With drugs costing Rs9 lakh, should govt invoke compulsory licensing?

With patented medicines for treatment of HIV/AIDS, cancer and hepatitis C beyond the reach of many patients due to their exorbitant prices, some say there is a case for invoking the provision of compulsory licensing.

Compulsory licensing is a green signal given by the government, judiciary, or competition commission to a third party to produce and supply a generic version of a patented drug in lieu of reasonable royalty to the patent holder. It is a legally recognised means of overcoming barriers to accessing medicines.

"It's not just poor and developing countries such as Mozambique, Zambia, Malaysia, Indonesia, Brazil, Ecuador that have invoked compulsory licensing in the past. Even developed countries such as Italy and Canada have invoked it in the past few years for medicines which were unaffordable or unavailable. India has never done so, despite prices skyrocketing and patients having no choice but to forsake treatment," said a health expert who works in Madhya Pradesh.

An intellectual property expert in Mumbai said compulsory licensing is the best option available as it allows production of low-cost generic versions of the drugs and also gives royalty income to the patent holder.

Loon Gangte, a HIV positive person and president of Delhi Network of Positive People said the older HIV/AIDS medicines are distributed by the government, but newer drugs, which are patented, are not. "They are beyond our reach despite being there in the market due to the prices."

Around 99% of hepatitis C patients across the country, especially in the northeastern states like Manipur, Mizoram and Nagaland, are beyond the purview of treatment, said Deepak Leimapokpam from the Manipur Network of Positive People in Imphal, who is afflicted by both HIV and hepatitis C.

"In a densely populated country like India, how many people can actually afford to pay lakhs for medicines? And treatments for cancer, hepatitis, HIV/AIDS are for long durations, often lifelong. Very few manage to source funds for a short while, and then just give up on treatment," said YK Sapru, founder chairman of Cancer Patients Aid Association.

Member nations of the World Trade Organisation have agreed in the 2001 WTO Doha Declaration on public health that every member has the right to grant compulsory licensing and has the
freedom do determine the reasons upon which it should be granted.

"Compulsory licensing is not reserved only in emergencies. In matters of public health, it can be issued. Government can't keep waiting for more and more people to go below poverty line due to healthcare spending before taking any concrete step," says the Mumbai-based intellectual property expert.

However, the Organisation of Pharmaceutical Producers of India, a group of multinational drugmakers, feels that provisions like compulsory licensing can impact foreign investment and innovation in the country.