TAC welcomes Harvard’s Consensus Statement on Antiretroviral Treatment for AIDS in Poor Countries

"We believe that on moral, health, social and economic grounds the international community should provide the scientific and financial leadership for a rapid scaling-up of AIDS treatment in the poorest and hardest-hit countries in the world. Initial efforts should be focused on those with more advanced HIV infection, with a target of at least 1 million AIDS patients in Africa in treatment within 3 years as a first objective, and indeed more if feasible, and with a
proportionate scaling up in hard-hit countries in other parts of the world." (Harvard Consensus Statement page 2)

1.	 Introduction: Why the Harvard Consensus Statement is important
The Treatment Action Campaign welcomes the The Harvard Consensus Statement on Antiretroviral Treatment for AIDS in Poor Countries (Harvard Consensus Statement) as the first major authoritative statement and practical vision from academics and scientists in the United States of America on the necessity and possibility of HIV treatment. We urge the global scientific community to sign on to this statement and to ensure its practical realisation.

The additional importance of the Harvard Consensus Statement is based on 
•	an unanswerable acknowledgement from an academic and scientific community that HIV/AIDS in poor countries can be treated; 
•	a practical vision that requires translation into an operational plan for treating one million people over the next three years; and
•	the bold recognition of global economic inequalities and the debt burden as obstacles to treatment that requires financial leadership from wealthy countries.

While the document is not an official statement from Harvard University (a leading US university), it represents the views of a significant number of the university's faculty members, many of whom have contributed important applied research about HIV/AIDS, tuberculosis, health care policies and economic development. Opinions emanating from Harvard University have some influence in the decision-making processes in North American and European governments, particularly the United States, as well as multinational companies. Therefore, activists need to understand the Harvard Consensus and make an appropriate response to it. 

The Harvard Consensus is a positive step forward. The plan to treat one million people in the next three years is, by the signatories own admission, ambitious, but it encompasses the minimum set of demands that activists should put to the international community. 

Some funding organisations, as well as the United States Treasury Department have been arguing that further HIV/AIDS funding should predominantly be moved into vaccine research at the expense of treatment.   The Harvard Consensus Statement correctly points to the inadequacy of “the available scientific tools” for HIV prevention.  It points to the need for better prevention efforts, additional funding for prevention research and programmes but, it uncompromisingly asserts that prevention and treatment efforts cannot be separated if they are to have sustainable positive results.

There is an emphasis in this response on what the Harvard Consensus Statement means to South Africa. TAC is based in South Africa and its understanding is based on the situation in this country, therefore this bias is inevitable. However, some of what is said here may apply to other developing countries.

2.	 The Central Points of the Harvard Consensus Statement
The Harvard Consensus Statement is easy to read and contains important, well-referenced facts and figures. A brief summary of the statement is given in this section, but everyone should read the original document (available on the TAC website). 

The basic premise of the Harvard Consensus Statement is contained in the following statement:

“Until a few years ago, HIV infection led almost inevitably to an early death from AIDS.  With the scientific breakthrough in the mid-1990s of highly active anti-retroviral therapy (HAART), using a “cocktail” of antiretroviral drugs, the disease has been transformed into a treatable and chronic condition for a significant proportion of those with access to this treatment.  Yet 95 percent of the 36 million HIV-positive individuals live in the developing world, and only a tiny fraction of those people have any access to HAART.” (p3)

The Harvard Consensus Statement challenges this inequality: "The disparity in access to effective treatment between wealthy countries and developing countries is neither scientifically nor ethically justified at this time." (p4)

The statement emphasises the need for treatment and prevention programmes to complement each other. Many donor agencies have been reluctant to fund treatment, because they have feared this would detract from prevention efforts. The signatories take issue with this and give four reasons for pursuing treatment:

(1)	Treatment is essential to the 36 million people already infected with HIV; -- though this is called a humanitarian rationale – as people with HIV/AIDS and as those affected by the disease – TAC says that access to treatment is based on universally recognised human rights such as the right to life, dignity, equality and access to health care services. 
(2)	Treatment is necessary to make prevention efforts more successful; “When treatment is not available, there is much less incentive for an individual to take an HIV test, since being HIV-positive is not only associated with social stigmatization but is tantamount to a death sentence. This in turn stifles prevention programs that depend on differentiating between those who are HIV-negative and HIV-positive.  It is only when HIV testing is coupled with treatment that people have an incentive to be tested, thus enabling a rational response to AIDS: primary prevention for those who are HIV-negative, and antiretroviral treatment for those who are HIV-positive.  Effective antiretroviral treatment of HIV-positive people also lowers the viral load within infected individuals, which in turn has a major effect in reducing the likelihood that they will transmit HIV infection to others. Thus appropriate treatment of infected individuals may become a major tool in AIDS prevention.” (p4-5)
(3)	 Treatment is essential to save children and the fabric of societies. The Harvard Consensus Statement grasps the need to reduce the projected number of orphans (44 million) by treating parents and children. Besides having the desired effect of maintaining family support, it will also contribute to stabilising social structures.  (p5)

(4)	 Treatment is necessary for continuing economic development.  The statement correctly insists that without treatment millions of productive adults will be lost and not only the direct costs of their training and physical skills but their knowledge necessary for “human and economic development” will be irrevocably lost. (p5)

The statement effectively counters the traditional arguments against providing AIDS treatment in the world's poorest countries, lack of infrastructure, lack of adherence leading to resistance, high cost and poor leadership. 

Infrastructure 
The Harvard Consensus Statement sees weak infrastructure in poor countries as a challenge to improve facilities and human resources rather than an excuse to deny HIV/AIDS treatment. “In those areas where existing treatment infrastructure is lacking, this should never be cited as an impasse by which to forego treatment.  Efforts should be initiated to build the clinical and diagnostic capacity to furnish and monitor therapy, making use in the interim of geographically distant infrastructures (including those in wealthy countries) to monitor for efficacy of the interventions and potential adverse effects of the antiretroviral drugs.”  (p12)

A proposal is put forward for improving adherence to highly active antiretroviral therapy (HAART) based on the Directly Observed Therapy (DOT) model used for treating Tuberculosis (TB). 

The cost of their treatment proposal is estimated to be about US$4.2 billion per year in 5 years time for treating 3 million people. This is approximately 0.01% of the GNP of the world's richest countries and "a small price to pay for treatment on a meaningful scale in the midst of the worst worldwide pandemic in 600 years." (p 18). The statement emphasizes that treatment programmes must be funded with grants to poor countries, not loans.

With regard to leadership, the signatories propose an HIV/AIDS Prevention and Treatment Trust Fund to be established. Wealthy countries should provide financial and scientific leadership, while poor countries should provide political leadership and institutional support. UNAIDS and WHO should assume leadership of the programme. All these recommendations are covered in detail in the statement. 

There are other important recommendations in the Harvard Consensus, relating to which patients should be treated and when, diagnostic tests and scientific research. An annexure describes the details of how the signatories have costed the programme. For treating 1 million people within three years, the following summary of costs per year as of the third year has been calculated:

Testing	US$143 million	
Medicines	US$650 million	
DOT	US$200 million	
Clinical (e.g. CD4 counts)	US$230 million	
Research	US$25 million	
Total	US$1.123 billion	

This works out to US$1,123 per patient per year or approximately R9000.00 per year.  The cost per patient per month would be approximately R750.00 per month. 

By the fifth year of the Harvard proposal, three million patients in developing countries, including India, would be on treatment. Projections past five years are not made, because by then treatment options are likely to have changed.  

3.	TAC comments on aspects of the Harvard Consensus Statement 
TAC sees the Harvard Consensus Statement as a practical vision rather than a plan.  In developing a plan a number of additional factors need to be taken into account.  Middle-income countries and countries with a major epidemic must raise the questions of sustainability and the political and economic dangers of dependency on development assistance to keep a substantial proportion of its population alive.  In addition, the ephemeral nature of compassion from governments in developed countries must be taken as a given in this instance.  The development of national or regional plans based on the Harvard Consensus Statement must take generic production into account as an additional source of production for ARVs and other medicines.  Social security is another key variable to consider. 

3.1 The Role of Generic ARV Production and TRIPS
The Harvard Consensus Statement points out the success of Brazil and Thailand in dealing with their HIV epidemics.  Extensive access in Brazil and the limited access in Thailand are based on lower prices generated by generic competition. The statement also mentions the price competition between generic producers like Cipla and the patent-holding multinationals. Co-operation between South Africa’s largest generic producer Aspen Pharmacare and Hetera of India suggests triple-drug therapy at the cost of US$347.00 per person per year.  This is nearly half the Harvard Consensus Statement estimate of the cost of triple-drug therapy. Countries and regional bodies must draw the logical conclusion that generic competition is essential for a sustainable supply of affordable medicines.

The HIV/AIDS epidemic is a disaster, but it has awoken the world to the injustice and harshness associated with the abuse of patent rights. A movement with the potential to modify draconian agreements like TRIPs is beginning to form.  Intellectual property rights, genuine innovation, research and development must be rewarded in the public interest.  The current patent system, especially for medicines must be revisited – it prevents access to the best medicines for the majority of people and it is not the best way to protect intellectual property rights. No aspect of health care service delivery should be regulated as trade issues.

Treating people with HIV/AIDS is TAC's highest priority. But sacrificing the rights of poor countries to issue compulsory licenses should not be a payment made in exchange for financing from rich countries. Therefore civil society and the governments of poor countries must implement the Harvard Consensus Statement, or similar plans, without poor countries having to give up the little that is favourable to them under TRIPs. Such a stance should have the support of most tax payers in rich countries, who will not be pleased about having to pay any more for treatment than is necessary. Furthermore, the economic hardships that poor countries are having to face as a result of HIV/AIDS are enormous. For countries like South Africa and India, the strengthening of their generic pharmaceutical industries will be one of the few compensations offered by the pandemic.

3.2 Directly Observed Treatment
The Harvard Consensus proposes using a methodology similar to monitoring TB patients for monitoring and improving the treatment adherence of HIV/AIDS patients. In the South African Health Review 2000, the Health Systems Trust reports that the expansion of DOTS has resulted in an increased TB cure rate.  Where DOT programmes are weak such as in KwaZulu Natal, the TB cure rate is worsening.   The Harvard Consensus Statement correctly emphasises the need for improved TB reasearch and programmes and TAC accepts the DOT model until the epidemic is brought under control. 

The HAART DOT model recommended in the statement, which has been used with success in Haiti, is definitely an option worth considering.  However, patient autonomy and dignity will assist treatment adherence.  Autonomy can be promoted through support groups and treatment counselors.  They can assist people living with HIV/AIDS to initiate and cope with the changes to their daily routines required by taking medication.   Increased treatment literacy levels, decreased stigmatisation and better direct access to medicines will all assist in the development of patient autonomy but they have to be considered as necessary at the outset. These models (DOT and patient autonomy) are not mutually exclusive and they could be developed in tandem.

3.3 Affordability of Treatment for South Africa and other Middle-Income Countries
Undoubtedly, many poor countries will need significant international aid in order to implement extensive treatment programmes. Discussing the pros and cons of international aid programmes is beyond the scope of this response, but at a minimum the more a country can afford to pay for its own treatment programme, the better its negotiating position will be with major international donors, i.e. the European Union and the United States.

The signatories state that South Africa cannot afford to implement HAART without international aid, even though it is a middle-income country, because the sero-prevalence rate is too high. "... substantial grant support will also be needed for a few middle-income countries, such as South Africa and Botswana, where prevalence of HIV infection is high, so that the fiscal burden would ... be too large for the country to manage out of its own resources" (page 15). 

This might be true, but cannot be verified until a treatment plan for South Africa is developed. TAC is campaigning for such a treatment plan at the moment. Furthermore, we have demanded that the South African government develop a treatment plan by the 16th of June. At a superficial first analysis, it can be said that a cost of US$1.123 billion per year, or approximately R9 billion per year, to treat one million people should be manageable within the South African economy if the private sector contributes a significant amount and the South African government stops wasting money on unnecessary purchases, such as the arms deal. 

The government should take a lead in developing and funding a treatment plan for South Africa.  This country has a dual health care system – an over-spending private sector that reaches a minority of people and a public sector that under-spends and serves the majority of the population.   In addition, South Africa’s economic base in mining, manufacturing and financial services employ large numbers of workers with HIV/AIDS.  Significant funding could be obtained for HIV/AIDS treatment in partnership with the country’s conglomerates.

The same might apply for other countries. Certainly the South African, Botswana and Indian governments cannot wait for a plan similar to the one in the Harvard Consensus to be adopted by the world's rich countries before proceeding with treatment programmes. 

3.4 Technical Aspects of the Harvard Consensus Cost Analysis

The Harvard Consensus's cost analysis must be seen as an approximation of the cost of a comprehensive treatment programme. A much more detailed analysis still needs to be done on a country-by-country basis. Nevertheless, it is worth noting some aspects of the statement's quantitative results, so that more detailed and accurate estimates can follow from it. 

•	The signatories state, "The proposal also recognizes the immediate need to build additional infrastructure in resource-poor countries through the support of donor funding."  However, there is no budget item for this in their quantitative analysis. 
 
•	The possibility of developing cheaper technologies for viral load monitoring, CD4 counts, better TB testing, liver tests and so on requires a clear plan

•	Administrative costs, such as managing the programme, seem to have been ignored. Hopefully these would, for the most  part, be fixed and amount to a small fraction of the total cost.  However, human resource development and managerial capacity are critical to ensure that HIV/AIDS treatment does not undermine a fragile health care system but that it builds a model health care service.

•	Mother-to-child transmission prevention (mtctp) of HIV is not considered in the statement. It should be because many women may be in the very early stages of HIV infection and therefore would not require ARVs.  In this scenario, mtctp is critical. It would  prevent thousands of HIV infections and there is a unanimous consensus in studies that have studied mtctp that it is cost-effective. Recent research indicates that it would also be cost-saving. While there are questions over whether  middle-income countries with high prevalence rates can cover the cost of HAART, there is little doubt that they can and should cover the cost of mtctp. Certainly mtctp  for the poorest countries should be accounted for by the  proposed HIV/AIDS Prevention and Treatment Trust Fund. 

•	Medicines constitute the largest portion of the cost of treatment. The signatories assume an average of US$650per year per patient. This figure is based on various unfulfilled promises made by both generic and  patent-holding companies. It is nevertheless a reasonable estimate, but if there is an unambiguous commitment by the international  community to allow generic competition to proceed unhindered in poor countries, an amount much lower than the $650  estimate should be feasible. (Note: the statement estimates US$500 per year for 70% of patients, but about US$1000 per year for the remaining patients needing more complicated regimens. This averages out to US$650 per year.)

4.	 Political Will and the Way Forward
The Harvard Consensus "calls on wealthy countries to provide financial and scientific leadership, and poor countries to provide necessary political and institutional support ..." (page 18). We agree.  It is critical that the international community also accepts that political leadership has many forms including mass mobilisation by civil society organisations such as religious bodies and trade unions.  Such leadership may also come from business, especially in a country such as South Africa where both civil society and business are not dependent or subjected by the government.

Political leadership will also be needed from rich countries to manage the frequent obstructionist behaviour of the multinational drug companies. 

There is much work to be done to convince both rich and poor governments of their responsibilities in treating HIV/AIDS. Not least the South African  government, which has displayed a remarkable unwillingness to face up to the realities of this pandemic. The focus of the Harvard Consensus Statement signatories should now be to convince the United States government of the need to begin implementing this plan, or similar, immediately.

TAC's focus will be to persuade the South African government to produce and implement a treatment plan for HIV/AIDS, to implement a country-wide mtctp programme and to allow the production of generic ARVs.

Once again, the Harvard Consensus Statement is a milestone in the management of the HIV/AIDS pandemic and an encouragement to people living with HIV/AIDS everywhere.