Lisa Forman, DALLA LANA SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF TORONTO

Lead Author: Lisa Forman
Organization: Dalla Lana School of Public Health, University of Toronto
Country: Canada

Abstract

Access to medicines is the lynchpin to realizing a range of human rights, public health and development imperatives. However without strong policy action to increase access to affordable medicines, there is little hope of achieving the Sustainable Development Goals or of realizing the human right to health. Yet access to medicines is a fundamental element of the right to health, and the majority of states are bound by core obligations in this regard. Accordingly states must ensure that this critical human rights, public health and development interest is appropriately prioritized against inadequate resource allocations and competing private or trade interests. In this submission, I explore interpretations in international human rights law regarding state duties towards medicines. I argue that at least two clear duties emerge to support the High Level Panel’s recommendations: (1) the duty to prevent unreasonably high costs for medicines from denying large segments of the population their rights to health and (2) the core obligation to provide essential medicines. Consequently I explore three areas of action implied by these duties: (1) consistent implementation of human rights impact assessment; (2) institutionalizing TRIPS flexibilities in law and policy; (3) making permanent the waiver of TRIPS for least developed countries (LDC), and waiving the application of TRIPS to essential medicines in low and middle-income countries.

Submission

(1) Reducing policy incoherence between human rights and trade
Access to affordable medicine is the lynchpin to realizing a range of human rights, public health and development imperatives: This is why essential medicines are understood as a core obligation of states under the right to health (United Nations 2000); why medicines are recognized as a fundamental building block of health care systems capable of providing universal health coverage (World Health Organization 2010); and why medicines features prominently within Sustainable Development Goal (SDG) 3 on health (United Nations 2015). Yet “essential medicines remain unaffordable and insufficiently available in developing countries” (MDG Gap Task Force 2015, p53). While generic medicine policies are broadly recognized as a key policy intervention to control health budgets and make medicines more affordable (WHO, WIPO and WTO 2012, p156), the policy space that countries have to provide affordable medicines is bound sometimes wholesale by trade rules around intellectual property rights.

The introduction of the Agreement on Trade-Related Intellectual Property Rights (TRIPS) in 1995 conferred unprecedented exclusive rights to pharmaceutical patent holders. The monopolistic pricing that resulted saw sometimes dramatic increases in drug prices, as in Malaysia where drug prices increased by 28 per cent per year between 1996 and 2005 (Smith et al 2009, p689). The use of flexibilities in TRIPS is an important mechanism to ensure that high prices resulting from exclusive patenting rights do not negatively impact public health imperatives. Yet their use continues to attract litigation, drug removals, trade sanctions and economic and diplomatic pressures. At the same time, TRIPS flexibilities are limited and eradicated in free trade agreements, and the global movement of generic medicines through international borders are obstructed under measures to eradicate counterfeit medicines. Global access to affordable medicines is under more not less threat and without for effective action at the international level it is unlikely that the SDGs on health or indeed the right to health will be realized.

Which countries are affected by conflicts between human rights and trade treaties?
The majority of states globally hold duties under the right to health and trade-related intellectual property rights. For example, the International Covenant on Economic, Social and Cultural Rights (ICESCR) had been ratified by 164 states as of 25 February 2016 – approximately two thirds of all states globally (United Nations Treaty Collection 2016). At the same time, 162 states globally are members of the WTO (WTO 2016a). The overlaps between these domains are extensive: at least 133 states that have ratified the ICESCR are also members of the WTO. Yet the overlap is far greater than these figures suggest: WTO members that have not ratified the ICESCR will certainly be bound by health rights in article 24.1 of the Convention on the Rights of the Child, which with 196 ratifications has an effective universality (applicable in almost country save for the USA), albeit that its rights and duties only apply to children. Irrespective of the precise figures the conclusion is clear: most states globally must balance right to health duties with trade-related intellectual property duties, and this has practical implications for how decision-makers at various levels should interpret and implement these duties.

Applying a principle of systemic integration to assure respect for human rights
The imperative to balance duties under competing international legal regimes is addressed in a 2006 International Law Commission (ILC) report exploring the problems created by fragmented legal regimes in international law (ILC 2006). The report emphasizes that no specialized regime, including the WTO, operates outside of international law (ILC 2006, para. 13.a). The report argues for application of the principle of systemic integration so as to link functional areas to a deeper normative idea in international law, so that the “common good of humankind [is] not reducible to the good of any particular institution or regime” (ILC 2006, para. 480, emphasis added). The report argues that two specific areas of international law offer support in this regard: first, the hierarchically superior norms within international law (such as jus cogens/peremptory norms and obligations ergo omnes/duties owed to all), and second, the Vienna Convention on the Law of Treaties (VCLT) which offers customary rules for international treaty interpretation.

I have previously explored the implications of both areas of international law for balancing right to health duties with trade-related intellectual property rights (see Forman 2011). For the purposes of this submission I will restrict my observations to the following:

(1) While current definitions of international law’s hierarchically superior norms (such as peremptory norms and obligations ergo omnes) do not specify the right to health, they do collectively prohibit gross violations of any rights (including health), and place reasonable limits on all human conduct (including trade) to protect human health and life. In any event, access to medicines is explicitly demarcated as a core obligation under the right to health, and this should elevate access to medicines into a hierarchically superior norm within international human rights law. The priority of a right to medicines does not suggest that it automatically ‘trumps’ competing interests. However the prioritized nature of this right provides an important governing principle for the type of balancing mechanisms between public and private interests that the High Level Panel (HLP) should propose accordingly.

(2) The right to health offers an important framework for interpreting intellectual property rights contained in TRIPS and other multilateral and bilateral agreements. That such treaties should be interpreted in this fashion is supported by article 31 of the VCLT, which specifies that treaties must be interpreted in good faith according to the ordinary meaning of treaty terms in their context and in the light of a treaty’s object and purpose (article 31.1). Adjudicators can ascertain treaty context, inter alia from “any relevant rules of international law applicable between the parties” (article 31.3.c). Article 31.3.c thus supports using ICESCR as a relevant rule of international law applicable between state parties in interpreting trade-related intellectual property rights. As such, article 31.3.c is the clearest textual avenue within international law for ensuring ‘systemic integration’ between human rights and trade rules when adjudicative bodies (including the HLP) assess potential conflicts.

(2) International human rights law and access to medicines

International human rights law is increasingly explicit regarding the human rights duties imposed on states by medicines, essential or otherwise, and their implications for other legal duties.

Access to medicines as a core obligation under the right to health
The right to health in article 12 of the ICESCR has been interpreted by the United Nations Committee on Economic, Social and Cultural Rights (CESCR) to place prioritized duties on states regarding essential medicines (United Nations 2000). In General Comment 14 on the Right to the Highest Attainable Standard of Physical and Mental Health, the Committee underscores the importance of state duties towards essential medicines in a number of domains:

First, the Committee indicates that the essential elements of the right to health include ensuring sufficient availability of functioning “public health and health-care facilities, goods and services” including “essential drugs, as defined by the WHO Action Programme on Essential Drugs” (United Nations 2000, para. 12.a).

Second, the Committee locates essential medicines within core obligations under the right to health. In General Comment 14, the Committee indicates that core obligations under the right to health include providing “essential drugs, as from time to time defined under the WHO Action Programme on Essential Drugs” (United Nations 2000, para. 43.d). The Committee is explicit about the significance of a core obligation: While all other duties under the ICESCR are subject to progressive realization within maximum available resources, “a State party cannot, under any circumstances whatsoever, justify its non-compliance with the core obligations set out in paragraph 43 above, which are nonderogable” (United Nations 2000, para. 47).

Whatever the strength of these duties, the implication holds that a state’s core obligations have a temporal and substantive priority over other human rights duties and indeed over duties under other legal regimes.

Balancing core obligations with other legal duties
These implications are made explicit in the Committee’s General Comment No. 17 (United Nations 2005). Here the Committee makes it clear that intellectual property rights are not to be confused with the human right to benefit from the protection of moral or material interests resulting from any scientific production protected in ICESCR article 15.1.c:

“In contrast to human rights, intellectual property rights are generally of a temporary nature, and can be revoked, licensed or assigned to someone else. While under most intellectual property systems, intellectual property rights, often with the exception of moral rights, may be allocated, limited in time and scope, traded, amended and even forfeited, human rights are timeless expressions of fundamental entitlements of the human person” (United Nations 2005, para. 2).

When it comes to balancing duties under other rights in the ICESCR, the CESCR is clear that “private interests of authors should not be unduly favoured and the public interest in enjoying broad access to their productions should be given due consideration” (United Nations 2005, para. 35). More concretely this means that states should ensure that their legal regimes to protect author’s interest “constitute no impediment to their ability to comply with their core obligations” including specifically those under the right to health (United Nations 2005, para. 35). The Committee goes on to emphasize that:

“Ultimately, intellectual property is a social product and has a social function. States parties thus have a duty to prevent unreasonably high costs for access to essential medicines … from undermining the rights of large segments of the population to health …” (United Nations 2005 para. 35, emphasis added).

I believe that this explicit interpretation of a state’s duties to balance core obligations to provide essential medicines and author’s rights provides a crucial foundation for the High Level Panel’s recommendations in this domain.

While CESCR general comments do not constitute binding law, they do constitute authoritative interpretations of the ICESCR. Moreover state consensus on the fundamental nature of duties towards medicines within the right to health is reflected in a series of UN General Assembly resolutions issued since 2001 recognizing that “access to medicines is one of the fundamental elements in achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” (United Nations 2013, para. 2; see also, United Nations 2009a, para. 1).

(3) Implementing right to health duties towards medicines

What are the concrete actions that should flow from core obligations to provide essential medicines and duties towards medicines more generally? The analysis above outlines at least two clear duties that should underpin the HLP’s considerations: (1) the duty to prevent unreasonably high costs for medicines from denying large segments of the population their rights to health; and (2) the core obligation to provide essential and other medicines. I suggest that these two duties are the foundation for at least three primary areas of action: (1) consistent implementation of human rights impact assessment (HRIA) before adopting law and policies affecting access to medicines; (2) institutionalizing TRIPS flexibilities in law and policy; and (3) making permanent the waiver of TRIPS for least developed countries (LDC) and waiving TRIPS for essential medicines in low and middle-income countries.

(1) Human rights impact assessment (HRIA)
State duties not to obstruct access to affordable medicines extend to when, how and whether they enter into legal regimes or agreements imposing intellectual property rights. There is very strong support for the contention that states should institutionalize the use of HRIA when entering into and implementing agreements on intellectual property rights:
• In General Comment 14 the Committee is explicit that it is a violation of the right to health to fail “to take into account its legal obligations regarding the right to health when entering into bilateral or multilateral agreements with other States, international organizations and other entities, such as multinational corporations” (United Nations 2000, para. 50).
• In General Comment 17 the Committee specifically argues that when entering agreements on intellectual property rights states should undertake human rights impact assessments before adopting and after implementing such legislation (United Nations 2005, para. 35).
• The Committee and two other treaty-monitoring committees have consistently called on countries to conduct assessments of the effect of international trade rules on the right to health and medicines (UNCESCR 2004, 2006, 2008; UNCEDAW 2006a, 2006b, 2007, UNCRC 2004).
• Olivier De Schutter, the former UN Special Rapporteur on the Right to Food, has argued that HRIA is in fact a human rights legal obligation and that all States should “prepare human rights impact assessment prior to the conclusion of trade and investment agreements” (United Nations 2011, p.5).

Gillian MacNaughton and I have developed an HRIA specifically focused on trade-related intellectual property rights and the right to health that provides a user-friendly framework for such assessments (Forman and MacNaughton forthcoming; see also Forman and MacNaughton 2014; MacNaughton and Forman 2014, and Forman 2012). An HRIA would provide clear evidence of how proposed intellectual property rights would impact drug affordability and access, allowing states to mitigate this impact in a number of ways (such as not adopting the rights and implementing measures to ensure affordability). HRIA are a practical and feasible way to ensure policy coherence between the right to health and intellectual property rights duties, and to ensure that population health is not unduly sacrificed to trade or commercial imperatives.

(2) Institutionalization of TRIPS flexibilities
There is very clear and explicit political support for using TRIPS flexibilities to advance access to affordable medicines:
• The Doha Declaration explicitly endorses the right of WTO members to protect public health and promote access to medicines for all, and to use TRIPS flexibilities to the full to do so (WTO 2001, para. 4).
• Numerous UN General Assembly resolutions urge states to promote access to medicines for all, including through using to the full, TRIPS flexibilities (see for example United Nations 2009b; 2013).
• SDG 3.8 calls on states to achieve universal health coverage that includes access to safe, effective, quality and affordable essential medicines and vaccines for all. SDG 3.b proposes an explicit means of implementation for this goal that states “provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all” (United Nations 2015).

This political consensus underscores the importance of TRIPS flexibilities in realizing the right to medicines not simply as a public health but human rights imperative. This interpretation is strongly supported by Anand Grover’s contention as UN Special Rapporteur on the Right to Health that states hold a right to health duty to use TRIPS flexibilities. Grover argued that duties to protect the right to health extend to ensuring “developing countries and LDCs should review their laws and policies and consider whether they have made full use of TRIPS flexibilities or included TRIPS-plus measures, and if necessary consider amending their laws and policies to make full use of the flexibilities” (United Nations 2009b, para. 97).

Recommendations: The High Level Panel should make strong explicit recommendations that explicitly specify the TRIPS flexibilities in question and that recommend:
(i) That states institutionalize the use of TRIPS flexibilities in domestic law and policy
(ii) That states consistently and effectively use these mechanisms to advance access to affordable medicines
(iii) That TRIPS flexibilities are protected from erosion in free trade and other agreements
(iv) That the imposition of TRIPS plus intellectual property rights that restrict TRIPS flexibilities violate the right to health

(3) Making permanent the LDC waiver from TRIPS and restricting the application of TRIPS to essential medicines in LMIC
TRIPS flexibilities are a necessary but insufficient solution to resolving the way that trade-related intellectual property rights contribute to restricting large segments of the population from accessing affordable medicines. In this regard the HLP could consider two interrelated mechanisms: a permanent waiver of TRIPS’s pharmaceutical patents to LDC and a permanent waiver of the application of TRIPS to essential medicines in low and middle-income countries.

TRIPS originally waived the application of TRIPS in toto to LDC until 2005 (TRIPS, article 66.1). This transition period has been extended twice after requests by the LDC Group, first to 2013 and then to 2021 (WTO 2016b). With regard to medicines, the Doha Declaration asked the TRIPS Council to extend the waiver for LDC to apply TRIPS to pharmaceuticals until 2016 (WTO 2001, para 7). The TRIPS Council approved this request. In November 2015 the TRIPS Council extended the transition period for pharmaceutical patents until 1 January 2033 or when a country ceases to be an LDC if that happens before 2033. The Council also waived obligations regarding mailbox applications and exclusive marketing rights that would otherwise apply to LDC (WTO 2015). This waiver applies only to LDC albeit that it extends to all pharmaceuticals. The 2012 UN Commission on HIV and the Law makes the more ambitious proposal that TRIPS is urgently suspended for essential medicines for low and middle-income countries while the UN Secretary General convenes a new body to recommend a new intellectual property regime for drugs (United Nations 2012, p86-7).

Recommendations: The UN Commission’s proposal underscores the appointment of the High-Level Panel, and should be adopted and expanded in the following ways:
(i) The HLP should recommend that the WTO waiver of TRIPS to LDC to 2021 and the waiver of TRIPS to pharmaceuticals in LDC to 2033 be made permanent.
(ii) The HLP should recommend that this waiver be extended to permanently suspend the application of TRIPS to essential medicines in low and middle-income countries generally.

(4) Potential public health impact and potential negative effects
Two related considerations should underpin the HLP’s considerations: First, expanding access to affordable medicines offers exponential population health benefits. This amplification effect is suggested by how the expansion of antiretrovirals in low and middle-income countries has resulted in significant reductions in AIDS-related morbidity and mortality and major improvements in AIDS prevention (UNAIDS 2015). Second, the proposals made in this submission pose little threat to the current system of innovation that drives the development of new medicines. This conclusion is strongly supported in the 2006 report of the WHO Commission on Intellectual Property, Innovation and Health which held that where “the market has very limited purchasing power, as is the case for diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to market” (WHO 2006, p34).

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