IMPACT OF TRIPS AND DOHA DECLARATION ON HEALTHCARE
It was emphasized in the Doha Declaration on the TRIPS Agreement and Public Health in 2001 that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) should be a part of broader action to address public health problems that are affecting developing economies and least-developed countries. This declaration also confirmed that members of the World Trade Organization have the right to take measures to protect public health. Consequently, it resulted in a formal change of the Agreement, which opened up a new avenue for gaining access to medicines at reasonable prices.
The Declaration of Doha Concerning the Trade-Related Intellectual Property Rights and Public Health[1]
In the run-up to the World Trade Organization’s Doha Ministerial Conference in 2001, a debate that had been going on for a long time about the relationship between intellectual property (IP) and public health, particularly innovation and access to medicines, became more heated. This was in part due to worries regarding the development of new medications that could save lives for HIV/AIDS. The Doha Declaration on the TRIPS Agreement and Public Health was adopted in order to address significant issues regarding the role of TRIPS in connection to pharmaceuticals and to clarify core concepts. The declaration also highlighted the significance of intellectual property for the development of new medications, while simultaneously addressing concerns regarding the impact that it has on prices.
It was reaffirmed in the Declaration that the TRIPS Agreement does not and should not hinder members from taking actions to protect public health, and that members have the right to fully utilize the flexibilities that are included in the Agreement for the purpose of protecting public health. It provides a list of many flexibilities, the most notable of which are forced licencing and the exhaustion of intellectual property rights. In the process of describing the function of “flexibilities,” it emphasizes the significance of national choices in the process of putting the TRIPS Agreement into effect in a manner that is beneficial to public health.
Change to the TRIPS agreement that mandates the issuance of export licenses for pharmaceutical items
The TRIPS Agreement gives countries of the World Trade Organization the authority to award compulsory licenses under their own domestic laws. These licenses give third parties the right to exploit intellectual property rights without the approval of the owners of those rights. These rights were reaffirmed and made clearer by the Doha Declaration. There are provisions in the majority of patent laws that allow for the overriding of patent rights in the benefit of the public. These provisions include a variety of means, such as compulsory licenses at the request of interested parties, government use authorizations, and usage by governments as such.
In the beginning, the terms of the TRIPS agreement stipulated that any authorized use of copyrighted technology should primarily be for the purpose of serving the local market, unless it was for the purpose of correcting anti-competitive behavior. The Doha Declaration acknowledged that this limitation could make it more difficult for nations who have little or no manufacturing facilities in the pharmaceutical sector to make good use of compulsory licencing.
In 2005, members of the World Trade Organization (WTO) reached a consensus to formally change the TRIPS Agreement, which resulted in the creation of an extra, innovative form of compulsory license that was specifically geared to the export of medicines to countries that were in need. In 2017, this amendment became effective after being formally ratified by two-thirds of the members of the World Trade Organization. This procedure for obtaining a special compulsory license for export is frequently referred to as the “paragraph 6 system,” which is a reference to the fact that it was initially derived from the Doha Declaration.
The amendment included the addition of Article 31bis to the Agreement, which provided this system with full formal legal effect and made it possible for low-cost generic medicines to be manufactured and exported under a compulsory license. This was done solely for the purpose of catering to the requirements of nations that are unable to produce those products themselves. Those members of the World Trade Organization (WTO) who have not yet accepted the change are still eligible for an interim waiver.
[1] World Trade Organization, ‘The TRIPS Agreement and Public Health’ (WTO, 2001) http://wto.org/english/tratop_e/trips_e/pharmpatent_e.htm#:~:text=The%202001%20Doha%20Declaration%20on,confirming%20the%20right%20of%20WTO accessed 14 April 2025.