma Ata

• Adopts essential drugs concept as 8th

component of primary health care

Late 1970s: economic crisis starts• Reduced health budgets and limited

availability of convertible currency result indrug shortages, leading to reneweddiscussion about need for national drugpolicies

1960s

1970sBefore and into the

1960s

1980sOperationalizing the essentialdrugs concept

1990sNew global challenges

21st centuryThe essential drugs concept ismore valid than ever before

At the turn of the century• 100 countries have national drug policies• 156 countries have national essential drugs

lists but face increasing numbers of patientsand restrained public budgets

• New essential medicines are expensive• In industrialized countries, medicines

expenditure shows unsustainable growthof 12–18% per year, underscoring need forprioritization and rational selection

Increasing profile for essential drugs2000• UN Committee on Economic, Social and

Cultural Rights states: “Functioning publichealth and health-care facilities, goods andservices have to be available in sufficientquantity within the State party…[and]include essential drugs”

• UN defines “access to affordable essentialdrugs” as one of 17 health-related Millen-nium Development Goals

2001• UN Commission on Human Rights recog-

nizes that access to drugs is, “one funda-mental element for achieving progressivelythe full realization of the right of everyoneto the enjoyment of the highest attainablestandard of health”

• Doha WTO Ministerial Declaration stressesimportance of implementing and interpret-ing TRIPS Agreement in a manner support-ive of public health, by promoting access toexisting therapies and research into newmedicines

• Global Fund to Fight AIDS, Tuberculosis andMalaria generates substantial new funds toprocure essential medicines

2002• Rejuvenating the concept and modernizing

the methods• Evidence-based methods introduced to

process for updating WHO Model List• First WHO Model Formulary issued• WHO Essential Medicines Library estab-

lished as web-based resource

2002: Essential Medicines is celebratedworldwide as a global concept

Early 1980s• Developing countries – with 75% of the

world’s population – produce less than 10%of the world’s drugs and account for lessthan 25% of global expenditure on drugs

• First medicines kit-based programme inKenya

• Some stakeholders strongly opposeessential drugs concept

1981 WHO and NGOs get started• Establishment of Action Programme on

Essential Drugs (DAP) formalizes WHO’sinvolvement in essential drugs

• Health Action International founded by 50nongovernmental organizations to promote“the safe, rational and economic use ofpharmaceuticals worldwide”

• Managing Drug Supply, with comprehen-sive information on selection, procurement,distribution and use, published by Manage-ment Sciences for Health

1983–1989• Operational national essential drugs

programmes established in Bhutan,Tanzania, Uganda, Yemen and Zimbabwe,but little success in larger countries

1985• WHO Conference of Experts in Nairobi,

Kenya brings all stakeholders togetherand they define Revised Drug Strategyas basis for future collaboration

• WHO Essential Drugs Monitor launchedto advocate for essential drugs

1986• World Health Assembly endorses Revised

Drugs Strategy

1988• WHO publishes Guidelines for

Developing National Drug Policies andEthical Criteria for Drug Promotion

1989• International Network for Rational Use of

Drugs (INRUD) established, with sixinterdisciplinary developing country teamsin Africa and Asia, to develop and testinterventions to promote rational drug use

Burden of TB, HIV/AIDS and malaria soarseven though appropriate drugs exist• HIV/AIDS, TB and resistant malaria rise

rapidly in many developing countries• New drugs available but very expensive –

triple therapy for AIDS costs US$ 10 000–12 000 per person per year, while drugsfor multidrug-resistant TB cost US$ 2000–3000 per year

1991• UNDP Human Development Report: “Many

countries recorded major reverses in humanprogress, with rising rates of child malnutri-tion and infant mortality, particularly insub-Saharan Africa and Latin America”

• World Bank World Development Reportpromotes basic social services and primaryhealth care as essential strategy foralleviating poverty

1991• Break up of Soviet Union creates challenges

for drug regulation and supply, but infollowing years, Newly Independent Statesdevelop essential drugs lists and nationaldrug policies

1995• Australia develops national policy on quality

use of drugs• Delhi State implements essential drugs

policy, which later expands to most of India

1997• First International Conference on Improving

Use of Medicines (ICIUM) in Chiang Mai,Thailand defines agenda for research intorational use of drugs

1998• WHO Action Programme on Essential Drugs

and Division of Drug Management andPolicies merge to form Department ofEssential Drugs and Medicines Policy

WHO’s mission in essential drugs andmedicines policy defined as “to help savelives and improve health by closing thehuge gap between the potential thatessential drugs have to offer and thereality that for millions of people –particularly the poor and disadvantaged –medicines are unavailable, unaffordable,unsafe or improperly used”

1990s 21st century1980s


A C C E S S

In 2000, the Abuja Declarationissued by the African Summit onRoll Back Malaria, called on Africancountries to “Make appropriatetreatment [of malaria] available andaccessible to the poorest groups inthe community.” With increasingproblems of resistance, this meansensuring access not only to 1st-, 2nd-,and 3rd-line antimalarial treatments,but also to the new, and hence moreexpensive, artemisinin-derivedantimalarials.

But in order to devise effectivestrategies to improve access to anti-malarials, a clear picture must firstbe drawn of their current availability,funding for procurement, capacityfor medicines regulation and control,and mechanisms for ensuringrational selection and use. Whilesome of the related data are availablewithin the ministries of health ofmalaria-endemic countries, they areoften not disaggregated, which meansthat they cannot be used optimally inplanning, budgeting or reporting.

To tackle this problem, a surveytool was developed and pilot-testedin Kenya. The tool incorporated

Measuring access to antimalarials

elements of a drug pricing methodol-ogy already developed by HealthAction International and WHO (seeWorking Out the Cost of Medicines onpage 14). Survey results showed that:• resources for procuring

antimalarials are limited• shortcomings exist in the quality

of prescribing, but dispensing ofantimalarials is often appropriate

• antimalarials are widely available• antimalarial prices in private

health facilities vary considerably• post-marketing surveillance for

quality assessment of antimalarialsis sporadic

Price (US$) of 8 artemisinin antimalarial products varied widely in the private sector inKenya in 2002

Pric

e (U

S$)

10.00

8.00

6.00

4.00

2.00DHA/8’s AM/14’sAS/12’s AM/Syrup

??? ??? ???DHA/8’s Dihydroartemisinin tablets (pack of 8) AM/14’s Artemether tablets (pack of 12)AS/12’s Artesunate tablets (pack of 12) AM/Syrup Artemether Syrup (120 ml)

2

Africa: a regional workshop onstrengthening national medicinessupply systems was held in Harare,Zimbabwe in July to develop aframework for improving nationalessential medicines procurement anddistribution systems in Africa. The36 participants from 20 anglophonecountries were drawn from nationalmedicine supply agencies, depart-ments of pharmacy within ministriesof health, nongovernmental organi-zations and donor agencies.

South-East Asia: Following discus-sion at the Health SecretariesMeeting of April 2002, a resolutionon bulk purchasing was passed at

Strengthening regional and national bulk procurement

• patients who suspect that theyhave malaria mainly consultpublic health facilities

• 83% of those seeking medical carefor malaria were diagnosed ashaving malaria

• 86% of patients diagnosed withmalaria obtained the medicinesthey were prescribed

• 77% of those who obtainedmedicines took them asprescribed.

A similar survey will be carried outin 2003 in Ghana, Tanzania, Ugandaand Zambia. ■

the SEARO Regional Committee inSeptember 2002. SEARO’s role is tobring together countries with similarsituations and requirements – bethese countries such as India,Indonesia and Thailand with sophis-ticated manufacturing capacity, orcountries such as Bhutan, theMaldives and Timor Leste with nomanufacturing capacity, or countriessuch as Nepal and the DemocraticPeople’s Republic of Korea, whichdo have manufacturing capacity, butwhich need to tackle quality prob-lems. Additionally, SEARO will workwith countries to develop commonmedicines specifications.

Western Pacific: In 2002, a work-shop on pooled medicines procure-ment for smaller island states (SIS)was held in Nadi, Fiji. The workshopevaluated implementation of aprocurement action plan developedat an earlier workshop, and identi-fied means of improving collabora-tion between the SIS and Fiji. Alsoin 2002, Practical Guidelines onPharmaceutical Procurement forCountries with Small ProcurementAgencies were published by theWestern Pacific Regional Office todemonstrate how small procurementagencies can minimize costs andensure product quality. ■


Many governments have introducedsupply reform strategies to increaseavailability of safe, effective andaffordable medicines. But littleevidence has been collected thatestablishes if and to what extent theyhave succeeded. Experience in anumber of countries in Africa, Asiaand Latin America suggests, how-ever, that contrary to what is oftenasserted, some supply systems areworking well.

Meanwhile, vastly increased fundsfor medicines procurement arebecoming available at global level. Tobe used effectively, much clearerunderstanding is needed of countryexperiences with alternative ap-proaches to medicines supply

Learning from successful supply systemsmanagement. Moreover, examinationof vertical versus comprehensiveapproaches to increasing access tomedicines is long overdue.

In 2002, WHO launched twocomplementary studies. The first ofthese is a multi-country study toassess reform strategies introducedby governments to centralizedmedicines supply systems. A start-upstakeholders meeting produced asituation analysis and status reporton innovative supply systems, anddeveloped a study protocol. Thestudy will identify why certainstrategies have succeeded – i.e. thecriteria and social and politicalconditions that would need to applyin order for success to be replicated.

Autonomous medicines supply agencies – three examples

Benin

The Benin Central Purchasing Office (BCPO) for essential medicines supplies was established in 1991. An autonomous supply agency,with a monopoly position, it is responsible for providing medicines to public health facilities and the private not-for-profit sector. BCPOhas a management committee, which monitors financial operations, while a steering committee ensures that the agency’s objectives aremet. In 1993, after devaluation of the CFA franc, procurement of essential medicines by generic name was initiated. Managementprinciples were also adopted, such as cash-only sales, no credits, responsibility for medicines collection and distribution assigned toclients, and minimum operations budget and personnel. Staff are selected through competitive application and recruited under contractrather than as permanent civil servants. Government regulations and medicines policies are followed, and BCPO’s performance ismonitored regularly by the government.

Sudan

In 1991, the Central Medical Stores became an autonomous agency under the name of CMS Public Corporation (CMSPC) and wascapitalized with a government grant. The number of staff was reduced considerably. It has no direct government involvement but worksclosely with the government. CMSPC has its own independent bank accounts and operates as a monoploy. Funds are received fromcash-and-carry sales. It operates an open tendering procurement system to obtain the required bulk quantities of essential medicines bygeneric name, in accordance with the national list of essential medicines. Following decentralization policies, each of Sudan’s 28 states –including those ravaged by war – has been obliged to organize its own medicines collection and distribution system, as well as its owncost-recovery system. “People’s pharmacies” (semi-private community pharmacies), nongovernment organizations, and sometimesprivate pharmacies, purchase medicines from CMSPC, which operates a price policy for the various buyers. Government regulations andmedicines policies are adhered to. CMSPC’s performance is monitored by the government. But the prevailing economic situationprevents CMSPC from functioning more effectively.

Zimbabwe

Commercialization of the Government Central Stores in Harare was approved in July 1997. NatPharm was created in 1998, capitalizedwith a government grant and operates as a commercial company. It has a Board of Directors that monitors operations. It operates inaccordance with a Memorandum of Understanding and within Articles of Association, and has signed a performance agreement with theMinistry of Health. Its main customers are the country’s 1300 public health institutions, but it can also make sales to the private sector. Itstender system is directed at obtaining the required bulk quantities of essential medicines by generic name, in accordance with thenational list of medicines.

The results will help generateguidance for governments andagencies working to improve medi-cines supply.

A second study will map the supplyand distribution activities of faith-based nongovernmental organiza-tions in Sub-Saharan Africa. Aquestionnaire has been developedand will be field-tested and appliedin 2003 by medicines supply staff offaith-based organizations. In addi-tion, a regional network of medicinessupply experts working for faith-based organizations will be created,to promote exchange of expertise,and to serve as a source of mutualassistance and support. ■

A C C E S S


A C C E S S

The Millennium Development Goals(MDG) are an ambitious agenda forreducing poverty and improvinglives that world leaders agreed on atthe Millennium Summit in September2000. For each goal one or moretargets have been set – most for 2015,using 1990 as a benchmark. MDGtarget 17 is, “In co-operation withpharmaceutical companies, provideaccess to affordable essential drugs indeveloping countries” and the indica-tor for monitoring progress is “the

Supporting MDG target on access to essential medicinesproportion of population with access toaffordable essential drugs on a sustain-able basis”.

WHO’s engagement to achieve theMDG access target involves fourcomponents. Helping countriesachieve better prices is pursuedthrough price information servicesand technical assistance on effectiveprice regulation, as well as byenlarging the supplier base foressential drugs. Careful selection is

Civil society organizations took aprominent early lead in drawingattention to the need to increaseaccess to medicines in the fightagainst poverty. Dialogue betweensuch organizations and WHO led toa joint WHO–Health Action Interna-tional project to promote greateropenness and better information onmedicines prices and availability, as ameans of tackling access problems.

The first phase of the project wascompleted in December 2002. Thisincluded development of a method-ology for monitoring medicinesprices and publication of a manual onhow to apply that methodology inindividual developing country settings.The methodology can be used toestablish whether prices are high orlow, availability, price differencesbetween branded medicines andgenerics, and between sectors, andthe elements of price composition.A worksheet enables investigatorsto measure the affordability oftreatment for 9 common conditions.

Field test results and potential impactsResults from the field tests showed, forexample, that in Kenya’s private retailsector the median “brand premium”(median price ratio of branded togeneric medicines) was “over 5” –

Working out the cost of medicines

meaning that innovator brands cost,on average, over 5 times more thanthe most-sold generic equivalents. InBrazil, by contrast, the “brand pre-mium” was much lower – close to0.33. Nevertheless, in Brazil’s privatesector, as in Kenya, big differences

were observed between internationalprices for individual medicines (theprice of brand ciprofloxacin was over80 times higher than the internationalreference price. The methodology isalso being used in Africa to investigateprices of antimalarials. ■

Private sector retail prices in 2002 for innovator brand ciprofloxacin, varied widelyacross 8 countries indicating considerable scope for more effective price regulation

In 2001, innovator brand and generic furosomide prices in relation to the internationalreference price varied considerably across five countries, indicating scope for improvingthe affordability of medicines

supported through the Model List ofEssential Medicines process, and itsuse at country and health facilitylevel. Better medicine supply systemsare supported by procurementinformation and advice. Strategies toraise and improve the fairness ofmedicines financing include provid-ing guidance and technical supportfor ensuring subsidies for keymedicines for poor people, andinclusion of drugs in expanded healthinsurance schemes. ■

Pric

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Brazil

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Keny

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Philip

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Armen

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Developed in 2002, the Handbookon Access to HIV/AIDS Treatment isa resource for the various groupsinvolved in providing treatment forHIV-related conditions. It is alsointended to be a concrete acknowl-edgement that, without the workof nongovernmental organizations(NGOs), the global response to AIDSwould have been much smaller andless effective than it is today.

While the International HIV/AIDSAlliance, WHO and UNAIDSSecretariat will provide the finishedproduct, the essential “raw material”was provided by dozens of individu-als and groups in Africa and Asia.Their participation during designand field-testing gave the handbookthe benefit of their experience andexpertise, and kept it focused on thepractical needs and challenges ofproviding treatment to people livingwith HIV/AIDS.

Groups of persons living with HIV/AIDS, NGOs and community basedorganizations (CBOs) have been atthe forefront of prevention and care

NGO toolkit for improving access to HIV/AIDStreatment

since the world first became awareof the epidemic two decades ago.Instead of leaving these tasks to themedical profession or public healthauthorities, they became partners inproviding HIV-related commoditiesand services – in some places, theyhave been the only providers. Theyhave also built roles for themselvesas advocates and teachers, changingthe way the world thinks about HIV/AIDS and responds to the peoplewho live with it. In so doing, theyhave built hope, spread importantskills and ensured better delivery ofHIV/AIDS-related services andcommodities.

The handbook aims to widen the par-ticipation of these groups yet furtherby providing a collection of informa-tion and tools for understanding,planning and undertaking work onHIV/AIDS-related treatment.

Initial feedback suggests that thehandbook is serving its purposes well:

Dr Chhim Sarat, Senior ProjectOfficer Care and Support, Khmer

HIV/AIDS NGO Alliance (KHANA),Cambodia: We use the handbook inall of our care and support workshops,taking some parts of it to develop thecurriculum and to discuss the issuesrelated to access to treatment, etc.

Chanda Fikansa, former AssistantProgramme Manager of the Inter-grated AIDS Programme of theCatholic Diocese of Ndola, Zambia:We used the handbook in a workshopsetting involving home-based careprogramme staff… [It] has also beenused with specific target groups ofcommunity volunteers. We used thehandbook to look at ways of improv-ing the quality of the care deliverythat the home-based care programmeswere providing. By looking at thebarriers to treatment we couldlook at what things we could doto improve care and support. Thehandbook was particularly useful forfacilitating the discussion and flowof ideas. It’s also useful for thosewho are not experienced in care andsupport, but familiar with some ofthe issues. It is a useful tool to show

Since 1997 WHO has providedsustained medicines support,including courses on pharmaco-economics, assistance for the BalticMedicines Conferences of 1997 and2001, and technical input fordeveloping reimbursement systems,to Estonia, Latvia and Lithuania. Asa result, these three Baltic countriessucceeded in bringing together theexpertise and necessary politicalsupport for developing and adoptinga common guideline on pharmaco-economic evaluation of new medi-cines. The Ministry of Welfare of the

Common guideline for evaluating new medicines inBaltic countries

Republic of Latvia, the Ministry ofSocial Affairs of Estonia and theMinistry of Health of the Republic ofLithuania signed a Memorandum ofUnderstanding in September 2002agreeing to:• strengthen co-operation between

institutions working on pricingand reimbursement of pharma-ceuticals and pharmacoeconomicanalyses at national level

• use a common methodology forassessing costs and cost-effective-ness of pharmaceuticals in orderto support decision-making on

resource allocation for health care• exchange information on prices

and pricing of pharmaceuticals• exchange information on legislative

changes relating to pricing andreimbursement of pharmaceuticals,and application of cost-containmentmeasures.

The three countries will now be ableto build on each other’s assessmentof applications for reimbursement,reducing duplication and leadingto more informed and consistentdecision-making on reimbursement. ■

A C C E S S


Q U A L I T Y A N D S A F E T Y

what information you need to pro-vide good care and support and tothink through the issues involved.

David Musendo, Deputy Director,Family AIDS Caring Trust (FACT),Zimbabwe: So far, we’ve used thehandbook in two regional work-shops and at one national workshop.FACT staff have also adopted someof the sections from the toolkit forlocal training workshops in theirdifferent projects. The toolkit is user-friendly and easy to adapt for localuse. The language is simple andrelates to what people can realisti-cally do at the grass-roots level.There is little medical jargon.

Boithumelo Huma, Vukuzenzele Pro-ject Co-ordinator, AIDS Consortium,South Africa: We used the handbookat a workshop for communityvolunteer facilitators from CBOs inthe Gauteng and MphulumalangaProvinces, NGO workers from Swazi-land and Lesotho, and lecturers fromWITTS University. After the work-shop, the community facilitatorsshared information in the handbookwith caregivers in their communities,most of whom are illiterate. This wasimportant in helping families knowwhat is available to them and toencourage them to demand that itbecomes accessible. The handbookalso helped facilitators to improverelationships with other care pro-viders – they’ve reached out to socialworkers and priests, and visitedclinics to discuss access issues withnurses. The handbook has showncaregivers the importance of differentservice providers working togetherto cover all aspects of care for peopleliving with HIV/AIDS. This hasresulted in more respect betweenservice providers and more cross-referrals. The WITTS Universitylecturers now include access totreatment in their curricula and havedeveloped a programme with theAIDS Law Project. ■

The pre-publication version of the hand-book can be accessed at: http://www.unaids.org/publications/documents/health/access/NGOtoolkit/index.html.

In the Americas, harmonization isconsidered key to ensuring theproduction of good-quality phar-maceutical products by the region.WHO’s Regional Office for theAmericas/Pan American HealthOrganization (AMRO/PAHO)promotes and facilitates harmoni-zation by integrating the variousstakeholders in the harmonizationprocess.

Every two years, a Conference onDrug Regulatory Harmonization isheld as an open forum for discussingand endorsing proposals presentedby technical expert groups. The 3rd

Pan American Conference on DrugRegulatory Harmonization tookplace in April 2002. The Conferencerecommends actions that countriescan undertake to promote harmoni-zation. The 3rd Conference mademany proposals, including:

Good Manufacturing Practice• giving priority to training activities

to improve GMP implementation

• adopting the WHO 1992 GMPguideline

• promoting implementation of aWHO-type Certificate of Quality

Harmonizing medicines regulationin the Americas

of Pharmaceutical ProductsSubject to International Commerce

Bioequivalence• using the same reference product

for bioequivalence studies

Good clinical practice (GCP)• harmonizing procedures for

evaluating clinical trial protocols

• developing inspection guidelinesfor audits on GCP.

Based on studies on implementingand enforcing GMP in the region, the2nd Conference (1999) recommendedthat GMP be the first priority in theharmonization process. AMRO/PAHO was especially active in GMPtraining – between April 2001 andSeptember 2002, it organized 18workshops on GMP in 18 countries.The workshops were attended bynearly 600 health professionals.Instructors were mostly professorsof Latin American universities, withexperience in GMP, pharmaceuticaltechnology and quality systems. Thecourses are now being replicated bypharmacy schools of universities inBolivia, Colombia, Honduras andNicaragua. ■

In the Annual Report 2001: EssentialDrugs and Medicines Policy, the numberof pharmaceutical manufacturersthat would be compliant with goodmanufacturing practice (GMP) by theend of 2002 was estimated at 1200.In fact, by the end of 2002, 1600pharmaceutical manufacturers werecompliant with GMP. This rapidprogress is due to China’s concertedeffort, with WHO assistance, toorganize GMP training and to translate

Good manufacturing practice inChina: rapid progress

WHO’s GMP basic training modulesinto Chinese (see: http://www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/trainingmodules/whobasictrainingmodulesgmp.htm). An article by K.Morimoto et al. entitled PromotingGMP implementation: developingtraining materials for the interna-tional audience, will appear inQuality Assurance: Good Practice,Regulation, and Law, 2003, 10(1). ■


Safety of Medicines: A Guide toDetecting and Reporting Adverse DrugReactions. Why Health ProfessionalsNeed to Take Action1 presents somealarming information. Problems withmedicines – known as adverse drugreactions (ADRs) – are the 4th to 6th

largest cause of mortality in theUSA. WHO is promoting pharmaco-vigilance2 to help prevent medicines-related morbidity and mortality.Collecting reports of ADRs is key topharmacovigilance.

WHO’s international ADR monitor-ing database was made available fornational pharmacovigilance centresin 2002. It is the cornerstone of theWHO Programme for InternationalDrug Monitoring operated by theUppsala Monitoring Centre (UMC)in which 68 countries now partici-pate. The programme held its 25th

annual meeting in 2002. A newprocedure introduced by UMC in2002 focuses on detecting seriousADRs associated with newer drugsand drug-ADR combinations.

In the last two years, specialefforts have been made to improvepharmacovigilance in the NewlyIndependent States (NIS), followinga request from eight NIS countriesfor assistance. Widespread economicand social changes had affectedhealth care in general and thepharmaceutical sector in particularin these countries, with negativeimpacts on not only availability,but also the quality of essentialmedicines.

In 2000, a project – Development ofNational Systems for Drug Monitor-ing in Newly Independent States –

Pharmacovigilance: detecting and reporting adversedrug reactions

was launched, covering Armenia,Belarus, Kazakhstan, Kyrgyzstan,Moldova, Russia, Ukraine andUzbekistan. Evaluation showed thatmonitoring and evaluation of ADRsvaried enormously. For example,Armenia, the Russian Federationand Ukraine each had a pharmaco-vigilance system in place, but thesewere not highly developed. Recom-mendations were made to countries

depending on their population size,economic and social conditions,and level of existing expertise. Forexample, since Kazakhstan, theRussian Federation and Ukraine eachhave a large population and exten-sive territory, it was recommendedthat they each establish severalregional pharmacovigilance centres,as well as a national pharmaco-vigilance centre.

Country progress in collecting information on adverse drug reactions(ADRs)

Cuba became a member of the WHO Programme for International Drug Monitoring in1994. In 1998, the Cuban system of pharmacovigilance collected around 900 reports.In 1999, responsibility for drug safety monitoring and promotion of ADR reportingbecame part of continuous education activities, resulting in a dramatic increase in thenumber of reports. In 2001, the national pharmacovigilance centre received 16 295 ADRreports. The reporting rate per capita is now the world’s highest.

Ghana became a full member of the WHO Programme for International Drug Monitor-ing in 2001. The spontaneous reporting system in Ghana is reported as going well, withincreasing acceptance of the programme by prescribers, dispensers and the generalpublic. Training courses on ADR reporting have been held.

New Zealand was one of the founding members of the WHO Programme for Interna-tional Drug Monitoring. New Zealand’s national monitoring centre for adverse reactionscollects and evaluates spontaneous reports of adverse reactions to medicines, vaccines,herbal products, dietary supplements, and blood products. Its database now holds over48 000 reports and provides New Zealand-specific information on adverse reactions tothese products, and serves to support clinical decision-making when unusual symptomsare thought to be therapy-related.

1 Published in 2002. See also The Importance of Pharmacovigilance, published in 2002 and available at: http://whqlibdoc.who.int/hq/2002/a75646.pdf.

2 Pharmacovigilance consists of methods to identify and quantitatively assess the risks related to the use of medicines in the entire population, orin specific population subgroups.


Growth of membership of International Drug Monitoring Programme since its inceptionin 1968

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The International Conference ofDrug Regulatory Authorities (ICDRA)was set up by WHO to developinternational consensus on medi-cines regulation issues. Given newregulation issues brought about byglobalization and development offree markets, and increased regula-tory responsibilities – for instance,in relation to the introduction ofinnovative treatments – such a forumis essential.

The 10th ICDRA (see: http://www.who.int/medicines/organization/qsm/activities/drugregul/icdra.shtml)took place in June in Hong Kongand was marked by recognition thataccess to medicines is a global andshared issue, commitment to im-proving medicines quality in devel-oping countries, and concern

10th ICDRA: an international basisfor medicines regulation

regarding how to ensure the safetyof traditional and complementarymedicines. Recommendationswere made on: access to drugs andvaccines; regulatory reform; medi-cines safety; regulation of clinicaltrials; harmonization; combatingcounterfeiting; herbal medicines;homeopathy; new technologies ande-commerce. The recommendationsare now serving as a basis for actionon medicines regulation by WHOMember States and WHO.

A pre-ICDRA workshop entitled,The Impact of Regulation on the SafeUse of Drugs, provided a venue fordrug regulatory authority staff todiscuss new trends in medicinessafety and to prioritize issues fordiscussion and recommendationsduring the ICDRA sessions. ■


To help in this task, WHO guidelineson setting up and running a phar-macovigilance centre were translatedinto Russian and distributed. Addi-tionally, four pharmacovigilancetraining seminars, using the “train-the-trainers” principle, were con-ducted. A further 200 educationaland information seminars andmeetings on pharmacovigilance

An international comparative study1

on regulatory medicines informationconducted in 2002 by WHO, theMario Negri Research Institute (Milan,Italy), the Institut Català de Farma-cologia, Universitat Autónoma(Barcelona, Spain) and the Interna-tional Society of Drug Bulletins (Paris,France), showed that medicinesrecommendations used by prescrib-ers and patients vary considerablybetween countries. Disagreementwas found even within a singlecountry, when written materials fromdifferent brands of the same drugwere compared. The discrepanciesarise because national regulatoryauthorities do not or may not havethe resources to conduct full andsystematic assessments of data fromclinical studies and post-marketingsurveillance, before approving pre-scribing information materials. Thediscrepancies are worrying becausethey can mislead prescribers andpatients regarding medicines use, andresearchers seeking to compare medi-cines use patterns across countries.

Summaries of product characteris-tics, package inserts and data sheetswere assessed for 26 countriesfor ciprofloxacin, fluoxetine andnifedipine. These three medicineswere chosen because they wereamong the top 30 medicines in

terms of global sales in 2000, andcover three therapeutic areas ofworldwide relevance in terms ofmortality and morbidity. For the fourvariables considered – indications,dosage range in adults, side-effectsand cautions – an informationchecklist was created, using theBritish National Formulary (BNF).

Out of 26 countries, 11 had informa-tion that matched BNF indicationsfor nifedipine. For ciprofloxacin,

Variations in prescribing information in 26 countriesmaterials from 3 countries did notmatch the dose range recommendedby the BNF, while for nifedipine andfluoxetine, materials from 7 coun-tries and 9 countries respectively didnot match. Also for ciprofloxacinand fluoxetine, none of the materialsfrom the various countries reportedall major side-effects listed in theBNF. None of the materials from anyof the countries reported all thecautions included in the BNF fornifedipine. ■

1 International Comparative Study on DrugInformation (ICSODI) CollaborativeGroup. Prescribing information in 26countries: a comparative study. EuropeanJournal of Clinical Pharmacology, in press.

were organized for health careproviders.

Concurrently, national pharmaco-vigilance systems were established inall eight countries through passing ofspecial legislation and/or regulations.Five of the countries also joined theWHO International Drug MonitoringProgramme. In Kazakhstan, Russiaand Ukraine, 30, 15 and 25 regional

ADR centres respectively have alsobeen set up. Reporting of ADRs isnow well under way and a nationaldatabase to collect information onADRs has been established in eachcountry. Armenia and Russia nowpublish special bulletins on drugsafety, while the other countriesinclude drug safety information intheir drug bulletins. ■


Medicines to improve the quality oflife of people with HIV/AIDS, tocure tuberculosis (TB) and to fightmalaria are needed more than everbefore. Increased financial commit-ment to supplying those medicinesmeans that the resources for procur-ing these medicines are more readilyavailable. But impacts will only beseen at country level if sufficientquantities of medicines of good qualitycan be procured and distributed.

Systematic procurement can bothspeed up medicines distribution andhelp maximize treatment outcomes –as well as optimize use of resources.WHO launched a project in 2001 tocreate unified standards for perform-ing inspections at suppliers, andassessing regulatory informationabout product quality, beforepharmaceuticals are sourced. Inshort, it created a Model QualityAssurance System. The vastlyenhanced rate of “pre-qualification”now possible with this system hasspeeded up adjudication andcontract award, and hence access tomedicines. It has also helped toeliminate or vastly reduce the risk ofsourcing sub-standard, counterfeitand/or contaminated medicines.

The initial focus of the project wason medicines for treating HIV/AIDS(but it has since been expandedto cover anti-TB medicines andantimalarials). By the end of 2002,69 products, for treating HIV/AIDS,had been pre-qualified. Just asimportantly:

• developing country capacity toproduce good-quality antiretro-virals (ARVs) had been increased

• developing country regulatorycapacity to assess ARVs had beenstrengthened

• international cooperation onmedicines quality had beenenhanced. ■

Fighting poor-quality drugs

R A T I O N A L U S E

In 1997, the first InternationalConference on Improving the Use ofMedicines (ICIUM) presented anddiscussed interventions from aroundthe world that aimed to promoteappropriate use of medicines. Itconcluded that a successful interven-tion should:• focus on a specific problem• address the underlying factors• use a problem-solving approach

Improving medicines use inhospitals in Cambodia and Lao PDR

The percentage of patients receiving antibiotics at HinbouneDistrict Hospital, Cambodia, fell immediately after imple-mentation of the monitoring, training and planning strategy

The MTP strategy was field-tested inCambodia and Lao PDR in a numberof, mostly provincial, hospitals (6 inCambodia and 8 in Lao PDR), andlater expanded to district hospitals(21 district hospitals in Lao PDR).Evaluation of implementation in thepilot hospitals showed that it waseffective in improving medicinespractices and that hospitals canadopt the strategy easily. The Minis-tries of Health in Lao PDR andCambodia are now seeking to extenduse of this strategy to additionalprovincial and district hospitals, withdonor support.

MTP was earlier adopted by theWHO Collaborating Center forResearch and Training on RationalDrug Use in Yogyakarta, Indonesia,for implementing rational medicinesuse interventions in Indonesia. ■

selects appropriate solutions. Theythen implement the chosen solutionsusing available scientific informationand other resources, and measuretheir (hopefully) improved perform-ance. Additionally, the group ofproviders holds a regular monthlymeeting to monitor the levels of thedefined problem, discuss improve-ments made and target levels ofimprovement for the following month.

• repeat the intervention• be interactive• provide feedback to

prescribers• be followed by monitor-

ing and supervision• develop peer group

commitments or guide-lines.

In 2001, the percentageof patients receiving anti-biotics was 60–100% inCambodia and approxi-mately 70% in Lao PDR,while injection use in bothcountries ranged from60–100%. A review by WHO indi-cated that monitoring and super-vision of medicines use in thetwo countries did not incorporateproblem-solving approaches, andwas neither generating prescriber,commitment to nor setting specifictargets for improved medicines use.In other words, the precepts recom-mended by ICIUM were not beingcomprehensively followed.

Following the ICIUM recommenda-tions, and working with the Minis-tries of Health in Cambodia and LaoPDR, WHO introduced and field-tested an innovative monitoring,training and planning strategy (MTP)for improving rational use of medi-cines. A group of providers identifiesmedicines use problems, quantifiesthem using suitable indicators,identifies their possible causes, and

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© World Health Organization 2003

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The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a resultof its use.

R A T I O N A L U S E

With assistance from WHO’s EasternMediterranean Regional Office, theDepartment of Rational Drug Use inOman conducted a national surveyof antibiotic use. It identified in-appropriate use in primary healthcare (PHC) centres in particular. Apilot study was thereafter conductedat the Muscat Health Centre todevelop a national tool for improvingantibiotic use. The study wasconducted over six months andcovered use of three antibiotics intwo dosage forms. Doctors wereencouraged to read selected scientificmaterials about evidence-based useof antibiotics for the most commonclinical conditions encountered in

Oman: improving antibiotic use inprimary health care

PHC practice. Simultaneously, theywere monitored, evaluated andinformed about any nonconformityobserved between their prescriptionsand the evidence-based materialsthey had been given.

At the end of the study, a 53%reduction in the consumption ofantibiotics was observed. The six-month follow-up period showeda similar antibiotic consumptiontrend. A similar approach forreducing antibiotic consumption inother PHC centres will accordinglybe incorporated into the 2003national annual plan for promotingrational use of antibiotics. ■

WHO expanded its support tothe WHO-India Essential DrugsProgramme in 1997. This was toenable the Programme to extendthe success of its Delhi CapitalTerritory Essential MedicinesProgramme, largely implementedby the Delhi Society for Promotionof Rational Use of Drugs (DSPRUD).DSPRUD’s activities during 1997–2002 were externally evaluated inOctober 2002.

The hallmark of DSPRUD activitieshas been close cooperation with theDelhi State Government. DSPRUDhas also assisted nongovernmentalorganizations (NGOs) in other states,such as Rajasthan, and large institu-tions such as the Municipal Corpora-tion of Mumbai, with activities topromote rational use of medicines.The evaluation found that DSPRUD’sdesign and implementation of atransparent pooled procurement anddistribution system had resulted ina consistent supply of good-qualityessential medicines for Delhi State’spublic health facilities. It also notedthat execution of the programmethrough an NGO had minimizedbureaucracy and encouraged flexi-bility for developing linkages withmedical schools, universities andother institutions.

By the end of 2001, the WHO-IndiaEssential Drugs Programme wasoperating comprehensive essentialdrugs programmes in 6 states andpartial programmes in a further 8states. In 2002, partial programmeswere introduced in Bihar, Chattisgarh,

WHO-India Essential Drugs Programme: multiplyingimpact

Kerala, Orissa and Uttar Pradesh,and significant progress made indeveloping standard treatmentguidelines (STGs). STGs weredeveloped as follows:

• Delhi State: STGs were preparedby DSPRUD, for treating patientswith specific clinical conditions,following an extensive consulta-tive process involving 70 clini-cians, from all levels of healthcare, and including some privatepractitioners.

• Karnataka State: STGs forprimary health care facilitieswere prepared and distributed todistrict health officers.

• Madya Pradesh State: STGs weredeveloped for reproductive andchild health.

• Maharashtra State: STGs fortreating in-patients of secondaryand tertiary health-care facilitiesin the Municipal Corporation ofGreater Mumbai were preparedand published by the Departmentof Clinical Pharmacology, BYLNair Charitable Hospital.

• Uttar Pradesh State: STGs wereprepared with technical supportfrom DSPRUD and will be distri-buted by the Government of UttarPradesh to doctors in hospitalsand primary health centres. ■

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