Justice Edwin Cameron
High Court of South Africa

http://www.lawyerscollective.org/lc-hiv-aids/Abstracts/abstracts.htm

When Justice Cameron spoke as quoted he echoed the HIV/AIDS reality that exists in much of the third world, including India. This reality is one in which most persons affected have little or no access to efficacious treatments for their condition. This reality exists mainly because of the exorbitant rate at which HIV related drugs including opportunistic infections and anti retrovirals (ARVs) are priced. Development of such drugs does not have any meaning without the larger community and those most in need having access to them. According to statistics 95% of people living with HIV/AIDS in the third world do not have access to affordable treatment.

One of the critical issues regarding accessibility of medical services and treatment of PLWHAs is the accessibility to drugs and this issue is of priority due to rapid and far-reaching changes in international and local legal regimes.

The Right to Health is well established as a part of every Indian citizen's Fundamental Right to Life. With the advent of the new legal regime, by 2005 access to drugs, an intrinsic part of a person's right to health, will be greatly affected. In the Indian scenario many factors play a part in limiting the accessibility of drugs for PLWHAs. They include:

1. Low purchasing power;
2. High cost of ARVs sold by pharmaceutical companies;
3. The lack of medical insurance schemes to reduce the burden on PLWHAs;
4. NACO's policy to provide free access for drugs to treat opportunistic infections but not ARVs;
5. A drastic change in law on intellectual property rights (IPRs) including the legal regime on atents, due to the enforceability of Trade Related Aspects of Intellectual Property (TRIPS).

The current law on drugs in India is governed mainly by the Drugs & Cosmetics Act which regulates research and development, manufacturing and quality control, the Drug Price Control Order (DPCO) which regulates the price of essential bulk & formulation drugs and the Patents Act which vests monopoly rights in patent holders.

Significantly, the emphasis of the DPCO till initially was to control the prices of those drugs that were required on a needs basis by the Indian populace. However, there has recently been a shift in emphasis whereby drugs are price regulated not on the basis of need of essential drugs but on the market-oriented basis of being "popular" drugs. Therefore, instead of controlling prices based on the need of the consumer, prices are now controlled based on the extent of market ability of the drugs. Since market ability does not necessarily reflect the need for drugs, especially among the vast Indian population for whom drugs are a luxury, the basis of price control is questionable.

The other law that has a significant impact on accessibility to drugs in India is the Patents Act. Patents are monopoly rights granted to the inventor or the manufacturer to commercially exploit an invention and to prevent others from doing the same. The Patents Act recognises the patent right of an inventor in the process of manufacture of a drug. However, unlike many other legal regimes, Indian law does not recognise the patent right of an inventor in the product (drug) itself. Therefore, at present a foreign manufacturer (X) and patent-holder of a drug cannot prevent an Indian manufacturer (Y) from making the same drug by a different process - X's product patent is not recognised in India, although it's process patent is, thereby permitting Y to produce the same product by changing the process known as reverse engineering. However this shall no longer be valid from 1.1.2005.

In 1995 India became a founder member of the World Trade Organization (WTO) which made the TRIPS agreement binding on it. Effectively, after 2005 product patents for drugs will be recognised under Indian law as compared to the hitherto followed process patent regime. This means that Indian companies will not be able to manufacture most drugs to combat HIV/AIDS whose patents are held by foreign pharmaceutical companies patent holders. Due to the monopoly that these pharmaceutical companies have over the manufacture and sale of these drugs, they will be sold at highly inflated and unaffordable prices. These high prices will not be subject to price control since the criteria for the same under the DPCO ('popular use' as opposed to a need based approach) may not cover HIV related and other essential drugs.

At present, in the absence of TRIPS compliant patent protection in India, the drugs are available at much lower prices.

COMPULSORY LICENSING
TRIPS, however, does give certain grounds under which governments can take steps to combat this. These grounds would permit the Indian government to compulsorily license certain drugs that are necessary in case of (i) national emergency, (ii) extreme urgency, (iii) anti-competition or (iv) for purposes of public non-commercial use. Compulsory licensing is a license granted by governments to commercially exploit a patented product/process during the protected period on stipulated grounds. Under TRIPS these grounds are widely defined, as mentioned above. It is left to individual governments to further specify the grounds when they incorporate the TRIPS regime in their respective national legislations. Therefore, the Indian government would be entitled to issue compulsory licenses for the drugs if the circumstances satisfied one of the four-aforestated grounds and the provisions were included in the national legislation.

India would not be the first country to use this clause in the TRIPS regime to tackle the HIV/AIDS pandemic. Brazil, a country that is economically comparable to India and compliant with the TRIPS regime, has provided ARVs to all PLWHAs who access the public healthcare system, free of cost. The Brazilian government has used its own public sector industry and, under TRIPS ('public non-commercial use'), has been able to provide free ARVs to its 90,000 PLWHAs. This has been done after a cost-benefit analysis, which demonstrated that if the government provided free ARVs, it would save considerably on drugs for opportunistic infections and hospitalization.

It is important to note that this is a model many Latin American countries have adopted with success. However this initiative would not have been possible in the absence of strong community mobilization and political commitment on the part of the government. The rights of PLWHAs in some of these countries (Venezuela, Costa Rica, and Argentina) have been further strengthened by decisions of their respective Supreme Courts which have held that PLWHAs have the right of free access to treatment and ARVs.

What can be done?

In the present situation Indian law is likely to undergo significant changes by 1.1.2005 to comply with TRIPS. However, such changes must also confirm in with the Indian constitutional framework that mandates the Right to Health as an inalienable Fundamental Right of every citizen. Article 7 of TRIPS provides that IPR protection should be in a manner that is conducive to social and economic welfare. Article 8 provides that amendment of domestic laws should be in a manner necessary to promote public health, nutrition and matters of public interest vital to socio-economic and technological development. It is important to note that TRIPS does not prohibit price regulation.

In light of this, it is the duty of the State to balance the Right to Health vis-à-vis its obligation to comply with TRIPS. The same can be done by acting in consonance with the objectives of Articles 7 & 8 of TRIPS and, inter alia, clearly defining exemptions to be provided through compulsory licensing in the national legislation so as to cover situations such as drugs required for major outbreaks of various illnesses including HIV/AIDS. A change in the criteria under the DPCO for inclusion of drugs under price regulation so as to include HIV/AIDS related drugs is also necessary. An insurance system also needs to be set in place for HIV/AIDS related drugs so that they become more affordable for PLWHAs. Hand in hand with this the Indian government must consider subsidizing ARVs, much like Brazil, if the HIV/AIDS pandemic is to be successfully tackled. At the same time strict protocols will have to be laid down for healthcare workers regarding the administering of ARVs.

Like the Latin American experience, this will require political commitment on the part of the government. It will also require commitment of another kind which we must brace ourselves for - a commitment to mobilize the populace (and not just PLWHAs, but all those concerned about our public health system) in a manner which convinces the political will that beneficial legislation and action on this front are the need of the hour.

Such mobilization has begun in South Africa and was witnessed at the recent International AIDS Conference in Durban. A conference of such magnitude was held on the African continent for the first time and in a country where a significant proportion of the population has HIV/AIDS, nearly 20%.

As discussed earlier, people in developing countries face a severe crisis of access to drugs and treatment. ARVs are largely unavailable in developing countries and if available are priced beyond the means of most people.

UNAIDS, WHO and a group of pharmaceutical companies recently announced that they were discussing price reduction of HIV/AIDS drugs. Though it appears to be a positive development, no concrete action or commitments have emerged from these discussions thus far.

Medicines Sans Frontiers (MSF) and the Treatment Action Campaign (TAC) hosted a joint satellite conference at Durban entitled "Improving Access to HIV/AIDS Drugs in Developing Countries". Speakers from Africa, Asia, Europe and USA talked about access to care for people living with HIV/AIDS and addressed issues of drug pricing including legal and political strategies to widen access to treatment for HIV/AIDS in developing countries.

The TAC is a South African-based umbrella campaign backed by 230 AIDS organisations from around the world. It works for access to affordable and quality treatment for all people with HIV/AIDS in South Africa and supports the global campaign for access to life saving drugs. The primary aim of TAC is to raise public understanding about issues surrounding the availability and affordability of many HIV/AIDS treatments through mass mobilisation.

The main objectives of TAC are as follows:
1. Ensure access to affordable and quality treatment for people with HIV/AIDS.
2. Prevent and eliminate new HIV infections.
3. Improve the affordability and quality of healthcare access for all.

On July 9, 2000 thousands of people gathered outside the Durban City Hall to demand accessible and affordable treatment for people living with HIV/AIDS. This was followed by a march on the streets of Durban, organized by the TAC and endorsed by 230 organizations from 33 countries. Thousands of demonstrators marched in support of cheaper drugs for the care and support of people living with HIV/AIDS in developing countries. ANC Women's League President, Winnie Madikizela-Mandela demanded treatment for the 4.2 million South Africans living with the virus. She said that more than 1600 people in South Africa become infected with HIV every day and 16000 people die every year.

TAC spokesperson Zackie Achmat called on governments to immediately implement a program that would prevent women from passing HIV onto their children. He said that the march was the beginning of a long struggle for poverty-stricken communities to gain access to treatment. He also accused pharmaceutical companies of putting profits before people's lives and governments for making their budgetary constraints more important than their nation's needs.

The theme of the Durban conference was to "Break the Silence" - around the urgency with which access to drugs and care should be made available to PLWHAs and around the vacuum in global and national political will which is making such access virtually impossible for most. Now that such silence has been broken it is time that political will is driven to reform the law in such a manner that makes access to care and drugs for PLWHAs a concrete reality.

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Campaign against the Suspension of the
People Living with HIV/AIDS Right to Marry

May 20, 2000 - A public meeting was organized by Foundation For Integrated Research in Mental Health (FIRM), Trivandrum, to create awareness and open a debate on the suspended Right of People living with HIV/AIDS to Marry. The meeting was addressed by Mr. Anand Grover, Director, Lawyers Collective HIV/AIDS Unit, Dr.C.R.Soman, Director of Health Action of People (HAP), Mr. BRP Bhaskar, Human Rights activists and Paulson Raphal, Secretary of ACS, Thrissur. The meeting was well attended by students, doctors, lawyers, and NGO representatives.

A signature campaign to challenge the decision of the Supreme Court of India has also been initiated. A form letter for the signature campaign is available from the Lawyers Collective HIV/AIDS Unit via fax, e-mail or the website. The signatures will be sent as a formal representation to the Supreme Court of India on the behalf of concerned individuals who oppose the judgment of the Supreme Court and want to restore the fundamental right of people living with HIV/AIDS to marry.