E-drug: Le Monde diplomatique on patents and fund
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SOUTHERN SICKNESS, NORTHERN MEDICINE
Patently wrong
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After years of lethargy the international community has declared
war on Aids. Following a special session of the UN in June and the
G8 summit in July, a fund will be set up by the end of the year. But
the agreement being negotiated with the pharmaceutical industry
may fail to provide much-needed care for millions in the South.
by PHILIPPE RIVI�RE
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The Aids war began in South Africa. At the Durban world
conference in June last year African sufferers denounced "medical
apartheid" and called for universal access to anti-viral drugs. Most
Aids victims are in the South, the medicines in the North. In
Pretoria, on 19 April, 39 pharmaceutical companies that were suing
the South African government took stock of the damage done to
their image by their defiant defence of their patents and suddenly
dropped proceedings. Their aim had been to show that South
Africa's laws, designed to ensure an affordable supply of drugs to
the country, contravened the Trips (trade-related aspects of
intellectual property rights) agreements negotiated under the
auspices of the World Trade Organisation (WTO).
This about-turn would have been a fine victory. But the South
African government then claimed it could not afford a large-scale
programme of medical care for Aids victims. "Anti-retrovirals are
still expensive," explained health department spokeswoman
Jo-Anne Collinge (1). Dr Bernard P�coul of M�decins sans
fronti�res (MSF) condemns this attitude. "In the Cape shantytown
where 3m people live, a clinic set up by various organisations has
been offering a programme of prevention and screening for 18
months, which also allows opportunistic infections to be treated. In
stark contrast to what the government says, we've been offering
antiretrovirals since early May."
The donations and price cuts announced by the laboratories and
described by French health minister Bernard Kouchner as
tremendous sacrifices (2) are, however, far from sufficient. Paying
for treatment will require international mobilisation on a new scale,
to be headed up by United Nations secretary-general Kofi Annan.
After four Security Council meetings devoted to the pandemic, he
committed himself personally to setting up a global fund to fight
Aids, tuberculosis and malaria.
Annan's initiative (3) follows a proposal from a group of researchers
and international experts gathered around economist Jeffrey Sachs
at Harvard University, Boston. Noting the medical and moral failure
of the international organisations in regard to Aids, they issued "a
consensus statement on anti-viral treatments for Aids in poor
countries" on 4 April that was widely reported in the international
press (4).
Declarations of war
The Harvard document begins by arguing in favour of antiretroviral
therapy: despite its success in wealthy countries, it "remains largely
inaccessible in the world's poorest countries, where interventions
have focused almost exclusively on prevention. With soaring death
rates from HIV/Aids in low-income countries, both the prevention of
transmission of the virus and the treatment of those already
infected must be global public health priorities."
The document refutes past objections such as "poor countries lack
the adequate medical infrastructure to provide Aids treatment safely
and effectively." It responds that some of the assistance provided
will go to improving health care structures. Moreover, according to
Dr P�coul, experience in the Cape shantytown shows that, "unlike
the white elephants proposed as pilot schemes by UNAids, quality
treatment can be provided with modest resources."
A second objection was that "difficulties with adherence to
complicated medication regimens would promote and spread drug
resistance". Andrew Natsios of USAid, America's largest
international development agency, goes so far as to say that many
Africans "have never seen a clock or watch in their entire lives" and
cannot be expected to take drugs at set hours of the day (5). If that
is the case, why not also deny treatment to illiterate people in the
North? This argument overlooks the fact that only a tiny minority of
patients will be involved in such rigid drug regimens, those for
whom treatments of first resort are not or have ceased to be
effective.
The third objection was that paying for treatment would siphon
resources away from prevention. But, the Harvard researchers
stress, "appropriate treatment can not only prevent infected
individuals from succumbing to life-threatening illness from Aids,
but may play a major role in prevention both by reducing the viral
load of those under treatment and by encouraging greater
participation in prevention programmes."
Targets have been proposed: 1m people undergoing treatment in
three years' time (compared with 10,000 today). In its fifth year,
the full programme, prevention and treatment combined, would
benefit 3m people and cost $6.3bn.
Access to drugs has suddenly become a viable proposition in
international circles. In Pretoria the pharmaceutical companies are
conceding defeat. Kofi Annan is looking to spend $7-10bn every
year, which will come from governments, corporations and
charitable foundations (6). Things are at last moving, hope
returning.
But the small initial contribution announced by the United States in
May ($200m, one tenth of the expected amount) has cast a
shadow. And the conference held in Geneva on 4 June felt like a
calling to order. The Global Fund, born of the need to finance
access to treatment, seems to be turning its back on it, again
focusing international solidarity on prevention alone. Dr David
Nabarro, executive director at the office of Gro Harlem Brundtland,
director-general of the World Health Organisation (WHO), said there
had been "an extraordinary degree of convergence" among
delegates. The outcome of the debate was that victims will receive
"a limited and carefully targeted amount of drug treatment" (7).
Sachs believes this "drift of the Global Fund away from a balanced
prevention-and-treatment strategy to a prevention-and-no-treatment
focus would be a disaster. Prevention and treatment are an
inseparable combination. The shocking underfunding of the effort so
far can be no excuse for abandoning the cause of treatment. At
least $7-10bn a year are needed for a serious effort. The
underfunding of disease control remains one of the greatest acts of
moral irresponsibility and political shortsightedness in the world
today" (8).
What good has come of these declarations of war by top
international figures? "No war in the world is more important,"
General Colin Powell intoned during his visit to Kenya at the end of
May. "I am the secretary of state of the United States of America,
not the secretary of health, so why would I pay this kind of
attention to this sort of an issue? This is more than a health issue.
This is a social issue. This is a political issue. This is an economic
issue. This is an issue of poverty" (9).
Deal and counter-deal
The US National Security Council had previously identified the Aids
epidemic as one of the greatest long-term threats to world stability.
Apart from the health risk, the anticipated population imbalances
will have drastic consequences beyond the borders of the countries
concerned. What will become of a country where half the adult
population is dying? What about the 13.2m Aids orphans?
But there was also an important legal issue that drove the new US
administration to look at the matter again. President George W
Bush's trade representative, Robert Zoellick, sees the controversy
over access to drugs as an important test of the administration's
broader drive to increase the adoption of free-trade principles in the
US and around the world. He has voiced concern that a backlash is
building against the drug industry for aggressively asserting its
patent rights in the face of a monumental health crisis. He says:
"The hostility that generates could put at risk the whole intellectual
property rights system" (10).
A highly restrictive reading of the international agreements on
industrial property has the effect of prohibiting the countries of the
South from producing generic drugs; it also prevents the poorest of
them from importing generics produced elsewhere at the lowest
cost. But this interpretation is challenged by many organisations,
including MSF, South Africa's Treatment Access Campaign and Act
Up. They are lobbying governments, international organisations and
in the streets for wider use of compulsory licences and "parallel
imports". The Trips agreement allows both these methods to be
used in the event of a health emergency, for example.
Early this year the backlash occurred. Arraigned before the WTO by
the US, Brazil mounted a forceful challenge against the financial
burden of patents for its policy of making anti-Aids drugs available
free of charge. On 25 June the US withdrew its complaint in
exchange for a promise of talks before any compulsory licence was
granted in an American patent. Convergence is emerging in
international forums between Brazil, India, Thailand and South
Africa. France is timidly putting forward proposals. "We must
explore other avenues, like producing new drugs in the developing
countries themselves," President Jacques Chirac told the Durban
conference on 9 July last year. Prime Minister Lionel Jospin took up
the same point during a visit to South Africa this June. And the
European communities are trying to take better account of public
health imperatives in their interpretation of the Trips agreements
(communication of 11 June 2001).
The Indian firm Cipla's offer to MSF to provide a cocktail of
antiretrovirals for less than $350 a year (compared to the big boys'
$10,000) resounded like a thunderbolt. Suddenly, the emergence in
the South of very low cost generics producers seems credible.
James Love, coordinator of the Consumer Project on Technology in
Washington and kingpin of the Cipla offer, stresses: "The success
in the developing world of the southern producers is quite
important. Otherwise there is no real leverage. It is important not to
link use of the global fund to purchases from European and US
producers, but rather, to permit competition and buy from the firms
with the best price that have acceptable quality. Sachs has been
terrible on this, urging purchases from big pharma exclusively."
Is that why the Harvard mechanism found favour with the Bush
administration, the European Commission, the WHO experts,
UNAids, the Bill and Melinda Gates Foundation and the
pharmaceutical industry? It offered an answer to "medical
apartheid" without dropping the guard on patents.
And yet, following Cipla, a lot of generics manufacturers have come
on the scene, making treatments available for $200 a year. The
Harvard formula would supply them for around $1000. "It would be
extremely dangerous for the Global Fund to centre around this deal
between the pharmaceutical companies and the American
administration," says Dr P�coul. "An open reading of Article 30 of
the Trips agreements would in fact allow the fund to purchase from
the generics manufacturers. The total costs of drugs for 5m
patients would then fall from $5bn to $1bn. That would resolve the
prevention-treatment dilemma from the outset and release funds for
infrastructure and patient follow-up."
In 1955 Dr Jonas Salk, creator of the first polio vaccine, was
interviewed on television. When asked who the patent belonged to,
he said: "Well, the people, I would say. There is no patent. Can you
patent the sun?" At the end of his life Salk was devoting most of
his work to the search for an Aids vaccine. Will his successors
manage to shed a ray of sunshine in this present darkness?
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(1) Financial Times, London, 5 June 2001.
(2) France 2 television channel, 31 May 2001. The minister appears
unaware that as a result of tax deductions a donation actually earns
the generous manufacturer 25% of the drug's list price - and that
the US taxpayer could buy between two and 10 times as much
from the generics manufacturers (source: MSF).
(3) The only precedent, with disappointing results, is the
International Therapeutics Solidarity Fund (FSTI) launched by
Kouchner in 1999. Now back in the government, he has just
launched a European hospital cooperation initiative.
(5) John Donnelly, "Prevention urged in Aids fight", Boston Globe,
7 June 2001.
(6) These figures may seem high, but if the EU were to fund the
operation on its own, it would amount to around $30 per inhabitant
per year.
(7) Financial Times, 5 June 2001.
(8) Email, 5 June 2001, distributed on the pharm-policy list
(9) Karl Vick, "General Powell's War: Aids in Africa", International
Herald Tribune, Paris, 29 May 2001.
(10) Paul Blustein, "US Trade Envoy Signals a New Approach to
Tough Issues", International Herald Tribune, 14 March 2001.
Translated by Malcolm Greenwood
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