The Council for Trade-Related Aspects of Intellectual Property Rights
(TRIPS) also approved a waiver that would exempt least-developed
countries from having to provide exclusive marketing rights for any
new drugs in the period when they do not provide patent protection.
The
waiver is to be submitted to the WTO General Council for approval on
8 July 2002.
Both
decisions are part of WTO members’ ongoing efforts to ensure that
intellectual property protection supports and does not obstruct poorer
countries’ need to tackle serious public health problems.
“I
am pleased that WTO members have acted promptly to implement this
important part of the Doha Declaration on TRIPS and public health, and
have seen fit to go beyond the strict reading of that declaration by
also approving a draft waiver on exclusive marketing rights,” said
WTO Director-General Mike Moore.
(Texts
of the decision and waiver follow this introduction.)
The
TRIPS Council’s decision formalizes part of paragraph 7 of the
Declaration on the TRIPS Agreement and Public Health, which WTO
ministers adopted on 14 November 2001 at their conference in Doha,
Qatar.
The
relevant part of paragraph 7 of the Doha declaration says: “We
… agree that the least-developed country members will not be
obliged, with respect to pharmaceutical products, to implement or
apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce
rights provided for under these Sections until 1 January 2016, without
prejudice to the right of least-developed country members to seek
other extensions of the transition periods as provided for in Article
66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take
the necessary action to give effect to this pursuant to Article 66.1
of the TRIPS Agreement”.
This
follows from the ministerial declaration’s opening statements: “We
recognize the gravity of the public health problems afflicting many
developing and least-developed countries, especially those resulting
from HIV/AIDS, tuberculosis, malaria and other epidemics.
“We
stress the need for the WTO Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS Agreement) to be part of the wider
national and international action to address these problems.
“We
recognize that intellectual property protection is important for the
development of new medicines. We also recognize the concerns about its
effects on prices”.
The
TRIPS Agreement allows developing countries extra periods to delay
providing patent protection for pharmaceuticals. But countries making
use of the extra period still have to allow inventors to submit patent
applications during the period (Article 70.8, sometimes called
the “mailbox” provision). If a country’s health authority then
approves a new drug for sale, the patent applicant has to be given
exclusive marketing rights for five years even though there is no
patent (Art.70.9).
The
waiver exempts least developed countries from having to give these
exclusive marketing rights.
More
information can be found on the WTO website:
The text
of the ministerial declaration
An
explanation
These
are the texts of the two decisions back to top
Extension
of the transition period under Article 66.1 of the TRIPS Agreement for
least-developed country Members for certain obligations with respect
to pharmaceutical products
Decision
of the Council for TRIPS of 27 June 2002
The
Council for Trade-Related Aspects of Intellectual Property Rights (the
“Council for TRIPS”),
Having
regard to paragraph 1 of Article 66 of the TRIPS Agreement;
Having
regard to the instruction of the Ministerial Conference to the Council
for TRIPS contained in paragraph 7 of the Declaration on the TRIPS
Agreement and Public Health (WT/MIN(01)/DEC/2) (the
“Declaration”);
Considering
that paragraph 7 of the Declaration constitutes a duly motivated
request by the least-developed country Members for an extension of the
period under paragraph 1 of Article 66 of the TRIPS Agreement;
Decides
as follows:
1.
Least-developed country Members will not be obliged, with respect to
pharmaceutical products, to implement or apply Sections 5 and 7 of
Part II of the TRIPS Agreement or to enforce rights provided for under
these Sections until 1 January 2016.
2.
This decision is made without prejudice to the right of
least-developed country Members to seek other extensions of the period
provided for in paragraph 1 of Article 66 of the TRIPS Agreement.
Least-developed
country Members — Obligations under Article 70.9 of the TRIPS Agreement with respect to pharmaceutical products
Draft
Waiver
The
General Council,
Having
regard to paragraphs 1, 3 and 4 of Article IX of the Marrakesh
Agreement Establishing the World Trade Organization (the “WTO
Agreement”);
Conducting
the functions of the Ministerial Conference in the interval between
meetings pursuant to paragraph 2 of Article IV of the WTO Agreement;
Noting
the decision of the Council for TRIPS on the Extension of the
Transition Period under Article 66.1 of the TRIPS Agreement for
Least-Developed Country Members for Certain Obligations with respect
to Pharmaceutical Products (IP/C/25) (the “Decision”), adopted by
the Council for TRIPS at its meeting of 25–27 June 2002
pursuant to the instructions of the Ministerial Conference contained
in paragraph 7 of the Declaration on the TRIPS Agreement and
Public Health (WT/MIN(01)/DEC/2) (the “Declaration”);
Considering
that obligations under paragraph 9 of Article 70 of the TRIPS
Agreement, where applicable, should not prevent attainment of the
objectives of paragraph 7 of the Declaration;
Noting
that, in light of the foregoing, exceptional circumstances exist
justifying a waiver from paragraph 9 of Article 70 of the TRIPS
Agreement with respect to pharmaceutical products in respect of
least-developed country Members;
Decides
as follows:
1.
The obligations of least-developed country Members under paragraph 9
of Article 70 of the TRIPS Agreement shall be waived with respect to
pharmaceutical products until 1 January 2016.
2.
This waiver shall be reviewed by the Ministerial Conference not later
than one year after it is granted, and thereafter annually until the
waiver terminates, in accordance with the provisions of paragraph 4 of
Article IX of the WTO Agreement.
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