WORLD TRADE  
ORGANIZATION  IP/C/W/427 
17 September 2004 
 
 (04-3908) 
Council for Trade-Related Aspects 
 of Intellectual Property Rights Original:   English 
 
 
 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION 
ON THE TRIPS AGREEMENT AND PUBLIC HEALTH 
  
NORWAY 
 
 
 The following communication, dated 13 Sept ember 2004, along with Annexes I and II, has 
been received from the Permanent Mission of Norway  with the request that it be circulated to 
Members. 
  
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On 14 May 2004, Norway amended its patent le gislation in order to implement the General 
Council Decision of 30 August 2003 on paragra ph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health.  The amendments entered into force on 1 June 2004 and provided 
Norway with a fully operational legislative framewo rk for the production of patented medicines for 
export under compulsory licence.   
I. BACKGROUND 
 The WTO Declaration on the TRIPS Agreement and public health adopted in Doha 
14 November 2001
1 was primarily intended to help alleviat e the AIDS situation in southern Africa 
and the difficulties faced by the developing countries in  obtaining vital patent-protected medicines at 
reasonable prices. The Declaration firmly establis hed that the TRIPS Agreement can and should be 
interpreted and implemented in a manner supportive of WTO members' right to protect public health 
and, in particular, to promote access to medicines for all.  
  However, according to Article 31(f) of the TR IPS Agreement, a compulsory license, i.e. a 
license issued by the public authorities to use a pate nted invention without the consent of the patent 
holder, is to be issued mainly with a view to s upplying the domestic market.  This provision has been 
widely regarded as the main obstacle to the effec tive use of compulsory licensing by WTO Members 
with insufficient or no manufacturing capacities in the pharmaceutical sector.  Paragraph 6 of the Doha Declaration instructed the Council for TRIPS to find a solution to the difficulties faced by these 
members.   
 The Decision by the General Council of 30 August 2003
2 on the implementation of paragraph 
6 of the Doha Declaration on the TRIPS Agreement and public health (the General Council Decision) 
makes exceptions to this limitation on exports for pharmaceutical products.  The Decision makes it 
                                                      
1 WT/MIN(01)/DEC/2 
2 WT/L/540 IP/C/W/427 
Page 2  
 
 possible for states that lack manufacturing capacity  to import pharmaceutical products produced under 
compulsory licence.   
II. THE CONSULTATION PROCESS 
 The Norwegian Government carried out extensiv e consultations with potential stakeholders 
before adopting the necessary amendments to Norw egian patent legislation. Substantive comments 
were received from the following institutions: the Biotechnology Advisory Board, the Bar 
Association, the Consumer Council, Helse Bergen (t he regional health administration of Bergen), the 
Ministry of Health, the Competition Authority, the Confederation of Trade Unions, the Association of 
Pharmaceutical Manufacturers, the Intellectual Prop erty Law Association, Norsk Patentingeniørers 
Forening (the association of patent engineers), the Mi nistry of Trade and Industry, the Patent Office 
and the Ministry of Foreign Affairs.    The consultation process revealed that there w as strong general support for the draft proposal.  
None of the commenting bodies opposed the pr oposal, but some commented on the method of 
implementation.  Possibly the most important outc ome of the consultation process was the decision to 
extend the system to cover eligible non-members of  the WTO.  Moreover, it was decided to introduce 
more detailed requirements for labelling of the produc ts that would clearly show that they were 
produced under this system.     The new provisions specifically stipulate that  the production and export of these products are 
to cease if they are used "to an appreciable degr ee" for purposes not in accordance with the conditions 
for granting the licence.   
III. THE AMENDMENTS TO NORW AY'S PATENT LEGISLATION 
 The first step in the implementation of the Ge neral Council Decision in Norwegian law was to 
amend the Norwegian Patents Act
3 to provide for exemptions from the requirements for the granting 
of a compulsory licence.  A further amendment prov ides that the Competition Authority is authorised 
to grant compulsory licenses as well as the courts.    On 14 May 2004 the Patent  Regulations
4 were amended to take a ccount of the substance of 
the General Council Decision.  These amendments are somewhat less detailed than the decision itself.  
It is a tradition in Norwegian law that if national pr ovisions are unclear, they should be interpreted in 
the light of the international public law provisions.    As provided for in the General Council D ecision, the regulations make the necessary 
derogation from the export restrictions of Article 31 (f) of the TRIPS Agreement.  They also stipulate 
that the right holder is to receive "adequate rem uneration", taking into account the economic value to 
the importing member.   The other provisions of Article 31 of the TR IPS Agreement and the Norwegian Patents Act 
will continue to apply in relation to applications for compulsory li cences.  In the case of the general 
requirements set out in Article 31 (b), for instance, this means that except in the event of a national 
emergency or in the case of public non-commercial use, prior efforts must have been made to 
negotiate an authorisation from the right holder on reasonable commercial terms and conditions.  
  The regulations establish that producers have a right to obtain a compulsory licence provided that the conditions of the General Council Decision  and the TRIPS Agreement have been fulfilled.  
                                                     
 
3 Act of 15 December 1967 No. 9 relating to patents 
4 The Regulations of 20 December 1996 No. 1162  IP/C/W/427 
 Page 3 
 
 
 Furthermore the Norwegian authorities should no rmally accept the information provided in the 
notification unless there are specific indications th at the public health needs of the importing state 
have been inaccurately described. Thus, if the im porting state's request is based on public health 
considerations and falls within the scope of th e General Council Decision and the TRIPS Agreement, 
and if the product is being produced solely for expo rt in order to meet that state's current need, a 
compulsory license should normally be issued.  
  The Competition Authority as well as the cour ts have been given the authority to grant 
compulsory licenses.  An administrative decision of the Competition Authority may always be challenged before the courts. 
 
IV. IMPLICATIONS OF THE LEGISLATIVE CHANGES 
 Given that Norway does not have a large pharma ceutical industry, at least in the product areas 
which are most likely to benefit from the General Council Decision, we do not expect the Norwegian 
industry to be a significant contributor under this system in the near future. 
 
 However, Norway's early implementation of the General Council Decision expresses its 
strong support for the mandate in the Doha Declarat ion on the TRIPS Agreement and public health.  
The threat to public health and economic developm ent posed by HIV/AIDS, tuberculosis, malaria and 
other epidemics is as serious today as it was three years ago, and although it is no panacea to the 
world's health problems, the implementation of the General Council Decisi on is a very important 
contribution amongst other efforts to provide access to affordable, life-saving medicines.  Norway 
hopes that its implementation of the General C ouncil Decision will induce other WTO members, both 
developed as well as developing country Members, to follow suit, thereby helping to provide an 
effective remedy for countries with insufficient or no manufacturing capabilities in the pharmaceutical 
sector.   
 
 The amendments to the Norwegian Patent Act and Regulations will be notified to the Council 
for TRIPS pursuant to Article 63.2 of the TRIPS Agreement.  They are al so attached to this 
communication as Annexes I and II.  
 
 
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 IP/C/W/427 
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 ANNEX I 
  
 The present document reproduces amendments to the Act of 15 December 1967 No. 9 relating 
to patents and the Patent Regulations of 20 D ecember 1996 No. 1162, in order to implement the 
General Council Decision of 30 August 2003
5 on paragraph 6 of the Doha Ministerial Declaration on 
the TRIPS Agreement and Public Health.   Sections 49 and 50 to the Act of 15 Decemb er 1967 No. 9 relating to patents as amended by 
Act of 19 December 2003 no. 127: 
 
Section 49: 
 
 A compulsory licence may only be granted to a person who has made efforts to obtain a licence on reasonable commercial terms by agreement without succeeding in this within a reasonable 
time, and who may be presumed able to exploit th e invention in a manner which is acceptable and in 
compliance with the terms of the licence.   A compulsory licence shall not prevent the patent holder from exploiting the invention himself or from granting licences.  
 A compulsory licence shall only be assignable in  conjunction with the enterprise where it is 
exploited or in which exploitati on was intended. Furthermore, a compulsory licence obtained pursuant 
to section 46, first paragraph, may only be assigned in conjunctio n with the dependent patent. 
  In the case of semi-conductor technology, a compulsory licence may only be granted for 
public non-commercial use or pursuant to section 47 (2). 
  A compulsory licence shall primarily be gran ted with a view to supply of the domestic 
market.  The King may by regulations lay down rules that deviate from this. 
 
Section 50: 
  
 A compulsory licence shall be granted by th e court pursuant to this section or by the 
Norwegian Competition Authority pursuant to section 50 a.   In a decision concerning a compulsory licence, it shall be decided to what extent the invention 
may be exploited as well as the amount of rem uneration and the other terms of the licence. The 
remuneration shall be adequate in relation to the ci rcumstances of each case.  Assessment shall take 
into account the economic value of the licence.    
 
 
                                                     
 
5 WTO Doc. WT/L/540  IP/C/W/427 
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 ANNEX II 
 
  Pursuant to sections 49 and 69 of the Act of 15 December 1967 No. 9 relating to patents, the 
Ministry of Justice and the Police laid down the following regulations by Royal Decree of 
14 May 2004: 
 
I 
 
 
The Regulations of 20 December 1996 No. 1162, which ha ve been issued pursuan t to the Patents Act, 
shall be amended as follows:   New section 107 shall read as follows:  
Section 107 . When the requirements set out in section 10 8 have been complied with, a producer of 
pharmaceutical products in Norway shall be granted on application a compulsory licence pursuant to 
section 47 of the Patents Act to manufacture pharm aceutical products for export to an eligible 
importing State that has requested the producer to supply the products.  For the purpose of these 
regulations, an eligible importing Stat e or customs territory is one that: 
 
1. at the time in question has been designated by  the UN as a least developed country or customs 
territory, or that has insufficient manufacturi ng capacity in accordance with the Annex to the 
decision of the WTO General Council of 30 Au gust 2003 (the General Council Decision);  
and 
2. has made a notification to the Council for TR IPS in accordance with the General Council 
Decision, paragraphs 1(b) and 2(a). 
States that are not party to the WTO Agreement sha ll make the notification referred to in the first 
paragraph (2) above to the Norwegia n Ministry of Foreign Affairs. 
 New section 108 shall read as follows:  
Section 108 . A compulsory licence may only be granted pursuant to section 107 if 
 1. the producer has tried to obtain a licence by ag reement in Norway insofar as this is required 
pursuant to section 49, first paragraph, of the Patents Act; 
2. the product is covered by paragraph 1(a) of the General Council Decision; 
3. the product is only to be produced for export to the eligible importing State in order to cover 
the said State's current need for the produc t for health purposes, as described in the 
notification mentioned in section 107;  and 
4. the invention is not protected by a patent in the eligible importing State or the eligible 
importing State has granted or has undertaken proceedings to obtain a compulsory licence 
pursuant to Article 31 of the Agreement of 15 April 1994 on Trade-Related Aspects of 
Intellectual Property Rights (the TRIPS Agre ement) and the General Council Decision. 
When assessing what are reasonable commercial term s and conditions pursuan t to section 49, first 
paragraph, of the Patents Act, and when determining the remuneration pursuant to section 50, second IP/C/W/427 
Page 6  
 
 paragraph, of the Patents Act, account shall be ta ken of the economic value to the importing State of 
the use of the invention.  More detailed requirements for granting a compulsory  licence may be imposed in the decision to grant 
such a licence, cf. section 50, first paragraph, of  the Patents Act. These shall include the following 
requirements: 
 1. the packaging and container shall be distinct from those of products being offered for sale in 
Norway or in another state by the patent-holder himself or with his consent; 
2. the products shall be labelled so as to clearly  indicate that the pharmaceutical product has 
been manufactured under compulsory licence in Norway for export to a specified importing 
state in accordance with the General Council Decision;  and 
3. the manufacture and export shall cease if the licence-holder learns the products are being used 
to an appreciable degree for purposes that ar e not in accordance with the conditions for 
granting the licence, cf. first paragraph (3). 
New section 109 shall read as follows:  
 Section 109 . The competent court or the Competition Au thority shall make a notification to the 
Council for TRIPS concerning the compulsory licence in accordance with the General Council 
Decision, paragraph 2(c). States that are not party to the WTO Agreement shall make a notification to the Norwegian Ministry of Foreign Affairs.  
 
The holder of a compulsory licence shall post in formation on its website in accordance with the 
General Council Decision,  paragraph 2(b)(iii). 
 
 
II 
 
 These regulations enter into force on 1 June 2004.    
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