WORLD TRADE  
ORGANIZATION  IP/C/41 
6 December 2005 
 (05-5806) 
Council for Trade-Related Aspects 
of Intellectual Property Rights  
 
 
  
IMPLEMENTATION OF PARAGRAPH 11 OF THE GENERAL COUNCIL DECISION OF 
30 AUGUST 2003 ON THE IMPLEMENTATI ON OF PARAGRAPH 6 OF THE DOHA 
DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH 
 
Proposal for a Decision on an Amendment to the TRIPS Agreement
 
   
 At its meeting of 6 December 2005, the Counc il for TRIPS decided to submit, in accordance 
with paragraph 1 of Article X of the Marra kesh Agreement Establishing the World Trade 
Organization, the attached proposal for a deci sion on an amendment to the Agreement on Trade-
Related Aspects of Intellectual Property Rights.  
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 IP/C/41 
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WORLD TRADE  
ORGANIZATION   
 
 (05-0000) 
General Council  
  
AMENDMENT OF THE TRIPS AGREEMENT  
 
Draft Decision of [date] 
 
 
 The General Council;  
 Having regard to paragraph 1 of Article X of the Marrakesh Agreement Establishing the 
World Trade Organization ("the WTO Agreement");   Conducting the functions of the Ministerial Confer ence in the interval between meetings 
pursuant to paragraph 2 of Article IV of the WTO Agreement;  
 Noting  the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2) 
and, in particular, the instruction of the Minister ial Conference to the Council for TRIPS contained in 
paragraph 6 of the Declaration to find an expeditious solution to the problem of the difficulties that 
WTO Members with insufficient or no manufacturi ng capacities in the pharmaceutical sector could 
face in making effective use of compulsory licensing under the TRIPS Agreement; 
 
 Recognizing, where eligible importing Members seek to obtain supplies under the system set 
out in the proposed amendment of the TRIPS Agreem ent, the importance of a rapid response to those 
needs consistent with the provisions of th e proposed amendment of the TRIPS Agreement; 
  Recalling paragraph 11 of the General Counc il Decision of 30 August 2003 on the 
Implementation of Paragraph 6 of the Doha Declar ation on the TRIPS Agreement and Public Health;  
  Having considered the proposal to amend the TRIPS Ag reement submitted by the Council for 
TRIPS (IP/C/41);  
 Noting  the consensus to submit this proposed amendment to the Members for acceptance; 
  Decides  as follows: 
 1. The Protocol amending the TRIPS Agreement attach ed to this Decision is hereby adopted and 
submitted to the Members for acceptance. 
 2. The Protocol shall be open for acceptance by Members until 1 December 2007 or such later 
date as may be decided by the Ministerial Conference.  
 3. The Protocol shall take effect in accordance with  the provisions of paragraph 3 of Article X of 
the WTO Agreement. 
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 ATTACHMENT 
 
PROTOCOL AMENDING THE TRIPS AGREEMENT 
 
 
 
 Members of the World Trade Organization;  
 
 Having regard to the Decision of the General Council in document WT/L/ , adopted 
pursuant to paragraph 1 of Article X of the Ma rrakesh Agreement Establishing the World Trade 
Organization ("the WTO Agreement");  
  Hereby agree as follows: 
 1. The Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS 
Agreement") shall, upon the entry into force of the Protocol pursuant to para graph 4, be amended as 
set out in the Annex to this Protocol, by inserting Article 31 bis after Article 31 and by inserting the 
Annex to the TRIPS Agreement after Article 73.  
2. Reservations may not be entered in respect of an y of the provisions of this Protocol without 
the consent of the other Members.  
3. This Protocol shall be open for acceptance by Members until 1 December 2007 or such later 
date as may be decided by the Ministerial Conference. 
4. This Protocol shall enter into force in accord ance with paragraph 3 of Article X of the WTO 
Agreement. 
5. This Protocol shall be deposited with the Dir ector-General of the World Trade Organization 
who shall promptly furnish to each Member a ce rtified copy thereof and a notification of each 
acceptance thereof pursuant to paragraph 3. 
6. This Protocol shall be registered in accord ance with the provisions of Article 102 of the 
Charter of the United Nations. 
 
Done  at Geneva this [date], in a single copy in the English, French and Spanish languages, 
each text being authentic.  
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 IP/C/41 
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 ANNEX TO THE PROTOCOL AMENDING THE TRIPS AGREEMENT 
 
Article 31 bis 
  
 
1. The obligations of an exporting Member unde r Article 31(f) shall not apply with respect to 
the grant by it of a compulsory licence to the extent necessary for the purposes of production of a 
pharmaceutical product(s) and its export to an elig ible importing Member(s) in accordance with the 
terms set out in paragraph 2 of the Annex to this Agreement. 
 
2. Where a compulsory licence is granted by an exporting Member under the system set out in this Article and the Annex to this Agreement, ade quate remuneration pursuant  to Article 31(h) shall 
be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in th e exporting Member.  Where a com pulsory licence is granted for the 
same products in the eligible importing Member, th e obligation of that Member under Article 31(h) 
shall not apply in respect of those products fo r which remuneration in accordance with the first 
sentence of this paragraph is paid in the exporting Member.  3. With a view to harnessing economies of scale for the purposes of enhancing purchasing 
power for, and facilitating the local production of , pharmaceutical products: where a developing or 
least-developed country WTO Member is a party to a regional trade agreement within the meaning of 
Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More 
Favourable Treatment Reciprocity and Fuller Partic ipation of Developing Countries (L/4903), at least 
half of the current membership of which is made  up of countries presently on the United Nations list 
of least-developed countries, the obligation of that  Member under Article 31(f) shall not apply to the 
extent necessary to enable a pharmaceutical produc t produced or imported under a compulsory licence 
in that Member to be exported to the markets of those other developing or least-developed country parties to the regional trade agreement that share the health problem in question.  It is understood that 
this will not prejudice the territorial nature of the patent rights in question.  4. Members shall not challenge any measures take n in conformity with the provisions of this 
Article and the Annex to this Agreement under s ubparagraphs 1(b) and 1( c) of Article XXIII of 
GATT 1994.  5. This Article and the Annex to this Agreemen t are without prejudice to the rights, obligations 
and flexibilities that Members have under the provisions  of this Agreement other than paragraphs (f) 
and (h) of Article 31, including those reaffirmed  by the Declaration on the TRIPS Agreement and 
Public Health (WT/MIN(01)/DEC/2), and to their in terpretation.  They are also without prejudice to 
the extent to which pharmaceutical products produc ed under a compulsory licence can be exported 
under the provisions of Article 31(f).  IP/C/41 
 Page 5 
 
 
 ANNEX TO THE TRIPS AGREEMENT 
 
 1. For the purposes of Article 31 bis and this Annex: 
(a) "pharmaceutical product" means any pate nted 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 Declaration on the TRIPS Agreement and Public Health (WT/MIN(01) /DEC/2).  It is understood that active 
ingredients necessary for its manufacture and diagnostic kits needed for its use would 
be included
1; 
(b) "eligible importing Member" means any least-developed country Member, and any 
other Member that has made a notification2 to the Council for TRIPS of its intention 
to use the system set out in Article 31 bis and this Annex ("system") as an importer, 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 onl y in the case of a national emergency or 
other circumstances of extreme urgency or in cases of public non-commercial use.  It 
is noted that some Members will not use the system as importing Members
3 and that 
some other Members have stated that, if they use the system, it would be in no more than situations of national emergency or  other circumstances of extreme urgency; 
(c) "exporting Member" means a Member using the system to produce pharmaceutical 
products for, and export them to , an eligible importing Member. 
2. The terms referred to in  paragraph 1 of Article 31 bis are that: 
(a) the eligible importing Member(s)
4 has made a notification2 to the Council for TRIPS, 
that: 
(i) specifies the names and expected quantities of the product(s) needed5; 
(ii) confirms that the eligible importing Member in question, other than a 
least-developed country Member, has esta blished that it has insufficient or no 
manufacturing capacities in the pharmaceuti cal sector for the product(s) in 
question in one of the ways set out in  the Appendix to this Annex;  and 
(iii) confirms that, where a pharmaceutical product is patented in its territory, it 
has granted or intends to grant a compulsory licence in accordance with 
Articles 31 and 31 bis of this Agreement and the provisions of this Annex6; 
                                                      
1 This subparagraph is without prejudice to subparagraph 1(b). 
2 It is understood that this notification does not need to be approved by a WTO body in order to use the 
system. 
3 Australia, Canada, the European Communities with, for the purposes of Article 31 bis and this Annex, 
its member States, Iceland, Japan, New Zealan d, Norway, Switzerland, and the United States. 
4 Joint notifications providing the information required under this subparagraph may be made by the 
regional organizations referred to in paragraph 3 of Article 31 bis on behalf of eligible importing Members using 
the system that are parties to them, with the agreement of those parties. 
5 The notification will be made available publicly by the WTO Secretariat through a page on the WTO 
website dedicated to the system. 
6 This subparagraph is without prejudi ce to Article 66.1 of this Agreement. IP/C/41 
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 (b) the compulsory licence issued by the exporting Member under the system shall 
contain the following conditions: 
(i) only the amount necessary to meet the needs of the eligible importing 
Member(s) may be manufactured under the licence and the entirety of this production shall be exported to the Memb er(s) which has notified its needs to 
the Council for TRIPS; 
(ii) products produced under the licence shall be clearly identified as being 
produced under the system through specific labelling or marking.  Suppliers should distinguish such products through special packaging and/or special colouring/shaping of the products themselves, provided that such distinction 
is feasible and does not have a significant impact on price;  and 
(iii) before shipment begins, the licensee shall post on a website
7 the following 
information: 
- the quantities being supplied to each  destination as referred to in 
indent (i) above;  and 
- the distinguishing features of the product(s) referred to in indent (ii) 
above; 
(c) the exporting Member shall notify8 the Council for TRIPS of the grant of the licence, 
including the conditions attached to it.9  The information provided shall include the 
name and address of the licensee, the product(s) for which the licence has been granted, the quantity(ies) for which it has b een granted, the country(ies) to which the 
product(s) is (are) to be supplied and the duration of the licence.  The notification 
shall also indicate the address of the website referred to in subparagraph (b)(iii) above. 
3. In order to ensure that the products imported under the system are used  for the public health 
purposes underlying their importation, eligible importing Members shall take reasonable measures 
within their means, proportionate to their administra tive capacities and to the risk of trade diversion to 
prevent re-exportation of the products that have actua lly been imported into their territories under the 
system.  In the event that an eligible importing Me mber that is a developing country Member or a 
least-developed country Member experiences difficu lty in implementing this provision, developed 
country Members shall provide, on request and on mu tually agreed terms and conditions, technical 
and financial cooperation in order to facilitate its implementation. 
4. Members shall ensure the ava ilability of effective legal means to prevent the importation into, 
and sale in, their territories of products produced under the system and diverted to their markets inconsistently with its provisions, using the mean s already required to be available under this 
Agreement.  If any Member considers that such measures are proving insufficient for this purpose, the 
matter may be reviewed in the Council for TRIPS at the request of that Member. 
                                                     
 
7 The licensee may use for this purpose its own website  or, with the assistance of the WTO Secretariat, 
the page on the WTO website dedicated to the system. 
8 It is understood that this notification does not need to be approved by a WTO body in order to use the 
system. 
9 The notification will be made available publicly by the WTO Secretariat through a page on the WTO 
website dedicated to the system.  IP/C/41 
 Page 7 
 
 
 5. With a view to harnessing economies of scale for the purposes of enhancing purchasing 
power for, and facilitating the local production of, ph armaceutical products, it is recognized that the 
development of systems providing for the grant of regional patents to be applicable in the Members 
described in paragraph 3 of Article 31 bis should be promoted.  To th is end, developed country 
Members undertake to provide technical cooperation in accordance with Article 67 of this Agreement, 
including in conjunction with other rele vant intergovernmental organizations. 
6. Members recognize the desirability of promoting the transfer of technology and capacity 
building in the pharmaceutical sector in order to  overcome the problem faced by Members with 
insufficient or no manufacturing capacities in the pha rmaceutical sector.  To this end, eligible 
importing Members and exporting Members are encouraged to use the system in a way which would 
promote this objective.  Members undertake to cooperate  in paying special attent ion to the transfer of 
technology and capacity building in the pharmaceutical  sector in the work to be undertaken pursuant 
to Article 66.2 of this Agreement,  paragraph 7 of the Declaration on the TRIPS Agreement and Public 
Health and any other relevant work of the Council for TRIPS. 
7. The Council for TRIPS shall review annually the functioning of the system with a view to 
ensuring its effective operation and shall annually report on its operation to the General Council. IP/C/41 
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 APPENDIX TO THE ANNEX TO THE TRIPS AGREEMENT 
 
Assessment of Manufacturing Capac ities in the Pharmaceutical Sector
 
  
 Least-developed country Members are deemed to have insufficient or no manufacturing 
capacities in the pharmaceutical sector.   For other eligible importing Members insufficient or no manufacturing capacities for the product(s) in question may be established in either of the following ways: 
 
 (i) the Member in question has established that it has no manufacturing capacity in the 
pharmaceutical sector; 
   o r  
 
 (ii) where the Member has some manufactur ing capacity in this sector, it has examined 
this capacity and found that, excluding any capacity owned or controlled by the patent owner, it is currently insufficient fo r the purposes of meeting its needs.  When 
it is established that such capacity has beco me sufficient to meet the Member's needs, 
the system shall no longer apply. 
 
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