Every once in a while comes a discovery that brings about a seismic change. And every once in a while, also comes a business decision that enhances the seismic effect. One such discovery was the drug sofosbuvir, approved in late 2013 by the US regulator for treating Hepatitis C. It was the first time a drug could ‘cure’ this deadly, but silent, viral infection. Gilead Sciences sized up the windfall and priced it at $1000 a pill, the total treatment tab amounting to $90,000. The whiplash against the offensively high pricing was global but in India, the mood of generics drug makers was somewhat combative. It isn’t so now, though.
Gilead had reacted swiftly. In September 2014, it chose to give voluntary licenses of its less-than-a-year old drug to Indian generics makers—not one or two, but to 11 of them for selling in over 90 countries. Its decision proved to be seismic. As the generics hit the market, the $10-a-pill price stirred up the global patient group; thousands travelled to India to buy the full course.
Looking back from the third anniversary of that epic decision, it’s fair to say it woke the world to the ticking time bomb. Some 130-150 million people worldwide and at least 8-10 million in India have Hepatitis C. On 28 July, the Indian government, under pressure from the WHO and patient advocacy groups, said it’d start a national programme on Hep-C, just like it has for TB and malaria, by December.
“For the first time, we have a drug that can finish the virus. Hepatitis C is a low hanging fruit for success and we must eradicate the disease, like polio,” says Dr SK Sarin, eminent gastroenterologist, and director of the Institute of Liver and Biliary Sciences in Delhi. “We were instrumental in convincing John Martin [current chairman and then CEO of Gilead] for lowering the price. Thanks to Gilead’s generosity, access to this care is now possible.”
A lot of Indian companies jumped into what was clearly a niche market. Prices crashed in no time. It turned out to be good in the short term but may prove tricky in the long term as the market hasn’t grown the way it was expected. As free promotional camps and diagnostics disappeared, so did the demand burst. Many manufacturers have decamped. In two years, Gilead’s license to Indian generic companies, which pay 7% royalty to the US pharma, will come up for renewal. Can Indian patients, generic makers, and government make a success of this opportunity?
A trigger came on 5 September when the Delhi High Court admitted a public interest litigation from patient groups asking for free testing and treatment for Hepatitis C in the National Capital Territory of Delhi. The Court has asked the Delhi government for a status report.