Indira Gandhi declared India's policy when she said, "idea of a better world is one in which medical discoveries would be free from patent and there will be no profiteering from life and death
". What happened to this policy? How did India - a champion of the world's poor and a major supplier of cheap medicine - miss the wood for the trees?
The Government of India initiated to amend the Patents Act 1970 to introduce product patent protection to drug, medicine or food. A Patent Amendment Bill was introduced to this effect in the 13th Lok Sabha but the Bill lapsed due to the dissolution of Lok Sabha. In the last week of August 2004, the Cabinet decided to refer the Bill to a Group of Ministers (GOM) to study the implications of contentious issues in the Bill. The provisions of the referred Bill were identical to the lapsed Bill. This was a matter of concern as the Bill in its present form seriously compromised on the accessibility and availability of medicines, two important components of right to health. The right to life and health is a fundamental right guaranteed to every person living in India and is non-negotiable.
India has amended the Patents Act in 1999 and 2002 to comply with the obligations of Trade-related Aspects of Intellectual Property Rights (TRIPS). The only pending obligation with regard to TRIPS is the introduction of product patents to medicines and agro-chemicals.
The product patent prohibits others from making, using, offering for sale, selling or importing the patented product. As a result, the product patent gives a monopoly to the patent owner for the production of patented article during the term of the patent (20 years).
Therefore, product patent protection for medicines and agro-chemicals creates monopoly and eliminates competition in the pharmaceutical market. Drug companies often abuse the patent monopoly and fix exorbitant prices for the patented medicines. The introduction of product patent thus reduces accessibility and affordability of drugs.
The net result of the TRIPS accord has been high cost of medicines and the consequent denial of access to medicines to the poor across the globe . Further, it has also led to a situation where medicines required to treat diseases that predominantly occur among the poor are not researched at all. Instead drugs that are being researched are drugs used for "lifestyle" diseases like impotence, baldness, obesity, etc . While the pharmaceutical industry claims that high prices are explained by the massive expenditure on R&D, the truth is that drugs they actually research have little relevance to real medical needs. Moreover, the kinds of profits that big pharmaceutical MNCs generate are an indication of profiteering and not just legitimate profit making.
Before signing of the WTO agreement, and in the ensuing 10 years till date, globally as well as in the country, diverse contentions have emerged about the impact of TRIPS compliant Patent Laws on domestic industry - especially in developing countries. There is, however, a wide consensus that domestic laws, while being TRIPS compliant, need to make full use of "flexibilities" available in the TRIPS agreement. This was reiterated in unequivocal terms by the WTO Doha Declaration on TRIPS Agreement and Public Health (2001), which, inter alia, commented that countries have the sovereign right to enact laws that safeguard domestic interests. It recognised the gravity of public health problems in developing countries and clearly provided that the member countries had the right to protect public health and to promote access to medicines for all.
Health and Patents
Health is one of the fundamental basic needs of all human beings. In legal terms, fundamental human rights treaties recognise the right to the 'enjoyment of the highest attainable standard of physical and mental health' . Health policies encompass a number of elements, from prevention to cure and access to drugs. While all elements are important, the question of access to drugs stands out in the context of the TRIPs Agreement.
Access to drugs generally requires their availability and affordability. There is thus a strong link between economic poverty and access to drugs. A group of international organisations recently estimated that less than 10 per cent of people living with HIV/AIDS in developing countries have access to antiretroviral therapy . The HIV-AIDS epidemic across the globe, and particularly in African countries, has devastated entire countries. The epidemic has served to focus on the inhuman conduct of global pharmaceutical MNCs who continue to sell drugs to treat HIV-AIDS at 20-50 times their actual cost by seeking shelter under laws mandated by the TRIPS agreement. In fact it was left to Indian companies like Cipla to offer these drugs at vastly reduced prices and thereby provide some succour to those affected by HIV-AIDS . The conduct of these MNCs has also led to an upsurge of public opinion the world over, including in the US and EU, questioning its rationale, particularly in the area of public health. Organisations such as the Medecens Sans Frontieres (Doctors Without Borders) have provided a powerful voice to this upsurge and soon became a global force contending the rationale of the new IPR regime. These developments ultimately resulted in the Doha Declaration on TRIPS Agreement and Public Health (November 2001) seeking to limit, to some extent, the damage done by the TRIPS agreement and its underlying philosophy.
The Controller of Patents has granted an Exclusive Marketing Right (EMR) to Novartis AG, for the drug called Gleevec used for the treatment of patients suffering from Chronic Myeloid Leukemia (CML), a life threatening form of cancer. EMR is granted as a transitional arrangement before providing product patent protection. Gleevec is sold by Novartis AG at Rs. 1,20,000 per month. The generic version of the drug was otherwise available to CML patients at Rs 9,000-12,000 per month . The EMR, if enforced will result in the withdrawal of generic version of Gleevec from the market. Consequently, the overwhelming majority of patients that suffer from CML every year in India will be denied access to this life saving drug.
Human Rights And Patents
The relationship between human rights and intellectual property requires elaboration. On the one hand, intellectual property does not provide much guidance concerning its links with other fields of law. On the other hand, human rights treaties show that the interests of the patent holder are recognised but not as fundamental rights and that the interests of the community at large come first.
TRIPs was adopted as a stand-alone agreement which makes no mention of the impacts it can have, for instance, in the field of health. Nevertheless, WTO member-states that are also parties to human rights treaties cannot draft legislation to implement WTO obligations without considering its compatibility with other international obligations, such as human rights commitments. In fact, the UN Committee on Economic, Social and Cultural Rights has specifically indicated in the case of the right to health that states should not agree to measures that are manifestly incompatible with their previous international legal obligations.
Even though the formulation of the right to health at the international level is vague, it gives at least a broad framework within which health policies should fall. Thus, it imposes on governments to progressively facilitate access to drugs. Since patents on drugs tend to push prices up, governments have a duty to ensure that the introduction of product patents does not jeopardize access to drugs. Indeed, not only should states refrain from taking any steps that limit access to drugs but also they should also actively pursue better access over time. In this sense, it is doubtful whether the amendment to the Patents Act of 1970 can stand scrutiny under human rights treaties. The 1970 Act introduced a number of limitations on the scope of the rights granted to patent holders with specific public health goals in mind. As widely acknowledged, the provisions of the 1970 Act may not have solved the problem of access to drugs, but they contributed to improving access. Dismantling the whole regime amounts to taking several steps back in terms of access to drugs. This seems even truer in the context of the HIV/AIDS crisis, where some of the existing drugs are often available only at prices that are prohibitive for the general public.
The patents bill attempts to put India in compliance with its TRIPs obligations. In the process, it sets aside some of the most salient elements of the current legal regime which, together with other instruments such as the Drugs Price Control Order, have generally served well the interests of the country and its inhabitants. It is likely to bring about a legal regime that is less favourable from the point of view of access to drugs for the people of this country. The rationale for introducing the bill in this form was partly that TRIPs does not provide much flexibility in the way it can be implemented. This has now been proved wrong as the examples from South Africa and Brazil indicate. There is today scope for flexibility within TRIPs itself. Further, TRIPs cannot be implemented in isolation. India has a number of other international obligations, particularly in the field of human rights. As interpreted by UN human rights organs, the right to health requires that countries progressively take positive steps towards facilitating access. Dismantling the 1970 regime may constitute a violation of India's obligations under the Covenant on economic, social and cultural rights. There are thus compelling reasons for redrafting the patents bill in a way which neither threatens the country's interests nor constitutes a potential violation of human rights.
So far we have dealt with arguments, which says as to why patent regime in India should be kept out of the purview of medicines. Now we look at the whole discussion from an International perspective. It can be categorized as follows:
1) United Nations
One key issue at the Special Session of the UN General Assembly (UNGASS) on Social Development was the right of people to essential medicines at affordable prices, and how this right is being undermined by patents and the intellectual property rights regime established by the WTO's TRIPS Agreement.
AT the end of the 24th Session of the United Nations General Assembly Special Session (UNGASS) in Geneva, governments agreed, after tough negotiations, that they would be allowed to freely exercise options already available to them under international trade agreements to protect and advance access to life-saving and essential medicines.
In terms of real progress in addressing the need of developing Countries and poor people's access to life-saving drugs, not much was achieved. In terms of bringing to light the efforts of some of the developed countries in pushing the agenda of pharmaceutical corporations, quite a bit was achieved.
2) Doha Declaration on Health
The Declaration neither amends the TRIPS Agreement nor provides a basis for developing Countries to link their patent and health legislations. The Patents (Amendment) Act, 2002 closely follows TRIPS and in the process does away with provisions of the 1970 Act that constituted India's own response to the challenge of providing exclusive commercial rights in a field concerned with the fulfillment of basic health needs.
The provisions of the 1970 act and similar legal regimes in other developing countries have been the source of significant complaints by the private sector pharmaceuticals industry in developed countries. The US pharmaceuticals lobby estimates that it currently loses more $1.7 billion annually because of India's insufficient intellectual property protection.
The Doha Declaration is a direct consequence of the multiple controversies concerning patents in the health sector, particularly in the context of the HIV/AIDS epidemics. Its importance is linked to the recognition that the existence of patent rights in the health sector does not stop from taking measures to protect public health. More specifically, it affirms that TRIPS should be
"interpreted and implemented in a manner supportive of WTO members right to protect public health and, in particular, to promote access to medicines for all"
. This strengthens the position of countries that want to take advantage of the existing flexibility within TRIPS. In other words, the declaration does not open new avenues within TRIPS but confirms the legitimacy of measures seeking to use to the largest extent possible the in-built flexibility found in TRIPS.
The declaration focuses mainly on questions related to the implementation of patents, such as compulsory licensing.
Compulsory licensing has long been used as a tool to regulate the exclusive rights conferred by patents. In the case of health, the rationale is to make sure that the existence of a patent does not create a situation where a protected medicine is not available to the public because of non-health related factors. The Patents Act, 1970 provided an elaborate regime that included both compulsory licences and licences of right . The TRIPS Agreement has not done away with the notion of compulsory licences but provides a more restrictive framework than the current regime in force in India. The recognition in the Doha Declaration that TRIPS member-states can use the flexibility provided in the agreement and can, for instance, determine the grounds on which compulsory licences are granted must thus be understood in the context of a generally increasingly restrictive international patent regime.
The declaration has been hailed as a major step forward in the quest for making the TRIPS Agreement more responsive to the needs of developing countries and more specifically to individuals who are unable to afford the cost of patented drugs. In fact, it addresses a number of important issues related to the implementation of medical patents. However, it fails to take up the much more fundamental questions of the scope of patentability and the duration of patents in the health sector. The Doha Declaration remains an important instrument in India for two main reasons. Firstly, at a political level, India was amongst the most vocal developing countries at the ministerial conference in putting forward developing Countries' interests . Secondly, the declaration was adopted while the joint committee of Parliament was finalizing its report.
3) Forthcoming WTO Negotiations
At this juncture, the WTO is far from providing a comprehensive response to the needs of developing Countries in the field of health in general. At the most, the Doha Declaration provides a temporary respite in some limited areas. The declaration does not even indicate that negotiations in the new round of trade negotiations will necessarily go towards a relaxation of the TRIPS requirements in this field. In fact, the recent aggressive posturing of the US pharmaceuticals industry seems to suggest that significant lobbying for further strengthening of patent rules is likely to take place in the future.
On the whole, the Patents (Amendment) Act, 2002 closely follows TRIPS and in the process does away with provisions of the 1970 Act. Firstly, there has been no official change in the policy underlying the Patents Act to justify such drastic changes. Secondly, India's domestic and international commitments regarding the fundamental right to health of all individuals have not changed in the past decade. Thirdly, it appears that the introduction of product patents in 2005 will adversely affect access to medicines for crores of people. One factor pushing the government in this direction may have been the desire to favour its own private sector pharmaceuticals industry. However, it is striking that there is no unanimity on the part of the industry, which remains today completely or mainly domestic. Some large companies that produce mainly generic drugs have been completely opposed to changes in the 1970 Patents Act, some large companies that have developed significant R and D facilities feel that the new regime may provide them an opportunity to grow overseas while small companies generally seem to have understood that they are not important enough to influence policy-making significantly and must concentrate on surviving either independently or by linking up with bigger domestic or foreign companies.
India follows the incorporation theory . This means that a treaty does not become law until enacted by the Parliament. Following the WTO ministerial conference, the joint parliamentary committee on the Patents (Second Amendment) Bill, 1999 finalised its report in December and submitted an amended version of the amendments to parliament . The recently passed legislation must therefore be analysed in the context of the declaration on the TRIPS Agreement and public health (Doha Declaration) and other relevant factors. By giving greater credence to WTO deadlines than democracy, India is prepared to
jeopardize its sovereignty . The WTO is not the only treaty that India has to comply with. The Supreme Court decisions culminating in and following
Vishakha's case (1997) have directly imported many human rights into the life and liberty provisions of Article 21, including the right to health. The WTO cannot over-ride these obligations. India this way is also putting its sovereignty, status, prestige and obligations at risk . Medicine without social justice is unacceptable. Patents are not a gift for drug companies to exercise power without responsibility. Given the importance of the issues at stake, the debate concerning the impact of medical patents on access to drugs is unlikely to subside in the near future even though the Patents (Amendment) Act, 2002 has just been adopted. This still leaves several years for further open debate concerning the final response to be given to TRIPS in the health sector.