WHO Library Cataloguing in Publication Data Regional strategy for improving access to essential medicines in the Western Pacific Region, 2005 -2010 1. Drugs, Essential. ISBN 92 9061 185 5 (NLM Classification: QV 704)
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Table of CONTENTS PREFACE 1. 2. 3.
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BACKGROUND .......................................................................................... 3 THE REGIONAL STRATEGY ...................................................................... 7 ISSUES AND CHALLENGES, STRATEGIES AND ACTIONS ............... 9 3.1 3.2 3.3 3.4 3.5 3.6 3.7 Rational selection ................................................................................. 9 Rational use .......................................................................................... 11 Affordable prices ................................................................................. 15 Access to medicines, trade globalization and the TRIPS agreement ... 17 Sustainable financing ............................................................................. 21 Supply and management systems ......................................................... 25 Quality .................................................................................................. 31 3.7.a 3.7.b 3.8 Counterfeit drugs .................................................................. 31 Substandard drugs .................................................................. 33
Monitoring and evaluation ................................................................... 35
4. ANNEXES Annex 1 Annex 2 Resolution WPR/RC/55.R4 "Regional Strategy for Improving Access to Essential Medicines in the Western Pacific, 2005-2010" ........................... 39 WPR/RC/55/9 Add.1"Annotations to the Regional Strategy for Improving Access to Essential Medicines in the Western Pacific Region, 2005-2010”.... 40
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PREFACE Regional Strategy for Improving Access to Essential Medicines in the Western Pacific Region 2005 - 2010
Despite the existence of national medicine policies and essential medicines lists, a persistent lack of access to essential medicines has become a serious public health problem in many countries and areas in the Western Pacific Region. The problem of insufficient access to essential medicines is also an issue of global importance as recognized by the fifty-sixth session of the World Health Assembly in May 2003. Improving access to essential medicines is, therefore, becoming a critically important area of work for the World Health Organization (WHO) and Member States in this Region. Responding to the concerns expressed by Member States during the fifty-third session of the Regional Committee in Kyoto in September 2002, and given the public health importance of access to medicines, WHO initiated the development of a Regional Strategy for Improving Access to Essential Medicines in the Western Pacific Region 2005 - 2010. The strategy is a product of a consultation process involving experts and counterparts from WHO, Member States and other partner organizations. The first draft was reviewed during the Consultation Meeting on Improving Access to Essential Medicines in Penang in July 2003. The revised draft strategy was presented to the fifty-fourth session of the Regional Committee in September 2003 in Manila. While delegates supported the development of the strategy, some Member States believed another round of consultation was needed. In response, WHO convened consultation meeting, consisting of experts and officials from a few member States, in the Regional Office in February 2004, to further review and revise the draft strategy. The regional strategy was endorsed with some annotations during the fifty-fifth session of the Regional Committee in Shanghai in September 2004. Resolution WPR/RC55.R4 urged Member States: (1) to use the Regional Strategy for Improving Access to Essential Medicines in the Western Pacific Region, 2005-2010 as a guide for actions to improve access to essential medicines in line with national medicines policies and for collaboration with WHO; and (2) to provide adequate resources to strengthen national essential medicines policies and programmes. The resolution also requested the Regional Director (1) to support Member States to improve access to essential
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(Continuation of Preface....)
medicines using the regional strategy as a guide in line with national medicines policies; and (2) to work with WHO Headquarters and international partners to improve access to antiretroviral medicines in the Region, and to strengthen biregional collaboration with WHO's South-East Asia Regional Office to improve access to such medicines across Asia and the Pacific. The overall objective of the regional strategy is to provide operational and practical guidance to Member States and WHO in improving access to affordable quality essential medicines and ensuring that they are appropriately used. The regional strategy complements the WHO global strategy in improving access to good quality essential medicines and their appropriate use. The regional strategy covers the following areas: rational selection, rational use, affordable prices, access to medicines, trade globalization and TRIPS Agreement, sustainable financing, supply and management system, quality, and monitoring and evaluation.
Following the endorsement of this strategy, Member States and WHO developed a work plan for implementation during planning workshops held in Fiji and in Manila in November 2004. Therefore, country and intercountry work plans have been jointly developed. The challenge now is to implement these plans. For this, WHO remains committed to collaborating with Member States and other partners to improve access to essential medicines in the Region.
Manila, 30 November 2004
Shigeru Omi, MD, Ph.D. Regional Director WHO Regional Office for the Western Pacific
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1 BACKGROUND I. BACKGROUND Essential medicines save lives and improve health, but only if they are available, affordable and properly used. Essential medicines are medicines that satisfy the health care needs of the majority of the population. Equity in access to essential medicines is a fundamental human right. They should be available at all times in adequate amounts, in the appropriate dosages and at a price that individuals and the community can afford. Over the past 25 years WHO has strongly advocated the essential medicines concept as part of national medicines policies. Despite this, regular access to medicines is denied to over one third of the world's population, particularly in developing countries. Serious problems of access to essential medicines are still frequently encountered in countries and areas in the Western Pacific Region, despite the existence of national medicines policies, national essential medicines lists and standard treatment guidelines (Box 1). A focused strategy for improving access to essential medicines in the Western Pacific Region is badly needed. The Region bears a significant part of the global burden of important diseases such as tuberculosis, malaria and childhood illnesses. Deaths and illnesses caused by all these diseases can be significantly reduced by simple essential medicines. For example, about 1000 people in the Region die of tuberculosis every day, despite the existence of an effective cure. There are more than 1 million deaths in children under five years of age every year in the Western Pacific Region. Approximately 700 000 of these are caused by diarrhoea, acute respiratory infections (in particular pneumonia), measles, malaria and dengue fever, with malnutrition as an important underlying condition. In the Western Pacific Region, an estimated 1.2 million people are living with HIV/AIDS.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Box 1. Challenges and progress towards improving access to essential medicines in the Lao People's Democratic Republic, Mongolia and Tonga The 2000 revised national medicines policy in the Lao People's Democratic Republic aims to improve access to essential medicines through revolving funds. These funds exist at all levels of the health system: hospital, health centre and village. They are integrated with Ministry of Health directives and conform to the national essential medicines list; follow the practices of rational medicine use; and assure medicine quality, prices and services. Revolving funds should not generate profit; the customer charge is 125% of cost and the funds are managed by local health staff. The Food and Medicine Directorate in the Ministry of Health has responsibility for revolving funds management. In August 2001, revolving funds were in place in 94% of hospitals, 83% of district hospitals, 86% of health centres and 11% of villages. The extent of revolving funds in remote areas needs to be determined (the aim is to reach 5000 villages) and the exemption system reviewed. Financing is from users, the government and donors, but many funds find it difficult to replenish their resources. Extensive political and socioeconomic changes in Mongolia in the 1990s led to an increase in counterfeit medicines and a lack of objective information on medicines. In a 1998 survey, using WHO indicators (a basket of 10 medicines), stock shortages ranged from 0 to 80 days. Variations in prices within the country also limit the Mongolia's effectiveness of attempts to improve access to essential medicines. Irrational medicine use and prescribing is widespread and injections are widely used. adopted in 1998. Tonga's efforts to improve access to essential drugs are very much centred on procurement and supply issues, which are made more acute by the fact that the country's 36 inhabited islands are widely scattered. Medicines are procured only once a year, which creates problems with deliveries, storage and shortages. The main island and urban areas have the best access to medicines and the referral hospital has all the necessary medicines available. However, irrational prescribing is widespread. Tonga is now addressing these and other issues in its first national medicines policy, adopted in 2000. Procurement procedures are being revised, training for prescribers is being carried out, guidelines are being issued, and medicine registration is being carried out. Efforts are also being made to ensure compatibility between the essential medicines list and clinical guidelines. parliament approved a national medicines policy in 2002. A new medicines law was
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The strategy is designed to reinforce national medicines policies and existing tools and guidelines such as essential medicines lists and standard treatment guidelines. It also examines such issues as sustainable financing and pricing mechanisms and a n a l y s e s t h e e ff e c t s o f t r a d e globalization and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS agreement). It proposes strategic options and actions to improve access to essential medicines. The draft strategy was developed through a process of wide consultation. This included a review of country experiences at a regional workshop on evaluating the implementation of national medicines policies in Phnom Penh, Cambodia, in November 2002. Comments from WHO technical programmes as well as from national counterparts and international experts have been incorporated. It was
reviewed in detail at a consultation on improving access to essential medicines in the Western Pacific Region in Penang, Malaysia, in July 2003. The draft strategy was presented during the fifty-fourth session of the WHO Western Pacific Regional Committee in September 2003. Member States supported the idea and framework of the strategy, but requested another round of consultation and that a small working group meeting should be convened. An informal consultation involving Member States and relevant experts was convened in February 2004 to review and to revise the draft strategy. The final draft was endorsed during the Regional Committee at its fifty- fifth session in Shanghai, China in September 2004. The resolution (see Annex 1) from the Regional Committee requests Member States to collaborate in improving access to essential medicines using the Regional Strategy as a guide.
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2 REGIONAL STRATEGY
The overall objective of the regional strategy is to provide operational and practical guidance to Member States and WHO on improving access to affordable essential medicines of acceptable quality, which are appropriately used by those who need them. The regional strategy is based on the essential medicines concept. This concept is more valid than ever, in both public and private sectors, following the emergence of epidemics of HIV/AIDS, drug-resistant malaria and tuberculosis, as well as the persistence of diseases with high morbidity and mortality, such as acute respiratory infections and diarrhoea. The implementation of the strategy by the Member States will depend on the existing health care system, and taking into account the national priorities, legislation and administrative framework, and resources.
The regional strategy covers “Issues and challenges”, “Strategies”, and “Actions" by Member States and by WHO under the following headings: 1. rational selection; 2. rational use; 3. affordable prices; 4. access to medicines, trade globalization and the TRIPS agreement; 5. sustainable financing; 6. supply and management systems; 7. quality; and 8. monitoring and evaluation.
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3 ISSUES, CHALLENGES, STRATEGIES and ACTIONS 3.1 Rational Selection Twenty-five years after the first WHO Model List of Essential Medicines (formerly Model List of Essential Drugs) was produced, model lists have been adopted by the majority of WHO's Member States (156 countries globally and 27 of 37 countries and areas in the Western Pacific Region). However, implementing these lists in health care services in order to improve access to medicines remains problematic. prescribing. Nor are they stratified according to level of care in many countries. · Certain essential medicines are often not available in the market as manufacturers are not interested in producing them.
Strategies
Issues and challenges · There is a lack of ownership of, acceptance of and confidence in the concept of essential medicines among both health care providers and consumers. · There are often misconceptions about essential medicines, for example, that essential medicines are cheap, of low efficacy and quality, for the poor and that they restrict professional freedom of prescribing. · In many countries, essential medicines lists are rarely used as the basis for pharmaceutical procurement, reimbursement or
· Focused advocacy and training for policy makers, health care providers, consumers and health care managers, in public and private sectors, to reinforce the essential medicines concept using an evidence-based approach. · A participatory approach and systematic process to the formulation, evaluation and revision of the essential medicines list, involving relevant stakeholders at different levels of the health care system. · Inclusion of the essential medicines and national medicines policy concepts in the undergraduate curricula of health care professionals as well as in the continuing education programme.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
(Continuation of Strategies...)
· Monitoring the use of the essential medicines list as the basis for procurement, reimbursement by insurance schemes, and as the basis for prescribing, taking into account different levels of health care. · Information exchange among Member States on national medicines policies and other issues related to essential medicines. · Create incentives for production and distribution of essential medicines.
· Involve relevant stakeholders at all levels in the development, evaluation and revision of essential medicines list. · Provide possible incentives for production and distribution of essential medicines, e.g. fast registration, tax exemption, financing mechanism.
Actions Member States · Undertake focused advocacy and training for policy-makers, health care providers, consumers and health care managers, in both public and private sectors, on the essential medicines concept in primary health care and hospital facilities. · Introduce the essential medicines concept and the national medicines policy into existing undergraduate curricula and continuing education programmes for health care providers. · Use the essential medicines list, linked with standard treatment guidelines, as one of the bases for procurement at different levels of care and for reimbursement. Monitor compliance.
WHO · Develop and field-test advocacy and training materials on the essential medicines concept targeted at policy makers, providers, consumers and health managers in public and private sectors. · Continue to publish a regional newsletter, Essential Drugs and Medicines Policy . Develop other means of networking that take advantage of information technology, i.e. WHO essential medicines library, website and databases. · Develop model curricula on the essential medicines concept and national medicines policy in undergraduate and continuing education programmes, and promote its adoption and use by Member States.
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(Continuation of WHO...)
· Support Member States to develop, revise, implement, monitor and evaluate their essential medicines lists, including their use for procurementandreimbursement. · Advocate possible incentives and exchange of information on the existing needs of essential medicines and on the potential suppliers/ manufacturers.
Issuesandchallenges · There is a widespread belief that training and developing standard treatment guidelines alone are enough to improve rational use of medicines, when in fact a wider combination of interventions is needed. · There is no comprehensive package of interventions (including educational, regulatory, managerial, financial and systems interventions) to enhance the rational use of medicines in most countries. · Intervention strategies rarely include evaluations of the impact of the interventions on prescribing and behaviour affecting medicineuse. · Most countries do not continuously monitor and supervise prescribing practices in health facilities. Adherence to standard treatment guidelines is rarely promoted and monitored. · Prescribing is often driven by profit motives and used for revenue generation.It is largely influenced by promotion of pharmaceuticals ethical criteria for promotion of pharmaceuticals. · There is increasing anti-microbial resistance (AMR) in the Region, caused by the uncontrolled availability and widespread inappropriate use of anti-microbials.
3.2 Rational Use Ineffective and harmful medicine use practices by both providers and consumers are commonly encountered in health care facilities and in the wider community. Such practices include, for instance, the misuse of anti-microbials, the overuse of injections and inappropriate multiple drugs prescribing or poly-pharmacy. The reasons for this are complex and require appropriate and consistent interventions. Rational use of medicines means that patients receive medicines appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time and at the lowest cost to them and the community.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Strategies · Development and implementation of a package of rational drug use interventions for providers and consumers, combining educational, managerial, regulatory, financial and systems interventions. This includes a framework for evaluation of impact. · Use of standard treatment guidelines and formularies linked to essential medicines lists in public and private facilities. · Supervision and monitoring of medicine use practices in health facilities, including compliance with standard treatment g u i d e l i n e s , essential medicines lists and formularies. Consumer education and empowerment on rational use of medicines. Networking and exchange of information on rational medicine use. Promotion of therapeutics and medicines committees with clear tasks and functions in hospitals. Implementation of ethical criteria for pharmaceutical promotion, monitoring of pharmaceutical promotion, restriction of unacceptable promotion through regulation and/or voluntary codes of conduct.
· Development and implementation of appropriate strategies to contain AMR.
Actions Member States Draw up and implement a comprehensive rational drug use strategy. Include evaluation plan in any drug use intervention. Formulate and use standard treatment guidelines and formularies linked to essential medicines list. Undertake supervision and monitoring of medicines use practices in health facilities. Undertake consumer education programmes. Form hospital therapeutics and medicine committees with clear tasks and functions.
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· Take measures to introduce rational drug use and problem-based pharmaco-therapy teaching into the curricula of health care providers. · Seek partnerships, particularly with nongovernmental organizations and academic institutions to promote rational drug use.
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(Continuation of Actions...)
· Develop, and implement regulations on ethical promotion of pharmaceuticals. Undertake monitoring and provide feedback on promotion. · Develop and implement a national strategy to contain AMR. · Improve the adherence and continuity of antiretroviral treatment WHO Support countries to formulate, implement and evaluate comprehensive rational drug use strategies. Advocate and support countries to undertake evaluation of drug use interventions. Support the development and fieldtesting of interventions on drug use practices, combining educational, managerial and regulatory interventions. Document experiences on effective rational medicine use interventions and work with countries to replicate them. Support countries to formulate and implement standard treatment guidelines and formularies linked with essential medicines list.
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· Draw up guidelines for supervision and monitoring of medicine use practices. · Develop materials for consumer education and empowerment on rational use of medicines. · Facilitate exchange of information on rational medicines use through the publication of a regional newsletter, Essential Drugs and Medicines Policy, and through electronic communication networks. · Undertake intercountry and country meetings on hospital therapeutics and medicine committees and rational drug use. · Support countries to introduce rational drug use and problembased pharmacotherapy teaching in the undergraduate curricula of health care providers. · Advocate the use ethical criteria for pharmaceutical promotion and provide technical support for monitoring and feedback. · Support countries and areas to develop, implement and evaluate strategies to contain AMR.
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3.3 Affordable Prices Affordable prices are fundamentally important if access to medicines is to be improved. Although the prices of many essential medicines have decreased significantly, they are still too high in relation to local purchasing power in many countries. There are several reasons for high prices, including lack of price competition, lack of transparency in the mark-up system, taxes and tariffs on medicines, the preference of health professionals and consumers for branded products, and the lack of alternative sources for patented medicines. · Health professionals and consumers are generally ignorant of price issues. · Information on taxation of essential medicines, including import duties, is not known in many countries. · In many countries there is a lack of awareness and knowledge on options for making prices affordable (i.e. price competition or price control).
Strategies
Issuess and challenges · Patented and branded products are often expenive because of a lack of competition and patent laws. · There are large price variations between countries for identical products. · In many countries, there are no price controls and price mark-ups are not transparent. This may lead to prices that are unaffordable to many people. · Generic prescribing and dispensing practices are not widely accepted. This means that more expensive brands are often prescribed and dispensed.
· Identification and dissemination of practices on pricing policies for essential medicines. · Price competition through legitimate measures to avoid monopoly and to reduce prices. · Dissemination of information on pricing controls (including analysis of the advantages and disadvantages). Creation of a fair and transparent mark-up system to make medicines more affordable (addressing such aspects as taxes, mark-ups and fees). · Reductions in taxes, duties and fees on essential medicines. · Establishment of a regional and local monitoring system on prices of selected essential medicines and participation in a global monitoring system.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
(Continuation of Strategies...)
· Adoption of policies on generic medicines, and development of appropriate national legislation, in line with international trade agreements. · Provision of comparative price information to health providers and consumers.
· Provide price information to providers and consumers. · Encourage collaboration among stakeholders involved in pricing and reimbursement schemes.
Actions Member States · Formulate pricing policies, including policies on relevant taxes, mark-ups, and reference pricing. · Formulate and implement policies on generic medicines and promote affordable and quality medicines to providers and consumers. · Establish and implement price monitoring, and participate in regional and global monitoring.
WHO · Identify and disseminate existing pricing policies, practices and feasible options. · Support the development of local price monitoring systems for selected essential medicines and information exchange on prices of essential medicines. Encourage Member States to participate in regional and global price monitoring systems and provide Member States with price information. · Provide support to countries for implementation of and improvements to policies on generic medicines.
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3.4 Access to Mediicines, Trade Globalization and the TRIPS Agreement The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS agreement) makes it obligatory for member countries to apply standards for patent protection for new medicines. The Declaration on TRIPS and Public Health agreed at the WTO Ministerial Meeting in Doha, Qatar, in November 2001 (Doha Declaration) was an important step forward in improving access to medicines. The Doha Declaration affirms that the TRIPS agreement can and should be interpreted and implemented in a manner supportive to protect public health and, in particular, to promote access to medicines for all. Countries can best utilise the public health safeguard provisions provided in the TRIPS Agreement, namely compulsory licensing and parallel importation, in accordance with the national legislation. · Most governments and many ministries of health are unclear about how to safeguard public health in the era of intensive trade globalisation. · Developing countries have insufficient capacity either for strategic planning or for conducting complex trade negotiations. Ministries of health in developing countries do not pay sufficient attention to these issues and lack expertise, knowledge and skills. There is a lack of collaboration among health, trade and other sectors, which often have different interests. · There is a lack or absence of intercountry collaboration for a mechanism to make HIV/AIDS medicines and other essential medicines available and affordable.
Strategies · Exchange of information on the impact of trade agreements on access to essential medicines. · Exchange of country experiences in dealing with the TRIPS agreement and other agreements, especially with regard to securing public health. Provision of information on the TRIPS agr eement and other r e l e va nt Agreements for informed decisionmaking by Member States.
Issues and challenges · The supply of generic equivalents of some patented products may be impacted as WTO Member States move to full implementation of the TRIPS agreement and other international agreements containing obligations on intellectual property rights.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
(Continuation of Strategies...)
· Strengthening national capacity to deal with trade-related matters that influence access to essential medicines. Use the flexibilities of the TRIPS Agreement to improve access to medicines in accordance with national legislation. · Collaboration between the health and other sectors (e.g. trade, finance, and justice) and other stakeholders (e.g. Nongovernmental organizations and universities) in domestic policy preparation to ensure that national health objectives are taken into account when there are any changes to World Trade Organization (WTO) agreements, national, regional or multilateral legislation related to regulations. · Collaboration among governments in such areas as price negotiations, import and export of essential medicines, reducing regulatory barriers, and developing appropriate policy initiatives on intellectual property. · International collaboration among international agencies, nongovernmental organizations, pharmaceutical manufacturers and other partners in order to identify and implement ways to ensure access to essential medicines, notably antiretrovirals, at affordable prices. · Differential pricing of patented medicines.
Actions
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Member States Review all national policies and regulations that affect pharmaceutical manufacturing and distribution, import and export, including tax, investment, trade and intellectual property regulation. The review should produce a coherent policy and regulatory framework aimed at increasing the supply of affordable quality medicines. Amend national intellectual property laws to include the public health safeguards of the TRIPS agreement. Establish collaboration between the health and other sectors and nongovernmental organizations in preparing domestic policies in order to ensure that national health objectives are taken into account when multilateral, regional and bilateral trade agreements are negotiated, or national legislation related to trade, health and intellectual property is drafted. Monitor policies, legislation and other factors influencing access to medicines in relation to the TRIPS agreement and other multilateral, regional and bilateral agreements that deal with intellectual property and trade globalisation.
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(Continuation of Actions...)
· Conduct national workshops and other training on trade globalisation and access to medicines for health and trade policy-makers. · Participation in existing regional associations (e.g. the Association of South-East Asian Nations, ASEAN) and collaboration to improve access to essential medicines in relation to trade globalisation and TRIPS agreement. Contribute actively to regional information exchange on the TRIPS agreement and other agreements dealing with intellectual property. · Undertake price negotiation of patented medicines, especially for antiretroviral medicines.
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WHO · Follow and disseminate information on international developments related to TRIPS, other relevant agreements and trade globalisation and their impacts. · Support country assessment in relation to health, trade and intellectual property. · Advocate and facilitate collaboration between the health and other sectors and nongovernmental organizations in preparing domestic policies to ensure that national health objectives are taken into account when multilateral, regional and bilateral
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agreements are negotiated, or when national legislation related to trade, health and intellectual property is drafted. Advocate the inclusion of the public health safeguards of the TRIPS agreement in national intellectual property laws and regulations and support countries to amend legislation accordingly. Support national workshops and other training on trade globalisation and access to medicines for health and trade policy-makers. Facilitate exchange of country experiences in dealing with the TRIPS and other agreements, especially in protecting the public health interest. Provide information regarding the TRIPS and other relevant agreements to Member States. Support collaboration among governments in such areas as price negotiation, imports and exports of essential medicines, reducing regulatory barriers, developing appropriate policy initiatives on intellectual property. Pursue regional collaboration with relevant partners such as pharmaceutical manufacturers and their associations, nongovernmental organizations and consumer organizations. Promote the concept of differential pricing between developed and developing countries.
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3.5 Sustainable Financing
Sustainable financing for medicines purchases is critical if essential medicines are to be made accessible. Government commitment for funding essential medicines is crucial, especially in primary health
care facilities and for poor populations. In many countries in the Region, most financing for medicines is “out-of-pocket" (Box 2). In several countries, hospitals use the sale of medicines as an important source of revenue.
Box 2. Out-of-pocket financing for health, including pharmaceuticals The World Health Report 2002 revealed an increasing trend towards private financing of health care in the Region. In China, private out-of-pocket financing increased from 53.3% in 1995 to 63.8 % in 2000. The same trend could be seen in Viet Nam (from 59.6% in 1995 to 74.2% in 2000) and Cook Islands (from 21.1% to 37.2 % in 2000), among others. In some countries there have been slight reductions in out-of-pocket payments, but these have often been from very high levels, for example in Cambodia (from 79% in 1995 to 75.5% in 2000) and Tonga (56.7% in 1995 to 53.2% in 2000). The funding allocated to medicines varies between countries and often comes from different sources. However, expenditure on medicines usually accounts for 25% to 50% of total public and private health expenditures in developing countries.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Issues and challenges · Allocations from public sector budgets for essential medicines are insufficient and contributions from consumers are often excessive. · Lack of financing and budgeting skills and inefficient financial planning and management. · Information on public and private sources of funding for essential medicines is not readily available. Financial and economic analysis of medicines expenditures in order to promote cost efficient and cost effective financing options, are rarely undertaken. · There are often conflicting incentives to promote cost-efficiency or rational use in health institutions and pharmacies. It is common for health facilities and providers to use medicines sales to generate revenue. · Insufficient awareness of the reasons and implications of out-of-pocket payments.
policies and practices. Increase financial planning skills in ministries of health and increase awareness and knowledge of health and essential medicines in ministries of finance. Encourage collaboration between ministries of health and finance in financial planning and analysis for health. · Establishment of information systems on existing sources of funding and expenditures on essential medicines. Financial and economic analysis of medicines expenditures to identify areas where cost containment measures are needed. · Application of cost containment measures to medicines expenditures, and cost effectiveness analysis in the selection of medicines, especially in the public sector. · Promotion of fair financing of essential medicines through, social insurance schemes and various forms of community financing. · Identification of effective public subsidy mechanisms for poor segment of the population. · Human resource development for financial economic analysis in medicine financing.
Strategies · Identification of policies and practices on essential medicines financing. · Improvement in knowledge and skills in order to be able to advocate best
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Actions Member States Review the impact of current health care and medicines financing on access to essential medicines. Maintain a coordinated information system on sources of medicines financing and expenditures as part of national health accounts or other national health financing information systems. Promote the use of such information and data on health statistics for analysing the impact of medicines expenditures. Undertake regular financial and economic analysis of medicines expenditures using cost efficiency and cost effectiveness analytical tools, especially in the public sector. Hold national meetings to bring together essential medicines, health and finance stakeholders to address key financing measures to ensure that national medicines policy is a part of health policy and financing. Maintain sufficient public financing for essential medicines, through improved financial management, especially for the public sector and primary health care, based on properly quantified health care needs. Ensure that essential medicines are covered by social health insurance and create mechanisms for social safety nets.
· Undertake training on budgeting, financial planning and management. WHO Undertake operational researches to document the practices and implications of out of pocket payment. Increase awareness of the implications of out of pocket payment for medicines and promote social health insurance to cover medicines cost, as part of broader health financing strategies. Identify and disseminate policies and practices of Member States in fair medicines financing, and efficient and effective financial management. Support countries to establish or maintain coordinated information system on sources of medicines financing and expenditures as part of national health accounts. Develop methods and tools to assess and monitor Member States' current medicines financing policies and practices and undertake analysis. Support capacity building in financial analysis and pharmacoeconomic analysis. Strengthen planning and management of human and financial resources. Provide support for the analysis of medicine financing and expenditures in order to improve cost-efficiency and cost effectiveness, especially in the public sector.
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3.6 Supply and Management System Several countries in the Region still find it difficult to ensure a consistent supply of essential medicines. This has an impact on access. Because of poor estimations of needs, essential medicines may sometimes be unavailable for unacceptably long periods or may have to be disposed of because they have expired (Box 3). Uneven distribution of essential medicines, leaving rural and remote areas without essential medicines, is also common. Poor storage conditions throughout the distribution system often lead to further wastage and quality problems.
Box 3. Country examples: drug availability in Cambodia, Malaysia and the Philippines Cambodia has a system for comprehensive monitoring of the supply of medicines and their use in health facilities. Using this monitoring system, the Ministry of Health was able to demonstrate 94%-95 % availability of essential medicines from 2000 to 2002. However, such a monitoring system may not guarantee an immediate response if there is a supply problem because of weaknesses in procurement. The system also requires continued supervision. In 2002 a survey in Malaysia revealed that the average percentage availability of essential medicines listed in the public sector was 95.4%, with an average out of stock duration of 6.5 days. In the Philippines, a study has shown that that the availability of essential medicines in the public sector is low: 34.1% in public health facilities and 38.0% in public warehouses.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Issues and challenges · In many countries, the procurement of essential medicines is carried out by different programmes and organizations, using different methods and quality standards, with no efficient coordination, which leads to inefficiencies and waste. · Public sector planning, monitoring and management information systems for procurement and distribution are usually inadequate and there are not enough trained people to manage the drug supply. There is inadequate stock management, leading to wastage at various levels. · Procurement of medicines is not based on essential medicines lists in many countries. There is poor estimation of essential medicines needs at various levels of health care systems. There is a lack o f information on prices and sources of good quality medicines.
· The principles of good procurement practices are not widely known or implemented in many countries. The WHO Certification Scheme is often not used when procuring imported products (Box 4). · Transportation and distribution in difficult geographical and remote areas can result in long lead times and changes in the quality of medicines because of adverse climatic conditions. This is aggravated by lack of management, infrastructure and skills. · Lack of bulk procurement mechanism often lead to higher cost and lower quality products. · In many countries, decentralization of the medicines procurement system very often result in inefficiencies with adverse impact on access to medicines. ! The distribution of medicine is often uneven, and not reaching the poor segment of the population.
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Box 4. What is the WHO Certification Scheme? The WHO Certification Scheme is an international voluntary agreement, devised to enable countries with limited regulatory capacity to obtain partial assurance from exporting countries concerning the safety, quality and efficacy of the products they plan to import.
How does the scheme function? · · · · It is a voluntary agreement that requires regulatory authorities of exporting countries to issue certificates when requested by importing countries. The certificates: explain whether a special product is approved for use in the exporting country, and if not, why; contain details of whether the premises where the product is manufactured are inspected regularly and meet good manufacturing practices standards; and attest to the fact that all submitted product information, including labelling, is currently authorized in the certifying country. What are the scheme's strengths and weaknesses? Strengths · · · · The scheme provides evidence that the exporting country has evaluated the It uses a standard format that helps importing countries to obtain all the information Use of a standard format obliges the certifying authority to disclose the important It promotes information exchange between countries about pharmaceutical products and manufacturers for which certificates are issued. they need about products they are importing. information to the importing country; products and can lead to harmonization of product information. Weaknesses · · · A certificate is only as good as the certifying authority. The scheme relies on the honesty and competence of the issuing authorities. The scheme does not cover pharmaceutical products while they are in transit, during
which time a product could be relabelled or mixed with other products. Procurement agencies should routinely request certificates under the scheme as one of several measures to ensure product quality.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Strategies · Coordinated medicine management, planning and monitoring systems in t h e p u b l i c s e c t o r, i n c l u d i n g procurement based on good procurement practices, national policies, essential medicines lists and standard treatment guidelines. · Training in drug management, including quantification, costing, procurement, distribution and inventory management of essential medicines. · Information exchange on prices and sources for medicines procurement. · Bulk and collaborative procurement, collective price negotiations for procurement of essential medicines. Use of WHO pre-qualified products (Box 5) and manufacturers for HIV/AIDS, tuberculosis and malaria drugs in procurement. · Promoting good and ethical pharmaceutical practices (procurement, distribution, storage and pharmacy) in public and private sectors. · Identifying experiences on pharmaceutical supply and procurement in systems that have been decentralized and reformed, clarifying the roles of central and local governments and the roles of public and private sectors.
· Strengthen system and human resource capacities in medicine supply management in decentralised setting and advocate for local government commitment. · Mechanism for social protection that covers essential medicines for the poor segment of the population.
Actions Member States · Implement a coordinated medicine management system for planning and monitoring. · Undertake procurement of medicines for the public sector based on national medicines policies, good procurement practices, essential medicines lists and standard treatment guidelines. · Undertake training in management of medicines, including quantification, costing, procurement, distribution and inventory management of essential medicines. · Pursue mechanisms for centralized or collaborative (bulk) procurement and collective negotiations.
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Box 5. WHO Prequalification project: access to antimalarial, antituberculosis and HIV/AIDS drugs and HIV/AIDS diagnostics of acceptable quality Many international, regional and national organizations are involved in the procurement of drugs. The supply of drugs that are effective and of acceptable quality for the treatment of HIV/AIDS, malaria and tuberculosis has become a major concern at both international and country levels. The WHO prequalification project aims to facilitate access to drugs of acceptable quality through assessment of compliance with WHO recommended standards. It was begun by WHO in collaboration with UNAIDS, UNICEF, UNDP and UNFPA.
The procedure for assessing the acceptability, in principle, of drugs consists of the following procedures: 1. The evaluation of product data and information provided by manufacturers and suppliers; 2. Inspection of manufacturing sites to ensure that good manufacturing practices are in place. Manufacturers who wish to supply drugs through this pilot project may express their interest to WHO. After ensuring that submitted documentation related to products and manufacturing facilities is satisfactory, WHO may organize a detailed evaluation of product dossiers and inspection of the manufacturing site. Only products and manufacturing sites that are found to meet the recommendations in the WHO guidelines are published in a list of suppliers. The list can be used as a tool to guide the selection of suppliers for procurement purposes. Member States are recommended to use these lists when sourcing products for procurement in order to ensure that medicines of acceptable quality are purchased. This will also facilitate the registration of medicinal products, as the listed products and suppliers already comply with WHO guidelines for registration and good manufacturing practices. The lists and additional information about the WHO prequalification project can be found at: http://mednet3.who.int/prequal
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
(Continuation of Action...)
· Monitor prices of essential medicines and contribute actively to regional information exchange. · Develop social protection mechanism covering essential medicines, such as exemption of user's fee for the lower income segment. WHO · Promote coordination of medicines procurement by different programmes, based on national medicines policies, good procurement practices, essential medicines lists and standard treatment guidelines. · Pursue mechanisms for collaborative (bulk) procurement and collective multi-country price negotiations for procurement of essential medicines. · Promoting good and ethical pharmaceutical practices (procurement, distribution, storage and pharmacy) in public and private sectors.
· Support the development and implementation of coordinated management planning and monitoring systems for medicines. · Provide technical support and training (international and national) in drug management, including quantification, costing, procurement, distribution and inventory management of essential medicines. · Monitor prices of selected essential medicines and facilitate information exchange on prices and sources for medicines procurement. Promote the use of WHO pre-qualified products and manufacturers for HIV/AIDS, tuberculosis and malaria medicines. · Support operational research to document and to evaluate practices on pharmaceutical supply systems and procurement in public and private sectors in health systems that have been decentralized and reformed.
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3.7 Quality The quality of medicines is an integral part of access in light of ensuring that the pharmaceutical products are fit for their intended use, comply with the requirement of the marketing authorization and do not expose consumers to risks. To attain this objective, there must be a system of quality assurance, which incorporates aspects including product development, manufacture, distribution and storage. Quality assurance of pharmaceuticals is part of WHO normative work under the concepts of National Medicines Policy and essential medicines. In some countries in the Region the manufacture of medicines is still not carried out according to internationally accepted requirements for pharmaceutical manufacture, such as WHO Good Manufacturing Practices (GMP), resulting in substandard drugs being manufactured, distributed and used. However, the urgent problem related to quality faced by countries in the Region is counterfeit medicines. The production, distribution and sales of counterfeit medicines have substantially increased in recent years, involving products for treating disease with high mortality like malaria, especially in the Mekong region. This issue directly affects access as consumers may waste their valuable resources on fake drugs. Effective medicines regulation and enforcement, promulgation of deterrent legislation, confiscation and destruction of counterfeit medicines and strong political will are all needed if counterfeit medicines are to be combated.
3.7 a Counterfeit Drugs
Issues and challenges · There is a lack of awareness on counterfeit medicines among policy makers, health professional and the general public. · Laws and regulations relating to quality assurance (e.g. drug registration, inspection and quality surveillance) are not properly enforced in many countries. · In some countries, the number of unlicensed private pharmacies is increasing. · Penalties for breaking laws or regulations are very lenient in most countries. Counterfeiting is commonly considered a trade violation rather than a serious criminal act violating public health. · There is a lack of political commitment to combat counterfeit medicines in many countries.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
(Continuation of Issues and challenges...)
· In many countries there is a lack of collaboration between law enforcement agencies and health officials in combating counterfeit medicines. · The definition of counterfeit medicines varies from country to country hampering intercountry collaboration.
· Training on combating counterfeit medicines. · A common definition of counterfeit medicines.
Actions Member States · Develop national strategies, guidelines and advocacy materials on combating counterfeit medicines. · Increase awareness of counterfeit medicines among policy-makers, law enforcement agencies, providers and consumers. · Strengthen collaboration among law enforcement agencies through meetings and training. · Share with WHO and other countries the regulatory status of medicines and the occurrence of counterfeit medicines found in the Region. · Conduct regular assessments on the extent of counterfeit medicines. · Conduct training on combating counterfeit medicines for law enforcement agencies and drug inspectors. · Strengthening of legislation and regulation including more deterrent penalties and a definition of counterfeit medicines in line with the WHO definition. Better implementation and enforcement of laws and regulations.
Strategies · Campaigns against counterfeit medicines targeting health care providers, policy-makers and the general public. · Formulation and implementation of comprehensive strategies for combating counterfeit medicines involving relevant stakeholders, including private manufacturers. · Strengthening, adoption and enforcement of legislation, regulations and inspection. · Information exchange among Member States, including a rapid alert mechanism, on the regulatory status of medicines and on counterfeit medicines. · Regular assessment of the extent of counterfeit medicines in the marketplace. · Intercountry collaboration and collaboration between medicine regulatory authorities and other law enforcement agencies.
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WHO · Provide support to countries in order to improve legislation, regulation and inspection. · Develop advocacy materials on combating counterfeit medicines for policy-makers, providers and consumers. · Provide support to countries for assessment of the extent of counterfeit medicines. · Support intersectoral and intercountry workshops on combating counterfeit 3.7 bmedicines. SUBSTANDARD DRUGS · Provide support for training on combating counterfeit medicines for law enforcement agencies and drug inspectors. · Promote and facilitate information exchange among Member States, including a rapid alert mechanism, on the regulatory status of medicines and on counterfeit medicines. · Collaborate with other international agencies on combating counterfeit medicines, such as INTERPOL, manufacturers associations, donors etc.
· Promote the WHO definition of counterfeit medicines.
3.7 b Substandard Drugs
Issues and challenges · Surveys in some Member States show a high incidence of substandard drugs found on the market. · In some countries manufacturers do not comply with Good Manufacturing Practices (GMP) because of lack of human resources as well as lack of commitment to invest for improving manufacturing facilities. · Medicine regulatory authorities do not have the sufficient capacity and skills to provide advice to and inspect manufacturers of medicines and to register medicines. Breaches on GMP are not followed by regulatory actions; law enforcement is weak. · Results of quality surveillance, if any, are not used to improve quality assurance.
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Strategies · Implementation of GMP and collaboration between manufacturers and drug regulatory authorities on improving GMP compliance. · Building capacities and skill of medicine regulatory authorities in the areas of GMP, inspection and product registration. · Regular surveys on the quality of medicines followed by appropriate interventions. · Strengthening, adoption and enforcement of legislation, regulations and inspection. · Intercountry collaboration and information exchange on medicines regulatory affairs, particularly on inspection and medicines registration.
· Collaborate with national regulatory authorities in other countries to take advantage of inspections and product evaluations already done. · Conduct quality surveys and evaluation of medicines. · Participate in intercountry information exchange on the regulatory status of medicines and the occurrence of substandard medicines in the market. · Collaborate with manufacturers association to undertake training programme in GMP certified manufacturers.
·
·
Actions Member States · Strengthen capacity and skills of the national regulatory authorities particularly in the field of GMP, GMP audits and inspections and drug registration through training of staff. · Strengthening of legislation and regulations and improve enforcement of these.
·
·
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WHO Provide technical support in the areas of GMP, inspection and drug registration. Support training of staff in the areas of GMP, inspection and drug registration. Provide technical support in strengthening legislation and regulations pertaining to quality. Provide support to the conduct of quality survey and evaluation of medicines. Facilitate information exchange between countries on the regulatory status of medicines and the occurrence of substandard medicines in the market.
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3.8 Monitoring and Evaluation of Access to Essential Medicines In the mid-1990s, WHO published a comprehensive set of indicators to monitor implementation of national medicines policies, including access to essential medicines. It soon became evident that a core set of indicators had to be selected to assess the pharmaceutical situation in a country and to monitor implementation of the national medicines policy r egularly (Box 6). However, suitable indicators to measure access to essential medicines have not yet been defined or agreed upon. often jeopardized when there is a change from a central to a decentralized system. · Many countries do not have sufficient capacity to evaluate the impact of interventions for improving access to essential medicines. · Suitable indicators for measuring access are not yet available.
Strategies · Monitoring and evaluating implementation of NMP, particularly with regard to access to essential medicines. Feedback of data derived from assessments of the pharmaceutical sector to stakeholders in order to improve policy implementation. · Operational research to develop, field test and measure the impact of interventions · Establishment of a technical advisory g r o u p ( TA G ) t o p r o v i d e recommendations for improving access to essential medicines in the Region. · Further refine and use of suitable indicators for measuring access to medicines.
Issues and challenges · In many countries, there is no regular system to monitor the implementation of the national medicines policy (NMP) or to measure its impact on access to medicines. Even if data are available, they are rarely analysed or used by policy-makers to help health managers and providers to improve NMP implementation and access to essential medicines. · Continuity of existing monitoring of implementation of NMP including access to essential medicines is
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Box 6. Country examples: use of indicators in Australia, Cambodia and Indonesia Although Australia does not yet have a nationally recognized set of national medicines policy indicators, the indicators and targets for the “quality use of medicines”, which began in 1992, have been regularly assessed and performance has been reported. Information on achievement or nonachievement has enabled continuity during periods of political change. The indicators monitoring the “quality use of medicines” component of Australia's national medicines policy (officially launched in 1999) have also been used to demonstrate successes and gaps in policy development and implementation. From the start of its national medicines policy in 1995, Cambodia introduced a set of 24 indicators to monitor and supervise medicine supply, storage and distribution, and rational use of medicines. While some indicators have reflected positive trends, such as the percentage of medicines prescribed from the national list of essential medicines ( from 92% in 1995 to 98% in 2002 ) and the percentage of children below the age of five years receiving oral rehydration salts (from 64% in 1995 to 86% in 2002), others, such as those used to assess medicines management, have remained the same, pointing to a need for interventions. Some of the problems in medicine management relate to current government procedures, which allow procurement only once per year, which frequently leads to stocks of some medicines running out and others being overstocked. Other constraints include the lack of a budget to measure the impact of some interventions, such those used to measure rational medicines use. Indonesia used indicators to measure the impact of the country's currency crisis in the late 1990s on the availability and affordability of medicines in both public and private sectors (public and private hospitals, public health centres, private pharmacies and medicines stores). Some findings were reassuring; such as the availability of key essential medicines throughout the crisis and consistently low injection use. Others were disconcerting but not surprising. For example, prescription practices did not improve during the crisis, indicating a need for improvement in private health facilities. The impact on affordability was lower in public facilities, where there is an essential medicines list, than in private facilities, which apply less restrictive procurement policies. Hospitals were affected by the crisis as they rely on sales of medicines to generate profit, which indicates the need for better financing schemes.
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Actions
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·
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Member States Establish systems for monitoring and evaluating the impact of the implementation of NMP , particularly with regard to access to essential medicines. Undertake assessment of pharmaceutical sectors using selected indicators. Develop or update NMP based on assessments of the pharmaceutical sector. Contribute actively to regional information exchange on implementation of NMP and other interventions to improve access.
WHO · Support assessments of the pharmaceutical sector and implementation of regular monitoring and evaluation systems for NMP, including operational research for measuring the impact of interventions on access, quality and proper use of essential medicines. · Establish a regional technical advisory group to provide recommendations on measures to improve access to essential medicines in the Region. · Refine, field-test, disseminate, promote and support the use of practical suitable indicators for measuring access to essential medicines.
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Annex 1 Resolution WPR/RC/55.R4 "Regional Strategy for Improving Access to Essential Medicines in the Western Pacific Region, 2005-2010” The Regional Committee, Recalling the discussions on access to essential medicines at the fifty-fourth session of the Regional Committee; Concerned that lack of access to essential medicines, irrational use of medicines, and poor quality of pharmaceutical products remain serious public health problems in many countries in the Region; Having reviewed the draft regional strategy for improving access to essential medicines in the Western Pacific Region, 2005-2010; Reaffirming the importance of the essential medicines concept and of national essential medicines lists for improving access to essential medicines; 1. ENDORSES the regional strategy for improving access to essential medicines in the Western Pacific Region, 2005-2010, taking into account the views of Member States, including those noted in document WPR/RC55/9 Add.1, as an annotation to the regional strategy; 2. URGES Member States: (1) to use the regional strategy for improving access to essential medicines in the Western Pacific Region, 2005-2010 as a guide for actions to improve access to essential medicines in line with national medicines policies and for collaboration with WHO; (2) 3. to provide adequate resources to strengthen national essential medicines policies and programmes; REQUESTS the Regional Director: (1) (2) to support Member States to improve access to essential medicines using the to work with WHO Headquarters and international partners to improve access to Regional strategy as a guide in the line with national medicines policies; antiretroviral medicines in the Region, and to strengthen biregional collaboration with WHO's South-East Asia Regional Office to improve access to such medicines across Asia and the Pacific. Eighth meeting, 17 September 2004 WPR/RC55/SR/8
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REGIONAL STRATEGY FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES IN THE WESTERN PACIFIC REGION 2005-2010
Annex 2
WPR/RC55/9 Add.1"Annotations to the Regional Strategy for Improving Access to Essential Medicines in the Western Pacific Region, 2005-2010”
A small group meeting to discuss the changes proposed by some Member States to the draft regional strategy for improving access to essential medicines in the Western Pacific (see document WPR/RC55.R4, Annex 1) was held on 16 September 2004. The meeting was attended by representatives from Australia, China, France, Japan, Kiribati, New Zealand, the United States of America and Vanuatu. Ms Catherine Halbert (Australia) was elected as the chairperson. The group agreed that the following annotations be added as an annex to the regional strategy, in order to reflect the views of some Member States. These annotations to the regional strategy for improving access to essential medicines in the Western Pacific Region, 2005-2010 identified the following points for consideration in the implementation of the regional strategy by Member States: 1. The overlap with trade-related matters is recognized within the strategy and hence implementation by Member States and WHO needs to recognize and comply with World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) principles and rules and be consistent with international obligations in so far as they apply to improving access to essential medicines. 2. The implementation of the strategy should not be premised on the assumption that generic medicines will always be more affordable than patented medicines. 3. In implementing the strategy, all relevant sectors need to be consulted, including the pharmaceutical industry. 4. The importance of research and development in supporting continuing access to essential medicines must be an ongoing consideration in the implementation of the strategy. 5. Implementation of the strategy must emphasize and build a platform for inter- and intraregional collaboration.
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