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J U R I D I C U M

Is there an Obligation to Share?

Pharmaceuticals in Global Health Law

Nejira Softic

VT 2020

RV600G Rättsvetenskaplig kandidatkurs med examensarbete, 15 HP Examinator:

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Abstract

This paper seeks to examine three different regimes under global health law for an answer to if there is a legal obligation on states to share medicine. Through intellectual property law and international trade law, the significance of patents on pharmaceutical products needed to ensure the access to medicine is examined. This regime intersects with international health law, that in this thesis is primarily governed by the World Health Organization, and the human rights instruments. The balancing of rights between inventors and the promotion of public health is discussed as an important element to understand the complicated, yet

essential, relationship that these regimes have. The most important findings are that while the access to medicine under the right to health is recognized without objections, global health law still cannot answer the question of cross-national medicine allocation in a simple manner. The paper finds that there are hard laws binding member states to rules of intellectual

property law, and through this equitable access to medicine can be impeded through patent-inflated pricing. It also finds that there needs to be incentives pertaining to inventions such as exclusive rights and economic gain.

The law solves this dichotomy between the promotion of public health and the right of patents holders through compulsory licensing, a predominantly domestic practice where manufacturers are forced to make a product for the needs of the domestic market. In an important declaration on the TRIPS agreement, the ‘paragraph 6 system’ granted member states to issue compulsory licenses specifically to export pharmaceuticals. The thesis concludes that, while this in itself is not an obligation on states, it is a means to sharing medicine. However, any other rules under public international law expressly stating that states are obliged to share medicine, do not exist.

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Table of Contents

ABSTRACT ... 1 1. INTRODUCTION ... 3 1.1. BACKGROUND ... 3 1.2. LEGAL QUESTION ... 4 1.3. DELIMITATIONS ... 4 1.4. KEYWORDS ... 5

1.5. MATERIAL AND METHODOLOGY ... 5

1.6. DISPOSITION ... 6

2. INTELLECTUAL PROPERTY LAW IN INTERNATIONAL TRADE – PATENT LAW AND HOW IT IS GOVERNED ... 7

2.1. INTELLECTUAL PROPERTY LAW OBLIGATIONS ON STATES ... 8

2.2. MINIMUM STANDARDS FOR PROTECTION UNDER TRIPS ... 10

2.3. PHARMACEUTICAL PATENTS ... 10

2.4. CONCLUSION ... 12

3. INTERNATIONAL HEALTH LAW ... 12

3.1. THE ACCESS TO MEDICINE AND PUBLIC HEALTH UNDER HUMAN RIGHTS LAW ... 13

3.2. LEGAL OBLIGATIONS UNDER THE WORLD HEALTH ORGANIZATION ... 16

3.3. CUSTOMARY PRACTICES ON HUMAN RIGHTS UNDER INTERNATIONAL HEALTH LAW ... 20

3.4. CONCLUSION ... 22

4. OBLIGATIONS ON STATES UNDER INTELLECTUAL PROPERTY LAW AND THE ACCESS TO MEDICINE ... 23

4.1. EXCEPTIONS UNDER INTELLECTUAL PROPERTY LAW ... 25

4.2. CONCLUSION ... 27

5. FINAL REMARKS ... 27

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1. Introduction

What happens when a pandemic of unprecedented scale is raging, and the entire world is scrambling for a solution? And what happens, especially in a situation where a discovery on a pharmaceutical product is made in a state, is that state obliged to share this product with other states?

There are multiple regimes of law involved in this matter. This thesis seeks to examine where some of them intersect and how they reconcile under global health law. This area of law exists for the promotion of health for all peoples and seeks to establish a global standard for public health. This is a hard task to manage in an unequal world, where some states have the capacity to research and develop medicine, and some cannot even afford to ensure their basic needs.

1.1. Background

The regimes discussed in this paper are international health law and intellectual law, as parts of global health law. The main international organization vested with the role of promotion of global health is the World Health Organization. Global health encompasses many aspects such as the human right to health, which can be divided into many parts. One of them stand out and will be the focus of this paper, which is the access to medicine. One of the principal areas of work for the World Health Organization is the promotion of access to medicine.

Intellectual property law is an area within the international trade law regime, and the rules on the global trade are primarily governed by the World Trade Organization as it has to do with the imports and exports between countries. Pharmaceutical products are covered in

international trade through intellectual property law, as they can be patented. A patent gives the inventor of the medicine the legal right to sell, use and export it and prevent others from doing so. Intellectual property rights are territorial in essence, but have through the

international trade order through export of these goods gained importance on an international level, to protect the right holders from counterfeits of their products.

These regimes intersect primarily under global health law, which is the main topic of this paper. Global health law encompasses many aspects of health, but the focus in this paper is right to health and access to medicine, and in extension to this, patents. This is where the topic departs; what happens when there is a global demand for a particular pharmaceutical product and there are huge economic profits to be made from this? From the start, the global health regime’s interference with international trade was kept at minimum, and that is why the areas of law developed separately. The integration of intellectual property rights within the international trade was met with criticism in some parts of the international community, and this might be the very reason to as why there is an issue to discuss here.

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Sharing within this topic, is considered the action of allocation of medicine under hard law between states, either without cost through exportation or minimal cost or through other means, under one of the regimes discussed in this paper. Sharing is, in other words, the transfer of technology or finished product, under directly binding law, and in extension the obligation of states to increase access to medicine under the right to health in cross-national relations.

1.2. Legal Question

Are there any state obligations to share medicine or discoveries of pharmaceutical inventions under global health law?

The purpose of this study is to discover if there are any binding laws under global health law under the specific intergovernmental entities chosen to discuss this topic through. It does so with an approach to the subject guided heavily by the human right to health and the access to medicine within the aspirational framework of social, cultural and economic rights. This is meant to highlight that within these regimes there is directly binding law on the subjects of public international law, or that there is not, and that this poses an issue to the realization of universal access to essential pharmaceuticals needed to uphold human life.

1.3. Delimitations

Pharmaceutical patents regarding vaccines are the focal point of this thesis, and therefore no other type of intellectual property will be studied. Other areas of intellectual property law and practices such as ‘loophole practices’ under intellectual property law will not be discussed, such as evergreening and ‘thicketing’. Furthermore, other areas of international trade law will not be discussed, only the areas that intersect with patents and access to medicine, such as the different types of flexibilities provided under the regime that affect trade.

There is much more to be said on the subject of the so-called developing nations under the international trade law regime and intellectual property, but the North-South discussion pertaining to international trade law will be excluded from this paper. Notwithstanding that the terms ‘developed’ and ‘developing’ sometimes will be used as it has been used in the sources to describe some socioeconomic differences that has called for some legal debate.

There is a lot of material on activities of funding of medical trials and development of

pharmaceuticals, donations of pharmaceuticals under this trilateral system under global health law, and each organization does by itself and in cooperation with the other two create

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guidelines for these types of activities. Nevertheless, they are far too extensive to be

discussed in detail under the scope of this topic and are not of directly legal character in the meaning of an obligation, as understood in this paper. However, research and development will be mentioned under the auspices of WHO and as an incentive for inventors of

pharmaceutical products, as well as a for the promotion of health. This is strictly discussed in the realm of balancing the right of inventors versus the public health, where they intersect.

The processes and laws on biological gene materials surrounding the making of vaccine, regarding their patentability, will not be discussed in greater depth. Since this area of patent law is an issue in itself where a discussion on if it is man-made or merely a discovery, and if it thus fulfills the patentability criteria, falls outside of the scope of this thesis.

1.4. Keywords

Global health law, global health governance, pharmaceutical products, patents, the right to health, access to medicine, accessibility, obligations, public international law, international trade law, public health, minimum standards, flexibilities, compulsory licensing, WHO, WTO, WIPO, Pandemic Influenza Preparedness Framework, Standard Material Transfer Agreements

1.5. Material and methodology

Through applying legal dogmatic method, the relevant current international primary law is going to be found and examined for answers. According to article 38(1)(a) and (b) in the Statute of the International Court of Justice, primary sources are international treaties and international customs. To this end, the relevant sources of law are, primarily, agreements ratified by state parties under the WHO, WIPO and the WTO. The relevant treaties are the Constitution of the World Health Organization, the Patent Cooperation Treaty as well as the Agreement on Trade-Related Aspects of Intellectual Property.

Under the discussion on World Health Organization, the majority of the sources will serve as persuasive authorities where there are no directly binding rules on cross-state relations that form mandatory provisions. This will serve as a discussion for de lege lata, as the sources mostly are considered soft law under the World Health Organization. This study will also examine customary norms of international law as regards the practice of the right to health and access to medicine, and the obligation to cooperate, to support the thesis, as one of the most important sources of international law under the ICJ Statute article 38(1)(b). Through the findings of the existing law, it is also possible to pinpoint where the law is missing and how it should be. The final part of this thesis will use sources to discuss de lege ferenda.

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Also, since the discussion is being conducted in light of obligations in the area of access to medicine, other persuasive sources will include human rights instruments. These include the International Covenant on Economic, Social and Cultural Rights (ICESCR), the United Nation’s Charter documents, articles and general comments are secondary sources used in the interpretation of the access to medicine through the right to health.

1.6. Disposition

Chapter two seeks to examine the obligations on states under international trade law and intellectual property law. An explanation of pharmaceutical patents is given, as well as the relationship between the organizations governing the laws. The relevant treaties are

introduced as well as the rights of patent holders through these. This serves as a background to the rest of the paper.

Chapter three examines if there are legal requirements on states through their membership in the World Health Organization. To do so, the human rights approach is deployed from which many of these obligations stem, and to interpret the work of the WHO. To this background, the topic is introduced with a short part where the right to health is explained. The WHO response to the public health needs of the world will be discussed as a development of this, in its primary purpose as the guiding authority on global health. Its main binding instrument will be discussed under subsection 3.2. to show which rules the member states are bound by, to discern how effective the actual hard law under WHO is. This serves as a depiction of the special status of the World Health Organization as an assisting organ to the member states, where hard laws are scarce. The section also discusses customs pertaining to the sharing of medicine within the right to health and the obligation to cooperate.

The final part under chapter four of the analysis of international law will be the topic of intellectual property and access to medicine. It will do so through a discussion of the obligations on states under the right to health pertaining to the access to medicine, and the patent protection regime. The discussion is conducted with a rights based-approach in the following subsection, on the balancing of rights between right holders and public health. A possible solution to the question is then given.

The last chapter will map out the legal gray areas of public international law, that makes the governance of global health law more challenging. The discussion will take form, with the background of the information on the current law discussed in this paper, to propose what the law should be to facilitate work on the access to medicine.

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2. Intellectual Property Law in International Trade – Patent Law

and How it is Governed

This section seeks to create an understanding of how international trade law works, and how intellectual property rights play into it and what they are as regards patents. It is going to do so by an account of the intergovernmental organizations on the area as well as the binding instruments that they are governing.

Intellectual property rights law within the area of patents is territorial is essence, as it is granted by the country of domicile of the individual seeking the patent. Intellectual property rights saw an upswing during the second industrial revolution and its major innovations pertaining to technology, where there was a need for international protection of intellectual property rights to ascertain that ideas would not be stolen and exploited in other countries. That marked the start of the era of treaties pertaining to multinational protection of

intellectual property goods, namely the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention) and Paris Convention for the Protection of Industrial Property (Paris Convention). The Bureaux for the Protection of Intellectual Property, best known as ‘BIRPI’ by its French Acronym, administered these treaties. BIRPI became the World Intellectual Property Organization (WIPO) in 1970, and in 1974 the WIPO joins the UN as a specialized agency. The functions of WIPO include promoting development and protection of intellectual property and promoting harmonization of legislation, encouraging international agreements and promoting the dissemination of information and conducting studies on intellectual property.1

WIPO also administers the Patent Cooperation Treaty (PCT),2 which assists rights holders in

getting the possibility of patent recognition in multiple contracting states by filing an

application under the PCT. The PCT gives detailed requirements on the formalities required to get a multinational patent but the final decision is not taken on the international level. It is the individual national authorities, under their jurisdiction, that grant patent protection within their territories. The inventor can obtain patent protection through other means, such as filing applications directly in other countries or going the ‘Paris-route’ and seek to obtain rights in the Paris convention contracting states, but the PCT route is the simplest and most cost-effective way.3

WTO was established during the Uruguay Round with the aim of creating a single entity to encompass the General Agreement on Tariffs and Trade (1994) and all other legal

1 Convention Establishing the World Intellectual Property Organization (WIPO) (Signed July 14 1967, amended

on September 28 1979) Art. 4.

2 WIPO, Patent Cooperation Treaty (Done June 19, 1970, amended on September 28, 1979, modified on

February 3, 1984, and on October 3, 2001) [hereinafter ‘PCT’]

3 WIPO, Protecting your Inventions Abroad: Frequently Asked Questions About the Patent Cooperation Treaty

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instruments under the multilateral trade order.4 The most important treaty on intellectual

property is the Trade Related Aspects of Intellectual Property Rights (TRIPS, the TRIPS Agreement) that was introduced through Annex 1C of the Marrakesh Agreement establishing the WTO. It brought minimum standards of the protection of intellectual property at the international level through international trade law. One of the reasons for this was the combatting of counterfeit goods undermining international trade.5 It does so by putting

requirements on the parties to comply with WIPO administered treaties, such as the Berne and Paris convention, as well as introducing modern-day technology to those protections.6

It is also important to keep in mind the relationship with a third actor under global health governance which is the World Health Organization (detailed discussion under section 3). The WTO, WIPO and WHO each have separate areas of work and law, but they complement each other on issues relating to public health. The Director-General of the WTO stated that this relationship consists of “(…) exploring how best to harvest the potential of [the three organizations'] reserves of knowledge and information, to strengthen cooperation towards a goal all can surely share: put simply, that of getting needed medicines to the people who are in most need.”7

2.1. Intellectual Property Law Obligations on States

An explanation to intellectual property law, what it entails and what it consists of, is

important to understand the topic of this thesis, before delving into the legal obligations that flow from the agreements. Patents are rights granted to inventors by their respective

governments, to things or processes that hold commercial value and is in short, the right to protect one’s invention from being exploited, i.e. “made, used, distributed, imported or sold by others” without the consent of the owner of the patent.8 Patents are of territorial character,

meaning that the protection is granted by the state of which the patent holder is a national and is enforced domestically.9

The idea of the rights pertaining to creating something and gaining both the positive rights to exploit the invention, and the negative right to prevent others from doing do, is important for the economic development as it should incentivize people to create.10 Since many of the

inventions that are protected by patents have direct relation to public health, proper

remuneration for these discoveries is an incentive to contribute to research and development

4 WTO Agreement: Marrakesh Agreement Establishing the World Trade Organization, (Signed April 15 1994,

entered into force 1 January 1995) 1867 U.N.T.S. 154, 33 I.L.M. 1144 (1994) [hereinafter ‘WTO Agreement’].

5 Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994) 1869 UNTS 299. (TRIPS

agreement)

6 ibid

7 Pascal Lamy, Opening Remarks “Access to Medicines: Pricing and Procurement Practices” [2010]

WIPO-WTO/WHO/GE/10

8 World Intellectual Property Organization, What is a patent? <https://www.wipo.int/patents/en/> accessed 19

April 2020, see also TRIPS Agreement Art. 28

9 Preamble to the TRIPS Agreement, (n 5)

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(R&D).11 Medical formulae, medicine, is one of these inventions. Another important aspect

of patent protection is that inventions most often are built upon at least some idea that has already existed, even another invention. Therefore, it is socially valuable for inventors to share their blueprints, for other inventors to be able to develop upon that.12 It is to this

background the dissemination of said blueprint is one of the cornerstones for patentability. It holds importance in the realm of public health as it can contribute to the development of pharmaceutical products, and these are always needed especially in the emergence of new diseases.

National laws should, as a result of this, require the patent applicant to provide disclosure of the invention that it is ‘sufficiently clear and complete’ that a person skilled in that same area can make and use it.13 The importance of the disclosure is a balancing of rights as regards the

inventor versus the public and other third parties. The inventor is awarded remuneration, full exploitation and commercial rights, against going public with the detailed information on the invention. The invention also needs to be finished, meaning a product or process that is not fully done and ready to use is not patentable and thus prevents applicants from filing claims.14 This means that there are limits to the patentability of products and processes,

because of the requirements of: ‘new, involve an inventive step and are capable of industrial application’.15

While the requirements are given as minimum standards in the TRIPS agreement, national laws are in many cases not identical to these provisions (depends on if the relationship between the state and the international law is monistic or dualistic) but article 63.2. requires member states to notify the TRIPS Council of its laws and regulations concerning the TRIPS agreement and the minimum standards, without delay.16 The WTO membership does, in other

words, impose direct legal obligations on the states as regards the protection of intellectual property.

As mentioned before, TRIPS bind the Member states to a number of minimum standards pertaining to intellectual property that should be provided and enforced through national legislation, and it does so through a requirement of compliance with the substantive

obligations under the conventions of, inter alia, WIPO.17 This gives even wider protection for

intellectual property because under the PCT, formal requirements in all its contracting states are collected. The formal requirements are, pursuant to the difference in the language of the rules under national laws, different in the contracting states. Through the assistance of the PCT, the patent can gain recognition in other countries and regions.18

11 Intellectual Property Handbook, (n 10) 12 ibid

13 TRIPS Agreement, (n 5) Art. 29 14 TRIPS Agreement, (n 5) Art. 27.1 15 ibid

16 World Trade Organization, (WTO), Procedures for Notification of, and Possible Establishment of a Common

Register of, National Laws and Regulations under Article 63.2. – Decision of the Council for TRIPS of 21 November 1995 (30 November 1996) 1-6

17 Preamble to the TRIPS Agreement, (n 5) 18 PCT, (n 2) Arts. 1-4

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2.2. Minimum Standards for Protection under TRIPS

The minimum standards provided by TRIPS are, as the objectives in the Preamble to the agreement speak to, aimed at a coherent intellectual property regime on the international level.19 By these, the member states are obliged to guarantee protection, limitations and

enforcement of patents in the national legislation.

The minimum standards pertaining to patents include the areas eligible for protection, the substantive and formal requirements for protection, and exceptions are found in article 27.20

Through these standards, the TRIPS agreement ensures a coherent system globally, through which international trade is facilitated. It also facilitates multilateral protection under WIPO. The terms are not defined in the agreement and are left to the member state’s discretion to an extent (discussed in section 4),21 especially in light of the special needs of least-developed

countries. However, the terms ‘inventive step’ and ‘capable of industrial application’ are regarded as synonymous with ‘non-obvious’ and ‘useful’ according to WTO,22 and provide

the general requirements for patentability. Other definitions of the requirement of the inventive step is that it is new, or meets the requirement of novelty meaning that it does not form part of the state of the art. The term invention has been loosely defined as a new solution to a technical problem. To ensure that the member states have a system in place which coherently issues patents on these grounds facilitates a wider recognition and protection for these products and processes.

The patent owner’s product has exclusivity on the market and all others are excluded to replicate it, thus the prices become inflated. This patent system works as an incentive as the exclusive right is a reward for creation, but even so, if patent rights were infinite, there would practically be no social benefit to them since the high prices unfortunately will exclude people that are in need of drugs since they cannot afford them. The solution to this issue is a term that is limited in time of the protection, which is according to the TRIPS agreement. As regards the price, in an article in the WIPO journal it has been stated: “Pharmaceuticals and life-saving medications hold a unique significance in the marketplace. Unlike consumer products, where demand is dependent on affordability, the demand for life-saving

medications is independent of affordability. Thus, in markets with low per capita income, such as developing countries, high prices sustain or even increase the demand as access becomes limited.” 23 In the next section, the peculiarities of pharmaceutical patents and their

implications on global health law through international trade are going to be discussed.

2.3. Pharmaceutical Patents

19 Preamble of the TRIPS Agreement, (n 5) 20 TRIPS agreement, (n 5) Art. 27

21 WIPO, Certain Aspects of National/Regional Patent Laws, Inventive Step (Obviousness), Status as of April

2020

22 TRIPS Agreement, (n 5) Art. 27

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A ‘pharmaceutical product’ is by the definition of a WTO General Council decision ”any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address the public health problems as recognized in paragraph 1 of the Declaration on TRIPS and Public Health [the Doha declaration].” 24 In paragraph 1, it is clear

that these public health problems are, according to the Doha Declaration, but are not limited to: ‘HIV/AIDS, tuberculosis, malaria and other epidemics’.25 Pharmaceuticals patents are a

special category of intellectual properties because they often have direct impacts on health. The difficulties lie first and foremost in the balancing of the right holder against public health, where the exclusivity of the product resulting from the protection under intellectual property law often means higher pricing.26

While it is clear that the topic is access to medicine, the question is how the world trade approached the matter from an intellectual property point of view. From the very start of the era of the WTO in 1995, concerns about it included the incorporation of intellectual property law into international trade through the TRIPS Agreement. The concerns were mainly based in the implications of the TRIPS and patents and how it would affect the access to drugs.27

This is primarily an issue in countries where the strong protection of patents poses an issue to the already existing problem in realizing the basic right to health. That means that these standards that are introduced by the intellectual property law as an area of international trade, are high in comparison to some socioeconomic contexts, especially in developing countries. The question then arises how the situation should be balanced when a drug is not accessible in regard to the patent inflated price, if the country needs to uphold the standards under the TRIPS agreement to honor the rights of the patent holder, or if e.g. copies of the products could be made to be able to ensure health to the population. Because accessibility is so closely tied with affordability, the brand-products are most often not readily accessible because of the price during the 20 years of protection.

However, after this period of exclusivity, generics can be made. These are ‘copies’ of the original drug. Generics can also be made through voluntary or compulsory licensing. This is what some argue is one of the components of the balancing of these rights, i.e. a limited time of protection against the public’s accessibility. .28 It is also important to state that there is no

generic version of a vaccine, because of its biological entities it is too complex to be treated in the same manner.

The WTO has concluded that the TRIPS agreement needs to be read in a manner consistent with public health. Interpretations and implementations of the agreement should not hamper

24 WTO, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health

"(Decision of 30 August 2003) WT/L/540 and Corr.1.

25 WTO Ministerial Conference, Doha, Qatar, Declaration on the Trips Agreement and Public Health (Adopted

14 November 2001) WT/Min01/DEC2 (Doha Declaration)

26 ibid

27 Correa, M, Carlos. Implications of the Doha Declaration on the Trips Agreement and Public Health, World

Health Organization, WHO/EDM/PAE/2002.3, (2002) pp. 1-2.

28 WTO, ‘Fact Sheet: Trips and Pharmaceutical Patents; What does ‘Generic’ mean?’ <

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governments in protecting public health.29 To this objective, WTO clarified some of the

flexibilities that states could make use of and also extended the period of which provisions on pharmaceutical patents had to be implemented until January 1st 2016 in the least-developed

countries.30 The issue relating to the latter part, was that some countries sought to not

recognize pharmaceutical patents in national legislation because of the inflated prices resulting from this. The transition period was extended until 2033 in 2015, or until a least-developed country ceases to be in this group.31 As regards the flexibilities, these have been

incorporated into the TRIPS Agreement since it came into existence, but the Doha

Declaration helped in interpreting them and also extending them. Further, the flexibilities mechanism covers pharmaceutical products, including medicines, vaccines and diagnostics, needed to combat an epidemic.32 This removed the obstacle of the patented product being

entirely inaccessible to some countries, through allowing for use through compulsory

licensing even when the importing state cannot manufacture pharmaceuticals themselves (see section 4 for detailed discussion on this).

2.4. Conclusion

The patent protection regime under the WTO in the TRIPS agreement imposes obligations on states as regards the least amount of protection of inventions. Through the PCT, the patents can provide multinational protection and recognition for the right holders. It is also clear that there are criteria for a patent to be granted, which include inventiveness, novelty, and

industrial application. These requirements ascertain that not everything can be patented, but the terms can have different wordings in national legislation. This means that a patent can be granted under the provisions under PCT in more countries than where the inventor is a national. This could also

The patent in itself gives the right holder grounds for adequate remuneration and this is in turn an incentive to invent. The minimum period of protection of 20 years serves as a time of exclusivity of the patent on the market, where the price can be decided on the basis of this exclusivity. The time of protection also serves as a limitation on the right, where the public in the end can benefit from it fully (For detailed discussion on the balancing of rights, see chapter 4).

3. International Health Law

29 WTO, “The Doha Declaration explained, TRIPS (pars 17-19)” (2006)

<https://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm#trips > accessed 2 May 2020

30 Doha Declaration, (n 25)

31 The Council for TRIPS, 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, Decision of 6 November 2015 (IP/C/73)

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The next section deals with global health law under a key participant in the area: The World Health Organization. In this paper, the definition of this area of law is in agreement with L. Gostin and A.L. Taylor’s wording of what it entails:

“Global health law is a field that encompasses the legal norms, processes, and institutions needed to create the conditions for people throughout the world to attain the highest possible level of physical and mental health. The field seeks to facilitate health-promoting behaviour among the key actors that significantly influence the public's health, including international organizations, governments, businesses, foundations, the media, and civil society. The mechanisms of global health law should stimulate investment in research and development, mobilize resources, set priorities, coordinate activities, monitor progress, create incentives, and enforce standards. Study and practice of the field should be guided by the overarching value of social justice, which requires equitable distribution of health services, particularly to benefit the world's poorest populations.”33

3.1. The Access to Medicine and Public Health under Human

Rights Law

The right to health is one, if not the most, basic human right recognized across both regional and international levels of protection. Under the United Nation (UN) Charter article 55, the objective is also the promotion and cooperation concerning economic and social relations where the UN shall promote ‘solutions of international, economic, social, health, and related problems (…)’ of which e.g. the fight against HIV/AIDS has been one.34 One of the priorities

of the UN has thus been the fight against diseases and the promotion of public health. Public health is a critical necessity for the development of all states and recognizes that cooperation is needed even beyond emergency,35 such as the emergency under Covid-19, meaning that

international cooperation is essential to the realization of public health.

The right to health is realized through progressive realization under article 12 of the International Covenant on Social, Economic and Cultural Right (ICESCR) and is based on the elements of availability, accessibility, acceptability, and quality.36 The focal point in this

thesis is the accessibility, especially in connection with public health concerns in pandemics and essential drugs. The right to health has to be interpreted and understood against the socio-economic and biological context within which the individual(s) exist,37 and the right

33 Lawrence O. Gostin, Allyn L. Taylor, Global Health Law: A Definition and Grand Challenges, Public Health

Ethics, Volume 1, Issue 1, April 2008, pp. 53–63, https://doi-org.db.ub.oru.se/10.1093/phe/phn005 accessed 1 May 2020

34 United Nations (UN), Charter of the United Nations, 24 October 1945, 1 UNTS XVI, Art. 55(b)

35 UN General Assembly (UNGA) Res 63/33 (27 January 2009) UN Doc A/RES/63/33, see also UN Repertory

of Practice of United Nations Organs Supp No. 10 (2000-2009) vol 4, paras. 125-126

36 UN Committee on Economic, Social and Cultural Rights, ‘General Comment No 14: The Right to the Highest

Attainable Standards of Health (Art. 12)’ (11 May 2000) ESCOR [2001] Para. 12

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encompasses much more than health care services, which widens the obligation on states.38

State parties’ obligations under article 12 requires them to make public health care available, and accessible through non-discrimination and economic accessibility.39 Under ICESCR,

state parties undertake to work toward: ‘the prevention, treatment and control of epidemic, endemic, occupational and other diseases’40 and ‘the creation of conditions which would

assure to all medical service and medical attention in the event of sickness’.41 This means

that states have agreed to, among other things, make treatment accessible for all people, and accessibility entails economic affordability. Further, the undertaking means the right to treatment that should be put in place through adequate health care in e.g. epidemics, and the states’ joint efforts to make available technologies, of which an example is immunization programmes.42

It is also vital to remember that states have undertaken to progressively move toward these goals in a manner that agrees with their socio-economic situation according to the obligation under the right to health. However, this does not entail that states can neglect their obligations under this provision because the right is not absolute and direct. In fact, the work needs to be consistent and the requirement on states to, at minimum, ensure the core obligations under article 12 ICESCR. The core obligations are the guarantees of ensuring satisfactory minimum essential levels of e.g. primary health care, through taking the necessary steps to the

maximum of available resources. States unwilling to act accordingly are in violation of their obligations under article 12.43

While states have obligations to take actions jointly to protect, respect and fulfill the right to health, the obligation is limited insofar as international human rights law does not require states to do so with other populations than their own. It was established in an advisory opinion by the ICJ that ‘territories over which a State party has sovereignty and to those over which that State exercises territorial jurisdiction’.44 This needs to be kept in mind when trying

to find an answer to the present issue in this paper. However, ICESCR itself does not have a provision on jurisdictional or territorial scope. But the provisions under the treaty can be interpreted as obliging states to at least not act in a manner that has extraterritorial harming effects, pursuant to e.g. article 2(1) where it calls for ‘international assistance and

cooperation’. Needless to say, it is a hard to make a case that promoting patent holders’ rights will harm others abroad. Nevertheless, it is important to seek out an answer where access to medicines is concerned, since the right to health is an obligation on individual states. If

38 General Comment 14, para. 4.

39 World Health Organization (WHO), ‘25 Questions and Answers on Health and Human Rights’, Issue 1 I July

2002, p. 12

40 International Covenant on Economic, Social and Cultural Rights (Adopted 16 December 1966, entered into

force 3 January 1976), UNTS 993 (ICESCR) art. 12(2)(c)

41 ICESCR, art. 12(2)(d)

42 General Comment 14, para. 16 43 General Comment 14, para. 32

44 Legal Consequences of the Construction of a Wall in the Occupied Palestinian Territory (Advisory Opinion)

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individual states have a medicine that is vital for another state’s population, does the withholding of said medicine harm that other state?

The UN Commission on Human Rights concluded in a resolution that: “access to medication in the context of pandemics such as HIV/AIDS, tuberculosis and malaria is one fundamental element for achieving progressively the full realization of the right of everyone to the

enjoyment of the highest attainable standard of physical and mental health.”45 The member

states, inter alia, are called upon to develop and put in place strategies through which they set out to realize this objective in accordance with applicable international law and agreements. These strategies include measures that build capacity in facilitating and realizing public health, especially in regards preparedness in new diseases with unknown origin, through cooperation between states and other international, regional, national and local subjects.46

Further, the United Nations Millennium Declaration adopted eight Millennium Development Goals (MDGs) in the year 2000 which all UN Member States had agreed to attempt to realize by 2015. Within these objectives the importance of health care was stressed, and in target 8e pharmaceutical companies were called for increased cooperation in order to facilitate and provide access to essential medicine in developing countries.47 In 2016, the Sustainable

Development Goals (SDGs) were initiated where the equivalent goal on health emphasizes the importance of further cooperation for developing and providing access to vaccine and medicine in accordance with the Doha Declaration on TRIPS Agreement and Public Health.48

Neither the MDGs nor the SDGs have legally binding effect on the international legal

subjects referenced, nevertheless they constitute guidelines for the work on the progression of the right to health.

The access to medicine is an integral part of the right to health, and it goes much further than the physical element of it, described in the UN MDGs as ‘having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population.’49 The issues surrounding it are in

this topic grounded in, as previously discussed, patent-inflated prices during the time of validity of the patent because of the exclusivity on the market and which will make the medicine directly unavailable for some people.

On the international level, article 57 of the UN Charter establishes a connection with

specialized agencies by intergovernmental agreements. In the preamble of the Constitution of the World Health Organization,50 it recognizes itself as a specialized agency awarded the

45 UN Commission on Human Rights (UNCHR) Res 29 (2003) UN Doc E/CN.4/2003/L.11/Add.3 para. 1 46 General Comment 14, (n 37), para. 33.

47 UNGA Res 55/2 ‘United Nations Millennium Declaration’ (8 September 2000) GAOR 55th Session UN Doc

A/RES/55/2

48 UNGA Res 70/1, ‘Transforming our world: the 2030 Agenda for Sustainable Development’ (21 October

2015) GAOR 70th session, UN Doc A/RES/70/1

49 MDG Gap Task Force Report, Millennium ‘Development Goal 8: Delivering on the Global Partnership for

Achieving the Millennium Development Goals’ (published 2008, United Nations Publication) ISBN 978-92-1-101172-2 p. 35

50 Constitution of the WHO (signed 22 July 1946, entered into force 22 July 1946) UNTS 185, (‘WHO

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responsibility of international cooperation in the promotion and protection of health of all peoples.51

In the following section, the World Health Organization’s regulations are going to be examined for answers and guidelines on legal obligations of states on public health and access to medicines. The issue is primarily when there is a disease crisis within a nation with potential cross-national effects, or otherwise, to seek out if there are legal obligations on states to maintain patent protection and/or are there legal obligations on states to share discoveries within the medical field with other nations under the WHO. The topic is going to be introduced with a brief historical background on the World Health Organization.

3.2. Legal Obligations under The World Health Organization

The international cooperation on public health started with the proliferation of diseases (dating back to the yellow fever, plague, cholera) resulting from the progression in the area of international relations in e.g. commercial exchanges. The cooperation consisted of three main measures that were initiated: quarantine52 for certain populations, expansion of scientific

knowledge for the leaders in the subject for prevention of the spreading and treatment of wide-spread diseases, and through these measures in ensuring that interference is kept at minimum regarding international commercial relation and transportation.53 It is therefore

important to keep in mind that the origins of international health law were characterized with an unwillingness to interfere with international trade and that the regimes developed largely separate from each other because of this.

Global health law today governed by a human rights-based approach, which means that development efforts are interconnected with a system of rights and the corresponding state obligations under international law. This means that all efforts that are deployed within global health law, are guided by the framework rights that are civil, cultural, economic, political and social.54 To this background, the work of the WHO is interpreted in this paper.

The WHO is a United Nation’s specialized organ dedicated to ‘promote and protect the health of all peoples’. It was adopted by the International Health Conference in July 1946 in the aftermath of World War II and entered into force in April 1948, referenced in article 55 of the UN Charter. The primary objective is the ‘highest attainment by all peoples of the highest possible level of health’.55 The realization of the right to health is awarded, inter alia, the

WHO through its programmes on development.

51 WHO Constitution.

52 Eibe Riedel, ‘Health, Right to, International Protection’, Max Planck Encyclopedias of International Law

(Last updated April 2011)

53 Yves Beigbeder, ‘World Health Organization’, Max Planck Encyclopedias of International Law (Last updated

July 2013)

54 Office of the High Commissioner for Human Rights OHCHR) andWHO, The Right to Health, Factsheet No.

31, 2008

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The WHO sets international health standards in a policy-based manner through its position as the directing and coordinating authority on international health work,56 among other things

through the collaboration with intergovernmental organizations, governments and other organizations57 and through its agreements, regulations and recommendations with respect to

international health,58 to ‘generally take all necessary action to attain the objective of the

organization’.59 Its core assignment is assisting member states in realizing and developing

health care and access to health within each nation primarily. The WHO response to the public health needs of the world includes: “strengthening the capacity of WHO and its Member States to integrate a human rights-based approach to health; advancing the right to health in international law and international development processes; and advocating for health-related human rights, including the right to health.”60

In the 1978 Declaration of Alma-Ata,61 the International Conference in Primary Health Care

took place, endorsed by WHO. This document is considered a milestone on the definition of the right to health through a primary health care system62 and the issues surrounding it,

preventing it from being fully realized especially in developing nations. It makes special remarks on the importance of the governments’ progressive work in matters relating to ensuring an adequate standard of health, and access to it through the establishment of a primary health care regime, and also in the effective combatting of the inequality in the health status of peoples. This inequity is particularly evident in comparing developed and developing nations, and the issues deriving from this is of ‘common concern to all

countries’.63 Within the definition of primary health care, the declaration expresses the need

for states to ensure access to essential medicine.64 This is important because it has more or

less had impact on defining the wide scope of the right to health.65 There are certain

medicines that the states should be able to provide for their nationals, but are hindered by inadequacy of health care systems and unaffordability of medicines, directly connected to their economic and developmental situation

In an article on the MDGs relating to health, the WHO listed its objectives aiming at progressing these goals through its functions in e.g. strategical development of preventing people from suffering from poverty because they have to pay for health care themselves (the WHO has calculated that 100 million people are forced into poverty each year as a result of

56 WHO Constitution, (n 51) Art 2(a) 57 WHO Constitution, (n 51) Art 2 (b) 58 WHO Constitution, (n 51) Art 2 (k) 59 WHO Constitution, (n 51) Art 2 (v) 60 The Right to Health, (n 55)

61 The 1978 Declaration of Alma-Ata, International Conference on Primary Health Care, Alma-Ata, USSR, 6-12

September 1978 II (‘Alma-Ata Declaration’)

62 Eibe Reidel, (n 53)

63 The Alma-Ata Declaration, (n 65) Para II

64 The Alma-Ata Declaration, (n 65) Para. VII.3, see also UNCHR, Human Rights Indicators, A guide to

measurement and implementation, (2012) UN Doc HR/PUB/12/5

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this).66 Had there been a functioning primary health care system and equity in the access to

medicine everywhere, this may not have been the case. These strategies highlight how the WHO cooperates with states to achieve the MDGs set out by the UN Millennium Declaration and were formulated as ‘the WHO helps countries’, which is a core function of the WHO.67

Here it also important to underscore the central role that the sovereign governments play and that is the level where the work needs to be done to realize these.

A Global Vaccine Action Plan (GVAP) was put in place in 2011 as a global immunization strategy until 2020 and during that time it brought together stakeholders under common goals and shared visions of the subject.68 Even though it brought with it success in many aspects, it

had its shortcomings, among them were difficulties in emerging challenges during that decade, where GVAP struggled in influencing responses to these challenges. The

Immunization Agenda 2030 was drafted by the WHA this year in replacement of the GVAP, and one of the aspirations is increasing equitable access and use of new and existing

vaccines. In its introduction the WHA concludes that ‘countries should identify essential services that [need] to be prioritized and maintained during emerging infectious disease threats and move as soon as feasible to provide missed vaccinations’.69

The WHO also works on a global approach to equitable access to pandemic influenza viruses, medical kits, medicine and vaccine through the Pandemic Influenza Preparedness and

Response (PIP) Framework. The PIP Framework is an umbrella term for different approaches to the subjects, such as the Global Influenza Surveillance and Response System (GISRS), through which influenza viruses are shared with public health laboratories to promote development of vaccine and antiviral medicine. The GISRS is an international network of laboratories that are coordinated by the WHO, and these include member state designated and authorized laboratories and researchers, as well as private public health researchers.70

The GISRS is comprised of institutions in 115 WHO member states (out of 194 total member states to the WHO Constitution). These are National Influenza Centers (NICs), WHO

Collaborating Centres (WHO CCs), Essential Regulatory Laboratories (ERLs) and H5 Reference Laboratories (H5 Labs) that make up what is called the GISRS under the PIP Framework. The NICs are national institutions created by the member states’ Ministries of Health. The NICs collect virus specimens in their respective countries and analyze these, which then are sent to WHO CCs for more advanced analysis.71 The WHO CCs and H5 Labs

are designated by the WHO, where the CCs have extensive global responsibilities and technical abilities, and the H5 Labs assist in diagnosing H5 virus infection until national and

66 Dr. Margaret Chan, Strengthening multilateral cooperation on intellectual property and public health, (2009)

World Intellectual Property Organization Conference on Intellectual Property and Public Policy Issues, <

https://www.who.int/dg/speeches/2009/intellectual_property_20090714/en/> accessed 2 May 2020

67WHO, ‘20 ways that the World Health Organization helps countries reach the Millennium Development

Goals’, WHO/DGO/2010.3 (2010)

68 World Health Assembly, ‘Immunization Agenda 2030: A global strategy to leave no one behind’, IA2030 p. 8 69 ibid, p. 4

70 WHO, Pandemic influenza preparedness framework for the sharing of influenza viruses and access to

vaccines and other benefits, (2011) ISBN 9789241503082

71 WHO, Global Influenza Programme, guidance for surveillance during an influenza pandemic, (2017) ISBN

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regional capacities can do so in a reliable manner as well.72 The WHO designated entitites are

contracted through a legally binding Standard Material Transfer Agreement (SMTA 1) under the GISRS, where the exchange of influenza viruses and vaccines between them happen.73

SMTA1 also prohibits parties from seeking patents on materials received under GISRS.74

The SMTA2 is binding on WHO and on the influenza product manufacturers who are non-GISRS entities.75 Further, the SMTA2 Annex 2 obliges entities that receive biological

materials under the PIP Framework to commit to at least two of the options provided by the SMTA2.76 These are ranged from donations of vaccine and antivirals, to fair and reasonable

licensing in developing countries, to royalty-free licensing, and these are to be agreed by the receiving party and WHO.77 SMTA2 does not prohibit patenting of the materials, but the

obligation under the agreement on the commitment of options that include, but are not limited to, donations or licensing is balanced against this.78 This has similarities with the compulsory

licensing mechanism under the TRIPS agreement that will be discussed in section 4.

While it is uncontestable that the right to access medicine exists within the sphere of WHO, it is clear that all efforts to realize this are primarily aimed at national levels as obligations on individual states, and the regime is careful in addressing the relationship between states. The obligation of the WHO does however cover ‘all peoples’ as is stated in its Constitution, and it does so through joint efforts with the states. As is seen with e.g, the MDGs, SDGs, GVAP, the Immunization Agenda, the PIP Framework and other efforts where the WHO operates by itself or in cooperation with other organizations on the international level, equitable access to pharmaceutical products is the aim. Through cooperation with nations and organization that grant and uphold intellectual property rights on pharmaceutical products, the affordability criteria of the access can be realized.

This is evident by the relationship under the SMTAs. The benefit sharing system under SMTA1 creates a legally binding relationship between national health entities and other entities under WHO through reciprocity on benefits, and these are prohibited from seeking to obtain intellectual property rights on materials shared between them, they must also share some of the products they make with the WHO, such as vaccine.79 SMTA2 on the other hand,

are bilateral contracts with manufacturers where these receive PIP materials, and in return that can choose from options under the SMTA2 on how to reciprocate. Some of these options are direct donations of vaccine and antivirals to the WHO. The total concluded SMTA2s are 13, 5 of which are with multinational companies. The benefit sharing system under the PIP Framework also concludes that member states should contribute to this, by inter alia, operate

72 PIP Framework, (n 70) p. 10

73 PIP Framework, (n 70) art. 5.4.1. p. 14

74 Standard Material Transfer Agreement 1, Annex 1 to the PIP Framework, Article 6

75 WTO, WIPO, WHO, ‘Promoting Access to Medical Technologies and Innovation, Intersections Between

Public Health, Intellectual Property and Trade’ (2012) ISBN 9789280523089 p. 138

76 Standard Material Transfer Agreement 2, Annex 2 to the PIP Framework paras. A-C (Model Agreement) 77 Ibid. paras. A1; A6.

78 SMTA 2 (n 76).

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to share benefits such as antiviral medicines and vaccines to developing countries and countries who do not have the capacity to manufacture or access these pharmaceuticals.80

The WHO works through setting ‘guidelines and other global norms and standards’.81 The

manner in which it works and words its recommendations and guidelines is consistent with the manner of e.g. the ICESCR through the progressive realization of the right to health, meaning that even though it indeed obliges states to implement measures to this goal, this goals is not yet met. That being said, the right to health is an obligation of states through progressive realization but progressive does not entail meaningless contents, contrary it means that states have a ‘specific and continuing obligation to (...) full realization of all rights enshrined in the covenant’.82 What can be said to this in conclusion is that states do not have

obligations vis-à-vis other countries resulting from their membership in the WHO directly, but under the PIP Framework and the SMTAs there are direct obligations on the benefit sharing. With that said, states that have connections to the GISRS are obliged to share pharmaceuticals that are made in connection with PIP derived materials, as are the non-GISRS entities. However, even if many of the WHO member states are parties to this, not all are, and the question still remains if the sharing would be equitable and how the allocation would happen during a pandemic. Also, the ability to patent under SMTA2 could create an obstacle to access to pharmaceuticals, even if the manufacturers choose to donate a

percentage of their product, that might not be enough to cover all people that are in need of it during a pandemic. Moreover, the rest of it could be patented and sold at an inaccessible price. It should also be said that the PIP Framework as well as the SMTAs lack enforcement mechanisms.

3.3. Customary Practices on Human Rights under International

Health Law

While it has become evident that primary law, such as binding treaties, is scarce under

international health law, there is another important source, namely customary law. Customary international law is state practice, that can take many forms, but it must be undertaken with a legal conviction. This chapter seeks to explore two things; the objective element of

customary international law, which is ‘general practice’ by states, and the subjective element, i.e. the opinio iuris.83 Firstly, if there is evidence of general state practice in the area of

disease outbreak control, prevention and cooperation, and if this in any way takes form as the

80 PIP Framework, (n 70) “The PIP Benefit Sharing System will operate to: (iii) prioritize important benefits,

such as and including antiviral medicines and vaccines against H5N1 and other influenza viruses with human pandemic potential as high priorities, to developing countries, particularly affected countries, according to public health risk and needs and particularly where those countries do not have their own capacity to produce or access influenza vaccines, diagnostics and pharmaceuticals. Prioritization will be based on assessment of public health risk and need, by experts with transparent guidelines (…)” p.15

81 Footnote (n 67)

82 CESCR, Human rights and intellectual property, Substantive Issues Arising in the Implementation of the

International Covenant on Economic, Social And Cultural Rights, United Nations, (14 December 2001) 27th

session, UN Doc E/C.12/2001/15,

83 Sir Michael Wood, Omri Sender, ‘State Practice’, Max Planck Encyclopedias of International Law (Last

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sharing of pharmaceutical products, and secondly, the acceptance of this as law.84 This

section is going to deal with this through a further examination of the rules under IHR and article 12 ICESCR, to find evidence of an obligation to cooperate through customary

international law. An obligation to cooperate in this sense entails, inter alia, the obligation to share medicine.

These recommendations, and soft laws overall, are treated as a pathology, but some argue that ‘relative normativity has been a feature of international law since its emergence in early modernity’.85 International law derives from a specific set of sources, but it does not exclude

the rules that are generated in the observance of international legal practice.86 To understand

this complexity it is vital to look beyond the usual, binding/non-binding distinction. Two examples of norms that outweigh the positive rules under binding agreements, such as treaties, are the ius cogens87 and erga omnes88. These are principles that do not need to be

reiterated in every treaty because of their intrinsic value. While this paper explicitly seeks to establish an obligation as hard law under the global health regime, the value of the right to health and the subsequent access to medicine is so basic that it is baffling that it is considered aspirational still.

While a discussion to prove that sharing of pharmaceuticals would be an obligation erga omnes, that would be a paper on its own and thus cannot be examined here. However, one could argue that the right to life as enshrined in International Covenant on Civil and Political Rights (ICCPR) is so closely related to the right to health and the subsequent access to medicine in ICESCR, that the need to discuss this topic is somewhat redundant because its wide acceptance and practice. States have practiced this at least as long as the term has existed, because what is a state without a population? And how would the economy thrive, with a sick population? Not very well, as is evident by the case of the mere aggregation of countries into developed and developing groups were

Without medication, people die. While this paper does not seek to explore state responsibility nor to pursue the morality/law discussion, it is important to mention that omissions to act can also constitute a violation.89 When adopting the view of the ICJ in the Wall,90 states may not

bear responsibility to fulfill and protect nationals of other states, however, at the least an obligation to respect exists, or at the least not to cause extraterritorial harm. In the case of pharmaceuticals, the obligation to respect may cease to exist where the supply of said

84 Sir Michael Wood, Omri Sender, (n 83)

85Matthias Goldmann, ‘Relative Normativity’ (2017). Jean d’Aspremont and Sahib Singh (eds.), Fundamental

Concepts of International Law. https://ssrn.com/abstract=2957069 accessed 15 May 2020

86 Roberto Ago, ‘Positive Law and International Law’ 51 American Journal of International Law (1957) 691,

708 et seq.

87 United Nations, Vienna Convention on the Law of Treaties, (publication 23 May 1969, entry into force 27

January 1980), United Nations, Treaty Series, vol. 1155

88 Barcelona Traction, Light and Power Company, Ltd. (Belgium v. Spain), Judgment of 15 February 1970,

I.C.J. Reports (1970)

89 International Law Commission, Draft Articles on Responsibility of States for Internationally Wrongful Acts,

November 2001, Supplement No. 10 (A/56/10), chp.IV.E.1, Art. 2.

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pharmaceuticals is not enough to share with others abroad, also because most states have national legislation that force manufacturers to sell domestically.91 This rule also exists on the

international level by e.g. article 31 of the TRIPS Agreement where compulsory licenses are predominantly for use in the domestic market. Hereby it is safe to conclude that there at least does not exist a legal rule against hoarding medical supplies.

What should be mentioned is the evidence of the calls for international cooperation throughout, in both the human rights instruments, as well as the ‘soft laws’ consisting of recommendations. To prove general practices of state cooperation on the matter of sharing medicine to establish a customary behavior, through legal undertakings, is beyond the grasp of this paper, but is nevertheless important to mention since the whole foundation of the WHO, WTO and the ICESCR would be rendered pointless without the component of international cooperation. However, an opinio iuris must be said to already exist within the access to pharmaceuticals, where countries sign on to explicitly guarantee this in numerous treaties,92 such as the ICESCR and the Declaration of Alma-Ata.

The Commission of Human Rights stated, within the topic of international cooperation, that it; “Calls upon states, at the international level, to take steps, individually and/or through international cooperation, in accordance with applicable international law, including international agreements acceded to, such as: a) to facilitate, wherever possible, access to other countries to essential preventative, curative or palliative pharmaceutical products or medical technologies used to treat pandemics such as HIV/AIDS, tuberculosis and malaria or the most opportunistic infections that accompany them, as well as to extend necessary

cooperation, wherever possible, especially in times of emergency.”93 This means that, even

though this resolution is non-binding, there are clear evidence of the need of undertakings to cooperate for the universal right to access pharmaceuticals to be realized.

3.4. Conclusion

Governments decide what they want to be bound by under international law, by becoming parties to a treaty. This means that they commit to act in accordance with the treaty provisions. The right to health enshrined in ICESCR has not adopted the wording of the comparable right in the WHO Constitution, but they both seek to oblige the member states to progressively realize the right to health. In addition, the Constitution, the IHR and ICESCR does oblige members, more or less, to cooperate. The UN charter articles 55 and 5694 obliges

members in international cooperation for development of human rights. As we have seen, public health and the right to health are in many ways synonymous, the first an expression of

91 David Fidler ‘Negotiating Equitable Access to Influenza Vaccines: Global Health Diplomacy and the

Controversies Surrounding Avian Influenza H5N1 and Pandemic Influenza H1N1’ (2010) PLoS Med 7(5): e1000247. https://doi.org/10.1371/journal.pmed.1000247 accessed May 18 2020

92 Holger P Hestermeyer, ‘Access to Medication as a Human Right’ (2004) Max Planck UNYB 8, p. 176

https://www.mpil.de/files/pdf2/mpunyb_hestermeyer_8.pdf Accessed 20 May 2020

93 UNCHR Res 29, (2003) (n 46) art. 8(a)

94 UN Charter (n 35), art 56. “All Members pledge themselves to take joint and separate action in co-operation

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the states’ obligations toward individuals, and the second the individuals’ rightful claim against their governments.

Taking all this into account, there is an obligation on states to protect and provide the right to health, and through the obligation through their commitment in agreements, cooperate internationally on the protection of public health. It was stated that strengthening public health is critical to the development of all Member States.95 The simple conclusion is thus

that states are legally obliged to cooperate under global health law, however, without effective enforcement mechanisms the compliance cannot be assured.

That being said, there is no provision under WHO law that states explicitly that there is an obligation on nations to share pharmaceuticals during a pandemic or otherwise, only what has been found under the GISRS. Even so, an adequate supply of pharmaceuticals cannot be guaranteed by the limited amount of entities that cooperate with WHO under the PIP Framework and the absence of enforcement mechanisms also limits the guarantees that can be drawn from this.

It is also important to keep in mind the vastly different socio-economic situations the countries find themselves in. To adopt regulations as a measure of more stringent nature, is not an easy task in this very unequal world, where not even clean water can be guaranteed to not speak of the minimum standards of health care to ensure a primary health care regime.

4. Obligations on States under Intellectual Property Law and the

Access to Medicine

As has been shown, what has been found under international health law under WHO may not be adequate so ensure access to pharmaceuticals and create direct legal obligations on states as regards the sharing of discoveries of medicine. Therefore, it is important to examine the other important regime in this paper: intellectual property. As mentioned before, the regime is an area of international trade law and is governed by WTO and WIPO. It has also been

shown that WHO has relations with intellectual property rights regarding patents and is influencing intellectual property through bringing together the private and the public under partnership for research and development. It works through the Global Immunization Plan and the PIP Framework toward the goal of equity in access to vaccine. Pharmaceutical products, such as medications and vaccine, are subject to patents under intellectual property protection, which is why this section is going to explore the possibilities of access to

medicine and if there are any obligations on states under intellectual property law.

95 UNGA, Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable

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