HIV is a slow-acting virus that typically takes years to produce illness in an infected person, in contrast to most viruses, which cause disease in a matter of days or weeks. Over the decade or so during which an HIV-positive person’s immune defences gradually become undermined, various pathogens in the environment – other viruses, bacteria, fungi and parasites – take advantage of this weakness to attack and cause illnesses of various kinds. This is why the infections and cancers seen in HIV-positive individuals are called "opportunistic".

Effective therapies exist to prevent, treat or even cure many of these opportunistic diseases, and to relieve the symptoms associated with them, which include fever, coughing, itching, difficulty in breathing or swallowing and chronic diarrhoea. Other drugs, developed much more recently, attack HIV itself – a so-called retrovirus, which explains why these new drugs are called antiretrovirals.

The needs of people with HIV or AIDS extend far beyond drugs and health care, however. Those who suspect or learn they are infected need psychological support to cope with the implications of having a life-threatening disease. The fear of being ostracized by one’s family or community must be dealt with. People who are married or in a stable relationship need support in protecting loved ones from the virus, breaking the news to their partner and dealing with the issue of extramarital sex (women may find themselves under suspicion even when they have been infected by their stable partner). At the same time, those affected by the epidemic need social support to alleviate the many consequences of an HIV diagnosis, repeated bouts of illness and ultimately death, including the impoverishment of families already near or below the poverty line (see page 27).

In high-income countries, care and support are now taken more or less for granted.

There is generally good access to antiretroviral drugs, which combat the virus directly and improve health and survival. People with HIV or AIDS and their organizations have played a role in health care, for instance by putting pressure on the pharmaceutical industry to reduce the prices of drugs. AIDS service organizations, created early in the epidemic by pioneers in the gay community, are still bringing psychological and social support to people with HIV.

Even in this favoured part of the world, however, care and support are not universally optimal. People who are prescribed antiretroviral therapy may not get enough help to devise practical ways of adhering to their often-complicated drug regimens.

Access to health care and especially to antiretroviral drugs can be problematic for illegal migrants, uninsured individuals in countries without national health insurance, and residents served by less-favoured health facilities in countries where expensive drugs are "rationed". Some people have poor contact with the health system, or may not be trusted to take their drugs regularly. In a study of drug users in one city in the USA, half the people who met the criteria for treatment under national guidelines were receiving no antiretroviral therapy at all, and just 14% were on the more expensive three-drug combinations. A study of injecting drug users in Canada showed that 60% were not receiving any antiretrovirals nearly a year after becoming medically eligible for this therapy; women were more than twice as likely as men to be untreated. In some countries, there is also less social support available for injecting drug users.

The developing countries faced a radically different situation. By the time the enormous new challenge of AIDS appeared, the health services with their dwindling resources were already hard-pressed to cope with a host of older diseases. Using the 1991 guidance published by the World Health Organization (WHO), many countries did draw up clinical management guidelines for handling AIDS in children and adults by the mid-1990s. In practice, however, little action followed – apart from the strengthening of tuberculosis programmes in places where an explosion of TB cases followed in the wake of the expanding epidemic of HIV. Carriers of the tubercle bacillus who become infected with HIV face a 30–50-fold increase in their risk of developing active tuberculosis.

In part, the health sector’s failure to deliver care for people with HIV was linked to the widespread perception of AIDS as a hopeless, untreatable disease, even though drugs did exist to combat opportunistic diseases and distressing symptoms. Until the development of highly active antiretroviral therapy around 1995, it seemed that one could do very little about HIV infection. Investing in care was rarely given high priority. The need to invest in HIV prevention and other essential services often took precedence over the provision of care services in many developing countries.

As the suffering caused by the epidemic grew, community-based and nongovernmental organizations, including organizations of people living with HIV or AIDS, stepped into the vacuum. Using a creative mixture of social, psychological and health care approaches, these groups did whatever they could to meet the wide-ranging needs of the millions of people developing HIV-related illness and dying of AIDS. At the same time, they kept up pressure on the health system for more effective support and therapy. These demands were fuelled by the realization in the mid-1990s that antiretrovirals were dramatically changing the prognosis of HIV infection for those fortunate enough to have access to these treatments.

As a result, health care for people with HIV has belatedly made its way onto the agenda of developing countries. In Uganda, for example, the new medium-term plan on HIV/AIDS for the first time includes a comprehensive section on care and support.

In parallel, for the reasons discussed below, donor agencies are increasingly looking on HIV/AIDS care as a good investment.

Activist pressure is not the only force driving the increased governmental investment in care and support. There is also growing recognition that care and support for people living with HIV or AIDS help protect the wider community.

As discussed earlier (see page 78), individuals who know they are infected and receive care can break through the denial about HIV by talking with their friends and neighbours and reducing the discomfort associated with the subject. Care providers who look after HIV-positive people demonstrate to others in the community that there is no reason to fear becoming infected through everyday contact, and thus help dispel misguided beliefs about HIV transmission. Providing diagnosis and treatment for tuberculosis and sexually transmitted infections – diseases that are common among people with HIV – also helps decrease their spread among HIV-negative people.

Thus, care has important spin-offs for prevention, in much the same way that prevention measures such as voluntary HIV counselling and testing can result in improved access to care. Recognizing these interlocking benefits, development assistance agencies and other financers of AIDS programmes are increasingly seeing care and support for HIV-infected people as a powerful tool for expanding the response to the epidemic.

In retrospect, our thinking about how to tackle the epidemic was revolutionized by the community-based groups, nongovernmental organizations and associations of people living with HIV that took up part or all of the challenge of care and support, and often the challenge of prevention too. Gradually, it was understood not merely that these groups had become key partners in the fight against the epidemic, but that their involvement would continue to be essential and needed to be strengthened. This is the principle known as the greater involvement of people living with HIV/AIDS (GIPA).

If anything, the involvement of HIV-positive people has become even more visible and credible since 1995. This is when the community stepped up pressure to increase access to highly active antiretroviral therapy – in memory of those who had not survived long enough to benefit from it and out of solidarity with the millions who still could not afford it.

Already in 1994, the GIPA principle was formally enshrined in the Declaration signed by 42 nations at the Paris AIDS Summit. The signatory nations resolved to "support a greater involvement of people living with HIV/AIDS through an initiative to strengthen the capacity and coordination of networks of people living with HIV/AIDS and community-based organizations".

This resolution was prompted by recognition that these groups had played a leadership role in increasing society’s acceptance of those living with HIV, in reducing their peers’ infection rates, in mitigating the personal and social impact of the disease, and in fighting for their right to health care.

Because community organizations play such an important role in care and support for people living with HIV, they and their clients have a stake in how health sector resources are allocated and distributed. Since 1997 UNAIDS has advocated that communities, alongside other stakeholders, should be involved in developing standards for HIV-related care and support. The goal of this working partnership between health planners and the local community (defined as a group of people sharing the same geographic, cultural and economic environment) is to reach a consensus on meeting the needs and expectations of people with HIV that is perceived as equitable and responsive to other equally important needs.

The process of discussing expectations and arriving at a consensus involves informing the participants about what support and resources the health system can potentially provide, sounding out the preferences of the community and identifying its potential for contributing to care.

Attempts to formulate community standards for care and support have been completed with some success in Burkina Faso, the Central African Republic, Malawi and in Phayao Province in northern Thailand. The process is not always easy; the inadequacy of knowledge about health care can be a limiting factor, for example.

However, the approach has enormous potential. Formulating community standards makes it possible to identify the resources for care already available in the community and to determine how they could be used to better effect through support from the formal health system. It also breaks the silence surrounding HIV and discourages discrimination by sending the message that people with AIDS have a claim on solidarity and support.

Despite decades of effort by communities and governments to improve access to health care, and despite the help of WHO and other institutions, the health sector deficiencies in the developing world appear to be growing instead of shrinking.

Even before the epidemic, the health care system did not get a fair share of the national budget. Typically, health centres and hospitals were short-staffed, facilities for diagnosis were inadequate and drug supplies erratic, and training for health care providers was uneven and often poor. These deficiencies have worsened with the arrival of the HIV epidemic, which has increased the demands for health care and simultaneously reduced the health system’s capacity to respond (see page 31). In the poorer developing countries, local health centres and small hospitals lack adequate facilities to diagnose the opportunistic diseases of people with HIV. They repeatedly run out of supplies of essential drugs, including the ones needed to alleviate distressing symptoms and to manage opportunistic infections. For example, oral thrush – a fungal disease which causes pain on swallowing – could be treated relatively easily, but millions of patients continue to suffer for lack of a simple anti-fungal drug. Tuberculosis, which can be cured, often goes untreated for the same reason. In Zambia, for example, where the tuberculosis case-load increased sixfold between 1992 and 1998, proper treatment became increasingly problematic because health facilities kept running out of TB drugs.

Even big teaching hospitals affiliated with urban medical schools – supposedly the best-supplied part of the health system – have serious problems, to judge from a UNAIDS survey of 22 university teaching hospitals in 19 African and 3 Asian cities completed in 1997. The hospitals surveyed had suitable diagnostic facilities and the right drugs to treat three conditions – pneumonia, pulmonary tuberculosis and oral thrush. These are the only HIV-related conditions that are easy to diagnose and inexpensive to treat. For any other HIV-related illness, diagnostic capacity (X-ray and laboratory facilities) and drug supplies were so inadequate that a patient would have less than a 50% chance of being correctly diagnosed and treated. This was true, for instance, of Kaposi sarcoma (a frequent HIV-related cancer), serious fungal infections such as cryptococcal meningitis, and viral infections affecting the brain. Relief for difficulty in breathing was unavailable in half the hospitals. Strong painkillers were available in only two-fifths, despite the fact that most people with advanced HIV infection require pain control at some point.

The high costs of antiretroviral drugs, and the sophisticated medical facilities required to track patients’ progress and monitor side-effects, have been major stumbling blocks to access for the vast majority of people with HIV in the developing world.

Enormous variations in access to antiretrovirals exist in middle-income countries. In most of Asia, people with HIV have limited access. In Thailand, for instance, the Government subsidizes the cost of antiretroviral drugs for patients enrolled in clinical trials in a few centres of excellence, but this currently ensures access for only around 2000 of the approximately 70 000 new AIDS cases occurring annually.

A few projects in sub-Saharan Africa aim to promote the rational use of treatment for people with HIV, including antiretrovirals (see Box 19, page 103). Even within the projects it has repeatedly been problematic for patients with opportunistic infections to have access to the essential drugs they need. Outside these projects, antiretrovirals can only be purchased from a poorly regulated private sector where concerns about inefficiency and the potential for counterfeit loom large.

There are some Latin American and Caribbean countries where even treatment for opportunistic infections is problematic. However, other countries in the region have responded to demands from groups of patients, doctors and human rights organizations and now lead the developing world in providing access to antiretrovirals. Argentina, Brazil, Colombia, Costa Rica and Uruguay provide a legal right to some form of antiretroviral therapy, though the application of the law is somewhat patchy. Coverage of eligible patients has been reported to be 100% in Brazil, 70% in Argentina, 65% in Chile and Uruguay, 40% in Panama and 20% in Ecuador. Some countries operate with a lottery system or limit antiretroviral drug access to those with social security or private health insurance. Experience in Brazil shows that the costs of such therapy, although high, are offset to some extent by savings on treatment for opportunistic infections and on hospital stays (see Box 18, page 101).

Nevertheless, some concern has been voiced over the risk that HIV prevention activities may suffer if too much effort and money is devoted to providing treatment.

Building on a long tradition of joint collaboration in the region, and the desire for more self-reliance and less dependency on donors, the Directors of national AIDS programmes from 12 countries agreed in 1996 to set up a new process for "horizontal" interregional technical cooperation. As part of the reciprocal process of exchanging experience, information and technology on equal terms, for example, the Horizontal Technical Collaboration Group (HTCG) has encouraged intercountry visits so that members can see first-hand how to improve drug management and distribution in rural areas. Through a multicountry survey conducted by the Group on the prices being paid for HIV-related drugs and commodities, countries became aware of major price differences and were in a better position to negotiate price reductions with pharmaceutical companies. Argentina, for instance, was able to reduce the cost of measuring viral load from US$ 250 to US$ 70. The HTCG also provided the initial impetus for establishing a revolving fund for HIV-related drugs under the auspices of the Pan American Health Organization, WHO’s Regional Office for the Americas. The fund is now in its initial trial phase.

As of May 1999, 21 countries belonged to the HTCG* and efforts are now under way to incorporate national AIDS programme Directors from Central America and from the English-, Dutch- and French-speaking countries in the Caribbean.

In the early 1990s, WHO’s Global Programme on AIDS advocated that care and support for people living with HIV or AIDS should be comprehensive – embracing the psychological/spiritual, social and medical dimensions – and integrated, with the various providers offering a "continuum of care" centred on the clients’ needs.

This vision remains relevant today. As discussed earlier (see page 85), people with HIV infection need a range of measures to support them (and their families) in coping with their situation and to enable them to live healthy, productive lives for as long as possible. Counsellors, religious communities and family members should provide vital care and support at home and in the community. For diagnosis and therapy, patients and their carers must in turn be able to rely on the support of health services, such as home and community care programmes, private practitioners, local health centres, and clinics and hospitals.

Since this vision was formulated, UNAIDS has identified new opportunities for prioritizing action and accelerating progress. UNAIDS proposes to target action along five strategic axes. Two are dealt with elsewhere in this report, while the others are discussed in separate sections below:

• creating political will and mobilizing resources (see pages 107-115)

• increasing access to voluntary HIV counselling and testing: over and above the benefits for prevention, discussed earlier (see page 78), individuals who learn they have HIV can gain access to support at an earlier stage and, with new preventive regimens, may live longer and healthier lives (see pages 105–106)

• increasing access to psychosocial support and impact alleviation

• improving health service delivery

• increasing access to drugs of special interest to people living with HIV infection.

When possible, it is best for countries to develop plans for care and support as part of their strategic planning on HIV/AIDS, whether at national or district level. Health system reform can offer an opportunity to look at the range of care and support needs in a comprehensive manner (see Box 17).

The Phayao Health Office undertook a review of its efforts to reform the health sector in the light of the lessons learnt from reducing the spread of HIV and caring for people with AIDS in this badly affected province of the country. The Office posed a number of questions to see whether the reform was really improving the health sector’s capacity to tackle the epidemic effectively.

• Does the health reform aim only to reduce rates of sickness and death?

• Or is the reform also geared to better quality of life, less dependence and greater autonomy?

• Does the health reform aim mainly at better provision of health care?

• Or does it also enable the health sector to catalyse community action and put health issues on the agenda of society and its decision-makers?

• Does the reform respect the three principles of health-care organization:

– integrated care achieved through teamwork by care providers of different disciplines?

– continuity of care throughout the levels of the health system?

– a focus by the care provider on the client’s priorities?

People living with or affected by HIV need support in confronting the multiple challenges of a chronic, incurable and generally fatal condition that can result in social ostracism (see page 38) and economic disaster (see page 27).

Psychosocial support – an essential element of the care and support package (see Table 1, page 98) – ranges from purely psychological support to the social measures needed to create an environment in which those affected can cope and thrive. Some types of support straddle the line.

Family members, representatives of religious communities, health-care providers and counsellors are important sources of psychological and spiritual support for coping with HIV infection in oneself or the family. However, they are often in need of support themselves. There is growing evidence of the great stress associated with care-giving, particularly in relatives who form the majority of front-line carers in developing countries. While ways of managing this stress are becoming better understood, it is unclear how these coping mechanisms can be financed.

An important goal of social support is inclusion – enabling affected people to live without fear and to continue functioning as normal members of society. Among the wide-ranging measures needed to bring this about are public statements by community and religious leaders urging solidarity with those affected, and legal and other mechanisms for protecting HIV-affected individuals and survivors from discrimination, loss of inheritance and property-grabbing.

Psychological and social support can help reduce stigma and other negative consequences of being HIV-positive and in this way make people less reluctant to seek HIV counselling and testing. In turn, the staff of counselling and testing facilities can contribute to psychological support, for example, by assisting individuals to share the news of their test result with their spouse or a trusted relative. Their contribution could be even greater if voluntary counselling and testing services were more widely accessible and more welcoming to certain categories of clients. In particular, these services need to be better geared to attracting young people, couples and men.

Another challenge is time. In busy community health settings, where staff have too much to do, it is important to find ethically acceptable ways of reducing the time required for counselling.

Associations of people living with HIV are a good example of community mechanisms that provide both psychological and social support. Formed to counter the social isolation often experienced by HIV-positive people and to allow them to share and discuss their experiences and problems openly and safely, these mutual support mechanisms provide peer support and help members cope with discrimination and stigma. One such group, at an antenatal clinic in South Africa, was described by the women members as the only place where they could relax and be themselves.

However, support groups are generally unable to meet one of the most important challenges facing people in developing countries: lack of income. Most people with HIV or AIDS are or become unemployed, and the stark reality is that unless they can rely on broader support from government and society there is little a community group can do to alleviate this impact.

Many support organizations have discovered the pitfalls of trying to alleviate the economic hardship of their members. The AIDS Support Organization (TASO) of Uganda, which runs support groups for people living with HIV, asked members of= one group how their home support could be improved. Three-fifths said they needed capital to start an income-generating activity and close to half asked for increased assistance of the kind already being provided, such as staple foodstuffs and cash for school fees, uniforms and books to enable their children to go to school.

In one scheme, selected TASO centres received funds to be given as revolving loans for income-generating projects. While 75% of the projects were later assessed as having been successful enough for the clients to repay their loans, only 12% did so. It emerged that while some people understood the concept of a revolving loan, others perceived it as a grant that did not have to be repaid.

The scheme soon collapsed. Avenues for tackling the economic impact of the epidemic range from loans or grants to individuals with HIV, at one end, to complex societal measures for averting and alleviating the epidemic’s impact on agriculture, the educational system and the private sector, for example (see pages 26–36). Alleviation measures may be directed at a well-defined problem, such as the increase in orphans, or may be more general in nature. In some cases the project’s beneficiaries may be restricted to people living with HIV or AIDS.

There is no perfect or universally applicable solution. For example, restricting grants to people affected by AIDS may help channel severely limited resources to where they are badly needed, but it can also have negative consequences. Organizations bringing support to AIDS orphans learned early on that it was better to target all orphans as a group so that the project would not create resentment among those excluded or attach an AIDS stigma to specific children.

Micro-credit, also known as micro-finance, is an effective poverty-alleviation instrument promoted by the United Nations Development Programme (UNDP). These group lending schemes grant small loans to individuals who want to start up a small business and who seem likely to be able to repay. Communities with HIV-positive people generally meet the criteria for these schemes, including the presence of many poor people, the existence of market opportunities and infrastructure facilities, high population density, approval of local authorities, and the ability to build trust in the community. Experience has already shown that the schemes can work very successfully in high HIV-prevalence areas of Africa. In Malawi and Uganda, for example, the Foundation for International Community Assistance (FINCA) has achieved 100% recovery of its loans.

While some micro-finance organizations are closing their eyes to the AIDS epidemic or even excluding sick members, some are helping their clients to accumulate savings by serving as a bank or banking intermediary, assisting them to carry on their business when they fall ill, and providing survivors with advice on inheritance and legal protection. Some have even joined the front-line fight against the epidemic. For instance, FINCA in Uganda is working with organizations such as TASO to promote condoms and educate its clients about safer sex, while the Zimbabwe Opportunities

Industrialization Centre (ZOIC), operating in small towns and rural communities affected by the epidemic, is organizing community-based orphan care programmes.

These practical examples of an integrated response to AIDS illustrate why it can be artificial to make a distinction between prevention, care, support and impact alleviation.

UNDP estimates that micro-finance at present covers only 1% of the potential market, affording great potential for expansion. It has been suggested that proxy indicators of possible HIV spread – such as military conflict and population migration – could be used to identify priority areas for expanding the coverage of micro-finance institutions.

In parallel, since the micro-credit approach will not be feasible everywhere, governments and other institutions should step up direct humanitarian aid to families in need through outright grants of food or cash. The two approaches must remain separate, however, if micro-credit schemes are to maintain their credibility.

Finally, in high-prevalence countries where the epidemic risks destroying the very fabric of society, the impact of AIDS has to be mitigated through intensified development strategies. Teachers, extension workers and other human resources who are crucial to development are falling ill and dying, sometimes at even higher rates than the general population. To minimize this impact, countries need urgently to establish human resource policies on absenteeism and recruitment while stepping up AIDS prevention and care programmes at the workplace. The coverage of social assistance programmes must be expanded to a wider group of households, defined by both poverty and AIDS indicators. And existing mechanisms for improving access to land, capital, education and other limited resources must be intensified and applied more widely. AIDS is a development problem.

The inadequacy of health service delivery to people living with HIV can be redressed by rationally selecting the services to be offered, upgrading the human resources of the health system, improving its infrastructure (e.g. buildings and laboratory equipment), and ensuring the availability of HIV test kits, drugs and other essential commodities.

These things have a cost, and therefore a prime consideration is to secure financing for the health system.

An in-depth study of total spending on AIDS – both public and private – in four countries and São Paulo State, Brazil, found that expenditure ranged from 60% of per capita gross domestic product in Tanzania to 300% in São Paulo, with average expenditure being about 150% of per capita GDP.

In Thailand, a policy of making zidovudine and didanosine (an antiretroviral regimen now recognized as suboptimal) available to patients free of charge would require a public subsidy amounting to six times that country’s entire AIDS budget, and would therefore be unaffordable for the Government. Even with this subsidy patients would have to pay just under US$ 500 a year for the related health care required – a sum that only around half of them could afford.

An analysis presented at a WHO/UNAIDS workshop concluded that, in most developing countries, antiretroviral treatment programmes aiming at universal coverage would not be affordable. For example, based on 1997 prices, the provision of triple combination therapy to all people with HIV in sub-Saharan Africa could consume between 9% and 67% of total GDP.

As these examples make clear, the ability to secure financing for health care, particularly for advanced care options such as antiretroviral therapy, is very limited in developing countries. Determining the best buy within the prevailing resource constraints

– a recurring challenge for health system decision-makers – must go hand in hand with efforts to make health service delivery more efficient and to mobilize additional resources for the sector.

One of the critical factors for service delivery is the availability of people to deliver services. As mentioned earlier, AIDS increases the demand on the health sector (see page 31), and at the same time reduces the human resources available to it by causing illness and death in the sector’s workforce. With fewer health care providers available to carry an ever-increasing workload, it is easy to understand why the remaining staff may experience burn-out, which results in a lower quality of service and further attrition in the workforce. It is urgent for governments to establish human resource policies aimed at mitigating these impacts on the health sector (see pages 94-96). The desirable response would be to increase the number of health care workers so as to maintain the sector’s ability to deliver services. This requires decisions about the kinds and numbers of health care workers that will be needed, and a clear idea of how the cost of the mitigation efforts will be shouldered.

The kind of care and support "package" made available to people living with HIV or AIDS will thus depend on the ability to mobilize human, infrastructure and financial resources. Where the ability to mobilize resources is extremely limited (such as in most of rural sub-Saharan Africa) or somewhat limited (as in northern Thailand), the package will necessarily be more limited than where resource availability is relatively unrestricted.

Examples of what the essential, intermediate and advanced packages could comprise are given in the Table 1, page 98.

It is important to emphasize that progress in improving health service delivery need not be strictly linear. For example, planners may discover an opportunity for expanding access to treatment for multiresistant tuberculosis (an option in the advanced package) in a region where people with HIV are receiving mainly the intermediate package. If so, they should not hesitate to push ahead with this option, in particular when the prospect for improving delivery of some of the less advanced options is poor.

In these examples of care and support packages, no consideration is given to improving health service delivery through greater efficiency and coverage. For instance, possible expansion of community-based care and home care is not taken into account, nor are considerations of more efficient referral patterns. A further limitation is that they omit health sector activities that are not specific to "care and support".

In addition, even when resource constraints are very serious, health services everywhere should provide care for sexually transmitted infections, family planning services, HIV testing of blood for transfusion, and the promotion of universal precautions to be taken by health workers in the handling of body fluids. Other imperatives come under the general heading of health policy, such as the licensing of nurses or other practitioners to prescribe morphine, and the regulation of the supply of drugs (including antiretrovirals) in order to minimize the risk of drug resistance and counterfeiting.

Where an intermediate care and support package is feasible, one would expect that prevention activities requiring intermediate levels of technical and human resources would also be available. These include measures aimed at reducing mother-to-childtransmission of HIV, and antiretroviral treatment to prevent HIV infection in health care workers who have been exposed occupationally to the virus (post-exposure prophylaxis).

Improving access to drugs of special interest to people living with HIV infection is a priority strategy for UNAIDS, and is currently mobilizing much interest worldwide.

Making drugs more accessible requires a broad look at the underlying reasons for poor access. One factor is the cost of drugs. Another is inadequate information about the drugs needed to manage HIV-related illnesses. Finally, drug access is hampered by the poor capacity of health systems in developing countries to select and use drugs in a rational manner, to monitor patients’ progress and side-effects, and to manage their drug supply. This is linked in turn to inadequate financing of the health system in general and of the drug supply in particular.

In the current context, attention has mainly focused on drug prices, and in particular= the price of antiretroviral drugs still under patent in high-income countries, which makes them financially inaccessible to most people with HIV. However, for the reasons mentioned above, people with HIV also have inadequate access to the "essential drugs" for treating HIV-related illness, including drugs that are no longer under patent. The poor availability of drugs for pain relief or respiratory distress and for the treatment of many HIV-related diseases found in a survey of university teaching hospitals shows how inadequate this access is, even at the highest echelon of the health system (see page 89). Another indicator of inadequate drug access is the limited coverage of tuberculosis programmes, which, according to WHO, manage to diagnose and treat only around 40% of TB cases. Overall, WHO estimates that access to essential drugs for health conditions of all kinds is guaranteed for only 50% of the population in developing countries.

Through collaboration between the UNAIDS Secretariat, WHO and UNICEF, some of the obstacles to essential drug access are being tackled. First, beginning in 1997, 15 new drugs of interest to people with HIV were included in the WHO Model List of Essential Drugs. The next step was to pinpoint the reason why most wholesalers of generic drugs were not distributing the newly included drugs, and why even several important older drugs were rarely on offer. Working with WHO and UNICEF, the Secretariat identified manufacturers and prices for 44 essential drugs whose procurement was being hampered by insufficient information on cost and availability.

This information has been posted on the UNAIDS, UNICEF and WHO websites along with an offer to assist countries in locating generic drug suppliers and organizing drug procurement. Information of this kind is also used to help convince planners that it is feasible to include HIV care and support in national strategic plans on HIV/AIDS.

One of the lessons learnt from the UNAIDS Drug Access Initiative in Côte d’Ivoire and Uganda (see Box 19, page 103) is that, with determination and good will, it is possible to negotiate a significant reduction in drug prices and improve the delivery of health care. End-user prices of antiretroviral drugs in both Côte d’Ivoire and Uganda decreased after negotiation with the pharmaceutical companies holding the patents on those drugs. The companies that participated in the initiative either donated a percentage of the drugs or agreed to sell them at a reduced price. Similar decreases in drug prices were achieved through a national drug access initiative conducted in Senegal.

Price reductions can be achieved through avenues other than negotiation with patent holders. One strategy is to produce or import generic alternatives to proprietary drugs. UNAIDS’ analysis of the patent situation of HIV-related drugs with WHO and UNICEF has shown that most proprietary drugs used in the treatment of people with HIV are not patent-protected in the majority of developing countries.

Table 2 shows the prices of proprietary antiretrovirals in the USA, Côte d’Ivoire and Uganda, and some generic equivalents in Brazil and Thailand. The lower price of generic products is partly explained by the lack, or low level, of investment in research and development by the manufacturers.

The Government of Brazil has a policy of universal access to antiretroviral drugs that currently benefits nearly all AIDS patients in the country (about 85 000). The introduction of combination antiretroviral therapy nearly halved the annual number of AIDS deaths between 1996 and 1999 and reduced the incidence of opportunistic infections by 60-80% over the same period.

The universal access programme would not have been possible without significant decreases in the cost of antiretroviral drugs. The Government decided to start local manufacture of drugs that were not patent-protected, and for which it had the know-how and infrastructure. Local production, combined with bulk purchases of imported antiretrovirals, led to significant decreases in the programme’s drug costs. The annual cost of double therapy with nucleoside analogues decreased on average by 80% between 1996 and 2000, from US$ 3812 to US$ 763. For triple therapy with two nucleosides and one protease inhibitor, the cost reduction was 36% over the same period (from US$ 7342 to US$ 4717) and for triple therapy with two nucleosides and one non-nucleoside it was 34% (from US$ 4584 to US$ 3009).

The programme’s annual drug costs were approximately R$ 611 million (US$ 339 million) in 1999, and are expected to rise to R$ 831 million (US$ 462 million) for the year 2000, taking into account both a higher proportion of patients on triple therapy and a larger overall number of patients. Between 1997 and 1999, approximately 146 000 AIDS-related hospitalizations were averted, resulting in savings of approximately R$ 521 million (US$ 289 million); this has partly offset the high cost of antiretroviral therapy. At the same time, condom sales increased by nearly half (from 216 million to 320 million pieces) between 1996 and 1999, and demand for voluntary HIV counselling and testing rose 35% between 1996 and 1998.

Yet another approach is to utilize a safeguard incorporated into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an international treaty that protects patent rights, including those for drugs. Patent protection provides an important incentive for innovative research and development of new HIV/AIDS drugs and, hopefully, the discovery of HIV vaccines, in particular, vaccines suitable for use in developing countries (see Box 14, page 68).

The TRIPS agreement sets out minimum standards in relation to intellectual property for Member States of the World Trade Organization (WTO). Countries that wish to be members of WTO must comply with the TRIPS standards, where necessary by changing their national laws and regulations. In practice, for many developing countries, this will mean giving patent protection for the first time to pharmaceutical inventions (both products and processes). Under TRIPS, patent protection must be available for a minimum period of 20 years. However, the TRIPS agreement also foresees that in certain circumstances, such as national emergencies, governments may grant third parties the right to produce and sell a patented product even without the consent of the patent holder, according to carefully prescribed conditions.

This safeguard, known as "compulsory licensing", was incorporated into the TRIPS agreement through negotiations by developing countries. Its maintenance as part of TRIPS has been vigorously defended by nongovernmental organizations and activist groups, such as Act Up, the Consumer Project on Technology and Médecins Sans Frontières, who have conducted international campaigns for improved drug access.

These organizations have also sought to obtain compulsory licences on drugs of interest to people with HIV/AIDS in South Africa and Thailand. The campaigns did not result in the issuing of compulsory licences. However, access to the target drugs improved when the pharmaceutical companies involved donated the drug free of charge to some patients (as was the case for fluconazole in South Africa), or agreed to a significant price reduction around the same time that non-patented alternative formulations were put on the market (as was the case for didanosine in Thailand). The fact that pharmaceutical companies have not yet decreased their prices enough to make their products affordable to the majority of people in developing countries does not preclude future progress. To achieve prices even lower than those available from small suppliers of generic drugs, it will be necessary to pursue discussion and collaboration with the pharmaceutical companies that developed the products.

"Differential pricing" of HIV/AIDS drugs and other pharmaceutical products is gaining increasing acceptance in industry and should help in making these products affordable in countries with limited local purchasing power.

At the same time, governments should increase access to drugs by reducing import duties, customs and taxes on HIV-related goods and lowering their cost, and by removing unduly restrictive regulations that impede drug availability. More broadly, at a time when the epidemic is increasing the demand for health services, governments and donor agencies should improve the affordability of drugs by giving higher priority and greater financial support to the health sector.

The Drug Access Initiative enrolled its first patients in Uganda and Côte d’Ivoire in

1998. In Chile and Viet Nam, the initiative became operational in early 2000. The initiative aims to evaluate ways of overcoming obstacles to the provision of drugs, using access to antiretrovirals as an entry point for wider access to a comprehensive package of HIV care in developing countries.

Some important lessons have already been learnt about the operational aspects of the initiative from the experience of Côte d’Ivoire and Uganda, where currently about 600 and 900 patients respectively are receiving antiretroviral therapy.

Advisory boards in both countries defined treatment policy, and training efforts were successful in ensuring physician compliance with the proposed treatment guidelines in the referral centres participating in the initiative. The guidelines and training took a comprehensive approach to the management of patients with HIV, including their opportunistic infections and diseases. However, the procurement guidelines focused almost exclusively on antiretroviral therapy until 1999. Since then, at the insistence of UNAIDS, both countries have shown a greater interest in the management of opportunistic diseases. Anticipating the March 2000 consultation on cotrimoxazole prophylaxis (see Box 20, page 106), Côte d’Ivoire and Uganda adopted guidelines on using this drug combination for the prevention of opportunistic infections in people with HIV. The increased emphasis on drugs for opportunistic infections will make the

Drug Access Initiative more relevant to clients who cannot afford antiretroviral drugs, and to follow-up centres where antiretrovirals are not prescribed.

Drug price negotiations led to a significant decrease in the price of antiretroviral drugs in the region, both within the Drug Access Initiative and beyond. However, a comparison of these prices with those obtained by Brazil or Thailand (see Table 2) makes it clear that further price reductions should be possible to achieve, if need be through the introduction of generic competition. Uganda, a relatively poor country, opted not to use any public funds to subsidize antiretrovirals supplied through the initiative (the cost being borne by the patients). In Côte d’Ivoire, a richer country, the Government committed itself to shoulder part of the cost for selected patients; however, the allocation of treatment subsidies was very slow. While an in-depth analysis of the use of antiretrovirals outside the initiative was not conducted, the fact remains that the programme in Côte d’Ivoire attracted fewer clients than that in Uganda.

The educational efforts of the initiative were assessed as positive in both countries. In Uganda, laboratory follow-up was strengthened by the donation of CD4 counting equipment. The growing interest of the countries’ advisory boards in opportunistic disease management has resulted in more operational follow-up centres.

Three challenges to be met in the months ahead are: integrating the advisory boards’ guidance on HIV management into national treatment guidelines; regulating antiretrovirals and advanced drugs for the treatment of opportunistic infections as part of the countries’ national drug management policy; and preparing to make the initiative sustainable after UNAIDS reduces its subsidy.

In both countries, the presence of the initiative galvanized people with HIV and AIDS by holding out some hope for them, and led to a wide mobilization of health sector staff around HIV and AIDS. It also resulted in a great deal of discussion of AIDS in the media – not only about the cost of HIV treatment but also HIV prevention. By raising the visibility of the epidemic, this level of discussion may enhance prevention efforts and yield significant benefits that extend beyond the clients and health care providers of the initiative.

Given the limited diagnostic facilities available in developing countries and the high costs of many drugs for treating opportunistic infections, let alone antiretrovirals, the option of prevention is receiving renewed attention. The bulk of evidence now suggests that a few relatively inexpensive drugs could help ward off severe illness and add months, if not years, to the lives of HIV-positive people in even the poorest developing countries. Indeed, preventive drugs had begun to prolong survival in the high-income countries even before antiretroviral therapy was available.

One drug is isoniazid, which has been shown to be effective in warding off 60% of active tuberculosis episodes in people with HIV. In at least one study, isoniazid prevention prolonged life significantly for those who were infected with both HIV and the bacillus that causes tuberculosis. A simple regimen costs on average just a few cents a day for both the medicine and the health services involved.

Tuberculosis prophylaxis is especially important because in half the cases HIV-infected individuals develop a form of TB which cannot be easily diagnosed and which thus goes untreated. Diagnosing disseminated tuberculosis requires sophisticated laboratory equipment that is largely unavailable in many of the poorer developing countries. This is why UNAIDS and WHO have recommended since 1998 that a simple and inexpensive regimen for preventing tuberculosis should be part of the essential care package for people with HIV (see Table 1, page 98).

New developments point the way to preventing other severe infections. Cotrimoxazole – a pill combining an antibiotic and a sulfa drug which has helped prevent Pneumocystis carinii pneumonia, the biggest AIDS-related killer in high-income countries – was tested for its preventive impact in Côte d’Ivoire. In one study in Abidjan, where the drug costs of a 12-month regimen were just US$ 17.50, cotrimoxazole prophylaxis resulted in significantly fewer severe infections (as measured by hospital admissions). In another study, cotrimoxazole warded off infections so successfully that it extended life by half a year. The drug combination appeared to be effective in preventing some bacterial pneumonias, diarrhoeal diseases and infections of the blood, and possibly toxoplasmosis (a parasitic brain disease) and isosporiasis (a parasitic infection of the intestines).

In the light of these hopeful findings it is urgent to implement cotrimoxazole regimens in sub-Saharan Africa as part of the essential care package for adults and children living with HIV (see Box 20). At the same time, scientists will need to keep careful watch so that the value of this drug combination is not undermined by the development of resistance to it.

In March 2000, UNAIDS and WHO brought together clinicians, public health specialists, national AIDS programme managers, people living with HIV/AIDS, donors and AIDS activists to discuss the use of cotrimoxazole as preventive therapy for HIV-positive individuals in Africa. The outcome of this consultative workshop in Harare, Zimbabwe, was that cotrimoxazole prophylaxis for people who have already developed symptoms of HIV infection should be part of the essential care and support package. The participants recommended dosages, defined criteria for patient eligibility, and issued recommendations for training, education and capacity development in countries.

The UNAIDS Secretariat is working with WHO to ensure rapid implementation of these recommendations through resource mobilization efforts. By July 2000, through consultative meetings with national governments, 14 African countries participating in the US Government’s LIFE Initiative will have considered making cotrimoxazole prophylaxis part of their care package.

Experience from around the world shows that seeking counselling and HIV testing is not an easy step to take. In the high-income countries, the hope of benefiting from early treatment created a major incentive for people to find out whether they were infected. As therapies improved – even before the advent of antiretrovirals – people who suspected they might have HIV saw that they stood to gain months or years of life by getting tested. Isoniazid and cotrimoxazole prophylaxis – which can only be offered to people with proven HIV infection, in contrast to some other forms of health care described in this chapter – may similarly increase people’s interest and willingness to be tested for HIV. If these preventive regimens are made more widely available along with HIV counselling and testing services, the survival benefits for individuals and their families are likely to be compounded by the benefits of large-scale testing, including reduced HIV transmission to partners and to infants, and greater visibility of the insidious HIV epidemic.