A precautionary approach to compulsory licensing and tempering the data exclusivity obstacle for access to medicines
Lim, PH; Li, P
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This article takes up further on a framework developed for a precautionary approach (PA) which developing countries should adopt for granting compulsory licences in a national health emergency. Working within the legal mechanism of the precautionary framework developed from the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) under the World Trade Organization (WTO) and the Agreement on Trade-Related Intellectual Property (TRIPS), the PA redefines a framework for compulsory licensing based on an adequate margin of safety when there are reasonable grounds for concern about uncertain risks that significant harm to human life and health may occur. The rationale adopted is based on legitimate differential treatment, precaution and risk management for a prescriptive, moderate and least restrictive measure to trade to enable access to medicines. Compulsory licensing under the TRIPS Agreement was developed as a buffer for tempering patent protection and health to “allow for other use of the subject matter of a patent without the authorisation of the right holder” subject to certain conditions. The August 2003 Doha Declaration and subsequent TRIPS amendments for all member countries to be eligible to import provided a breakthrough for access by poorer countries to cheaper generic drugs. The chilling effect of the waiver is shrouded by obvious reticence on the part of developing countries to adopt the WTO language of “national emergency” and “extreme urgency” as a condition for compulsory licensing. The bold efforts by Thailand and Brazil in issuing compulsory licences in 2007 were adopted on grounds of “public non-commercial use” and “public interest”. An objective mechanism to trigger the grant of compulsory licensing would not leave developing member countries at the mercy of possible trade retaliation and sanctions that results only in price reduction bargains instead of a proper use of the inbuilt flexibilities under Article 31(f) of the TRIPS Agreement. In addition to the patent obstacle, data exclusivity under the ambiguous Article 39.3 of the TRIPS Agreement poses another obstacle for access to medicines and the production of generic drugs even under compulsory licensing. Such regulatory protection of undisclosed pharmaceutical test data and the application of confidentiality to test data submitted by pharmaceutical companies so as to be able to obtain marketing approval of the products creates a data monopoly. It prevents the marketing of generic drugs even though the patent licences may have been granted by the government as generic drug manufacturers are unable to access the data. The authors query the obligation set out under Article 39.3 and consider the question of an implicit data exclusivity exception. The authors further argue holistically from a human rights perspective that a wider application of the precautionary approach to temper data exclusivity as a justification for disclosure in a public health emergency would enhance its prescriptive value. This article contemplates a parallel approach to overcome the issue of data exclusivity in the international trade and intellectual property regimes once a precautionary approach is adopted for compulsory licensing.