As activists attempted to deliver a fake coffin to the Washington DC office of the pharmaceutical giant Novartis and large demonstrations are underway in India and other countries over the seeming dichotomy between the rights of patent holders and patients, one has to ask if the predictable, and predicted, crisis could have been averted. For those of us who have attempted to alert everyone over many years that a serious problem was brewing, it is little consolation about the accuracy of the forecast. To their credit, a few senior U.S. Senators and Representatives and their aides have worked extensively on this matter, and I and an ex-Senator who was a close personal friend of the late President Ronald Reagan, together, repeatedly alerted top management of a major international agency that there were serious limitations in the assumptions on which the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (WTO's TRIPS) Agreement was built. Using concrete proposals, we urged this agency chief and his agency, that receives billions of dollars from the U.S. Congress, to take proactive measures to avert this impending crisis through a combination of market and humanitarian compassionate means.
What is the crisis? Once the TRIPS agreement was acceded to by most nations and they in turn amended their national laws in conformity with the inter-governmental agreement, it became international law that product patents have superceded process patents. In less technical-speak, product patents i.e. the patenting of the molecule itself, and not the recipe to construct the molecule, became the norm. This is seen as vital to protect the rights of innovators that include individual scientists, companies, universities, government institutions and others that make up the networks of research and development. But what about the rights of several billion patients who live in countries where R&D was not an ingrained part of academic or professional life? Even in the U.S., patients who are able to afford medicines can do so only via multiple healthcare mechanisms such as health insurance coverage. But layers of mechanisms and functions to cover patients like medical insurance, specialized distribution chains etc. hardly exist for some 5 billion people living in the developing countries.
Suddenly, citing product patents and TRIPS, if companies make most new medicines unavailable to those who could previously access them, without any attempt to cover patients through alternate means, what sort of outcry from patients and doctors can one expect? That is the very crisis that is before us.
Former President Bill Clinton's Foundation, among others, procures anti-AIDS medicines from the Indian pharmaceutical industry, that is one of the world's largest as calculated in terms of volume of production, and it supplies an estimated 80% of African AIDS patients on medication with reverse-engineered medicines. And indeed, the vast majority of the world's 40 million HIV/AIDS patients live outside North America, Europe and Japan. Newer generations of more potent medicines against AIDS could be denied to those patients because of the changes necessitated by TRIPS. And, cancer patients who suffer from Chronic Myeloid Leukemia could lose access to Gleevec (imatinib mesylate) because of the patent case filed by Novartis before an Indian High Court, which explicitly attempts to get the Indian judiciary to rule on ensuring that the recently amended Indian patent laws become even more tightly congruent with TRIPS.
A fatal interpretation by many ingrained within TRIPS is the belief that when public health emergencies emerge, countries can issue compulsory licenses to permit any manufacturer to reverse-engineer the medicine needed. First, it takes a lifetime for most bureaucracies to even detect the presence of an epidemic of chronic diseases like cancers and heart diseases because of the paucity of reliable and timely data from across vast nations and continents. Second, contemplating to repeatedly issue compulsory licenses ignores the basic tenants of international finance in today's era. Every time it appears that a country is disrespecting intellectual property rights, capital will flee or take another generation to reappear. Why then did the TRIPS negotiators and framers make such unworkable safeguards the basis of inducing countries to sign on to the Agreement? And what can be done now that the Agreement has become codified into international law?
This should take up the urgent attention of the Congress, among the few parliaments in the world with truly open democratic traditions insisted upon by the founders, that can invite experts and patients to testify and build remedial measures. Because, once this crisis picks up even more steam, it will create yet another jarring roadblock to the duality of free and fair trade that is expected to create opportunities for all.