PRESS RELEASE 
 
PRESS/426 
6 December 2005 
 
(05-5808) 
INTELLECTUAL PROPERTY 
Members OK amendment to make  health flexibility permanent 
WTO members on 6 December 2005 approved chan ges to the intellectual property agreement 
making permanent a decision on patents and public  health originally adopted in 2003. This General 
Council decision means that for the first ti me a core WTO agreement will be amended. 
 
The decision directly transforms the 30 August 2003 “waiver” into a permanent amendment of the 
WTO Agreement on Trade-Related Aspects of Intell ectual Property Rights (TRIPS). That waiver 
made it easier for poorer countries to obtain cheaper generic versions of patented medicines by 
setting aside a provision of the TRIPS Agreement that could hinder exports of pharmaceuticals 
manufactured under compulsory licences to countries that are unable to produce them.  
This will now be formally built into the TRIPS Agreement when two thirds of the WTO’s members 
have ratified the change. They have set themselves until 1 December 2007 to do this. The waiver remains in force until then. 
 
The latest decision comes a week after WTO member s agreed to extend the transition period for 
least-developed countries, allowing them until 1 July 2013 to provide protection for trademarks, 
copyright, patents and other intellectual proper ty under the WTO’s agreement. Least-developed 
countries had already been given until 2016 to protect pharmaceutical patents.  
“The agreement to amend the TRIPS provisions co nfirms once again that members are determined 
to ensure the WTO’s trading system contributes to humanitarian and development goals as they 
prepare for the Hong Kong Ministerial Conference,” Director-General Pascal Lamy said. 
 
“This is of particular personal satisfaction to me, since I have been involved for years in working to ensure that the TRIPS Agreement is part of the solution to the question of ensuring the poor have 
access to medicines,” Mr Lamy said. 
 The amendment is designed to match the 2003 waiver as closely as possible. Other procedures 
used in 2003 are also matched, including a statement read out by the General Council chair. In 
order to achieve this, delegations have been involved in intricate legal discussions aimed at ensuring that the legal meaning and weight, and the hierarchy of provisions, are preserved as 
exactly as possible. 
 The amendment completes a process that began wi th the declaration on TRIPS and health that 
ministers made at the Doha Ministerial Confer ence in November 2001. The deadline for least- PRESS/426 
Page 2 of 3 
 
 
 developed countries to protect pharmaceutical pate nts revised in June 2002. This was followed by 
the waiver in August 2003, which itself called for the eventual amendment. 
The decision 
Article 31(f) of the TRIPS Agreement says that production under compulsory licensing must be predominantly for the domestic market. The concern was that this could limit the ability of 
countries that cannot make pharmaceutical products from importing cheaper generics from countries where pharmaceuticals are patented. 
 
As with the 2003 waiver, the permanent amendmen t will allow any member country to export 
pharmaceutical products made under a compulsory  licence for this purpose. They may need to 
change their own laws in order to do so. 
 So far, Norway, Canada and India have informed the WTO that their laws are complete, while the 
Republic of Korea and the EU have said their new laws are on the verge of coming into force. 
 A group of developed countries are listed as a nnouncing that they will not use the system to 
import.  
 A number of other countries announced separately that if they use the system as importers 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. 
 
A separate statement by General Council chair Amina Mohamed, Kenya’s ambassador, is designed to provide comfort to those who feared that the decision might be abused and undermine patent 
protection. 
 The statement 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. 
 
The amendment 
The amendment itself is in three parts. Five paragraphs come under Article 31 “bis” (i.e. an additional article after Article 31). The first allows pharmaceutical products made under 
compulsory licences to be exported to countries lacking production capacity.  
Other paragraphs deal with avoiding double re muneration to the patent-owner, regional trade 
agreements involving least-developed countries, “non-violation” and retaining all existing flexibilities under the TRIPS Agreement. 
 
A further seven paragraphs are in a new annex to the TRIPS Agreement. These set out terms for using the system, and cover such issues as definitions, notification, avoiding the pharmaceuticals 
being diverted to the wrong markets, developing regional systems to allow economies of scale, 
and annual reviews in the TRIPS Council.  
An “appendix” to the annex deals with assessing lack of manufacturing capability in the importing 
country. This was originally an annex to the 2003 decision. PRESS/426 
Page 3 of 3 
 
 
 The new Article 31 “bis” and annex of the TRIPS Agreement are attached to a protocol of 
amendment. This in turn is attached to a General Council decision, which adopts the Protocol and 
opens it for members to accept it by 1 December 2007.  
Find out more on the WTO website: 
The 6 December 2006 texts and the 2003 decision: http://www.wto.org/english/tratop _e/trips_e/pharmpatent_e.htm  
TRIPS: http://www.wto.org/english/tr atop_e/trips_e/trips_e.htm  
  
 
END