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Challenges in International Essential Medicines Supply and Drug Development under the TRIPs Agreement: Focused on Compulsory License and Evergreening

  • DONG-A LAW REVIEW
  • 2019, (82), pp.279-314
  • DOI : 10.31839/DALR.2019.02.82.279
  • Publisher : The Institute for Legal Studies Dong-A University
  • Research Area : Social Science > Law
  • Received : January 28, 2019
  • Accepted : February 26, 2019
  • Published : February 28, 2019

BYUNG-WOON LYOU 1

1홍익대학교

Accredited

ABSTRACT

The core of the right to health, as one of the international human rights, is the guarantee of universal access to essential medicines. The “flexibility” in application of the WTO TRIPs Agreement under the 2001 Doha Declaration has contributed to 93% of HIV carriers today to be able to use antiretroviral generic drugs. However, developing countries such as India are in reality abolishing the patent rights of medicines by abusing measures related to flexibility of the TRIPs agreement, rather than coexistence of intellectual property rights and public health. Some developing countries also use the flexibility of the TRIPs agreement for its industrialization strategy for economic development rather than the original purpose of public health. The international balance between public health and patent rights of medicines should start from the conformity with the TRIPs agreement. Because TRIPs Agreement flexibility is based on public health, the WTO Member States’ measures related to the flexibility, such as compulsory license or decision on patentability, should be considered in terms of the welfare increase that patients can receive, including therapeutic effects. Compulsory license, which is an exceptional market intervention by government, should be implemented in a limited and strict manner in accordance with the TRIPs agreement. Especially, the WTO Member States should not prescribe cases where compulsory enforcement can be enforced unless they are produced locally, on the principle that they should not be discriminated against, regardless of whether they are imported or produced locally. The international community needs to look for a proper approximation of the patentability standards, in particular improved technology or clearer definition about new formulations of existing compounds. The WTO will be able to search for and propose a proper approximation of the patentability standards through cooperation with WIPO and WHO. In order to ensure the distribution of good quality generic drugs, each State should have a powerful and well regulated drug administration with a sufficient inspection budget. The international community should cooperate with the crackdown on counterfeit drugs and the prevention of the circulation of poor quality generic drugs resulted from poor manufacturing process and inadequate regulatory supervision. States and the international community should resolve the current and future essential medicines supply challenges through a rational balance between public health and pharmaceutical patents. With the role of international organizations such as WHO and State governments in the development and supply of present and future essential medicines, patent guaranteeing incentives for new drug in the market can improve the substantiality and value of human life.

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