LIFE, DEATH, AND DATA: EXAMINING THE HUMAN RIGHTS IMPLICATIONS OF INTRODUCING DATA EXCLUSIVITY TO INDIA'S PHARMACEUTICAL SYSTEM

Patricia Anne D. Sta. Maria (JD'15)

ABSTRACT

The interactions between Human Rights and Intellectual Property laws are complicated ones. There is at any one time, a flurry of competing interests which aim to take precedence over each other. Caught in the crossfire are the people who depend on the benefits of both areas of law for the improvement of their lives. There is no more evident illustration of this than the ongoing debate on access to medicines. Human Rights insist on respect, protection, and, fulfillment of the rights to health and life, which is argued to include access to medicine, while Intellectual Property law claims to be protecting the interests of the owners of the information and formulation necessary for producing medicine from exploitation, and from the unjustness of not being able to benefit fully from their creative and commercial endeavors. Neither is this debate purely academic. It took on a life of its own during the advent of the TRIPS agreement and the subsequent DOHA declaration. One of the more important arguments in relation to access to medicine that was raised and settled during this time was that the TRIPS agreement obligated States to implement data protection, and not data exclusivity. Data exclusivity is a practice whereby generics companies are prohibited from availing of bioequivalency tests for a certain period. This means that government regulatory boards cannot rely on data submitted in relation to an already approved drug in order to make conclusions about a new drug's efficacy, safety, and quality. This results in a stalling of new entrants, the more affordable generics, into the market. Because the TRIPS agreement does not espouse data exclusivity, States have been resorting to the negotiation of Free Trade Agreements in order to ensure that other States introduce these measures in their respective legal systems. Currently the European Union is negotiating such an agreement with India, and a concern is that the former is insisting on data exclusivity periods, something it has included in past agreements with States such as Korea and the Andean States.

The agreement between the EU and India is of special concern because India is known to be a large source of generic medicine, not only for its own population but for other developing nations as well. Furthermore, affordable medicine produced in India includes antiretroviral medicine designed to treat HIV/AIDS. Those who depend on these medicines include both AIDS stricken areas such as Africa, as well as international organizations which aim to address the situation such as Medecins Sans Frontieres (Doctors Without Borders). On the home front, the Free Trade Agreement currently being negotiated between the EU and India is also a concern. The Philippines does not have the capacity to produce all the medicines needed by its citizens, and is therefore highly dependent on imports. Furthermore, prices of drugs in the Philippines are among the highest in Asia, and among developing countries. This makes the availability of affordable generics imported .from abroad very important to the Philippines. In fact, imported generics from India and Pakistan have proved to be highly significant in government projects which make affordable generic medicine more available to the population. Adding to the Philippines' dilemma are the facts that, one, its number of HI V/AIDS infected persons is rising, and two, resources for addressing the disease are very limited. The trade agreement between the EU and India in particular and the impact of data exclusivity on access to medicine in general, renew the debate between Intellectual Property and Human Rights. This study examines the various components of each area of law, and ultimately comes to a conclusion as to how the competing interests that are once again clashing with each other may be reconciled, given the rights, liberties, and even lives, that are at stake.