WORLD TRADE  
ORGANIZATION  IP/C/W/437 
10 December 2004 
 
 (04-5466) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
  
IMPLEMENTATION OF PARAGRAPH 11 OF THE 30 AUGUST 2003 DECISION 
 
Communication from Nigeria on behalf of the African Group
 
 
  The following communication, dated 29 November 2004, is being circulated at the request of 
the Delegation of Nigeria on behalf of the African Gr oup.  It was circulated as an advance copy for 
the Council's meeting on 1-2 December 2004. 
 
_______________ 
 
 
I. INTRODUCTION 
1. On 30 August 2003, the General Council adopted a decision
1 ("Decision") to implement 
paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.2  The Decision took 
the form of two waivers, that is, a waiver to th e obligations under Article 31(f) and a second waiver 
on to the obligations under Article 31(h) of the TR IPS Agreement.  The Decision was adopted on the 
understanding that the Council for TRIPS would pr epare an amendment to replace the waivers for 
each Member on the date on which the amendment takes effect for that Member. In particular, 
paragraph 11 of that decision provided that: 
 This Decision, including the waivers grante d in it, shall terminate for each Member on 
the date on which an amendment to the TRI PS Agreement replacing its provisions takes 
effect for that Member.  The TRIPS Council shall initiate by the end of 2003 work on 
the preparation of such an amendment with a view to its adoption within six months, on 
the understanding that the amendment w ill be based, where appropriate, on this 
Decision and on the further understanding that it will not be part of the negotiations 
referred to in paragraph 45 of the Doha Ministerial Declaration (WT/MIN(01)/DEC/1).3 
2. Members therefore explicitly agreed that " the amendment will be based, where appropriate, 
on the Decision ".  In this regard, the appropriateness of particular elements should be understood to 
mean those elements in the Decision that are necessary to ensure the amendment is legally 
predictable, secure and economically and socially sustainable. 
3. This proposal by the African Group is aimed at providing the basis for the amendment.  It is 
proposed to amend Article 31 of the TRIPS Agreemen t by adding a second paragraph to the Article so 
that the current text of Article 31 would become  Article 31 paragraph 1 and the amendment text 
                                                      
1The Decision is contained in WTO document WT/L/540, dated 2 September 2004. Available at 
http://www.wto.org. 
2WTO document WT/MIN(01)/DEC/2, dated 20 November 2001. Also available at 
http://www.wto.org. 
3 See para. 11 of the Decision. IP/C/W/437 
Page 2  
 
 would become Article 31 paragraph 2.  The proposed  amendment would be based on the waivers with 
modifications, as appropriate.  In essence, it is proposed to eliminate a number of provisions in the 30 August Decision as they would be redundant in the context of an amendment or where their purpose would otherwise be served by other prov isions of the TRIPS Agreement, such as the 
Agreement's already existing provisions on compulso ry licences read together with the provisions on 
enforcement. 
II. PROPOSAL FOR AMENDING ARTICLE 31 OF THE TRIPS AGREEMENT 
4. The following is the proposed text of the amendment.  For consistency and clarity, the actual 
text of the amendment has been modified including w ith respect to the arrangement of paragraphs to 
fit into the TRIPS Agreement.  Also note that th e footnote would be renumbered appropriately to 
follow the numbering in the TRIPS Agreement. 
Text of Amendment to Article 31 of TRIPS 
 
[Article 31] 
 
[2] The obligations under subparagraph 1(f) of this Artic le shall not apply to such use that is necessary 
for the purposes of production of a pharmaceutical pr oduct(s) and its export to an eligible importing 
Member(s) who notifies
4 the Council for TRIPS of its intenti on to use the system established under 
this paragraph in accordance with the terms set out below. 
(a) For the purposes of this paragraph: 
(i) "pharmaceutical product" means any patented product, or product manufactured 
through a patented process, of the pharmaceu tical sector needed to address the public 
health problems as recognized in paragraph 1 of the Doha Declaration.  It is understood that, among others, active ingredients necessary for its manufacture and diagnostic kits needed for its use would be included;  
(ii) "eligible importing Member" means an y least developed country Member, and 
any other Member with no or insufficient manufacturing capacity in the pharmaceutical sector that has made a notification to the Council for TRIPS of its intention to use the system as an impor ter, it being understood that a Member may 
notify at any time that it will use the system in whole or in a limited way, for example, only in the case of a national emergency or other circumstances of extreme 
urgency or in cases of public non-commercial use; 
 (iii) "exporting Member" means a Member usi ng the system set out in this paragraph 
to produce pharmaceutical products for, and export them to, an eligible importing 
Member. 
 
(b) Where use is made by an eligible importing Member of the subject matter of a patent 
under this paragraph, adequate remunera tion for purposes of subparagraph 1(h) of 
this Article shall be paid in that Memb er taking into account the economic value to 
the importing Member of the use that has b een authorized in the exporting Member.  
Where a compulsory licence is granted for the same products in the importing 
                                                     
 
4 It is understood that this notification does not need to be approved by a WTO body in order to use the 
system set out under this paragraph. The notification w ill be made available publicly by the WTO Secretariat 
through a page on the WTO website dedicated for this purpose. 
  IP/C/W/437 
 Page 3 
 
 
 Member, the obligation of that Member under subparagraph 1(h) of this Article shall 
be waived in respect of those products fo r which remuneration in accordance with the 
first sentence of this subparagraph has been paid in the exporting Member. 
(c) Products produced under the licence shall be clearly identified as being produced 
under the system set out in this paragra ph through specific labelling or marking. 
Suppliers should distinguish such products through special packaging and/or special 
colouring/shaping of the products themselv es, provided that such distinction is 
feasible and does not have a significant impact on price. 
(d) Members shall ensure the availability of effective legal means to prevent the re-
exportation or unlawful importation into, a nd sale in, their territories of products 
produced under the system set out under th is paragraph, using the means available 
under Part III of this Agreement.  If an y Member considers th at such measures are 
proving insufficient for this purpose, the matter may be reviewed in the Council for 
TRIPS at the request of that Member. 
(e) With a view to harnessing economies of  scale for the purposes of enhancing 
purchasing power for, and facilitating th e local production of, pharmaceutical 
products; where a developing or least deve loped country Member is party to a 
regional trade agreement within the mean ing of Article XXIV of the GATT 1994 or 
the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the membership of which is made up of  countries on the United Nations list of 
least developed countries, the obligation of  that Member under subparagraph 1(f) of 
this Article shall be waived to the ex tent necessary to enable a pharmaceutical 
product produced or imported under a compulsory licence in that Member to be exported to the markets of those other deve loping or least developed country parties 
to the regional trade agreement. 
(f) Members recognize the desirability of promoting the transfer of technology and 
capacity building in the pharmaceutical sector in order to help importing Members establish their own manufacturing capacities in this sector.  To this end, eligible importing Members and exporting Members are encouraged to use the system set out in this paragraph in a way which would promote this objective. Members undertake 
to cooperate in paying special attention to  the transfer of technology and capacity 
building in the pharmaceutical sector in th e work to be undertaken pursuant to 
Article 66.2 of this Agreement, paragraph 7 of the Declaration and any other relevant 
work of the Council for TRIPS. 
(g) Members shall not challenge any measures taken in conformity with the provisions of 
this paragraph under subpar agraphs 1(b) and 1(c) of Article XXIII of GATT 1994. 
III. FINAL REMARKS 
5. This proposal presents a viable basis for undert aking an amendment as foreseen in paragraph 
11 of the Decision of 30 August 2003.  The proposal  is based, as appropriate, on the Decision.  Only 
those elements of the Decision which are otherwise redundant or whose purpose would otherwise be served by the existing provisions of the TRIPS Agreement have been eliminated. 
 
__________