[Ip-health] Brazil declares Efavirenz to be of public interest

[MSF Michel Lotrowska]

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25.04.2007



Brazil declares Efavirenz to be of public interest



The Brazilian Minister of Health, Jos=E9 Gomes Tempor=E3o, has signed a dec=
ree
published today in the Federal Official Gazette declaring the antiretrovira=
l
drug Efavirenz to be of public interest. It is the most used imported drug
for AIDS treatment. Currently, 38% of people with AIDS use the drug as part
of their treatment schemes. It is estimated that by the end of this year,
75,000 of the 200,000 National Health System AIDS patients will be using
Efavirenz.

The declaration is the first step towards the compulsory licensing of the
patent for public non-commercial use =96 this flexibility is provided for i=
n
article 31 of the Trade-Related Aspects of Intellectual Property Rights
Agreement (TRIPS Agreement), and may be implemented in several situations
provided for by the Brazilian Industrial Property Law (Law No. 9279/96).

The measure has been taken because the Merck laboratory, owner of the
Efavirenz patent, did not accept a price reduction proposal that was
satisfactory for Brazil, one of the world=92s biggest buyers of the drug.

In November 2006, the federal government began negotiations aimed at
reducing the price of the drug for this year=92s contract. It was proposed
that the laboratory should charge the same price as that paid by Thailand,
which is US$ 0.65 per 600mg tablet, whilst Brazil pays US$ 1.59. The
difference between the price of the drug charged to the two countries is
136%.

The proposal for an equal price to be charged was not accepted by the
company, which in turn proposed a reduction of just 2%. The Ministry of
Health considered the laboratory=92s counterproposal to be unacceptable, si=
nce
there has been a reduction in production costs, as recently announced by
Merck itself; in addition to the existence of offers of lower prices from
other producers.

Proposals by international organisms exist to purchase the generic version
of Efavirenz, produced by World Health Organization (WHO) prequalified
laboratories, at a cost varying between US$ 163.22 and US$ 166.36 per
patient per annum. The price that Brazil currently pays for the drug is
equivalent to US$ 580 per patient per annum, so that the expected cost of
purchases of the drug would reach the figure of US$ 42.9 millions this year
alone. These proposals therefore represent a possible reduction in
expenditure in 2007 of around US$ 30 million. The estimated savings by the
year 2012, when the patent expires, are expected to be US$ 236.8 million.
However, the generic version of the drug can only be purchased once the
patent has been compulsorily licensed.

As such, in absolute compliance with the internationally required precepts,
and with prevailing national legislation, the compulsory licensing of
Efavirenz in the public interest is a legitimate and necessary measure to
guarantee access to it by all those patients who are provided with it
through the Ministry of Health=92s National STD and AIDS Programme.

Definition =96 Compulsory licensing is a flexibility provided for in articl=
e
31 of the Trade-Related Aspects of Intellectual Property Rights Agreement
(TRIPS Agreement). This practice is adopted by developed countries, such as
Italy and Canada in relation to pharmaceutical products, as well as by
developing countries. In the case of antiretroviral drugs, Mozambique,
Malaysia, Indonesia and Thailand have already made use of this provision.
Furthermore, Thailand recently decreed the compulsory licensing of
Efavirenz.

 In Brazil, compulsory licensing can implemented in the event of several
circumstances provided for in the Brazilian Industrial Property Law, such a=
s
such as the abusive exercising of such rights, the abuse of economic power,
absence of local production, unsatisfactory commercialization, national
emergency and public interest.

Compulsory licensing based on the public interest must be granted for
non-commercial use, non-exclusive production, and temporarily or, in other
words, the period of its validity must be defined, although it may be
extended and remain in force for as long as the public interest exists. It
must be emphasized that independently of this the remuneration due to the
patent=92s owner remains ensured.





Further Information


Press Office =96 National STD and AIDS Programme


Tel.: +55 61 3448-8100 / 3448-8088

E-mail: imprensa@aids.gov.br

Portal: www.aids.gov.br







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ASSINE A PETI=C7=C3O DE MSF =93ABANDONE O CASO=94

Hoje milh=F5es de pessoas em todo o mundo dependem dos medicamentos vendido=
s a
pre=E7os acess=EDveis e produzidos pela =CDndia. A empresa farmac=EAutica N=
ovartis
est=E1 processando o governo indiano para for=E7ar a modifica=E7=E3o da lei=
 de
patentes do pa=EDs. Caso a Novartis ven=E7a, uma das principais fontes de
medicamentos vendidos a pre=E7os acess=EDveis para milh=F5es de pessoas em =
todo o
mundo poder=E1 desaparecer.



MSF faz um apelo para que a Novartis ABANDONE O CASO.



Saiba mais e assine nossa peti=E7=E3o AQUI.
http://www.msf.org/petition_india/brazil.html



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