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Nordic Journal of Commercial Law 
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Establishing Coherence:  
The Right to Access to Medicines, Pharmaceutical Patents and the WTO Medicines Decision 

by  

Elina Saxlin-Hautamäki 



 

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I. Introduction 

“It is a well-known paradox of globalization that while it has led to increasing uniformization of social life 
around the world, it has also led to its increasing fragmentation - that is, to the emergence of specialized 
and relatively autonomous spheres of social action and structure. The fragmentation of the international 
social world has attained legal significance as it has been accompanied by the emergence of specialized and 
(relatively) autonomous rules or rule-complexes, legal institutions and spheres of legal practice.”1 

The era of globalization has had a fundamental impact on international relations and 
international law. From 1970 through 1997, the number of international treaties more than 
tripled2. This has lead to a situation where States are increasingly bound to treaties that may 
appear to include conflicting norms, i.e. a situation where adherence to one provision may lead 
to the violation of another. How to govern this fragmentation of international law is a 
challenge. The relationship between the right to access to medicines and protection of 
pharmaceutical patents is a current example of this ambitious task.3  

The Agreement on Trade-Related Aspects of Intellectual Property Rights (“the TRIPS 
Agreement”) created a global patent system that can be enforced, when necessary, through the 
World Trade Organization (“WTO”) and its dispute settlement mechanism. Article 27 of the 
agreement stipulates that patents must be available also for pharmaceutical products and 
processes on a non-discriminatory basis.4 Simultaneously, however, most WTO Members have 
other kinds of obligations that are arguably of more fundamental character – namely, human 
rights obligations. The right to health covered e.g. by Article 12 of the International Covenant 
on Economic, Social and Cultural Rights (“the ICESCR”) concluded in 1966 obligates 

 
1 Koskenniemi 2006, paras. 7–8. 
2 Alvarez 2002, p. 216. 
3 For an in-depth research on the relationship between global patent protection and the right to access to 
medicines in international law, see Hestermeyer 2007.  
4 Article 27(1) of the TRIPS Agreement: “Subject to the provisions of paragraphs 2 and 3, patents shall be available 
for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve 
an inventive step and are capable of industrial application. […] patents shall be available and patent rights 
enjoyable without discrimination as to the place of invention, the field of technology and whether products are 
imported or locally produced.” 



 

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contracting states to ensure access to affordable medicines.5 The ICESCR has 160 Parties; over 
80 percent of the Members of the WTO are simultaneously bound by both agreements.6 The 
conflict between the TRIPS Agreement and the right to access to medicines has inspired a 
wealth of literature: while access to affordable medicines forms an integral part of the right to 
health, pharmaceutical patents tend to increase the prices of pharmaceuticals and may, thus, 
hinder access to medicines in developing countries.  

The current health crisis related to HIV/AIDS and other epidemics in developing countries has 
highlighted the gap between the haves of industrialized countries and the have-nots of 
developing countries: approximately 90 percent of deaths due to infectious diseases occur in 
developing countries that represent 10 percent of the global pharmaceuticals market7. Human 
rights advocates have been calling for the supremacy of the right to access to medicines in 
relation to pharmaceutical patents. However, the fact is that the TRIPS obligations are more 
precisely formulated and backed up by an efficient dispute settlement mechanism, whereas the 
ICESCR and other agreements on human rights are drafted in broader terms and lack efficient 
enforcement systems.8 Similarly, the right to access to medicines as a norm of customary 
international law seems to have no practical significance in trade negotiations.9 Yet, at a time 

 
5 Article 12 of the ICESCR:”1. The States Parties to the present Covenant recognize the right of everyone to the 
enjoyment of the highest attainable standard of physical and mental health. 2. The Steps to be taken by the States 
Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) The 
provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the 
child; (b) The improvement of all aspects of environmental and industrial hygiene; (c) The prevention, treatment 
and control of epidemic, endemic, occupational and other diseases; (d) The creation of conditions which would 
assure to all medical service and medical attention in the event of sickness.” Access to medicines is not mentioned 
in the ICESCR as an independent right. It is yet a critical component of the right to health both as a means of 
prevention, treatment and control of epidemic and endemic diseases and as a part of medical attention in the 
event of any kind of sickness. See Yamin 2004, p. 112.  
6 Hestermeyer 2007, p. 102; A list of Parties and signatories is available at http://treaties.un.org/Pages/ 
ViewDetails.aspx?src=TREATY&mtdsg_no=IV-3&chapter=4&lang=en (last visited 26.3.2010). States have binding 
health-related obligations also through myriad other global and regional human rights instruments. See e.g. Article 
12 of the Convention on the Elimination of All Forms of Discrimination Against Women, Article 24 of the 
Convention on the Rights of the Child, Article 5 of the International Convention on the Elimination of All 
Forms of Racial Discrimination, Article 16 of the African Charter on Human’s and People’s Rights (“Banjul 
Charter”), Article 11 of the European Social Charter, Article XI of the American Declaration on the Rights and 
Duties of Man and Article 10 of the subsequent Additional Protocol to the American Convention on Matters of 
Economic, Social and Cultural Rights (“Protocol of San Salvador”). In addition, access to medicines can be 
invoked in favour of various other human rights, such as the right to life (Article 6 of the International Covenant 
on Civil and Political Rights, “ICCPR”), rights to an adequate standard of living to social security, to education 
and to work, the right to benefits of scientific progress (Articles 6, 9, 13 and 15 of the ICESCR). Bearing in mind 
the indivisibility and interdependence of human rights, there is yet no need to further explain the significance of 
the right to health in relation to other human rights.  
7 World Health Assembly (resolution WHA56.27): Intellectual property rights, innovation and public health (2003), 
preamble, para. 3.  
8 Cullet 2006, p. 195.  
9 For an analysis of the right to access to medicines as a customary norm, see Hestermeyer 2007 p. 122 ff.  



 

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when approximately 17,6 million people in low- and middle-income countries die each year 
from communicable diseases and maternal and neonatal conditions10 – the occurrence of which 
is far lower in developed countries – individuals in need of medicines should not be exposed to 
any additional burdens. Thus, the issue is how to strike a balance between global intellectual 
property protection and universal access to medicines – a task that literally turns into a life-and-
death question with respect to pharmaceutical patents in developing countries. 

The negative impact of pharmaceutical patents on access to medicines in developing countries 
was one of the central issues during the WTO Doha round. The well-known cases of South-
Africa11 and Brazil12 generated a strong reaction from non-governmental organizations and 
international human rights organs that have been calling for exceptions to pharmaceutical 
patents on a public health basis as part of the reforms that should take place in the WTO 
context.13 As the Sub-Commission on the Promotion and Protection of Human Rights put it, 

“[…] since the implementation of the TRIPS Agreement does not adequately reflect the 
fundamental nature and indivisibility of all human rights, including [...] the right to health, there 
are apparent conflicts between the intellectual property rights regime embodied in the TRIPS 
Agreement, on the one hand, and international human rights law, on the other”14.  

Faced with immense public pressure and obscurities related to the implementation of the 
agreement, WTO Members managed to adopt the Declaration on the TRIPS Agreement and Public 
Health at the 4th Ministerial Conference held in Doha in November 2001 (“the Doha 
Declaration”). In the declaration, WTO Members agree that the TRIPS Agreement does and 
should not prevent WTO Members from taking measures to protect public health15. The need 
to extend the deadline for least-developed country Members to apply provisions on 
pharmaceutical patents was recognized and the transitional periods have since been extended to 

 
10 Dutfield 2008, p. 107.  
11 For an overview of the case of South-Africa, see Nagan 2002. 
12 For an overview of the case of Brazil, see Lazzarini 2003.  
13 See e.g. Subcommission on the Promotion and Protection of Human Rights (resolution 2000/7): Intellectual 
property rights and human rights; Commission on Human Rights (resolution 2001/33): Access to Medication in the 
context of pandemics such as HIV/AIDS; World Health Assembly (resolution 28 May 2003): Intellectual Property Rights, 
innovation and public health; Oxfam: Oxfam Briefing Paper 4 (2001): Priced out of reach – How WTO policies will reduce 
access to medicines in the developing world.  
14 Subcommission on the Promotion and Protection of Human Rights (resolution 2000/7): Intellectual property 
rights and human rights, para. 2.  
15 Doha Declaration, para. 4.  



 

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January 201616. Most importantly, the TRIPS Council was called upon to find a solution to 
the problem that many WTO Members lack the capacity to effectively utilize the exceptions to 
patent rights authorized by the TRIPS Agreement17.  

The adoption of the Doha Declaration thus launched a set of negotiations with the purpose of 
ensuring the ability of developing countries to use patented medicines in consistency with the 
TRIPS Agreement. In September 2003, after long negotiations and intensive politics, the 
General Council of the WTO adopted the Decision on implementation of paragraph 6 of the Doha 
Declaration on the TRIPS Agreement and Public Health (“Medicines Decision”). The decision 
waives (i.e. temporarily suspends) certain obligations set out in Article 31 of the TRIPS 
Agreement. The provision concerns the use of patents without permission of the patent holder, 
a practice most often referred to as compulsory licensing. A WTO waiver means that a WTO 
Member will not initiate a complaint against another WTO Member, if the latter acts in 
accordance with the terms of the adopted waiver18. In December 2005, the General Council of 
the WTO adopted a decision to amend the TRIPS Agreement to make the Medicines Decision 
a permanent part of it19. This is done by inserting Article 31bis, which corresponds with the 
content of the Medicines Decision, to the TRIPS Agreement. The protocol amending the 
agreement was initially open for acceptance until the 1st of December 2007; the deadline was 
subsequently extended to the 31st of December 200920. Meanwhile, the Medicines Decision 
applies to all WTO Members. The three texts, the TRIPS Agreement, the Doha Declaration 
and the Medicines Decision, now provide the main legal framework regulating the use of 
compulsory licenses as a public health safeguard protecting developing countries against the 
possible negative effects of pharmaceutical patents on access to medicines.  

The conflict sketched out above, between pharmaceutical patents supported by the TRIPS 
Agreement and access to medicines as part of the human right to health, is an excellent 
example of fragmentation of international law – a situation where States are bound by 
obligations under different specialized systems that each establish their own principles and 

 
16 Ibid., paras. 6 and 7; Council for TRIPS: Decision on the Extension of the Transition Period under Article 66.1 of the 
TRIPS Agreement for Least-developed Country Members for Certain Obligations with Respect to Pharmaceutical Products (1 
July 2002) and WTO General Council: Decision on Least-developed Country Members — Obligations Under Article 70.9 of 
the TRIPS Agreement with Respect to Pharmaceutical Products (12 July 2002). It should be noted, however, that some 
least-developed countries have nevertheless chosen to enforce patent systems despite the transitional periods they 
have been granted (Oh 2006, p. 30).  
17 Doha Declaration, para. 6.  
18 See also Article 56 of the Vienna Convention of the Law of Treaties.  
19 WTO General Council: Amendment of the TRIPS Agreement (8 December 2005).  
20 WTO General Council: Amendment of the TRIPS Agreement – Extension of the period for the acceptance by members of 
the protocol amending the TRIPS Agreement (21 December 2007). In order to replace the waiver, the amendment has 
to be formally accepted by two thirds of WTO Members in accordance with paragraph 3 of Article X of the 
Marrakesh Agreement.  



 

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institutions. Assessment of the phenomenon varies. Authors calling for coherence of 
international law have stated that the so-called sub-regimes or sub-systems of modern 
international law, such as WTO law and human rights law, must not be considered separate 
and self-contained regimes, as this kind of assumption would nullify the significance of general 
international law. Accordingly, even though a State can in theory contract out of all rules of 
international law, it cannot do that with respect to the system of international law, the 
maintenance of which requires a prohibition against the creation of sub-systems completely 
delinked from the rules of international law agreed upon elsewhere21. Others have given up on 
searching for unity and are calling for “weak compatibility between the fragments” of 
international law22. Institutional fragmentation is considered a natural expression of political 
plurality in a world where it is doubted that any legal unity existed in the first place. Having 
rejected the idea of any “abstract consistency”, the proponents of this view believe that each 
special regime will continue speaking its own professional language and “seeks to translate that 
into a global Esperanto”, while no overall solutions are available as to which system of law 
should be preferred in a particular situation23.  

The point of departure of this article is that no international regime can choose to exist in a 
legal vacuum – instead, all norms of international law can interact with each other. Similarly, 
international intellectual property regulation is applied in a context where the right to health is 
a well-established human right, codified in several human rights instruments. The feasibility of 
exclusive rights introduced by the TRIPS Agreement must, however, also be ensured as an 
important part of economic relations between WTO Members. The issue, therefore, is how to 
maintain coherence between the sets of norms examined. In the following, I will first examine 
the obligations imposed by the right to access to medicines and its relationship to and position 
in the TRIPS regime, in order to elucidate why these norms should be efficiently reconciled. I 
will continue by examining the content of the Medicines Decision – the amendment that was 
supposed to harmonize the TRIPS Agreement with the right to access to medicines – in order 
to provide a practical answer to the question of how to ensure that pharmaceutical patents do 
not hinder access to medicines in developing countries.  

 
21 Pauwelyn 2003, p. 9–10, 37–38.  
22 Fischer-Lescano and Teubner 2004, p. 1046. The authors present (p. 1024–1034) that with respect to 
pharmaceutical patents and the amendments made within the WTO, the organization managed to create an 
internal limitation on its own logic through the reformulation of a principle of health protection – an act that the 
authors describe as the internal achievement of the regime that allowed it to maintain its autonomy over 
conflicting regimes and laws. 
23 Koskenniemi & Leino 2002, p. 557, 578. 



 

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II. An Illusion of Incoherence?  

2.1.  The Right to Access to Medicines And the TRIPS Agreement 

The obligations imposed by the right to access to medicines as part of the human right to 
health, and their position with respect to TRIPS obligations, can be approached by the well-
known tripartite analysis of human rights: the obligations to respect, protect and fulfill. The 
obligation to respect is the negative dimension of the right to access to medicines, which requires 
States to refrain from interfering directly or indirectly with the enjoyment of the right.24 This 
obligation is closely connected to the prohibition of retrogressive measures.25 States must 
refrain from adopting legislation or policies that interfere with the enjoyment of any of the 
components of the right to health. They must thus take into account legal obligations regarding 
also the right to access to medicines, when entering into bilateral or multilateral agreements 
with other States, international organizations and other entities, such as multinational 
corporations.26  

The introduction of pharmaceutical patents that have a price-increasing effect can constitute a 
violation of the obligation to respect the right to health if the regulation in question hinders 
access to medicines by increasing prices. It should be noted, however, that in accordance with 
the Doha Declaration, the TRIPS Agreement “shall be read in the light of the object and 
purpose of the Agreement as expressed, in particular, in its objectives and principles”.27 
Pursuant to Article 7 of the TRIPS Agreement, the object of the agreement is to promote 
technological innovation “in a manner conducive to social and economic welfare, and to 
balance of rights and obligations”. The provision is based on a proposal submitted by 
developing countries during the negotiations of the TRIPS Agreement and it represents a 
compromise between the global intellectual property protection, on the one hand, and the need 
to secure access technology in the South, on the other. It can well be used to legitimize 
exceptions to exclusive rights in order to strike a balance between the private and the public 

 
24 Dowell-Jones 2004, p. 29; ESCR Committee, General Comment 14, para. 33. 
25 ESCR Committee, General Comment 14, para. 32 (stating that if such measures are taken, “the State party has 
the burden of proving that they have been introduced after the most careful consideration of all alternatives and 
that they are duly justified by reference to the totality of the rights provided for in the Covenant in the context of 
the full use of the State party's maximum available resources”).  
26 ESCR Committee, General Comment 14, para. 50. The UN Commission on Human Rights also called States to 
“refrain from taking measures which would deny or limit equal access for all persons to preventive, curative or 
palliative pharmaceuticals or medical technologies used to treat pandemics such as HIV/AIDS or the most 
common opportunistic infections that accompany them” in its resolution 2002/32 Access to Medication in the 
Context of Pandemics such as HIV/AIDS (para. 3[a]).  
27 Doha Declaration, para. 5(a). Similarly, in The United States – Standards for Reformulated and Conventional Gasoline, 
the Appellate Body stated (ch. 13) that if applying Article 31(1) of the VCLT (which refers to the object and 
purpose of a treaty) provides the answer, it does not need to apply other rules of international law.  



 

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interest.28 Article 8 of the TRIPS Agreement (“Principles”), in turn, explicitly grants all WTO 
Members a right to adopt policies that promote public health as long as they are consistent with 
the agreement.29 In addition to the significance of the provision in the interpretation of the 
TRIPS Agreement, it also means that a WTO Member challenging a measure adopted by 
another Member in pursuance of public policy objectives should have the initial burden of 
proof regarding inconsistency with the TRIPS Agreement. The claimant should also be 
conscious of the fact that if there ever were doubts that the requirement of consistency with the 
agreement could override public health measures, these doubts would have been removed by 
the Doha Declaration.30  

Articles 7 and 8 of the TRIPS Agreement are of profound significance in the interpretation and 
implementation of the rights and obligations under the agreement.31 Even though they do not 
give WTO Members an unlimited amount of room for exceptions to pharmaceutical patents, 
they nevertheless imply that TRIPS norms have not been meant to over-run the pre-existing 
human rights obligations of WTO Members.32 The TRIPS Agreement should therefore be 
interpreted in a manner that does not constitute a retrogressive measure in relation to access to 
medicines. Simultaneously, one must bear in mind that pharmaceutical patents can also 
enhance the realization of certain important aspects of the right to health: namely, availability 
and quality of medicines33.  

Pharmaceutical patents contribute to the research and development of new medicines by 
making this profitable through an arrangement in which the inventor discloses and publicizes 
his invention to the society in exchange for the exclusive right granted by the State to exploit 
the invention for a fixed period of time. Patents are thus needed for sustainable availability of 
effective medicines. Similarly, the right to health requires health facilities, goods and services to 
be scientifically and medically appropriate and of good quality. This requires, inter alia, 
scientifically approved and unexpired medicines.34 To this end, new medicines must undergo 

 
28 Correa 2007, p. 91–92, 103.  
29 Article 8(1) of the TRIPS Agreement: “Members may, in formulating or amending their laws and regulations, 
adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of 
vital importance to their socio-economic and technological development, provided that such measures are 
consistent with the provisions of this Agreement.” 
30 Correa 2007, p. 108.  
31 Ibid., p. 92. 
32 Frankel has stated that the significance of the articles should not be exaggerated. She refers to the Canada – 
Patent Protection of Pharmaceutical Products, where the respondent invoked Article 8 in favor of its policies by 
claiming that said article supported liberal interpretation of permissible exceptions to patent rights. The panel, 
however, stated that the interpretation of the relevant articles must be a case-by-case factual analysis that does not 
equal to renegotiation of the basic balance of the agreement (Frankel 2006, p. 20–21).  
33 See ESCR Committee, General Comment 14, para. 12. 
34 Ibid., para. 12(d).  



 

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extensive clinical trials and other tests that demonstrate their efficacy and safety before the 
medicines are granted marketing authorizations. Many developing countries do not require this 
kind of data but approve a drug on the basis that it has been approved by a reliable authority in 
an industrialized country.35 These clinical trials represent the lion’s share of the research and 
development costs of new medicines: it has been estimated that the total average cost of 
developing a medicine is approximately USD 802 million, of which approximately USD 467 
million represent clinical trial expenditures.36 These expenditures are partly covered by the 
revenues pharmaceutical companies receive by selling their patented medicinal products. To 
summarize, instead of considering pharmaceutical patents as a mere hindrance to access to 
medicines, it should be remembered that a patent system is also conducive to the right to 
health.  

The obligation to protect implies the “horizontal effectiveness” of the right to access to medicines, 
often known as the Drittwirkung of a right. This means that States must take all necessary 
measures to safeguard persons in their jurisdiction from infringements of the right by third 
parties – if a State is not in a position to realize the right itself, it must regulate private acts in 
order to ensure that individuals are not arbitrarily deprived of the enjoyment of their rights by 
other individuals.37 The obligation to protect includes, inter alia, the duties of States to adopt 
legislation or to take other measures ensuring equal access to health care services provided by 
third parties and to ensure that privatization of the health sector does not constitute a threat to 
the availability and accessibility of medicines. Such omissions, as the failure to regulate the 
activities of individuals, groups and corporations so as to prevent them from violating the right 
to health, constitute a violation of the obligation to protect.38  

Article 8 of the TRIPS Agreement allows WTO Members to take necessary measures in order to 
protect public health. The provision can be considered a policy statement that explains the 
rationale for measures taken under Articles 30 and 31 of the TRIPS Agreement that authorize 
exceptions to exclusive rights.39 Article 30 allows exceptions to exclusive rights as long as they 
are kept limited, they do not unreasonably conflict with the normal exploitation of the patent 
and they do not unreasonably prejudice the legitimate interests of the patent owner.40 In 
relation to pharmaceutical patents and access to medicines, exceptions of paramount nature 

 
35 Dutfield 2008, p. 117.  
36 DiMasi, Hansen & Grabowski 2003, p. 165–167.  
37 Craven 1995, p. 111–112. 
38 ESCR Committee, General Comment 14, paras. 35 and 51. See also Human Rights Guidelines for Pharmaceutical 
Companies in relation to Access to Medicines drafted by the UN Special Rapporteur on the right to the highest 
attainable standard of health. Even though the guidelines are of non-binding character, they can be used as a 
guideline in order to specify the content of the obligation to protect.  
39 Gervais 2003, p. 121.  
40 Gervais 2003, p. 243–244; see also WTO Panel Report Canada – Patent Protection of Pharmaceutical Products, 17 
March 2000.  



 

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allowed by the provision are 1) the use of an invention before the expiration of the patent in 
order to commercialize a generic version of the product immediately after the expiration of the 
patent (the so-called Bolar exception) and 2) parallel imports.41 Article 31 of the TRIPS 
Agreement, in turn, allows for “other use without authorization of the right holder”. 
Compulsory licenses referred to in this article can be granted in accordance with the conditions 
set forth in the provision e.g. in cases of national emergency.42 Regardless of the fact that certain 
grounds are specifically referred to in the article, WTO Members can also determine other 
grounds for making exceptions to patent rights. Similarly, compulsory licenses can be conferred 
to import or to produce a patented product locally.43 The conditions regarding the practice and 
their deficiencies that were addressed by the Medicines Decision are examined more closely 
below. However, taking into consideration the above mentioned provisions, it can be 
concluded that the TRIPS Agreement does not entail any legal impediments to States 
protecting the right to access to medicines. On the contrary, implementing any of the named 
practices is a question of political will. WTO Members can thus meet their obligation to protect 
access to medicines despite their obligation to grant patent protection to pharmaceutical 
products.  

The obligation to fulfill requires States to, inter alia, “give sufficient recognition to the right to 
health in national political and legal systems, preferably by way of legislative implementation” 
and to ensure provision of health care for all.44 States should actively implement policies and 
programs that enable individuals to enjoy access to underlying determinants of health where 
this has not been forthcoming through implementation of the previous two duties. The 
obligation to fulfill thus seems to remain a “catch-all” category the obligations of which require 

 
41 Based on current comparative law and other proposals made on the subject, Correa has defined the following 
additional exceptions: acts done privately and on a non-commercial scale and for non-commercial purpose; using 
the invention for research and experimentation and for teaching purposes; preparation of medicines for individual 
cases according to a prescription, and use of the invention by a third party who started – or undertook bona fide 
preparatory acts – before the application for the patent or its publication (Correa 2007, p. 303).  
42 Additional grounds specifically mentioned in Article 31 are a refusal by the patentee to voluntarily license its 
patent, the use of compulsory licenses to remedy anti-competitive practices or for public non-commercial use, such 
as educational intentions, or for dependent patents (Article 31[b], [c], [l]). 
43 Correa 1998, p. 210, 214. Sean Flynn has proposed developing countries to employ ”access gap theory” for 
exploring when a patent holder is abusing its dominant position in the relevant market in a manner that justifies 
the issuance of compulsory licenses. Under this theory, a presumption on the existence of the preconditions for 
the issuance of compulsory licenses is present when there is a lack of access in society to a patented medicine 
needed to address an important public health problem and this deficiency is at least partly due to its significantly 
higher pricing when compared to a situation in a competitive market with reasonable royalties paid to the patent 
holder. Where these factors are present, the burden should be on the patentee to prove that it has promoted the 
lowest price possible consistent with receiving due reward for use of its invention e.g. by opening a licensing 
program that issues licenses at reasonable royalties to any potential competitor. This kind of policy converts the 
patent right from an exclusive property right (right to exclude) to a right to be paid in the specific situation where 
competition is needed to increase access to medicines (Flynn 2003, p. 538–539).  
44 ESCR Committee, General Comment 14, para. 39. 



 

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the mainstreaming of the right nationally on e.g. economic level.45 With respect to the right 
to access to medicines, the obligation to fulfill requires States to take positive measures in order 
to foster research into health-related areas.46 This can be considered as, inter alia, requiring 
States to subsidize research and development of new medicines.  

Statistics indicate the unfortunate fact that medicines are currently developed only for diseases 
prevalent in developed countries, where their sales are most profitable. Less than 1 percent of 
the nearly 1400 medicines that were registered between 1975 and 1999 were for the treatment 
of tropical diseases that mainly occur in the southern hemisphere47. It is often pointed out that 
developing countries seem to benefit from research and development today mainly when the 
rich also suffer from the same diseases48. As noted by Sell, “market mechanisms to deliver 
innovation into the public domain fail spectacularly in the oligopolistic markets of the 
contemporary life sciences industries”49. However, the failure is not one of patents as such. In 
an economic sense, it is perfectly rational – whether or not admirable – to prioritize research in 
ways that generate most revenues. Thus, other ways than giving up on patent protection must 
be found that make up for the market failure, i.e. ways that make research and development of 
medicines needed for the treatment of “neglected tropical diseases”50 economically feasible. 
Government subsidies are one alternative that can surely be considered as being consistent with 
the obligation to fulfill.  

Finally, human rights obligations of third States must also be considered. All Members of the 
United Nations have pledged themselves to take both joint and separate action in cooperation 
with the organization for the solutions of international economic, social, health, and related 

 
45 Dowell-Jones 2004, p. 31–33.  
46 ESCR Committee, General Comment 14, para. 37.  
47 WHO: 10 facts on neglected tropical diseases (17 April 2007). In order to give a concrete example, it should be 
mentioned that while 95 percent of active TB cases occur in developing countries, no new medicines has been 
developed since 1967 (Dutfield 2008, p. 112–113).  
48 Commission on intellectual property rights, innovation and public health 2006, p. 77. 
49 Sell 2007, p. 43. 
50 Neglected tropical diseases (“NTDs”) refer to diseases that affect circa 1 billion people (i.e. one out of six) in 
developing countries. Preventing, eliminating and eradicating these diseases is largely neglected due to the fact that 
they persist exclusively in the poorest populations of the world (WHO: 10 facts on neglected tropical diseases [17 
April 2007]).  



 

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problems.51 The Limburg Principles on the Implementation of the ICESCR note that 
“international co-operation and assistance pursuant to the Charter of the United Nations and 
the Covenant shall have in view as a matter of priority the realization of all human rights and 
fundamental freedoms, economic, social and cultural as well as civil and political”.52 The 
principle of international cooperation has been incorporated also to the ICESCR. Pursuant to 
Article 2(1) of the ICESCR, each Contracting State “undertakes to take steps, individually and 
through international assistance and co-operation, especially economic and technical, to the 
maximum of its available resources” in order to progressively realize all the rights included in 
the Covenant. The significance of the phrase has two diverging interpretations. On the one 
hand, it has been said to give rise to quite specific international obligations on the part of 
industrialized countries and to provide the foundations for the existence of a right to 
development. On the other hand, no legally binding obligation to provide aid to foreign 
countries has been read to the phrase.53  

Yet, the UN Committee on Economic, Social and Cultural Rights (“ESCR Committee”) 
formulates specific obligations for third States in relation to the right to health.54 Accordingly, 
Contracting States must, inter alia, respect the enjoyment of the right to health in other 
countries and prevent third parties from violating the right to health in these countries, if they 
are able to influence them by way of legal or political means. They should also facilitate access 
to essential health goods in third countries when possible and provide needed aid. With respect 
to the conclusion of other international agreements, Contracting States should ensure that 
these instruments do not adversely impact upon the right to health and ensure that their 
actions as Members of international organizations take due account of the right to health.55 
These obligations can easily be applied also to the TRIPS Agreement. When examining the 
implementation of the Medicines Decision, it will become clear that access to patented 
medicines in the South can only be ensured if also industrialized countries implement the 
Medicines Decision appropriately. If the aim is to ensure that pharmaceutical patents do not 
hinder access to medicines, the above presented obligations of States to respect, protect and 
fulfill the right to access to medicines of their own citizens must be considered to constitute 

 
51See Articles 55 and 56 of the Charter of the United Nations. See also Article 3 of the Declaration on the Right 
to Development: “1. States have the primary responsibility for the creation of national and international 
conditions favorable to the realization of the right to development; 2. The realization of the right to development 
requires full respect for the principles of international law concerning friendly relations and co-operation among 
States in accordance with the Charter of the United Nations; 3. States have the duty to co-operate with each other 
in ensuring development and eliminating obstacles to development. States should realize their rights and fulfill 
their duties in such a manner as to promote a new international economic order based on sovereign equality, 
interdependence, mutual interest and co-operation among all States, as well as to encourage the observance and 
realization of human rights. “ 
52 The Limburg Principles, principle no. 29.  
53 Alston & Quinn 1987, p. 187.  
54 ESCR Committee, General Comment 14, para. 39.  
55 ESCR Committee, General Comment 14, para. 39.  



 

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only one side of the coin, while efficient assistance from industrialized countries forms the 
other. Assuming this kind of joint responsibility is in line with the fact that decisions that may 
have a reverse impact on the lives of millions are also made jointly in an international setting, 
e.g. in inter-state trade negotiations.  

2.2.  The Myth of a Self-Contained Regime 

As pointed out above, the relationship between the obligations arising from the right to access 
to medicines and the TRIPS norms may not be as complex as it is often claimed to be – 
permissive norms corresponding to the obligations WTO Members have based on the access 
norm can, to some extent, be found in the TRIPS Agreement. Since the right to access to 
medicines is binding on all WTO Members as a well-established human rights norm, and since 
all States are expected to meet their obligations in good faith, it may prima facie seem difficult to 
find a strong legal justification for claims concerning the existence of conflict between these sets 
of norms. However, nothing in the TRIPS Agreement directly commands WTO Members to 
interpret TRIPS norms in consistency with the access norm. If the TRIPS regime, as part of the 
WTO, would constitute a “self-contained” regime, its norms could be interpreted solely from 
the perspective of trade and thus human rights could be ignored. In order to construe a legal 
justification for why TRIPS norms, that grant exclusive rights to medicinal compounds and 
products, should be interpreted harmoniously with the access to medicines norm, one has to 
examine the relationship between WTO law and public international law, the latter referring to 
the aggregate of norms regulating relationships between States.  

A wealth of discussion exists over the applicability of public international law within the world 
trading system. The current opinion is spread across three main views, endorsing full, partial or 
no applicability of international law to trade disputes. Those who see the WTO as a closed legal 
system hold that as the jurisdiction and substantive mandate of WTO panels and the Appellate 
Body are strictly limited to claims under WTO governed agreements, only internal regulation of 
the organization should apply to the dispute resolution. Proponents of partial applicability of 
international law are willing to give WTO law a privileged status in relation to rules of public 
international law. They claim that the covered agreements should prevail against any attempt to 
introduce new rights or duties on behalf of other international rules. These privileged or 
autonomous positions nevertheless find little basis in the texts of the actual agreements and are 
not supported by the recent case law either.56 In fact, the Appellate Body itself has stated that 
the WTO Agreement “is not to be read in clinical isolation from public international law”.57 It 
is undisputable that the mandate of WTO panels is to interpret WTO law and to determine 

 
56 Lindroos & Mehling 2006, p. 862–866.  
57 WTO Appellate Body Report, The United States – Standards for Reformulated and Conventional Gasoline, at 18.  



 

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whether a provision of the “covered agreements” has been violated.58 Furthermore, in their 
decisions the panels “cannot add to or diminish the rights and obligations provided in the 
covered agreements” either.59 Hence, the panels lack competence to reach a legal conclusion on 
violation or compliance with other treaties or customs, such as human rights norms. They 
cannot enforce or give effect to human rights provisions in a way that would add to or diminish 
WTO rights and obligations either.60 However, this limited domain of the WTO does not 
mean that the WTO Agreement exists in a “hermetically sealed system, closed off from general 
international law and human rights law”.61 A distinction should be made between its 
jurisdiction and the applicable law: the limited jurisdiction of the panels does not limit the 
scope of law they may apply.62  

The binding nature of the rules of general international law in the WTO is explicitly confirmed 
in Article 3.2. of the Dispute Settlement Understanding (“DSU”). Accordingly, the WTO 
covered agreements must be clarified “in accordance with customary rules of interpretation of 
public international law”. WTO panels and the Appellate Body have in their decisions 
explicitly recognized the role of Articles 31 and 32 of the Vienna Convention on the Law of 
Treaties (“VCLT”) with respect to Article 3.2. of the DSU. The provisions are generally 
accepted as embodying customary international law.63 Therefore, even though not all WTO 
Members are parties to the VCLT, to the extent that these provisions reflect customary 
international law, they are binding on all Members.64 In the following, the content of Article 31 
of the VCLT is illuminated so as to explain why the right to access to medicines should be 
considered in the interpretation of the TRIPS provisions. It should be noted that each WTO 
Member has the right to make exceptions to pharmaceutical patents in consistency with Articles 
30 and 31 of the TRIPS Agreement as well as the Medicines Decision despite their general 
obligation to protect intellectual property rights. Thus, making exceptions to intellectual 
property protection in order to ensure access to medicines would not as such “add to or 

 
58 According to Article 1.1 of the DSU, the DSU only applies to disputes brought pursuant to the consultation and 
dispute settlement provisions of the “covered agreements”. Article 23(1) of the DSU also refers only to ”covered 
agreements”: “When Members seek the redress of a violation of obligations or other nullification or impairment of 
benefits under the covered agreements or an impediment to the attainment of any objective of the covered 
agreements, they shall have recourse to, and abide by, the rules and procedures of this Understanding.” 
59 The DSU, Articles 3(2) and 19(2).  
60 Marceau 2002, p. 762–763; Pauwelyn 2001, p. 554. Petersmann has suggested de lege ferenda the enforcement of 
human rights through WTO dispute settlement system in order to exploit its strong enforcement mechanism. His 
suggestion, however, has faced strong opposition. See Petersmann 2002 and Alston 2002.  
61 Marceau 2002, p. 779.  
62 Pauwelyn 2001, p. 554–566; Koskenniemi 2006, paras. 44–45.  
63 WTO Appellate Body Report, The United States – Standards for Reformulated and Conventional Gasoline at 16; 
Lindroos & Mehling 2006, p. 867.  
64 Mitchell 2007, p. 807–808.  



 

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diminish the rights and obligations provided in the covered agreements” – something that 
the panels would be prohibited from doing by virtue of Articles 3(2) and 19(2) of the DSU. 

In accordance with Article 31(1) of the VCLT, a treaty shall be interpreted in good faith and in 
the light of its object and purpose. Pursuant to Article 7 of the TRIPS Agreement, the object of 
the agreement is to promote technological innovation “in a manner conducive to social and 
economic welfare, and to balance of rights and obligations”. Article 8 of the TRIPS Agreement, 
in turn, explicitly grants all States a right to adopt policies that promote public health as long as 
they are consistent with the agreement. Good faith interpretation of the agreement in the light 
of these articles would surely lead to a decision that adequately considers the right to access to 
medicines.  

Pursuant to Article 31(3)(b) of the VCLT, any subsequent practice between the Parties to an 
agreement regarding its interpretation must also be considered when interpreting the treaty.65 
Thus, the Doha Declaration holds relevance in the interpretation of the TRIPS Agreement. It is 
a common, unanimous statement of all WTO Members regarding the interpretation of the 
TRIPS Agreement and, as such, must be considered as a subsequent practice. In paragraphs 1 
and 2 of the declaration, WTO Members stress the need for the TRIPS Agreement to be part of 
an international action addressing public health problems affecting many developing countries. 
In paragraph 4, they agree that the TRIPS Agreement does not and should not prevent WTO 
Members from taking measures to protect public health – instead, the agreement can and 
should be interpreted and implemented in a manner supportive of Members’ right to protect 
public health and to promote access to medicines for all. Moreover, WTO Members reaffirm in 
paragraph 5 that in applying the customary rules of interpretation of public international law, 
each provision of the TRIPS Agreement shall be read in the light of the object and purpose of 
the agreement as expressed in Articles 7 and 8.  

In many respects, the Doha Declaration repeats the contents of the TRIPS Agreement and re-
states matters that should have been considered in the interpretation of the treaty by virtue of 
the DSU already prior to the adoption of the declaration. The declaration has, in fact, been 
called “a politically convenient overstatement that turns blind eye to the principles of treaty 
interpretation”66. Nevertheless, as the juggling act between the rights of patent holders and the 
public interest is far from simple, the Doha Declaration brings an end to any possible 
speculation on the significance of public health needs in the application of the TRIPS 
Agreement. It should be considered an authoritative interpretation of the agreement, granting 
WTO Members an indisputable right to make exceptions to patent rights in order to realize an 

 
65 Article 31(3) of the VCLT:”There shall be taken into account, together with the context: (a) any subsequent 
agreement between the parties regarding the interpretation of the treaty or the application of its provisions; (b) any 
subsequent practice in the application of the treaty which establishes the agreement of the parties regarding its 
interpretation; (c) any relevant rules of international law applicable in the relations between the parties.” 
66 Frankel 2006, p. 390.  



 

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individual’s right to access to medicines. As such, it manifests the common will of the WTO 
and its Members to ensure coherence between the right to access to medicines and the TRIPS 
Agreement.  

In accordance with Article 31(3)(c) of the VCLT, any relevant rules of international law 
applicable between the Parties must also be taken into account when interpreting a treaty. The 
words cover all sources of international law, including custom, general principles and, where 
applicable, other treaties.67 The overall aim of the article is to promote coherence in 
international law: all treaties should be interpreted in good faith so as to avoid conflicts, taking 
into consideration all relevant rules between the Parties.68 Accordingly, also WTO panels must 
consider all rules of international law that hold relevance in a given case.  

General international law has been frequently considered by the DSB and the Appellate Body 
and its applicability to dispute settlement in the WTO is generally accepted69. It was affirmed 
e.g. in Korea – Measures Affecting Government Procurement. The panel took note to the content of 
Article 3.2. of the DSU and went on to state that “the relationship of the WTO Agreements to 
customary international law is broader than this. Customary international law applies generally 
to the economic relations between WTO Members. Such international law applies to the extent 
that the WTO treaty agreements do not ‘contract out’ from them. To put in another way, to 
the extent there is no conflict or inconsistency, or an expression in a covered WTO agreement 
that implies differently, we are of the view that the customary rules of international law apply to 
the WTO treaties and the process of treaty formation under the WTO”70. In the absence of any 
“contracting-out”, the right to access to medicines as a customary norm should therefore also be 
considered when interpreting TRIPS provisions relating to pharmaceutical patents.  

In addition to customary law, the WTO dispute settlement bodies have referred to rules derived 
from other treaties in numerous cases.71 In Article 31(3)(c) of the VCLT, reference is made to 
“any relevant rules of international law applicable in the relations between the parties” (emphasis 
here). The question of which treaties can be used to interpret WTO obligations arises. A 

 
67 Koskenniemi 2006, para. 426(b). .  
68 Marceau 2002, p. 785–786; Marceau 2001, p. 1089. Koskenniemi refers to the principle of systemic integration, 
according to which Article 31(3)(c) of the VCLT requires the “integration into the process of legal reasoning – 
including reasoning by courts and tribunals – of a sense of coherence and meaningfulness.” See Koskenniemi 
2006, paras. 410–423.  
69 For a closer examination on the application of rules of general international law in the practice of the Appellate 
Body, see Pauwelyn 2003, p. 268–274. 
70 WTO panel report, Korea – Measures Affecting Government Procurement, para.7.96 (19 June 2000). The decision 
was not appealed. In addition, Lindroos and Mehling also point out in their study that the WTO dispute 
settlement organs have repeatedly relied on decisions of other international tribunals, including the ICJ, the 
European Court of Human Rights and the Inter-American Court of Human Rights as well as on the work of the 
international law commission (Lindroos & Mehling 2006, p. 871–873).  
71 Lindroos & Mehling 2006, p. 865. 



 

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narrow interpretation would require identical membership between the non-WTO treaty and 
the WTO-treaty. This, however, has several shortcomings. It would, inter alia, strongly limit the 
use of other international treaties by virtue of Article 31(3)(c) of the VCLT since identical 
memberships are rare in today’s world. As WTO Membership grows, fewer international 
agreements will match its membership. Hence, a requirement of identical membership would 
lead to a paradoxical result that the WTO would on some level become more and more isolated 
from the system of international law as the amount of its Members increases. In addition, the 
Appellate Body seems to have adopted an approach that does not require identical 
membership: in the United States – Shrimp, it examined provisions of the Convention on 
International Trade in Endangered Species and several other environmental agreements that 
did not have identical membership with the WTO in order to define the term “exhaustible 
natural resources”. The requirement of identical membership therefore seems to be 
unnecessary. An alternative approach would be to allow the use of treaties with potentially 
universal membership or to allow the use of norms that are not strictly binding on most States 
but nevertheless reflect the common intention of WTO Members by being agreed to or 
tolerated. On the whole, it seems that the treaty provision in question must be of relevance for 
the international community. The membership, however, is no guarantee of its authentic 
relevance.72 Considering the nearly universal membership of the ICESCR (see above) and the 
wide coverage of other human rights agreements and the relevance of the norms contained by 
these agreements for everyone, there is little doubt of the ability of WTO panels to consider the 
right to access to medicines as formulated in the ICESCR when interpreting the scope of the 
patent protection granted for pharmaceuticals in the TRIPS Agreement.  

Finally, the pacta sunt servanda principle requires that “every treaty in force is binding upon the 
Parties to it and must be performed by them in good faith”, as stated in Article 26 of the 
VCLT. States cannot contract out from this principle by establishing a new regime.73 Even 
though human rights law cannot be given direct effect within the WTO, the adjudicating 
bodies of the organization must presume that WTO Members comply with their human rights 
obligations just as they are expected to do with all their international obligations at all times. 
The WTO law must thus be applied in good faith and in harmony with human rights law.74 
Any other kind of conclusion would essentially transform the organization into a “safe haven” 
for all WTO Members seeking to backtrack on obligations entered into elsewhere.  

To conclude, WTO norms should be interpreted in consistency with general international law 
– a matter that is clearly manifested in the DSU. The panels have also adopted a clear approach 
to dispute settlement, signaling that the organization can hardly be considered a self-contained 

 
72 Marceau 2002, p. 780–782.  
73 Koskenniemi 2006, para. 176 (noting that it would only be possible if the regime was meant to create no 
obligations at all). See also Pauwelyn 2003, p. 37 where he presents that States cannot contract out of the system of 
international law due to the principle of pacta sunt servanda that could be considered a part of the jus cogens.  
74 Marceau 2002, p. 786.  



 

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regime, isolated from international law75. Further, the Doha Declaration should be 
considered a manifestation of the common will of WTO Members to maintain coherence 
between the right to access to medicines and exclusive rights covering pharmaceutical products. 
Despite the incompetence of the panels to enforce the right to access to medicines or to allow it 
to supersede and set aside a WTO provision, the access norm must be considered in the 
interpretation of the TRIPS norms. All in all, it has become clear above that WTO law does not 
operate in isolation from other rules of international law. As Lindroos and Mehling note, “the 
chimera of ‘self-contained regime’ remains a phantom with no legal basis in international law, a 
notion which, despite its persistent appearance in jurisprudential debate, is best confined to the 
lively world of myth and debate”76.  

2.3.  Facilitating Coherence: Definition of Conflict of Norms 

Interpreting TRIPS norms harmoniously with the pre-existing human rights norms is also in 
line with the principle of presumption against conflict, a widely accepted principle of treaty 
interpretation that allows for avoidance of conflicts. Accordingly, every new norm of 
international law, alike with norms of national legislation, is created within the context of pre-
existing regulation. There is a presumption that this new norm builds upon and further 
develops existing law77. In other words, the strong presumption against normative conflict in 
international law appears as “the thumb-rule that when creating new obligations, States are 
assumed not to derogate from their obligations”78. Consequently, any deviation from existing 
law must be made in explicit language. When faced with two possible interpretations, the one 
that allows for harmonization of the two norms – and hence avoids conflict – ought to be 
preferred79.  

WTO Members have not contracted out of the access norm: the TRIPS Agreement is silent on 
the issue. Therefore, based on matters presented above, the TRIPS Agreement can well be 
interpreted in consistency with human rights norms. It would consequently be tempting to 
conclude that no normative conflict exists between the right to access to medicines and 
pharmaceutical patents. Nonetheless, one must first define what constitutes a “normative 
conflict” in order to see if reconciliation of the norms through interpretation is possible – 
namely, the presumption against conflict simply requires that an effort is made to interpret a 
new norm (here, a TRIPS-norm) in harmony with the existing law (here, the access norm) and 
that this kind of interpretation is feasible. If reconciliation between the two norms is not 

 
75 Lindroos & Mehlig 2006, p. 875.  
76 Ibid., p. 877.  
77 Pauwelyn 2003, p. 240. 
78 Koskenniemi 2006, paras. 37–38.  
79 Pauwelyn 2003, p. 240–241.  



 

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feasible, that is where the presumption ends.80 Therefore, if it turns out that the TRIPS 
Agreement is in a normative conflict with the right to access to medicines, the norms can no 
longer be interpreted harmoniously as this would mean that the conflict would be solved in 
favour of the earlier rule (i.e. the access norm). One would, instead, need to resort to rules of 
conflict resolution.  

Most norms of international law can be divided into obligations and rights. They can be further 
divided into four categories: norms obligating States to do something (commands), norms 
obligating States not to do something (prohibitions), norms granting States a right not to do 
something (exemptions) and, finally, norms granting States a right to do something 
(permissions).81 These categories apply both to human rights norms, on the one hand, and the 
TRIPS norms, on the other. For States, the right to access to medicines constitutes both a 
command (obligation to respect, protect, fulfill and cooperate) and a prohibition (prohibition 
of retrogressive measures). The TRIPS Agreements similarly contains norms obligating 
(obligation to grant pharmaceutical patents) and prohibiting (prohibition of discrimination) 
States. However, these TRIPS commands and prohibitions are accompanied by flexibilities that 
are either permissions (e.g. Articles 30 and 31 examined above) or exemptions (e.g. rights of 
least-developed country Members not to enforce patents during the transitional periods, right to 
exclude certain subjects of patentability).  

Conflict of norms in the strict sense can be defined as a situation in which “Party to the two 
treaties cannot simultaneously comply with its obligations under both treaties”. 82 This narrow 
definition of conflict has been followed also in the WTO jurisprudence. In Indonesia – Autos, 
the panel stated that “in international law for a conflict to exist between two treaties [....] [their] 
provisions must conflict, in the sense that the provisions must impose mutually exclusive 
obligations [...]. Technically speaking, there is conflict when two (or more) treaty instruments 
contain obligations which cannot be complied with simultaneously”83. The Appellate Body has 
subsequently defined conflict as a situation “where adherence to the one provision will lead to a 
violation of the other”84. In accordance with the narrow definition of conflict, we have above 
arrived at a situation where no normative conflict exists between the right to access to 
medicines and pharmaceutical patents. Although the TRIPS Agreement obligates WTO 
Members to provide exclusive rights for pharmaceutical inventions, it also exempts them from 

 
80 Ibid., p. 242–244; Koskenniemi 2006, para. 42. Koskenniemi notes that there are no normative conflicts whose 
intrinsic nature makes them unsuitable for harmonization – anything can be harmonized as long as the will to 
harmonization is present between the Parties. However, if this will is not present, harmonization of the competing 
norms is no longer possible.  
81 Pauwelyn 2003, p. 159.  
82 Jenks 1953, p. 426.  
83 WTO Panel Report, Indonesia - Certain Measures Affecting the Automobile Industry, para. 14.28, footnote 649.  
84 WTO Appellate Body Report, Guatemala - Anti-Dumbing Investigation Regarding Portland Cement from Mexico 
(1998), para. 65.  



 

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certain obligations related to their enforcement and permits them to take necessary measures 
in order to protect public health. The right to access to medicines, in turn, prohibits States from 
taking retrogressive measures and commands them to exploit the flexibilities of the TRIPS 
Agreement when necessary for the protection of the right. WTO Members can thus comply 
with both agreements simultaneously by exploiting TRIPS flexibilities and no conflict of norms 
arises. Nonetheless, in order to comply with its human rights obligations, they no longer have a 
mere permission to execute exceptions to patents. Instead, it has an obligation to do so if the 
TRIPS Agreement is to comply with the access norm. What used to be a may has now turned 
into a must85. Exemptions and permissions have thus lost an integral part of their essence since 
WTO Members are now obligated to exploit these norms. This constitutes a “contradictory 
conflict” since both norms cannot be fully applied at the same time – a situation which is 
recognized as a conflict of norms in prevailing legal theory86.  

A wider definition of normative conflict has recently been supported by several scholars. It 
seems to lead to a requirement of complete harmony between international norms that can be 
considered cumulative, i.e. falling outside conflict. A mere possibility of inconsistency between 
divergent norms breaks this harmony. According to Pauwelyn, norms of international law 
conflict if they cannot be “applied together and without contradiction at all times”87. He defines 
conflict of norms as a relationship between two norms where “one norm constitutes, has led to 
or may lead to a breach of the other”88. Hestermeyer, albeit admitting that WTO law is not in 
systemic conflict (i.e. conflict between principles or goals rather than mere norms) with the 
human rights regime, has also assumed a broad definition of normative conflict. He concludes 
that the TRIPS Agreement conflicts with the right to access to medicines since a permission to 
exploit TRIPS flexibilities has now turned into an obligation to do so89.  

Even though genuine conflicts cannot be “interpreted away”, conflict resolution and 
interpretation should not be completely distinguished from each other as rules always appear to 
be compatible or conflicting as a result of interpretation90. Therefore, before it is possible to 
establish whether TRIPS norms are in normative conflict with the right to access to medicines, 
the norms should be placed in their context. The main objective of any treaty interpretation is 
to identify the intention of the Parties. Taking in to consideration Articles 7 and 8 of the 
TRIPS Agreement, it is evident that efforts have been made for maintaining balance. Further, it 

 
85 Hestermeyer 2007, p. 176. 
86 Vranes 2006, p. 409. Vranes (p. 415) suggests the following definition of conflict: “There is a conflict between 
two norms, one of which may be permissive, if in obeying or applying one norm, the other one is necessarily or 
possibly violated.“  
87 Pauwelyn 2003, p. 161.  
88 Pauwelyn 2003, p. 175 ff. 
89 Hestermeyer 2007, p. 174–181.  
90 Koskenniemi 2006, para. 412.  



 

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has been established above that the right to access to medicines must be considered in the 
interpretation of the TRIPS Agreement by virtue of the DSU, where reference is made to the 
VCLT. The Doha Declaration also reaffirms that the agreement should not hinder access to 
medicines. If norms granting exclusive rights would nonetheless be considered to conflict with 
the right to access to medicines on theoretical grounds and since the regimes in question have 
divergent objectives, these efforts for maintaining coherence through interpretation would be 
nullified.  

A closer examination of the overall aim of the VCLT to promote coherence in international 
law and the presumption against conflict reveals the inherent striving for coherence in 
international law that can be attained through harmonious interpretation of divergent norms. 
States are presumed to perform all their international obligations in good faith pursuant to the 
pacta sunt servanda principle. It can consequently be presumed that States have also negotiated 
all their treaties in good faith, taking into account their existing obligations. In the absence of 
any evidence to the contrary, all States’ obligations must be considered cumulative and should 
be read together91. It can be assumed that permissive norms have throughout time been 
included in treaties as well as domestic laws in order to allow for accumulation of norms and 
consistency between existing obligations and the new regulation. Similarly, norms permitting 
exceptions and norms exempting WTO Members from certain obligations of the TRIPS 
Agreement are aimed at maintaining unity between the pre-existing human rights obligations of 
States and the new intellectual property regulation. If, however, wide definition of conflict of 
norms is assumed, relationships between various sets of norms that were previously considered 
consistent with each other would most likely turn out conflicting. Interpreting these divergent 
norms so as to render them compatible would become even more difficult and these “sub-
systems” could no longer coexist without the means of conflict resolution. This kind of 
conclusion would be contrary to the striving for coherence in international law and be 
especially detrimental in times of fragmentation of the international community and 
international relations.  

To conclude, there is little reason to support a wide definition of conflict of norms in the 
present context. Instead, one must allow interplay between the norms examined. As formulated 
by Marceau, “if one believes that international commitments should be understood in the light 
of some coherent international legal order, one favors narrow definitions of conflicts, 
interpretations and applications of opposing norms that promote their harmonization”92. 
Coherence between the TRIPS Agreement and the right to access to medicines can be 
maintained as long as conflict is defined in accordance with the traditional view: as a situation 
where a State cannot simultaneously meet its obligations derived from two distinct norms. 
Since the permissive norms of the TRIPS Agreement ensure that WTO Members can still 

 
91 Marceau 2001, p. 1084, 1089.  
92 Marceau 2001, p. 1082–1083.  



 

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comply with obligatory norms enshrining access to medicines, no conflict exists between the 
norms examined. The often alleged incoherence between them has thus proven to be an 
illusion.  

Since no normative conflict exists between the right to access to medicines and the TRIPS 
Agreement, the norms can and should be interpreted harmoniously in order to avoid conflict, 
in accordance with the presumption against conflict. WTO Members have an obligation to 
ensure access to medicines, as outlined above, and the TRIPS obligations must be interpreted 
accordingly. This requirement leads one to assume a human rights approach to the 
implementation of intellectual property regulation, meaning that human rights are employed as 
a guiding principle to the implementation and enforcement of exclusive rights93. It should be 
emphasized that a human rights approach to the implementation of these rights does not, 
however, mean that interpretation would be used to solve a conflict in favor of the relevant 
human right, i.e. it should not lead to de facto disregarding of exclusive rights. Instead, it must 
preserve the viability of both sets of norms under examination. A model for this kind of 
implementation of the Medicines Decision – a permissive TRIPS norm of key importance – is 
provided in the following. 

III. Establishing Coherence: A Human Rights Approach to the 
Implementation of the Medicines Decision 

3.1.  In Search of a Golden Mean 

The Medicines Decision – a result of the negotiations that followed the adoption of the Doha 
Declaration – forms an integral part of compulsory licensing as a means to ensure that the 
TRIPS Agreement does not hinder access to medicines. The aim of the decision is to ensure 
that the TRIPS Agreement does not hinder the right of WTO Members to adopt necessary 
measures for the protection of public health, as stated in paragraph 4 of the Doha Declaration. 
In the following, I will explore the practical implications of the right to access to medicines in 
the harmonious interpretation of the decision. As Eide put it, “what counts, in the end, is 
whether human rights are realized in practice – whether the standards and institutions serve to 
bring about the changes which are required in order to make it possible for all to enjoy all 
human rights” 94. Nothing in the TRIPS Agreement obligates WTO Members to implement the 
Medicines Decision in a manner that best considers the right to access to medicines – the access 
norm, however, does. Nevertheless, as mentioned above, a human rights approach to the 

 
93 See Haracoglou 2008, p. 90–93 on the right to health as an interpretative principle in patent law and report of 
the High Commissioner of the Commission on Human Rights: The impact of the Agreement on Trade-Related Aspects 
of Intellectual Property Rights on human rights (2001).  
94 Eide 2001, p. 553. 



 

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implementation of the Medicines Decision should not undermine the integrity of the 
international patent system. The golden mean should, instead, be found in an implementation 
that ensures access to medicines in developing countries but simultaneously ensures that 
exclusive rights are adequately protected.  

Representatives and proponents of the research based pharmaceutical industry often criticize 
exceptions to patent rights for strongly debilitating the position of right holders. Exceptions to 
patent rights in the auspices of the Medicines Decision have similarly been claimed to be 
detrimental to research and development of new medicines needed in developing countries.95 
These statements emerge from the raison d’être of patents which is to encourage innovations by 
rewarding the inventor with an exclusive right to exploit the invention for a predetermined 
period of time. If exceptions are repeatedly made to pharmaceutical patents covering medicines 
needed in developing countries, why would anyone contribute to their development as they will 
not receive any compensation for this work? This juxtaposition is inherent in the TRIPS 
context. Similarly, it was visible throughout the negotiations regarding the Medicines 
Decision.96  

However, as pointed out above, today’s patent protection is not contributing to research and 
development of medicines needed in developing countries anyway – these countries are likely to 
benefit only when developed countries with purchasing power suffer from the same diseases.97 
Further, research based companies are not relying on the rents they receive from developing 
countries in their research budgets. Some estimates suggest that only USD 1–1,5 billion per 
year of pharmaceutical budgets of companies based in the OECD may be dependent on 
developing country rents, while expenditures for research and development of these companies 
in 1995 were in the range of USD 25 billion and are substantially higher today.98 A study 
prepared for the British Commission on intellectual property rights suggests that if developing 
countries gave no patent protection to pharmaceuticals at all, it would generate an aggregate 
loss of about one and a half billion dollars out of a total of USD 35 billion spent to research 
and development annually by the U.S. PhRMA companies. Circa 90 percent of the revenues 
these companies received in 2001 came from sales in the United States, Canada, Western 
Europe and Japan, while 0,3 percent came from sales in Africa.99 Furthermore, research based 
companies spend on average only 15 percent of their revenues on research and development, 
while a much larger portion goes to administration and advertising (in developed countries).100  

 
95 Hoen 2006, p. 216.  
96 See Abbott [1] 2005 for a detailed presentation of the negotiations.  
97 Commission on intellectual property rights, innovation and public health 2006, p. 77; see footnote 47 above 
and the accompanying text.  
98 Abbott [1] 2005, p. 325 (note 58). 
99 Abbott [2] 2005, p. 420.  
100 Abbott [1] 2005, p. 325.  



 

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All things considered, markets of developing countries currently hold minor significance for 
research based companies. Exceptions to patents in the auspices of the Medicines Decision are 
thus unlikely to cause neither significant loss to right holders nor decrease research and 
development of medicines needed in developing countries. If re-diversion of medicines 
manufactured under compulsory licenses to the markets of developed countries is prevented, 
status quo of the research based industry in the pharmaceutical markets is preserved. A strict 
distinction must thus be made between patent protection in developed countries, on the one 
hand, and developing countries, on the other. 

3.2.  Compulsory Licensing Under Article 31 of the TRIPS Agreement 

Article 31 of the TRIPS Agreement (“Other use without Authorization of the Right Holder”) 
regulates the use of compulsory licenses. The provision comprehends use by a government or a 
third party authorized by the government. As mentioned above, the TRIPS Agreement does not 
set any specific grounds based on which compulsory licenses can be granted as long as the 
conditions set forth in Article 31 are followed. The Medicines Decision waives obligations set 
forth in paragraphs (f) and (h) of the provision which means that WTO Members are still 
obligated to follow most of the conditions set forth in the provision.101 They are, inter alia, 
obligated to provide for judicial or another independent review by a higher authority on the 
legal validity of any decision related to unauthorized use of patents102. This means that right 
holders can still challenge the compliance of WTO Members with the requirements embodied 
in Article 31.  

Pursuant to Article 31 of the TRIPS Agreement, each license has to be considered on its 
individual merits.103 Efforts shall be made in order to obtain authorization from the right 
holder on reasonable terms and conditions, apart from cases of national emergency or other 
circumstances of extreme urgency. In case of a national emergency, the right holder must, 

 
101 In situations where government claims that it has lost “an expected benefit” as a result of actions of another 
government, it can initiate proceedings within the DSB regardless if a specific article has been breached. The 
purpose of this is to ensure that governments hold on to the commitments they make during multilateral trade 
negotiations (see TRIPS Agreement Article 64.2). These non-violation complaints are not applicable to disputes 
related to intellectual property rights. Thus, in order to initiate proceeding within the DSB, a WTO Member must 
address a specific provision of the agreement that the respondent has allegedly breached. Currently non-violation 
complaints have been excluded by a moratorium while WTO Members are searching for a permanent solution that 
would be acceptable to all parties. See e.g. Implementation-Related Issues and Concerns, Decision of 14 November 
2001, Para 11.1.; Doha Work Programme, Ministerial Declaration of 18 December 2005, paragraph 45. Most countries 
are in favour of excluding matters related to intellectual property from the possibility of non-violation complaints 
altogether; others, e.g. the United States and Switzerland, claim that they are necessary in order to prevent WTO 
Members from getting around their TRIPS commitments (Sun 2004 p.142–143).  
102 TRIPS Agreement, Article 31(i). 
103 TRIPS Agreement, Article 31(a).  



 

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regardless, be notified as soon as possible after the unauthorized use.104 The use of the patent 
shall be non-exclusive and non-assignable.105 The scope and duration of the license must be 
limited to meet the purposes for which it was granted: it must be terminated when the 
circumstances that lead to its issuance cease to exist. Legitimate interests of licensees must 
nonetheless be protected: WTO Members shall guarantee that they also have access to justice 
on the basis of the relevant decision.106 Patent holders are entitled to adequate remuneration 
pursuant to paragraph (h) of Article 31. In accordance with the Medicines Decision, this 
remuneration will be paid in the exporting WTO Member (see below). Any decision relating to 
the amount of remuneration must also be subject to judicial or other independent review in 
that Member.107  

The most crucial condition set forth in Article 31 of the TRIPS Agreement is the requirement 
that compulsory licenses shall be granted “predominantly for the supply of domestic 
markets”.108 The provision limits the opportunities of developing countries with no local 
manufacturing capacity to utilize the mechanism. WTO Members are eligible for importing 
pharmaceuticals under compulsory licenses. This, however, is not possible from another 
Member that has granted the medicine a patent, unless the exporting country has manufactured 
the product under a compulsory license for its national demands to a larger extent.109 Only few 
countries, e.g. India, Brazil and South-Africa, possess manufacturing capacity of generic 
medicines that could suffice to export. In order to be eligible as exporters, they would first have 
to issue a compulsory license “predominantly for the supply of domestic markets” pursuant to 
Article 31(f). Then, they would be allowed to export a part of the amount manufactured under 
the license to other countries in need. The limitations entailed by the provision are obvious. 
Another way to import generic medicines would be to import them from a non-WTO country 

 
104 TRIPS Agreement, Article 31(b). In accordance with paragraph 5(c) of the Doha Declaration, each WTO 
Member has the right to determine which circumstances qualify as a national emergency. Prior request is neither 
required for public non-commercial use nor in situations where licenses are granted to remedy anti-competitive 
practices (TRIPS Agreement, Article 31[b], [k]).  
105 TRIPS Agreement, Article 31(d), (e). 
106 TRIPS Agreement, Article 31(c), (g). 
107 TRIPS Agreement, Article 31(j). Pursuant to Article 31(k), the obligation to pay adequate remuneration does 
not apply to cases where the license has been issued to remedy anti-competitive measures. Durojaye has even 
suggested the use of Article 31(k) and rules concerning anti-competitive measures as an alternative for the 
Medicines Decision. This would waive some of the essential conditions set forth on Article 31. However, it would 
also require interpreting pharmaceutical patents and a refusal to license as anti-competitive measures which 
exposes said suggestion to criticism. See Durojaye 2008, p. 30 ff.  
108 TRIPS Agreement, Article 31(f). According to paragraph (k) of Article 31, said condition does not concern 
situations whereby licenses have been issued to remedy for anti-competitive practices either. 
109 It is noteworthy, however, that some developed countries allow exceptions to patents without the limitation 
imposed by article 31(f); e.g. Patent Acts of Australia and New Zealand allow exports under an agreement with a 
foreign country to supply products required for the defence of that country (Correa 2002, p. 27).  



 

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that has not enforced patents for the product in question or where the term has expired110. 
In any case, finding a non-WTO country that possesses sufficient manufacturing capacity for 
exporting medicines remains a mere theoretical possibility. 

The end of transitional period initially granted for developing countries highlighted the 
problem embodied in paragraph (f) of Article 31. India, for example, has been the most 
influential supplier of generic medicines for many developing countries. Its pharmaceutical 
industry is producing generic AIDS medicines for a half of the 700,000 HIV patients taking 
antiretroviral medicines in developing countries, at five percent of the price that pharmaceutical 
firms based in Europe or the United States charge for the same product111. India has managed 
to develop an extensive industry that produces generic medicines by not enforcing patents on 
pharmaceutical products and only allowing patents on manufacturing processes. This kind of 
policy encourages the search for cheaper and cheaper processes for the manufacture of 
pharmaceutical compounds112. Other WTO Members have previously been able to import 
medicines from India; in case the product in question would have been patented in their 
territory, they could have issued a compulsory license in accordance with Article 31. Medicinal 
products developed after January 2005 are, however, subject to patenting also in developing 
countries, including India113. Due to the requirement that the generic medicines were intended 
“predominantly for the supply of domestic markets”, the end of the transitional period meant 
that it became difficult to obtain affordable versions of newly developed medicines.114  

By failing to pay due attention to the needs of developing countries, Article 31 fails to redeem 
the promise of leaving all WTO Members enough room to adopt necessary measures in order 
to protect public health despite newly introduced intellectual property regulation. These 
deficiencies are addressed by the Medicines Decision. Several scholars have criticized the 
decision for not being faithful to the spirit of Doha; civil society groups and activists have 

 
110 Correa 2004, p. 20.  
111 Yalamanchili 2007, p. 211. 
112 Finland is also among the countries that did not enforce product patents on pharmaceuticals before the entry 
into force of the TRIPS Agreement. Said policy has resulted in a myriad of ongoing litigations between generic 
manufacturers and the holders of the original, so-called analogous process patents where the crux of the dispute is 
the scope of protection of these patents. 
113 See Articles 65.4; 70.8; 70.9 of the TRIPS Agreement. The end of transitional periods also meant that countries 
such as India started processing patent applications collected in its “mailbox” since January 1995. These medicines 
will be granted protection for the remainder of the 20-year term of filing date of the mailbox application. Hitherto, 
however, the processing has been slow and India has allowed the generic producers to continue supplying 
medicines already in production in January 2005 under certain conditions, e.g. upon payment of a reasonable 
royalty (Abbott & Reichman 2007, p. 945). 
114 Furthermore, paragraph (f) is discriminatory against WTO Members with smaller markets. In countries such as 
India, the UK or the United States, it is economically profitable to produce medicines under a compulsory license 
due to the large amount of potential consumers in the national markets. For Members with small sized domestic 
target groups, it is rather difficult to establish economically viable production if the product has to be 
“predominantly” sold in the domestic market of the licensee (Correa 2002, p.19).  



 

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described the Medicines Decision as a “gift bound in red tape”115. The question is: does the 
Medicines Decision and its implementation comply with the objective set forth in the Doha 
Declaration, i.e. does it secure the ability of countries with no manufacturing capacity to make 
effective use of compulsory licensing under the TRIPS Agreement for the protection of public 
health and access to medicines?  

3.3.  Exporting under Compulsory Licenses: Unnecessary Red Tape? 

One of the controversies raised during the negotiations that followed the adoption of the Doha 
Declaration related to the question of which TRIPS provision the future decision should base 
on. Different alternatives, such as temporary solutions in which permission to manufacture 
medicines would be granted in individual cases, were presented. An alternative strongly 
advocated by NGOs and human rights organs was a system in which relevant exceptions would 
be legitimized under Article 30 of the TRIPS Agreement that allows for limited exceptions to 
patent rights.116 However, the final system builds on Article 31 of the TRIPS Agreement and is, 
as described below, a rather complex system.  

In order to initiate the procedure defined in the Medicines Decision, the importing country 
must make a notification to the TRIPS Council in which names and expected quantities of the 
products needed are specified. In case the importing WTO Member is not a least-developed 
country117, it has to confirm in the notification that it has insufficient manufacturing capacities. 
This is a matter of self-assessment and the results cannot be challenged by any of the 
Members118. The importing country also has to confirm that it has granted or intends to grant a 
compulsory license to the pharmaceutical product patented in its territory in accordance with 

 
115 Durojaye 2008, p. 53–54.  
116 The representative of the WHO, for example, reminded the TRIPS Council in its meeting in September 2002 
that the basic public health principle being followed in the solution to be found was that the people of a country 
that did not have the manufacturing capacity to produce a needed product should be no less protected by 
compulsory licenses and other provisions and safeguards in the TRIPS Agreement, nor face greater procedural 
hurdles in comparison to the people of a country capable of producing the product. Accordingly, the solution 
most consistent with this principle would have been the provision of a limited exception under Article 30 (Council 
for TRIPS, Minutes of meeting held in September 2002, para. 5). See also e.g. MSF: Why Article 30 Will Work. Why 
Article 31 Will Not (24 June 2002) and MSF, Oxfam, CPTech, Health Gap, Third World Network, & Essential 
Action, Joint Letter to Members of TRIPS Council (28 January 2002). 
117 Least-developed countries are defined by the UN Committee for Development Policy based on their gross 
national income per capita, human asset index and economic vulnerability index. For further information, see 
http://www.un.org/esa/policy/devplan/profile/criteria.html (last visited 18.1.2008). 
118 Correa 2004, p. 17, 29. Once it is established that such capacity has become sufficient to meet its needs, the 
system created by the Medicines Decision no longer applies. This is also assessed by the Member itself (see 
Annex of the decision). In the Chairperson’s statement accompanying the Medicines Decision, Members are 
urged to provide information in the notification on how the establishment has been rendered. All notifications 
are brought to the attention of the TRIPS Council (see General Council Chairperson’s statement, 13 November 
2003, para. 5).  



 

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Article 31 of the TRIPS Agreement. The Medicines Decision waives its obligation to pay 
remuneration – the compensation is paid in the exporting WTO Member119. All other 
conditions set forth in Article 31 remain valid. Due to the extension of the transitional 
periods120, least-developed country Members may regardless be excluded from obligations 
related to compulsory licensing. This follows from a possible decision by a government to 
refrain from offering legal protection to pharmaceutical patents.121  

National legislation and Article 31 of the TRIPS Agreement, apart from paragraph (f), 
determine the course of proceedings also in the exporting country. This means that the 
interested supplier first has to ask for a voluntary license in accordance with Article 31(b). It can 
be argued that the exporting WTO Member is entitled to consider the situation in the 
importing country as an emergency or to recognize its public non-commercial use; then, it is 
possible to accelerate the process by ignoring this step122. The duration of the license is 
determined by the government of the exporting country. Pursuant to Article 31(g), legitimate 
interests of the licensees must be adequately considered. Thus, the duration of the license 
should allow enough time to recoup production costs. According to paragraph 3 of the 
Medicines Decision, adequate remuneration pursuant to Article 31(h) of the TRIPS Agreement 
shall also be paid in the exporting WTO Member, taking into account the economic value of 
the unauthorized use to the importing State. The generic company will thus compensate the use 
of the patent to the right holder. The competent national authority is responsible for 
determining the appropriate amount of compensation. The exporting State is only allowed to 
grant a license for the manufacture of the amount needed by the eligible importing country123. 
Thus, the importing Member must establish its exact needs when making the final agreement 
with the license holder. 

Prevention of re-exportation is of crucial significance for the protection of patent rights. Parallel 
imports of generic medicines manufactured under the system are thus not allowed. All WTO 
Members must take reasonable measures in order to prevent re-exportation of these 
medicines.124 The requirement of identifying the products produced under the system set out in 
the Medicines Decision also enhances the prevention of re-exportation: suppliers must 
distinguish such products through special packaging, shaping or colouring of the original 
product. Such a distinction is to be feasible and have no significant impact on price. It applies 
to both formulated pharmaceuticals and active ingredients produced and supplied under the 
system. Finished products using such active ingredients are also covered by this obligation: in 

 
119 The Medicines Decision, para. 3. 
120 See footnote 16 above.  
121 The Medicines Decision, para. 2(a). 
122 Correa 2004, p. 19, 21.  
123 The Medicines Decision, para. 2 (b)(i).  
124 The Medicines Decision, paras. 4 and 5.  



 

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case developing countries manufacture generic medicines locally, they have to make these 
products identifiable.125  

The final step of the procedure is that the licensee shall post technical information, i.e. the 
quantities of products supplied to each destination and the distinguishing features of these 
products, to a website before the shipment begins.126 Similarly, the exporting WTO Member must 
notify the TRIPS Council of the grant of the license, including the conditions attached to it.127  

Pursuant to Article 31(i) of the TRIPS Agreement, the legal validity of any decision relating to 
the authorization shall be subject to judicial review or other independent review by a higher 
authority in the involved WTO Member. This means that a patent holder has an opportunity 
to hamper the actions taken under the Medicines Decision in both countries involved – an 
opportunity that is well catered for under an Article 31 based solution. The Medicines Decision 
has been called a complex system satiated with several administrative conditions to fulfil that 
hinder the effective implementation of the decision128. The legislation implementing the 
decision in Canada, for example, has been criticized for permitting dilatory litigation as it grants 
the patent holder the right to petition for various reasons other than grounds related to the 
possible misuse of the system129. Correa has noted that a patent owner may exploit the complex 
system and exercise its rights under relevant national laws so as to block all use of the patent – a 
situation which effectively transforms the application of the Medicines Decision into a conflict 
between the country demanding access and the patent owner unwilling to supply130. The 
question arises: are these administrative hurdles turning the Medicines Decision into an 
excessively complex system that protects the rights of patent holders at the expense of access to 
medicines in developing countries?  

 
125The Medicines Decision, para. 2(b)(ii). In the General Council Chairperson’s statement accompanying the 
Decision, “Best practices” guidelines have been established (Attachment to the statement). There, examples are 
given of policies companies have used in order to prevent diversion of products donated. Correa has suggested that 
the obligation to distinguish is not absolute: if it would not be feasible or would have significant impact on price, it 
could not be required under the Medicines Decision (Correa 2004, p. 23). However, distinguishing products is a 
part of a normal manufacturing procedure and as such it cannot be assumed to constitute an unreasonable burden 
for the generic manufacturer.  
126 The Medicines Decision, para. 2(b)(iii). 
127 The Medicines Decision, para. 2(c).  
128 Abbott & Reichman 2007, p. 934; see also e.g. MSF 2006: Neither expeditious, nor solution: The WTO August 30th 
decision is unworkable. 
129 Lazo 2007, p. 266. A license issued in Canada may be terminated if e.g. the generic company fails to maintain or 
update the relevant webpage, fails to notify the relevant parties during the exporting process or fails to pay the 
remuneration in time (The Jean Chrétien Pledge to Africa, Section 21.14).  
129 Correa 2007, p. 339. 
130 Ibid, p. 339. 



 

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The obligation of all States to protect the right to access to medicines and the duty of Third 
States should be considered here. Accordingly, also WTO Members must ensure that third 
parties do not curtail the right to access to medicines. This obligation also extends to the 
implementation process of the Medicines Decision. As stated in the Maastricht Guidelines on 
Violations of Economic, Social and Cultural Rights, Contracting States themselves “are 
responsible for violations of economic, social and cultural rights that result from their failure to 
exercise due diligence in controlling the behaviour of such non-State actors”131. The legislation 
implementing the decision must thus ensure efficiency of the system. If it turned out that 
patent holders tried to abuse the system and prevent exportation of medicines manufactured 
under it, any laws enabling such behaviour should be amended in consistency with the human 
rights obligations of the States involved. One important practical matter is whether patent 
holders are provided with an opportunity to obtain an injunction against the execution of the 
license decision for the duration of the possible appellate procedure. If this is possible, right 
holders may have the means to hinder the procedure to an unreasonable extent. Thus, when 
implementing the Medicines Decision, WTO Members should – in consistency with their 
obligation to protect and duty to cooperate – avoid any provisions that may lead to an 
unnecessary interference with the utilization of the decision. 

Correa has also referred to the difficulties faced in the Philippines. 120 applications for 
compulsory licenses were filed under the former Philippine patent law, out of which 51 
compulsory licenses were granted. The appellate procedure, however, hindered the 
execution of the licenses. The beneficiary companies were not able to market their 
product during this appellate procedure. The delay also caused the dismissal of 23 
applications while 14 applications were dismissed due to a compromise agreement 
between the parties. 8 applications were dismissed because the patent expired while the 
procedure was still pending. Up until 2003, only one compulsory license applied for 
during the old patent legislation had been executed – the application had been lodged 
in 1991 and the execution took place in December 2001.132 

The fact that the Medicines Decision was achieved by amending Article 31 of the TRIPS 
Agreement ensures that the rights of patent holders are adequately protected. It does not 
necessarily imply inefficiency of the decision – as long as WTO Members meet their obligation 
to protect access to medicines and draft their laws accordingly. It may also be that basing any 
exportation on Article 31 better justifies the action in the eyes of patent holders and thus 
increases their willingness to cooperate under the system. Finally, the Medicines Decision is 
without prejudice to other flexibilities WTO Members have under the TRIPS Agreement133. 
This means that e.g. exceptions allowed under Article 30 still remain available.  

 
131 Maastrict Guidelines, para. 18.  
132 Correa 2004, p. 7.  
133 The Medicines Decision, para. 9.  



 

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In the following, main issues of the Medicines Decision are tackled by using the 
implementing regulations of Canada134 (“Jean Chrétien Pledge to Africa”), the EC135 (“EC 
regulation”) and Switzerland136 (“Gesetzesänderung”) as concrete examples of the policies WTO 
Members have adopted at national level.137 These Members have implemented the decision and 
they also have the capacity to export medicines under the system established. In addition, some 
of the solutions proposed in the U.S. amendment (“Life Saving Medicines Export Act”) will be 
used as examples even though the bill never became a law138. What are alternatives that should 
be chosen if WTO Members are to meet their obligations to respect, protect and fulfil the right 
to access to medicines?  

3.4.  Eligible Importing Countries 

3.4.1.  Treatment of WTO Members 

The first essential issue is which countries are eligible to use the system established by the 
Medicines Decision. Paragraph 6 of the Doha Declaration was intended to solve the problems 
of WTO Members “with insufficient or no manufacturing capacities in the pharmaceutical 
sector”. Defining eligible importer countries proved divisive. Developing countries supported 
the definition given in the declaration, whereby determination of eligibility would be made 
case-specifically. The EC and the United States, in turn, were interested in limiting the amount 
of prospective importing countries. Using national income as a determinant or creating a 
predetermined list of eligible importing countries based on the level of local production 
capacity were options suggested during the negotiations.139  

Under the Medicines Decision, only least-developed country Members are automatically eligible 
for importing generic medicines. Other WTO Members can notify the TRIPS Council if they 
intend to use the system. This is a precondition for being eligible to import generic medicines 
that have been manufactured under the system. The notification may be unqualified or it can 

 
134 Chapter 23 of the Canadian Patent Act (Bill C-9): An Act to amed the Patent Act and the Food and Drugs Act 
(The Jean Chrétien Pledge to Africa), assented to 14th of May 2004.  
135 Regulation (EC) No 816/2006 of the European Parliament and the Council of 17 May 2006 on compulsory 
licensing of patents relating to manufacture of pharmaceutical products for export to countries with public health 
problems.  
136Bundesgesetz vom 25. Juni 1954 über die Erfindungspatente (Patent Gesetz, PatG), Article 40(d), 40(e). 
137 Among other countries that have implemented the Medicines Decision are India, South-Korea, Norway and 
China. See Consumer Project on Technology: http://www.cptech.org/ip/wto/p6/index.html (last visited 
10.4.2010).  
138 See The United States: The Proposed Life Saving Medicines Export Act (http://www.govtrack.us/ 
congress/bill.xpd?bill=s109-3175 [last visited 10.4.2010]). 
139 Abbott [1] 2005, p. 326–327.  



 

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be limited to certain exceptional circumstances, such as national emergencies140. Further, 
pursuant to Article 2(a)(ii) of the Medicines Decision, other than least-developed country 
Members must make a determination that they have insufficient or no manufacturing capacity 
in the pharmaceutical sector for the products in question once they have decided to import 
medicines under the system. The criteria for this determination are set out in the annex to the 
decision. The matter is in the discretion of the officials of the importing WTO Member141. 
Manufacturing capacity covers both technical aspects (i.e. availability of technology, trained 
personnel, equipment, access to raw material etc.) and economic feasibility of production. The 
notification is declaratory, i.e. it does not have to be approved by a WTO organ. The 
Chairman’s statement accompanying the Medicines Decision encourages WTO Members to 
include in the notification the information on the methodology they have used for assessing 
their manufacturing capacity – this, however, has no legal impact on the actual content of the 
decision142. The implementing legislations of Canada, the EC and Switzerland, for example, all 
give the importing WTO Member the power to determine whether it qualifies for importing 
the medicine in question while least-developed country Members are automatically considered 
eligible143. Thus, no prior limitations have been set for the eligibility of a WTO Member to 
utilize the Medicines Decision. 

3.4.2.  Treatment of Non-WTO-Countries 

Treatment of non-WTO countries lacking sufficient manufacturing capacity is an issue not 
covered by the Medicines Decision. It can be argued that exporting medicines to a non-WTO 
country constitutes a limited exception to patent rights and as such is allowed under Article 30 
of the TRIPS Agreement. However, the Medicines Decision is silent on the issue. Requiring 

 
140 The Medicines Decision, para. 1(b).  
141 Annex of the Medicines Decision, para. 2: ”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.” 
142 Correa 2004, p. 17–18. It should be noted that several WTO Members notified the TRIPS Council that they 
will not use the system as importing countries and some made a statement that in case they would use it, it would 
only be in cases of national emergency or extreme urgency. Practically, all OECD countries are not using the 
system as importing States, including all members of the EC (the Medicines Decision, para. 1 [b]). Abbott has 
explained this as a factor that made the EC to concede to an approach that set no prior limitations for possible 
exporter countries. The EC was primarily concerned on the possible price erosion and low-priced imports in 
developed countries – along with the control mechanism and the statement that developed countries would not 
employ the system as importers, the rights of patent holders seem to be adequately taken into account (Abbott [1] 
2005, p. 329).  
143 Jean Chrétien Pledge to Africa, Section 21.04(3)(d)(iii); EC Regulation, Article 4; Gesetzesänderung, Article 
40(d)(1).  



 

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membership in the WTO as a precondition for benefiting from the established system 
would, in any case, be unreasonable from a human rights perspective. In order to take steps 
towards the realization of universal access to patented medicines, all prospective exporting 
WTO Members should tackle this question when implementing the decision. Membership in 
the WTO has not been set as an absolute precondition for utilizing the Medicines Decision in 
the implementing legislations under examination144. Certain restrictive conditions have 
nonetheless been set e.g. in the EC. 

The EC regulation defines all least-developed countries as eligible importers regardless of their 
membership in the WTO.145 It yet sets a strict criterion for the eligibility of other non-WTO 
countries: pursuant to Article 4 (c), “any country that is not a member of the WTO, but listed 
in the OECD Development Assistance Committee’s list of low-income countries with a gross 
national product per capita of less than USD 745, and has made a notification to the 
Commission of its intention to use the system as an importer, including whether it will use the 
system in whole or in a limited way”, is eligible to import medicines manufactured under the 
system. Thus, the scope of eligible non-WTO countries is strongly limited in Europe where the 
initial wish to set a predetermined criteria for eligible countries based on national income 
seems to be held on to in relation to non-WTO countries. This can be criticized for its possible 
negative effects on access to medicines in certain countries.  

For example, Turkmenistan is eligible for official development assistance as it is listed by the 
OECD as a low middle income country with a per capita gross national income between USD 
936 and USD 3 705.146 However, the country is not a Member of the WTO.147 It is thus not 
eligible to receive any medicines manufactured under compulsory licenses from the territory of 
the EC. Surely, Turkmenistan does not possess manufacturing capacity of generic medicines 
sufficient to secure access to medicines for its people. If the government of Turkmenistan 
wanted to provide its population access to patented medication that otherwise is unaffordable, 
it would have to turn to other potential exporters as the Members of the EC have excluded 
themselves from this kind of action. This situation is untenable from the perspective of the 

 
144 In Switzerland, eligible country is a country “das über keine oder ungenügende eigene Herstellungskapazitäten 
auf pharmazeutischem Gebiet verfügt und diese Produkte zur Bekämpfung von 

Problemen der öffentlichen Gesundheit benötigt, insbesondere im Zusammenhang mit HIV/Aids, Tuberkulose, 
Malaria und anderen Epidemien”. Only countries that have notified the TRIPS Council that they will not use the 
system or that they will only use it in extreme circumstances are excluded from eligibility (Gesetzesänderung, 
Articles 40[d][1] and 40[d][2]).  
145 EC regulation, Article 4(a).  
146See OECD list of countries eligible for official development assistance, available at 
http://www.oecd.org/dataoecd/62/48/41655745.pdf (last visited 16.2.2010).  
147 List of WTO Members available at http://www.wto.org/english/theWTO_e/whatis_e/tif_e/org6_e.htm (last 
visited 16.2.2010). 



 

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goals all EC members have accepted by being Members of the United Nations and parties to 
various human rights conventions.148 

When implementing the Medicines Decision, WTO Members should not set restrictive 
conditions for potential importing countries based on their membership in the WTO. All 
countries should have the right to utilize the Medicines Decision for the protection of access to 
medicines. Needless to say, this entails obligations also: they should have a duty of preventing 
re-exportation of the medicines in accordance with the decision (see section 3.6.6. below). Such 
duties can, however, easily be established through license agreements – thus, patent rights 
would be respected just as they are if the importer is a WTO Member. Finally, Article 30 of the 
TRIPS Agreement remains applicable and there are no clear reasons why a WTO Member 
could not export medicines to a non-WTO country under the article149.  

3.4.3.  Position of Non-Governmental Organizations 

NGOs and international organizations are responsible for the supply and distribution of 
pharmaceutical products in many developing countries that are short of working local 
governance. The Medicines Decision is silent on whether these organizations are entitled to 
request importation of patented medicines under the decision. However, in the implementing 
legislations of Canada and the EC, other than governmental entities are also specifically 
mentioned. Pursuant to the EC Regulation, evidence of a specific request from the importer 
must be attached to the license application. A request made by a non-governmental 
organization or a UN body or other international health organization acting with the formal 
authorization of the importing country qualifies for this purpose150. Similarly, products 
manufactured in Canada can be sold to a non-governmental entity authorized by the 
government of the importing country151. In the proposed U.S. amendment, non-governmental 

 
148 In Canada, for example, eligible countries are listed in different schedules based on their economic status and 
WTO membership. Schedule 4 includes non-WTO countries that are eligible for official development assistance. 
The scope of eligible countries is hence rather wide considering that the OECD list of countries eligible for official 
development assistance includes upper middle income countries that had per capita gross national income of up to 
USD 11 455 dollars in 2007.  
149 Abbott & Reichman 2007, p. 958. The authors refer to the resolution adopted by the European Parliament on 
the TRIPS Agreement and access to medicines. In paragraph 10 of the resolution, the parliament “calls on the 
Council to adopt a Joint Policy Statement with Parliament to the effect that WTO Members remain free to use all 
exceptions from the TRIPS Agreement under their domestic patent laws to authorise production and export to 
address public health needs in importing Members (emphasis added) and asks the Council to ensure that the 
Commission refrains from taking action to interfere with these proceedings. 
150 EC Regulation, Article 6(3)(f)(ii) and (iii).  
151 Jean Chrétien Pledge to Africa, Section 21.04(2)(f). The requirement of permission from the government of the 
importing country has been criticized in Canada (Elliot 2007, p. 53).  



 

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agencies were referred to for supportive purposes which would have seemingly left them in a 
less independent position152. 

NGOs should be encouraged to promote the use of the system established by the Medicines 
Decision in countries where they are largely responsible for the provision of medicines. They 
may often have more accurate information on how the system can best be utilized in these 
countries. They may also have more knowledge on the needs of the local population. Some 
scholars have gone as far as claiming that generic companies should be permitted to enter into 
an importation agreement directly with NGOs, provided that the NGO in question supplies 
medicines to the eligible importing country153. Despite the advantages of this suggestion, it 
would be questionable to allow NGOs to act independently of the government as only States 
have the ability to take measures needed for the prevention of re-exportation (e.g. custom 
clearance). Therefore, in order for a country to be able to utilize the Medicines Decision, its 
government has to be willing to cooperate. This, in turn, is an obligation of every State for the 
realization of access to medicines. Including non-governmental agencies in the legislation 
implementing the Medicines Decision for supporting purposes is nevertheless essential and 
represents an up-to-date view on the measures that are required for ensuring universal access to 
medicines – a mission that can only be completed through efficient cooperation between all 
stakeholders involved.  

3.5.  Scope And Coverage of Products and Diseases 

In paragraph 1 of the Doha Declaration, WTO Members “recognize the gravity of the public 
health problems afflicting many developing and least-developed countries, especially those 
resulting from HIV/AIDS, tuberculosis, malaria and other epidemics”. Paragraph 4 refers to 
public health and access to medicines without any further qualifications while in paragraph 6, 
reference is made to “WTO Members with insufficient or no manufacturing capacities in the 
pharmaceutical sector”. Even though no limitations are set in the declaration, some WTO 
Members presented that the future decision should be limited only to medicines used for the 
treatment of diseases specifically named in the declaration. For home countries of major 
research based pharmaceutical companies, this would have been a way to minimize the amount 
of revenues eroded.154 The United States insisted on limiting the applicability of the Medicines 
Decision to the diseases named in paragraph 1 of the Doha Declaration.155 Similarly, the 
representative of Australia claimed that the declaration clearly articulated the scope and 
coverage of the future decision. Accordingly, the future decision should only cover medicines 

 
152 Life-Saving Medicines Export Act Section 298(b)(1), Section 298(c)(2)(F). 
153 Lazo 2007, p. 264.  
154 For the different suggestions presented in the negotiations, see Abbott [1] 2005, p. 327–334.  
155 See e.g. Council for TRIPS, Minutes of meeting held in November and December 2002, para. 34 (where the 
inability of the U.S. delegation to agree to the consensus reached on the scope of diseases is expressed).  



 

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for the treatment of HIV/AIDS, tuberculosis, malaria and other epidemics. Additional 
products like active ingredients or diagnostic kits should only be included in the agreed criteria 
if they were related to the diseases specifically mentioned156.  

Limiting the scope of diseases seems incomprehensible – after all, diseases individuals in 
developing countries suffer from are not limited to those that can be classified as epidemics. 
Non-communicable conditions such as cardiovascular disease, cancer, diabetes and respiratory 
and musculoskeletal diseases are major causes of death also in developing countries157. 
Similarly, medicines on the WHO list on essential medicines are increasingly for the treatment 
of chronic diseases such as cancer and diabetes158. Newer, more effective medicines for these 
conditions are and will be patented also in the future. In the light of the human right to health, 
it is impossible to justify why compulsory licenses should only apply to infectious diseases of 
epidemic nature. As pointed out by Abbott and Reichman, “there is no public health 
justification for denying access to treatment for certain diseases because trade officials have 
decided that some diseases should be on (or off) an official list”159. 

“Pharmaceutical products” as defined in paragraph 1 of the Medicines Decision mean “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 Doha 
Declaration”, including “active ingredients necessary for its manufacture and diagnostic kits 
needed for its use”. The word “especially” used in paragraph 1 of the Doha Declaration implies 
that diseases specifically named in the declaration are mere illustrations. No exhaustive list is 
presented in the declaration. Thus, the Medicines Decision cannot be interpreted as limiting 
the scope of diseases either. It neither limits the use of the system to certain types of products 
nor makes its applicability dependent on their characterization as e.g. essential medicines. The 
decision may also be applied to a patent covering a pharmaceutical formulation or a process for 
its manufacture. Vaccines are not specifically named in the decision but by using e contrario 
deduction, one can conclude that had the drafters wanted to exclude them, they would have 
explicitly done so – after all, vaccines are produced by the pharmaceutical industry and they are 
used to solve public health problems.160 All in all, no limiting conditions have been set in the 
Medicines Decision regarding the scope of products or diseases.  

 
156 Council for TRIPS, Minutes of meeting held in September 2002, para. 30. See also statement supporting this 
view by the representative of Japan. The EC and the United States favored a term of “constructive ambiguity” in 
order to find a desirable solution to the problem by interpretation. Ibid., paras. 15 and 44.  
157 See World Health Report 2002, Annex Table 3. Accordingly, 45,9 % of the total amount of deaths was due to 
noncommunicable conditions in 2001.  
158 WHO: 10 facts on essential medicines (22 October 2007).  
159 Abbott & Reichman 2007, p. 937. See also Abbott [1] 2005 on the relevant negotiations.  
160 Correa 2004, p. 10–11.  



 

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In consistency with the Medicines Decision, neither the EC nor Switzerland has nationally 
limited the scope of pharmaceutical products or diseases the decision can be used for.161 
Canada, in turn, has limited the applicability of the decision to patented products that were on 
the WHO list of essential medicines and were patented in Canada at the time of the adoption 
of the national amendment. The decision also applies to antiretroviral medicines that were then 
approved for sale in Canada.162 These products are listed in the annex (Schedule 1) to the 
national amendment.163 The Governor in Council may amend the list by removing or adding a 
medicine, a dosage form, strength or a route of administration of a medicine “that may be used 
to address public health problems afflicting many developing countries and least-developed 
countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other 
epidemics” on the recommendation of the Minister of Health who is assisted by an advisory 
committee.164  

The Canadian policy narrows down the applicability of the Medicines Decision and is 
problematic for at least two reasons. Firstly, taking this kind of retrogressive measures in 
relation to the Medicines Decision violates the obligation also touching upon Canada to ensure 
that its acts do not adversely impact on access to medicines in third States. As pointed out by 
Richard Elliot, “by introducing a limited list of products in its implementing legislation, 
Canada, which had repeatedly indicated it would wait for a multilateral solution to be agreed at 
the WTO, has unilaterally undermined that consensus”165. Secondly, a lot of discretionary 
powers are given to national officials. It is clear that a great deal of lobbying takes place around 
leading politicians wherefore politicizing an essential issue such as the one at hand is at least 
questionable. To conclude, WTO Members should not introduce any limitations as to the 
scope and coverage of products and diseases in the implementing legislation – instead, the 
Medicines Decision should, as a starting point, apply to all pharmaceutical products needed to 
address public health problems.  

 
161 In the EC, “pharmaceutical product” is defined as “any product of the pharmaceutical sector, including […] 
active ingredients and diagnostic kits ex vivo.” (EC Regulation, Article 2). In Switzerland, reference is made to 
“pharmazeutisher Producte […] zur Bekämpfung von Problemen der öffentlichen Gesundheit benötigt, 
insbesondere im Zusammenhang mit HIV/Aids, Tuberkulose, Malaria und anderen Epidemien” 
(Gesetztsänderung, Article 40d1).  
162 Elliot 2007, p. 47.  
163 Jean Chrétien Pledge to Africa, Section 21.02. 
164 Ibid., Section 21.03 (a)(i). Since the passage of the legislation, the list in Schedule 1 has been amended twice in 
response to requests from generic manufacturers and NGOs: in September 2005 to add a fixed-dose combination 
AIDS drug containing the antiretroviral drugs zidovudine (AZT), lamivudine (3TC) and nevirapine (NVP) (a fixed-
dose combination of which was subsequently manufactured by generic producer Apotex), and again in September 
2006 to add the anti-influenza antiviral oseltamivir (marketed by the patentee under the brand-name Tamiflu). In 
each case, what had been repeatedly represented as being a simple process, turned out to be slow and complex. In 
fact, it took months before the government acted in consequence of repeated urging by NGOs and would-be 
manufacturers (Elliot 2007, p. 49).  
165 Elliot 2007, p. 48.  



 

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3.6.  Procedural Issues 

3.6.1.  Prior Negotiations 

In accordance with Article 31(b) of the TRIPS Agreement, the interested supplier first has to 
ask for a voluntary license. In Canada, the EC and Switzerland, prior negotiations are expected 
to take place at least 30 days prior to the filing of the application166. Pursuant to the proposed 
U.S. amendment, request for a voluntary license was to be performed at least 60 days before the 
submission of the application167. Interpreting this to constitute “a reasonable period of time” 
within the meaning of Article 31(b) of the TRIPS Agreement seems unreasonable for its part: it 
practically means that a person is denied access to medicines while it is obvious that the 
additional 30 days will do little for the achievement of a voluntary license agreement between 
the patent holder and the generic producer. Thus, the definition of “reasonable” should not 
exceed 30 days.  

As previously mentioned, the exporting WTO Member can be entitled to consider the situation 
in the importing country as an emergency or to recognize its public non-commercial use; then, 
it is possible to accelerate the process by passing the prior negotiations168. After all, the 
exportation takes place for the control of a health crisis in the recipient country, not in the 
exporting Member. However, from the national amendments examined only the EC regulation 
specifically allows for this kind of interpretation169. Further, evidence of efforts that have been 
made in order to obtain a voluntary license is to be attached to the application pursuant to all 
national implementing legislations under examination170. In the absence of a specific mention 
on the possibility not to perform a prior request, the patent holder may challenge the issuance 
of a compulsory license for violating the requirement set forth in Article 31(b) if no prior 
negotiations have occurred within a set period of time. It is thus desirable to provide for an 
explicit opportunity in the national legislation to pass the prior negotiations in case of 
outbreaks of epidemics that require immediate action.  

 
166 EC Regulation, Article 9 (1), Jean Chrétien Pledge to Africa, Section 21.04(3)(c), Gesetzesänderung, Article 40e.  
167 Life-Saving Medicines Export Act, Section 298(2)(F). 
168 Correa 2004, p. 19, 21.  
169 EC Regulation Article 9 (2): “The requirement in paragraph 1 shall not apply in situations of national 
emergency or other circumstances of extreme urgency or in cases of public non-commercial use under Article 31(b) 
of the TRIPS Agreement.” 
170 During the process that lead to the adoption of the Jean Chrétien Pledge to Africa in Canada, suggestions were 
made according to which the patent holder would have obtained a right to block the issuance of a compulsory 
license if it agreed to match the terms of the agreement between the importing country and the generic producer 
(Elliot 2007, p. 43). This kind of provision would have been unreasonable for generic producers and unnecessary 
when considering that patent holders have the chance to voluntarily license their patent when the required prior 
request is performed.  



 

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3.6.2.  Notification from the Importing Country 

Pursuant to paragraph 2 of the Medicines Decision, the importing country has to make a 
notification to the TRIPS Council in which names and expected quantities of the products 
needed are specified. It also has to confirm that, if the pharmaceutical is patented in its 
territory, it has granted or intends to grant a compulsory license in accordance with Article 31 
of the TRIPS Agreement and the provisions of the decision. Determining which patents are 
required in both countries and their legal status is difficult and time-consuming. A compulsory 
license covering all patents related to a specific product to be acquired, whether identified or 
not, is an advantageous solution to this problem. This is possible if the license is applied for in 
cases of national emergencies when no prior request from the patent holder is required 
pursuant to Article 31(b). This kind of comprehensive coverage would include e.g. processes 
and possible indications of the medicine.171  

Where prior negotiations with the patent holder are required, i.e. when the compulsory license 
is granted in other situations than those exempted from said obligation, there is regardless a 
need to recognize all patents related to the pharmaceutical product in question. In addition, 
right holders must in any case be notified as soon as reasonably possible after the unauthorized 
use, regardless of whether prior request has been performed172. The relevant patents must thus 
be recognized eventually. This is when assistance from developed countries is needed in order 
to secure effective implementation of the Medicines Decision. In the proposed U.S. 
amendment, for example, establishment of a separate office in connection with the national 
Patent and Trademark Office was suggested that would have e.g. assisted in the identification of 
covered patents173. This model should be followed either in all exporting countries separately or 
on international level as a common enterprise. 

In article 67 of the TRIPS Agreement, developed countries commit themselves to cooperate 
and assist developing and least-developed country Members technically and financially in order 
to facilitate the implementation of the agreement. In order to offer technical assistance and 
capacity building for the implementation of WTO rules, the organization announced 
Integrated Framework for Trade-Related Technical Assistance to Least-developed Countries in 
1996 which brings together six international agencies, including UNCTAD and UNDP. The 
rationale for this framework is to, inter alia, offer support for WTO-related aspects of a 
country’s development strategy as well as to assist with the costs of the implementation of WTO 
obligations. The technical assistance programs carried out to serve this purpose have often been 
criticized for being inadequate and inefficient. However, since the Doha Round was launched 
in 2001, donors have provided more funding for the programmes and the WTO Secretariat has 

 
171 Correa 2004, p. 39.  
172 TRIPS Agreement, Article 31(b).  
173 Life-Saving Medicines Export Act Section 298(c)(1)(b)(i). 



 

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also improved in delivering its part.174 Providing something similar to solve possible technical 
problems in countries that are willing to utilize the Medicines Decision might face, is an idea 
worth looking into. This kind of action would increase the effectiveness of the Medicines 
Decision: it would, first of all, familiarize the system in general and lower the political threshold 
for its use. It would also accelerate the procedure and thus enable more rapid reactions to 
emergency situations.  

Importing countries, in turn, must ensure that the procedure for obtaining a compulsory 
license in their jurisdiction remains sufficiently simple. In case the receiving country has not 
enforced a patent on the product in question, the country only has to contact a generic 
producer and negotiate an agreement that meets its needs. The situation is more complex, if the 
country has enforced a patent on the needed product. In many countries, decisions concerning 
compulsory licensing require the involvement of various government departments and agencies. 
This prolongs and complicates the procedure in the importing country. In order to facilitate 
coherence and coordination, WTO Members should explore other available alternatives. 
Establishing a separate multi-agency committee that is responsible for decision-making, for 
example, can provide the necessary means for simplifying the procedure175. All in all, activeness 
also on behalf of the importing country is important. While much depends on the political will 
of its government to employ the system, importing countries will nevertheless also need 
technical assistance in using the Medicines Decision.  

3.6.3.  Determination of the Amount of Medicines Needed  

It is difficult to estimate the amount of medicines that eventually need to be exported: the 
developments of health crises are hard to foresee. When making the notification to the TRIPS 
Council, the importing WTO Member must only specify the expected quantity of 
pharmaceuticals needed.176 Reference to “expected” quantities means that it does not need to 
establish its exact needs before the conclusion of the actual license agreement: nothing in the 
decision prevents a WTO Member from modifying the notified quantity over time if its needs 
change or are specified.177 The decision does not establish any form or template for the 
notification regarding the expected quantities either. Thus, the importing WTO Member is left 
with certain room for discretion. It could, for example, define the quantities needed by 
reference to a quantity of pharmaceutical product X sufficient to treat X number of patients 

 
174 Shaffer 2005, p. 660–661.  
175 Oh 2006, p. 28.  
176 The Medicines Decision, Article 2(a)(i).  
177 Abbott & Reichman 2007, p. 933.  



 

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over a period of X amount of time.178 The exporting WTO Member is not bound by the 
amount indicated in the notification according to the Medicines Decision either. Yet, only the 
amount necessary to meet the needs of the importing party may be manufactured under the 
license pursuant to Article 2(b)(i) of the decision. The “amount necessary to meet the needs” of 
the importing country may nevertheless be established on the basis of several criteria depending 
on the degree to which the needs of the importing country can be determined ex ante – thus, it 
does not necessarily imply recourse to the notification.179  

The national implementing legislations of Canada and the EC nonetheless only allow 
manufacture of the amount specified in the notification to the WTO or, if the importing 
country is not a WTO Member, to other relevant entity.180 This makes it even more important 
to prefer flexible formulations already at the notification stage – otherwise, the amount 
imported may turn out insufficient. Furthermore, an application for a compulsory license 
lodged in Canada must set out the maximum quantity of the pharmaceutical to be 
manufactured and sold for export under the authorization181. Canada does not provide for a 
chance to modify the license in order to export additional quantities to meet the needs of the 
importing country either. This can lead to the requirement of renewing the entire 
administrative procedure in order to obtain a new compulsory license for any possible increases 
in the products needed, regardless of their magnitude. Needless to say, this is inconsistent with 
a human rights approach to the implementation of the Medicines Decision.  

The EC, instead, provides for an opportunity to revise the conditions of the license if necessary 
in accordance with a simplified and accelerated procedure. In case the amount exported turns 
out to be insufficient, the importing country must notify the competent authority of the matter. 
The licensee must then file a new application that contains relevant information regarding the 
amount of pharmaceuticals manufactured and the importing country. If prior negotiations 
would normally be required, this obligation is waived if the amount requested does not exceed 
25 percent of the amount granted under the original license182. In accordance with the 
proposed Live Saving Medicines Act, the generic manufacturer would have notified the 
competent official on insufficiency of the estimated quantity. Then, the amount could have 

 
178 Abbott & Puymbroeck 2005, p. 24. The authors suggest the following text for the notification: “Based on its 
present evaluation of its public health needs, [Member] expects to import [quantity(ies)] of [pharmaceutical product 
name( s)]. However, because it is not possible to predict with certainty the extent of its public health needs 
[Member] reserves the right to modify the foregoing estimate as necessary or appropriate.” 
179 Correa 2004, p. 21.  
180 Jean Chrétien Pledge to Africa, Section 21.05(2)(b); EC Regulation, Article 8(2). In the United States, it was 
suggested that an estimate of the quantities of the products to be exported as well as a stipulation that the amount 
manufactured and exported does not exceed the amount necessary to meet the needs of the country would be 
required by virtue of Section 298(c)(2)(B) of the proposed amendment. 
181 Jean Chrétien Pledge to Africa, Section 21.04(2)(c).  
182 EC Regulation, Article 16 (4).  



 

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been adjusted to the quantity proposed by the licensee unless there would have been 
compelling evidence that the proposed quantity was excessive183. The EC has thus 
comparatively preferred a more limited approach.  

Although the European approach does not allow for great flexibility, it is reasonable from the 
perspective of all parties involved. The importing country and the applicant should be able to 
assess the necessary amount at least to some extent in advance – otherwise, the situation 
becomes legally insecure for patent holders. During prior negotiations, they need to have as 
accurate information as possible on the exception that will be made to their rights in case they 
refuse to deal. In addition, the model proposed in the United States is unclear with respect to 
the burden of proof. What constitutes “compelling evidence”? Who has the burden of proof? It 
would be unreasonable to expect the patent holder to provide this evidence, taking into 
consideration that the product may be exported to a country the existence of which they are 
hardly aware of. It is, in any case, important to allow revision of the license if needed. 
Otherwise, States and generic manufacturers have to be overly cautious when making the 
notification or filing the national application which would delay the process. 

3.6.4.  Adequate Remuneration 

According to paragraph 3 of the Medicines Decision, adequate remuneration pursuant to 
Article 31(h) of the TRIPS Agreement shall be paid in the exporting WTO Member, taking 
account of the economic value of the unauthorized use to the importing State. This means that 
the competent authorities in the exporting Member determine the amount of compensation 
paid by the licensee to the patent holder. Since the purpose of a pharmaceutical patent is to 
generate income for its holder who can exploit the exclusive right in its products or license the 
patent to another party, it is understandable that the issue of remuneration is of relevance when 
making exceptions to patents. In order for an exception to these rights to be as limited as 
possible, the patentee must receive adequate compensation. At the same time, however, 
attention should be paid to the effect these royalties have on the price of the exported product. 
The price must remain reasonable. The UNDP estimates royalties of four percent or less of the 
generic sales price, depending on the circumstances and the economic value of the medicine to 
the importing country, to be an appropriate policy of remuneration.184 Due to the price effect of 
this kind of royalty rate, developing countries may find it unreasonable. For example, Thailand, 
that issued compulsory licenses to certain medicines during years 2006 and 2007, had initially, 
without any success, offered a royalty of 0,5 percent to the patent holders in order to obtain 
voluntary licenses.185  

 
183 Life-Saving Medicines Export Act, Section 298(d)(5).  
184 UNDP: Human Development Report 2001, p. 108.  
185 Abbott & Reichman 2007, p. 953. 



 

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The policy of four percent introduced by the UNDP seems to be followed in several 
countries. For medicines exported from the area of the EC, the remuneration shall, in case of a 
national emergency or other circumstance of extreme urgency and in cases of public non-
commercial use, be a maximum of four percent of the total price paid by the importing country 
or another entity. In other cases, compensation shall be determined taking account of the 
economic value of the authorized use to the importing country or countries, as well as the 
humanitarian or non-commercial circumstances relating to the issuance of the license.186 In 
Switzerland, the remuneration must take account of the economic value the license has to the 
importing country, as well as the level of development and health in that country, and the 
humanitarian urgency with respect to the need of medicines. The Federal Council determines 
the appropriate royalty rate.187 

In Canada, the Governor of Council determines the royalty rate. When doing so, the 
humanitarian and non-commercial reasons underlying the issuance of the license are 
considered.188 Separate guidelines have been established for the determination of the royalty 
rate. The rate is dependent on the Human Development Index (“HDI”) of the importing 
country assessed by the UNDP. There is a sliding scale of 0,02 percent up to four percent: most 
developing countries would be required to pay less than three percent royalties, whilst the rate 
would be less than one percent for most countries in Africa.189 The Federal Court may on the 
application of the patent holder order payment of a rate greater than this, if it is dissatisfied 
with the original royalty rate. When doing so, it must take into account the reasons underlying 
the issuance of the license and the economic value of the use of the invention to the recipient 
country.190 It should be noted that Article 31(j) of the TRIPS Agreement as such demands that 
any decision relating to the remuneration is subject to judicial review or other independent 
review by a competent authority in that WTO Member. Therefore, the provision mentioned 
does not add anything to the rights of patent holders. 

The most detailed formulas for the determination of the appropriate royalty rate are found in 
the proposed U.S. Life Saving Medicines Act. The competent authorities would determine the 
royalty rate considering factors such as 1) the need of the licensee to make a reasonable return 
that is sufficient to sustain continued operations, and 2) the need for low-cost pharmaceutical 
products of the people in the importing country. The maximum royalty rate would be four 
percent of the commercial value of the supply agreement. Alternative royalty rate formulas that 

 
186 EC Regulation, Article 9.  
187 Gesetzesänderung, Article 40e(5).  
188 Jean Chrétien Pledge to Africa, Section 21.08(1); 21.08(2). In the original draft of the bill, the government had 
proposed a flat 2 percent royalty rate for the patent holder. However, the industry association for pharmaceutical 
patent owners objected to this proposition (Elliot 2007, p. 45).  
189 Oh 2006, p. 32.  
190 Jean Chrétien Pledge to Africa, Section 21.08(4) - 21.08(7).  



 

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utilize the HDI ranking of the recipient country are then presented from which the 
competent official would choose the most appropriate one. Exportation to least-developed 
countries would, in accordance with the formulas established, lead to royalties below 0, 5 
percent.191 It is important to fix the royalty rates as clearly as possible in order to accelerate the 
issuance of the license. Including these formulas in the implementing legislation increases 
transparency; this is why the proposed U.S model seems most adequate. Due to the economic 
interests underlying the entire issue, unambiguous rules are necessary.  

The global patent system has been a joint venture of developed countries and, as presented 
above, there are reasons to hold on to this venture. Since these exclusive rights are of economic 
nature, respecting the rights of the inventors of pharmaceuticals exported under the Medicines 
Decision is possible by ensuring that they receive adequate remuneration. The recipient country 
may, nonetheless, claim that it cannot afford this kind of compensation. Would it then not be 
in the interests of all parties that the government of the exporting WTO Member would 
subsidize this action in the form of development assistance (without decreasing the amount of 
other public development aid)? In case the exporting WTO Member would also be a developing 
country, international organizations offering development assistance could come to the rescue. 
A fund could also be created for this purpose in connection with the WTO secretariat. WTO 
Members could decide on a fixed amount of royalties, say four percent, which would be paid to 
the patent holder. After all, providing medicines would be an efficient means of development 
assistance and it would thus promote the search for solutions of international economic, social, 
health and related problems in the spirit of Articles 55 and 56 of the UN Charter. Similarly, it 
would be consistent with Article 2(1) of the ICESCR, according to which Contracting States 
must “take steps, individually and through international assistance and cooperation, especially 
economic and technical,” for the realization of the rights recognized in the Covenant192. At the 
same time, the money spent could be considered the price that must be paid in order to 
maintain the international patent system created by the TRIPS Agreement.  

 
191 Life-Saving Medicines Export Act, Section 298 (e). The proposed act includes detailed formulas for the 
calculation of the royalty rate. For example, if the name of the importing country would have been on the HDI 
maintained by the UNDP, the royalty rate would have been determined as follows: (total number of countries 
listed on the HDI + 1 – the numerical rank on the HDI of the country to which the pharmaceutical product is to 
be exported) / (total number of countries listed on the HDI) × 0,04. In case the importation would have taken 
place in e.g. Tanzania, which is a country of low human development, the royalty rate in accordance with this 
formula would be (178 – 159) / 178 × 0,04 = 0,0043. In comparison, exportation to Kazakhstan, a country of 
medium human development, would have generated the patent holder royalties with the rate of 0,0237. If there 
would have been only one patentee, the total monetary value of the license agreement would have been multiplied 
by this royalty rate obtained; in case of several patentees entitled to compensation, the amount would have been 
divided by the number of patentees. HDI rankings are available at http://hdr.undp.org/en/statistics (last visited 
11.4.2010).  
192 See also ESCR Committee, General Comment 3, paras. 13 and 14. In the latter, the committee emphasizes that 
“in accordance with Articles 55 and 56 of the Charter of the United Nations, with well-established principles of 
international law, and with the provisions of the Covenant itself, international cooperation for development and 
thus for the realization of economic, social and cultural rights is an obligation of all States. It is particularly 
incumbent upon those States that are in a position to assist other in this regard.”  



 

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3.6.5.  Making Exportation Economically Efficient 

In order for the system established by the Medicines Decision to work, it has to be economically 
efficient. Generic producers in both developed and developing countries have argued that, in 
addition to those of procedural character, economic barriers prevent their participation in the 
arrangements under the Medicines Decision. After all, they share with the research-based 
industry the common motivation of serving the interests of their shareholders193. As pointed 
out by Lazo, no matter how altruistic a generic company may be, or how severe a pandemic – 
like AIDS – may become, failure to incorporate greater financial incentives will render the 
implementing legislation in question useless in the fight to improve the life or death problem of 
access to medicines in developing countries.194 This means that there has to be a sustainable 
operational framework for anyone willing to apply for a license and decent economic incentives 
for the manufacture of the generic product. The requirement of economic efficiency hence 
seems to lead to two requirements: firstly, the license has to remain valid for a period of time 
sufficient to recoup the production costs. Secondly, the amount of medicines ordered and 
manufactured under the license has to be large enough. These conditions are interdependent: a 
license valid for the lifetime of the patent fails to encourage generic production if the amount 
manufactured remains limited. 

It is important that enough time is granted for the production and marketing of the generic 
product and for the recovery of the costs of this process. In many cases, this may require a 
license for the lifetime of the patent. Otherwise, producing generic medicines is economically 
insecure and incentives for such action remain low.195 Pursuant to Article 31(c) of the TRIPS 
Agreement, the scope and duration of a compulsory license must be limited to the purpose for 
which it was granted. The Medicines Decision does not amend this requirement. In the EC and 
Switzerland, no prior limitations as to the duration of the license have been set, but it has been 
restated that the duration shall be limited.196 Canada, instead, has assumed a different kind of 
approach: an authorization granted under the Jean Chrétien Pledge to Africa is valid for a 
period of two years beginning on the day on which the authorization was granted.197 In the 
proposed Life Saving Medicines Act, the term of a compulsory license issued under the 

 
193 Commission on Intellectual Property Rights, Innovation and Public Health 2006, p. 120.  
194 Lazo 2007, p. 241.  
195 Correa 1998, p. 214. 
196 EC Regulation Article 10(3), Gesetzesänderung Article 40e(2).  
197 Jean Chrétien Pledge to Africa, Section 21.09.  



 

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Medicines Decision expires on the date that is the earliest of seven years after the date of 
issuance of the license.198 

The generic producer incurs the costs of producing the exported medicine. These include e.g. 
the costs of reverse-engineering the pharmaceutical in question, presumably without any 
assistance from the patent holder. In addition, the generic producer must pay the royalties set 
in the exporting WTO Member.199 Setting limitations for the duration of the license that are 
not required under the Medicines Decision forms an additional disincentive for generic 
producers to consider using the system: financial costs and risks associated with obtaining the 
required regulatory approvals and scaling up production appear greater than the short-term 
revenues that could be made under the contract. The alternative of applying for a new license 
includes additional costs and opportunities for the patent holder to intervene in the procedure, 
thus decreasing its value as a true alternative.200 Therefore, setting unreasonable limitations for 
the duration of the license should be avoided.  

In addition to the duration of the license, the amount of medicines manufactured under a 
compulsory license must be as large as possible for the action to be profitable. Contrary to 
original medicines, generic medicines should be produced with high volume and low margin 
returns. In order to ensure high volume of medicines manufactured, the importing countries 
should pool their purchasing power in order to bargain down the prices of pharmaceuticals. 
The wording in paragraph (2)(b)(i) of the Medicines Decision “only the amount necessary to 
meet the needs of the eligible importing member(s)” implies that it is possible to incorporate 
the needs of several eligible importing countries under one license. In the EC regulation, 
reference is also made to “importing country or countries”201. This seems to enable exporting to 
several countries under one license. The proposed Life Saving Medicines Act, in turn, would 
have taken a step forward by specifically addressing the issue of combined license applications. 
The national authority could have established procedures to permit a combined license 
application from more than one eligible country or issued a multi-country license if 
appropriate202.  

There is plenty of potential in allowing combined license applications. Many developing 
countries suffer the same public health problems and lack the necessary manufacturing 

 
198 Life-Saving Medicines Export Act, Section 298(d)(3)(a). Pursuant to paragraph (c), termination of the license 
would have naturally been possible prior to this date on a petition from the original patent holder if the 
circumstances that lead to the issuance of the license cease to exist and it appears probable that such circumstances 
will not reoccur. 
199 See Lazo 2007, p. 271–274 (suggesting that one possible way of reducing the costs would be to motivate the 
patent holder to cooperate by rewarding such action by higher royalty rates). 
200 Canadian HIV/AIDS Legal Network 2006, p. 4.  
201 EC Regulation, Articles 6(3)(d) and 10(2).  
202 Life Saving Medicines Act, Section 298(c)(3).  



 

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capacity. At the same time, they may not have sufficient information on the possibility of 
importing generic medicines. Cooperation could improve the ability of these countries to 
obtain medicines under Medicines Decision. In consequence of pooling their purchasing 
power, States could additionally obtain medicines at lower prices. However, the Medicines 
Decision requires each importing WTO Member to make a notification to the TRIPS Council 
which means that each importing Member would yet have to notify its intentions to the 
Council. Allowing exportation to several countries under the same license is nevertheless a 
practical way of improving the economic efficiency and accelerating the procedure of obtaining 
a license. After all, the importing countries have the same legal right to import medicines and 
the same legal duties imposed by the Medicines Decision. Since there are no legal obstacles for 
allowing combined licenses, it would be important to explicitly provide for this opportunity in 
the implementing legislations in order to avoid obscurity.  

In order to better cater to the needs of developing countries, an exception related to the ban of 
re-exportation was included in paragraph 6 of the Medicines Decision. Where a developing or a 
least-developed country Member is a party to a regional trade agreement at least half of which 
consists of countries presently on the UN list of least-developed countries, re-exportation is 
allowed. The obligation to obtain an additional export license is waived to the extent necessary 
to enable exportation of a pharmaceutical produced or imported under the Medicines Decision 
to another developing or least-developed country that is a party to this regional trade agreement 
and shares the health problem in question203. This exception does not allow the generic 
producer to supply medicines for other States than those that are eligible to import medicines 
in accordance with the decision; it only allows re-exportation by the original importer. The new 
importing country also has to issue a compulsory license pursuant to Article 31 of the TRIPS 
Agreement in case the imported product is covered by a patent in its territory. In addition to 
these restraints, it is worth remembering that most least-developed countries are situated in 
Africa. The exception in question is thus relevant only in relation to some regional trade 
agreements in Africa.204  

In their article, Abbott and Reichman sketch the establishment of a Regional Pharmaceutical 
Supply Centre (“RPSC”) inside a loose trade association which would have at least six least-
developed country Members. The RPSC could organize the procurement of pharmaceuticals 
needed to fulfil the demand of as many as twelve countries. It would act on behalf of its buyer 
governments that would now be in a better position to obtain low prices after having pooled 
their purchasing power. The RPSC would first make efforts to obtain voluntary licenses from 
patent holders who might be more willing to cooperate with a larger amount of buyers. If it 

 
203 The Medicines Decision, para. 6(i). 
204 The EC insisted that the solution should be limited to what is effectively Sub-Saharan Africa. It rejected 
proposals that would have made it unnecessary for importing countries to separately issue compulsory licenses. In 
addition, developing countries considered the provision for assistance in the creation of regional patents as a part 
of an EU strategy to support its pharmaceutical industry (Abbott & Reichman 2007, p. 942).  



 

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would fail to negotiate a voluntary license, it could purchase the product abroad under the 
system established by the Medicines Decision. The system established by the decision could also 
be used for importing active ingredients to be used for the manufacture of pharmaceutical 
products in the importing countries. Through cooperation, developing countries could hence 
increase local production facilities.205  

The proposal of Abbott and Reichman is one example of innovative thinking that expands the 
use of the Medicines Decision without requiring any legislative reforms. All it calls for is 
cooperation between States that employ the decision. Similar suggestions should be presented 
in the WTO context and, more importantly, they should be put into action. It is somewhat 
ironic that in a world where millions of people lack access to medicines, one obstacle for 
efficient use of the Medicines Decision could be the small size of relevant markets.  

3.6.6.  Diversion of Medicines 

In order for the Medicines Decision to serve its purpose, medicines manufactured under 
compulsory licenses must be diverted to individuals who lack access. This issue of appropriate 
diversion of medicines has two dimensions: internal and external. From the perspective of an 
effective patent regime and patent holders, the most central issue with respect to the Medicines 
Decision is the external aspect of diversion: re-exportation of medicines manufactured under 
the decision must be prevented. This is also important for the beneficiaries of the system, i.e. 
individuals lacking access to affordable medicines. Otherwise, someone else is taking advantage 
of their suffering and the humanitarian concerns underlying the system are left unresolved. It is 
understandable that preventing re-exportation was one of the main issues during the 
negotiations – after all, it is the only way to ensure that patent protection is not eroded in the 
developed countries.206  

Preventing re-diversion of medicines requires cooperation. It is undisputable that if the 
products manufactured in the auspices of the Medicines Decision are re-diverted to the markets 
of developed countries, the rights of patent holders are infringed in an illegitimate manner. 

 
205 Abbott & Reichman 2007, p. 974–977. During the negotiations preceding the adoption of the Medicines 
Decision, the representative of Switzerland suggested an additional instrument of voluntary public tender 
procedure. In a voluntary public tender procedure the WTO Member with insufficient manufacturing capacity 
could be assisted in the examination of the offers by another organization with the necessary expertise and the 
know-how to choose the best offer (for example, the WTO or the WHO). A voluntary public tender would ensure 
wide participation of potential suppliers in the process and as such is a proposition worth looking into (Council 
for TRIPS, Minutes of meeting held in June 2002, para. 106). 
206 See e.g. Council for TRIPS, Minutes of meeting held in September 2002. The representative of Switzerland, for 
example, stated that safeguards against diversion were most important to his delegation (Council for TRIPS, 
Minutes of meeting held in September 2002, para. 82). It should be noted that the TRIPS Agreement as such 
obligates Members to prevent the importation of any infringing goods into their territory (TRIPS Agreement, 
Articles 28 and 44.1).  



 

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According to paragraph 4 of the Medicines Decision, importing WTO Members must take 
reasonable measures in order to prevent re-exportation. In addition, all importing WTO 
Members must ensure the availability of effective legal means to prevent importation that is 
inconsistent with the decision. Concrete actions range from efficient custom clearance to 
injunctions and liability for compensation. If a WTO Member considers that such measures are 
insufficient, the matter can be reviewed in the TRIPS Council207. It should yet be noted that 
developed countries are expected to assist the importing WTO Members in the prevention of 
re-diversion by providing them with technical and financial assistance208. Further, developed 
countries pledge to cooperate and assist developing countries technically and financially in 
order to facilitate the implementation of the TRIPS Agreement in Article 67 of the agreement. 
These are commitments that must be taken seriously, if the wish is to create efficient patent 
protection globally.  

A closer examination of the global patent system reveals that its gains are anything but 
distributed equally: ten developed countries account for 84 percent of global resources spent on 
research and development annually, and receive 91 percent of global cross-border royalties and 
technology license fees.209 In total, industrial countries account for the vast majority – 97 
percent – of patents worldwide. For example, only 31 of the 26 088 applications for patents 
filed in 1997 under the auspices of the African Intellectual Property Organization were from 
residents of Africa while only seven of 25 731 applications registered that year by the African 
Regional Industrial Property Organization were filed by residents.210 Considering this unequal 
distribution of the advantages of a global patent system, it would only be reasonable to hold the 
governments who benefit the most liable for the expenses caused by measures that secure the 
rights of patent holders. Why should developing countries, that have no resources to secure 
their citizens access to very basic commodities, allocate their resources to the maintenance of a 
patent system that is more or less a joint venture of developed countries – an enterprise that 
they did not want in the first place and that at present hardly benefits them at all?  

Although the Medicines Decision only addresses the external dimension of diversion of 
medicines, a few words can be said regarding its internal aspect. After all, the arrival of 
medicines manufactured under the system to the importing country as such can be considered a 
mere first step, while just distribution within that country forms the second step. The importing 
States are responsible for providing appropriate channels of distribution that ensure effective 
diversion of medicines within their territory. Here, the physical accessibility of medicines is of 
significance: medicines must be within safe reach for all sections of the population211. Similarly, 

 
207 The Medicines Decision, para. 5.  
208 The Medicines Decision, para. 4.  
209 Correa 2007, p. 91.  
210 World Bank: World Development Report 2000/2001, p. 184–185.  
211 ESCR Committee, General Comment 14, para. 12 (b).  



 

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any price decreases attained with the help of the Medicines Decision must be directly visible 
in the sales price of these medicines. This means that the government should not include any 
additional taxes in their prices. Instead, it must ensure affordability of the imported medicines 
for all212. All this requires working governance. Since NGOs can participate in the distribution 
of the medicines manufactured under the decision, this is a choice a country ought to look into 
if its own capability turns out to be insufficient. Invoking defences based on the level of 
development in this connection is unacceptable as ensuring internal diversion of medicines is 
less a matter of resources than a matter of political will.  

IV. From Normative to Political Coherence 

As established above, the Medicines Decision leaves WTO Members sufficient room to strike a 
balance between the public interest and the private rights under examination. Efficiency of the 
decision depends on the approaches assumed on the national level – how the obligations 
arising from the right to access to medicines are put into practice when implementing the 
decision. WTO Members must choose the alternatives that best ensure that pharmaceutical 
patents do not hinder access to medicines in developing countries; some examples have been 
given above. As Hestermeyer commented the implementation of the Medicines Decision, “the 
adoption of such legislation is not just laudable, but a way to comply with the obligation to 
cooperate”213. As another matter, all WTO Members should accept the protocol amending the 
TRIPS Agreement in order to make the Medicines Decision a permanent part of the 
agreement. So far, a very limited amount of countries have done this, among these, only few 
developing countries214. 

Although WTO Members have been given an opportunity to meet their obligations to respect, 
protect and fulfil the right to access to medicines despite protection of pharmaceutical patents, 
they have, for the time being, been unwilling to do so by utilizing the Medicines Decision. So 
far, only Ruanda has notified the TRIPS Council of its intention to import medicines from a 
Canadian generic manufacturer215. The reasons underlying this passivity are most often claimed 
to be of political nature: governments of developing countries are unwilling to publish their 

 
212 Ibid.  
213 Hestermeyer 2007, p. 169.  
214 These are (in chronological order) the United States, Switzerland, El Salvador, Rep.of Korea, Norway, India, 
Philippines, Israel, Japan, Australia, Singapore, Hong Kong (China), China, the EC, Mauritius, Egypt, Mexico, 
Jordan, Brazil, Morocco, Albania, Macau (China), Canada, Bahrain, Colombia, Zambia, Nicaragua and Pakistan 
(WTO: Members accepting amendment of the TRIPS Agreement, last visited 11.3.2010). 
215 Council for TRIPS: Notification under paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of the 
paragraph 6 of the Doha Declaration – Rwanda (19 July 2007); Notification under paragraph 2 (c) of the Decision of 30 
August 2003 on the Implementation of Paragraph 6 of the Doha Declaration – Canada (8 October 2007). See also 
Intellectual Property Quarter Update 2005. 



 

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intentions to exploit the flexibilities in the TRIPS Agreement as they are worried about its 
possible negative impact on foreign investment in their country and any additional political 
pressure it may cause216. These fears have been nourished by the policies of some developed 
countries. For example, when Thailand issued three compulsory licenses from November 2006 
through February 2007 to manage the costs of providing universal access to antiretroviral 
medicines (that amount to up to ten percent of the national budget), it found itself faced with 
immense political pressure. The United States placed the country on its “Priority Watch 
List”217, stating that regardless the fact that the licenses issued were in consistency with the 
TRIPS Agreement, the lack of transparency and due process exhibited in Thailand represented 
a serious concern. The Trade Commissioner of the European Commission claimed that the 
actions taken could lead to the isolation of Thailand from “the global biotechnology investment 
community” and that a systematic policy of applying compulsory licenses whenever medicines 
exceed certain prices, was inconsistent with the agreement218. The hostilities targeted at the 
government of Thailand are neither legally supported by the TRIPS Agreement nor the 
subsequent regulation, which, on the contrary, specifically elucidates that “the TRIPS 
Agreement does not and should not prevent Members from taking measures to protect public 
health”219. What is even more important, these hostile actions violate the obligation of third 
States to cooperate by virtue of Articles 55 and 56 of the UN Charter and Article 2(1) of the 
ICESCR. The Thai government was wise to declare its intention to bring a claim to the WTO 
dispute settlement body, if trade sanctions were wrongfully imposed – there is little doubt that 
it would win a possible dispute on TRIPS-compliance of its licensing for government use220.  

Finally, it should be noted that compulsory licenses represent a last resort to access to patented 
medicines. Voluntary licensing should be encouraged since patent holders may be willing to 
cooperate. For example, when the Canadian generic producer Apotex Inc. requested voluntary 
licenses from the pharmaceutical companies that hold patents covering the pharmaceuticals 
that are exported to Ruanda, all right holders expressed interest in the exploitation of their 
patents under a humanitarian initiative. They agreed to a royalty rate of zero percent, while 
their main concern was to ensure that the medicines would not be re-diverted from the original 
recipient country. Boehringer Ingelheim Pharmaceuticals Inc., one of the four pharmaceutical 
companies involved, went even further by offering a voluntary license that would have, inter 
alia, been valid for the entire patent life of the product, as opposed to the two year term 
provided by Canadian law. Furthermore, it permitted Apotex Inc. to extend the license to other 
developing countries in addition to Ruanda by way of a simple letter of intent to the patent 

 
216 Oh 2006, p. 31.  
217 ”Priority Warch List” is one category a country can fall to by virtue of Section 301 of the US Code that allows 
unilateral measures if a country is denying adequate protection of intellectual property rights.  
218 Abbott & Reichman 2007, p. 947; 949–951.  
219 Doha Declaration, para. 4.  
220 Abbott and Reichman 2007, p. 956.  



 

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holder.221 As noted by Oh, prior negotiations with pharmaceutical companies constitute an 
integral part of the government’s strategy to cope with its public health crisis also in Malaysia. 
These companies have become more cooperative, since authorized government use took place 
in the country between 2003 and 2005.222 It is thus not merely imaginary to claim that one day 
voluntary cooperation between the actors involved will result in affordable patented medicines 
in countries lacking manufacturing capacity. In the meanwhile, the Medicines Decision can be 
employed as a band-aid solution which allows for coherence between the right to access to 
medicines and pharmaceutical patents. Either way, what is required at the moment are politics 
that are consistent with the normative regulation underlying the access dilemma.  

Unfortunately, it seems that the recent developments in international intellectual property 
regulation point in the opposite direction. Among these are bilateral and regional free trade 
agreements: by February 2010, 462 regional trade agreements had been notified to the 
GATT/WTO.223 Also issues of intellectual property protection are increasingly settled outside 
the WTO: several bilateral and regional agreements contain provisions that may hinder the use 
of the flexibilities in the TRIPS Agreement described above.224 This hinders access to medicines. 
It thus seems that matters related to access to pharmaceutical patents in developing countries, 
should be negotiated in multilateral settings, where weaker States can be backed up by the 
wider international community. Intellectual property protection is unsuited to be regarded as a 
matter falling exclusively within the scope of an economic “sub-system” of international law. It 
has become evident in the TRIPS era that exclusive rights have an impact on fundamental 
human rights and therefore they are a matter of the human rights “sub-system” also. As such, 
intellectual property rights, at least to the extent they concern pharmaceutical products, should 
be negotiated in multilateral settings where human rights advocates are also able to express their 
concerns. Then, coherence in international law is more likely to remain. 

V. Conclusions 

In my article, I have explored whether coherence can be maintained in international law 
between the right to access to medicines and pharmaceutical patents introduced by the TRIPS 
Agreement. The TRIPS Agreement contains certain flexibilities that enable WTO Members to 
meet their obligations arising from the right to access to medicines. Further, the TRIPS 

 
221 Intellectual Property Quarter Update 2005, p. 6.  
222 Oh 2006, p. 28. 
223 WTO: Regional Trade Agreements (http://www.wto.org/english/tratop_e/region_e/region_e.htm [last visited 
6.4.2010]).  
224 For a critical view on the regional and bilateral free trade agreements, see e.g. Drahos 2007 and Sell 2007. For a 
review of the intellectual property provisions used in FTAs concluded by the United States, see e.g. Vivas-Eugui 
2003 (concerning the Free Trade Area of the Americas).  



 

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Agreement should be interpreted in consistency with human rights law pursuant to the 
customary rules of interpretation guiding the construction of the agreement. Since WTO 
Members can exploit the permissive norms of the TRIPS Agreement in order to follow the 
obligatory norm of the right to access to medicines, no conflict of norms exists between the two 
and they should be interpreted harmoniously in accordance with the presumption against 
conflict. The Medicines Decision constitutes a permissive norm that plays a central role in this 
kind of reconciliation. By assuming a human rights approach to its implementation, WTO 
Members can simultaneously ensure that access to medicines is not hindered by pharmaceutical 
patents in developing countries and maintain an efficient patent system that is also in the best 
interest of the world community.  

As presented above, ensuring access to medicines necessitates the use of compulsory licenses. 
This inevitably erodes patent protection. However, a clear distinction must be made between 
developed and developing countries. Policies relating to exclusive rights in the former must be 
distinguished from policies assumed in the latter. Despite the formal creation of global 
intellectual property system, it has become evident that it will take time before global exclusive 
rights can be enforced in practice. For this to happen, people living in developing countries 
must afford to provide this kind protection. Unfortunately, it seems unlikely that this will occur 
within the foreseeable future. For the time being, different standards of protection must be 
followed in developing and developed countries. Using compulsory licenses in practice means 
that the scope of public domain is expanded at the expense of exclusive rights. It hence seems 
that the scope of public domain should remain wide in the southern hemisphere whereas it is 
increasingly limited in the North. However, there seems to be no alternative available for this 
double standard, since the models developed and upheld in industrialized countries fail to meet 
the reality in the developing world.  

As mentioned in the beginning of this article, the relationship between the right to access to 
medicines and exclusive rights enshrined by the TRIPS Agreement is an excellent example of 
the consequences of fragmentation in international relations. However, any legal fragmentation 
caused by this phenomenon can be ruled by means of the existing international norms. In my 
study, I have provided an example of how two divergent systems of international law can 
interact with each other in a manner that preserves coherence in international law. The 
Medicines Decision must be considered an affirmation of this kind of cross-fertilization 
between different sets of rules. The phenomenon in question is not a mere coincidence but a 
natural consequence of the emergence of divergent international institutions and structures 
within international law that by its nature favours coherence and presumes norms to be 
cumulative. Allowing for interplay between norms of divergent “sub-systems” of international 
law provides a counterforce to the general phenomenon of fragmentation. As Cassese has 
stated, “it shows that at least at the normative level the international community is becoming 
more integrated and – what is even more important – that such values as human rights and the 



 

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need to promote development are increasingly permeating various sectors of international 
law that previously seemed impervious to them”225. Further, it ensures the surveillance of 
diverging regimes simultaneously which is most often in favour of the entire international 
community.  

As a final remark, it should be emphasized that patents are not the main issue in relation to the 
right to access to medicines. The overwhelming poverty of individuals, absence of state health 
care financing, lack of medical personnel and distribution infrastructure are also issues of high 
importance226. Furthermore, the current health crisis in the South is influenced by certain 
matters of even more fundamental character such as ecological and social conditions, including 
the lack of education and gender issues 227. All these issues are related to poverty that, needless 
to say, is the most fundamental problem underlying the access dilemma but one that cannot be 
resolved as easily as the relevant patent policies can be altered. The access dilemma can only be 
solved one piece at a time. Ensuring that pharmaceutical patents do not hinder access to 
medicines must thus be considered as one of the pieces in the puzzle of global public health. 
Yet, other pieces must be collected and put in their places as well. It must be borne in mind 
that the current public health crisis prevailing in the developing world is a sum of hundreds of 
individuals facing a human tragedy each day. As put by the Commission of Macroeconomics 
and health, “fighting disease will be the truest test of our common capacity to forge a true 
global community. There is no excuse in today’s world for millions of people to suffer and die 
each year for lack of USD 34 per person needed to cover essential health services. A just and 
far-sighted world will not let this tragedy continue”228. 

 
225 Cassese 2005, p. 45.  
226 Commission on Intellectual Property Rights, Innovation and Public Health 2006, p. 202.  
227 Commission on Macroeconomics and Health 2001, p. 74–76.  
228 Ibid., p. 110.  



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TABLE OF REFERENCES 
 
Literature 
 
Abbott, Frederick M. [1]: The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of 
Public Health. 99 American Journal of International Law 317 (2005).  
 
Abbott, Frederick M. [2]: Managing the Hydra: The herculean task of ensuring access to essential medicines. In: 
Maskus, Keith E. & Reichman, Jerome H.: International Public Goods and Transfer of Technology. Cambridge 
University Press. Cambridge 2005. 
 
Abbott, Frederick M. & van Puymbroeck, Rudolph: Compulsory Licensing for Public Health, A Guide and Model 
Documents for Implementation of the Doha Declaration Paragraph 6 Decision, World Bank Working Paper No. 
61 (2005). Accessible at http://www-
wds.worldbank.org/external/default/WDSContentServer/WDSP/IB/2005/08/30/000012009_2005083013022
5/Rendered/PDF/334260rev0pub.pdf (last visited 8.11.2008). 
 
Abbott, Frederick M. & Reichman, Jerome H.: The Doha Round's Public Health Legacy: Strategies for the 
Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions. 10 Journal of 
International Economic Law 921 (2007). 
 
Alston, Philip & Quinn, Gerard: The Nature and Scope of States Parties’ Obligations under the International 
Covenant on Economic, Social and Cultural Rights. 9 Human Rights Quarterly 156 (1987).  
 
Alvarez, Jose E.: The New Treaty Makers. 25 Boston College International and Comparative Law Review 213 
(2002).   
 
Vivas-Eugui, David: Regional and bilateral agreements and a TRIPS-plus world: the Free Trade Area of the 
Americas. Quaker United Nations Office TRIPS Issue Papers 1 (2003). Accessible at 
http://www.quno.org/economicissues/intellectual-property/intellectualLinks.htm#QUNOPUB (last visited 
16.11.2008). 
 
Correa, Carlos M.: Patent Rights. In: Correa, Carlos M. & Yusuf, Abdulqawi A.: Intellectual Property Rights and 
International Trade: The TRIPS Agreement. Kluwer Law International. London 1998. 
 
Correa, Carlos M.: Implications of the Doha Declaration. World Health Organization (2002). Accessible at 
http://www.who.int/medicinedocs/index.fcgi?sid=q7hObeB79ee80ca700000000474ca8a4&a=d&d=Js2301e (last 
visited 18.1.2008).  
 
Correa, Carlos M.: Implementation of the WTO General Council Decision on Paragraph 6 of the Doha 
Declaration. World Health Organization (2004). Accessible at 
http://www.who.int/medicines/areas/policy/WTO_DOHA_DecisionPara6final.pdf (last visited 18.1.2008).  
 
Correa, Carlos: Trade Related Aspects of Intellectual Property Rights. A commentary on the TRIPS Agreement. 
Oxford University Press. New York 2007.  
 
Craven, Matthew C.R.: The International Covenant on Economic, Social and Cultural Rights. A Perspective on 
its Development. Clarendon Press. Oxford 1995.  
 
Cullet, Philippe: Patents and Medicines. The Relationship between TRIPS and the Human Right to Health. In: 
Gruskin, Grodin, Annas and Marks (eds.): Perspectives on health and human rights. Routledge. London 2006. 
 
DiMasi, Joseph A. et al.: The Price of Innovation: New Estimates of Drug Development Costs. 22 Journal of 
Health Economics 151 (2003). 
 



2 

 

Dowell-Jones, Mary: Contextualising the International Covenant on Economic, Social and Cultural Rights : 
Assessing the economic deficit. Martinus Nijhoff. Leiden Boston 2004.  
 
Drahos, Peter: Four Lessons for Developing Countries from the Trade Negotiations over Access to Medicines. 28 
Liverpool Law Review 11 (2007).  
 
Durojaye, Ebenezer: Compulsory Licensing and Access to Medicines in Post Doha Era: What Hope for Africa? 
Netherlands International Law Review p. 33 - 71 (2008).  
 
Dutfield, Graham: Delivering Medicines to the Poor: Will the TRIPS Amendment help? 34 American Journal of 
Law and Medicine 107 (2008).   
 
Eide, Asbjørn: The Obstacles and Goals to be Pursued. In: Eide, Krause and Rosas: Economic, Social and 
Cultural Rights A Textbook. Martinus Nijhoff Publishers. The Netherlands 2001.  
 
Elliot, Richard: Delivering on the Pledge: Global Access to Medicines, WTO Rules, and Reforming Canada’s Law 
on Compulsory Licensing for Export. Vol. 3 Issue 1 McGill International Journal of Sustainable Development 
Law & Policy 23 (2007).  
 
Fischer-Lescano, Andreas & Teubner, Gunther: Regime Collisions: The Vain Search for Legal Unity in the 
Fragmentation of Global Law. 25 Michigan Journal of International Law 999 (2004). 
 
Flynn, Sean: Legal Strategies for Expanding the Access to Medicines. 17 Emory International Law Review 535 
(2003).  
 
Frankel, Suzy: The WTO’s Application of the Customary Rules of Interpretation of Public International Law to 
Intellectual Property. 46 Virginia Journal of International Law 365 (2006).  
 
Gervais, Daniel: The TRIPS Agreement – Drafting History and Analysis. 2nd edition Sweet & Maxwell Ltd. 
London 2003. 
 
Haracoglou, Irina: Competition Law and Patents. A Follow-on Innovation Perspective in the Biopharmaceutical 
Industry. Edward Elgar. Cheltenham 2008.  
 
Hestermeyer, Holger: Human Rights and the WTO. The Case of Patents and Access to Medicines. Oxford 
University Press. New York 2007. 
 
Hoen, Ellen ‘t: TRIPS, Pharmaceutical Patents, and Access to Essential Medicines. A Long Way From Seattle to 
Doha. In: Gruskin, Grodin, Annas and Marks (eds.): Perspectives on health and human rights. Routledge. 
London 2006. 
 
Jenks, Wilfred: Conflict of Law-Making Treaties. 30 British Yearbook of International Law 401 (1953). 
 
Koskenniemi, Martti: Fragmentation of International Law: Difficulties Arising from the Diversification and 
Expansion of International Law. Report of the Study Group of the International Law Commission. Fifty-eighth 
session of the International Law Commission. UN Doc A/CN.4//L.682 (13 April 2006).  
 
Koskenniemi, Martti & Leino, Päivi: Fragmentation of International Law? Postmodern Anxieties. 15 Leiden 
Journal of International Law 553 (2002).  
 
Lazo, Jennifer A.: The Life-Saving Medicines Export Act: Why the Proposed U.S. Compulsory Licensing Scheme 
Will Fail to Export Any Medicines or Save Any Lives. 33 Brooklyn Journal of International Law 237 (2007). 
 
Lazzarini, Zita: Making Access to Pharmaceuticals a Reality: Legal Options Under TRIPS and the Case of Brazil. 6 
Yale Human Rights & Development Law Journal 103 (2003).  
 



3 

 

Lindoos, Anja & Mehling, Michael: Dispelling the Chimera of ‘Self-Contained Regimes’ International Law and 
the WTO. 16 (5) The European Journal of International Law 857.  
 
Marceau, Gabrielle: Conflicts of Norms and Conflict of Jurisdictions. The Relationship between the WTO 
Agreement and MEAs and other Treaties. 35(6) Journal of World Trade 1081 (2001).  
 
Marceau, Gabrielle: WTO Dispute Settlement and Human Rights. 13 (4) European Journal of International Law 
753 (2002).  
 
Mitchell, Andrew D.: The Legal Basis for Using Principles in WTO Disputes. 10 Journal of International 
Economic Law 795 (2007).   
 
Nagan, Winston P.: International Intellectual Property, Access to Health Care, and Human Rights: South Africa 
v. United States. 14 Florida Journal of International Law 155 (2002). 
 
Oh, Cecilia: Compulsory Licenses: Recent Experiences in Developing Countries. Vol 1, Nos 1/2 International 
Journal of Intellectual Property Management (2006).  
 
Pauwelyn, Joost: The Role of Public International Law in the WTO: How Far Can We Go? 95 American Journal 
of International Law 535 (2001).  
 
Pauwelyn, Joost: Conflict of Norms in Public International Law. Cambridge University Press. Cambridge 2003.  
 
Sell, Susan K.: TRIPS-Plus Free Trade Agreements and Access to Medicines. 28 Liverpool Law Review 41 (2007).  
 
Shaffer, Gregory: Can WTO Technical Assistance and Capacity-Building Serve Developing Countries? 23 
Wisconsin International Law Journal 643 (2005). 
 
Sun, Haochen: The Road to Doha and Beyond: Some Reflections on the TRIPS Agreement and Public Health. 
15 (1) European Journal of International Law 123 (2004). 
 
Vivas-Eugui, David: Regional and bilateral agreements and a TRIPS-plus world: the Free Trade Area of the 
Americas. Quaker United Nations Office TRIPS Issue Papers 1 (2003). Accessible at 
http://www.quno.org/economicissues/intellectual-property/intellectualLinks.htm#QUNOPUB (last visited 
16.11.2008). 
 
Vranes, Erich: The Definition of ‘Norm-Conflict’ in International Law and Legal Theory. 17 European Journal of 
International Law 395 (2006). 
 
Yalamanchili, Vijay: State of India’s TRIPS-Compliant Patent Regime. 26 Biotechnology Law Report 211 (2007). 
 
Yamin, Alicia Ely: Not just a Tragedy: Access to Medications as a Right under International Law. 21 Boston 
University International Law Journal 101 (2004).  
 
Other Private Publications 
 
Canadian Hiv/AIDS Legal Network: The Jean Chrétien Pledge to Africa and its impact on improving access to 
HIV/AIDS treatment in developing countries (2008). Accessible at 
http://www.aidslaw.ca/publications/interfaces/downloadFile.php?ref=696 (last visited 10.10.2008). 
 
Consumer Project on Technology: Patent Exception for Exports to Address Health Needs (Legislation to Allow 
for the Export of Pharmaceuticals Produced under Compulsory License). Accessible at 
http://www.cptech.org/ip/wto/p6/index.html (last visited 23.1.2009).  
 
Intellectual Property Quarter Update: Rwanda and Canada: Leading the Implementation of the August 2003 
Decision for Import/Export of Pharmaceuticals Produced Under Compulsory License. 3 Intellectual Property 
Quarter Update 5 (2007).  



4 

 

Accessible at www.ciel.org/Publications/IP_Update_3Q07.pdf (last visited 10.10.2008).  
 
Maastrict guidelines on Violations of Economic, Social and Cultural Rights. Maastricht 1997. Accessible at 
http://www1.umn.edu/humanrts/instree/Maastrichtguidelines_.html (last visited 24.10.2008). 
 
MSF: Why Article 30 Will Work. Why Article 31 Will Not (2002). Accessible at http://www.accessmed-
msf.org/fileadmin/user_upload/medinnov_accesspatents/WhyArticle30willworkwhyArticle31willnot_2002.pdf 
(last visited 5.8.2008). 
 
MSF, Oxfam, CPTech, Health Gap, Third World Network, & Essential Action, Joint Letter to Members of TRIPS 
Council (28 January 2002). Accessible at http://www.accessmed-msf.org/resources/key-publications/key-
publication-detail/Article/joint-letter-to-the-trips-council-january-2002/ (last visited 5.8.2008). 
 
MSF: Neither Expeditious, Nor Solution: The WTO August 30th Decision Is Unworkable (2006). Accessible at 
http://www.msf.ch/fileadmin/user_upload/uploads/communiques/images_2006/pdf/came_Neither_expeditiou
s_nor_a_solution_-_August_30_and_the_JCPA_single_page.pdf (last visited 28.10.2008). 
 
Oxfam: Priced Out of Reach: How WTO Patent Policies Will Reduce Access to Medicines in the Developing 
World. Oxfam briefing paper 4 (2001). Accessible at 
http://www.oxfam.org.uk/resources/policy/health/index.html (last visited 24.10.2008). 
 
Official sources 
 
Decisions, declarations and  resolutions  
 
Council for TRIPS: Decision on the Extension of the Transition Period under Article 66.1 of the TRIPS 
Agreement for Least-developed Country Members for Certain Obligations with Respect to Pharmaceutical 
Products. IP/C/25 (1 July 2002). Accessible at http://www.wto.org/english/tratop_e/trips_e/art70_9_e.htm (last 
visited 24.10.2008). 
 
UN Commission on Human Rights (resolution 2001/33): Access to Medication in the context of pandemics such 
as HIV/AIDS. UN Doc. E/CN.4/RES/2001/33 (71st meeting, 20 April 2001). Accessible at 
http://www.unhchr.ch/huridocda/huridoca.nsf/Documents?OpenFrameset (last visited 24.10.2008). 
 
UN Commission on Human Rights (resolution 2002/32): Access to Medication in the Context of Pandemics 
such as HIV/AIDS. UN Doc. E/CN.4/RES/2002/32 (49th meeting, 22 April 2002). Accessible at 
http://www.unhchr.ch/huridocda/huridoca.nsf/Documents?OpenFrameset (last visited 24.10.2008). 
 
UN High Commissioner of Human Rights: The impact of the Agreement on Trade-Related Aspects of Intellectual 
Property Rights on human rights. Report of the High Commissioner. UN Doc. E/CN.4/Sub.2/2001/13 (27 June 
2001). Accessible at http://documents-dds-
ny.un.org/doc/UNDOC/GEN/G01/143/45/pdf/G0114345.pdf?OpenElement (last visited 24.10.2008). 
 
UN Sub-Commission on Human Rights (resolution 2000/7): Intellectual Property Rights and Human Rights. UN 
Doc. E/CN.4/SUB.2/RES/2000/7. 25th meeting (17 August 2000). Accessible at 
http://www.unhchr.ch/Huridocda/Huridoca.nsf/0/c462b62cf8a07b13c12569700046704e?Opendocument (last 
visited 12.10.2008). 
 
World Health Assembly (resolution WHA56.27): Intellectual property rights, innovation and public health. 56th 
World Health Assembly (28 May 2003). Accessible at 
http://ftp.who.int/gb/archive/pdf_files/WHA56/ea56r27.pdf  (last visited 20.10.2008). 
 
WTO General Council: Implementation-Related Issues and Concerns. WTO Doc.  WT/MIN(01)/17 (14 
November 2001). Accessible at 
http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.htm#trips (last visited 
24.10.2008). 
 



5 

 

WTO General Council: Declaration on the TRIPS Agreement and Public Health. WTO Doc. 
WT/MIN(01)/DEC/W/2 (14 November 2001). Accessible at 
http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm (last visited 24.10.2008). 
 
WTO General Council: Decision on Least-developed Country Members – Obligations Under Article 70.9 of the 
TRIPS Agreement with Respect to Pharmaceutical Products. WTO Doc. WT/L/478 (12 July 2002). Accessible at 
http://www.wto.org/english/tratop_e/trips_e/art70_9_e.htm (last visited 24.10.2008). 
 
WTO General Council: Decision on Implementation of paragraph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health. WTO Doc. WT/L/540, Corr.1 (1 September 2003). Accessible at 
http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm (last visited 23.10.2008). 
 
WTO General Council: Doha Ministerial Declaration. WTO Doc. WT/MIN(05)/DEC (18 December 2005). 
Accessible at http://www.wto.org/english/thewto_e/minist_e/min05_e/final_text_e.htm#non_viol (last visited 
13.1.2008). 
 
WTO General Council: Amendment of the TRIPS Agreement. WTO Doc. WT/L/641 (8 December 2005). 
Accessible at http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm (last visited 25.10.2008). 
 
WTO General Council: General Council´s Chairperson’s statement. Excerpt from the minutes of the General 
Council meeting 30 August 2003. WTO Doc. WT/GC/M/82 (13 November 2003). Accessible at 
http://www.wto.org/english/tratop_e/trips_e/gc_stat_30aug03_e.htm (last visited 3.2.2009).  
 
WTO General Council: Amendment of the TRIPS Agreement – Extension of the period for the acceptance by 
members of the protocol amending the TRIPS Agreement. WTO Doc. WT/L/711 (21 December 2007). 
Accessible at http://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm (last visited 24.10.2008). 
 
Other Official Publications and Documents 
 
Commission on Intellectual Property Rights, Innovation and Public Health: Public Health, Innovation and 
Intellectual Property Rights. WHO 2006. Accessible at   
http://www.who.int/intellectualproperty/report/en/index.html (last visited 24.10.2008). 
 
Commission on Macroeconomics and Health: Investing in Health for Economic Development (2001). Accessible 
at http://www.paho.org/English/HDP/HDD/Sachs.pdf (last visited 6.2.2009).  
 
Council for TRIPS: Minutes of meeting held in the Centre William Rappard 17–19 September 2002. 
IP/C/M/37 (11 October 2002). Accessible at http://www.wto.org/english/tratop_e/trips_e/intel6_e.htm (last 
visited 24.10.2008). 
 
Council for TRIPS: Minutes of meeting held in the Centre William Rappard on 25-27 and 29 November, and 20 
December 2002. IP/C/M/37 (5 February 2003). Accessible at 
http://www.wto.org/english/tratop_e/trips_e/intel6_e.htm (last visited 24.10.2008). 
 
Council for TRIPS: Minutes of meeting held in the Centre William Rappard 4–5 June. IP/C/M/40 (22 August 
2003). Accessible at http://www.wto.org/english/tratop_e/trips_e/intel6_e.htm (last visited 24.10.2008).  
 
Council for TRIPS: Notification under paragraph 2(a) of the Decision of 30 August 2003 on the Implementation 
of the paragraph 6 of the Doha Declaration – Rwanda. IP/N/9/RWA/1 (19 July 2007). Accessible at 
http://www.wto.org/english/tratop_e/trips_e/public_health_notif_import_e.htm (last visited 23.10.2008). 
 
Council for TRIPS: Notification under paragraph 2 (c) of the Decision of 30 August 2003 on the Implementation 
of Paragraph 6 of the Doha Declaration – Canada. IP/N/10/CAN/1 (8 October 2007). Accessible at 
http://www.wto.org/english/tratop_e/trips_e/public_health_notif_export_e.htm (last visited 23.10.2008). 
 
Limburg Principles on the Implementation of the International Covenant on Economic, Social and Cultural 
Rights, UN. Doc. E/CN.4/1987/17, Annex. 9. Human Rights Quarterly 122 (1987).  



6 

 

 
OECD list of countries eligible for official development assistance. Accessible at 
http://www.oecd.org/dataoecd/62/48/41655745.pdf (last visited 16.2.2010). 
 
UNDP: Human Development Report 2001: Making New Technologies Work for Human Development.  
 
UNDP: Human Development Indices: A statistical update 2008 – HDI Rankings. Accessible at 
http://hdr.undp.org/en/statistics (last visited 14.8.2008).  
 
UN Committee on Economic, Social and Cultural Rights: General comment 3: The Nature of States Parties 
obligations (Article 2, par. 1). 5th Session (1990). UN Doc. 14/12/1990. Accessible at 
http://www.unhchr.ch/tbs/doc.nsf/(symbol)/CESCR+General+comment+3.En?OpenDocument (last visited 
25.10.2008).  
 
UN Committee on Economic, Social and Cultural Rights: General comment 14: The right to the highest 
attainable standard of health (Article 12). 22nd Session, 11 August 2000.  UN Doc. E/C.12/2000/4 Accessible at 
http://www.unhchr.ch/tbs/doc.nsf/(symbol)/E.C.12.2000.4.En (last visited 25.10.2008).  
 
UN Development Policy and Analysis Division: The criteria for identifying Least Developed Countries. Accessible 
at http://www.un.org/esa/policy/devplan/profile/criteria.html (last visited 18.1.2008).  
 
UN Special Rapporteur on the right to highest attainable standard of health: Human Rights Guidelines for 
Pharmaceutical Companies in relation to Access to Medicines. Accessible at  
www2.ohchr.org/.../Guidelinesforpharmaceuticalcompanies.doc (last visited 10.4.2010). 
 
UN Treaty Collection: International Covenant on Economic, Social and Cultural Rights. Status as at 26.3.2010. 
Accessible at http://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV-3&chapter=4&lang=en 
(last visited 26.3.2010). 
  
The United States: The proposed Life Saving Medicines Export Act: GovTrack.us. S. 3175--109th Congress 
(2006): Life-Saving Medicines Export Act of 2006. GovTrack.us (database of federal legislation). Accessible at 
<http://www.govtrack.us/congress/bill.xpd?bill=s109-3175> (last visited 9.10.2008). 
 
WHO: World Health Report 2002. Accessible at http://www.who.int/whr/2002/en/whr2002_annex3.pdf (last 
visited 9.10.2008). 
 
WHO: 10 facts on neglected tropical diseases. Accessible at  
http://www.who.int/features/factfiles/neglected_tropical_diseases/en/index.html (last visited 24.10.2008). 
 
WHO: Selection of essential medicines. Accessible at  http://www.who.int/selection_medicines/list/en/ (last 
visited 20.8.2008). 
 
World Bank: World Development Report 2000/2001: Attacking poverty. Accessible at 
http://web.worldbank.org/WBSITE/EXTERNAL/TOPICS/EXTPOVERTY/0,,contentMDK:20194762~pageP
K:148956~piPK:216618~theSitePK:336992,00.html (last visited 3.12.2008). 
 
WTO: List of WTO Members, accessible at http://www.wto.org/english/theWTO_e/whatis_e/tif_e/org6_e.htm 
(last visited 16.2.2010). 
 
WTO: Members accepting amendment of the TRIPS Agreement, accessible at 
http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm (last visited 11.3.2010). 
 
WTO: Regional Trade Agreements. Accessible at http://www.wto.org/english/tratop_e/region_e/region_e.htm 
(last visited 6.4.2010).  
 



7 

 

Relevant Domestic Legislation 
 
Canada: Use of Patents International Humanitarian Purposes to Address Public Health Problems (“Jean Chrétien 
Pledge to Africa”). Patent Act, Section 21. Accessible at http://laws.justice.gc.ca/en/showdoc/cs/P-4/bo-
ga:s_21_01//en#anchorbo-ga:s_21_01 (last visited 24.10.2008).  
 
The European Communities: Regulation (EC) No 816/2006 of the European Parliament and the Council of 17 
May 2006 on compulsory licensing of patents relating to manufacture of pharmaceutical products for export to 
countries with public health problems. Accessible at http://eur-
lex.europa.eu/LexUriServ/site/en/oj/2006/l_157/l_15720060609en00010007.pdf (last visited 24.10.2008).  
 
Switzerland: Zwangslizenzen für die Ausfuhr pharmaceutische Producte. Bundesgesetz über die Erfindungspatente 
(25 June 1954), Articles 40d and 40e. Accessible at http://www.admin.ch/ch/d/sr/2/232.14.de.pdf (last visited 
9.10.2008). 
 
Case Law 
 
WTO Appellate Body: Guatemala-Anti-Dumbing Investigation Regarding Portland Cement from Mexico. WTO 
Doc. WT/DS60/AB/R, para. 65 (5 November 1998). Accessible at 
http://www.wto.org/english/tratop_e/dispu_e/ab_reports_e.htm (last visited 24.10.2008).   
 
WTO Appellate Body Report: United States – Standards for Reformulated and Conventional Gasoline. WTO 
Doc. WT/DS2/AB/R (5 May 1996). Accessible at 
http://www.wto.org/english/tratop_e/dispu_e/ab_reports_e.htm (last visited 29.12.2008).   
 
WTO Panel Report: Canada-Patent Protection of Pharmaceutical Products. WTO Doc. WT/DS114/R (17 March 
2000). Accessible at http://www.wto.org/english/tratop_e/dispu_e/7428d.pdf (last visited 5.9.2008). 
 
WTO Panel Report: Korea – Measures Affecting Government Procurement. WTO Doc. WT/DS163/R (1 May 
2000). Accessible at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds163_e.htm (last visited 
24.10.2008). 
 
WTO Panel Report: Indonesia--Certain Measures Affecting the Automobile Industry. WTO Doc. WT/DS54/R, 
WT/DS55/R, WT/DS59/R, WT/DS64/R (2 July 1998). Accessible at 
http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds54_e.htm (last visited 24.10.2008).  
 
International Agreements 
 
Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural 
Rights. 17 November 1988. OAS Treaty Series No. 69. Accessible at 
http://www.oas.org/juridico/English/treaties/a-52.html (last visited 24.10.2008).  
 
African (Banjul) Charter on Human and Peoples’ Rights. 18th assembly of heads of State and Government, 27 
June 1981. OAU Doc. CAB/LEG/67/3. Entered into force 21 October 1986. Accessible at 
http://www.achpr.org/english/_info/charter_en.html (last visited 24.10.2008).  
 
Agreement on Trade-Related Aspects of Intellectual Property Rights. Annex 1C of the Marrakesh Agreement 
Establishing the World Trade Organization. 15 April 1994. Accessible at 
http://www.wto.org/english/docs_e/legal_e/legal_e.htm#TRIPs (last visited 24.10.2008). 
 
Charter of the United Nations (26 June 1945, effective 24 October 1945).  Accessible at 
http://www.un.org/aboutun/charter/ (last visited 25.10.2008).  
 
Convention on the Elimination of all Forms of Discrimination against Women. GA Resolution 34/180. UN 
Doc. A/34/46, 18 December 1979 (entered into force 3 September 1981). Accessible at 
http://www.un.org/womenwatch/daw/cedaw/text/econvention.htm#intro (last visited 24.10.2008). 
 



8 

 

Convention on the Rights of the Child. GA resolution 44/25. UN Doc. A/44/49, 20 November 1989 (entered 
into force 2 September 1990). Accessible at http://www.unhchr.ch/html/menu3/b/k2crc.htm (last visited 
24.10.2008).  
 
Dispute Settlement Understanding. Annex 2 of the Marrakesh Agreement Establishing the World Trade 
Organization. 15 April 1994. Accessible at http://www.wto.org/english/docs_e/legal_e/legal_e.htm#TRIPs (last 
visited 24.10.2008).  
 
European Social Charter. 18 October 1961. Accessible at 
http://conventions.coe.int/Treaty/EN/Treaties/Html/035.htm (last visited 24.10.2008).  
 
International Covenant on Civil and Political Rights. GA  Resolution 2200A (XXI). UN Doc. A/6316, 16 
December 1966 (entered into force 23 March 1976). Accessible at  
http://www.unhchr.ch/html/menu3/b/a_ccpr.htm (last visited 24.10.2008).  
 
International Covenant on Economic, Social and Cultural Rights. GA Resolution 2200A (XXI). UN Doc. 
A/6316, 16 December 1966 (entered into force 3 January 1976). Accessible at 
http://www.unhchr.ch/html/menu3/b/a_cescr.htm (last visited 24.10.2008).  
 
International Convention on the Elimination of all Forms of Racial Discrimination. GA Resolution 2106 (XX). 
UN Doc. A/6014, 21 December 1965 (entered into force 4 January 1969). Accessible at 
http://www.unhchr.ch/html/menu3/b/d_icerd.htm (last visited 24.10.2008).  
 
Marrakesh Agreement Establishing World Trade Organization. 15 April 1994. Accessible at 
http://www.wto.org/english/docs_e/legal_e/04-wto_e.htm (last visited 24.10.2008). 
 
Vienna Convention on the Law of Treaties (23 May 1969, entered into force 27 January 1980). United Nations, 
Treaty Series, vol. 1155, p. 331. Accessible at 
http://untreaty.un.org/ilc/texts/instruments/english/conventions/1_1_1969.pdf (last visited 25.10.2008).