One important step forward for access to medicines in India, but are two giant steps backwards just around the corner?March 23rd, 2012 | by Guest Blogger
Cross posted from Global Health Check and written by Rohit Malpani and Mohga M Kamal-Yanni. Rohit Malpani is a campaigns advisor at Oxfam and leads the organization’s access to medicines campaign. Mohga M Kamal-Yanni works for Oxfam as a Senior Health & HIV Policy Advisor.
Last week, the Indian Patent Office took a major step to decrease the price of a previously unaffordable life-saving medicine by issuing a ‘compulsory license’ on Sorafenib, a medicine used for the treatment of kidney and liver cancers. But such welcome action is unlikely to be repeated if the EU and Novartis have their way.
Up until now Sorafenib has been sold exclusively by Bayer, the German drug firm, at a very high price that nearly no one in India could afford. The new compulsory license permits Indian pharmaceutical manufacturers to make and sell low-cost copies of the medicine while paying royalties to Bayer, the patent owner.
The Indian Patent Office stated that Bayer had failed to make the medicine “available to the public at a reasonable price”. Through the manufacture of generic versions, the price of the medicine will fall drastically and ensure it is more affordable. News reports suggest that only about 49 patients were placed on treatment last year. So the impact will be significant.
A compulsory license is a basic safeguard, enshrined in global trade rules, whereby a country can override a drug patent to enable production or importation of a generic medicine needed for public health purposes in the country (and to a limited extent, for export). Although drug prices have been shown to be consistently too high in developing countries, and in spite of the increased public health demand for new medicines to address diseases, very few countries have issued compulsory licenses to date. This is due mostly to political and corporate pressure placed on developing country governments.
For example, Thailand issued a number of compulsory licenses for medicines to treat HIV, cancer and heart disease in 2006 and 2007. In response, both the EU and the US sent strong messages to the Thai government requesting they cancel its compulsory licenses. At the same time, Abbott, a drug company, withdrew registration of seven medicines, including a critical, heat-stable version of an HIV and AIDS medicine, to retaliate against the Thai Government. It was an unprecedented action.
Pharmaceutical companies, supported by rich nations, have tried to also stem (or even abolish!), the use of compulsory licensing to very limited circumstances (e.g. only to address an epidemic or emergency or to only treat HIV and AIDS). Yet WTO rules make clear that compulsory licensing should be a tool available for all medicines needed for the benefit of public health. With an ever growing burden of cancer and other non communicable diseases (NCDs) in developing countries [about 70% of all cancer deaths in 2008 occurred in low- and middle-income countries and NCDs are responsible for 53% of all deaths in India] it is crucial to ensure that effective new treatment is available and affordable to patients in these countries.
Given the disappointing number of compulsory licenses issued to date, India has clearly made an important step in the right direction. Yet the good fortune for India’s people may be short-lived. Through the rest of 2012, the Indian government will face at least two serious challenges from rich countries and drug companies that could threaten the country’s ability to manufacture affordable generic medicines. Firstly, the EU is putting enormous pressure on India to introduce new IP rules through a free trade agreement whose negotiations should be completed this year.
At the same time, and for the second time since 2005, the drug company Novartis has hauled the Indian Government through its own court system to force changes to the country’s intellectual property law – alleging that in its current form it is not compliant with global trade rules. The Indian law being challenged was introduced in 2005 and plays a critical role in keeping down the price of medicines by discouraging the practice of ever-greening. To take action on the Novartis case visit: http://sumofus.org/campaigns/novartis-lawsuit/
Despite meeting all its obligations under global trade rules, India faces tremendous pressure to tighten its intellectual property rules. If either the EU or Novartis gets its way the impact will be catastrophic, blocking access to affordable medicines for millions of people in India and across other developing countries.
India’s actions, whether it be issuing a compulsory license, or pushing back against the aggressive pressure of the EU and Novartis, are especially important because India is considered the ‘pharmacy of the developing world’. Since India has stuck out its neck to issue a compulsory license, hopefully others will follow suit. Conversely, if the Indian government cedes to the pressure of the EU and Novartis it will be a huge set back to other countries fighting for affordable medicines.
Let’s hope India keeps taking steps in the right direction.