India must keep patent laws for manufacture of cheap generic drugs

Recently, trade ministers from 10 Asean countries, India, China, Japan, Australia, New Zealand and South Korea gathered to negotiate a deal on the Regional Comprehensive Economic Partnership (RCEP) trade agreement. But, RCEP negotiations on intellectual property (IP) are at a standstill because India and the Asean countries are unwilling to trade away health by adopting IP provisions that go beyond what is required of them under international trade rules.

Médecins Sans Frontières and millions of people who rely on cheap India-made generic medicines are depending on New Delhi to resist pressure to undermine the public health protections in India’s existing laws. India could build a robust generic medicines industry before 2005 because it did not grant product patents on medicines.

When India, under World Trade Organization rules, started granting pharmaceutical patents in 2005, India’s law makers set the bar high for what merits a patent in the interest of public health. At the same time, India introduced public health safeguards which paved the way for continued supply of affordable generic medicines.

Being a treatment provider, MSF relies heavily on Indian generics to treat more than 200,000 people living with HIV/AIDS across the world. MSF also uses Indian generics to treat many other diseases and conditions. As the world now grapples with an estimated 130-150 million people chronically infected with Hepatitis C virus (HCV), another revolution for affordable generic life-saving medicines is needed.

With the arrival of oral HCV drugs — direct-acting antivirals (DAAs) — people living with HCV and governments around the world have high expectations that these medicines can provide effective, non-toxic and simplified treatment. MSF is starting to treat people with HCV with DAAs in India and eventually at least eight other countries, and so needs access to low-cost treatments. But prices for the DAAs can be shockingly high; for example, the DAA sofosbuvir is as much as $1,000 per tablet in the US.

Yet, broad treatment scale-up with these drugs in developing countries will be possible only if governments can use the public health safeguards at their disposal. We must take our cues from history, where the HIV/AIDS experience showed how critical it was for a number of countries to use public health safeguards like stricter patentability criteria and/or compulsory licensing, to manufacture or import affordable generic versions of HIV medicines.

These same public health safeguards could be on the chopping block if countries like Japan and other developed countries manage to get India and ASEAN countries to cave in on the IP negotiations under RCEP. The leaked RCEP draft text has incorporated some of the most damaging IP provisions that will put in place far-reaching regulatory and patent monopolies that would restrict generic competition and keep medicine prices unaffordable for MSF and for millions of people in the developing world.

MSF has launched the #HandsOffOurMeds campaign to urge the Indian government to resist external pressure to change its regulatory and patent laws, and to reject any proposal that undermines generic competition from India. India must stand strong; millions of lives are on the line.

(Leena Menghaney is Asia Regional Head, Médecins Sans Frontières’ Access Campaign
The views expressed are personal)