Background
A grave injustice of today's world is that lifesaving drugs are widely available, but priced out of reach of so many of the people who need them the most. In the late 1990s, we were confronted with a stark representation of that reality: Most people infected with HIV in wealthy countries were leading healthy and productive lives, thanks to antiretroviral drugs, or ARVs; but in poor countries, HIV meant a rapid decline and certain death.
The international community — donor countries, developing countries, pharmaceutical companies and AIDS activists — has worked hard to correct this injustice. In 2001, the Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health established that intellectual property rights should not prevent countries from taking measures to protect public health. Indian generic drugs producers marketed ARVs at a fraction of earlier prices. Some pharmaceutical companies lowered their prices significantly in low- and middle-income countries. As a result, the number of people on ARVs soared: 10 times more people in developing countries were on ARVs in 2006 than in 2001. This has kept parents with children longer, helped societies stay productive and improved the overall quality of life for millions.
Novartis' Lawsuit Challenging Indian Patent Law: What's At Stake
A lawsuit now underway in India could reverse this progress. After India's Patents Office rejected its patent application on Glivec, a drug used to treat chronic myeloid leukemia, the Swiss pharmaceutical company Novartis filed two lawsuits against the government of India. The first case appeals the rejection of its patent application. The second challenges Section 3(d) of the Patents Act, the clause that seeks to safeguard public health by permitting new forms of known substances to be patented only if they demonstrate higher efficacy.
Flexibilities in international trade rules, reflected in the TRIPS Agreement and the Doha Declaration, exist to protect public health and promote access to medicines for all. Consistent with those rules, India requires that patentable inventions be new and asserts its right to define what an inventive step is. Although this case involves a cancer drug, the Section 3(d) lawsuit is worrying because of the negative precedent it could set for generic competition more broadly and, thus, affordable access to a range of essential medicines.
The quality and affordability of its generic drugs have made India a virtual "pharmacy to the world." Nearly 70 percent of generic drugs manufactured in India are exported to other developing countries. The expansion of AIDS treatment over the past few years has been driven by the accessibility and affordability of generic ARVs from India. For example, Lesotho buys nearly 95 percent of all its ARVs from India; 90 percent of the ARVs used in Zimbabwe's AIDS treatment program come from India. Indian generic drugs have even enabled the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) to rapidly expand access to AIDS treatment. Of the 36 generic AIDS drugs approved by the Food & Drug Administration for use in PEPFAR, 33 are produced in India. In 2006, purchase of generic drugs saved PEPFAR nearly $1.7 million, and thousands more people could access ARVs because of these cost savings.
If Novartis wins its Section 3(d) case, and other pharmaceutical companies follow in Novartis' footsteps, minor modifications of existing drugs would be eligible for patents in India. That would prevent generic competition. If fewer generic drugs could be produced in India, fewer poor people around the world would have access to essential drugs for a range of illnesses. In particular, AIDS and TB treatment programs all over the world are likely to suffer.
Case in Point
In Peru, CARE's HIV program procures 99 percent of its ARVs from India. Restricted ability to import generic medicines from India would lead to significant increases in the cost of purchasing drugs. Because health budgets are severely limited, this would mean that fewer AIDS and TB patients could receive treatment. In the case of one specific combination drug, the availability of generics from India allowed CARE and the Peruvian Ministry of Health to purchase more than twice as many drugs as they could have had only the brand-name drug been available. This price difference provided free, lifesaving treatment to close to 600 additional patients. |
The Balance to Be Struck
Fulfilling the public interest requires both a regular stream of safe, effective and innovative medicines and access to affordable medicines for all who need them. This requires a balance between protecting intellectual property rights (to provide an incentive for research) and safeguarding public health (to provide access to essential medicines for all). Internationally agreed safeguards, reflected in the Doha Declaration, are in place to ensure a balance between patents and public health. But these safeguards have meaning only if they are respected and upheld. CARE is concerned that Novartis' lawsuit against the government of India could limit the access of millions of poor people around the world to essential generic drugs.
Take Action
Arguments in the Section 3(d) case have been heard and the judgment is expected in the coming weeks. CARE asks Novartis to drop its case against the government of India - and we urge our partners, supporters and friends to do the same. CARE applauds the many ways in which Novartis demonstrates its social responsibility, and we call on Novartis to show such responsibility in this case as well.
Take action! Urge Novartis to drop the case against the Indian government.
