New hepatitis C treatment costs only $1000
Indian generics of new hepatitis C treatment cost a fraction of the original drug, but can only be sold in “low-income countries”
On January 13, 2015, Indian Patent Office has taken a decision to reject Gilead’s application for sofosbuvir patent. Shortly after, Gilead started putting pressure on India, including the Indian Department of Industrial Policy overseeing the Patent’s Office, trying to reverse this decision. One of the Gilead’s arguments is that regardless of the patent decision, accessible sofosbuvir will still be available in India and other developing countries.
In September 2014 Big Pharma signed voluntary license agreements – no doubt, aimed at saving their patent rights – with seven India-based generic manufacturers: Zydus Cadila, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy, Sequent Scientific and Strides Arcolab. These agreements are meant to broaden access to innovative hepatitis C drugs, sofosbuvir (known in the US under the trademark Sovaldi™) and ledipasvir (which later became one of the active components of Harvoni™), by enabling the production of their generic versions for some countries, defined by Gilead.
This license, however, was widely criticized by many experts and HCV advocates. Questions arouse whether Gilead will really allow access to the medication – or this is just a trick to avoid open generic competition that could disturb the market and bring down the new hepatitis C treatment cost.
“…Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 % of people with hepatitis C live today.” Médecins Sans Frontières
There are several problems that license agreements might cause.
These measures might restrict access to affordable hepatitis C treatment to only certain groups of patients, experts argue. Among the excluded groups are people who are not covered by government programs or covered by private health programs, as well as foreign residents. Not only are these measures discriminating, but they also violate basic human rights and medical ethics by forcing to disclose confidential patient data.
Raw material limitations
Experts say that the voluntary license might restrict the sale of raw materials used for generics production, limiting it to Gilead-licensed producers only. It means that manufacturers in other countries that did not accept the patent, such as Egypt or China, will have to stop producing their affordable sofosbuvir generics.
|Both India and Egypt have about 12 million people citizens with hepatitis C.
However, with total population of India exceeding 1.2 billion, it’s just 1% of Indians.
Egypt’s population is only 86 million people, meaning that 15% of this population is suffering from the deadly virus – world’s highest prevalence.
New hepatitis C treatment costs only $1000, but not for everyone
Despite the rejection of sofosbuvir patent application in India and the likely availability of generic versions, existing Gilead patents in other countries – South Africa, for example – will still block access to affordable generic sofosbuvir.
“… sofosbuvir is not yet registered or available in South Africa, and existing patent barriers could hinder the country from looking for multiple generic sources of the drug in order to get the most affordable prices” Médecins Sans Frontières
Under the voluntary licensing agreement, the seven licensees can produce cheap generic sofosbuvir and ledipasvir-sofosbuvir combo for delivery in 91 developing countries, thus giving treatment access to around 100 million patients, or about 54% of the total infected population. What about the other 46%?
Many countries – mostly middle-income ones – that do not have patent protection and could otherwise benefit from cheap generic sofosbuvir are explicitly excluded from voluntarily license. Among others excluded are China, Brazil, Ukraine, Mexico, Romania, Thailand, Russia and Malaysia. These countries won’t be able to afford original Sovaldi™ with the scandalously high price tag proposed by Gilead. It seems that these countries are trapped. The new hepatitis C treatment cost is sky-high, and with the new license agreement prohibiting export to these markets, they can’t buy cheap generic sofosbuvir either.