domingo, outubro 23, 2005
Tamiflu genérico para África
October 21 2005
Generic Tamiflu : no time left for "talk", Roche must take action now
Act Up-Paris and the Burkina Faso Network for Essential Drugs (1) call on
Roche to unblock generic production for Africa
Roche CEO Franz Humer said Wednesday in an interview to Reuters that "Roche
will discuss possible licenses with anybody able to manufacture the drug."
For African countries, who have been unable to make stockpiles of Tamiflu,
and who are already seeing migrating birds arrive from contaminated regions,
there is no time left for talk: Roche must immediately authorize and
facilitate the launch of a generic production of Tamiflu.
Faced with a pandemic, Roche is not free to dictate its terms
- Roche is not the inventor of Tamiflu: the Swiss company has merely come to
reap the fruit of others' research by buying the rights to oseltamivir from
Gilead in 1996. The 50 million dollars Roche paid Gilead for Tamiflu (2)
have long since been recouped: total cumulated orders are now well in excess
of 1 billion dollars.
- Roche claims to be willing to grant licenses to other manufacturers, but
refuses to specify its terms: criteria for grant, royalty level, pricing
freedom vs imposition of anti-competitive fixed prices, or even timeframe
and transparency of the licensure "talks".
- With HIV medications, Roche's track record on voluntary licensing is to
systematically foil efforts to launch generic production, and to refuse to
issue licenses, for example to the Brazilian government (3).
Taking account of the opacity of Roche's voluntary licensing offer, one
cannot take the company's intent to facilitate a generic response to the
needs (amounts, prices) and the urgency (timeframe) seriously.
Thus, considering the huge profits already reaped over Tamiflu, as well as
the terrible vulnerability of Africa to an avian flu epidemic, it is
inacceptable that Roche should dictate it terms and slow down the launch of
massive generic Tamiflu production for poor countries.
People with AIDS at special risk from avian flu
- people with AIDS and other people with impaired immunity (the elderly,
children below 12 months) are at highest risk of lethal avian flu
complications like pneumonia (4) ; in France the government recommends that
PWAs should receive priority access to Tamiflu, but what will happen to the
millions of PWAs who live in Africa and other Tamiflu-less regions ?
- Africa will likely be hit by the avian epizootic well before Europe, since
in winter birds migrate from North to South ;
- Even without the avian flu, Africa is already the region with the highest
rate of respiratory infection mortality ; moreover, nearly 30 million
Africans are infected with the AIDS virus ;
- launching a generic production of Tamiflu will take between 4 and 15
months, depending on whether Roche keeps its manufacturing know-how secret
or not, according to experts from the generic drug industry.
In this context, Africa cannot afford to wait until Roche is done "talking".
Act Up-Paris and African Essential Drug Network (RAME) demand that Roche:
- renounce all its exclusive rights on Tamiflu in developing countries ;
- grant generic manufacturers complete access to Tamiflu manufacturing and
quality assurance know-how ;
- commit to taking all measures necessary to facilitate the soonest possible
launch of mass production of generic Tamiflu, especially for Africa and
other impoverished regions.
Act Up : Khalil Elouardighi + 33 6 63 15 38 82 ; RAME : Simon Kaboré +226
(1) RAME = Network for Access to Essential Drugs (Réseau Accès pour les
Médicaments Essentiels), Ouagadougou, Burkina Faso, www.rame-bf.org. RAME
is a member of est Panafrican AIDS Treatment Access Movement www.patam.org/
(3) "Brazil to Break Roche's Patent on AIDS Medication", Wall Street
Journal, August 23 2001 ; "Roche Reaches Accord on Drug with Brazil", New
York Times, September 9 2001.
(4) Colds and Influenza (the Flu), a report by the Well Connected Project of
Harvard Medical School, www.reutershealth.com/wellconnected/doc94.html