Promoting Generic Competition

© Michel Lotrowska

Keeping the door open for generic products: In late 2006, MSF launched an effort to get Swiss pharmaceutical company Novartis to drop its legal case aimed at strengthening patents in India.

The importance of the generic pharmaceutical industry – particularly that in India – in widening access to essential medicines cannot be emphasized enough. India is a vital source of affordable medicines for people across the developing world. This is because until 2005, India did not grant pharmaceutical patents, and so, affordable versions of medicines patented elsewhere could be freely produced in India.  However, since India is now required by World Trade Organization membership to start granting pharmaceutical patents, there is a real risk that India could dry up as a source of affordable medicines.

MSF relies on affordable antiretroviral drugs (ARVs) from India to treat over 80% of the more than 100,000 people receiving treatment in MSF projects. MSF has been fighting to make sure the production of affordable medicines in India is able to continue. That’s why in 2006 MSF launched a campaign urging Swiss pharmaceutical company Novartis to drop its case against the Indian government over its patent law.

The landmark Novartis case:
When in 2005 India had to develop a patent law to become compliant with its obligations under the World Trade Organization (WTO), India’s parliament designed a patent law that prioritized public health, with strict criteria for what deserves a patent and what does not. This was aimed at helping maintain healthy generic production and competition so that access to affordable versions of medicines could be secured.

One provision within India’s patent law states that no patent should be granted on a small change in a drug unless it can be proven that the newer version is more effective than the previous one. This is to prevent a common practice in wealthy countries called ‘evergreening,’ whereby pharmaceutical companies are able to receive consecutive patent terms of 20 years on small changes to an existing drug. According to this provision, the patent examiner of India in January 2006 rejected a patent on the cancer drug imatinib mesylate, which Novartis markets as Gleevec. In response, the company launched legal action against the Indian government in May 2006, challenging not only the patent rejection for Gleevec, but also the provision of the law on which the rejection was based.

Novartis claimed that India’s patent law was not in line with the country’s WTO obligations. The company’s legal battle provoked outrage among patient groups, politicians and activists around the world, and recalled the actions taken by 39 pharmaceutical companies – including Novartis – in South Africa in 1998. Companies at that point tried to block access to cheaper generic medicines by taking the South African government to court, but an international outcry forced the companies to finally back down and drop their case in 2001.

Together with several patient and public health groups in India, including the People’s Health Movement, the Delhi Network of Positive People and the Indian Network of Positive People, MSF launched an international effort to get Novartis to back down in December 2006. A petition gathered more than 420,000 signatures worldwide and elicited calls of support from global figures including Archbishop Desmond Tutu, Global Fund Director Michel Kazatchkine, the Indian Health Minister Anbumani Ramadoss, members from the European Parliament and the US Congress, former Swiss President Ruth Dreifuss, former UN Special Envoy for AIDS in Africa Stephen Lewis, German Development Minister Heidemarie Wieczorek-Zeul, Norwegian Development Minister Erik Solheim, as well as authors John Le Carré and Naomi Klein.

Novartis refused to back down, but in August 2007, the company lost its case in court to try to change India’s patent law, allowing it, for now at least, to remain the ‘pharmacy of the developing world’.

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