Proposal for a COUNCIL DECISION establishing the position to be taken on behalf of the European Union within the Council for TRIPS and the General Council of the World Trade Organisation as regards the request from least developed country members for an extension of the transitional period under Article 66(1) of the Agreement on Trade Related Aspects of Intellectual Property Rights concerning certain obligations related to pharmaceutical products, and for a waiver from the obligations under Article 70(8) and (9) of that Agreement
Date: 2015-09-10
Institutions: Directorate-General for Trade and Economic Security, European Commission
Subjects: TRIPS, development policy, intellectual property, least-developed country, pharmaceutical product, trade policy

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   EUROPEAN COMMISSION  Brussels, 10.9.2015  COM(2015) 426 final 2015/0190 (NLE)   Proposal for a COUNCIL DECISION establishing the position to be taken on behalf of the European Union within the Council for TRIPS and the General Council of the World Trade Organisation as regards the request from least developed country members for an extension of the transitional period under Article 66(1) of the Agreement on Trade Related Aspects of Intellectual Property Rights concerning certain obligations related to pharmaceutical products, and for a waiver from the obligations under Article 70(8) and (9) of that Agreement  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The objective of this proposal is to allow the European Union to join a consensus in the World 
Trade Organisation (WTO) on the adoption of two decisions.  

First, a decision granting an extension for least developed countries (LDCs) of the Transition 
Period  under  Article  66.1  of  the  Trade  Related  Aspects  of  Intellectual  Property  Rights 
Agreement  (TRIPS)  for  certain  obligations  with  respect  to  pharmaceutical  products  for  as 
long as they remain least developed countries.  

Second a decision granting a waiver from obligations with respect to pharmaceutical products 
under  Article  70.8  and  Article  70.9  of  that  Agreement  for  least  developed  countries  for  as 
long as they remain least developed countries.  

The  extension  and  the  waiver  are  due  to  expire  on  1  January  2016.  Bangladesh  on  23 
February  2015  on  behalf  of  the  least-developed  country  Members  requested  an  indefinite 
extension  of  the  Transition  Period  under  Article  66.1  from  TRIPS  and  an  indefinite  waiver 
from obligations under Article 70.8 and Article 70.9 with respect to pharmaceutical products 
for as long as they remain least developed countries. 

The proposal provides that the Council authorises the Commission to take a position on behalf 
of the European Union within the WTO to join a consensus as regards the said decisions.  

• 

Consistency with existing policy provisions in the policy area 

The initiative is fully consistent with existing policy provisions. Similar decisions have been 
adopted previously.  

The  European  Union  supported  the  Doha  Declaration  on  TRIPS  and  Public  Health  of  14 
November 2001 in which it was agreed that the least-developed country Members would not 
be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 
of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 
1  January  2016,  without  prejudice  to  the  right  of  least-developed  country  Members  to  seek 
other  extensions  of  the  transition  periods  as  provided  for  in  Article  66.1  of  the  TRIPS 
Agreement,  and  the  Council  for  TRIPS  was  instructed  to  take  the  necessary  action  to  give 
effect  to  this  pursuant  to  Article  66.1  of  the  TRIPS  Agreement  (WTO  document 
WT/MIN(01)/DEC/2).  

The  European  Union  supported  the  Council  for  TRIPS  Decision  of  27  June  2002  under 
Article  66.1  TRIPS  which  extended  the  Transition  Period  during  which  least-developed 
countries  do  not  have  to  provide  patent  protection  for  pharmaceuticals  products  until  1 
January 2016 (WTO document IP/C/25).  

The European Union supported the related Decision by the WTO General Council on 8 July 
2002,  giving  least-developed  countries  a  waiver  from  granting  exclusive  marketing  rights 
under  Article  70.9  of  the  TRIPS  Agreement  until  1  January  2016  (WTO  document 
WT/L/478).  

The European Union also supported extending the general transition period, agreed by WTO 
members  on  11  June  2013,  for  least-developed  countries  to  apply  TRIPS  provisions  until  1 
July 2021 (WTO document IP/C/64).  

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• 

Consistency with other Union policies 

The  initiative  is  fully  consistent  with  European  Union  policies.  It  is  coherent  with  the  EU's 
global health policy as defined in the Commission Communication on Global Health and its 
objective  to  keep  essential  medicines  accessible  and  affordable  in  line  with  the  Doha 
Declaration (COM (2010) 128 Brussels).1 It is coherent with other actions to promote access 
to  medicines  for  all  as  noted  in  the  EU  2013  Report  on  Policy  Coherence  for  Development 
(SWD (2013) 456 final).  

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

Article 218(9) of the Treaty on the Functioning of the European Union (TFEU) provides that 
when a Decision having legal effects needs to be taken in a body set up by an international 
agreement, the Council, on a proposal from the Commission or the High Representative of the 
Union for Foreign Affairs and Security Policy, shall adopt a Decision establishing the position 
to be adopted on the Union’s behalf.  

The  extension  of  the  Transition  Period  and  the  waiver  fall  under  this  provision  as  the 
Decisions  are  taken  in  bodies  set  up  by  an  international  agreement  (the  WTO  Council  for 
TRIPS and the General Council) affecting the rights and obligations of the Union. 

The  envisaged  extension  of  the  Transition  Period  and  the  waiver  relate  to  matters  falling 
within the scope of the common commercial policy (Article 207 TFEU) and in particular, to 
obligations under the TRIPS Agreement.  

• 

Proportionality 

The  policy  choice  is  proportional  as  the  proposed  two  Decisions  at  WTO  level  do  not  go 
beyond what is necessary to achieve the objective of joining the consensus at the World Trade 
Organisation  on  the  request  of  least-developed  country  Members  and  the  policy  choice  to 
support the request is in line with the policy the Union subscribed to in the Doha Declaration 
on TRIPS and Public Health of 14 November 2001.  

• 

Choice of the instrument 

As  the  two  Decisions  are  to  be  taken  at  WTO  level  a  Council  Decision  is  the  appropriate 
instrument. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

Not applicable.  

• 

Stakeholder consultations 

Not applicable.  

• 

Collection and use of expertise 

Not applicable.  

1 

http://ec.europa.eu/health/eu_world/global_health/index_en.htm  

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• 

Impact assessment 

No  Impact  Assessment  was  carried  out  as  the  two  Decisions  to  be  taken  at  WTO  level  are 
implementing existing policy  subscribed to by the European Union in the Doha Declaration 
on TRIPS and Public Health of 14 November 2001. 

• 

Fundamental rights 

The  two  Decisions  at  WTO  level  will  provide  least-developed  country  Members  the 
flexibility to choose how best to exercise their right to protect public health and, in particular, 
to promote access to medicines for all.  

4. 

BUDGETARY IMPLICATIONS 

There  are  no  budgetary  implications  aside  from  the  human  and  administrative  resources 
required to support the adoption of the two Decisions at WTO level. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

No  separate  monitoring  is  required  aside  from  general  monitoring  of  compliance  of  WTO 
Members with WTO obligations. 

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2015/0190 (NLE) 

Proposal for a 

COUNCIL DECISION 

establishing the position to be taken on behalf of the European Union within the Council 
for TRIPS and the General Council of the World Trade Organisation as regards the 
request from least developed country members for an extension of the transitional 
period under Article 66(1) of the Agreement on Trade Related Aspects of Intellectual 
Property Rights concerning certain obligations related to pharmaceutical products, and 
for a waiver from the obligations under Article 70(8) and (9) of that Agreement 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 207(4), in conjunction with Article 218(9) thereof,  

Having regard to the proposal from the European Commission,  

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

The  Doha  Declaration  on  the  Agreement  on  Trade-Related  Aspects  of  Intellectual 
Property Rights (the ‘TRIPS Agreement’) and Public Health stated that the extension 
provided  for  in  Article  66(1)  of  the  TRIPS  Agreement  was  without  prejudice  to  the 
right of least-developed country members to seek further extensions of the transitional 
periods.  

Pursuant  to  Article  66(1)  of  the  TRIPS  Agreement,  the  Council  for  TRIPS  is,  upon 
duly motivated request by a least-developed country member, to accord extensions of 
that transitional period. 

In accordance with paragraph 7 of the Doha Declaration on the TRIPS Agreement and 
Public Health and with Article 66(1) of the TRIPS Agreement, the Council for TRIPS, 
by  Decision  of  27  June  2002,  extended  the  transitional  period  during  which  least-
developed  countries  do  not  have  to  provide  patent  protection  for  pharmaceuticals 
products until 1 January 20162.  

On 8 July 2002, the General Council of the World Trade Organisation (WTO) adopted 
a  closely  related  decision,  giving  least-developed  countries  a  waiver  from  granting 
exclusive  marketing  rights  under  Article  70(9)  of  the  TRIPS  Agreement  until  1 
January 20163.  

On 23 February 2015, Bangladesh, on behalf of the least-developed country members 
group, requested an indefinite extension of the transitional period under Article 66(1) 
and an indefinite waiver from the obligations under Article 70(8) and (9) of the TRIPS 
Agreement4 for as long as they remain least-developed countries. 

2 
3 
4 

WTO document IP/C/25. 
WTO document WT/L/478. 
WTO document IP/C/W/605. 

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(6) 

(7) 

(8) 

As  there  has  been  a  separate  waiver  for  pharmaceutical-related  intellectual  property 
rights since 2002, it is appropriate for the Union to agree with the extension so as not 
to hinder least-developed country members access to pharmaceuticals products. 

Several WTO members appear ready to grant that indefinite extension and permanent 
waiver, and therefore the Union should join the consensus in line with its continuous 
support for the Doha Declaration on TRIPS and Public Health. However, if a further 
temporary extension and waiver is the solution finally reached by the WTO members, 
the Union should also agree. 

It is therefore appropriate to establish the position to be taken on behalf of the Union 
within the Council for TRIPS and the General Council of the WTO with regard to the 
request  from  least-developed  country  members  for  an  extension  of  the  transitional 
period  under  Article  66(1)  of  the  TRIPS  Agreement  concerning  certain  obligations 
related to pharmaceutical products, and for a waiver from the obligations under Article 
70(8) and (9) of the TRIPS Agreement, 

HAS ADOPTED THIS DECISION:  

Article 1 

The position to be taken on behalf of the Union within the Council for Trade-Related Aspects 
of Intellectual Property Rights and the General Council of the World Trade Organisation shall 
be as follows:  

(a) 

(b) 

(c) 

(d) 

to agree with the request for the granting to least-developed country members of an 
extension  of  the  transitional  period  under  Article  66(1)  of  the  Agreement  on 
Trade-Related  Aspects  of  Intellectual  Property  Rights  (the  ‘TRIPS  Agreement’) 
concerning certain obligations related to pharmaceutical products; 

to  agree  with  the  request  for  the  granting  to  least-developed  country  members  of  a 
waiver from the obligations under Article 70(8) and (9) of the TRIPS Agreement;  

to accept the proposal for the extension referred to in point (a) or the waiver referred 
to in point (b) or both to continue to be applicable for as long as each least-developed 
country member of the World Trade Organisation remains a least-developed country; 

alternatively  to  point  (c),  to  accept  a  proposal  for  a  temporary  extension  or  a 
temporary waiver or both where the proposal is also acceptable to the other members 
of the World Trade Organisation.  

This Decision shall enter into force on the day of its adoption. 

Done at Brussels, 

Article 2 

For the Council 
The President 

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