Proposal for a Council Decision accepting, on behalf of the European Community, of the Protocol amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), done at Geneva on 6 December 2005
Date: 2006-04-27
Institutions: European Commission
Subjects: TRIPS, World Trade Organisation, developing countries, intellectual property, pharmaceutical product, public health, trade agreement, trade cooperation, trade licence

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 27.4.2006 
COM(2006) 175 final 

2006/0060 (AVC) 

Proposal for a 

COUNCIL DECISION 

accepting, on behalf of the European Community, of the Protocol amending the 
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), done at 
Geneva on 6 December 2005 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

Objective of this proposal 

This  proposal  for  a  Council  Decision  aims  at  accepting,  on  behalf  of  the  European 
Community,  the  Protocol  amending  the  Agreement  on  Trade-Related  Aspects  of 
Intellectual Property Rights (hereinafter referred to as the “TRIPS Agreement”), done 
at Geneva on 6 December 2005. 

On  6  December  2005,  the  General  Council  of  the  World  Trade  Organization 
(hereinafter referred to as the “WTO”) submitted a proposed amendment to the TRIPS 
Agreement  to  the  WTO  Members  for  acceptance.  This  amendment  would  make 
permanent a waiver decision on compulsory licences originally adopted in 2003. Once 
accepted  and  in  force,  this  amendment  will  complete  a  process  that  began  with  the 
Declaration  on  the  TRIPS  Agreement  and  Public  Health  that  ministers  made  at  the 
Doha Ministerial Conference in November 2001. 

This is the first time that a core WTO agreement is amended. 

The Doha Declaration on TRIPS and Public Health 

On  14  November  2001  at  Doha,  the  Fourth  Session  of  the  WTO  Ministerial 
Conference adopted the Declaration on the TRIPS Agreement and Public Health. The 
Doha Declaration clarifies the relationship between the TRIPS Agreement and public 
health  policies  of  WTO  Members,  confirming  the  right  of  Members  to  issue 
compulsory licences on patents for reasons of public health. 

As  to  WTO  Members  with  no  manufacturing  capacity  in  the  pharmaceutical  sector, 
which could not import medicines they needed, Paragraph 6 of the Doha Declaration 
instructed the Council for TRIPS to find an expeditious solution to this problem. 

The waiver decision of 30 August 2003 

On  30  August  2003,  the  WTO  General  Council  adopted  the  decision  on  the 
implementation of Paragraph 6 of the Doha Declaration on the TRIPs Agreement and 
Public Health.  

This  decision  allows  WTO  Members  to  export  patented  medicines  to  third  countries 
with  no  manufacturing  capacity  in  the  pharmaceutical  sector,  by  making  use  of 
compulsory  licences.  It  includes  substantial  safeguards  against  trade  diversion  and 
rules to ensure transparency. 

The  decision  was  accompanied  by  a  statement  by  the  chair  of  the  General  Council, 
describing  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. It stipulates that 
issues such as preventing the medicines getting into the wrong hands are important. 

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In  order  to  make  sure  that  the  system  would  be  aimed  at  relieving  the  neediest, 
developed country Members of the WTO (among which all EU Member States1) have 
taken  the  commitment  not  to  use  the  system  as  importers.  High  income  developing 
country members have made a statement that they would not use the system except in 
exceptional circumstances. All WTO Members have the right to act as exporters. 

The 30 August 2003 decision takes the form of a provisional “waiver” in the meaning 
of  Article  IX:3  of  the  Marrakech  Agreement  Establishing  the  World  Trade 
Organization  (hereinafter  referred  to  as  the  “WTO  Agreement”)  and  provides  for  its 
replacement  by  an  amendment  to  the  TRIPS  Agreement,  on  which  work  was  to  be 
completed by mid 2004. 

Following  the  waiver,  the  Commission  has  proposed  to  the  European  Parliament  and 
the Council the adoption of a Regulation on compulsory licensing of patents relating to 
the manufacture of pharmaceutical products for export to countries with public health 
problems2, the adoption of which is imminent. 

The decision of 6 December 2005 

The decision of 6 December 2005 is intended to transform the 30 August 2003 waiver 
decision into a permanent amendment of the TRIPS Agreement. 

The amendment will allow any WTO Member to export pharmaceutical products made 
under  a  compulsory  licence  for  the  purpose  of  supplying  developing  countries  with 
insufficient  manufacturing  capacities.  It  will  ensure  a  legally  secure,  predictable, 
effective and sustainable solution for those countries which want to use the system to 
get affordable medicines they need. 

The new rules will be formally incorporated into the TRIPS Agreement. In accordance 
with Paragraph 3 of Article X of the WTO Agreement, the amendment takes effect for 
the Members that have accepted it when two thirds of the WTO Members accept the 
amendment  and  thereafter  for  each  other  Member  upon  acceptance  by  it.  WTO 
Members have set themselves until 1 December 2007 to do this. The waiver remains in 
force for each Member until the amendment becomes effective for that Member. 

The  amendment  is  designed  to  match  the  30  August  2003  decision  as  closely  as 
possible. Other procedures used in 2003 are also matched, including the statement by 
the chair of the WTO General Council. In order to achieve this, the 6 December 2005 
decision  ensures  that  the  legal  meaning  and  weight,  and  the  relationship  between  the 
statement  and  the  new  rules,  are  preserved  as  exactly  as  possible.  This  reflects  the 
approach that the EC had defended in the WTO. 

A  group  of  developed  countries,  including  the  European  Community,  is  listed  as 
announcing  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. 

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2 

Before accession to the EU, the then ten accession countries made a statement that they would not use 
the system except in exceptional circumstances. Upon accession to the EU, their commitment is not to 
use the system as importers at all. 
COM(2004) 737 final of 29.10.2004. 

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Contents of the amendment 

The amendment itself is composed of three parts: 

– 

– 

– 

Five  paragraphs  come  under  Article  31bis  (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  remuneration  to  the  patent  owner, 
regional  trade  agreements  involving  least-developed  countries,  non-violation 
and  situation  complaints,  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 and transparency, avoiding the pharmaceuticals being diverted to 
the wrong markets, developing regional systems to allow economies of scale, 
and annual review in the Council for TRIPS. 

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. 

The new Article 31bis and annex of the TRIPS Agreement are attached to the Protocol 
of amendment. This is attached to a WTO General Council decision, which adopts the 
Protocol and opens it for Members to accept it by 1 December 2007. 

Conclusion of the Protocol 

The European Commission participated, on behalf of the European Community, in the 
negotiation of the Protocol. 

In  accordance  with  paragraph  5  of  Article  133  of  the  EC  Treaty,  the  European 
Community is competent to conclude agreements in the field of commercial aspects of 
intellectual  property.  Therefore,  the  Protocol  should  be  accepted  on  behalf  of  the 
European Community. 

Following the adoption of the Regulation of the European Parliament and the Council 
on  compulsory  licensing  of  patents  relating  to  the  manufacture  of  pharmaceutical 
products for export to countries with public health problems, the Community will have 
an exclusive competence over this matter. Member States should therefore not accept 
the Protocol. 

The President of the Council shall be authorised to designate the person empowered to 
deposit the instrument of acceptance of the Protocol with the WTO Director-General. 
In  its  instrument  of  acceptance,  the  European  Community  shall  also  confirm,  in 
accordance  with  Article  300  paragraph  7  of  the  EC  Treaty,  that  the  Protocol  will  be 
binding on its Member States. 

For  these  reasons,  the  Commission  proposes  to  the  Council  to  adopt  the  attached 
decision. 

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. 

2006/0060 (AVC) 

Proposal for a 

COUNCIL DECISION 

accepting, on behalf of the European Community, of the Protocol amending the 
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), done at 
Geneva on 6 December 2005 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
paragraph 5 of Article 133 in conjunction with the first sentence of the first subparagraph of 
paragraph 2 and the second subparagraph of paragraph 3 of Article 300 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the assent of the European Parliament2, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

On 14 November 2001 at Doha, the Fourth Session of the Ministerial Conference of 
the  World  Trade  Organisation  (hereinafter  referred  to  as  the  “WTO”)  adopted  the 
Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2). 

Paragraph  6  of  this  Declaration  instructed  the  Council  for  TRIPS  to  find  an 
expeditious  solution  to  the  problem  of  the  difficulties  that  WTO  Members  with 
insufficient or no manufacturing capacities in the pharmaceutical sector could face in 
making effective use of compulsory licensing under the Agreement on Trade-Related 
Aspects  of  Intellectual  Property  Rights  (hereinafter  referred  to  as  the  “TRIPS 
Agreement”). 

On  30  August  2003,  the  WTO  General  Council  adopted  a  temporary  decision 
implementing  paragraph  6  of  the  Declaration  on  the  TRIPS  Agreement  and  Public 
Health. 

Paragraph 11 of the 30 August 2003 decision provides that this decision, including the 
waivers  granted  in  it,  shall  terminate  for  each  Member  on  the  date  on  which  an 
amendment  to  the  TRIPS  Agreement  replacing  its  provisions  takes  effect  for  that 
Member. 

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2 

OJ C , p.  
OJ C , p.  

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(5) 

(6) 

(7) 

(8) 

On  6  December  2005,  in  order  to  transform  the  30  August  2003  decision  into  an 
amendment  of  the  TRIPS  Agreement,  the  WTO  General  Council  adopted  a  Protocol 
amending  the  TRIPS  Agreement  and  submitted  it  to  the  Members  of  the  WTO  for 
acceptance. 

Paragraph 3 of the Protocol provides that 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. 

The European Commission participated, on behalf of the European Community, in the 
negotiation of the Protocol. 

In  accordance  with  paragraph  5  of  Article  133  of  the  EC  Treaty,  the  European 
Community is competent to conclude agreements in the field of commercial aspects of 
intellectual property. 

(9) 

The Protocol should be accepted on behalf of the European Community. 

(10) 

In  its  instrument  of  acceptance,  the  European  Community  shall  also  confirm,  in 
accordance  with  Article  300  paragraph  7  of  the EC  Treaty,  that  the  Protocol  will  be 
binding on its Member States, 

HAS DECIDED AS FOLLOWS: 

Article 1 

The  Protocol  amending  the  Agreement  on  Trade-Related  Aspects  of  Intellectual  Property 
Rights, done at Geneva on 6 December 2005, is hereby accepted on behalf of the European 
Community. 

The text of the Protocol is attached to this Decision. 

Article 2 

The  President  of  the  Council  is  hereby  authorised  to  designate  the  person  empowered  to 
deposit the instrument of acceptance of the Protocol with the Director-General of the World 
Trade Organization. 

Article 3 

In its instrument of acceptance, the European Community shall confirm, in accordance with 
Article  300  paragraph  7  of  the  EC  Treaty,  that  the  Protocol  will  be  binding  on  its  Member 
States. 

Done at Brussels,  

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For the Council 
The President 

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ANNEX 

PROTOCOL AMENDING THE TRIPS AGREEMENT 

Members of the World Trade Organization; 

Having  regard  to  the  Decision  of  the  General  Council  in  document  WT/L/641, 
adopted  pursuant  to  paragraph  1  of  Article  X  of  the  Marrakesh  Agreement  Establishing  the 
World Trade Organization ("the WTO Agreement");  

Hereby agree as follows: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

The Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS 
Agreement") shall, upon the entry into force of the Protocol pursuant to paragraph 4, 
be  amended  as  set  out  in  the  Annex  to  this  Protocol,  by  inserting  Article 31bis  after 
Article 31 and by inserting the Annex to the TRIPS Agreement after Article 73.  

Reservations  may  not  be  entered  in  respect  of  any  of  the  provisions  of  this  Protocol 
without the consent of the other Members.  

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. 

This Protocol shall enter into force in accordance with paragraph 3 of Article X of the 
WTO Agreement. 

This  Protocol  shall  be  deposited  with  the  Director-General  of  the  World  Trade 
Organization who shall promptly furnish to each Member a certified copy thereof and 
a notification of each acceptance thereof pursuant to paragraph 3. 

This Protocol shall be registered in accordance with the provisions of Article 102 of 
the Charter of the United Nations. 

Done  at  Geneva  this  sixth  day  of  December  two  thousand  and  five,  in  a  single  copy  in  the 
English, French and Spanish languages, each text being authentic. 

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1. 

2. 

3. 

4. 

5. 

ANNEX TO THE PROTOCOL AMENDING THE TRIPS AGREEMENT 

Article 31bis 

The  obligations  of  an  exporting  Member  under  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  eligible 
importing  Member(s)  in  accordance  with  the  terms  set  out  in  paragraph  2  of  the 
Annex to this Agreement. 

Where a compulsory licence is granted by an exporting Member under the system set 
out in this Article and the Annex to this Agreement, adequate 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  the  exporting 
Member. Where a compulsory licence is granted for the same products in the eligible 
importing Member, the obligation of that Member under Article 31(h) shall not apply 
in  respect  of  those  products  for  which  remuneration  in  accordance  with  the  first 
sentence of this paragraph is paid in the exporting Member. 

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 Participation 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 
product  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. 

Members shall not challenge any measures taken in conformity with the provisions 
of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of 
Article XXIII of GATT 1994. 

This  Article  and  the  Annex  to  this  Agreement  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 
and  Public  Health 
by 
(WT/MIN(01)/DEC/2), and to their interpretation. They are also without prejudice to 
the  extent  to  which  pharmaceutical  products  produced  under  a  compulsory  licence 
can be exported under the provisions of Article 31(f). 

the  TRIPS  Agreement 

the  Declaration 

on 

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ANNEX TO THE TRIPS AGREEMENT 

1. 

For the purposes of Article 31bis and this Annex: 

(a) 

(b) 

"pharmaceutical  product"  means  any  patented  product,  or  product 
manufactured through a patented process, of the pharmaceutical sector needed 
to  address  the  public  health  problems  as  recognized  in  paragraph 1  of  the 
Declaration 
Public  Health 
TRIPS  Agreement 
(WT/MIN(01)/DEC/2). It is understood that active ingredients necessary for its 
manufacture and diagnostic kits needed for its use would be included1; 

and 

the 

on 

"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 31bis 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 only 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 Members3 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 
to  produce 
pharmaceutical  products  for,  and  export  them  to,  an  eligible  importing 
Member. 

the  system 

2. 

The terms referred to in paragraph 1 of Article 31bis 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  established  that  it  has  insufficient 
or  no  manufacturing  capacities  in  the  pharmaceutical  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 

1 
2 

3 

4 

5 

This subparagraph is without prejudice to subparagraph 1(b). 
It is understood that this notification does not need to be approved by a WTO body in order to use the 
system. 
Australia, Canada, the European Communities with, for the purposes of Article 31bis and this Annex, 
its member States, Iceland, Japan, New Zealand, Norway, Switzerland, and the United States. 
Joint  notifications  providing  the  information  required  under  this  subparagraph  may  be  made  by  the 
regional  organizations  referred  to  in  paragraph 3  of  Article 31bis  on  behalf  of  eligible  importing 
Members using the system that are parties to them, with the agreement of those parties. 
The notification will be made available publicly by the WTO Secretariat through a page on the WTO 
website dedicated to the system. 

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Articles 31  and  31bis  of  this  Agreement  and  the  provisions  of  this 
Annex6; 

(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 Member(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  website7  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  been  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. 

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  administrative 
capacities and to the risk of trade diversion to prevent re-exportation of the products 
that have actually been imported into their territories under the system. In the event 
that an eligible importing Member that is a developing country Member or a least-
developed  country  Member  experiences  difficulty  in  implementing  this  provision, 
developed country Members shall provide, on request and on mutually agreed terms 

This subparagraph is without prejudice to Article 66.1 of this Agreement. 
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. 
It is understood that this notification does not need to be approved by a WTO body in order to use the 
system. 
The notification will be made available publicly by the WTO Secretariat through a page on the WTO 
website dedicated to the system. 

3. 

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4. 

5. 

6. 

and  conditions,  technical  and  financial  cooperation  in  order  to  facilitate  its 
implementation. 

Members  shall  ensure  the  availability  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  means 
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. 

With  a  view  to  harnessing  economies  of  scale  for  the  purposes  of  enhancing 
purchasing  power  for,  and  facilitating  the  local  production  of,  pharmaceutical 
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 31bis  should  be  promoted.  To  this  end,  developed  country  Members 
undertake  to  provide  technical  cooperation  in  accordance  with  Article 67  of  this 
Agreement, 
intergovernmental 
organizations. 

in  conjunction  with  other  relevant 

including 

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 
pharmaceutical  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 attention 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. 

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APPENDIX TO THE ANNEX TO THE TRIPS AGREEMENT 

Assessment of Manufacturing Capacities 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; 

or 

(ii)  where the Member has some manufacturing 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  for  the 
purposes of meeting its needs. When it is established that such capacity 
has  become  sufficient  to  meet  the  Member's  needs,  the  system  shall  no 
longer apply. 

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