28 June 2002
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 not have to provide patent protection for pharmaceuticals.
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.
information can be found on the WTO website:
The text of the ministerial declaration
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
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.