 PRESS RELEASE
PRESS/301
28 June 2002
(02-3681)
INTELLECTUAL PROPERTY: TRIPS AND PUBLIC HEALTH
Council approves LDC decision with additional waiver
The WTO council responsible for intellectual property, on 27 June 2002, approved a decision
extending until 2016 the transition period during which least-developed countries (LDCs) do nothave to provide patent prot ection for pharmaceuticals.
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 WT O 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 prom ptly to implement this important part of the
Doha Declaration on TRIPS and public health, and ha ve seen fit to go beyond the strict reading of
that declaration by also approving a draft waiv er 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 theirconference 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 de veloping and least-developed countries, especially
those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.PRESS/301
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“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 countri es 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:
http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
An explanation:
http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm#trips
These are the texts of the two decisions:
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 Ag reement 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.PRESS/301
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2. This decision is made withou t 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 TRIPSAgreement.
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 atits 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 Ar ticle 70 of the TRIPS Agreement, where
applicable, should not prevent attainment of th e 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 Agreemen t 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 Minister ial Conference not later than one year after it
is granted, and thereafter annually until the waiver terminates, in accordance with the provisions ofparagraph 4 of Article IX  of the WTO Agreement.
END