A health care emergency

There is a growing demand that in India, which has the second largest number of people living with HIV/AIDS, the government provide public anti-retroviral treatment free of cost.

BUCKLING under pressure from activists, scientists, community workers and academics at the South African AIDS Conference held in Durban in the first week of August, the government in Pretoria conceded that public anti-retroviral (ARV) treatment should become a part of the country's response to the disease. So far in South Africa, ARVs have been available only to those who can afford private treatment. President Thabo Mbeki, who believed that AIDS should be fought through traditional medicines and by tackling poverty, ordered his Department of Health to draw up plans detailing when and how ARVs will be available to half a million infected South Africans. Mbeki's change in stance appears to be the result of a combination of international pressure, domestic activism, intervention by former President Nelson Mandela and the fear of fighting elections in KwaZulu-Natal without a proper strategy to combat AIDS.

According to UNAIDS, South Africa has the largest number of human immunodeficiency virus (HIV)/AIDS patients in the world - nearly five million people or more than 11 per cent of its population. The AIDS Foundation of South Africa says that the average life expectancy in South Africa is expected to fall from 60 years to around 40 years in the period between 1998 and 2008. The South African government cited high costs, side-effects and lack of health care infrastructure to monitor treatment as reasons for delaying providing access to ARV treatment.

Specialists from the Clinton Foundation HIV/AIDS Initiative, set up by former U.S. President Bill Clinton, along with Zachie Achmat, chairman of the Treatment Access Campaign (TAC), will help draw up plans for making ARVs available. The TAC has been instrumental in organising the campaign to change the government's stance. The main objective of the TAC, which was launched in 1998, has been to campaign for greater access to treatment for all South Africans by raising public awareness about issues surrounding the availability, affordability and use of HIV treatments. The TAC's strategies included a civil disobedience campaign in March 2003, when activists accused Health Minister Manto Tshabalala-Msimang and Trade and Industry Minister Alec Irwin of culpable homicide for failing to prevent 16 specific deaths.

In India, which has the second largest number of persons living with HIV/AIDS (PLWHA), there is a growing demand that the government provide free ARVs. According to National AIDS Control Organisation (NACO) estimates, there were 3.97 million PLWHAs at the end of 2001. A NACO policy document says that the government does not support ARV treatment because of its prohibitive cost, the indefinite period of treatment and the need for supportive investigations to monitor the progress of the disease. NACO policy states that the Central government is supposed to provide financial support to the States for the treatment of opportunistic infections (such as tuberculosis, which occur because the immune system has been weakened by HIV) in all public sector hospitals.

Recently, the Supreme Court issued notice to the Centre, NACO and all States and Union Territories on a public interest petition seeking a directive to them to provide PLWHAs the right to treatment under the country's public health system. The petition, filed by the Punjab Voluntary Health Association, was taken up by a Bench comprising Chief Justice V.N. Khare and Justice S.B. Sinha. It is the latest in a series of petitions that have dealt with the right to medical treatment for PLWHAs. The petition wants the state to provide free and equitable access to ARV treatment for HIV positive persons by creating the required infrastructure in public health institutions, including trained doctors and paramedics.

Earlier petitions specifically dealt with the right of PLWHAs to receive non-discriminatory treatment from health care workers and the right to a safe working environment for health care workers and medical practitioners. The Delhi Network of Positive People (DNP), an organisation formed by PLWHAs in 1998, believes that the larger issue of discrimination can be addressed if issues like providing ARVs is taken care of. Naveen Kumar, former DNP president said: "We have already filed a petition in the Delhi High Court asking for the state to provide access to treatment, by providing ARVs and access to hospitals. We have not had a chance to look at the petition in the Supreme Court as yet."

ARV treatment, introduced in 1996, meant that HIV infection became a treatable problem for many PLWHAs. The function of ARVs is to lower the HIV virus load in the body, thus enabling PLHWAs to live longer. But once ARV treatment begins, it cannot be discontinued.

According to Anand Grover, from the Lawyers Collective HIV/AIDS Unit, one of the leading advocacy and research organisations working with PLWHAs, there are many issues that need to be addressed before a therapeutic system providing ARVs can be put in place. A significant number of PLWHAs cannot tolerate ARVs because of toxicity or because they are resistant. A major challenge is to ensure that once ARVs are commenced they are continued for life. Before starting ARV treatment, the person has to be counselled and his or her informed consent has to be sought. The person taking ARVs has to be constantly monitored and the drugs may have to be changed if resistance or toxicity is observed.

Says Purushothaman Mulloli, coordinator of the Joint Action Council, a non-governmental organisation (NGO) involved in the issue: "In April 2002, the South African government had to intervene and stop an ARV trial in which five patients died. There are many such instances that are not given prominence in the media." There are examples of countries where successful AIDS care programmes have been put in place. The most prominent of these is Brazil, where the government, since 1996, has put in place a system of providing universal access to all AIDS-related treatment, including ARVs, through the public health system to PLWHAs. According to Brazil's National AIDS Drug Policy, the high cost of ARVs is largely offset by a reduction in the cost of drugs and by lowering hospitalisation expenses.

The same applies to India. The cost of ARVs and monitoring tests is around Rs.4,000 for the first line of treatment. According to a conservative estimate by the Lawyers Collective HIV/AIDS Unit, ARVs will cost approximately Rs.43,300 annually, based on current prices. As of now the Employees State Insurance Scheme, the Central Government Health Scheme and the Railways are the only public schemes that make ARVs available free of charge to PLWHAs in their employment.

Though Indian pharmaceutical companies took the lead in reducing the global prices of ARVs by offering generic drugs at $350 a year, or 3.5 per cent of their global prices, the government has not taken advantage of the situation. The strong generic drug industry in India can be attributed to the country's patent laws, which protect only process patents and not product patents in pharmaceuticals. A process patent only protects the method or process that the patent holder uses to manufacture the drug. This allows other pharmaceutical companies to make the same drug using a process different from the one that is patented. The different versions of the medicine thus produced are called generic drugs. Indian pharmaceutical companies have used this provision to manufacture drugs at a much lower cost than their global prices. However, India is a signatory to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, which means that it has to amend the patent laws by December 31, 2004 to provide protection to product patents of drugs that are internationally patented after 1995.

There are options within TRIPS allowing countries to meet public health goals. One of these is Article 31, or the Compulsory Licensing provision, which enables member-countries to make provisions in their patent laws, under which governments of member-countries or third parties authorised by these governments can use the subject matter of the patent without the permission of the patent holder. In India, the Patents Act, 1970, was amended recently to provide for compulsory licensing. According to the Act, the Central government can provide for compulsory licensing in "circumstances of national emergency, or in case of extreme urgency or in case of public non-commercial use".

Countries with compulsory licensing provisions face intense pressure from the United States and other Western countries, which have a strong lobby of pharmaceutical multinational companies. In South Africa, the Medicines and Related Substances Control Act, 1997, allowed for compulsory licensing and for parallel importing (importing drugs from countries where medicines are available more cheaply). The Pharmaceutical Research and Manufacturers of America (PhRMA) challenged the legislation and was forced to withdraw its case after pressure from both domestic and international activists. Despite this, the South African government has still not issued a single compulsory licence for the manufacture of ARVs.

The Indian government can still use the 2001 Doha Declaration to issue a compulsory licence to a local firm for producing a drug patented by a foreign company. Drug prices in India are regulated by the Drug Price Control Order (DPCO) issued under the Essential Commodities Act, 1955. It fixes the prices of drugs based of the cost of manufacturing and reasonable return to the producer. Grover says: "We are arguing for ARVs to be included under the DPCO. The problem is that, of late, the government has been reducing the number of drugs on the list on the grounds that liberalisation requires it."

There are many international norms that support the right to access of the health care of PLWHAs. India is a signatory to the United Nations General Assembly Special Session Declaration of Commitment, 2001(UNGASS Declaration of Commitment). Paragraph 55 of the declaration makes it obligatory for states to "make every effort to provide progressively and in a sustainable manner, the highest attainable standard of treatment for HIV/AIDS , including the prevention and treatment of opportunistic infections and effective, quality-controlled ARV therapy in a careful and monitored manner to improve adherence and effectiveness and reduce the risk of developing resistance...", by 2003.

The United Nations Economic and Social Council in its 59th session in April 2003, called upon states "to develop and implement national strategies, in accordance with applicable international law, including international agreements acceded to in order progressively to realise access for all to ... goods, services and information as well as access to comprehensive treatment, care and support for all individuals infected and affected by pandemics such as HIV/AIDS, tuberculosis and malaria."

The Committee on Economic and Social and Cultural Rights has laid down certain core obligations with respect to the right to the highest attainable standard of health as laid down by Article 12 of the International Covenant on Economic and Social Rights.

India's Supreme Court, in a series of cases, including Parmanand Kataria vs Union of India and Others (1989), Surjit Singh vs State of Punjab (1989), Dr. Ashok vs Union of India (1997) and State of Punjab vs Ram Lubhaya Bagga (1998), has interpreted the right to life provided by Article 21 of the Constitution to include the right to health and a healthy life. In Vincent Panikulangara vs Union of India (1987), the court has held that maintaining and improving public health has to rank high among the state's obligations, as this is indispensable to the physical existence of the community.

One option before the government is to rely on the funds released to it by the Global Fund to Fight HIV/AIDS, tuberculosis and malaria (or the Global Health Fund). India has received $100 million for HIV/AIDS and $30 million for tuberculosis. The government's proposal provides for ARV prophylactic care to 350,000 HIV-positive pregnant women and their families and ARV treatment to 15,000 PLHWAs through public-private partnership with pharmaceutical companies. The funds have not been made available as yet. The fund is an international public-private partnership and, unfortunately, contributions to it have been slow to come. Though the Indian government could use the resources, there are legitimate fears that this could have implications for the independence of the government in making policy decisions on public health - a fear that is accentuated in a situation where there remain many unanswered questions on the viability of providing ARVs through the public health system in the country.