Shamiso Zinzombe, Erasmus University Rotterdam

Lead Author: Shamiso Zinzombe
Organization: Erasmus University Rotterdam
Country: Netherlands

Abstract

Appropriately the Sustainable Development Agenda prioritises access to medicine and other health technologies for the prevention, treatment and control of communicable and non-communicable illnesses or diseases. Astutely, the United Nations Secretary-General's High Level Panel on Access to Medicines has been timeously convened with the important task of exploring ways of recalibrating the system of innovation into new medicine and other health technologies so as to recommend solutions of ensuring purposeful work toward attainment of the Sustainable Development Goals for millions of people. This submission seeks to contribute to those objectives by addressing the rights of inventors and the duties of pharmaceutical corporations under international human rights and public health law because this could greatly assist in improving law and policy frameworks intended to enhance specifically access to medicine. It does so by examining the entitlement to access medicine in terms of the right to health Article 12 of the International Covenant on Economic Social and Cultural Rights and the right to science Article 15 of the same treaty. In this submission aspects of these rights relevant to the rights of inventors and the duties of pharmaceutical corporations are discussed and policy and law implications outlined. Finally, it makes proposals that could be used to implement the law and policy implications flowing from these rights. Whilst moving toward a public health and international human rights law based framework is the ultimate goal, incremental steps toward this may also be taken using these existing legal human rights and some of these steps are listed in the proposal.

Submission

1. INTRODUCTION

Appropriately the Sustainable Development Agenda prioritises access to medicine and other health technologies for the prevention, treatment and control of communicable and non-communicable illnesses or diseases. Astutely, the United Nations Secretary-General's High Level Panel on Access to Medicines has been timeously convened with the important task of exploring ways of recalibrating the system of innovation into new medicine and other health technologies so as to recommend solutions of ensuring purposeful work toward attainment of the Sustainable Development Goals (SDGs) for millions of people. This submission seeks to contribute to those objectives by addressing the rights of inventors and the duties of pharmaceutical corporations under international human rights and public health law because this could greatly assist in improving law and policy frameworks intended to enhance specifically access to medicine. Purposefully moving toward accomplishment of the SDGs on access to medicine, amongst other things, requires states to develop and implement appropriate legal and policy frameworks domestically, reinforced internationally by human rights based legal principles. Ultimately, this requires recalibration from a legal framework based on an inseparable linkage between innovation and access to one based on public health and international human rights law. However, incremental steps directed at the rights of inventors and duties of pharmaceutical corporations may be taken based on the existing international human rights law and public health framework.

Policy incoherence stems from the current system on which innovation is based which, does not sufficiently reflect neither is it consistent with nor founded on international human rights law. At a minimum nor is the current system fully guided by public health principles grounded within an international human rights law framework. This incoherence is reflected in the current framing of rights of pharmaceutical corporations in terms of international economic law such as the World Trade Organisations (WTO) treaty the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Within this framework access to medicine is hindered both by the limitations created by this treaty and the manner in which recipients of its rights, such as patents, exercise those rights. The effects of which are most keenly felt in developing countries.

2. AN ENTITLEMENT TO ACCESS MEDICINE

2.1. One of the sources of the entitlement to access medicine is the right to health Article 12 International Covenant on Economic Social and Cultural Rights (ICESCR). The Committee for the International Covenant on Economic Social and Cultural Rights (CESCR) in General Comment 14 interpreted the right to health as ‘a right to the enjoyment of a variety of facilities, goods, services and conditions necessary for the realisation of the highest standard of health’. Moreover, it affirmed and illustrated how this right contains freedoms and entitlements, corresponding to the central object of the right articulated above.

2.2. Specifically, it identified a series of core listed obligations which empower the entitlement to access medicine. In particular, the core listed obligations are:
"(a) [t]o ensure access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable and marginalised groups; ....
(b) [t]o ensure access to the minimum essential food…
(d) [t]o provide essential drugs, as from time to time defined under the WHO Action Programme on Essential Drugs;
(e) [t]o ensure equitable distribution of all health…goods…
(f) [t]o adopt and implement a national public health strategy and plan of action, on the basis of epidemiological evidence, addressing the health concerns of the whole population; the strategy and plan of action shall be devised, and periodically reviewed, on the basis of a participatory and transparent process; they shall include methods, such as right to health indicators and benchmarks, by which progress can be closely monitored; the process by which the strategy and plan and action are devised, as well as their consent, shall give particular attention to all vulnerable or marginalised groups ….
(b) [t]o provide immunization against major infectious diseases…
(c) [t]o take measures to prevent, treat and control epidemic and endemic diseases”.

2.3. The entitlement to access medicine flows, among other things, from the states obligations clearly articulated in General Comment 14. These oblige states to develop, among other things, a legal and policy framework for the provision of medicine and other health technologies. Moreover, the framework must be designed to ensure everyone has equal access to medicine. Further, right holders of the right to health are also entitled to participate in the development of this framework.

2.4. In relation to framing a legal system for an entitlement to medicine General Comment 14 points out as principle that the right to health is in a [constant position] of independence and interdependence in relation to other human rights. With regard to its interdependence, it enhances the enjoyment of other rights, whilst itself being enhanced by other rights. Thus, each context where the right to health is invoked would need to take into account the relationship between the right to health and other applicable human rights, if any. Applying this principle in the context of access to medicine, rights that have reinforced this principle include the right to life, as in the noteworthy case of interventions unlocking greater access to HIV/AIDS. However, in terms of framing a legislative system both domestically and internationally it is important to explore other existing rights, such as the right to science in Article 15 ICESCR, which is applicable to scientific inventions like medicine.

2.5. Law and policy implications to empower the right to health Article 12 ICESCR:

2.5.1. Amongst other things, an entitlement to access medicine encompasses equal access to medicine in the event of medical need and it includes an entitlement to a legal and policy framework designed to accomplish this.

2.5.2. To address the policy incoherence in the current framework, it is important to look to the right to health in Article 12 ICESCR and its connections with other human rights, like the right to science Article 15 ICESCR.

2.5.3. In keeping with the right to health Article 12 ICESCR core listed obligation to participate, development of this space should occur in a space free from corporate interest or influence, and one which promotes participation from civil society and non-governmental organisations not affiliated with corporate interests.

3. THE RIGHT TO SCIENCE ARTICLE 15 ICESCR

3.1. The right to science in Article 15 ICESCR provides:

“1. The States Parties to the present Covenant recognize the right of everyone:
(a) To take part in cultural life;
(b) To enjoy the benefits of scientific progress and its applications;
(c) To benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.
2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for the conservation, the development and the diffusion of science and culture.
3. The States Parties to the present Covenant undertake to respect the freedom indispensable for scientific research and creative activity.
4. The 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."

3.2. Critical rights outlined in this article include, but are not limited to, the right of the community to enjoy the benefits of scientific progress and application, the right of human scientists to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the author, an obligation on states to take steps to develop science, an obligation on states to apply international cooperation and contacts in scientific fields.

3.3. Crucially these aspects of the right highlight some important existing features for a domestic and international framework on science and in the context of access to medicine for development of medicine. Also, the right clearly identifies the subject and object of the right both of which are critical to addressing the policy incoherence in the current international system on innovation and access.

3.4. In General Comment 17, in relation to inventors the CESCR clarified that this right protects human beings. Thus, corporations are not entitled to human rights protection in the framework of this right. Applying this to the context of access to medicine it only protects scientists engaged in researching or creating new medicines.

3.5. Moral interests the CESCR stated that are protected in Article 15 ICESCR cover the inventor's right to perpetual recognition and a right to protect the authenticity of the work in the event of reproduction.

3.6. Of material interests the CESCR stated, '‘material interests’…reflects the close linkage of this provision with the right to own property, as recognized in article 17 [UDHR] and in regional human rights instrument, as well as with the right of any worker to adequate remuneration’. Elaborating further the CESCR underscored material interests are those that contribute to the inventor’s right to an adequate standard of living. This can be achieved in various ways of paying for the work to the inventor.

3.7. In relation to the phrase benefit from the protection the CESCR articulated in principle states are allowed to determine the modalities of the protection involved. Further, states should ensure, at the minimum, the protections provided protect the moral and material interests as outlined above. In relation to intellectual property, such as in TRIPS, the state is not required to fix the human rights protection of the inventor’s rights to those standards. Whilst states are also permitted to protect the human right of the inventor beyond the minimum; however, in so doing, the state is obliged to ensure this does not impede access or the rights of others to benefit from scientific advancement.

3.8. Intellectual property is not an obligation on states, neither is it a human right in the framework of this right. However, it is a modality which states can regulate to ensure compliance with Article 15 ICESCR. For example, states are obliged to take measures to protect indigenous knowledge, in so doing they have the option, which must be exercised in a manner that takes account of the preferences of indigenous people, to register indigenous knowledge under national intellectual property systems. In relation to intellectual property on medicine states have a,

'duty to prevent unreasonably high costs for access to essential medicines...Moreover, States parties should prevent the use of scientific and technical progress for purposes contrary to human rights and dignity, including the rights to life, health and privacy, e.g. by excluding inventions from patentability whenever their commercialization would jeopardize the full realization of these rights'.

Thus, while states may use intellectual property to give effect to some features of the right, they are obliged to regulate it, including by excluding certain inventions from patentability to avoid jeopardizing the full realisation of rights, such as the right to health. This enables and obliges states to explore various modalities of giving effect to Article 15 ICESCR, including setting restrictions to intellectual property like exclusions to patentability.

3.9. Law and policy implications:

3.9.1. Article 15 ICESCR provides protection for inventors in their moral and material interests, and it protects their freedoms indispensable for scientific research and activity. Also it ensures the communities right to enjoy in the benefits and application of scientific progress. Further, it obliges states to develop modalities in order to give effect to the above rights, and others intended to promote the development and diffusion of science. Thus, some of the rights and obligations critical to a system capable of providing medicine in terms of the right to health already exist in international law.

3.9.2. While states may use intellectual property as a modality, it is not obligatory neither is it a human right, instead it is one of many options to consider. Further, if states elect to use intellectual property, it should be brought in line with the right to science Article 15 ICESCR and the right to health Article 12 ICESCR.

4. PHARMACEUTICAL CORPORATIONS AS A MEANS OF REALISING THE RIGHT TO HEALTH

4.1. The current system of innovation on new medicine and other health technologies relies on private actors such as pharmaceutical corporations. It also relies on intellectual property from TRIPS. Law and policy incoherence stems from the current framing of intellectual property in TRIPs and the manner in which it is exercised by pharmaceutical corporations which together deprive millions of people from accessing much needed medicine.

4.2. According to the CESCR in terms of the tripartite obligation to fulfil, private means may be used to promote, provide and facilitate access to medicine. This indicates that a functional connection exists; wherein, pharmaceutical corporations are one of many private means or tools used to realise the right to health. This nexus is one of the conduits through which duties consistent with their activities and the impact of those activities, on the enjoyment of the right, may be identified and elaborated on. Similarly, the Guidelines on Pharmaceutical Companies recognise such a functional connection stating, ‘[e]nhancing access to medicines, however, has the central place in the societal mission of pharmaceutical companies’. Pharmaceutical corporations, thus, operate in this sector because the state determines that they are a useful means by which to discharge and implement certain right to health obligations related to medicine. This principle can therefore be used to identify duties in concrete situations related to the use of intellectual property. In this way the corporation is a tool because the elements of the right to health, including medicine, may be realised through public or private means.

4.3. State practice already demonstrates that states already make use of private actors as implementing duty bearers in various ways. For example, state reports submitted by India, and the Netherlands each demonstrate that corporate actors are involved in implementing the right to health and the various ways in which this is represented in law. India for example in the 2007 Combined Report discusses the local pharmaceutical manufacturing industry responsible for producing low cost quality medicine for its local population. Furthermore, it discusses various steps taken to ensure the system of intellectual property remains one supportive of its goal to ensure access to medicine to its population. The Netherlands in its reports has demonstrated principles applicable to some corporate health actors within its jurisdiction. For example, health insurers, beginning from the recognition that a 'well-functioning health service is considered a constitutional right'. It also demonstrates that obligations are clearly placed on private actors, for example again with health insurers stating, ‘[t]he Private Medical Insurance Access Act obliges private medical insurers to accept those seeking private medical insurance for the first time and to offer them a standard insurance package at a standard premium, both of which are prescribed by government’. Other legal measures applied by the Netherlands to regulate corporations engaged in health activities include total bans and agreements on self-regulation.

4.4. Law and policy implications:
i. Pharmaceutical corporations are implementing, rather than norm setting duty bearers states can elaborate on their specific duties in relation to access to medicine based on Article 12 ICESCR the right to health and Article 15 ICESCR the right to science could elaborated on more clearly.

ii. States as seen above use various modalities to place duties on these corporate actors, it may be useful to consider various modalities in relation to pharmaceutical corporations and the manner in which they currently exercise intellectual property with a view to promoting access to medicine.

5. Implementation proposals:

5.1. United Nations Level

Over a two to three year period identify, develop or articulate a set of common principles based on or drawn from international human rights law applicable to rights of inventors and duties of pharmaceutical corporations which states may apply along with TRIPS flexibilities and which will also form the basis for discussion on a new treaty on innovation into medicine.

Potential mechanisms to carry out this proposal could be:
i. Committee on the International Covenant on Economic Social and Cultural Rights could be tasked to prepare a General Comment on Access to and Availability of Medicine and Other Health Technologies, or States could themselves in General Assembly outline at most 10 principles; and
ii. Within the Open-ended Intergovernmental Working Group on Transnational Corporations and Other Business Enterprises with respect to Human Rights include a provision in the treaty addressing pharmaceutical corporations and intellectual property to bring pharmaceutical corporations within the jurisdiction of any adjudicating mechanism created in the treaty; and
iii. Lessons from the above could be used to frame a new treaty on innovation and access of medicine and other health technologies.

5.2. World Trade Organisation Level

i. World Trade Organisation should respect the obligations of member states party to ICESCR.

5.3. Domestic Level

i. States should participate in the development of common principles for the promotion of access to medicine based on international human rights law, ensuring public consultation within their territories and they should implement these at the domestic level once the principles are identified.

Bibliography and References

References
UNGA 'Draft outcome document of the United Nations summit for the adoption of the post-2015 development agenda' (12 August 2015) UN Doc A/69/L.85 (UN Doc A/69/L.85) (SDGs) Goal 3.
United Nations Secretary-General’s High-Level Panel on Access to Medicines 'Terms of Reference' <http://www.unsgaccessmeds.org/new-page/> accessed 28 February 2016.
Holger Hestermeyer, Human Rights and the WTO: The Case of Patents and Access to Medicines (OUP 2007) pages 94, 99-102,229-289 points out in the least that World Trade Organisation (WTO) is obliged to respect obligations of WTO member states party to the International Covenant on Economic Social and Cultural Rights (adopted 16 December 1966, entered into force 3 January 1976) 993 UNTS 3 (ICESCR) or human rights obligations that have attained the status of ius cogens.
The notion of public health in the Agreement on Trade Related Aspects of Intellectual Property Rights (15 April 1994)
LT/UR/A-1C/IP/1 is weakened by the fact that it is not linked to human rights where with such a link, the duty bearing role of the state and non-actors engaged by the state in the delivery of health goods would be properly reflected. UN Committee on Economic, Social and Cultural Rights ‘General Comment 14’ (11 August 2000) UN Doc E/C.12/2000/4 (General Comment 14) para 4, 12 (a) indicates that public health is integral to the notion of the right to health, whilst also maintaining that public health does not determine the boundaries of the right to health. This is consistent with academic work which also demonstrates a link between the right to health and public health, see Brigit Toebes, The Right to Health as a Human Right in International Law (School of Human Rights Research 1999) pages 7-8, 10, on the drafting history of the right to health also see UNCHR ‘Report of the Drafting Committee to the Commission on Human Rights’ (1 July 1947) UN Doc E/CN.4/21 page 19 at Article 35, Richard Pierre Claude and Bernardo W. Issel, ‘Health, Medicine and Science in the Universal Declaration of Human Rights’ (1998) 3/2 Health and Human Rights 126 (Claude and Issel) page 130. This matters in relation to the role of the duty bearer as an illustration. Compare public health in the context of Framework Convention on Tobacco Control (FCTC) (adopted 21 May 2003, entered into force 27 February 2005) 2302 UNTS 166 or Codex Alimentarius <http://www.fao.org/fao-who-codexalimentarius/codex-home/en/ >accessed 28 February 2016, International Code of Marketing of Breast-milk Substitutes (adopted 21 May 1981) 34th World Health Assembly – in all these instances the state for example is not placed in a situation where it can experience a conflict of interest because it is only a duty bearer, this contrasts with TRIPS where it is duty bearer and right holder. Also in relation to the role of non-state actors who are duty bearers its ability to regulate is uninhibited and the non-state actors who are duty bearers are clearly identified and their duties specified.
Ellen F.M. t’Hoen, The Global Politics of Pharmaceutical Monopoly Power (AMB 2009) page 87, Heinz Klug, ‘Law, Politics, and Access to Essential Medicine in Developing Countries’[2008] Politics & Society 207 pages 210, 231-232, Mohammed El Said and Amy Kapczynski, 'Access to Medicines: The Role of Intellectual Property Law and Policy' [2011] Working Paper prepared for the Third Meeting of the Technical Advisory Group of the Global Commission on HIV and the Law, 7-9 July 2011 page 1-2, 16-17.
ICESCR Article 12, other sources of the right to health in international treaty law include Article 12 Convention on the Elimination of All Forms of Discrimination against Women (adopted 18 December 1979, entered into force 3 September 1981) 1249 UNTS 13 and Article 24 Convention on the Rights of the Child (adopted 20 November 1989, entered into force 2 September 1990) 1577 UNTS 3.
General Comment 14 para 9.
General Comment 14 para 8.
General Comment 14 para 43.
General Comment 14 para 43.
General Comment 14 para 1, 3.
General Comment 14 para 3.
Noah Novogrodsky,"The Duty of Treatment: Human Rights and the HIV/AIDs pandemic"[2009] Yale Hum. Rts. & Dev. L.J. 1 page 55-56.
UN Committee on Economic, Social and Cultural Rights ‘General Comment No 17’ (12 January 2006) UN Doc E/C.12/GC/17 (General Comment 17) para 35, 39 (e).
ICESCR Article 15, this article was preceded by Article 27 of the Universal Declaration of Human Rights (adopted 10 December 1948) UNGA Res 217 A (III).
ICESCR Article 15 (1) (b).
ICESCR Article 15 (1) (c).
ICESCR Article 15 (2).
ICESCR Article 15 (4).
General Comment 17 para 18, 28, 31, 35.
General Comment 17 para 7-8.
Text para 4.
General Comment 17 para 12-14.
General Comment 17 para 15. It is however, important to point out that in relation to Article 17 UDHR the drafters of the article did not define property, that is to say they did not state that which is or is not recognised as property on a universal level. Rather they left this to the determination of each state party within its jurisdiction. This reflected the diversity of traditions as explained by van Banning see discussion in dissertation Shamiso P. Zinzombe, The Right to Health, Pharmaceutical Corporations and Intellectual Property: Access to Medicine (School of Human Rights Research 2015) page 194-196.
General Comment 17 para 15-16.
General Comment 17 para 10.
General Comment 17 para 11.
General Comment 17 para 32.
General Comment 17 para 35.
Text para 4.
Text para 1.
General Comment 14 para 33, 36-37.
UN Human Rights Council ‘Report to the General Assembly of the UN Rapporteur on the right to the highest attainable standard of health Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicine’ (11 August 2008) UN Doc A/63/263 para 1.
General Comment 14 para 36.
UNCHR ‘Periodic reports submitted by State parties under articles 16 and 17 of the Covenant Combined second, third, fourth and fifth report of India’ (1 March 2007) UN Doc E/C.12/IND.5 (India Combined Report 1 March 2007) para 515.
India Combined Report 1 March 2007 para 520.
UNCHR 'Third periodic reports submitted by States parties under articles 16 and 17 of the Covenant The Netherlands' (5 August 2005) UN Doc E/1994/104/Add.30 (Third Report Netherlands) para 407.
Third Report Netherlands para 420 emphasis added, it is important to point out the insurance scheme discussed here occurred prior to the changes which are discussed in subsequent reports; namely, UNCHR ‘Combined fourth and fifth reports submitted by States parties under articles 16 and 17 of the Covenant The Netherlands’ 17 July 2009 UN Doc E/C.12/NLD/4-5 (Fourth and Fifth Report Netherlands 2009).
Fourth and Fifth Report Netherlands 2009 para 114 (a), (b), 257.

Bibliography

Treaties and Other Legal Instruments

Agreement on Trade Related Aspects of Intellectual Property Rights (15 April 1994)
LT/UR/A-1C/IP/1.
Convention on the Elimination of All Forms of Discrimination against Women (adopted 18 December 1979, entered into force 3 September 1981) 1249 UNTS 13.
Convention on the Rights of the Child (adopted 20 November 1989, entered into force 2 September 1990) 1577 UNTS 3.
Framework Convention on Tobacco Control (FCTC) (adopted 21 May 2003, entered into force 27 February 2005) 2302 UNTS 166.
International Code of Marketing of Breast-milk Substitutes (adopted 21 May 1981) 34th World Health Assembly.
International Covenant on Economic Social and Cultural Rights (adopted 16 December 1966, entered into force 3 January 1976) 993 UNTS 3.
UN Committee on Economic, Social and Cultural Rights ‘General Comment 14’ (11 August 2000) UN Doc E/C.12/2000/4.
UN Committee on Economic, Social and Cultural Rights ‘General Comment No 17’ (12 January 2006) UN Doc E/C.12/GC/17.
UNGA 'Draft outcome document of the United Nations summit for the adoption of the post-2015 development agenda' (12 August 2015) UN Doc A/69/L.85.
UN Human Rights Council ‘Report to the General Assembly of the UN Rapporteur on the right to the highest attainable standard of health Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicine’ (11 August 2008) UN Doc A/63/263.
Universal Declaration of Human Rights (adopted 10 December 1948) UNGA Res 217 A (III).
UNCHR ‘Report of the Drafting Committee to the Commission on Human Rights’ (1 July 1947) UN Doc E/CN.4/21.

Academic Literature

Claude R.P. and Issel B. W., ‘Health, Medicine and Science in the Universal Declaration of Human Rights’ (1998) 3/2 Health and Human Rights 126.
El Said M. and Kapczynski A., 'Access to Medicines: The Role of Intellectual Property Law and Policy' [2011] Working Paper prepared for the Third Meeting of the Technical Advisory Group of the Global Commission on HIV and the Law, 7-9 July 2011.
Hestermeyer H., Human Rights and the WTO: The Case of Patents and Access to Medicines (OUP 2007).
Klug H., ‘Law, Politics, and Access to Essential Medicine in Developing Countries’[2008] Politics & Society 207.
Novogrodsky N.,"The Duty of Treatment: Human Rights and the HIV/AIDs pandemic"[2009] Yale Hum. Rts. & Dev. L.J. 1.
t’Hoen E.F.M., The Global Politics of Pharmaceutical Monopoly Power (AMB 2009).
Toebes B., The Right to Health as a Human Right in International Law (School of Human Rights Research 1999).
Zinzombe S.P., The Right to Health, Pharmaceutical Corporations and Intellectual Property: Access to Medicine (School of Human Rights Research 2015).

Other

UNCHR ‘Periodic reports submitted by State parties under articles 16 and 17 of the Covenant Combined second, third, fourth and fifth report of India’ (1 March 2007) UN Doc E/C.12/IND.5.
UNCHR ‘Combined fourth and fifth reports submitted by States parties under articles 16 and 17 of the Covenant The Netherlands’ 17 July 2009 UN Doc E/C.12/NLD/4-5.
UNCHR 'Third periodic reports submitted by States parties under articles 16 and 17 of the Covenant The Netherlands' (5 August 2005) UN Doc E/1994/104/Add.30.

Websites

Codex Alimentarius <http://www.fao.org/fao-who-codexalimentarius/codex-home/en/> .
United Nations Secretary-General’s High-Level Panel on Access to Medicines 'Terms of Reference' <http://www.unsgaccessmeds.org/new-page/> .