Access to medicines
Affordable Medicines and Treatment Campaign
[L]ife in good health and free from disease is the foremost human right and is a constitutional fundamental. The humbler the Indian human, the higher the State’s duty to protect the person.
Mr. Justice V.R. Krishna Iyer, Former Judge, Supreme Court of IndiaFormer Judge
My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death.”
Mrs. Indira Gandhi, Prime Minister of India, World Health Assembly, 1981Prime Minister of India
Can private actors be allowed to determine whether or not a person ought to live or die? For this, is precisely what patents, which allow the patent holder to exclude other competitors for a certain period and set monopolistic prices, do. By setting exorbitant prices on medicines, the patent holder basically tells a patient, “If you want to get well, be prepared to pay me the price I demand.” This was brought vividly to the fore in the late 1990s in Africa in the context of access to medicines to treat HIV.
Against a backdrop of the glaring inequity in access to lifesaving anti-HIV medicines and the impending change to the Indian patent lawwith respect to medicines, described below,the Lawyers Collective HIV/AIDS Unit, along with other Indian civil society actors, launched the Affordable Medicines and Treatment Campaign.
When HIV was first detected in the 1980s, there was no medicine available to treat HIV itself, no medicine that would halt or reverse HIV progression. HIV progression rendered people living with HIV susceptible to opportunistic infections. These opportunistic infections could be treated. But, further HIV progression and the accompanying decline of the immune system, would render the medicines to treat opportunistic infections ineffective. HIV progression, absent any treatment, then meant inevitable certain death on account of opportunistic infections and other conditions. In the mid-1990s, it was discovered that certain antiretrovirals (ARVs), when taken in combination, could be used to treat HIV, to halt HIV progression and even reverse it. This transformed HIV from a death sentence to a manageable chronic condition.
But, this transformation came with a price tag attached. Pharmaceutical companies in the West, who manufactured these medicines, priced the medicines at over USD 10,000 per patient per year. This meant that the transformation could be realised primarily by persons living with HIV in the developed world, who were able to buy the medicines themselves or through insurance cover or government-sponsored social security schemes. For millions of persons living with HIV in the developing countries, HIV continued to remain a death sentence. Thousands of people lost their lives, despite treatment being available. This was brought home to the Lawyers Collective HIV/AIDS Unit when some of its clients died due to HIV-related complications without access to antiretrovirals. In a moving speech—the Jonathan Mann Memorial Lecture—delivered at the International AIDS Conference in Durban in 2000, Justice Edwin Cameron, a judge living with HIV, described himself as the “living embodiment of the inequity of drug availability and access in Africa” and said, “I am here because I can afford to pay for life itself.”
In 2001, Indian pharmaceutical companies were able to offer a fixed dosed combination of ARVs at a price of USD 350 and lower per patient per year as against a price of USD 10,000 per patient per year charged by multinational pharmaceutical companies. The absence of product patent protection for medicines in India was what enabled Indian pharmaceutical companies to make generic versions of these medicines and fixed dose combinations thereof. The availability of ARVs at low prices made it possible to upscale access to treatment for persons living with HIV in the developing world.
How were Indian companies able to offer the same medicines at such low prices—at a fraction of the cost charged by multinational pharmaceutical companies from the West? This was possible primarily due to the fact that India did not recognise product patent protection for medicines. Until 1972, India provided product and process patent protection for medicines. The consequent import dependence and exorbitant prices of medicines—amongst the highest in the world—led India to change its law. In the 1970s, India changed its patent law to exclude product patent protection for medicines in the Patents Act, 1970. It did, however, continue to provide protection for process patents on medicines. The absence of product patents allowed generic competition, which led to low prices of medicines. Indian generic companies became, and remain today, the largest supplier of low-cost generic medicines throughout the developing world. With the conclusion of the Marrakesh Agreement establishing the World Trade Organization (WTO), of which India was a founding member, however, all this was set to change.
The Marrakesh Agreement included the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). The TRIPS Agreement was pushed for by the developed countries at the behest of vested private interests of pharmaceutical companies. Developing countries, under the threat of sanctions, were constrained to consent to the inclusion of intellectual property in the trade agreement. Under the TRIPS Agreement, it would be mandatory for WTO-member countries to provide product and process patent protection for inventions in all fields of technology, including medicines. Yet, the TRIPS Agreement reflected a compromise between developed and developing countries. For instance, developing countries fought to ensure that it contained certain flexibilities that allow them to take measures to protect public health.
As a developing country which, in 1995, did not provide product patent protection for medicines and agrochemicals, India had until 2005 to change its patent law. Nonetheless, a change in India’s patent law to provide product patent protection for medicines was imminent.
Against this backdrop, Lawyers Collective HIV/AIDS Unit organised a national consultation with civil society actors in August 2001 in Mumbai. Subsequently, the Affordable Medicines and Treatment Campaign was launched on World AIDS Day that year—on 1 December 2001. The objective of the Campaign is to demand and create an environment that will ensure sustained accessibility and affordability of all medicines and treatment for every individual in India, including access to affordable medicines for people living with HIV. The Campaign envisions a democratic and participatory involvement of civil society and key stakeholders in all the initiatives taken to ensure access to affordable medicines and treatment.
Post 2001, through the campaign, Lawyers Collective HIV/AIDS Unit started working on intellectual property issues affecting access to medicines. It engaged in litigation to challenge the grant of exclusive marketing rights—a monopoly right that could be granted to pharmaceutical companies in the interregnum transition period allowing them to prevent others from marketing the medicine for which it had applied for a patent in India post-1995. This litigation marked the beginning of a case, now known as the Novartis case, which would influence subsequent legislative developments and which is also likely to set the way public health safeguards in India’s patent law will be interpreted.
Simultaneously, the Lawyers Collective HIV/AIDS Unit engaged in advocacy to challenge the lack of transparency and consultation with civil society stakeholders by the Government on the impending amendment. It underscored the likely adverse impact of the product patent regime on prices of medicines and also the importance of ensuring that the patent law contained public health safeguards.
Given that the impact of the impending change in India’s patent law would affect patients in other developing countries too, Lawyers Collective HIV/AIDS Unit also started engaging with treatment activists and civil society actors from the Global South. In March 2005, it organised the first Global South Dialogue on HIV/AIDS and Access to Medicines at Mumbai. The opening of this conference coincided with the tabling of the Patents Amendment Bill, 2005 in Parliament—a bill to make India’s law TRIPS-compliant by reintroducing product patents for medicines in India.
Extensive advocacy—both national and international—by civil society actors ultimately resulted in the retention and inclusion of key public health safeguards in the Patents Act, 1970, when Parliament finally amended by patent law in 2005 to make India’s patent law TRIPS-compliant. One such public health safeguard in the patent law is the establishment of stricter patentability criteria. In a bid to prevent evergreening—a practice of pharmaceutical companies to obtain multiple follow-on patents on the same medicine in a bid to extend their monopolistic period—Indian Parliament excluded patenting of new forms of already known substances unless there was a significant enhancement in efficacy [section 3(d), Patents Act, 1970]. Other public health safeguards include retention of pre-grant opposition proceedings, inclusion of post-grant opposition proceedings and amendment of provisions relating to compulsory licensing.
Presently, India is the primary source of generic medicines for patients in the developing world. How the product patent regime on medicines affects this remains to be seen.
New threats continue to emerge. Developed countries are now attempting to push through their unfinished agenda at WTO through regional and bilateral trade and economic partnership agreements. These agreements generally push for greater levels of intellectual property protection and enforcement, which are beyond countries’ present obligations under the TRIPS Agreement and which are not compatible with the needs of developing countries. There are also efforts to restrict the use of flexibilities available to countries under the TRIPS Agreement. Of particular concern to India are the multi-pronged efforts to dilute public health safeguards in the Indian patent law.
After the introduction of the product patent regime for medicines in India, Lawyers Collective HIV/AIDS Unit has been engaged in litigation to use the public health safeguards and also oppose attempts to introduce TRIPS-plus provisions in the Indian law. As a component of this, it provides free legal and technical aid to patients’ groups to file patent oppositions against key life-saving medicines. It also provides free legal aid to patients’ groups in other cases, where issues pertaining to intellectual property are likely to have an impact on availability of and accessibility to medicines.
The Lawyers Collective HIV/AIDS Unit also engages in research and advocacy on various issues pertaining to intellectual property rights and other issues that affect pricing, availability of and accessibility to medicines to counter any legislative or regulatory moves that would adversely affect access to medicines.