[Ip-health] Le Monde diplomatique article on 2002/2003 CL/scope of disease debate

[James Packard Love]

This is something I wrote for Le Monde diplomatique in March 2003,
about the WTO debate over the scope of diseases.  Jamie

http://mondediplo.com/2003/03/12generics

Le Monde diplomatique, March 2003

WTO RENEGES ON DRUG PATENTS
Prescription for pain

Despite the promise made by the World Trade Organisation in 2001,
Northern pharmaceutical companies and wealthy Western nations are
still preventing Southern countries from getting desperately needed
drugs cheaply.

By James Love

WAS it a policy change or a slip of the tongue? One phrase in
President George Bush=92s State of the Union address in January left
observers bewildered. After announcing a major increase in US funding
for the worldwide battle against Aids, he noted that the cost of
retroviral treatments had fallen from $12,000 to $300 a year, even
though only manufacturers of generic copies charge $300. Bush, like
President Bill Clinton before him, has noisily combatted generic
drugs in international forums, even though, to quote Bush, their
lower cost "places an immense possibility within our grasp".

For the past two years the World Trade Organisation has been in
bitter dispute over patents on medicinal drugs. Powerhouses such as
the US, the European Union, Japan and Canada want to backtrack on the
Doha agreement of November 2001. And US intransigence scuttled last-
minute WTO talks in Geneva last December.

The argument is about the right of countries to provide health care
by overriding drug patents. Wealthy countries, which have a virtual
monopoly on drug patents, compiled a list of suitable diseases: Aids,
tuberculosis, malaria and a few mainly tropical ailments of little
commercial interest. Wealthy countries have been trying to apply the
Doha agreement only to these diseases; no provision for cancer,
diabetes or asthma.

Those wealthy countries also raised technical questions in order to
further restrict the scope of the agreement. These pertained to
limiting the number of countries authorised to override patents;
restricting qualifying technologies; and creating complicated, costly
and restrictive legal requirements that threaten supplies of generic
equivalents of patented drugs. Wealthy countries have conspired
against the poor, undermining and breaking the promises made in 2001.

How did this happen? The events leading to the WTO meeting in Doha
were dramatic: large pharmaceutical companies filed a lawsuit to
force South Africa to drop an amendment to its patent laws. What
ensued was a public-relations nightmare: HIV-positive South Africans
protested in 2001 and broadcasts of the courtroom proceedings were
devastating for the plaintiffs; people in wealthy countries were
ashamed. The US also asked the WTO to overturn a Brazilian law on
overriding patents, although it eventually dropped the case amid
widespread public criticism.

After the 11 September 2001 attacks the US faced a bioterrorism
threat. Public officials and news organisations received anthrax
spores in the mail, leading to five deaths and widespread panic over
access to Cipro, a drug used to treat strains of the disease. To
ensure adequate low-cost supplies, Canada and the US threatened to
override Bayer=92s patents on Cipro. Even though this action was
justifiable, it defied the vigorous attempts to prevent Brazil and
South Africa from taking similar steps to fight Aids.

The WTO then met in November 2001. Forced on to the defensive,
wealthy countries approved a statement affirming the right of all
countries to protect public health. Hailed as the beginning of a new
era in international trade, the arrangement was seen as fairer for
poor countries. But in the 14 months after the WTO meeting,
negotiations on implementing the Doha agreement went out of control
as the US and the EU consolidated their support for big
pharmaceutical exporters. The progress in Doha was a setback for
public health groups and developing countries.

The battle centres on the WTO=92s agreement on trade-related aspects of
intellectual property (Trips), one of the organisation=92s three
pillars (1). In theory the Trips agreement is flexible, allowing
countries to protect public-interest concerns, including health care.
One of the most important provisions concerns compulsory licences on
patents. Governments can legally force patent holders to authorise
licences enabling drugs to be produced locally; the patent holders
are entitled to modest financial compensation under the terms of the
licences.

In Doha the WTO=92s entire membership approved a powerful statement on
the Trips agreement and public health issues. It stipulated that
Trips "should be interpreted and implemented in a manner supportive
of WTO members=92 right to protect public health and, in particular, to
promote access to medicines for all". This shocked the big
pharmaceutical companies, which responded by focusing on one of the
statement=92s key implementation provisions.

Paragraph 6 of the Doha statement called on the WTO to resolve
restrictions on drug exports. When a country issues a compulsory
licence for a patent, any generic copies made by local companies are
assumed to be primarily for the domestic market. But if countries
manufacturing generic drugs cannot export them, how can a country
without a domestic pharmaceutical industry acquire generic drugs?
Because economies of scale are so crucial to the pharmaceutical
industry, how will domestic manufacturers in a small country ever
achieve commercial viability? One reasonable solution fits the WTO=92s
free-trade agenda: allowing all countries with public health concerns
to override patents and import generic copies of patented drugs. This
would be a prac tical way to make low-cost medication available,
easing suffering and saving millions of lives. But how will the
statement be implemented? To Robert Zoellick, the US trade
representative, and Pascal Lamy, the EU trade commissioner, paragraph
6 is a pretext allowing them to turn the Doha statement on its head,
after enjoying its media benefits. In the final days of marathon
negotiations last December, the US, under pressure from the
pharmaceutical lobby, reduced the list of diseases covered by the
Doha statement.

Unsupported by any public health criteria, Washington=92s list was
opposed by 143 of the 144 WTO member-countries, and also by Dr Gro
Harlem Brundtland, the outgoing director- general of the World Health
Organisation and her successor, Dr Jong Wook Lee. This did not stop
the EU trade commissioner from trying to relaunch negotiations in
January by producing a similar list. Referring to diseases not
included on his list, Lamy=92s office implied that prior consultation
with the WHO would ensure the involvement of "a trusted authority to
smooth the progress of negotiations" (2). Trust is a loaded term that
emphasises a range of bilateral pressures.

The US and the EU are offering poor countries a cruel and difficult
choice: either accept a tainted deal with complexities, limitations
and restrictions that in the end will function, badly, in only a few
countries, or get nothing at all. As Zoellick said: "The problem on
that issue was that more and more countries wanted the ability to
import from third countries, including countries that have very
strong pharmaceutical industries. And so you expand the set of
countries that were supposed to use this special privilege to about
120. And then some countries wanted to expand the scope of disease.
So if you take what=92s supposed to be an exception for special
circumstance, expand it to almost every country except the OECD
[Organisation for Economic Cooperation and Development] countries,
and expand it to every disease, you=92ve blown a hole in the whole
intellectual property regime" (3).

Overriding patents will continue to be a simple procedure in wealthy
countries, where markets are large and governments quick to issue
compulsory licences. Cipro was not an isolated case: the US recently
issued hundreds of compulsory licences on a range of technologies,
including tow trucks, corn varieties, pharmaceuticals, gene patents,
computer parts and software.

After informing developing countries that "drugs don=92t invent
themselves", Lamy took no action when Japan called for vaccines to be
excluded from the negotiations. His staff tell reporters that patents
should be overridden only for Aids and tropical diseases, not for
diabetes, cancer or asthma. Meanwhile the EU is in the process of
implementing compulsory licences for patents on new plant varieties.
The United Kingdom, France and Canada have all indicated that they
will override Myriad=92s patents on genes linked to breast cancer (4).
The Roche pharmaceutical group recently used a compulsory licensing
law in Germany to obtain a "voluntary" licence from Chiron, a
California-based biotechnology firm that holds patents on an HIV
blood-screening procedure.

The arguments are complex, but some points are clear. What Lamy and
Zoellick say about the merits of compulsory licensing is a false
debate. After all, the WTO agreement already gives every member-
country the right to override patents on any product for any reason.
The real issue is whether this right can be asserted effect ively by
countries with small domestic markets, considering that the WTO=92s
patent rules become binding in 2005, when generic drug producers will
no longer be able to supply low-cost exports.

Nothing indicates that developing countries will abuse their right to
issue compulsory licences; if anything, they are not using compulsory
licensing enough, since they fear intimidation and reprisals. Last
year South Africa, with 5 million HIV-positive citizens (5), turned
down a request for a compulsory licence relating to Aids drugs from
Cipla, an Indian manufacturer. Brazil negotiated lower prices after
threatening to issue compulsory licences three times: twice for high-
priced Aids treatments and once for Glivec, a $50,000-a-year
leukaemia drug.

Proclaiming that pneumonia, diabetes, asthma, heart disease and
cancer do not primarily affect the poor is either cynical or
incredibly ignorant. Most cancer deaths happen in poor countries,
where 80 million cancer patients have no access to health care.
Hypertension affects 22% of the adult population in the Seychelles
and 30% in Cuba. Every year there are 180,000 deaths from asthma
around the world, mostly among the poor; in non-lethal cases patients
often suffer from lack of treatment. Asthma also affects 20-30% of
children in countries such as Brazil, Costa Rica, Kenya, Panama, Peru
and Uruguay. Two-thirds of the deaf people in the world live in
developing countries. India has more than twice as many diabetics as
the US, and Ethiopia has more cases of diabetes than Switzerland.
Aids-compromised immune systems mean that every illness, no matter
how trivial, can be fatal.

The developing countries are not investing enough in health care
because they are deep in debt. Every dollar saved on drug treatments,
vaccinations and tests could be earmarked for new supplies, more
expensive medications, improved health-care infrastructure or higher
salaries for doctors and nurses. The Doha agreement was a good-faith
effort that was supposed to remove the main legal barriers preventing
developing countries from achieving universal access to medical care.
But since November 2001 the world=92s wealthiest countries, best-off in
living standards and health care, have sabotaged it.


*James Love is a director of the Consumer Project on Technology,
Washington (www.cptech.org)

(1) The WTO=92s other two pillars are the general agreement on tariffs
and trade (Gatt), covering rules for international trade in goods,
and the general agreement on trade in services (Gats).

(2) Lamy=92s office was responding to Le Monde diplomatique, which
questioned the source of his list.

(3) Press conference, 16 January 2003: www.ustr.gov

(4) See John Sulston, "Heritage of humanity", Le Monde diplomatique,
English language edition, December 2002

(5) See Philippe Rivi=E8re, "South Africa=92s Aids apartheid", Le Monde
diplomatique, English language edition, August 2002.

----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"