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Article 31 Bis of the Trips Agreement

Article 31 bis of the TRIPS Agreement: A Comprehensive Guide

The Agreement on Trade-Related Aspects of Intellectual Property Rights, also known as the TRIPS Agreement, is an international agreement administered by the World Trade Organization (WTO). It sets out minimum standards for the protection and enforcement of intellectual property (IP) rights in member countries.

In 2005, the TRIPS Agreement was amended to include a new provision, Article 31 bis, which deals with compulsory licensing of pharmaceutical products in countries facing public health crises.

Compulsory licensing is a mechanism that allows a government to grant a license to a third party to produce and sell a patented product without the authorization of the patent holder. This mechanism is typically used to address public health emergencies and ensure access to affordable medicines for those who need them.

Prior to the introduction of Article 31 bis, the TRIPS Agreement allowed for compulsory licensing only in limited circumstances. The new provision expands the scope of compulsory licensing to include situations where a country is facing a public health crisis, such as an epidemic or a pandemic.

Under Article 31 bis, countries are able to issue compulsory licenses for the production and sale of patented pharmaceutical products in situations of national emergency or other circumstances of extreme urgency, without needing to negotiate with the patent holder. This mechanism can be used to address situations where there is a high demand for a lifesaving drug but the patent holder is unable or unwilling to supply it at an affordable price.

Moreover, Article 31 bis requires that countries provide compensation to the patent holder for the use of their patent, in accordance with the principles of fairness and equity.

Since its introduction, Article 31 bis has been used by several countries to address public health crises. For example, in 2007, Indonesia issued a compulsory license for the production of a generic version of an antiretroviral drug used for the treatment of HIV/AIDS. Similarly, in 2012, India issued a compulsory license for the production of a cancer drug that was sold at a much higher price than the generic version.

In conclusion, Article 31 bis of the TRIPS Agreement is an important provision that expands the scope of compulsory licensing to address public health emergencies, particularly in developing countries. This mechanism can ensure access to affordable medicines for those who need them, while also protecting the rights of patent holders. As such, it stands as a vital tool to address public health crises, especially in the current global pandemic scenario.