Patent holder and pharma major Gilead, announced voluntary
licences with seven generic drug manufacturers in India to sell lower-cost versions
of a $1,000-a-pill for hepatitis C treatment in poorer countries.
Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories,
Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab, under the
licensing agreement have the right to develop and market generic versions of
sofosbuvir in 91 developing countries. However Indian manufacturers will not be
allowed to sell sofosbuvir in Brazil, Russia, China, Thailand and many other
Greg H Alton, executive vice president of Gilead says, "We believe in the
capabilities of our partner companies for high quality, low cost, high volume
manufacturing. The competition between them will bring down the price of the
generic version of sofosbuvir and thus this partnership will help bring about
better access to patients globally. Gilead will have no control over their
pricing. Our partner companies will set their own prices,"
Gilead's price per bottle of sofosbuvir is at $300 (28 pills meant for one
month of treatment at one pill per day), which is about 1% of the US price. The
Indian companies' representatives said they would need to complete one
production cycle to give an estimated price at which the drug available.
Sharing needles, receiving contaminated blood transfusions
or having sex with an infected person are all various causes of the Hepatitis C
According to the World Health Organization (WHO), approximately 350,000 people
die of Hepatitis C-related liver diseases every year, and as many as four
million people are newly infected each year. About 185 million of infected
people across the world have no idea they have the disease. It is in most cases
detected with diagnoses and discovered after a person develops cirrhosis,
end-stage liver disease or liver cancer.
Barry, a well known Liver Transplant Surgeon from USA said to Medindia,
"Until recently, chronic Hepatitis C Virus (HCV) infection was a very
difficult disease to treat, and liver failure due to HCV cirrhosis has been the
major indication for liver transplant in Western countries."
He added, "The advent of very effective HCV drugs has brought great hope
and excitement, as the disease can be completely cured in 60-90% of cases.
Sofosbuvir, a second generation HCV protease inhibitor drug manufactured by
Gilead, is even more effective and with less side effects than the first
generation drugs, but it is extremely expensive."
Medecins Sans Frontieres (MSF) pointed out that the Gilead
licence excluded countries like China, Brazil and Ukraine considered to have
the highest burden of people living with hepatitis C virus (HCV). Other
countries with large HCV burden like Thailand, Malaysia, Peru, Argentina,
Ecuador and Colombia have also been omitted from agreement.
The agreement essentially covers poorer countries where the burden is not as
high, MSF pointed out. These countries would not have borne the burden of
patent system, as they have been exempt from patent obligations. Prof Brook K
Baker, senior policy analyst in the School of Law in Northeastern University
pointed out, "Generic entrants might be particularly reluctant to serve
all smaller volume, poorer countries because of the cost of registering their
products and establishing distribution systems."
MSF Access Campaign's, Director of Policy and Analysis, Rohit Malpani, said,
"We welcome the interest of generic companies to scale up production of new
direct-acting antivirals and Gilead's decision to make the final agreement
public; however, a highly restrictive voluntary license that blocks millions of
people with Hepatitis C from affordable prices is not acceptable. MSF hopes
that excluded governments will take all relevant measures available under
global trade rules and national patent laws to secure low-cost generic versions
of these medicines."
A complete treatment
course lasting 24 weeks costs Rs.50.4 lakh in the US. It was announced that
Gilead will be offering voluntary licenses to Indian pharmaceutical companies
to manufacture Sofosbuvir and sell for only Rs 1.1 lakh per treatment course (1%
of the US cost). This is wonderful news for the over 18 million Indians infected with