Recent commemorations on November 14, the 5th anniversary of the Doha Declaration, and December 1, World Aids Day, have served as somber reminders of the critical unsolved issue of access to essential medicines for poor people around the world. A legal case currently under way in India may hold the key to whether generic forms of essential medicines will be available to low-income patients in that country and worldwide, now and in the future.
Brief background: The Doha Declaration on Trade-Related Aspects of Intellectual Property Rights ( TRIPS) and Public Health was a Ministerial agreement signed by Member States of the WTO or World Trade Organization. It stipulated that the intellectual property (IP) rules in the TRIPS Agreement not prevent the utilization and enforcement of TRIPS safeguards deemed necessary to protect the public health of a country. It also directed members to facilitate access to generic medicines in poor countries with little or no manufacturing capability, i.e., to allow export and/or import of these drugs. To date, however, little progress has been made in increasing access to affordable essential medicines in developing countries. Instead, the wealthy countries, especially the US, have undermined the Doha Declaration by pressuring poor nations to enact IP rules that are even more restrictive than the TRIPS obligations, by means of bilateral and regional free trade agreements. Multinational pharmaceutical companies have been key players in these efforts, focusing on protecting patents for certain brand-name, expensive drugs as well as trying to challenge the patent laws in effect in specific countries.
The present case in India involves the Swiss pharma Novartis, which has filed two cases: one challenging India’s denial of a patent to the cancer drug Glivec, and the other challenging the Indian law itself that determines which medicines are patentable. These cases have serious implications both in India and worldwide, as many generic medicines sold in developing countries are manufactured in India. If Novartis is successful in its challenges, this source of remedies for all types of diseases affecting people worldwide, and especially in poor countries, is in danger of being cut off. Although the need for cancer drugs has not been given much publicity, some of the newest and most effective cancer drugs are outrageously expensive even in wealthy countries, and cancer is a rapidly-growing public health problem worldwide. It is estimated that by 2020, 60% of new cases of cancer will be in the developing world, and there is no known means to prevent blood cancers like leukemia, whose rates are increasing. Effective and affordable medicines are urgently needed to treat all diseases, not only HIV/AIDS, across the globe.
Glivec is a drug originally approved to treat certain forms of leukemia and stomach cancer. While it has been hailed as a new treatment in handy pill form to control (but not cure) these diseases, it also made headlines when Novartis announced at its launch in 2001 that it would be sold at a global price, i.e, at the same price worldwide, regardless of the economic situation of any individual country. Currently the basic minimum dose of Glivec (spelled Gleevec in North America) is $27,000 US per year. Patients are thought to need to take the drug for the rest of their lives. Generic versions which had been made in India cost one-tenth that price. Novartis contends that its donation program for Glivec makes the drug accessible to all those who need it, despite widely reported limits and difficulties with that program.
Julien Reinhard, the director of an awareness and action campaign being spearheaded by Berne Declaration, a Swiss NGO that monitors the activities of multinational corporations based in Switzerland, shared the following in the group’s Open Letter to Novartis:
We are shocked that five years after the end of the trial brought by Novartis and other pharmaceutical companies against the South African government, Novartis is trying again to restrict the flexibility given to a country to adapt the TRIPS Agreement to its public health needs.
This matter needs our urgent attention, as unfortunately it has not received much coverage in the US.
Here’s how you can help:
The NGOs Oxfam International and Berne Declaration have launched an international campaign to get Novartis to drop the lawsuits it has filed in India. Individuals and organizations are being asked to send a letter to Novartis CEO Daniel Vasella making that request. This can be done either via an electronic form on the Oxfam website, or with a personal letter. The two organizations, as well as Doctors Without Borders, have created educational websites on the campaign, which explain the matter and its grave implications for global health.
Here are links to campaign websites and related information:
Oxfam’s Make Trade Fair Campaign (includes e-mail letter to send to Novartis)
Questions and Answers on Novartis and the Glivec Patent Case in India
Berne Declaration’s pages on the Novartis Glivec campaign
Open letter to Novartis
Novartis challenges the Indian Patent Law
Doctors Without Borders press release
As Novartis Challenges India’s Patent Law, MSF Warns Access to Medicines Is Under Threat
New York Times articles on Glivec donation program.
Company’s Vow to Donate Cancer Drug Falls Short
Questions on Choice of Foundation for Drug Program