Executive Summary
1. The fourth WTO Ministerial Conference held at Doha in November 2001 adopted a Declaration on the TRIPS Agreement and Public Health ("the Doha Declaration") that recognised (in paragraph 6) that:
"WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement [and instructed] the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002".
2. The Declaration, in particular the instruction in paragraph 6, was implemented by a decision of the WTO General Council on 30 August 2003. This established a waiver of the some of the compulsory license requirements of the TRIPS Agreement, so as to allow WTO Members to issue compulsory licenses for the production and export of patented pharmaceuticals to "eligible importing Members". The General Council also agreed to begin work on a Protocol amending the TRIPS Agreement to replace the waiver.
3. This Protocol was agreed to in December 2005, and is open for acceptance until 31 December 2009. It will come into force when two-thirds (101) WTO Members have accepted it. To date (February 2008) 40 WTO Members1 have accepted the Protocol. A number of other members have begun preparations for acceptance. So far, one country (Rwanda) has used the waiver to import pharmaceuticals under compulsory license.
4. A discussion document, seeking the views of interested parties on the question of New Zealand's acceptance of the Protocol, and on options for amending New Zealand's patent legislation to implement the Protocol as an exporting Member, was released on 19 October 2007.
5. Five submissions were received. The submitters were: The Researched Medicines Industry Association of NZ (RMI); GlaxoSmithKline (GSK); The New Zealand Council of Trade Unions (CTU); Sarah Meads (who describes herself as an independent submitter with no commercial interests or affiliations) and the New Zealand Ministry of Health. A summary of the submissions and copies of the submissions are attached to this report.
6. With the exception of the CTU, all of the submitters supported acceptance of the Protocol by New Zealand. None of the submitters objected to New Zealand becoming an exporting member under the Protocol. Those submitters that considered the issues argued that, in implementing the Protocol in its patent legislation, New Zealand should adopt broad and non-prescriptive definitions of the public health problems and the pharmaceuticals for which compulsory licenses could be granted.
7. It was argued by submitters that the legislation should not exclude non-WTO members They agreed that the "take reasonable steps" requirement of the compulsory license provisions in New Zealand's patent legislation may be stricter than the "make efforts" requirement in the TRIPS Agreement.
8. Officials consider it is appropriate for New Zealand to take the broad and non-prescriptive approach suggested by submitters. It is also considered appropriate that non-WTO members not be excluded and that our compulsory license provisions be amended to incorporae the "make efforts" requirements contained in the TRIPS Agreement. It is recommended that New Zealand should accept the Protocol and amend its patent legislation appropriately.
9. If you agree, the Ministry will prepare a paper, together with a National Interest Analysis for submission to the Cabinet Economic Development Committee seeking agreement to present the Protocol to the House. The paper will also seek conditional approval to instruct the Parliamentary Counsel Office to undertake conditional drafting of amendments to the Patents Bill to implement the Protocol if accepted.
10. It is intended that the amendments to the Patents Bill be submitted by way of a Supplementary Order Paper once the Protocol has passed through the Parliamentary treaty examination process.
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