Recasting the Debate on Intellectual Property Rights
THE DOHA DECLARATION on the TRIPS Agreement and Public Health was a symbolic and powerful statement reflecting the popular world-wide movement for access to medicines. The movement showed that patent rights do not justify denial of access and that pharmaceutical companies should not consider developing countries merely from a marketing point of view. The healthcare world has become globalised, and a balance between ensuring strong patent protection and safeguarding patient access to patented medicines has become difficult to strike.
The Doha approach to intellectual property came to lead subsequent discussions among various international organisations on other issues, such as development and transfer of technology and, more recently, within the United Nations Framework Convention on Climate Change (UNFCCC).1 For the access to climate change mitigation and adaptation technologies, TRIPS ‘flexibilities’ (particularly those relating to compulsory licensing, limitations and exceptions to patent rights and exclusion from patentability), have been sought on behalf of developing countries. Most of the solutions proposed for the access to medicines problems have been similar to those proposed to increase access to different types of technologies. This has been done on the assumption that IPRs prevent access, technology transfer and research. Why the same assumption is made and the standardised solution has been followed is not entirely clear. It seems meaningful therefore to summarise the implications from 15 years of debate over IPRs and access to medicines for future considerations in the discussions on global rules relating to IPRs.
I LONG-TERM RESEARCH AND DEVELOPMENT (R&D)
In the discussions leading up to the Doha Declaration, the idea that affordability is possible only by limiting intellectual property rights was accepted as given, while other options were not discussed. The idea of dynamic welfare through innovation was made subordinate to arguments that patents only hinder access to technologies.
The interest of long-term R&D has been left out in these discussions. The concept of ‘innovation’ has come to be often understood to equate with the short-term goal of producing goods cheaply. While this in itself contributes to welfare, little attention has been paid to the question of how long-term technological innovation could be achieved and accelerated globally.
Nor has much attention been paid to the actual obstacles to long-term R&D in developing countries.2 Lack of expertise, insufficient institutional framework and lack of support for undertaking and funding biotechnology research for clinical studies are frequent obstacles, as well as insufficient information on the existing research technologies. Few companies in emerging economies would forgo short-term profits for long-term research. It is probably for this reason that the Chinese Government is re-centralising long-term R&D activities. Strengthening the legitimacy of IPR protection and eliminating barriers to entry for new local technologies and human resources would also help build local R&D infrastructure. Creating R&D infrastructure for clinical testing adapted to local needs will improve the availability of new technologies and contribute to access to medicines.
Encouraging local innovation realistically (and not simply subsidising those domestic companies close to the government) may have a real impact on developing-country efforts to build local businesses (chapter 11). Developing countries successful in clinical research should play a key role in regional cooperation in such research fields.
Concerns have been expressed by developing countries about the lack of R&D on the medicines for treatment of neglected diseases. The following figure shows that there are ongoing research projects. For developing drugs for HIV/AIDS, malaria and tuberculosis, ‘Big Pharma’3 is relatively active, but for other truly neglected diseases, unknown, unexpected researchers are more active. Their main difficulty is a lack of funds to undertake clinical studies and information, particularly on available research tools such as animal models for a particular virus. The WHO Expert Working Group on Research and Development Financing recently published a report entitled ‘Research and Development – Coordination and Financing’, emphasising the importance of coordination among researchers.4 This solution seems to be a little removed from the realities of R&D, and from the obstacles that researchers actually face.
Table 15.1: PCT Patent Filing Publication References to Neglected Diseases (Database: MICROPAT (IPC-A61K, 1991–2000, 51,267 cases)
Big Pharma 10
Source: H Yamane, Globalisation of Intellectual Property Protection (Tokyo, Iwanami, 2008, in Japanese) 401.
II POLITICS CONTINUE
In the developed world, more and accelerated innovation is necessary, and the need for clear and well-functioning IP protection in emerging economies is increasingly expected. A balanced, factual analysis convincing projections should persuade emerging economies not only to improve their public health situations but also to engage in long-term, effective R&D with appropriate protection of IPRs.
B Tempest, former CEO of Ranbaxy, predicts that there will be two systems of IPR protection and two systems of pricing medicines in the next decade: one for developed (OECD) and one for developing countries.5