Under the constitutionally guaranteed right to health, the Indian government has to do more to ensure that the most effective treatment is available to all HIV-positive people who need it, say Atiya Bose and Kajal Bhardwaj of the Lawyers Collective

The right to treatment for HIV/AIDS is as enforceable as treatment for any other disease. Article 21 of the Indian Constitution recognises every individual’s right to life and liberty, which the Supreme Court has held includes the right to health. The Supreme Court has also held that the maintenance and improvement of public health have to rank high amongst the State’s obligations, as these are indispensable to the very existence of the community.

Additionally, courts have ruled that providing adequate medical facilities for people is an essential part of the government’s obligation. Article 47 of the Indian Constitution, which is a Directive Principle of State Policy, also directs the State to regard the improvement of public health as amongst its primary duties. India is also a signatory to various international instruments that strengthen its commitment to ensuring the highest attainable standard of health for its people. Therefore, the Indian government has a duty to protect and preserve the health of its citizens, which in the context of HIV/AIDS addresses the crucial issue of providing universal access to treatment.

The emergence of antiretrovirals (ARVs) as a treatment for HIV has drastically improved the quality of life, and prolonged the lifespan of persons living with HIV/AIDS (PLHA). Through the use of ARVs, HIV has gone from meaning certain death, to being a chronic but treatable life-long condition. HIV and AIDS care therefore necessitates antiretroviral therapy (ART) as a treatment option. ARVs also play a significant role in reducing the risk of transmission by drastically lowering a person’s viral load lowering the chances of the transmission of the virus. Providing ARVs is a matter of treatment as well as prevention, and is therefore the critical means by which the government can discharge its duty to ‘protect and preserve the health of its citizens’.

Second-line treatment for HIV

India has provided free ARVs since 2004, and now, three years into the programme, several PLHA are developing resistance and need newer first/second-line drug regimens in order to stay alive. Conservative estimates suggest that already about 3000-5000 people receiving ART from the government sponsored programme need second line drugs. Though these are expensive, the government is bound to provide them.

The experience with first line ARVs showed that with increased demand and availability of drugs from different producers, prices were drastically slashed. In January 2008, the Indian government started a pilot programme offering second-line antiretroviral drugs to five people who had developed resistance to first line drugs. The drugs, provided by the Clinton Foundation, cost Rs 8000 per month. The pilot programme will run till June 2008 and will then be replicated in 10 other ‘centres of excellence’ across the country.

Intellectual property regimes

ART is expensive largely due to intellectual property regimes that have created monopolies in which multinational pharmaceutical companies are able to charge exorbitant prices for ARVs. Prior to amending its patent laws in 2005 in compliance with the World Trade Organisation’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), India had developed a dynamic generic pharmaceutical industry that produced a significant proportion of the ARVs used throughout the world.

This was because Indian patent law only granted ‘process’ patents and not ‘product’ patents, meaning that a pharmaceutical company only got a monopoly on its process for arriving at a drug and not on the drug or molecule itself, allowing other companies that devised different processes to create the drug or molecule to also manufacture and sell generic versions of drugs.

The advent of these generics forced the prices of once unaffordable ARVs down, from US$ 10,000 to US$ 130 in 2001, showing that the only way to make lifesaving drugs affordable, available, and accessible, is by promoting competition. India, too, could afford to start providing much needed ARV treatment on a limited scale from 2004. The Supreme Court in the Sankalp case on HIV related discrimination in healthcare settings is also hearing issues related to the provision of HIV treatment by the government.

Since January 2005, amendments to India’s Patent Act 1970 have been in effect and India now grants 20 year patents or monopolies on drugs; India’s ability to produce the newer and more effective first and second line HIV drugs has accordingly been jeopardised. However, public pressure during the passing of the 2005 amendment to the Patents Act did result in the inclusion of key public health safeguards in India’s patent law. This includes Section 3(d) which has been included to prevent evergreening, that is, the practice of pharmaceutical companies to extend their monopolies by making minor changes or modifications to existing molecules or finding new uses for them or new forms. India’s patent law also allows ‘oppositions’ both before and after the grant of a patent.

The case of ‘imatinib mesylate’ is most relevant in these discussions. In 1998, the Swiss multinational pharmaceutical company, Novartis AG, filed a patent application in the Chennai Patent Controller's office for the B-crystalline of imatinib mesylate, brand name Glivec (Gleevec) on the ground that they invented the salt form (imatinib mesylate) of the free base, imatinib, as also the B crystalline form. The patent application was not opened until 2005 when India’s patent law changed. In the meantime, Novartis was selling Gleevec at Rs 1,20,000 per patient per month while generic companies were selling their versions at Rs 8000-10,000 per patient per month.

In 2005, the Cancer Patients Aid Association filed a pre-grant opposition against Novartis' patent application for imatinib mesylate claiming, among other things, that Novartis' alleged "invention" lacked novelty, was obvious to a person skilled in the art, and that it was merely a "new form" of a "known substance" that did not enhance the substance's efficacy, and was thus not patentable under section 3(d) of the Patents Act.

In January 2006, the Chennai Patent Controller, in a landmark decision, rejected Novartis’ patent application. The rejection meant that generic companies could manufacture and market their drug, both in India and abroad. However, in May 2006, Novartis filed writ petitions before the Madras High Court, claiming that the Patent Controller erred in rejecting its patent application, and further challenging the constitutional validity of section 3(d) of the Indian Patents Act claiming that it was, among other things, vague, ambiguous, and contrary to the requirements of TRIPS. A series of hearings on the case were held from January to April of 2007 and in August 2007 the Madras High Court rejected Novartis’ challenge and ruled that it had no jurisdiction to decide whether Indian patent laws complied with intellectual property rules which are set by the World Trade Organisation. The WTO was therefore the proper forum to resolve this question. (Only countries, not individuals or companies, can approach the WTO disputes settlement tribunal).

Civil society organisations have also filed several pre-grant oppositions to key drugs. The Patent Act also has several other key provisions like compulsory licensing which the government will have to consider using if drugs remain unaffordable and unavailable.

Susceptibility to quacks

PLHA have been found to be exceptionally susceptible to untested cures and treatments advertised and sold by charlatans and quacks, and many PLHA have spent, and continue to spend vast amounts of money they can ill-afford, on fake remedies and medicines. This heightened susceptibility arises out of the absence of a cure for HIV, the high costs of antiretrovirals (ARVs) and the desperate hope of being cured of an infection that attracts social ostracism the way HIV does.

The term ‘quack’ can include unqualified practitioners, persons who prescribe or dispense substances, powders or drugs that are unlicensed, licensed medical practitioners who cross-practice and tantriks or godmen who claim cures by way of magic remedies. Indian laws do not directly prohibit or deal with quackery, and provisions in the existing law that prohibit the practice by unregistered medical practitioners in specific areas of medicine are used to deal with quacks. Legal restrictions have also been imposed on advertisements that mislead or give false impressions of a drug or make a false claim for it.

The false claims about cures for AIDS that are made by quacks are a problem not only because they are patently untrue, bolster hope on false pretences, and fleece PLHA of their money, but also because they are dangerous, and can have serious health consequences for the person who is taking the cure. There have been instances of people stopping ARVs based on a quack’s claim of being able to cure them by other means. The problem is, once you discontinue ARV treatment, you cannot restart it because you develop drug immunity, and so you essentially cut yourself off from the only known treatment that can help improve the quality of life for PLHA. From the public health perspective interruptions in treatment can mean the emergence of drug resistant strains of HIV. The schedule to the Drugs and Cosmetics Act, 1940 prohibits any claim that a drug prevents or cures AIDS while the schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 specifically prohibits advertisements that claim cures, treatment or prevention of AIDS.

The case of Indian Network of Positive People v T.A. Majeed & Ors. [Order of the Supreme Court in SLP (Civil) No(s). 5527/2004 dated 03/01/2007] is an instance of the courts in India responding to the issue of false claims for HIV cures. T A Majeed was licensed by the Drug Controller of Kerala to manufacture 'Immuno QR' powder, an ayurvedic medicine that claimed to increase immunity. When Majeed started selling Immuno QR as a "cure" for AIDS, the Drug Controller cancelled his licence.

Extensive litigation in the Kerala and Bombay high courts ensued as a result of which Majeed was prevented from advertising, but was allowed to continue manufacturing and selling his drug. Eventually, the Indian Network for Persons living with HIV/AIDS (INP+) filed a special leave petition in the Supreme Court asking for the manufacture and sale of Immuno QR to be stopped. In January 2007 the Supreme Court directed Majeed to stop manufacturing and selling Immuno QR till the final disposal of the cases pending in the Kerala high court, which was also directed to expedite the hearings in the cases.

(Atiya Bose is media and communications officer and Kajal Bhardwaj is head of the technical and policy unit at the Lawyers Collective HIV/AIDS Unit. The Lawyers Collective HIV/AIDS Unit was set up in 1998 based on a realization that law, policy and judicial action that upheld the human rights framework had a central role to play in effectively containing the HIV epidemic. The Unit comprises lawyers, law students and activists working in offices in Mumbai, Delhi and Bangalore, and offers free legal services to persons living with, affected by or vulnerable to HIV and undertakes advocacy and research initiatives related to law, rights and HIV.)

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