[Ip-health] Bridges Weekly: THE DOHA DECLARATION ON TRIPS AND PUBLIC HEALTH, FIVE YEARS ON

[Thiru Balasubramaniam]

--
[ Picked text/plain from multipart/alternative ]
  BRIDGES Weekly Trade News Digest - Vol. 10, Number 38 15 November 2006

THE DOHA DECLARATION ON TRIPS AND PUBLIC HEALTH, FIVE YEARS ON

Government officials, businesses and civil society groups alike are
this week commemorating the fifth anniversary of the adoption of the
Doha Declaration on the WTO TRIPS Agreement and Public Health
(WT/MIN(01)/DEC/2).

Signed by WTO Members on 14 November 2001 at the global trade body's
fourth Ministerial Conference in Doha, Qatar, the declaration aimed to
address concerns that the patent protections and other rules set out in
the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS)
could raise the price of pharmaceuticals. Hailed at the time as "a
giant victory" for access to affordable medicine, it was said to be
proof that the multilateral trading system could respond to global
public health concerns.

Five years down the road, although most concur that the declaration was
an important milestone, many remain deeply concerned about the impact
of intellectual property rules on access to medicine.

"The Doha Declaration said all the right things but to date has
delivered virtually nothing to poor patients," said Celine Chaveriat of
Oxfam International. "We've gone backwards in five years." Guy Willis
of the International Federation of Pharmaceutical Manufacturers &
Associations disagreed. He told Bridges that that the "Doha Declaration
represents a balanced approach" and that developments over the last
five years have "helped to clarify the declaration."

Adopted in conjunction with the launch of the Doha Round trade talks,
the declaration marked international consensus just two months after
the terrorist attacks of 11 September 2001. It came at a time when
concern over intellectual property rights' effects on access to
medicines was higher than ever before. Fears of a possible outbreak had
rich country governments threatening to override patents on anthrax
drugs. Major legal battles over South Africa and Brazil's attempts to
make treatment more affordable for their millions of HIV/AIDS patients
had thrust the issue to the forefront of the WTO agenda.

In the declaration, government agreed that the "TRIPS Agreement does
not and should not prevent Members from taking measures to protect
public health." Recognising "the gravity of public health problems"
that poor countries face, especially due to epidemics such as HIV/AIDS,
tuberculosis, and malaria, they stressed that the agreement "can and
should be interpreted and implemented in a manner supportive of WTO
Members' right to protect public health and . . . promote access to
medicines for all."

The declaration aimed to clarify ambiguities in WTO intellectual
property rules about countries' ability to produce and import
affordable drugs. It reaffirmed Members' rights to "determine what
constitutes a national emergency or other circumstances of extreme
urgency," and to "to determine the grounds" for granting 'compulsory
licences' authorising the production of patented medicines without the
consent of the patent holder.

Although the TRIPS Agreement permitted governments to use compulsory
licences, Article 31(f) specified that the generic copies of patented
drugs thus produced could only be sold on a country's domestic market.
This rendered compulsory licensing useless for countries lacking
sufficient pharmaceutical manufacturing capacity, no matter how severe
their public health problems. The declaration instructed Members to
find "an expeditious solution to this problem" by the end of 2002.

In addition, the Doha declaration reaffirmed Members' right to export
and import legitimate medicines at lower prices. Known as 'parallel
trade' or parallel import/export," the legitimacy of this practice had
been questioned by some countries.

Finally, it specified that least developed countries could delay
implementation of the TRIPS agreement with respect to pharmaceuticals
until January 2016.

Speaking in 2001, James Love of Consumer Project on Technology called
the declaration the "strongest and most important international
statement yet on the need to refashion national patent laws to protect
public health interests." Oxfam's Michael Bailey added that the
principles set out within the document would make it "much harder for
the US and drug companies to bully poor countries over their patent
policies."

However, five years later, the struggle to improve countries' access to
medicines continues.

It took WTO Members until August 2003 -- long after the 2002 deadline
in the Doha declaration -- to reach an accord on helping countries
lacking manufacturing capacity to make use of compulsory licenses. The
so-called '30 August 2003 decision' was effectively a temporary waiver
of the requirement that medicines produced under compulsory licence be
restricted to the domestic market, pending an amendment of the TRIPS
agreement (see BRIDGES Weekly, 4 September 2003,
http://www.ictsd.org/weekly/03-09-04/wtoinbrief.htm#1). Even at the
time, critics charged that its numerous requirements set an
impracticably high bar for the legal importation of drugs produced
under compulsory licences.

So far, not a single country has used the waiver. Nevertheless, in
December 2005, WTO Members agreed to make the 30 August 2003 decision a
permanent amendment to the TRIPS agreement. The amendment will enter
into force when two-thirds of the WTO's 150 Members ratify it. To date,
three countries have ratified the amendment: the US, Switzerland, and
El Salvador. In the meantime, the waiver decision remains in effect.

Some have explained that since developing countries were allowed to
delay patent protection for pharmaceutical products until January 2005,
the full effect of the agreement has not been realised. The mechanism
"hasn't been used because it's too early," clarified one WTO official.
"It will come up when there is a single supplier in the market," which
will be the case once developing countries and LDCs fully implement
their TRIPS commitments.

At a 14 November meeting in Geneva to commemorate the fifth anniversary
of the declaration, Ellen 't Hoen of the Campaign for Access to
Essential Medicines suggested that since some major generics producers
such as India are now providing patent protection for newer medicines,
their prices are being driven up. "It should alarm us," she said.
"We're getting back to where we were five years ago."

Third World Network's Sangeeta Shashikant said that five years after
Doha, WTO rules were far from the only trade-related threat to access
to medicine. She pointed to the impact of bilateral and regional free
trade agreements (FTAs) on "limiting the grounds on which governments
can issue compulsory licences," for example, to cases of national
emergency, government non-commercial use, and to address
anti-competitive practices. She also warned that new protections for
clinical test data in FTAs delay generics from coming to market. Added
Oxfam's Jennifer Brant, "What's the point in having the Doha
declaration if it's being chipped away?"

"The Doha declaration was of politically symbolic importance by making
people stop and think about it," said Guilherme de Aguiar Patriota, a
Brazilian trade diplomat. Since then, however, multinational
corporations had steadily engaged in "damage control," quietly eroding
the impact of the declaration. He added that dissatisfaction with the
WTO process had motivated countries such as Brazil and Kenya to propose
setting up a global framework for research and development in the World
Health Organization.

One trade expert suggested that the declaration had served to open the
eyes of the WHO to the effects of intellectual property rules. In
recent years, the WHO has commissioned high-level investigations into
the relationship between intellectual property, innovation, and public
health.

ICTSD reporting; "Views on the Draft Declaration on the TRIPS Agreement
and Public Health," CONSUMER PROJECT ON TECHNOLOGY, 13 November 2001;
"Views on the TRIPS Agreement and Public Health: 5 Years down the
Road," CONSUMER PROJECT ON TECHNOLOGY, 14 November 2006.
------------
Thiru Balasubramaniam
Geneva Representative
CPTech
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@cptech.org
--