By Samantha L. Plesser, Esq.
In 1994, the World Trade Organization (WTO) created the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), setting down minimum standards for intellectual property (IP) rights that applied to all members of the WTO. WTO members could obtain access to numerous international markets only if they accepted the new regulations. Arguably, this makes TRIPS the most important multilateral instrumental for the globalization of IP property laws.
The biggest unforeseen consequence of TRIPS, however, is its effect on global public health, specifically on the worldwide AIDS epidemic. In November 2001, after much debate, the Doha Declaration was negotiated, reaffirming TRIPS’ commitment to circumventing patent rights for better access to essential medicines. Specifically, Doha stated:
The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.
Doha was not aimed, however, at protecting global public health policy, but rather at making clear certain rights of the WTO and explaining TRIPS’ policies.
One of the most significant aspects of Doha is its specification regarding IP rights. Doha acknowledged the role of IP “for the development of new medicine,” but stated that TRIPS “should be interpreted and implemented in a manner of WTO Members’ rights to protect public health, and in particular, to promote access to medicine for all.”
Most importantly, Doha allowed for a number of public health related flexibilities that were not before listed in the original TRIPS Agreement. Doha also made compulsory licenses legitimate, which allows an individual or a company seeking to use another’s intellectual property without their consent, so long as they pay that individual or company a set fee for the license.
At the time of Doha’s implementation, many hoped that it would be the beginning of a new era in which humanitarian interests triumphed over corporate interests. James Love, the Director of Knowledge Ecology International, however, said that it was more useful to look at the outcomes over divisions among member states over the limits, over the limits of intellectual property. Love, who was involved in the 2001 and 2003 negotiations surrounding the Doha Declaration, stated it was a "political negotiated outcome with opposition on both sides" and that "corporate interests and humanitarian ones were not as much aligned, but reconciled, as part of a larger battle over trade rules." The Doha Delclaration was never meant to solve global health crises.
Despite the flexibilities that have been given toward developed countries, many have taken little to no advantage of the agreement. 29 developing countries have exhausted access to low-price medicine entirely, and at least 45 developing countries have allowed patents from pharmaceutical companies into their countries, giving up their rights entirely. Although Article 39.3 of TRIPS does not require the grant of exclusivity with respect to test data (because of Doha), at least 41 developing nations have allowed pharmaceutical companies such patents on this data.
While there are TRIPS safe-guards available to developing countries like compulsory licensing and parallel importation, pressures from First World pharmaceutical companies and a lack of understanding of other types of agreements have resulted in Third World nations entering into Free Trade Agreements (FTAs) and other bilateral agreements with developed nations in exchange for trade concessions. This limits the capacity of developing countries to effectively issue compulsory licenses, allow parallel importation, or use other TRIPS flexibilities.
Additionally, some developing countries have not received appropriate technical assistance or capacity building to understand and incorporate the TRIPS flexibilities that they have been given in the first instance.
Thus, pressure from First World countries and pharmaceutical lobbyists have resulted in developing nations giving up rights that were guaranteed by Doha protections (e.g. data exclusivity, linkage between drug registration, and patent protection.) By giving up these rights, the use of compulsory licensing has become almost impossible to implement for these developing countries.
The decision to keep the waiver of the exportation of medicines under compulsory licenses subject to two-thirds approval by WTO members is also subject to a number of conditions and limitations (e.g. a specific quantity of medicine to a particular country).
Doha does not provide enough incentives for generic companies to supply low-cost medicines because these companies, through obtaining compulsory licenses, can reduce the prices of required medicines and undermine the efforts made to supply generic versions of the products.
Although the Doha Declaration was not a panacea for global health issues, it was the first time that the world valued human interests above corporate interests, which is pride-worthy. The best lesson to be learned from TRIPS is best summed up by H.L. Mencken: “For every complex problem, there is an answer that is clear, simple, and wrong.”
Samantha L. Plesser, Esq. is a Brown graduate, a Cornell Law School graduate, a former financial attorney, and a current student at The Milano School for Nonprofit Management.
[Photo courtesy of Dan Berger]