| Summary: | 碩士 === 國立交通大學 === 科技法律研究所 === 93 === A variety of epidemics such as HIV/AIDS, malaria and tuberculosis have ravaged numerous developing countries on an enormous scale, resulting in severe public health crises. Although those diseases are curable or manageable, some treatments, for example, the antiretroviral medications for AIDS, are prohibitively expensive. Consequently, many people in developing countries that lack adequate health infrastructures cannot afford expensive drugs. Without life-saving drugs, millions of people lose their lives; the loss of human capital may even cause economic decline and developmental crises across several generations.
Prior to the enactment of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), developing countries could depend on cheap generic drugs. However, under the full implementation of the TRIPS Agreement, as a patent has been granted and remains in force, the generic pharmaceutical manufacturers of most WTO members can supply generic drugs only in exceptional circumstances. Consequently, as substitutes for patented drugs decrease, prices of pharmaceuticals could rise and access to drugs could worsen.
Some governments of developing countries sought solutions to the access dilemma in the form of parallel imports and generic versions of patented drugs made under compulsory licenses. Nevertheless, multinational pharmaceutical companies and some developed countries protested that those measures contradicted the provisions of the TRIPS Agreement, and threatened to impose trade sanctions. Therefore, the dilemma of access to essential medicines, i.e., how to ensure access to drugs in developing countries without discouraging the innovation of new drugs, has been the focus of controversy under the WTO. To solve the problem and clarify the divergent interpretations of the TRIPS Agreement, WTO members adopted the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) in 2001 and approved a decision on 30 August 2003 after lengthy negotiations.
This article argues that it is necessary to contemplate both efficiency values and distributive values under the WTO in the context of health crises. From the perspective of efficiency, patent systems are trade-off and unavoidable evil resulting from the market failure. Though patents facilitate innovation, thereby contributing to economic growth and welfare, the negative impacts on efficiency, specifically access to technology, cannot be ignored. In the access dilemma, WTO members must pay attention to the enormous social costs due to the unavailability of essential drugs. From the angle of distribution, the WTO has to provide developing country members with opportunities for sustainable development. At least, the WTO must assure the benefits resulted from the operation of patent systems outweigh the costs for each member in the events of public health crises. This article finds that the flexibilities contained in the TRIPS Agreement, for example, the compulsory licenses, are beneficial and vital to the pursuit of efficiency values and distributive values. To solve the access dilemma, effective use of the flexibilities plays an important role.
Bearing these in mind, this article highly values Doha Declaration and the subsequent decision. Moreover, in the international level, this article suggests that WTO members should shape a balanced and flexible intellectual property regime, reexamine related provisions about technology transfer under the TRIPS Agreement, and monitor and evaluate the executive effects of the 30 August decision. Additionally, WIPO have to assist WTO developing country members to amend their law according to Doha Declaration and the subsequent decision. In the national level, this article suggests that developing country members should seek an appropriate protection level of the patent system, make effective use of the flexibilities embedded in the TRIPS Agreement, prevent the protection for marketing approval data from blocking the marketing of generic drugs, and create conditions beneficial for differential pricing.
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