[Ip-health] Scale up of hepatitis C treatment possible as Brazil rejects patent on key drug

Joanna Keenan joanna.l.keenan at gmail.com
Fri Mar 31 08:14:58 PDT 2017

*Scale up of hepatitis C treatment possible as Brazil rejects patent on key


Decision enables price reductions and scale-up of treatment that leads to
cure in 95% of cases

Rio de Janeiro, 31 March, 2017 – Treatment for hepatitis C using the key
drug sofosbuvir could be vastly scaled up in Brazil after the decision by
the National Agency of Health Surveillance (Anvisa) to reject a key patent
application on the drug marketed by pharmaceutical corporation Gilead. The
decision could pave the way to enable generic competition in Brazil, which
should lead to price reductions, making it more affordable to scale up

“In Brazil, as in many other countries, the high price charged by Gilead
for sofosbuvir has meant treatment rationing. A report by WHO issued in
October 2016 shows that out of 80 million people infected with hepatitis C
worldwide, only 5.4 million people,  including only 1 million people from
low- and middle-income countries, had access to new treatment options”,
said Felipe de Carvalho, Brazil Coordinator of Médecins Sans Frontières’
Access Campaign. “On the other hand, it is very encouraging to see in the
report that countries achieving great results in treatment coverage are the
ones where generics are available. We need a coordinated global effort to
ensure effective medicines are available to the largest number of people as
soon as possible – and this decision in Brazil is a step towards that.”

The exorbitant cost of sofosbuvir has prompted a global debate about
inaccessible and unacceptable prices of patented drugs. In the United
States, Gilead originally set the price of sofosbuvir at US$1,000 per pill
– making the drug more expensive than gold – while studies show it can be
produced for less than $1 per pill. This week, in Europe, MSF and partners
have challenged the same patent that was rejected in Brazil by Anvisa at
the European Patent Office, in order to increase access to the treatment.

In Brazil, sofosbuvir has been used in the Brazilian Public Health System
(SUS) since the end of 2015. Prior to that, the Working Group on
Intellectual Property (GTPI) – a collective of civil society organisations
coordinated by the Brazilian Interdisciplinary Aids Association (ABIA) –
had filed a patent opposition on the drug showing the patent is not
merited. In the decision, Anvisa took into account GTPI’s argument that the
patent application does not meet patentability criteria established in
Brazilian law. Patent applications on sofosbuvir have already been rejected
in Egypt, China and Ukraine.

“This decision is extremely beneficial for the 1.6 million Brazilians
living with hepatitis C, because it allows the government to be more
ambitious with its treatment goals. Currently, we see the violation of
universal access to medicines in favour of Gilead’s abusive price”, said
Pedro Villardi, GTPI coordinator. “It is important now to ensure that this
decision will not be appealed and that it is validated by INPI, allowing
the government to quickly buy affordable generic versions. There is an
agreement under discussion that can eliminate Anvisa’s ability to reject
patents based on patentability criteria. This cannot happen. If Anvisa’s
decision on sofosbuvir is respected, we could potentially now treat seven
times the number of people currently on hepatitis C treatment without
spending more money, if Brazil buys generic sofosbuvir at the lowest global

Gilead currently charges $6,293 for a 12-week treatment course of
sofosbuvir in Brazil. The best generic prices are currently available for
around $200 per treatment course, but access is restricted by voluntary
licences signed by Gilead, which block sales to countries like Brazil. In
June 2016, an initiative for local production of a generic version of
sofosbuvir was announced by a consortium that announced a price less than
half of what Gilead charges. In early 2017, this consortium also filled a
patent opposition. Following the patent rejection, generic versions could
soon enter the market, reducing the price and expanding access to

“Brazil is a high-burden country for hepatitis C and so far, around 30,000
people have received new treatments – it’s crucial we scale up treatment
with affordable versions of sofosbuvir. In some States, even people in an
advanced stage of the disease have had to wait a long time to get
treatment”, said Arair Azambuja, president of the Brazilian Movement of
Viral Hepatitis (MBHV). “We are talking about a cure that is cheap to
produce; it should not be priced out of reach. We hope Brazilian
stakeholders make efforts to bring prices to the lowest levels, so we can
really tackle the hepatitis C epidemic in Brazil.”

*Joanna Keenan*

Press Officer

Médecins Sans Frontières - Access Campaign

P: +41 22 849 87 45

M: +41 79 203 13 02

E: joanna.keenan[at]geneva.msf.org

T: @joanna_keenan




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