The goal of treating 3 million patients with HIV in the developing world by the end of this year is an ambitious one, but even should that target be met, millions more in the developing world will still be waiting for antiretroviral therapy (ART). In some resource-limited settings, it will take years to develop the infrastructure, and marshal the human and financial resources to meet the demand for first-line treatment. Access to expensive second line treatments will be even more limited.

In the meantime, rationing of access to treatment will be inevitable and is already occurring implicitly in most settings - even where treatment is being doled out on a first come first serve basis, or to those able to commute to the clinic. But is this really the most rational and ethical basis for allocating treatment?

In a December 2004 commentary in The Lancet (see http://www.aidsmap.com/en/news/D8D8D2ED-601D-4ABD-9AF0-ACB2448B5DF2.asp ), researchers from the United States and South Africa suggest that where rationing occurs, criteria need to be transparent and need to be openly debated by civil society, donors and other stakeholders. The commentary is available online in pdf form http://image.thelancet.com/extras/04art3077web.pdf.

WHO recently published `Guidance on ethics and equitable access to HIV treatment and care` (see http://www.who.int/ethics/resource_allocation/en/ ), the result of an international expert consultation in January 2004.

The key recommendations of the guidance are:

1. Scale up HIV treatment and care, as it is an ethics and human rights imperative
2. Establish broadly representative ethics advisory bodies
3. Create opportunities for public dialogue on equitable access to HIV treatment and care
4. Develop policies for scaling up HIV treatment that are firmly based in human rights and ethical principles
5. Identify vulnerable, marginalized or other potentially underserved populations
6. Consider the need for special policies and outreach programmes to prioritize these groups and to overcome barriers to their accessing care
7. Establish a fair process for setting priorities in the distribution of HIV treatment
8. Define or adopt a set of five to seven measurable indicators to monitor the fairness of HIV treatment scale up at the national and community level.
9. Use monitoring and evaluation data to ensure that HIV programmes are producing equitable results.

Currently, efforts towards dissemination and country work are under way. The goal is to raise awareness among policy makers for distributive justice and equity in HIV/AIDS, to promote best practice in conducting fair consultative processes, and to facilitate the formulation of national policy papers on the topic. In addition, equity indicators for monitoring and evaluation of these policies under severe resource constraints are being developed. (See: http://www.who.int/hiv/pub/advocacy/guidelines/en/ )

Equity in practice

But what does equity mean in practice? When health care is in short supply, a multitude of criteria can be applied to decide who receives what level of care. Although based on apparently neutral clinical criteria that appear `common-sense` to clinicians, all clinical guidelines imply value judgements about who is most needy, or how scarce resources can be most equitably distributed.

For example, countries such as Botswana have prioritised the sickest to receive ARVs first. Although this is a practical consideration - if they don't receive ARV treatment they will die or tie up health care worker time in the treatment of serious illnesses - an ethical consideration is also implicit here. These people are the most needy of immediate care, and as a global society we generally agree in the abstract that those most in need should receive scarce resources first.

However, when talking about scarcity, we often talk about how scarce resources can be put to the best use (utility). Those who believe in this `greatest good of the greatest number` approach to health care would argue that it is better to prioritise those who will respond better to treatment and live longer - generally not the sickest patients. This approach also argues for the prioritisation of less sick patients because they will require less health care worker time, thus allowing more patients to be enrolled, and quicker too.

Arguments about utility and ethics often raise the question of whether the benefit of treatment should be calculated solely in terms of the benefit to an individual or to the wider society. For example, an individualist or non-consequentialist approach would be to say that a woman deserves priority in treatment because women have poorer access to health care in general. A social utilitarian approach would be to argue that women should also be treated in order to reduce mother to child transmission and the burden of HIV-infected children and orphans, and that these may be more important justifications for prioritising this group of patients in the long run.

Access to treatment is also determined by decisions about the siting of treatment facilities. Those who argue for all due speed and efficiency tend to advocate using existing centres of excellence to spearhead treatment roll out. Critics of this approach say that it further entrenches existing inequities of health care distribution within countries, and risks squandering the transformative potential for the health care system of new resources from bodies such as the Global Fund to Fight AIDS. In particular, it risks further entrenching the gap between rural and urban populations and reinforcing the division between hospital-based and primary care.

In some programmes, rationing is implicit, for example, treatment is limited to those with access to the ART-dispensing clinic. Most facilities probably will treat everyone who is medically eligible on a first-come, first-served basis until they run out of drugs or expertise.

Systems based on queuing may be biased in favour of those who are free to wait in a queue: those with jobs, child-care responsibilities, or other obligations may never get to the front.

While queuing may be a one-time ordeal to get on the ART waiting list, at some sites in Africa, patient waiting times (in general) are extraordinarily long (4+ hours). Patients without emergencies are often turned away and told to come back on another day.

Queuing also depends on who gets tested at a particular site, If, for example, women do not come forward for testing due to concerns about stigma at one particular site, a first come first served allocation of treatment will pay little attention to gender equity. If on the other hand testing and treatment for mothers and families is prioritised at another site, "it would be unfair to nonpregnant women, men and children who learned of their HIV-positive status at a later time," observed Ruth Macklin of New York's Albert Einstein College of Medicine in a discussion paper prepared for the 2004 WHO consultation on equitable access to treatment.

She also notes: "Giving priority to pregnant women would be unfair to nonpregnant women. In societies that discriminate against women generally but place a high value on women only when they are pregnant, gender equity would not be served by giving pregnant women preference for treatment over non-pregnant women."

Other criteria for rationing treatment

Other programmes use explicit socio-economic criteria to define the populations that have priority.

Examples include:

• Mothers of new infants (to prevent mother-to-child transmission)
• Skilled workers, health care workers, teachers, bureaucrats, armed forces - to preserve to social order/and or the country's economic viability. Uganda has recently announced that it will provide free ART to its healthcare workers who qualify for treatment, see http://www.aidsmap.com/en/news/2B975DAF-4A42-4402-860A-46DDFF159489.asp
• The poor or any individual who cannot afford treatment - again, here demand is likely to outstrip supply. However, in some countries such as South Africa, it is a constitutional mandate that any large public health programme should be equitable.

In contrast, other programmes have chosen to require co-payments from patients in order to receive treatment - essentially rationing by income. At least some of Uganda's patients receive treatment through a fee-for-service model: http://www.aidsmap.com/en/news/AFB128B5-AEF7-4FAF-9A0B-E0322C3BA99F.asp .

Other programmes employ geographical rationing, in which some regions have preferential access to treatment, either because of the nature of available infrastructure or explicit decisions made on epidemiological or political grounds.

Hard choices are unavoidable

"Different ways to ration antiretroviral therapy will have different social and economic consequences for African populations. Understanding these outcomes is important if the decisions made about resource allocation and programme design are to help a nation accomplish its goals for fighting HIV/AIDS and sustaining economic development", say the authors of The Lancet commentary.

"Hard choices are unavoidable." The authors warn that at each decision-making level, from international donors, though governments and local health services, there will be a temptation to use implicit systems of rationing rather than to make and enforce hard choices.

They conclude: "African governments can ration deliberately, on the basis of explicit criteria, or they can allow implicit rationing to prevail. Without analysis and debate about public policy, people will make arbitrary decisions about access to treatment, and implicit rationing will foster both inequity and inefficiency."

"We believe that governments that make deliberate choices about rationing antiretroviral therapy, and then explain and defend those choices to their constituencies, are more likely to sustain economic development and social cohesion and secure a socially desirable return from the large investments now being made."

Commentary

When discussing treatment rationing, a distinction should be made between:

• vanguard programmes piloting antiretroviral therapy (ART) in various settings, and
• national programmes that are responsible for providing antiretroviral care within a country (or province/region).

Small pilot ART programmes manage their limited resources with patient selection or eligibility criteria. Naturally the criteria varies depending upon the purpose of the programme - such as the programme that Chris Green mentions that provides ART to treatment advocates (see below).

Another example is Columbia University's MTCT+ Initiative, which provides care and support to women, children, and their family members at a number of sites in different countries. There are programmatic criteria that limit resources to women, children, partners and household members, and then there are clinical criteria for treatment. However, the initiative devolves responsibility to each site regarding how to define "households" and other criteria - using community boards to reach decisions.

But national programmes rarely devolve responsibility for treatment rationing to local community boards. In most settings, responsibility is devolved down to the provincial or district level - but it rarely goes much further than that. This varies by setting. In Uganda, for example, as Dr. Henry Barigye points out (see below), there is a mix of programmes/funders, so there will be a variety of rationing/selection criteria).

But how do national programmes with a mission to provide comprehensive care to their citizens with HIV honestly tackle treatment rationing and equity? During start-up, most national programmes have little choice but to employ geographical rationing because the healthcare delivery infrastructure is initially limited to the clinics already in operation.

This likely reinforces longstanding inequities in healthcare (between rich and poor, urban and rural) but it makes sense to first rollout ART in established centres. How ART programmes expand from there is another matter.

An issue that the Lancet article didn't really touch on is that ART cannot be divorced from the delivery of a basic package of primary care and the need to improve the health care structure in general - otherwise overburdened health care systems could buckle under the weight of the roll-out. (On the other hand, it could be argued that healthcare systems are already buckling under the increased burden of illness associated with HIV itself - and that the rollout will reduce that burden).

Nonetheless, in most developing countries, the resources available to primary care are insufficient to cope with both the volume of patients and the provision of even the most basic primary care package. Resources being directed to managing HIV could improve healthcare infrastructure and improve equity in healthcare. But if managed poorly, the introduction of ART could increase rationing of other general healthcare services due to the human resource and time commitments required to run ART programmes.

This is one of the reasons why monitoring and evaluation is so important. It might be possible to reach 3x5 targets in terms of numbers of patients put on treatment, and yet fail to measurably improve the general health outcomes of people living in resource limited settings.

(Part Two of this article follows in a second email).