[Ip-health] IPS: Brazil considers compulsory licenses, defends Doha p6 deal

[James Love]

http://www.ipsnews.net/interna.asp?idnews=3D19997

WTO-CANCUN:
Brazil Imports Generic AIDS Drugs from India, China

Mario Osava*

RIO DE JANEIRO, Sep 5 (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
Organisation last week, but the import policy was never contingent on
international consent.

Brazil's president, Luiz In=E1cio 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.) (END/2003)