[Ip-health] KEI Europe Asks Romanian Government To Issue Compulsory Licences On Hepatitis C Medicines

Andrew S. Goldman andrew.goldman at keionline.org
Wed Mar 18 11:48:50 PDT 2015


Press Release


Date: 18 March 2015
For more information: See contacts below

[Compulsory licence request and Proposed Order available here:

Geneva, Switzerland 18 March 2015. On 10 March 2015, Knowledge Ecology
International Europe (KEI Europe), in collaboration with affiliate
Knowledge Ecology International (KEI), submitted a request to Romanian
Minister of Health, Nicolae Banicioiu, to petition the Court of Bucharest
to issue compulsory licenses on patents necessary for the supply of
low-cost hepatitis C virus (HCV) medicines. The request provides a legal
basis, as well as an economic, medical and moral basis, for compulsory
licences as the pathway to affordable treatment for the approximately 1
million Romanian citizens living with HCV.

Most studies put Romania at the highest rate of HCV-incidence in the EU,
estimated at between 3.2 and 6 percent of the population. Hepatitis C can
cause cirrhosis, liver cancer, and death, often drawn out over decades,
driving up costs and causing unnecessary suffering and pain for affected
populations. In Romania, the highest rates of HCV-incidence are found in
patients over forty years old, most of whom were infected through blood
transfusions prior to developments in medical safety in the 1990's.

Until recently, treatment for this disease has been very painful, difficult
to use and largely ineffective. But the recent development of new
Direct-Acting Antiviral (DAA) medicines for HCV, including sofosbuvir and
the sofosbuvir/ledipasvir combination, make treatment shorter and easier
with less toxic side effects, easy to use, and have cure rates of
approximately 90 percent or higher.

Yet these new medicines are very expensive because "companies weigh the
consequences of discounts in Romania on the prices they can obtain in other
countries in the European Union." For a country with a gross national
income (GNI) per capita of $9,060, roughly one-quarter of the overall GNI
per capita across the EU, the medicines are simply too costly to be within
reach of patients in need, and put strains on the government's ability to
provide reimbursements. This combination of factors has exacerbated the
problem of access to medicines in the country.

Thiru Balasubramaniam, Managing Director of KEI Europe: "KEI Europe and KEI
have received requests for assistance from stage-three and stage-four
Romanian HCV patients -- patients either in the end-stages prior to
cirrhosis or actually in the cirrhotic stage -- because they need the new
DAA HCV medicines, but cannot afford them. They are afraid that they are
going to die, in spite of the fact that a treatment is at their fingertips.
The World Health Organization's (WHO) HCV treatment guidelines clearly
identify compulsory licensing as a pathway for securing access to
affordable HCV medicines. The KEI and KEI Europe proposals focus on the
practical steps for implementing compulsory licenses."

By obtaining compulsory licenses to HCV patents, the Government of Romania
can authorize third-parties to use the relevant patented inventions to
"import, export, manufacture, offer for sale, sell, or use HCV medicines"
without the authorization of the patent holders within Romania. KEI Europe
predicts that cost of generic versions of the new HCV drugs, including some
regimes with less than 50 grams of active pharmaceutical ingredients, will
eventually fall well below $200 per 12 week course of treatment, and
indeed, as low as $20, if the drugs can be obtained at the same $.40 per
gram the U.S. government is now paying for the combination of TDF+FTC to
treat HIV. The lower prices will provide the possibility of much wider
access to the drugs in Romania than are likely from voluntary negotiations
with patent holders.

The legal basis for compulsory licences in Romania is Romanian patent law,
and other international regulations and trade agreements. Andrew S.
Goldman, KEI Counsel for Policy and Legal Affairs, said, "We drafted the
request in such a way as to emphasize its compliance with Romanian law,
relevant EU regulations, and with TRIPS Agreement. The Romanian Government
is asked to petition the Court of Bucharest to issue compulsory licences
that would expand access while reducing healthcare costs."

KEI Europe is a not-for-profit Swiss association which includes in its
mission efforts to improve access to medicines. KEI Europe is an affiliate
of KEI, a 501(c)(3) based in Washington, D.C., founded in 2006 to search
for better outcomes, including new solutions, to the management of
knowledge resources.


Thiru Balasubramaniam, Managing Director
Knowledge Ecology International Europe Association (KEI Europe)
Office phone: 41.22.791.6727
Cell phone: 41.76.508.0997
thiru at keieurope.org

Andrew S. Goldman, Counsel for Policy and Legal Affairs
Knowledge Ecology International
Office phone: 202.332.2670
Cell phone: 917.348.5579
email: andrew.goldman at keionline.org

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

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