IP/C/W/649  
 
29 October 2018 
(18-6783) Page: 1/3 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
 
INTELLECTUAL PROPERT Y AND THE PUBLIC INT EREST:  
PROMOTING PUBLIC HEA LTH THROUGH COMPETIT ION LAW AND POLICY  
COMMUNICATION FROM SOUTH AFRICA  
The following communication, dated 26  October 2018, is circulated at the request of the delegation 
of South Africa .  
 
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1.   This communication continues the ad hoc item on "Intellectual Property and the Public Interest: 
Promoting Public Health Through Competition Law and Policy " that was  introduced by the cosponsors 
in document s IP/C/6 43 and Add.1 of 24 May  and 29 May 2018 respectively.  
2.  IP protection per se  cannot be presumed to confer market power or to indicate anti -competitive 
behaviour . IPR holders are for this reason, as a general rule, not prevented from exercising their 
exclusive rights. Different ap proaches are taken by various  jurisdiction s regarding the interface of 
competition law  and policy and IP. A recent WTO staff working paper1 found that despite different 
levels of development, constitutional systems and/or economic structures and industrial profiles  in 
jurisdictions surveyed2 displayed a pervasive interest in the interface between competition law and 
policy and IP. All the jur isdictions surveyed  in this study  have rudimentary rules that have a bearing 
on potential anti -competitive abuses of IPRs. It is also apparent that clearer competit ion policy 
treatment of IPRs has  evolved over time through either iterative processes or evo lving practice of 
competition authorities.3 This evolution is informed by jurisdictional cross -fertilization  and peer 
learning as evidenced by greater interest in and concerns with ensuring an appropriate balance 
between IP and competition law and policy  in these jurisdictions . This development underscores the 
need for further debate  and analysis since competition law and policy is no longer the preoccupation 
of only a few jurisdictions.  
3.  During the June  2018 TRIPS Council session, the cosponsors demonstrate d that there are various 
pro-competitive provisions in the TRIPS Agreement, including Article 6, Article 8.1, Article 31(k) and 
Article 40. There is no doubt that these provisions leave WTO Members broad policy space to apply 
competition law in respect of acts related to the acquisition or exercise of IP rights. As a consequence 
of accommodating the variety of potential competition approaches, remedies available to address 
anti-competitive behaviour may permit a broader range of remedial action than some ot her public 
health -related flexibilities associated solely with patents. Competition policy has an important role 
to play in ensuring access to medical technology and fostering innovation in the pharmaceutical 
sector.  WTO Members have absolute policy space under international law to design their national 
competition laws in accordance with their domestic interests and needs and the level of their 
development.   
4.  The use of competition  law is not without difficulties, since many developing countries may not 
have the capacity to administer or enforce such a system. Since a  substantial body of precedent 
                                              
1 WTO Staff Working Paper ERSD -2018-02 entitled "Competition Agency Guidelines and Policy Initiatives 
Regarding the Application of Competition Law vis -à-vis Intellectual Property: An Analysis of Jurisdictional 
Approaches and Emerging Directions ", p. 63. 
2 United States, Canada, the European Union, Austra lia, Japan, Korea, Brazil, China, India, Russia and 
South Africa . 
3 WTO Staff Working Paper 2018 , p. 64. IP/C/W/649  
 
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  exist, the sponsor  of this document  wishes to demonstrate that many WTO Members already use 
competition law to address various anti -competitive practices that affect access to medicine s and 
medical technologies. Pract ices that have been identified as detrimental include, but are not limited 
to the following instances: (i) abuses of IPRs due to a refusal to deal with or imposition of overly 
restrictive conditions in medical technology licensing; (ii) preventing generic competition through 
anti-competitive patent settlement agreements; (iii) mergers between pharmaceutical companies 
that lead to undesirable concentration of research and development and IPRs; (iv) cartel agreements 
between pharmaceutical companies, including between manufacturers of generics; (v) anti -
competitive behaviour  in the medica l retail and other related sectors; and (vi) bid rigging in public 
procurement.4 In this respect, not all jurisdiction s follow the same approac h, for instance, refusal to 
license may amount to an abuse of dominance in some jurisdictions while others consid er this within 
the rights of IPR holders.   
5.  The "objectives " and "principles " enshrined in Articles 7 and 8 of the TRIPS Agreement form 
central elements of the interpretation of the TRIPS Agreement, especially with regard  to the  relevant  
provisions that recogniz e flexibilities to legislate at the national level. In the WTO case of Canada  – 
Patent Protection for Pharmaceutical Products5, the panel noted that "the exact scope of Article 30 's 
authority will depend on the specific meaning given to its limiting conditions. " To this end, the goals 
enumerated in Articles 7 and 8.1 are relevant when doing so.  
6.  The Panel in  Australia  – Tobacco  Plain Packaging  referred to  the report in Canada -Patent 
Protection for Pharmaceutical Products regarding the interpretation of  the terms of Article 30 of the 
TRIPS Agreement in light of its object and purposes.6 It noted that paragraph 5 of the Doha 
Declaration is formulated in general terms, thereby inviting the interpreter of the TRIPS Agreement 
to read "each provision of the T RIPS Agreement " in light of the object and purpose of the Agreement, 
as expressed in particular in its objectives and principles.7 Fundamentally, the p anel concludes that 
paragraph 5 of the Doha Declaration constitutes a subsequent agreement of WTO Members  within 
the meaning of Article 31(3)(a) of the Vienna Convention on the Law of Treaties.8 This find ing may 
have important consequences for how flexibilities in the TRIPS Agreement are interpreted.  
7.   Competition law and policy remains an important topic and is subject to much multilateral focus 
and discussion. The United Nations Conference on Trade and Development (UNCTAD) produces 
seminal work on this subject -matter and provides technical assistance in order to improve worldwide 
cooperation on competition po licy matters. Each year, an  Intergovernmental Group of Experts 
(IGE)  on Competition Law and Policy meets to discuss ways of and enhancing convergence through 
dialogue. UNCTAD produces a list of competition laws and annotated commentary contained in the 
Handbook on Competition Laws (Volume II)  (UNCTAD/DITC/CLP/2009/2).9 It also has a Model Law 
on Competition which is available in all the UN languages.10 
8.  The World Intellectual Property Organisation (WIPO) has actively discussed the issue of IP and 
competition.11 At its thirteenth session (3 – 5 September 2018), the WIPO Advisory Committee on 
Enforcement discussed , inter alia , the interface between IP enforcement and competition  law. Brazil 
and Peru presented case studies of competition on administrative approach es to address the 
interplay of IP enforcement and competition law.12  Through concrete examples, the contributors 
discussed the limitations of unfair competition laws in relation to the exercise of IP rights as well as 
                                              
4 WHO, WIPO, WTO, Promoting Access to Medical Technologies and Innovation  - Intersections Between 
Public Health, Intellectual Property and Trade (2013) , pp. 75–76. 
5 WT/DS114/R, 17 March 200 0, par. 7.26.  
6 Australia – Certain Measures Concerning Trademarks, Geographical Indications and Other Plain 
Packaging Requirements Applicable to Tobacco Products and Packaging (28 June 2018) WT/DS435/R, 
WT/DS441/R, W T/DS458/R, WT/DS467/R , par. 7.2402 . The DSB adopted the panel reports concerning the 
complaints by Cuba and Indonesia on 27 August (DS458 and DS467, respectively). Honduras and the 
Dominican Republic have appealed certain findings by the Panel (DS435 and D S441, respectively).  
7 Ad par . 7.2408.  
8 Ad par.  7.2409.  In their respective appeals, Honduras (WT/DS435/23) and the Dominican Republic 
(WT/DS/441/23) claimed that the Panel erred in finding that  paragraph 5 of the Doha Declaration on the TRIPS 
Agreement a nd Public Health constitutes a subsequent agreement within the meaning of Article 31(3)(a) of the 
Vienna Convention on the Law of Treaties.  
9 https://unct ad.org/en/Pages/DITC/CompetitionLaw/National -Competition -Legislation.aspx  
10 https://unctad.org/en/Docs/tdrbpconf7d8_en.pdf  
11 http://www.wipo.int/ip -competition/en/  
12 http://www.wipo.int/edocs/mdocs/enforcement/en/wipo_ace_13/wipo_ace_13_5.pdf  IP/C/W/649  
 
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  interventions of competition rules in cases where the IP system was abused to prevent competitors 
from entering or remaining in a market.  
9.  The sponsor  urges Members to once again share their national experiences and examples of how 
competition law is used to achieve public health and related n ational objectives. Debate and 
information exchange could serve to enhance the understanding of Members of various approaches 
to the use of competition law and policy to prevent or deter practices such as : collusive pricing or 
the use of abusive clauses in  licensing agreement that unreasonably restrict access to new 
technology, and the use of measures that prevent the entry of generic companies and result in 
higher prices for medicines. Capacity building and technical assistance remain the most important 
means to enable WTO Members to increase their capacity to administer and implement competition 
law regimes.  
Guiding Questions  
10.  The questions are designed to build on previous question s circulated in document IP/C/W/643 . 
Some delegations indicated that they may revert to some of t he questions that were posed during  
the last TRIPS Council  session . Bearing this in mind, delegations are invited to share their 
experiences of using competition law regimes to address anti -competi tive practices that affect access 
to medicine s and medical technolog ies or to share challenges that they face in the enforcement of 
competition law issue s that affect access to medicines or medical technologies .  
(1) What types of behaviou rs do WTO Members  consider abuses of intellectual property rights in the 
pharmaceutical and medical sectors? Has there been any evolution in the approaches that WTO 
Members take to assess such types of behaviours?  
(2) What examples of best practice  can Members identify on the subject of the control and remedies 
for excessive pricing? Are there context -specific methodologies employed by Members for 
determining if prices are excessive, and the mechanisms to remed y and control pricing abuse?  
(3) What examples of best practice can be identified through national competition law s and 
practice s? Are there certain common trends that can be identified across various jurisdictions?  
(4) To what extent can technical assistance and capacity building contribute to the delivery of more 
effective policies by WTO Members in the field of competition law to address the abuse of intellectual 
property rights?  
 
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