The decision settles the one remaining piece of unfinished business on
intellectual property and health that was left over from the WTO
Ministerial Conference in Doha in November 2001.
“This is a historic agreement for the WTO,” said Director-General
Supachai Panitchpakdi. “The final piece of the jigsaw has fallen into
place, allowing poorer countries to make full use of the flexibilities
in the WTO’s intellectual property rules in order to deal with the
diseases that ravage their people.
“It proves once and for all that the organization can handle
humanitarian as well as trade concerns,” he went on. “This particular
question has been specially difficult. The fact that WTO members have
managed to find a compromise in such a complex issue bears testimony to
“It also gives WTO members a good momentum to take to the Ministerial
Conference in Cancún. I sincerely hope ministers can work together to
reach agreement on the other outstanding issues that they will deal with
in Cancún,” he said.
The decision waives countries’ obligations under a provision of the
WTO’s intellectual property agreement. Article 31(f) of the
Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement
says that production under compulsory licensing must be predominantly
for the domestic market. This effectively limited the ability of
countries that cannot make pharmaceutical products from importing
cheaper generics from countries where pharmaceuticals are patented.
In the decision, WTO member governments have agreed that the waiver will
last until the article is amended.
Flexibilities such as “compulsory licensing” are written into the TRIPS
Agreement — governments can issue compulsory licenses to allow other
companies to make a patented product or use a patented process under licence without
the consent of the patent owner, but only under certain conditions aimed
at safeguarding the legitimate interests of the patent holder.
But some governments were unsure of how these flexibilities would be
interpreted, and how far their right to use them would be respected. The
African Group (all the African members of the WTO) were among the
members pushing for clarification.
A large part of this was settled at the Doha Ministerial Conference in
In the main Doha Ministerial Declaration of 14 November 2001, ministers
stressed that it is important to implement and interpret the TRIPS
Agreement in a way that supports public health — by promoting both
access to existing medicines and the creation of new medicines.
They therefore adopted a separate declaration on TRIPS and Public
Health. They agreed that the TRIPS Agreement does not and should not
prevent members from taking measures to protect public health.
They underscored countries’ ability to use the flexibilities that are
built into the TRIPS Agreement, including compulsory licensing and
And they agreed to extend exemptions on pharmaceutical patent protection
for least-developed countries until 2016. (The TRIPS Council completed
the legal drafting task on this in mid-2002, see
press release 301.
On one remaining question, they assigned further work to the TRIPS
Council — to sort out how to provide extra flexibility, so that
countries unable to produce pharmaceuticals domestically can import
patented drugs made under compulsory licensing. (This is sometimes
called the “Paragraph 6” issue, because it comes under that paragraph in
the separate Doha declaration on TRIPS and health.)
Article 31(f) of the TRIPS Agreement says products made under compulsory
licensing must be “predominantly for the supply of the domestic market”.
This applies directly to countries that can manufacture drugs — it
limits the amount they can export when the drug is made under compulsory
licence. And it has an indirect impact on countries unable to make
medicines and therefore wanting to import generics. They would find it
difficult to find countries that can supply them with drugs made under
Members were deadlocked over how to resolve this question, and the
original deadline of 31 December 2002 was missed.
This 30 August 2003 agreement allows any member country to export
pharmaceutical products made under compulsory licences within the terms
set out in the decision (text below). All WTO member countries are
eligible to import under this decision, but 23 developed countries are
listed in the decision as announcing voluntarily that they will not use
the system to import.
A separate statement by General Council chairperson Carlos Pérez del
Castillo, Uruguay’s ambassador, is designed to provide comfort to those
who feared that the decision might be abused and undermine patent
protection. The statement (see below) describes members’ “shared
understanding” on how the decision is interpreted and implemented. It
says the decision will be used in good faith in order to deal with
public health problems and not for industrial or commercial policy
objectives, and that issues such as preventing the medicines getting
into the wrong hands are important.
A number of other countries announced separately that if they use the
system it would only be for emergencies or extremely urgent situations.
They are: Hong Kong China, Israel, Korea, Kuwait, Macao China, Mexico,
Qatar, Singapore, Chinese Taipei, Turkey and United Arab Emirates
The decision covers patented products or products made using patented
processes in the pharmaceutical sector, including active ingredients and
It is designed to address the public health problems recognized in
Paragraph 1 of the Doha Declaration on TRIPS and Public Health, which
says that WTO ministers “recognize the gravity of the public health
problems afflicting many developing and least-developed countries,
especially those resulting from HIV/AIDS, tuberculosis, malaria and
The decision takes the form of an interim waiver, which allows countries
producing generic copies of patented products under compulsory licences
to export the products to eligible importing countries. The waiver would
last until the WTO’s intellectual property agreement is amended.
The negotiations on the decision were conducted by the chairpersons of
the TRIPS Council: Ambassador Eduardo Pérez Motta of Mexico (2002) and
Ambassador Vanu Gopala Menon of Singapore (2003).
The text of the decision and the General Council chairperson’s statement
on implementation of paragraph 6 of the Doha Declaration on the TRIPS
Agreement and public health
General Council Chairperson’s statement
For more information, go to the WTO website:
> The Doha Declaration on TRIPS and Public Health
> The Doha Declaration explained
> TRIPS and pharmaceutical patents