UNAIDS HIV Drug Access Initiative: Providing Wider Access to HIV-related Drugs in Developing Countries, Pilot Phase

UNAIDS JOINT UNITED NATIONS PROGRAMME ON HIVIAIDS UNAIDS HIV DRUG ACCESS INITIATIVE Providing Wider Access to HIV-related Drugs in Developing Countries PILOT PHASE Update and Lessons Learned August 1999: uliii iiii iiiiiiii r5 1 1111 1 i8 0ii 11Th

The UNAIDS HIV Drug Access Initiative at a Glance INTRODUCTION Launched in November 1997, the UNAIDS HIV Drug Access Initiative is designed to develop innovative, effective models to improve access to needed drugs to treat HIV, its opportunistic infections, and sexually transmitted diseases (STDs) in the developing world. The Initiative is being conducted as a pilot project in two phases, lasting a total of four to five years. In the initial phase, lasting two to three years, the project is being implemented in a small number of countries. In phase II, the lessons learned in the pilot phase will be adapted and applied more widely. The project is being evaluated on an ongoing basis. The countries participating in the initial phase of the Initiative are Chile, C6te d'lvoire, Uganda, and Viet Nam. The Initiative seeks to address the many challenges of developing world drug access, such as lack of medical infrastructure, drug distribution channels, professional training, and patient support, by creating an environment of collaboration between pharmaceutical companies, health care providers, governments, donors, non-governmental organizations, and people living with HIV/AIDS. Implementation of the Initiative in each country involves the establishment of a National HIV Drug Policy, coordinated by a National Advisory Board made up of local government and NGO representatives, medical experts, and a representative of UNAIDS. Drugs are purchased from participating companies at a subsidized rate by a non-profit company established in each participating country, and the project is managed in each country by a Project Management Team. These ensure the consistent supply and rational use of HIV drugs provided through the Initiative. Drugs are paid for through participating governments, donors, and by individuals through private purchase. Funding for the programme infrastructure, which builds on existing infrastructure and projects in the participating countries, is provided by UNAIDS, its Cosponsors, and other donors. Pharmaceutical partners in the UNAIDS Initiative include Glaxo Wellcome plc, F. Hoffmann-La Roche, Virco NV, Bristol-Myers Squibb, Organon Teknika, Merck and Co., and Dupont Pharma, with discussions with other companies ongoing. The U.S. Centers for Disease Control and the French government's Agence Nationale de Recherche sur le SIDA (ANRS) have also committed financial support for project evaluation. 2

OVERVIEW The Challenges of Global Drug Access In recent years, medical science has produced tremendous advances in human health for many people. While laudable, these advances in medical treatment have also served to highlight stark inequities in the global healthcare system. Over 90% of the over 33 million people in the world with HIV/AIDS live in developing countries, yet almost none receive the antiretroviral therapies that have improved lives and reduced death rates so dramatically in other parts of the world, and many do not even receive much less sophisticated treatments for HIV-related opportunistic infections. This inequity in basic medical resources is intolerable. Yet the problems inherent in creating access to drugs for HIV/AIDS and other diseases can seem overwhelmingly complex. Building sustainable solutions involves more than simply purchasing and distributing drugs, although that in itself is a tremendous financial and logistical challenge. Establishing stable distribution channels, training healthcare workers, providing education and support to improve patient adherence to difficult therapies, guaranteeing a flow of drugs and diagnostics at prices that are realistic for poor nations, building local support, and taking appropriate steps to control drug resistance are all inherent challenges in building drug access. Funding also remains an enormous challenge. The supporters of the UNAIDS HIV Drug Access Initiative -- the governments of participating nations, community leaders, AIDS service organizations, people living with HIV/AIDS, and the participating pharmaceutical companies --believe it is now urgent to work collaboratively to develop innovative pilot projects and models for actions that can start to bring quality care to the parts of the world where it is needed most. At the same time they recognize that there is no single answer, and no programme, including this Initiative, can address all of the obstacles. About the Drug Access Initiative The purpose of the UNAIDS HIV Drug Access Initiative is to develop models to improve access to basic drugs for the prevention and treatment of opportunistic infections and sexually transmitted disease (STDs), and to provide, where possible, targeted access to antiretrovirals and other sophisticated drugs for the treatment of HIV/AIDS. 3

The Initiative creates flexible mechanisms to build linkages between private drug providers, health systems, communities and patients, and to address various levels of obstacles to drug access, including issues of pricing, distribution, and drug dispensation. Through collaboration between pharmaceutical companies and healthcare providers, the Initiative seeks to create an environment in which companies can safely provide HIV/STDrelated drugs at appropriate prices in affected countries, and health care providers can make these drugs available to patients within optimal standards of care. UNAIDS acts as a facilitator of this process, marshalling the contributions of pharmaceutical companies, donors, governments, non-governmental organizations (NGOs), community based organizations (CBOs), and individuals living with HIV/AIDS, and helping them work towards a coordinated response to the many complicated issues of drug access in the developing world. The Priorities of the Initiative HIV prevention initiatives have been, and will continue to be, an essential component of the global response to HIV/AIDS. Yet it is essential to recognize that the continuing spread of HIV in developing countries is also leading to increased demand for proper HIV care, which includes access to HIV-related medicines together with an adequate social support and health care infrastructure to support their rational use. The priorities of the Drug Access Initiative are to increase developing world access to needed drugs by developing, evaluating, and implementing systems that: * Facilitate appropriate pricing for drugs and diagnostics that reflect the economic reality of the affected country, without disrupting or altering existing Essential Drugs Programmes; * Ensure rational -- the most effective and humane -- use of drugs; * Provide an adequate and responsive distribution system to ensure a continuous flow of drugs and avoid use of expired drugs; * Provide the appropriate information and training to health workers and communities and foster the establishment and improvement of an adequate health information system; * Strengthen national healthcare infrastructures to create a favourable setting for wider access to HIV-related drugs; * Provide a framework and serve as a catalyst for the increased activities of the programme supporters, each of whose participation is necessary to address the underlying obstacles to expanded HIV drug access; 4.

* Ultimately make essential HIV/AIDS and STD drugs more widely available in each participating country...) Basic Principles of the Initiative The overriding principles that inform the Initiative were developed by UNAIDS in consultation with affected communities. These include: * Solutions must be tailored to the needs and situation in individual countries; * A rational HIV strategy in a particular country should be built on an objective assessment and prioritization of medical and public health interventions in the context of the country's existing infrastructure and needs; * While responsibility for care and treatment of people living with HIV/AIDS rests with the government and national public health systems of the countries in which they live, any successful effort to improve access to HIV-related drugs requires a multipartite approach that engages all interested parties; * The involvement and support of local leaders, health personnel, NGOs, governments, people living with HIV/AIDS, and the pharmaceutical industry are essential; * Suppliers of HIV-related drugs should be encouraged to recognize their own market-based incentives to facilitate access to their products by differentiating or subsidizing their prices to address the economic, medical, and public health characteristics of individual countries - An effective price, representing an agreed mutual value between supplier and purchaser, will by definition vary according to the economic circumstances in which the product is acquired and its benefit realized - A patient in a developing country, where income is far lower than in industrialized countries, should pay less for costly HIV-related medicines; * The Initiative makes HIV-related drugs available for purchase through public or private funds, with decisions about the allocation of public funds resting with the governments of the affected countries; * The Initiative seeks to improve funding for HIV-related drugs by: - mobilizing political support for increasing the proportion of national resources dedicated to healthcare in participating countries, as well as in the international community 5

- identifying innovative private and public sector funding mechanisms - building public/private sector partnerships - creating an appropriate environment for increased health care spending by building and improving channels for health care delivery - generating social, economic and epidemiological data which will help to provide a technical and scientific rationale for increased spending on HIV-related drugs; * The programmes in each country must be self-sustaining; * Selection of treatments and interventions should be based on the objective assessment of their medical, public health, and health economic merits; * Barriers to drug access can best be addressed through the development of pilot projects and models that are then carefully evaluated to ensure that the most effective systems are implemented in larger-scale projects in the future; * A multipartite framework that addresses HIV treatment access issues on the basis of public health criteria can provide a model that may have applicability to treatments for diseases beyond HIV. Each Country is Unique Each country is unique, especially in the context of HIV/AIDS. There are differences in health care systems, economic capacities, HIV prevalence, culture and geography. The obstacles to drug access vary widely, and there is no single sustainable solution for all countries. In sub-Saharan Africa, home to two out of three people living with HIV/AIDS in the world today, per capita GDP in some cases as low as US$80 per year dims the prospects for access to expensive drugs. Health care infrastructure in many sub-Saharan countries is indeed so limited that it could not currently provide for an adequate distribution and prescription of drugs, even if they were provided at no cost. In Latin America, where resources are greater and access to care is often a constitutional right, political and ethical considerations need to be reconciled with the technical, financial and social capacities of existing private and public sector healthcare institutions. Recognizing the value of an approach targeted to local needs, the Drug Access Initiative has been designed to start with a limited scope, gradually increasing the number of drugs available and the numbers of patients reached, while ensuring that the strategies and procedures employed address 6

local needs and capacities. How the Programme Works: Phases of the Initiative The UNAIDS HIV Drug Access Initiative consists of two pilot phases, with ongoing evaluation a key component of the programme. The initial phase of the Initiative is designed to set up the necessary infrastructure and systems to increase access to HIV-related drugs on a small but sustainable scale, with the objective of expanding access once workable models are developed. Phase I of the Pilot Project, lasting two to three years, is being implemented in countries where the health care infrastructure is reasonably developed or may only require moderate strengthening to allow rapid implementation and evaluable results. Phase I evaluations will identify specific prerequisites for improving access to HIV-related drugs and provide recommendations on how to strengthen the health care infrastructure to address these needs. The results will help in establishing an action plan to broaden access to HIV-related drugs in the four pilot countries, as well as in additional countries. UNAIDS will prepare a guideline of best practices based on the phase I evaluations, which will be made available to the governments of those developing countries that wish to implement similar drug access programmes. To date, four countries have been chosen to participate in the pilot phase of the Drug Access Initiative. These are: * Chile * C6te d'lvoire * Uganda * Viet Nam Countries were selected taking into consideration a number of criteria and the need for the Initiative to be implemented initially in a variety of situations for evaluation purposes. The selection factors included: * Political and social stability; * Estimated HIV prevalence and incidence; * Existing health care infrastructure; * The country's political commitment to respond to the HIV/AIDS epidemic, and to provide care and support of people with HIV infection;

* The presence of an active National AIDS Programme, and a wellestablished public health platform; * The capacity to implement and evaluate the pilot phase. Additional countries may join the Initiative as it progresses. National Advisory Boards Any country participating in the Drug Access Initiative is required to have a National HIV Drug Policy, to ensure that all drugs made available through the Initiative are consistently and properly supplied and rationally prescribed and used. A well-coordinated National HIV Drug Policy, addressing both drug supply mechanisms and health care delivery systems, is critically important to the success of the Initiative in each participating country. This National HIV Drug Policy is determined by each country's Ministry of Health, based on the recommendations of a National Advisory Board or equivalent body. In each participating country, the Advisory Board: * Proposes a National HIV Drug Policy, including recommendations on currently available therapies and the clinical management of HIV infection; * Establishes a list of locally needed HIV-related drugs, estimates the country's needs for HIV-related drugs, and recommends country-specific treatment guidelines; * Recommends minimum requirements for two levels of health care facilities: - First-level centres, where basic drugs are available - Referral centres, where well-trained health workers and sophisticated diagnosis and management facilities allow for the prescription of complex treatments for opportunistic infections as well as antiretrovirals; * Makes recommendations on the selection of qualifying centres; * Recommends objective criteria for a profile of patients to participate in the pilot project; * Recommends over time an action plan for improvements of the health care infrastructure to make HIV/AIDS drugs more widely accessible; * Recommends regulations concerning privately funded purchases and the proper use of drugs supplied through the Non-Profit Company. 8

Unless a national body already exists, an Advisory Board of 10-15 members is established by the Ministry of Health in collaboration with UNAIDS, and includes: * Representatives of the Ministries of Health and other relevant government Ministries such as Planning and Finance; * The National AIDS Programme Manager, as well as representatives of relevant AIDS authorities in the country; * A representative of UNAIDS; * Representatives of NGOs involved in HIV/AIDS care; * People living with HIV/AIDS; * Experienced clinicians and academic public heath persons; * The Manager of the Non-Profit Company (as observer and liaison). The Non-Profit Company Pharmaceutical companies participating in the Drug Access Initiative supply drugs through a Non-Profit Company (NPC) established and registered under the laws of each participating country. The NPC negotiates subsidies from the participating suppliers, purchases drugs from those companies, and supplies drugs to the participating medical centres at the subsidized prices. The financial mechanism proposed in this Initiative enables pharmaceutical companies to provide HIV-related drugs at country-specific subsidized prices, defined separately and independently by each company in discussion with national officials. The NPC ensures appropriate and timely supply of drugs, and coordinates financial transactions in a manner that does not compromise international competition and open market rules. The supplying companies continue to assume direct responsibility and liability for their respective products. The NPC requires only a manager and an administrative assistant, and its administrative and operating costs are covered by the participating companies. Project Management Project management in each participating country begins with a preliminary visit from a UNAIDS team to evaluate existing infrastructures and make an assessment of the tasks and activities to be completed to ensure the successful establishment of a pilot programme in that country. 9

An experienced Project Manager is recruited in each pilot country to supervise the start of the project and head the Project Management Team. The Project Management Team, in turn: * Assists the Advisory Board in the selection of clinics on the basis of a proposal, assessment of the clinical and laboratory facilities, as well as the appropriate staffing by doctors and other health workers in each clinic; * Estimates the needs of drugs for the selected centres; * Holds training workshops for health and social workers; * Prepares and distributes standardized information, including patient chart and prescription formats; * Provides appropriate computer training and stock management software for drug dispensation at the clinic. Delivering Care: Identifying and Supporting Qualified Health Care Centres To receive drugs through the initiative, a referral health care centre must be able to provide patients with: * Well-trained doctors and other health workers; * Good clinical facilities for diagnosis and management; * Standard laboratory facilities; * Appropriate social support; * Appropriate drug dispensation facilities. Community-based organizations (CBOs) and NGOs involved in health care delivery systems are encouraged and assisted to establish qualified health care centres. Distributing Needed Drugs Drugs are dispensed against a medical prescription issued by a qualified physician at the centre. All qualifying centres are required to keep proper prescription and dispensing records in accordance with normal professional practice. Stock management programmes, featuring anonymous patient data including CD4 cell count, viral load, clinical staging, prescriber's code and drugs names, are provided and standardized by UNAIDS. 10

Products are delivered by the pharmaceutical companies through the NPC to either a central distribution point, which could be the Government Central Medical Stores, or directly to the health care centres. Each qualifying health care centre receives a single procurement number authorizing the centre to purchase the type of drugs allowed by its qualification. Information, Training, and Support Information and training programmes for health workers, patients, and affected communities are developed by the Ministry of Health and the National AIDS Programme, in accordance with the recommendations of the National Advisory Board. Information and training strategies address both clinical management issues and the psychosocial support of patients. Specific workshops will standardize the clinical as well as the social approach to patients. Community-based and non-governmental organizations play an active role in implementing information and training strategies, and a crucial one in supporting the community-based care, counselling and psychosocial services provided to patients in all participating health care centres. CBOs and NGOs are also involved in delivering targeted prevention and care messages to patients and the general population. Educational information and materials may also be provided by the participating pharmaceutical companies. Those companies will also be able to participate and contribute to the training and education programmes designed by the Advisory Board. Selection of Patients Because of the tremendous need, and the limited resources dedicated to the pilot phase of this project, the initial phase cannot provide access to HIVrelated drugs to all patients in need. Therefore, it is critically important that every effort be made to ensure that the pilot phase reaches those patients with the greatest need. Rigorous and objective patient selection criteria is established in each pilot country through a wide consensus process involving government officials, people living with HIV, clinicians, ethicists, religious groups and others. The Advisory Board has the responsibility to implement patient selection criteria and ensure that they are evenly applied. The Initiative is committed to ensuring that individuals who participate in phase I of the Pilot Project receive ongoing, sustainable access to treatment both during and after the pilot phase. Participating companies are expected to ensure that individuals participating in the pilot phase will continue to have 11

access to drugs at the subsidized prices after the completion of the pilot phase. The National Authorities are also expected to ensure sustainability of the programme for these patients. Evaluation and Expansion Ongoing evaluation is a key component of the Drug Access Initiative. A UNAIDS evaluation team provides continuous monitoring and assessment of the Initiative's pilot phases. As new problems are identified, new strategies are designed to overcome the obstacles. At the end of Year 1, a detailed review of the structure and administration of the Initiative evaluates the fit between the Initiative's theoretical design and its practical implementation. A further evaluation at the end of Year 2 provides the first concrete results with regard to the real impact of the Initiative in participating countries. An action plan for expanding the Initiative, within currently participating countries as well as to other countries, is established on the basis of the second year evaluation. Aspects of the Initiative to be evaluated include: * Economic and pharmacoeconomic: The evaluation will determine potential savings achieved through avoided illness, as well as increases in survival and productivity. This economic evaluation will include a review of the overall economic picture of the country, and a qualitative assessment of the economic constraints on individuals, households, and families regarding both ability to pay for treatment and the impact on individual and family financial resources. * Clinical: The evaluation will include a review of the clinical effect of antiretroviral treatments and drugs for the prevention and treatment of opportunistic infections and STDs, with respect to survival of patients, immune status improvement, and reduction in HIV-related illnesses. * Epidemiological: A crucial public health issue is the emergence of drug resistant strains of HIV, which can proliferate when patients do not take their drugs properly. Itis critically important to evaluate patient compliance by monitoring drug supply through the local medical centre pharmacy, and by testing blood samples for viral load and the emergence of resistant viral strains. * Social and behavioural: A qualitative study will be undertaken to shape an epidemiological survey on compliance. The role of social support in treatment compliance will be also be assessed, as will the impact of treatment on prevention messages and behaviour. * Logistical: The logistical evaluation will include needs assessments, procurement procedures, distribution to the clinics, stock management at the clinics, laboratory procedure, and delivery of test results. 12

* Health system impact: The larger impact of the Initiative on the health system in each country will also be evaluated. Evaluation will provide important information on the impact in localized areas with possible projections in view of the expansion. * The subsidy mechanism: All financial transactions of the NPC will be reviewed in terms of their efficiency and ease of application. NPC accounts will be audited annually by a recognized international firm of auditors whose reports will be made available to UNAIDS, the participating companies, and the government of the participating country. In addition, a confidential report detailing the NPC's financial transactions will be produced and disclosed to the Board of Directors. Any company participating in the Initiative may have access to the relevant section of the detailed report. LESSONS LEARNED Implementation of the UNAIDS Drug Access Initiative - The Political Context Improving access to drugs requires strong political will to change current drug supply and delivery systems. An important element in the programme design has been the inclusion of mechanisms for political decision-making that involve all interested parties. This has resulted in new constellations of political stakeholders. One of the values of the initiative is that it diminishes the boundaries between public and private sectors. The Initiative has served to strengthen public/private sector linkages, not only in terms of public sector negotiations with the pharmaceutical companies, but also, for example, in developing training courses, the provision of private sector facilities for use by the Initiative, and the incorporation of drugs obtained through the private sector. Concerns: ARVs and 1OI drugs SThe more or less explicit assumption among international agencies dealing with health and drugs has been that if countries focus attention on making ARVs available to their populations, less attention and funds would be available for other drugs, such as those used to treat Ols. To date, there is no evidence that access to these drugs has actually worsened. The evaluation of the Drug Access Initiative will provide data to determine whether the Initiative has had positive or negative consequences on the provision of different types of drugs. In terms of providing wider access, there is little difference in terms of costs, infrastructure requirements, and difficulty in administration between ARVs and expensive 01 drugs. The more important distinction is between expensive 13

drugs such as ARVs and sophisticated OI drugs, and non-expensive and essential drugs. With this respect, programmes to make available basic drugs for Ols should be integrated with essential drugs programmes. Addressing Expectations SIt is clear that the announcement of the Initiative created high expectations, Swhich could not be met by the programme. Despite the clear statement that this was a pilot phase, small-scale effort, many believed the Initiative would solve the issue of access to drugs. Furthermore, while Initiative communications addressed both ARV and OI aspects of the programme, the ARV aspects received the most attention. A number of factors help to explain this tendency: * Since the reports presented in 1996 at the international AIDS conference in Vancouver, ARVs have been widely perceived as life-saving drugs. This perception has been reinforced by dramatic improvements in morbidity and mortality rates in developed countries. * As a result of these dramatic effects, access to ARVs became a very visible political issue taken up by politicians as well as by people living with HIV/AIDS. This created a bias in reporting on the ARV component. On the positive side, however, the visibility of the issue has served to highlight discrepancies in drug access between developed and developing countries more generally. * The Initiative was one of few international actions, however limited, that proposed to address this discrepancy. It therefore received disproportionate attention. The negative consequences of this, given the reality of its small scale and pilot nature, have been partly offset by the impression that at least "something can and is being done". The Advisory Board The advisory boards have played a crucial role in decision-making and in the implementation of the Initiative. In the initial model, the advisory board was designed to include political stakeholders as well as members who have technical expertise. However, in the countries in which advisory boards are operational, the board members appointed are usually top executives in their areas and are influential at the political level. A number of subcommittees have then been formed to address specific technical issues such as policy and pricing, clinical care and counselling, and evaluation. Within this set up, the board has both the expertise to make recommendations on technical issues, and the influence to have most recommendations approved and transformed into policy. 14

As might be expected, the influence and effectiveness of the advisory board has been related to the personal power and knowledge of the members and the role of the advisory board in decision making was also proportional to the number and frequency of meetings. While the start up phase (months 0-6) did require a large number of meetings, the board will only need to meet every 3 -6 months in the subsequent period. Negotiating with Pharmaceutical Companies Pharmaceutical companies are large multinational bodies with differing decision-making processes. These vary considerably and working effectively with these companies requires time and knowledge of each company's culture. One element that contributed to the success of the negotiations was the fact that the pharmaceutical companies were approached with a very concrete proposal (reduced ARV prices in return for increased volumes of sales). This is particularly important when working in the area of public-private collaboration. The principles and scopes of the collaboration should be clearly stated in the form of concrete projects if we expect the private sector to actively participate. Implementing the Initiative - Approach and Personnel A high degree of flexibility is crucial for the success of a pilot endeavour such as the Initiative. If-the Initiative's original design no longer reflects the local reality, it must be changed to accommodate the new situation. In Uganda, for instance, ARVs are now being sent to individuals from abroad. These clients are encouraged to bring their drugs to treatment centres under the Initiative for clinical monitoring and counselling. A multidisciplinary approach including clinical, pharmacological, commercial, logistical and social science perspectives is essential to designing a viable and flexible approach not only for ARVs and expensive drugs, but also for essential drugs including treatments for Ols. A diverse project team is necessary for the implementation of the Initiative or any other project on access to drugs, so that the coordinator can have up to date information on drug prices, patient compliance and perception of quality of treatment, and epidemiological trends. Procurement and Supply of Drugs and the Non-Profit Organization In the Initiative model, the NPC was designed to: * Channel the companies' subsidies and donations which contribute to price reduction. The sales prices from the NPC are therefore lower than the open market prices. 15

* Ensure continuous procurement and supply of drugs and avoid any shortage in stocks. * Assist the centres in their stock management to ensure continuous supply of drugs to patients. The following lessons can be drawn from the experience of the Initiative: * The issue of channelling subsidies is currently less relevant, as the more favourable political outlook on differential pricing has led most companies to reduce their prices directly. * When the country has medical stores that are operational in the public sector, the added value of the NPC with respect to ensuring continuous procurement and supply of drugs to the centres becomes less evident. * A key element remains the flexibility of the medical stores to purchase directly in emergency situations in which the volume of drugs required has been underestimated. The medical stores should also have the flexibility to issue tenders and have room to adjust drug volumes during the course of the year. This is essential since the needs estimates established for one year may vary, especially in situations in which drug consumption is growing. * The NPC plays a vital role in improving and maintaining adequate stock management of drugs, including placing orders, maintaining adequate financial facilities, and keeping sufficient but not excessive stocks of all Sdrugs. It is clear that stock management of ARVs is more complicated than that of average drug supplies, since clients take different combinations and may switch in the middle of treatment. Stock movements of ARV drugs are therefore interdependent, reducing the accuracy of needs estimates. Computerized Stock Management The computerized stock management system has been designed specifically for the Drug Access Initiative by UNAIDS. This unique system combines clinical and anonymous data of individual patients with data on drug stocks, turnover and accounts. The combination is extremely useful for the centres since it allows a tracking record of the patients which can operate at the pharmacy as well as at the physician's level, optimizing patient monitoring and follow-up. The stock management software has been improved following feedback from people in the field, resulting in a flexible system that can be adapted to any country context and any language. 16

The Treatment Centres The use of clear qualification criteria for the participation of treatment centres in the Initiative has created a positive climate of competitiveness, in which centres try to improve their delivery systems in order to be selected. Participation in the Initiative has resulted in the definition of clear standards and guidelines for: * the clinical monitoring of ARV treatment * psychosocial support * the regular updating of the technical capacity of medical and psychosocial support personnel involved in ARV treatment inside and outside the Initiative * the continuous availability of drugs for opportunistic infections at the centres Ability of households to pay Patients on ARVs may be able to obtain significant funding for their treatment from their extended families, including the possibility of having ARVs sent from abroad. Therefore the mechanisms of financing and the ability of households to pay should be measured on the basis of the extended family and not the household per se. NGO Involvement In Uganda, there is little NGO involvement in the counselling or follow up of patients who are monitored at the treatment centres. In Cote d'lvoire, NGOs are involved in psychosocial support at the treatment centres, but in a manner that lacks clear systems, mandates, or functions. Most psychosocial support is provided by qualified social workers who are employed to do this job. Psychosocial support could be further optimized through a formal collaboration between NGOs and people living with HIV, particularly in terms of peer support groups and follow up at home. Ideally, NGOs and organizations of PWLA should be present to support patients in all centres. This has not happened to date, primarily for the reasons listed below: * Not all NGOs have the technical capacity to assure adequate psychosocial support at the clinics. Those individuals who are qualified have been employed as social workers on an individual basis. * NGOs that are not qualified to replace social workers in psychosocial support activities could still play an important role in providing peer 17

support and in supporting patients outside the treatment centres. This could include home visits to patients with special needs or who fail to come for treatment, or home care assistance when individuals are sick. * Another barrier may be the lack of formal mechanisms for collaboration among NGOs. Without such mechanisms it is difficult for NGOs to make coordinated proposals for funding or collaboration with the public sector. Scaling Up Countries are no longer waiting for the Initiative in order to starttheir own treatment access programmes. Whatever the rational of using ARVs, it is clear that the decision to make ARVs available will not wait for the results of the Initiative. Therefore, the scaling up should concentrate on providing guidance and assistance to the countries willing to introduce or optimize ARV management. Such assistance will focus on the model of the initiative as adapted to the specific context as well as the experience from the pilot countries. Approaches to creating such adapted models for expanding access to AIDS drugs should include: * An adequate situation analysis, conducted before the model is created. Without a thorough understanding of the local situation, the sustainability and adequacy of the programme is in jeopardy. * Clear qualification criteria for the referral centres, including the ability to adequately diagnose and manage the most common opportunistic infections. * A commitment to provide sophisticated drugs for Ols and STDs in parallel to ARVs. Improving the coverage of basic 01 drugs in rural areas often poses very difficult challenges because of the malfunctioning of distribution systems and wider systemic issues such as inadequate salaries in the public sector, lack of local managerial capacity, etc. HIV- specific solutions should not be sought in this context. Instead, any action or programme to improve the availability of basic O and STD drugs should be integrated into existing essential drug programmes as part of the basic health package. 18

THE PILOT SITES Uganda With a population of 21 million, Uganda had an estimated HIV-positive population of 930,000 at the end of 1997. The Drug Access Initiative is now in its first phases of drug provision in the country: * Six mid-level centres outside Kampala have been assessed for the provision of more sophisticated treatments for opportunistic infections and AIDS-related cancers. * A full training plan has been approved by the Advisory Board, which includes continuous updates and training of health personnel as new clinics are brought into the Initiative. * A total of 183 physicians and health care workers have attended clinical training sessions on the use of ARVs, and nearly every medical officer in Uganda has undergone a comprehensive training programme on HIV/AIDS under this Initiative. * Five clinics in Kampala now prescribe ARV therapy. Advisory Board A 15-member advisory board was appointed in June 1998, and has met monthly ever since. The board reports to the Health Ministry, with a representative of the Ministry present at every meeting. Also on the board are the Minister of Finance, a UNAIDS-funded in-country manager of the Initiative, the head of the non-profit company, and a number of prominent Ugandan HIV/AIDS experts, including researchers, clinicians, a pharmacist, and NGOs representing persons living with HIV. Three sub-committees of the advisory board have been formed: drug policy and pricing, vertical transmission, and care and practice. The advisory board and the subcommittees meet regularly and follow strict procedures. Non-Profit Company A non-profit company, Medical Access Uganda Ltd, has been established, with one full-time manager, a pharmacist (who sits on the advisory board) and a part-time administrative assistant. The company receives orders and cash payments directly from the health centres, then places orders and pays the companies on a long-term credit basis. The manager of Medical Access is in direct contact with the referral centres and the prescribers and has helped them substantially in the needs estimates and stock management. This has improved the dialogue between the parties and the accuracy of the purchase orders. 19

In a significant improvement for patient care, a standard patient medical record has been established and each clinic now maintains centralized records for patients. Prior to the development of this system, patients were given a hand-written record after each physician visit and were responsible for keeping their own records and bringing them to the doctor at each visit. As a result, patient medical records were not always reliable. CSte d'Ivoire With a population approaching 13 million and, by 1998, an HIV-infected population of over 800,000, C6te d'Ivoire was, like Uganda, chosen for the pilot programme with the full commitment of its government. The Minister of Public Health later announced that the equivalent of US$ 1 million would be made available, in the form of a Solidarity Fund, to help the poorest categories of patient to meet the cost of treatment. The "Fonds de Solidarit6 Th6rapeutique International" has also provided US$1.3 million for the next two years to provide long-term antiretroviral treatment to HIV pregnant women who are symptomatic or at the stage of immune depression as well as to help people on double therapy to reach triple therapy. * More than 190 physicians, other health care workers, and social workers have been trained in three large 5-day workshops. The sessions included training on the use of ARVs, drugs for opportunistic infections and psychosocial counselling. / Approximately 650 patients are receiving drugs through the Initiative. This number is expected to increase rapidly as the rebate schemes of the National Solidarity Fund and of the International Therapeutic Solidarity Fund become operational. * Participating facilities include 8 referral centres and 4 follow-up centres in Abidjan, and 4 follow-up centres outside the city (Bouak6, Korhogo, Daloa and Bondoukou). Plans are underway to upgrade the follow-up centres to referral centres through the expansion of laboratory facilities. * Each referral centre employs at a minimum a medical officer, several nurses, a person responsible for the delivery of ARV and a social assistant. Follow-up centres are provided with drugs for opportunistic infections. Advisory Board A 26-member advisory board was appointed in June 1998 and is meeting regularly. The board reports to the Health Ministry and is chaired by the first ministry advisor. Board members include representatives of other ministries, the UNAIDS-funded manager of the initiative, the non-profit company manager, HIV/AIDS researchers, and NGOs representing persons living with HIV. The board is assisted by a technical secretariat, who prepares the technical issues prior to discussions in the board meetings. 20

Non-Profit Company As in Uganda, a non-profit company, "Medical Access Cote d'lvoire," has been established, with one full-time manager who sits on the advisory board. Viet Nam The Initiative in Viet Nam is in its first phase, with the various mechanisms for drug prescribing, dispensing, purchasing and importation being finalized. * Seven referral centres have been selected for the provision of ARV therapy to patients, including two in Hanoi, two in Ho Chi Minh City, one in Quang Ninh, one in Khanh Hoa and one in Can Tho. * In Viet Nam, hospital pharmacies can only sell drugs to inpatients, as there are currently no administrative procedures to sell drugs to outpatients. The advisory board is devising a mechanism to allow health stations to have regular access to essential drugs for HIV/AIDS and opportunistic infections (Ols). This mechanism will begin with two health stations in Ho Chi Mihn City. * Health worker training for physicians and nurses is planned to improve clinical capabilities in the treatment, follow-up, management and care of HIV infected patients. * In addition, an extensive training programme is planned for pharmacists, social workers, and peer educators. Advisory Board An Advisory Board was appointed in early 1998 and has met regularly since. Members include heads or representatives of 12 different entities in the field of HIV/AIDS in Viet Nam. Advisory board participants include the Director of the Therapy Department of the Ministry of Health and Chairperson of the Advisory Board; the ViceChairman of the National AIDS Committee and National AIDS Bureau; the Heads or representatives of the referral centres; a sociologist; a representative of the Ministry of Health, AIDS Division; four representatives of AIDS Committees in the relevant provinces (Hanoi, Ho Chi Minh city, Khanh Hoa, Can Tho); and the representative of UNAIDS in Viet Nam. Drugs are procured by a government agency in cooperation with the pharmaceutical companies and will be distributed by VIMEDIMEX, an existing state-owned import-export company, under the direction of the Ministry of Health. 21

Chile Chile differs from other Drug Access Initiative pilot countries in that it is stronger economically, and has an extensive and relatively stable healthcare infrastructure in place. An Advisory Board was appointed in July 1998 and has met regularly since. The Board has formed working groups to address drug protocols, psychosocial support, resource mobilisation and ethics in HIV/AIDS responses. Patient enrolment is underway, and drug procurement and the formal launch of the therapy programme began in early 1999. Chile currently has satisfactory drug purchasing and inventory controls, making a non-profit drug purchasing company unnecessary. The procurement of drugs in Chile will be performed through an arrangement with UNDP, which will reduce the cost of the drugs by over 25%. Negotiations continue with drug companies to seek further cost reductions. Potential for patient treatment in the pilot phases Initial Qtr 3/99 Qtr 4/99 Qtr 1/00 Qtr 2/00 Qtr 3/00 Qtr 4/00 projections Uganda __,, Centres 4 5 5 5 6 6 6 Patients 750 850 900 1000 1100 1200 3000 Vietnam Centres 0 7 7 7 7 7 7 Patients 0 50 100 200 300 400 2000 Chile Centres 26 26 26 26 26 26 Patients 625 1500 1600 1700 1750 1800 2500 Cote d'lvoire Centres 4 6 6 6 6 6 6 Patients...550 A900 1050 1200 1350 1500 3000 22

DRUG ACCESS INITIVE ACHEIVEMENTS TO DATE In addition to providing direct treatment, the Drug Access Initiative has: * Contributed to international and public acknowledgement of the problem of access to HIV drugs and treatment. Initiative activities have lead to greater recognition of the benefits of treatment for patients, economies, and societies. The Initiative has helped to generate political will and commitment at all levels. * Helped to expand international commitment beyond education, social support and palliative care. * Helped to bring together the private sector, medical and social care professions, NGOs, charities and international organizations in complementary efforts to address HIV/AIDS in the developing world. * Created commitment from leading manufacturers of HIV, OI and other essential drugs, not only in the supply of drugs but also in training and educational programmes. * Demonstrated that a model can be constructed and successfully tested to bring treatment to people with HIV in a professionally managed way; that the treatment regime can be maintained under local management, and can be progressively extended both within and beyond the scope of the pilot programme. * Demonstrated that such an Initiative can be operated under financial disciplines that enable suppliers' commercial criteria to be met on a continuing basis. NEXT STEPS Compiling Experiences UNAIDS will produce best practice guidelines for regulated access to drugs for STDs, Ols, palliative care and ARVs based on the pilot experience and evaluation of the Drug Access Initiative. This blueprint will be available during the first half of 2000 and will be published and disseminated through the Internet. UNAIDS will also publish social and economic data considered from the perspectives of the public sector, insurance companies, employers, households and extended families. The first data should be available for publication during the international conference in Durban in June 2000. 23

Integration of the Pilot Projects in National Programmes and the Expansion Phase Once the pilot phase of the initiative is completed and has provided the required information, the pilot programmes will be integrated into the national institutions and health systems of each country to ensure the sustainability of the mechanisms. UNAIDS will take the lead in facilitating the exchange of information between public sectors of the pilot countries as well as other interested countries. This facilitation may include regional meetings and workshops, and the establishment of regular electronic communication channels to exchange information between governments on: * clinical guidelines for the management of HIV * epidemiological trends * collaboration between public and private sectors * training guidelines and standards for doctors, nurses, counsellors, pharmacists and other relevant staff * a computerized UNAIDS brand clinical and drug management system that allows effective stock management in any language * updating of university and other training curricula for health staff to include ARVs and other HIV-related treatment * information on the impact of the Initiative of national drug policies and distribution systems * selection criteria for treatment centres * cost issues related to drugs, tests, diagnostic tools, etc. * establishment of monitoring and feedback systems on ARV treatment * implications of patients utilizing treatment systems in more than one country * factors affecting patients' compliance and ability to adhere to treatment 24