[A2k] Brazil's CL for Efavirenz

[Pedro Moniz]

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[ Picked text/plain from multipart/alternative ]
http://www.a2kbrasil.org.br/ENG/In-a-historical-decision-Brazilian

A2K Brasil Programme of the Centre for Technology and Society (CTS) of
Funda=E7=E3o Getulio Vargas School of Law in Rio de Janeiro


In an historical decision, the Brazilian Government issues a compulsory
licence for an anti-retroviral drug

Yesterday, for the very first time in Brazilian history, a pharmaceutical
company had its patent compulsorily licensed by the Federal Government due
to its public interest. Before the issuance of the compulsory license,
President Luis Inacio Lula da Silva issued a decree declaring the
anti-retroviral Efavirenz of public interest.

The anti-retroviral Efavirenz, used by 38% of Brazilians under AIDS
treatment, is currently held by the North-American laboratory Merck Sharp &
Dohme <http://www.msd.com/>, the owner of the patent. According to the
Brazilian Government, the measure will allow a decrease of 72% on the drug'=
s
current price now that generic versions of Efavirenz will be imported from
Indian laboratories.

Merck will receive from Brazil royalties of 1,5% over the amount invested o=
n
purchising of the drug from Indian laboratories. The compulsory licensing i=
s
a legal and legitimate instrument recognized by both Brazilian law and
international trade agreements, namely the TRIPs agreement of the World
Trade Organisation.

According to informations provided by the Brazilian Ministry of
Health<http://portal.saude.gov.br/portal/aplicacoes/noticias/noticias_detal=
he.cfm?co_seq_noticia=3D29719>,
"the practice of compulsory licensing for pharmaceutical products is
frequently used both by developed (Italia and Canada, for example) and
developing countries. In antiviral drugs case, developing countries already
used that flexibility: Mozambique, Malasya, Indonesia and, more recently,
Thailand".

We from the Center for Technology and
Society<http://www.direitorio.fgv.br/cts>from Funda=E7=E3o
Getulio Vargas School of Law in Rio de
Janeiro<http://www.direitorio.fgv.br/>supports the historical decision
held by the Brazilian Federal Government,
as well as work of the Brazilian Interdisciplinary AIDS
Association<http://www.abiaids.org.br/>and the Medecins
Sans Frontiers <http://www.msf.org/> in Brazil.

Below, we reproduce the document released by the Working Group on
Intellectual Property
(GTPI)<http://www.rebrip.org.br/_rebrip/pagina.php?id=3D655>from the
Brazilian
Network for the Integration of Peoples (REBRIP)-><http://www.rebrip.org.br/=
>,
on Friday, the 4th of May, 2007.
------------------------------

The Working Group on Intellectual Property (GTPI) from the Brazilian Networ=
k
for the Integration of Peoples (REBRIP) expresses its support for the
federal government's decision to issue a compulsory licence for the
antiviral drug, Efavirenz, whose patent is current held by Merck Sharp &
Dohme. This historical decision reinforces the efforts of civil society
groups fighting for access to medicines, for the sustainability of public
health policies, such as universal and unlimited access to antiretroviral
medicines used in the treatment of HIV/AIDS, and for the strengthening of
the Brazilian public health care system, the Unique Health System (SUS).

We understand that the use of compulsory license allows the procurement and
production of more affordable generic versions, providing the guarantee of
fundamental human rights, especially health's rights. The measure taken by
the Brazilian government takes into account the government's conditions to
guarantee the supply, considering the possibility to immediately import
medicines with quality and the local production subsequently.

We would like to emphasize that the use of compulsory licences is a legal
and legitimate instrument recognized by both Brazilian law and internationa=
l
trade agreements, namely the TRIPS agreement of the World Trade
Organisation. The interests behind the drafting and adoption of this
agreement are becoming clearer every day and demonstrate how private
interests, increasing the profit margins of multinational companies, are
appropriating knowledge and technological goods. These profits are extremel=
y
high, especially when one considers that they are earned thanks to the
protection of products that are essential for human survival =96 in this ca=
se,
medicines.

Finally, we consider sovereignty as a central political and legal
institution of the State. As such, trade agreements must not prevent States
from adopting measures that aim to protect health, safety and the
independence of the people. In this sense, the measure adopted by the
Brazilian government today represents a victory of common-sense in dealing
with the question of access, and can and should stimulate the issuing of
licences for other medications that are fundamental for the treatment of
various diseases affecting the country.

[image: -]Efavirenz is one of the most used for the anti-retroviral therapy=
.
Currently, 38% of the patients are using this medicine. It is estimated tha=
t
until the end of 2007, 75.000 of the 200.000 patients being treated with
anti-retrovirals will be using efavirenz.

[image: -]Due to the increasing number of people living with HIV/Aids in
Brazil, current price for efavirenz threatens the sustainability of the
Brazilian Aids Program. Based on the current prices (US$1,59/tablet), the
purchase of efavirenz (600 mg) for the Aids Program accounts for almost US$
42,9 millions to the Brazilian government. This means about US$ 580 per
patient per year. Proposals received by international organizations for the
procurement of this medicine, from WHO pre-qualified laboratories, which ar=
e
between US$163,22 and US$ 166,36 per patient per year. These proposals woul=
d
mean a reduction of government expenses, in 2007, of US$ 30 millions per
year. After issuing the compulsory license for efavirenz, it is estimated
that the savings until 2012 will be of US$236,8 millions, when the patent o=
f
this anti-retroviral expires.

Brasilia, 4th of May, 2007.

*Contacts*

Renata Reis: renata [at] abiaids [dot] org - Mobile: (55) (21) 9114-1838

Gabriela Chaves: Gabriela [at] abiaids [dot] org - Mobile: (55) (21)
8879-5680

Michel Lotrowska: access [at] msf [dot] org [dot] br - Mobile: (55) (21)
8111-3666

posted by Paula Martini