Human Rights, Intellectual Property, Innovation and Access to Medicines
Along with domestic bills of rights, international human rights law requires States to make their domestic law and policies compatible with human rights standards.1 The area of intellectual property law and policy is no exception. A series of reports or statements from the UN human rights mechanisms directly or indirectly addressed the role of human rights in relation to intellectual property. The CESCR stated that intellectual property protection should serve ‘the objective of human well-being’ and ‘international human rights instruments give legal expression’ to it.2 The CESCR has attached ‘fundamental importance’ to ‘the integration of international human rights norms into the enactment and interpretation of intellectual property law’.3 The High Commissioner for Human Rights recommended ways that human rights can be factored into the objectives of the implementation of TRIPS.4 The first Special Rapporteur on the Right to Health (Paul Hunt) has set out the right-to-health responsibilities of States5 and has also developed human rights guidelines for pharmaceutical companies,6 each of which bear upon intellectual property law and policy. The second Special Rapporteur on the Right to Health (Anand Grover) has highlighted intellectual property policies that States can use to guarantee the right to health.7 Building upon the existing human rights recommendations for intellectual property and access to medicines, this chapter aims to develop a human rights framework for intellectual property, innovation and access to medicines that can guide States in enacting and implementing intellectual property law and policy.
Importantly, a human rights framework for intellectual property, innovation and access to medicines should be firmly embedded within the right to health. Therefore, the right-to-health framework in relation to access to medicines, developed by the UN human rights mechanisms, is a cornerstone for any further discussion on a human rights framework for intellectual property and access to medicines. On the other hand, it also has to be noted that there are other human rights relevant to this human rights framework for intellectual property, innovation and access to medicines, for instance the right to enjoy the benefits of scientific progress and its applications (Art. 15.1(b) ICESCR), the right to benefit from the protection of the moral and material interests of authors (Art. 15.1(c) ICESCR), and the right to property in the European context.
This chapter highlights essential features of primarily the right to health, but also other human rights listed above.8 All these human rights have been analysed in earlier chapters. While clarifying human rights responsibilities of pharmaceutical companies is equally important to ensure access to affordable medicines, this chapter focuses on States’ human rights obligations in relation to the issue of intellectual property and access to medicines. Delineating the boundary of justifiable limitations upon relevant human rights is crucial for preserving the nature of the human rights at stake and for shaping the appropriate relationship between intellectual property and access to medicines. Clauses on limitations in the ICESCR are analysed for this purpose, as these can provide guidance in balancing different human rights and interests in the context of access to medicines. This chapter concludes with a series of human rights recommendations for States concerning the issue of intellectual property and access to medicines.
Relevant Human Rights
The human rights listed here as relevant to the issue of intellectual property and access to medicines have already been analysed in chapters 4, 5 and 6. This section highlights the relevant aspects of each of them in developing a human rights framework for intellectual property, innovation and access to medicines.
Right to Access to Medicines
The right to access to medicines is an essential element of the right to health and the right to life. The right to health and the right to life are enshrined in numerous international and regional human rights instruments.9 The right to access to medicines in the context of pandemics is emerging as part of customary international law.10 Intellectual property law and policy has a particular bearing upon the promotion of research and development for primary health needs, and access to affordable essential medicines.11 The right to access to medicines should be embedded in a human rights framework for this issue.
Where primary health needs are not effectively addressed by existing medicines, the right to access to medicines places an obligation upon States parties to the ICESCR to take reasonable measures to ensure research and development for new medicines addressing primary health needs.12 Diseases predominantly affecting people in developing countries, known as ‘neglected diseases’, have attracted little medical research and development because effective market demand does not exist due to the insufficient purchasing power of people in those countries.13 The UN General Assembly recognised that insufficient market incentive to the development of new medicines addressing diseases primarily affecting people in developing countries directly impacts upon the right to health in those countries and thus requires international cooperation, in its Resolution 58/173 which highlights:
the need for further international cooperation and research to promote the development of new drugs, vaccines and diagnostic tools for diseases causing a heavy burden in developing countries, and stresses the need to support developing countries in their efforts in this regard, taking into account that the failure of market forces to address such diseases has a direct negative impact on the progressive realization in these countries of the right of everyone to the highest attainable standard of physical and mental health.14
Accordingly, States, individually and through international assistance and cooperation, have to take effective measures to promote the development and the availability of new essential medicines addressing the primary health needs of people.
Also, the right to access to medicines obliges States parties to ensure that existing medicines are available, accessible, culturally acceptable and of good quality.15 At least, in the context of pandemics, all States, not only States parties, are bound to ensure access to medicines treating pandemics. While the right to access to medicines in general is subject to progressive realisation in accordance with Article 2.1 of the ICESCR, the provision of essential medicines is a minimum core obligation of States under the right to health. States must, as a minimum core obligation, make sure that essential medicines on the national list16 are available in sufficient quantity and economically accessible throughout their jurisdiction.17
Right of Everyone to Enjoy the Benefits of Scientific Progress and its Applications
One important factor in progressively realising the right to access to medicines is ‘our ability to enjoy the benefits of scientific progress and its applications’.18 Intellectual property systems can have a significant impact upon the realisation of the right to enjoy the benefits of scientific progress and its applications (REBSP). Thus, this right is another necessary feature of a human rights framework for intellectual property, innovation and access to medicines.
Considering the provisions in Article 15 of the ICESCR19 and the Venice Statement on the Right to Enjoy the Benefits of Scientific Progress and its Applications,20 two elements of REBSP are pertinent to intellectual property law and policy: freedom of scientific research, and equitable access to scientific information and applications.21 There are scientific applications and technologies that have particularly significant impacts on people’s lives. Innovations essential for a life with dignity must be made accessible to all as a matter of the right to enjoy the benefits of scientific progress. In the context of access to medicines, duties of States parties to fulfil REBSP include taking measures to promote medical research and development, and making products resulting from this development available and accessible. Where medical research and development is necessary for addressing primary health needs, States parties have duties to facilitate an environment where such development is undertaken, and also to ensure its outcome is accessible for those who need it.
The right of everyone to benefit from the protection of the moral and material interests of the author can provide guidance on how the society should treat creators, including authors and inventors. A caveat should be entered that entitlements provided by the existing intellectual property system are different, both conceptually and functionally, from the right to benefit from the protection of the moral and material interests of the author.22 In the context of medicines, researchers23 developing new medicines in academic institutions, the biotechnology industry and the pharmaceutical industry, as well as individuals and communities who preserve and develop traditional medicines, are entitled to the right to benefit from the protection of the moral and material interests of the author. As the CESCR clarified, companies cannot claim this human right.24 The protection of moral interests of authors refers to ‘safeguard[ing] the personal link between authors and their creations and between peoples, communities, or other groups and their collective cultural heritage’.25 The protection of material interests of authors within the human rights context is essentially to enable authors to enjoy the right to an adequate standard of living under Article 11.1 of the ICESCR, as enunciated by the CESCR.26 The obligation of States is, therefore, ‘to respect and protect the basic material interests of authors resulting from their scientific, literary or artistic productions, which are necessary to enable those authors to enjoy an adequate standard of living’.27
The right to property provisions in international human rights conventions protect those who have acquired property, according to the relevant laws that apply, from arbitrary interference with their property, and spell out the conditions for permissible limitations to the right.28 A proposition that rights borne by companies are human rights deviates from the idea that human rights derive from the recognition of the dignity of human persons.29 The CESCR implied that companies are outside the protection of human rights by stating that entitlements owed to corporations under intellectual property regimes ‘are not protected at the level of human rights’.30 However, under Article 1 of the First Protocol to the ECHR, even a patent held by companies falls within the scope of protection.31 Therefore, the right to property should also be considered in developing a human rights framework for intellectual property, innovation and access to medicines, although its application is confined to the States parties to the ECHR.
Non-discrimination and Equality
Non-discrimination and equality are among the most fundamental principles in international human rights law. They are enshrined in various international human rights instruments, such as the UDHR, ICESCR and ICCPR.32 General Comment No. 3 of the CESCR affirms that ‘even in times of severe resources constraints … the vulnerable members of society33 can and indeed must be protected by the adoption of relatively low-cost targeted programmes’.34 The principle of non-discrimination and equality calls for special attention to be paid to the needs of vulnerable people, including women, children and people living in poverty.35
In the context of access to medicines, States must prohibit any discrimination in access to medicines on internationally prohibited grounds.36 This constitutes a minimum core obligation under the right to health. This obligation also relates to REBSP in that medicines are an outcome of scientific application.37 In addition, States parties have a core obligation ‘to ensure equitable distribution of all health facilities, goods and services’ according to General Comment No. 14 of the Committee.38 Addressing inequitable access to medicines involves a positive duty to take measures in favour of disadvantaged individuals and communities:39 i.e. a State has to collect disaggregated data on access to medicines in relation to each of the vulnerable groups and a national medicines policy should include programmes specifically designed to enhance access to medicines of vulnerable people, considering economic, social and cultural factors that inhibit vulnerable people’s access to medicines.40
The concept of international assistance and cooperation is embodied in Article 2(1) of the ICESCR, a covering article for the implementation of the provisions, which states: ‘[e]ach State Party to the present Covenant undertakes to take steps individually and through international assistance and cooperation, especially economic and technical, to the maximum of its available resources’ (emphasis added). International assistance and cooperation implies the existence of certain extraterritorial obligations of States parties to realise the rights in the ICESCR.41 Notably, the ICESCR does not place a territorial or jurisdictional restriction to its application, in contrast to the ICCPR, ECHR and ACHR.42 The principle of international cooperation among States is initially established in Articles 55 and 56 of the Charter of the United Nations, which is legally binding on all UN Members.43 It is also reflected in Articles 22 and 28 of the UDHR.44
Based on Articles 55 and 56 of the UN Charter and Article 2(1) of the ICESCR, the CESCR notes that ‘international co-operation for development and thus for the realization of economic, social and cultural rights is an obligation of all States’.45 The CESCR explained that ‘“to the maximum of its available resources” was intended by the drafters of the Covenant to refer to both the resources existing within a State and those available from the international community through international cooperation and assistance’.46 The embodiment of the concept of international assistance and cooperation in the ICESCR indicates that international assistance and cooperation for the realisation of economic, social and cultural rights is not only a moral obligation but also a legal obligation of States parties to the ICESCR, although its scope and content as a legal obligation is in a formative stage.47 International cooperation has also been given particular importance in the CRC.48 Article 4 of the CRC provides that ‘States Parties shall undertake all appropriate legislative, administrative, and other measures for the implementation of the rights recognized in the present Convention. With regard to economic, social and cultural rights, States Parties shall undertake such measures to the maximum extent of their available resources and, where needed, within the framework of international co-operation’ (emphasis added). Explicit reference to international cooperation is found in many substantive articles of the CRC including Article 24 on the right of the child to health, which states that ‘4. States Parties undertake to promote and encourage international co-operation with a view to achieving progressively the full realization of the right recognized in the present article. In this regard, particular account shall be taken of the needs of developing countries’ (emphasis added).
The principle of international assistance and cooperation also appears in numerous soft-law documents. The normative importance of international cooperation lies at the heart of the right to development, recognised in the Declaration on the Right to Development (DRD)49 While the DRD recognises that individual States have the primary duty to realise all human rights, including the right to development of individuals and peoples within their territory or jurisdiction,50 it importantly creates the duty of States ‘to co-operate with each other in ensuring development and eliminating obstacles to development’.51 Such emphasis on the duty to cooperate came from the recognition that the realisation of human rights can be constrained by global institutional arrangements in this increasingly interconnected world, and an equitable and just national and international order is a condition for the enjoyment of all human rights.52 The UN Millennium Declaration53 also reaffirmed that ‘in addition to our separate responsibilities to our individual societies, we have a collective responsibility to uphold the principles of human dignity, equality and equity at the global level’.54
While the legal character of the obligation of international assistance and cooperation is not yet certain, the Maastricht Principles on Extraterritorial Obligations of States in the Area of Economic, Social and Cultural Rights (hereinafter Maastricht Principles), adopted in September 2011 by leading experts in international law and human rights, help to clarify the scope of extraterritorial obligations of States on the basis of existing international law.55 As to obligations to respect, States must refrain from not only direct interferences (Principle 20) but also indirect interferences such that impair ‘the ability of another State or international organisation to comply with that State’s or that international organisation’s obligations as regards economic, social and cultural rights’ (Principle 21). To prevent causing harm to the enjoyment of human rights in other countries, the Maastricht Principle 14 provides that States must carry out ‘impact assessments, with public participation, of the risks and potential extraterritorial impacts of their laws, policies and practices on the enjoyment of economic, social and cultural rights’. Concerning obligations to protect, the Maastricht Principle 24 affirms that ‘all States must take necessary measures to ensure that non-State actors which they are in a position to regulate … such as private individuals and organisations, and transnational corporations and other business enterprises, do not nullify or impair the enjoyment of economic, social and cultural rights’.
Regarding the fulfil aspect, the Maastricht Principles highlight the obligation of international cooperation for the creation of an international enabling environment (Principle 29), as well as a procedural obligation to establish an international system of responsibility allocation (Principle 30) and mobilisation of resources for the universal fulfilment of economic, social and cultural rights (Principle 31). While the CESCR has affirmed that international assistance and cooperation is ‘particularly incumbent upon States parties and other actors in a position to assist’,56 international human rights law does not provide precise criteria for States in a position to assist in determining how to allocate responsibilities and mobilise necessary resources. The Maastricht Principles 30 and 31 highlight procedural requirements to establish a system of international coordination, which are complementary to the substantive obligation of international cooperation.57 Principles for priorities in cooperation such as the obligation to prioritise the realisation of the rights of disadvantaged, marginalised and vulnerable groups and the core obligations to realise minimum essential levels of economic, social and cultural rights are also enunciated, based on the views of the CESCR (Principle 32).
In the context of intellectual property and access to medicines, the CESCR’s interpretive comment on the right to health sheds light on the relevant extraterritorial obligations of States parties:
To comply with their international obligations in relation to article 12, States parties have to respect the enjoyment of the right to health in other countries, and to prevent third parties from violating the right in other countries, if they are able to influence these third parties by way of legal or political means, in accordance with the Charter of the United Nations and applicable international law. Depending on the availability of resources, States should facilitate access to essential health facilities, goods and services in other countries, wherever possible and provide the necessary aid when required. States parties should ensure that the right to health is given due attention in international agreements and, to that end, should consider the development of further legal instruments. In relation to the conclusion of other international agreements, States parties should take steps to ensure that these instruments do not adversely impact upon the right to health. Similarly, States parties have an obligation to ensure that their actions as members of international organizations take due account of the right to health.58
International assistance and cooperation is also crucial to enabling States to build their capacities in the field of science and technology, which are necessary to ensure the availability of new medicines for addressing the primary health needs of people in their own territory. In this regard, Article 15.4 also states that ‘[t]he States Parties to the present Covenant recognize the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields’. Accordingly, States must ensure that domestic and international law and policy, including intellectual property rules, are conducive, rather than restrictive, to the transfer of technology and cooperation in scientific fields,59 with a view to assisting capacity building in countries where the scientific inquiry and the diffusion of scientific knowledge is not active.60 States should also internationally cooperate in the mobilisation of resources for innovation addressing unmet health needs of people living in poverty as well as ensuring access to essential medicines for all with a view to fulfilling a core obligation under the rights to life and health.61
Limitations upon Human Rights
Given that these several human rights and potentially other interests are relevant to the issue of intellectual property and access to medicines, a human rights framework for intellectual property, innovation and access to medicines has to clarify the relationship among these human rights, as well as between human rights and other interests relating to intellectual property, and should provide guidance upon how to achieve a fair balance of human rights and other interests. For this purpose, this section examines the boundary of justifiable limitations to the right to access to medicines, the right to enjoy the benefits from scientific progress and its applications, and the right to benefit from the protection of the moral and material interests of the author. Human rights, with certain exceptions mentioned earlier under ‘Interpreting TRIPS in Light of Human Rights’ in Chapter 6,62 are also subject to derogations and limitations. The ICESCR does not contain any derogation clause, but does have clauses regulating limitations. These clauses should be considered with respect to the human rights in question. In delineating the scope of justifiable limitations upon human rights, it is necessary to reflect upon the concept of core obligations that the CESCR has developed through its General Comments. In the European context, permissible limitations in relation to the right to property should also be taken into account. This analysis may shed light on how to strike a right balance among human rights, and between human rights and other interests, which is crucial to a human rights framework for intellectual property, innovation and access to medicines.
Limitations clauses in the International Covenant on Economic, Social and Cultural Rights
A general limitation clause is found in Article 4 of the ICESCR. While Article 2.1 does not explicitly regulate limitations, the notion of ‘progressive realisation’ and ‘maximum available resources’ in the provision requires the clarification as to the permissible scope of ‘retrogressive measures’ in relation to resource constraints. General Comment No. 3 of the CESCR addresses the issue of ‘retrogressive measures’ as it elaborates Article 2.1.63 Article 5.1 is also relevant to the present discussion as it concerns the relationship among the rights in the ICESCR. In order to understand the boundary of justifiable limitations to the right to access to medicines, the right to enjoy the benefits from scientific progress and its application, and the right to benefit from the protection of the moral and material interests of the author, this section begins with an analysis of Article 4, Article 2.1 and Article 5.1 of the ICESCR in turn.
Article 4: The States Parties to the present Covenant recognize that, in the enjoyment of those rights provided by the State in conformity with the present Covenant, the State may subject such rights only to such limitations as are determined by law only in so far as this may be compatible with the nature of these rights and solely for the purpose of promoting the general welfare in a democratic society.
Article 4 permits States parties to limit the rights contained in the Covenant, but there are conditions upon such limitations.
‘General welfare’ and ‘determined by law’ The solely legitimate purpose of limitations to the rights in the Covenant is the promotion of the general welfare in a democratic society. Alston and Quinn suggest that the term ‘general welfare’ should be interpreted restrictively, and reasons such as ‘national security’ or ‘economic development’ can be invoked only to the extent that ‘they are genuinely synonymous with “the general welfare”’.64 In accordance with Article 4, any limitations on the rights must be determined by national law and ‘solely for the purpose of promoting the general welfare in a democratic society’.
‘Compatible with the nature of rights’ Critically, any limitations must be ‘compatible with the nature of these rights’ in the Covenant. According to the negotiating history of the Covenant, this condition was included to make sure that ‘the problem of restrictions, and limits to their scope, should be closely studied in connexion with each of the rights contained in the Covenant’.65 ‘Minimum core obligations’ with respect to each of the rights are understood to elaborate ‘the nature of these rights’. In General Comment No. 3, the CESCR notes that ‘a minimum core obligation to ensure the satisfaction of, at the very least, minimum essential levels of each of the rights is incumbent upon every State party’.66 The CESCR stresses that without the minimum core contents and obligations, the Covenant ‘is largely deprived of its raison d’être’.67 Commentators also suggest that the concept of human rights presumes the existence of a minimum core within each right that is not subject to limitations.68 The African Commission on Human and Peoples’ Rights has also used ‘the minimum core obligations’ in the context of the African Charter on Human and Peoples’ Rights,69 and the Inter-American Commission on Human Rights has taken a similar concept, ‘a minimum threshold of rights’.70 Thus, no limitations to minimum core obligations are permitted because such limitations are not compatible with ‘the nature of these rights’.71
Implicit condition: Proportionality This phrase also leads to another implicit requirement for limitations to the rights: the principle of proportionality. Limitations are restricted to such that are necessary to promote ‘general welfare’, and the least restrictive limitations on a particular right in question, where several types of limitations are available, must be adopted. The proportionality of limitations is stressed by the CESCR in its General Comment on the right to health.72
Article 2.1: Each State Party to the present Covenant undertakes to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures.
The notion of ‘progressive realisation’ and ‘to the maximum of its available resources’ in Article 2.1 indicates that retrogressive measures with respect to the rights in the Covenant due to resource constraints may not automatically constitute a violation of the rights. If Article 2.1 is read in isolation from Article 4, a State may readily rely on the ground of resource constraints to justify its failure to fulfil its obligation rather than making efforts to meet conditions upon limitations, required by Article 4.73 Therefore, as Alston and Quinn suggested and Müller recently further elaborated, it seems reasonable to read Article 2.1 as requiring any retrogressive measures under Article 2.1 to meet the conditions under Article 4.74 The CESCR stated that ‘any deliberately retrogressive measures in that regard would require the most careful consideration and would need to be fully justified by reference to the totality of the rights provided for in the Covenant and in the context of the full use of the maximum available resources’.75 States parties must justify not only that retrogressive measures are unavoidable due to resource constraints, but also that the retrogressive measures are adopted in a manner that takes into account ‘general welfare’ under Article 4.76 The Committee illustrates criteria for assessing whether any retrogressive steps can be attributable to resources constraints:
a. the country’s level of development;
b. the severity of the alleged breach, in particular whether the situation concerned the enjoyment of the minimum core content of the Covenant;
c. the country’s current economic situation, in particular whether the country was undergoing a period of economic recession;
d. the existence of other serious claims on the State party’s limited resources; for example, resulting from a recent natural disaster or from recent internal or international armed conflict;
e. whether the State party had sought to identify low-cost options;
f. whether the State party had sought cooperation and assistance or rejected offers of resources from the international community for the purposes of implementing the provisions of the Covenant without sufficient reason.77
In principle, ‘minimum core obligations’ must not be subject to retrogressive measures. This line of interpretation is consistent with the view of the CESCR in General Comment No. 14 on the right to health that non-compliance with the core obligations constitutes violations.78 On the other hand, in General Comment No. 3, the CESCR appears not to exclude an exceptional situation where non-implementation of even a core obligation may be justified, provided that a State party ‘demonstrate[s] that every effort has been made to use all resources that are at its disposition in an effort to satisfy, as a matter of priority, those minimum obligations’.79 Such circumstances may be comparable to force majeure, ‘the occurrence of an irresistible force or of an unforeseen event, beyond the control of the State, making it materially impossible in the circumstances to perform the obligation’, recognised as circumstances precluding wrongfulness in the International Law Commission’s final draft Articles on Responsibility of States for International Wrongful Acts.80 However, even in such situations, States have ‘an obligation to do the utmost to remedy the situation, be it in asking and receiving foreign assistance’.81 All in all, it can be concluded that retrogressive measures due to resource constraints have to meet the general conditions set out in the general limitation clause, Article 4. Logically, retrogressive measures inconsistent with minimum core obligations, as other limitations under Article 4, prima facie constitute a violation of the respective right.
Article 5.1: Nothing in the present Covenant may be interpreted as implying for any State, group or person any right to engage in any activity or to perform any act aimed at the destruction of any of the rights or freedoms recognized herein, or at their limitation to a greater extent than is provided for in the present Covenant.
Article 5, paragraph 1 aims at preventing a State from interpreting any provision of the Covenant in a way to neglect or violate one right on the grounds that protecting another right in the Covenant makes it unavoidable.82 Considering that there exist circumstances where rights in the Covenant compete, the question is what amounts to ‘the destruction of any of the rights or freedoms’ within the meaning of Article 5.1. In accordance with Article 4, parameters should be whether a measure to promote one right is compatible with the nature of other rights in the Covenant. Given that minimum core obligations are to ensure the very nature of the rights in the Covenant, a State party cannot justify an act inconsistent with the minimum core obligations of any of the rights in the Covenant on the ground of promoting the realisation of some other rights in the Covenant.
Limitation to the right to property under the European Convention on Human Rights
Varying forms of property, including patents, fall within the meaning of ‘possessions’ under Article 1 of the First Protocol to the ECHR. A legal person is also entitled to the protection of the right to property under this provision, unlike under other international human rights instruments such as the UDHR and ACHR.83 However, do all types of property receive the same level of protection under the ECHR? Henry Schermers made distinctions between different kinds of property, and concluded that only the right to property without which any normal way of life is impossible may qualify as a fundamental human right.84 Schermers adds that what kinds of property are necessary for a life with dignity may vary depending on economic and social circumstances,85 and that drawing the line between the fundamental rights to property from the other property rights is ‘gradual rather than absolute’.86 The scope of permissible limitations upon the right to property has been determined taking into account the degree of importance of the property in question to leading a normal way of life in a particular society, along with other social and economic considerations.87
In Sporrong and Lönnroth v. Sweden, the European Court of Human Rights (ECtHR) clarified three rules contained in this provision: