We, economists, public health experts and citizens involved in the fight against AIDS are committed to scaling up access to health care, including ARVs, for HIV positive people. We consider it a rational economic decision and an absolute priority. We, economists, public health experts and citizens involved in the fight against AIDS believe that a prerequisite to ensuring treatment programs are (1) scaled up, (2) equitable and (3) effective is to have universal free access to a minimum medical package, including ARVs, through the public health system. We believe that the treatment package should include HIV tests, prophylaxis and treatment of opportunistic infections, all laboratory and associated examinations, consultation and hospitalisation fees, and ARVs. We argue that WHO, UNAIDS, the governments of resource poor countries and international donors, among them the Global Fund, the World Bank, and bilateral cooperation agencies, must adopt the principle of universal free access to treatment (including ARVs). We urge that additional resources be mobilized through long term commitments. These should come from a mixture of donor funding, governments, firms, health insurance, and health assistance systems. Governments in resource poor settings should engage in the reallocation of domestic resources to show commitment to achieving this goal. We are committed to spreading the principle of free treatment and to contribute to implement it. Otherwise, the idea of scaling up access will remain a dream. Introduction There is consensus on the necessity for providing health care in general, and ARV programs in particular, for HIV positive people in resource poor settings. In June 2001 the United Nations General Assembly Special Session on HIV/AIDS unanimously adopted a Declaration of Commitment recognizing that: ‘effective prevention, care and treatment will require behavioural changes and increased availability of and non-discriminatory access to (…) drugs, including anti-retroviral therapy, diagnostics and related technologies’ . In 2004 the Copenhagen consensus of economists identified the fight against AIDS as the top priority in advancing global welfare on the grounds that ‘the scale and urgency of the problem - especially in Africa, where AIDS threatens the collapse of entire societies – are extreme’ . The consensus accords the highest priority to preventing the spread of HIV/AIDS. We note that if ‘collapse of societies’ is to be averted treatment is essential as so many people are already infected. Treatment is justified on economic grounds, for human rights reasons and because if we fail to provide it societies face catastrophe. We, economists, public health experts and policy makers involved in the fight against AIDS are committed to scaling up access to health care including ARVs for HIV positive people. We consider it a rational economic decision and an absolute priority. The goal set by WHO is to have 3 million people on treatment by the end of 2005. What it will cost, who will do it and how it will be done is still being debated and we have much to learn. There are, of course, major concerns around the scaling up of access to treatment; how can these programs improve the uptake? How can they reach the most vulnerable and poor populations , ? How can they achieve a high level of adherence to ARV treatments in order to avoid the spread of resistance? This declaration sets out a principle we all should subscribe to and apply : the principle of a comprehensive minimum package of treatment provided for free to all the people living with HIV / AIDS. The current situation: many patients are being asked to pay for their treatment The first programs that were set up, such as that in Uganda, asked the patients to pay for the total cost of treatment . Today there are a range of programs and conditions for access to treatment; Brazil and Venezuela are providing free ARV therapy ; other countries including South Africa are starting to implement ARV programs where all medical needs will be covered. But in the vast majority of resource poor countries, access to treatment is not free. In Senegal ARVs, CD4 counts and viral load tests are free, but other laboratory exams required to initiate therapy have to be paid for and are a major obstacle to access to ARVs. People who would qualify for free drugs cannot afford the tests to obtain them so die before treatment can be initiated. Laboratory exams and drugs for opportunistic infections are not free. The result is that people may die of opportunistic infections despite the fact they have free access to ARVs. In other countries ART is heavily subsidized, but a monthly contribution is sought from patients : in Burkina Faso patients are expected to contribute 8 000 FCFA per month (12 euros); in Cameroon the current cost for the patient is between 15 000 and 28 000 FCFA (between 23 and 43 euros) ; and Niger, in its proposal presented to the Global Fund, will have a range of contributions from 8 000 FCFA (12 euros) to 75 000 FCFA (114 euros) according to the patient’s income. The cost of drugs for opportunistic infections, laboratory exams, consultations and hospitalisations fees must be added to these contributions. A study in Senegal assessed the cost to patients and found that those on ARV treatment had to pay an average of 5200 FCFA per month (7,9 euros) , ie 95 euros per year for their medical expenses additional to the cost of ARVs and CD4s. On the level of the patient, the French National Agency for AIDS Research (ANRS) estimated that, other than ARVs and CD4 counts, an amount of 150 euros per patient per year is needed to cover all medical expenses . These examples give an idea, however imprecise, of the burden of medical expenses on the patients’ and their families’ finances Are there international guidelines as far as free or affordable treatments are concerned ? The WHO strategy “Treating three million by 2005, making it happen”, published in 2003, only mentions the word “affordable” once without questioning what affordability means . There is no other reference to free or affordable treatments. In November 2003, the participants in the Lusaka meeting -whose aim was to draw technical and operational recommendations for scaling up- did not reach a consensus on free ARVs. The report indicates : “most participants considered that ARV therapy should be provided free of charge to the person receiving the therapy with a minority cautioning against stating this as a principle” . The 2003 revision of WHO treatment guidelines argues that we should: “provide medications free of charge for those who can least afford treatment through subsidized or other financing strategies”, without defining who these patients are. This important issue of what affordability means and how equity can be achieved in treatment programs in resource-poor settings is not dealt with at international levels. Why do we need free treatment ? There many reasons for the free provision of HIV/ AIDS treatments, among them are public health and ethical arguments. Uptake It is unrealistic to believe that treatment programs can be scaled up if treatment is not provided free. In order to reach a large number of people, most of them living below the poverty line, and to achieve the 3 x 5 goal, treatment will have to be free for most. Equity Providing free treatment will enable poor people to have access. Research shows that even when the contribution sought from the patient for ARVs is small, some are excluded because they cannot afford it . Providing treatment free of charge will contribute to achieve equity. Efficacy Research in Senegal shows the main reason patients were not adherent was that financial problems led to treatment interruptions . Adherence must be high in order to avoid resistance and ensure long term efficacy for the patient. Providing treatment for free will contribute to both adherence and efficacy at an individual and population level. Moreover, free treatment is the best way to reduce demand for antiretroviral drugs on the informal market, misuse and consequent viral resistance and to reduce the number of people lost to follow up. Do we need free treatment for all? Some countries seek a contribution from the patient, but give the poorest or special populations free access to treatment. WHO argues for free treatment for the poorest only . But this will not achieve equity nor is it a rational utilization of scarce human resources in many settings. The poor are the majority In resource - poor settings the poorest are not a minority ! In Senegal, 60% of the population lives below the poverty line ; in Botswana, it is 50,1% of the population, in China 47,3%, in India 79,9%, in Ivory Coast 49,4%, in Nigeria 90,8% , and in Uganda 96,4% If the vast majority of the population are entitled to free treatment what is the rational for exemptions that will be costly to put in place and administer? Asking people to pay will increase vulnerability Research by economists shows AIDS is impoverishing . Death and sicknesses cost money and increase poverty. People are usually diagnosed HIV positive after a long period of treatment seeking when they have mobilized all their (and extended family) resources and when it is difficult to mobilize additional money. In affected households, money devoted to healthcare of HIV positive people is diverted from other uses such as care of other members of the family, education of the children and investment . Even in cases of diseases that require simple and inexpensive treatment regimens, it has been shown that increases in out-of-pocket health costs have driven some families into poverty and increased the hardship of those who are already poor. AIDS increases inequality and affected households could be pushed in deep poverty; in Kenya death of a male household head is associated with a 68% reduction in the net value of the household’s crop production; in South Africa’s Free State Province, per capita expenditures on food were 23% and 32% less among urban and rural affected households than among unaffected urban and rural households. Asking patients to pay for their treatment will increase economic vulnerability of affected households and strengthen the devastating impact of AIDS. Exemptions cannot achieve equity Exemptions for the poor are difficult to administer and may lead to arbitrary decisions about who will be given access to free treatment and who will not. Even the definition of poverty may be arbitrary, and once a level is set then assessing peoples’ incomes – especially where the informal sector dominates- is fraught with difficulty. Recent studies have shown that systems including exemptions or waivers do not enable to achieve equity because they were seldom offered to patients who would have needed them and had the right to obtain them . Finally, it may also open the way to corruption. These observations challenge the capacity of “positive discrimination” based on income criteria to ensure equity in access to treatment. An alternative route is to identify specific groups for treatment – such as people belonging to declared PLWHA groups or women undergoing PMTCT+. Such decisions are not economic and can also be arbitrary. Exemptions or waivers systems are not cost-effective Finally, the process of defining who gets free treatment and who will not is a resource consuming process. It takes time, money and personnel, and the amount of money collected is usually not worth it. Scarce human resources can be used for other purposes (providing support for adherence, looking for people lost to follow up and so on). Moreover, the patient may die or be lost during the process. Contrary to the idea that free treatment “would be difficult to implement in many health systems” , we believe that it will be easier and more cost-effective to provide treatment to all patients for free. What are the main arguments against free treatment and why they are not valid? “People must pay to give value to the treatment and thus be adherent” Studies conducted in Senegal show exactly the opposite : the more patients have to pay, the less they are adherent, because frequent treatment interruptions occur due to financial problems. This led the President of Senegal to make ARVs universally free. “There should be no AIDS exceptionalism” One of the major arguments opposed to free treatments in the field of HIV is based on the principle that what cannot be done for all must not be done at all. There are three arguments against this. (1)In fact, there is an AIDS exceptionalism as UN Secretary General Koffi Annan stated : “HIV / AIDS is the worst epidemic humanity has ever faced. It has spread further, faster and with more catastrophic long-term effects than any other disease. Its impact has become a devastating obstacle to development” . This exceptionalism of the epidemic justifies exceptionalism in the responses. WHO Director general Lee Jong-Wook affirms : “lack of access to antiretroviral treatment is a global health emergency… To deliver antiretroviral treatment to the millions who need it, we must change the way we think and change the way we act.” (2) Other diseases are treated for free in various countries (TB, leprosy for example) when there is a public health reason to do so. (3) Dealing with equity, we should not consider that “the lowest common denominator” must be the rule. Because we cannot provide immediate free treatment for all diseases and to all people, this does not mean we should not provide free treatment for as many diseases to as many people as possible. “Patients’ contribution is necessary to ensure sustainability of HIV / AIDS treatment programs” Some argue that patients’ contribution is important to ensure the sustainability of treatment programs. However it is unlikely that in resource poor settings this will make a significant contribution to the total cost. The Senegalese experience shows that only 10% of the cost of the drugs were paid by the patients, and this does not take into account other costs such as medical staff, training, social service etc. The only way to achieve sustainability is to obtain long term commitments from donors or reallocation of domestic resources. “The health system will be overwhelmed by people coming from other countries” It has been recorded in French Guyana in South America that people move across borders in search of treatment. There are indications of it happening in Botswana. That is why the issue of equity must be dealt with at the international and regional level : comparable regional treatment initiatives may be essential to avoid this. “Financial contributions avoid excessive consumption of health care” This argument is based on the experience of the rich world – where health care demands are unlimited. There is little evidence of ‘excessive consumption’ in the resource poor world. But do we want to limit the consumption of AIDS treatment? Precisely not ; the challenge is to manage to improve the uptake of ARVs. For example, in Zambia, only 4000 patients are on treatment when the program planed to have 10 000 people on treatment at the end of 2003. One of the reasons may be the cost of laboratory examinations required prior to initiation of therapy (70$ for viral load and CD4 prescribed by the physicians) and the cost of ARVs (10$ per month) . This low uptake could lead Zambia to throw away 18 000 doses of ART that will expire in August 2004. What is to be made free ? If treatment is to be free then more than drugs are needed. The question of what is to be made free is a big issue, and needs further research, reflection, and international guidelines. At this stage, we propose a minimum package that should be made available for free. This should include: · HIV tests · Consultations with medical staff · Laboratory examinations (according to WHO medical guidelines or to national medical guidelines if they are more extensive) · Hospitalisations · Treatment of common opportunistic infections · Prophylactic treatment · ARVs A comprehensive minimum package of treatment must be provided for free through the public health care system. We recognize that choices will still have to be made. For example in most countries, at this stage, only one or two combinations of therapy may be available ; few laboratory exams may be used, etc. But that should be monitored because prices change and technologies improve . Who will pay for it? We believe that the implementation of free treatment will not fundamentally change the level of contributions asked of donors, health insurance systems and governments because patients contributions would have always been marginal in the overall cost. The total cost of providing treatment through the 3 by 5 initiative alone ranges from $4.98 to $5.74 billion for the two years 2004 and 2005 . It is estimated that the current funding gap involved in providing a comprehensive package of care is over $2.5 billion. We note that currently the minimum package is under resourced. Therefore we urge international donors, social security and health insurance systems, firms, mutual and private insurances, and governments, to fund the minimum package through long term commitments. This is realistic knowing the amounts concerned. We further expect resource poor countries to make the appropriate contribution. In April 2001, African leaders meeting in Abuja committed themselves to allocating 15% of their public expenditure to health. The First Conference of Health Ministers of the African Union in Tripoli, April 2003 approved the NEPAD Health Strategy, which reconfirms the Abuja targets and aims to scale up communicable disease control programs. African leaders have endorsed these policy statements and must ensure they are implemented. Provision of free treatment must be a partnership of all stakeholders and all have responsibilities. Conclusion To meet the equity and efficacy objectives, policy makers should move beyond concepts and values resulting from a decade of public health emphasis on user fees, and implement free treatment for people living with HIV / AIDS in developing countries . Free treatment should be provided through the public health care system. These programs should reach those who do not have access to private medical care We are fully aware that giving access for free to HIV treatments is only a beginning; it will not be sufficient to achieve equity in these programs, and far more needs to be done. In particular, the needs of the most vulnerable groups must be recognized. We should not confuse access with availability. Nor will it be sufficient to achieve a high level of adherence and far more needs to be done. There is much work and a research agenda need to be developed. It must start with a common agreement on what is non-negotiable. We, economists, public health experts and citizens involved in the fight against AIDS believe that a prerequisite to ensuring treatment programs are (1) equitable and (2) effective is to have universal free access to a minimum medical package, including ARVs, through the public health system. We believe that the treatment package should include HIV tests, prophylaxis and treatment of opportunistic infections, all laboratory and associated examinations, consultation and hospitalization fees, and ARVs. We argue that WHO, UNAIDS, the governments of resource poor countries and international donors, among them the Global Fund, the World Bank, PEPFAR and bilateral cooperation agencies must adopt the principle of universal free access to treatment (including ARVs). We urge donors to mobilize additional resources needed through long term commitments, and governments to engage in the reallocation of domestic resources. We are committed to spreading the principle of free treatment and to contribute to implement it. We believe that this declaration represents one of a number of steps that will enable us to engage with the issue of AIDS and what it will cost both to deal with it and if we do not do so. This draft declaration was primarily prepared by Professor Alan Whiteside the Director of the Health Economics and HIV/AIDS Research Division of the University of KwaZulu-Natal, Durban and Veronique Collard. We received many comments on earlier drafts but particularly acknowledge Bernard Taverne, Gorik Ooms, and Alice Desclaux. This declaration is available in French on the following website : www.heard.org.za