By Irene Khan, Director-General, IDLO
As we mark World Intellectual Property Day, much of the debate has been focusing on access to life-saving medicines in the developing world. The echo endures of the Indian move to refuse the pharmaceutical group Novartis a patent for a reformulation of its cancer drug Gleevec.
The April 1st ruling by the Supreme Court in New Delhi is national in its effect, but global in its resonance. It decisively repudiates evergreening, the practice of securing new patents for non-essential changes to existing drugs. Evergreening is the pharmaceutical equivalent of repainting your old banger to pass off as new. It must not be condoned. Health is a fundamental right: any step that brings it closer, for the greater number, is to be applauded as a victory for the rule of law. Equally, there can be no rule of law without property rights, intellectual or otherwise.
Protecting intellectual property acts as a spur to innovation. But it comes at a cost. Pharmaceutical companies are driven by profits, not charitable motives. Developing a mid-level antibiotic – let alone, say, an HIV vaccine or other drug of similar magnitude – costs as much as half a billion dollars. Balancing corporate interests against public goals is a tough call. It is this which makes the Indian ruling, quite simply, an outstanding vindication of the rule of law. Within the framework of national and international law, the judges struck a balance between competing interests: intellectual property has been acknowledged, but the limits of its protection defined in a manner consistent with the right to health.
The Indian court’s decision was not in defiance of the international intellectual property regime, but based on it. The judges made good use of Article 7 of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which links intellectual property to nations’ welfare.
TRIPS seeks to balance the corporate incentive for profit with the public interest in access to drugs. In November 2001, the Doha Declaration further clarified the conditions for compulsory drug licensing, giving states greater leeway to produce generics. In August 2003, a Decision by the WTO General Council set out ways for the poorest nations, with no pharmaceutical industry of their own, to have their generics manufactured elsewhere. Yet all too often, developing countries fail to take advantage of the exceptions and flexibilities contained within TRIPS. They lack the knowledge, resources, institutions or political will to make intellectual property laws work for their people. Many have failed to adopt the domestic legislation that would unlock TRIPS’ benefits. Some are unwittingly, or under pressure, entering into regional or bilateral trade deals with extremely restrictive provisions. Their courts are too weak or subservient or corrupt to litigate health rights. Their civil society is gagged and shut out of national debates of vital consequence.
India’s case is proof that the intellectual property regime, when properly applied, can work for the poor as well as the rich. The decision by the country’s Supreme Court has created a giant legal footprint for others to follow. All it takes is political will, good laws, and a vigorous and independent judiciary.