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Page 2:How to develop and implement a national drug policy Access: equitable availability and affordability ofessential medicines, including traditional medi-Quality: the quality, safety and efficacy of all medi-Rational use: the promotion of therapeuticallysound and cost-effective use of medicines byhealth professionals and consumers.The more specific goals and objectives of a nationalpolicy will depend upon the country situation, thenational health policy and political priorities set bythe government. In addition to health-related goalsthere may be others, such as economic goals. Forexample, an additional objective may be to increasenational pharmaceutical production capacity. Itis critical that all the drug policy objectives areexplicit, so that the roles of the public and privatesectors and of the various ministries (health, finance,trade and industry) and government bodies (such asthe drug regulatory authority) can be specified.A drug policy can have a rapidly noticeable impact.For example, Chad adopted its drug policy and devel-oped an implementation plan in 1995. Based onthe results of the baseline survey carried out at thattime, the national drug policy and its implementationplan focused on two strategies to improve access to Official national drug policy less than 10 years old(66) Official national drug policy more than 10 years old(5) Draft national drug policy(36) No national drug policy(43) Status unknown(41) Figure 21995…2001 essential medicines: (1) appropriate selection and useof generic drugs, and (2) improved drug procurementand management through training, central medicalstore, and regional bulk procurement. In six years, thepolicy has had a significant impact (see Figure 2). Availability (cost to treat pneumonia/food basket): publicAffordability (cost to treat pneumonia/food basket): private ($0.12) that can be applied in any country, in the private andpublic sectors and at different levels of the health caresystem. It promotes equity and helps to set prioritiesor the health care system. The core of the concept isthat the use of a limited number of carefully selectedleads to a better supply of medicines, to more rationalprescribing and to lower costs. There is substantialmedicines has contributed to an improvement inthe quality of care and to a considerable saving inmedicine costs.A national drug policy involves a complex processof development, implementation and monitoring.First, the policy development process results in theulation of the national drug policy. Second,strategies and activities aimed at achieving policyobjectives are implemented by the various parties.Finally, the effect of these activities is monitored andIdentify the main problems and stakeholdersMake a detailed situation analysisWhoIdentify questions relevant for management decisionsLimit data collection to data likely to be usedhe National Drug Policy of South Africa was developed byparties, other ministries, academia, provincial and districtrepresentatives, professional bodies, the pharmaceuticalindustry and consumer representatives. The final documentas adopted by Cabinet and presented to Parliament inyear Implementation Plan. Part of its success was due tothe political Òwindow of opportunityÓ immediately after A national drug policy is a comprehensive frameworkin which each component plays an important role inachieving one or more of the general objectives ofthe policy (access, quality and rational use). The policyshould balance the various goals and objectives, cre-ating a complete and consistent entity. For example,access to essential medicines can only be achievedthrough rational selection, affordable prices, sustain-ble financing and reliable health and supply systems.Each of the four components of the Òaccess frame-is essential but not sufficient in itself to ensureaccess. Similarly, rational use of medicines dependson many factors, such as rational selection, regulatorymeasures, educational strategies and financial incen-tives. Table 1 lists the key components of a nationaldrug policy. It shows how they relate to the three mainobjectives of the policy and that most componentscannot be linked to one objective only.the programme adjusted if necessary. Throughoutthe process careful planning and the involvement ofall parties are needed, and the political dynamicshave to be considered at all times.Throughout the policy process there should be con-sultation, dialogue and negotiations with all interestedgroups and stakeholders. These include other minis-tries (education, trade, industry), doctors, pharmacistsand nurses, local and international pharmaceuticalindustries, drug sellers, academia, nongovernmentalorganizations, professional associations and consumergroups. It is also important to consult with provincialand district personnel, and traditional and herbalmedicine practitioners. Other government agencies,such as the drug regulatory agency, governmentsponsored health care schemes and insurancecompanies, must be involved. Page 4:How to develop and implement a national drug policy or single-source products: price negotiations,competition through price information and thera-peutic substitution, and TRIPS-compliant measuressuch as compulsory licensing, Òearly workingsÓ ofpatented medicines for generic manufacturersand parallel imports.Ensuring stable and adequate financing for healthcare is becoming increasingly difficult in the face of nomic pressures, continued population growth andthe growing burden of disease. Countries vary greatlywith respect to income levels, population, health careexpenditure and national spending on pharmaceu-ticals which may vary from US$2 to US$400 per capitaper year. In countries where government policies arenot geared to protecting the needs of the poorestpeople, the poor may be denied access to drugs. Keypolicy issues are:commitment to measures to improve efficiencyand reduce waste;increased government funding for priority diseases,and the poor and disadvantaged;omotion of medicine reimbursement as part ofpublic and private health insurance schemes;use of user charges only as a temporary druglimiting the use of development loans withinidentified national priorities;ollowing national or WHO guidelines for medicinedonations.Another essential component is a reliable supply sys-tem. Various types of supply systems exist which varyconsiderably with respect to the role of the privatesector and the incentives for efficiency. But whateversystem is developed, its aim is to ensure continued avail-bility of essential medicines with low rates of stock-outsand low costs of medicines. Key policy issues are to:omoting a public-private mix in medicine supplyand distribution systems;commiting to good pharmaceutical procurementpractices in the public sector;publishing price information on raw materials andinished products;ensuring medicine supply systems in acute emer-carrying out inventory control, and taking measuresor prevention of theft and waste;ensuring disposal of unwanted or expired medicines.The drug regulatory authority is the agency thatdevelops and implements most of the legislationand regulations on pharmaceuticals, to ensure thequality, safety and efficacy of medicines, and theaccuracy of product information. This is done byaking certain that the manufacture, procurement,AccessQualityRational useSelection of essential medicinesX(X)XAffordabilityXinancing optionsXSupply systemsX(X)Regulation and quality assuranceXXRational useXResearchXXXHuman resourcesXXXMonitoring and evaluationXXXX = direct link; (X) = indirect link public sector or health insurance system can affordto supply or reimburse all medicines that are availableon the market. The selection of essential medicineshelps setting priorities for all aspects of the phar-aceutical system. When linked to national clinicalguidelines, it is a crucial step in ensuring access toessential medicines and in promoting rational use ofmedicines. Key policy issues are:identify priorities for government involvement in thepharmaceutical sector;election of essential medicines in a two-step proc-ess: (1) market approval; (2) selection of essentialmedicines relevant to the national morbiditypattern;defining the selection criteria (i.e. sound andadequate evidence, cost-effectiveness, etc.);defining the selection process (i.e. appointmentensuring a selection mechanism for traditional andherbal medicines.Affordable prices are an important prerequisite forensuring access to essential medicines in the publicand private sectors. This issue is important becausesistance to well-known antibiotics, which are widelyavailable as generic products, is increasing. Newessential medicines for the treatment of some infec-tious diseases, such as malaria, tuberculosis and HIV/AIDS, are often very costly. Key policy issues are:ernment commitment to ensuring accessthrough increased affordability;or all medicines: removal or reduction of tariffs on essential medicines; control of distribu-tion margins; pricing policy;or multi-source products (generic medicines andbranded generics): promotion of competitionthrough generic policies, generic substitution andgood procurement practices; import, export, distribution, supply and sale of drugs,product promotion and advertising, and clinical trialsare carried out according to specified standards.Drug regulation is a complex task, with manystakeholders and vested interests involved. For thisreason there are a number of basic requirements:ernment commitment to drug regulation,including the need to ensure a sound legal basisand adequate human and financial resources;Independence of the regulatory authority toensure that there is no conflict of interest;Commitment to good manufacturing practices,inspection and law enforcement;Regulation of traditional and herbal medicines;Ensuring adverse drug reaction monitoring systems;Commitment to regulation of information anddrug promotion;International exchange of information.The rational use of medicines means that patientsreceive medicines appropriate for their clinical needs,in doses that meet their individual requirements, foran adequate period of time, and at the lowest costto them and their community. Irrational drug use byprescribers and consumers is a very complex andwidespread problem, which calls for the implemen-tation of many different interventions at the sametime. Efforts to promote rational use of medicinesshould also cover the use of traditional and herbalmedicines. Key policy issues include:Mandated multidisciplinary national body toelopment of clinical guidelines as the basis forthe selection of essential medicines and trainingof health professionals;oblem-based training in pharmacotherapy inundergraduate training;ontinuing in-service medical education as alicensure requirement;Independent and unbiased medicine information;Public education about medicines;oidance of perverse financial incentives toprescribers and dispensers.There are two categories of research that are ofparticular importance in the development andimplementation of national drug policies:Operational researchin medicine access, qualityand rational use is aimed at better understandingof factors affecting drug use, and identifying thebest methods of selecting, procuring, distributingand correctly using drugs. It is an essential tool inassessing the drug policyÕs impact and its resultsunderpin management decisions.Drug development and clinical researchcludes research into new drugs, drugs forneglected infectious diseases, new dosagems and manufacturing processes, and clinicalassessments of efficacy and safety.Implementing a national drug policy and achievingits objectives depend on people. They will implementthe policy only if they understand its rationale andobjectives, when they are trained to do their jobs well,paid adequate wages, and motivated to maintainhigh standards. Lack of appropriate expertise hasbeen a decisive factor in the failure of some coun-tries to achieve the objectives of their national drugpolicy. Key policy issues are:ernment responsibility for planning and over-seeing the development, training, team buildingand career planning of human resources neededor the pharmaceutical sector;definition of minimum education and trainingrequirements for each category of staff;the need for external technical cooperation(national and international).Monitoring and evaluation are essential componentsof a national drug policy. Provisions for monitoring andaluation need to be included in the policy itself.Adequate staff and an operating budget also needto be set aside. Key indicators for each componentof the policy should be defined. These indicators canbe measured to assess progress. Key aspects of anational drug policy include:explicit government commitment to the principlesof monitoring and evaluation;baseline survey of the whole country carried outearly in the implementation of the policy;monitoring of the pharmaceutical sector throughregular indicator-based surveys;independent external evaluation of the impact ofthe policy on all sectors of the community and theeconomy, preferably every 2 to 3 years.In the 1990s the Government of Australia carried outof a national drug policy. Examples are:treatment guidelines (e.g. antibiotic guidelines),prescriber training programmes, public educationHowever, it was only in 2000 that these and other effortswere integrated into the National Medicines Policy inAustralia Ð making Australia one of the first developedcountries with an official comprehensive national drug policy. Page 6:How to develop and implement a national drug policy Original: English© World Health Organization 2002.All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: bookorders@who.int).hatsoever on the part of the World HealthOrganization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on mapshe World Health Organization does not warrant that the information contained in this publication is complete and correct and sresult of its use. Director, Essential Drugs and Medicines Policy Departmentel: +41 22 791 4443 E-mail: quickj@who.inteam Coordinator, Policy, Access and Rational Useel: +41 22 791 3528 E-mail: hogerzeilh@who.intDr Jean-Marie TrapsidaCoordinator, Essential Drugs and Medicines Policyel: +263 4 742829 E-mail: trapsidaj@afro.who.intRegional Adviser for Pharmaceuticalsel: +1 202 974 3282 E-mail: dalessir@paho.orgMr Peter GraaffRegional Adviser, Pharmaceuticalsel: +20 3 483 0096 E-mail: graaffp@emro.who.intMr Kees de Joncheereel: +45 3 917 1432 E-mail: cjo@who.dkDr Krisantha WeerasuriyaRegional Adviser, Essential Drugs and Medicines Policyel: +91 11 331 7804 E-mail: weerasuriyak@whosea.orgel: +63 2 528 9848 E-mail: santosob@wpro.who.inteam Coordinator, Quality and Safety: Medicinesel: +41 22 791 4420 E-mail: ragol@who.intDr Germ‡n Vel‡squezeam Coordinator, Drug Action Programmeel: +41 22 791 3509 E-mail: velasquezg@who.inteam Coordinator, Traditional Medicineel: +41 22 791 3639 E-mail: zhangx@who.intld Health Organization. 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Promoting Rational Use ofGeneva: WHO, 2002(WHO Policy Perspectives on Medicine, No. 5) (WHO/The documents marked with * are also available onhttp://www.who.int/ Page 1:How to develop and implement a national drug policy WHOon MedicinesJanuary 2003World Health OrganizationGeneva he world pharmaceuticals market has witnessedan increase in the number of pharmaceuticalproductscirculating worldwide, leading to a rapid Box 1 Why is a national drug policyneeded?