[Ip-health] The French Government Must Issue a Compulsory License for Sofosbuvir and Seek the Usage of Generics [English version]

Pauline Londeix pauline.londeix at gmail.com
Sat Jul 12 16:41:57 PDT 2014

Cost of Treatment against Hepatitis C: The French Government Must
Issue a Compulsory License for Sofosbuvir and Seek the Usage of


Saturday 12 July 2014

Act Up-Basel called the French government to learn from the current
situation regarding access to new direct-acting antivirals (DAAs)
molecules used in the treatment of hepatitis C (HCV), to exercise
Article L613 -16 of the Code of Industrial Property on the
transmission and loss of patent holder rights to issue a compulsory
license [i] and make available generic versions of sofosbuvir.

Paris - Basel - Casablanca - Press Release - Act Up-Basel

Since Sofosbuvir was licensed for sell on the European market,
hepatitis experts and organizations working on HCV in France are quite
certain : According to their computation, access to HCV new treatments
in France will only be possible through an out-of-reach spending from
the national health insurance. To treat 55% of people infected with
chronic HCV in France (133,000 patients, with an advanced stage of
infection - stage 2-4 fibrosis or "F2" to "F4"), the national health
insurance must pay the equivalent of the annual budget of all Parisian
hospitals and health centres (Assistance Public - Hôpitaux de Paris -
AP-HP) for the purchase of sofosbuvir (SOF) alone [ii] or EURO 7 billion.
To cover the cost of the triple therapy with peg-interferon (PEG-IFN)
and ribavirin (RBV) for genotype 1 (Western Europe's most common
genotype) and then, in the near future, another DAA, the price of a
two-or triple therapy will be even higher. With a new DAA such as
datasclavir (BMS-052), it would cost between EURO 100,000 and 150,000 per
person for a 12 week treatment, while the production cost of
sofosbuvir and datasclavir combined is estimated between EURO 57 and EURO 122.
The profit reached by Gilead Sciences, the pharmaceutical corporation
marketing Sovaldi (followed by Bristol Myers Squibb for datasclavir
very soon) is huge. It exceeds the margins of all other industries by
far, including luxury industry. For example, Sovaldi currently
marketed in the United States has already helped Gilead to rake
approximately $2.3 billion in a quarter [iii].

A pill that costs EURO 2.5 to produce, sold EURO 650: the pharmaceutical
industry is the most "profitable" for all industries.

If the French Ministry of Health does not currently appear to wish to
select or to deny treatment initiation based on the infection stage -
such as the raffles during the first moments of HAART -, can we accept
the national health insurance subsidize such exorbitant prices which
are more than ever unjustified? The French president and the
government of the prime mister Manuel Valls pound the importance of
bailing out public accounts and thus controlling state spending. In
such a context, why should the pharmaceutical industry benefit from
special favours? On which ground could this industry continue to
benefit without limit during the current economic crisis?

France must urgently change its price negotiation mechanism for
medicines. The committee in charge obviously failed, since they
accepted Gilead's price of EURO 50,000 per person for a 12 week treatment
with such low estimated production costs [iv].

"The acceptance of such a price, when we know Sofosbuvir's low
estimated production costs, the obvious lack of real innovation
compared to existing molecules, and how quick generic formulation
could be manufactured, all these show a glaring evidence of the
incompetence and therefore failure of the health authorities in charge
of this issue, "said Pauline Londeix, co-founder of Act Up-Basel and
member of the International Treatment Preparedness Coalition (ITPC).

Solutions exist and they are in the hands of the French government.

For the 2001 Anthrax "crisis", the United States exercised their right
to issue a compulsory license for "government use" to make Bayer's
patented medicine broadly accessible. This measure led to a
substantial decline in the medicine's price.

In 2010, France ordered 94 million doses of H1N1 vaccine. Instead of
questioning the price of this vaccine, France went for the EURO 50 branded
version, while generic alternatives existed and cost less than EURO 5. The
anti-H1N1 plan eventually cost more than EURO 2 billion to the national
health insurance [v].

Like the United States in 2001 for Anthrax, or low-or-middle-income
countries such as India, Thailand, China, Brazil and Indonesia for
AIDS, France must urgently take the lessons from such a situation and
quickly use the flexibilities of the World Trade Organization (WTO)
Agreement on Trade-Related Intellectual Property Rights (TRIPS) and,
more specifically, the legal provisions that allow the use of generic
versions even in the case of patented molecules, as it is the case for

Since public health interests are at stake, France's Minister of
Health Mrs. Marisol Touraine should ask Mr. Arnaud Montebourg in
charge of the Ministry of Economy, Productive Recovery and Digital
Media to submit a compulsory license, in accordance with Article L.
613-16 and L. 613-17 of the Code of Industrial Property, against the
patent granted to sofosbuvir [vi] and allow the use of a generic

France could also use another legal provision, under the WTO TRIPS in
1995 [vii] and reaffirmed by the Doha Declaration in 2001. In the
Article 31, the TRIPS agreement states that any country may use
compulsory licenses, and "allow someone else to produce the patented
product or use the patented process without the consent of the patent

"In the past, countries, mostly low-and-middle-income ones, have used
TRIPS flexibilities including compulsory licenses and patent
oppositions especially for HIV /AIDS medicines. It would be very
surprising that France puts Gilead's interests before those of its
citizens!" said Othoman Mellouk of the International Treatment
Preparedness Coalition (ITPC).

Act Up-Basel calls the French government to take all measures,
including political ones, to show that equality in health care access
and public interests prevail over private interests of a
pharmaceutical corporation.

"While our policymakers advocate austerity measures, it would be
indecent to ask French citizens to fill the coffers of Gilead and its
shareholders" concluded Arthur Vuattoux, in charge of France at Act



[i] "If the interest of public health demands and in the absence of
agreement with the patent holder, the Minister responsible for
industrial property, at the request of the Minister of Public Health
can submit an halt to the regime of statutory license in accordance to
Article L. 613-17, any patent granted for: a) a medicine [...]"

[ii] See the report of Médecins du Monde: Hepatitis C: A strategy for
universal access to new treatments

[iii] http://www.bloomberg.com/news/2014-...

[iv] See the study by Andrew Hill Minimum Costs for Producing Hepatitis C DAA

[v] See the article of Le Monde, "A Flu for two billion"

[vi] From nucleoside phosphoramidate prodrugs, Pharmasset / Gilead
Sciences / Patent Number: WO 2008121634

[vii] http://www.wto.org/french/docs_f/le...


Special acknowledgment : Pierre de Vasson

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