The Patents Amendment Act and access to medicines
The new Patents Act uses some of the exceptions and qualifications included in TRIPS to foster public health goals.
Some of the amendments to the Patents Act required by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have just been adopted by Parliament. Among the many issues dealt with by the amendments, one of the most debated questions has been their impact in the health sector and more specifically on access to medicines. The debates are unlikely to subside with the adoption of the Bill. On the one hand, the amendments have already been attacked for not going far enough to allow compliance with the TRIPS Agreement. On the other hand, the amendments are fundamentally changing the 1970 Patents Act and are likely to negatively affect people's access to medicines.
To understand how significant the adopted amendments are concerning access to medicines, it is necessary to look back at the regime adopted in 1970. The law adopted then drastically restricted the rights of holders of medical patents to foster the availability of cheaper medicines. The patents legislation together with other measures such as price control have had significant positive impacts: Medicine prices have, for instance, decreased significantly since the 1960s compared internationally. Further, there is now a vibrant local generic pharmaceutical industry. In addition, some local companies have developed sufficient expertise to produce their own new medicines.
The TRIPS Agreement has imposed the wide-ranging changes that have just been adopted. The controversial nature of these amendments explains in fact why the Government was initially reluctant to accept TRIPS in the WTO context and why Parliament initially refused to adopt the first Patent Amendment Bill in 1995. The changes imposed by TRIPS on India include increasing the duration of all patents to 20 years, broadening the scope of patentability and the introduction by 2005 of product patents on medicines. These legislative modifications will eventually lead to higher medicine prices in India.
While the TRIPS Agreement lays down a number of precise standards and rules, it also includes a number of exceptions and qualifications. Over the years, the exceptions and qualifications have been largely ignored or sidestepped in most developing countries. Following increasing controversies concerning the impact of TRIPS in the health sector, the last WTO ministerial conference addressed the issue of health and adopted a Declaration on the TRIPS Agreement and Public Health (Doha Declaration). The Doha Declaration does not modify TRIPS but restates that member States are allowed to fully use the exceptions provided in the treaty to foster public health goals. In other words the Declaration gives countries like India further authority to fully use the exceptions and qualifications provided in TRIPS. The amendments just adopted by Parliament must be read in the context of the recently adopted Doha Declaration.
Two main trends
The new Patents Act is characterised by two main trends. On the one hand, it generally follows quite closely the requirements of the TRIPS Agreement. The amendments thus generally alter the balance between the interests of patent holders and the interests of society at large in favour of the former. The duration of patents in the health sector is, for instance, dramatically increased from seven to 20 years. The amendments also strike out an important provision of the Act seeking to oblige patent holders to manufacture their inventions in India.
On the other hand, the new Patents Act uses some of the exceptions and qualifications included in TRIPS to foster public health goals. It uses, for instance, the health-related exceptions in Sec. 3 of the Act which determines which inventions are not patentable. Some of the most interesting and most controversial new provisions are found in the chapter on compulsory licensing. While TRIPS generally imposes a stricter compulsory licensing regime than what was provided under the Patents Act, 1970, the amendments strive to make use of some of the possibilities opened by the Doha Declaration. The section of the compulsory licensing chapter (Sec. 83) which sets out the general principles applicable to compulsory licensing is particularly noteworthy. It specifically mentions that patents granted should not `impede protection of public health' and should not prohibit the Central Government from taking measures to protect public health. Further, it recalls that patents should be granted to make the benefits of the patented invention available at reasonably affordable prices to the public.
On the whole, the framework for compulsory licensing set out in Sec. 83 is quite progressive from the point of view of access to health. However, the most noteworthy feature of the principles set out is that they only inform the specific chapter on compulsory licensing. The Doha Declaration generally recognises member States' right to take measures to protect public health. This is not limited to compulsory licenses but applies generally to patenting in the health sector. In other words, there is no reason why the principles enunciated at Sec. 83 should only apply at the level of the implementation of patents. It is noteworthy that while the amended Patents Act does not make innovative use of the leeway provided by the Doha Declaration beyond Sec. 83, some members of the Joint Parliamentary Committee on the Patents Bill did propose an exception to the uniform 20-year rule for medical patents. The fact that these progressive principles do not inform the whole Patents Act are indicative of the increasingly regressive nature of the debates concerning patents in the health sector. Indeed, while ten years ago the issue of patentability in the health sector was a subject of intense discussion, the amended Patents Act shifts the debate to the single issue of compulsory licensing, and thereby indirectly creates a situation where it will become extremely difficult to discuss broader issues in the future.
On the whole, the amended Patents Act is noteworthy for dismantling most of the specificities of the 1970 Act. The 1970 Act constituted a carefully crafted response to specific socio-economic challenges that has served India well over the past three decades. It is therefore surprising that the removal of exceptions meant to foster better access to medicines has happened without any revision of the underlying policy. In fact, the socio-economic needs are more or less the same as before as universal access to medicines has not been achieved. Further, while India's intellectual property obligations have changed with the TRIPS Agreement, its obligations in the field of the human right to health have not changed in recent decades. A significant shift in the orientation of the patent policy in the field of health without careful consideration of the implications for the right to health is thus surprising. There is still scope for debate in the next few years since product patents on medicines do not have to be introduced before 2005. This may give a chance for a further broad-based debate on the advantages and shortcomings of strengthening the patents system in the health sector.