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REPORTS: BRAZIL |
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Saturday 6
September 2003
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Brazil
Imports Generic AIDS Drugs from India,
China
Mario
Osava*
RIO DE JANEIRO, (IPS) - Brazil's
decision to import generic HIV/AIDS
drugs, manufactured in China and
India, has gained greater legitimacy
with the related agreement approved by
the World Trade Organization last
week, but the import policy was never
contingent on international consent.
Brazil's president, Luiz Inácio Lula
da Silva, issued a decree Friday that
authorises importation of generic
medications -- drugs identified by
their main active ingredient, and
usually much cheaper than their
trademarked equivalents -- even
without the consent of the holders of
the corresponding patents.
The 146 WTO member states agreed Aug.
30 that developing countries can
import generic versions of patented
medications in order to tackle serious
and epidemic diseases, like HIV/AIDS,
tuberculosis and malaria.
That accord was achieved despite
criticisms from some nations of the
developing world -- notably Argentina
and Philippines -- that the
negotiations were rushed as a means to
allay fears of broad failure of the
trade liberalisation talks at the
WTO's Fifth Ministerial Conference, to
take place in the Mexican resort city
of Cancun, Sep. 10-14.
But in India, Abhay Shukla,
coordinator of the Mumbai-based
People's Health Movement, said,
"The change in WTO rules to
respond to public health
emergencies... will certainly help
India's pharmaceutical industry, which
is strong on generic drugs and is a
major player in the export
trade."
Non-governmental organisations (NGOs)
specialising in humanitarian issues,
like Oxfam International and Doctors
Without Borders, say the WTO's generic
drugs agreement still favours the big
pharmaceutical transnationals based in
industrialised countries. Its rules
say that these medications can only be
used in the countries authorised to
import them, and only in the quantity
stipulated.
However, Alexandre Granjeiro,
coordinator of the HIV/AIDS and
sexually transmitted disease programme
at the Brazilian health ministry, says
the NGOs made a "strategic
error" in making "an
erroneous assessment of the
moment."
The low-cost drugs agreement "is
a major victory" and benefits all
countries that face health crises,
especially in Africa, where millions
of lives are lost each year to AIDS,
malaria and other epidemics, Granjeiro
said in an IPS interview.
The control measures, which prohibit
re-exportation, do not mitigate the
positive consequences of this accord
for public health, he said.
Most nations do not manufacture their
own medicines, due to lack of
industrial capacity or the limited
size of their domestic markets.
If these countries cannot import
inexpensive drugs, then the principle
that public health prevails over
intellectual property -- approved in
Doha, Qatar, by the WTO Fourth
Ministerial Conference in 2001 -- is
meaningless, said the health official.
Brazil's foreign minister, Celso
Amorim, applauded the accord because
it reduces the cost of medicines that
are often purchased by the government
to distribute to those in need through
health programmes, free of charge.
Brazil has been one of the countries
at the forefront of generic
medications use as a means to handle
health emergencies.
The South American giant has done so
through "compulsory
licensing", which allows a
government to temporarily override a
patent so that AIDS-fighting drugs --
antiretrovirals -- can be produced
domestically. However, costs are
incurred because the pharmaceutical
company that holds the patent must be
paid royalties.
These medications are distributed in
Brazil free through an internationally
recognised programme that currently
attends to some 130,000 people with
HIV/AIDS, costing some 195 million
dollars a year.
The government's purchase of just
three antiretrovirals, whose generic
names are efavirenz, lopinavir and
nelfinavir, absorbed 63 percent of the
programme's budget. As such, Brasilia
sought price reductions of at least 40
percent in negotiations with the
transnational drugs labs Merck, Abbott
and Roche.
The response from "big pharma"
was a maximum reduction of 6.7
percent, which prompted the Brazilian
government to apply the compulsory
licensing measure, as laid out in its
national laws, and begin importing the
three AIDS drugs in their generic
forms.
This is why there was no need for new
WTO rules, Granjeiro explained. India
and China have not yet signed on to
the international patents protection
system, and they produce at very low
cost the generic AIDS drugs, which
they can freely export until 2005.
Even so, the agreement reached last
week by the WTO members lends
"greater legitimacy" to
Brazil's policy, he said.
The imports are necessary for now,
because it will be another year before
Brazil is able to manufacture the
three antiretrovirals at home. When it
does, it will reduce the current costs
of these drugs by half, estimates
Granjeiro.
But even in India, where the drugs are
manufactured, access is limited, as 40
percent of the population of one
billion lives below the poverty line,
notes physician and health activist
Shukla.
Like Brazil, "The Indian
government will have to step in and
subsidise the cost of drugs so that
they are within the reach of the
poor," he said.
Brazil has 18 state-run laboratories
with the capacity to produce surplus
quantities of generic drugs, "but
their vocation is to attend to the
needs of the domestic population, not
commercial demands," Carlos
Alberto Gomes, head of the Association
of Official Pharmaceutical
Laboratories (ALFOB), told IPS.
These labs, most of which are tied to
universities or research centres,
respond to requests from the Health
Ministry and from state and municipal
governments. Gomes does not rule out
the possibility of future exports
under the auspices of government
accords to help other countries fight
epidemics.
Brazil's pharmaceutical industry saw
rapid development in the past five
years, kick-started by a government
policy to distribute HIV/AIDS drugs
and foment the use of generics, and
promote national production, says
Pedro Rolim Neto, technical director
of the Pernambuco state laboratory,
LAFEPE, in the country's northeast.
In addition to technological
modernisation, it has helped reinforce
human resources in the area, Rolim,
professor at the Federal University of
Pernambuco, told IPS.
LAFEPE produces medications to treat
tuberculosis, hypertension, diabetes,
cholera and hanseniasis (leprosy), as
well as the three antiretroviral
drugs.
The AIDS crisis has played a key role
in this process, says ALFOB chief
Gomes. It forced the country to use
creativity to overcome financial
difficulties, and pursue initiatives
that turned Brazil into a "public
policy designer" to be emulated
by other countries.
And it made the country a leader,
alongside India, in the movement
challenging pharmaceutical patents,
particularly in the case of public
health emergencies in the developing
world, he said.
The next step for India, says Shukla,
is for the government to "heavily
subsidise drugs or even distribute
antiretrovirals free of cost,"
using the National AIDS Control
Organisation (NACO) to check the
spread HIV.
Shukla pointed out that so far the
World Bank-funded NACO has contented
itself with its HIV/AIDS testing
programmes and has yet to address the
question of treatment, despite India's
growing AIDS epidemic.
(* With reporting by Ranjit Devraj
from India.)
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