The Doha is merely a clarification not the change of WTO members’ legal obligations, however, the Doha Declaration, in short, greatly reduced the TRIPS limitation to member states’ health promotion efforts by construing ambiguous treaty terms in health-friendly fashion. It urges all government to ensure that their implementation of the TRIPS Agreement not negatively impact the enjoyment of public health. The formal legal significance of the Doha Declaration is certain, though what the Declaration clearly did is neither amend the TRIPS Agreement nor interpret the Agreement in accordance with the procedure for interpretation established by multilateral treat when the WTO was created.
As a practical matter, it is difficult to imagine that Doha will carry less than decisive weight in WTO dispute resolution proceedings.
The Doha Declaration expressly acknowledges the significance of public health concerns. The Doha Declaration marks a fundamental shift in the baseline that will determine future tradeoffs between public health and intellectual property rights; but there is still a long way to go in order to balance the IPR protection and human health.
Part 3: A template of post-TRIPS options about IPR and health
The third section of this article discusses what measures can be seized in order to resolve the conflict between the international IPR protection under the TRIPS Agreement.
In particular, this article analyzes the following possibilities: Compulsory licensing, parallel importing and exhaustion of patent rights, International price discrimination, application of Art.30 of TRIPS, increasing donation of essential medicines by their producers, generic drugs, and other incentives besides patent. It tries to provide a template that can maintain the integrity of intellectual property rights and on the same time respecting humanitarian concerns access to lifesaving drugs.
Article 31 of TRIPS provides a detailed set of rules concerning when and how a compulsory license can be granted. The compulsory licensing opportunities opened by TRIPS and confirmed by the Doha Declaration should be seized effectively. Differential pricing of essential drugs is an intuitively obvious component of any comprehensive response to the AIDS crisis. There are three possible models for differential pricing due to the different parameters.Theoretically, a pharmaceutical company should be economically indifferent to a regime of differential pricing that prevented arbitrage and priced the product at its marginal cost. Further, if the company could recoup some portion of its fixed costs of R&D, then global price discrimination could actually enhance R&D incentives. Treat the public health crisis under Article 30 of the TRIPS Agreement in some circumstance may open up an alternative legal basis for framing a resolution to the problem. The Article 30’s requirement that exception “ not unreasonably conflict with the normal exploitation of the patent” could be read as a jurisdictional provision, limiting this exception to economic contexts where no real markets exist. However, from this article’s point of view, the idea of treating Art. 30 as the legal basis for the differential pricing cannot be accepted. While drug donation can make a strong contribution to patient welfare especially in less affluent countries, one cannot expect this to be the cornerstone to solve the global public health crisis. The economic incentives provided by the US Orphan Drug Act involved R&D tax credits, a clinical research grants program, accelerated reviews at the FDA, and a guaranteed market exclusivity period of 7 years from the date of FDA approval separating any normal patent protection that might also apply to these products. However, this article cannot approve the annexed market exclusivity period of 7 years beside patent protection. In any set of future policies, generic drugs can still provide a solution, but this has no important implication, because, existing medicines are continuously losing there effectiveness, requiring new medicines to be developed.
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