Political Economy of Reforms in India's Pharmaceutical Sector

Sohrabji Research

In 2004, India introduced a new patent law in accordance with the guidelines of the World Trade Organization. These guidelines were designed to place protections for intellectual property rights among member countries affected by trade, referred to as Trade Related International Property Rights (TRIPS). This meant that member countries had to conform their patent laws to global patent rules agreed upon by the members of the WTO. The purpose of TRIPS was to set up international rules to provide minimum protection for intellectual property rights of all member countries. There were flexibility provisions built into the agreement in case of public health crises.

Niloufer Sohrabji's project focuses on the global impact of this revised patent law. India is frequently referred to as the “pharmacy of the world” because of its large-scale, cheap generic drug production. This has helped several countries facing health crises (including the AIDS crisis) by providing cheap alternatives to expensive patented medicines. Generic production is allowed under WTO TRIPS rules in times of crises; this is one of the flexibility provisions built into the WTO TRIPS. However, the rules do not allow for unrestricted generic drug production. Most importantly, once India instituted its new patent law, the rules became more restrictive -- making generic production more difficult in some cases, and illegal in others. This immediately impacted the access that the world’s poorest and most vulnerable populations had to life-saving drugs. Without generic drugs, most of these populations, including the governments and institutions (such as the Clinton Foundation) that help them, cannot afford life-saving medication.

Will India’s 2004 intellectual property rights law worsen access to life-saving medicines for the world’s poorest populations? Or will stricter intellectual property rights laws attract greater resources to India's vibrant pharmaceutical sector, translating into greater drug research, production, and access for poor populations? These are the questions Sohrabji will explore by analyzing India’s patent law and its pharmaceutical sector.