COVID-19 and the Rebirth of Compulsory Licensing: An Examination of the Right to Health Care

Licensing

COVID-19 AND THE REBIRTH OF COMPULSORY LICENSING: AN EXAMINATION OF THE RIGHT TO HEALTH CARE

by

Emaediong Ofonime Akpan[1]

Chinonyerem Ini Ememobong [2]

Abstract: The covid-19 epidemic has ravaged nations leaving a high death toll in its wake. This article examines the intellectual property issues that may surround an invention of a vaccine for Covid-19. Chief amongst these issues being compulsory licensing. The compulsory licensing of a Covid-19 vaccine patent was examined with respect to the right to health. International treaties on compulsory licensing and the right to health was discussed as a justification for making vaccines such as that which may be discovered for the Covid-19 available to developing countries like Nigeria. It was discovered that the Nigerian Constitution does not make justiciable the right to health. It was recommended amongst others that the Nigerian State should leave up to its international commitments as contained in treaties signed by making policies that ensure access to health care.

Keywords: Right to Health, Covid-19, Compulsory Licensing, Patents, Vaccine

I. Introduction

The world has been brought to its ‘knees’ by the raging death toll of the COVID-19 epidemic. Despite the advances in medical science a vaccine for the Corona virus has continued to elude scientists. Till date, there is no known vaccine that has been earmarked to protect one against the Corona virus neither are there globally accepted pharmaceutical treatments registered for the indication.[3] This will likely change following the efforts of research groups.[4] Breakthrough in medical science is not different from innovation in other disciplines hence, the mental effort and economic contribution are usually protected to yield profits for the innovator through patents.

Patents typically allow the general public to access essential medicines, which would otherwise have unlikely been invented.[5] Given the current global political climate, however, critics fear that a nation’s right to control how and when a COVID-19 vaccine is distributed may wind up being wielded in a restrictive manner. There is currently no vaccine for COVID-19, but several pharmaceutical companies in Europe, the United States, and China believe they are close to producing successful treatments. In the light of the foregoing it is necessary to examine the issues that surround innovations of this nature. Principal amongst these issues is compulsory licensing.

II. Patents and compulsory licensing

A patent is an exclusive right granted to a person who has invented a new and useful product or process or has improved an existing product. It is a monopoly of rights preventing others from exploiting the invention, the rationale being that rewarding the inventor for the effort, skill and resources expended will encourage innovation.[6] In the case of conferring monopoly rights over life-saving drugs such as a vaccine for the covid-19, patents are highly contentious. It can be that pharmaceuticals should be excluded from the purview of patent law, due to the possibility of abusing monopoly rights and taking unfair advantage of the absence of competition that results in high pricing of the patented drug making it inaccessible to the poor. On the other hand, it would appear that patent law justifies patents on drugs by arguing that removing or limiting patent rights will drastically affect research and development in the pharmaceutical sector.[7] 

Compulsory license is a method to check the abuse of patent rights, while not defeating the law itself. Compulsory licenses are licenses under which others may work the invention against the wishes of the proprietor of the patent.[8] It has always been argued that there is a danger that the proprietor of a patent will abuse the monopoly granted to him.  The WTO defines a compulsory license as “when a government allows someone else to produce the patented product or process without the consent of the patent owner”.[9] International laws exists to allow for compulsory licenses as a remedy for a variety of scenarios including abusive pricing, anti-competitive behaviour and emergencies.[10]

III. The right to health care

It behooves on government to protect lives and property.[11] The covid-19 epidemic has seen citizens meet with harsh economic times. Considering the transmission method of Covid-19, it is more than necessary for any vaccine or treatment to be made available to every citizen. This is in line with their right to health as entrenched in the Universal Declaration of Human Rights (UDHR) which affirms that ‘everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services’.[12] Hence, based on Article 25 (1) UDHR, a state has the obligation to achieve the standard stipulated on the Article. Besides, there are some International instruments, which regulate the right to health, such as Article 12 (1) of the International Covenant on Economic, Social, and Cultural Rights (hereinafter ICESCR).[13] Article 5(e) (iv) of the International Convention on the Elimination of All Forms of Racial Discrimination of 1965, and Articles 11 (1) (f) and 12 of the Convention on the Elimination of All Forms of Discrimination against Women of 1979.[14] Access to medicine affects the right to health. The fundamental legal basis the right to health is stipulated in the article 12 (1) of ICESCR, which recognises “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” Consequently it needs the active effort of a state to materialise it, which includes the prevention, treatment and control of epidemic, endemic, occupational and other diseases and the creation of conditions which would assure to all medical service and medical attention in the event of sickness.[15]

In the face of a global epidemic like the Covid -19 the Nigerian constitution in its present state has rendered the right to health care an aspirational goal as opposed to a legally enforceable entitlement. To further enervate the right to health are, the courts are precluded in section 6(6)(c) of the Constitution from entertaining matters set out in chapter II. The constitution under section 17(3) (c) requires the State to direct its policy towards ensuring the health and safety of all persons in employment are safeguarded and no endangered or abused. Section 17(3)(d) requires that provisions be made for adequate medical facilities for all persons. Despite these lofty provisions the right to health care is not such which a court can grant a remedy for its violations. This is clearly in conflict with the standards of the Universal Declaration of Human Rights which Nigeria is a signatory to.

IV. Conflict or congruence between compulsory license of pharmaceutical product in the TRIPS agreement and the protection of the right to heath in developing countries

TRIPs agreements are auspicious steps toward helping developing nations have ‘unfettered’ access to medicines for epidemics.[16] The WTO negotiations and agreements outstandingly avoid any obvious recognition of human rights, particularly the right to health. The TRIPs Agreement appears to shy away from individual human rights, such as the right to health in justifying compulsory licenses hence there is an emphasis on public health rather than the discussion to the protection of individual human rights, such as the right to health.[17] Consequently, it results in less legally binding laws to achieve access to medicines. A majority of TRIPs Agreement Members are also the Members of the ICESCR, thus, there is possibility of conflict between the obligations in the TRIPs Agreement and the obligation in the ICESCR. These agreements regulate two different things; the TRIPs Agreement regulates intellectual property right while ICESCR regulates the protection of human right. Their seeming congruence is blurred when it is considered that both the ICESCR and TRIPs Agreement interrelate since the access of medicine affects the protection to the right to health. The TRIPs Agreement should be flexibly interpreted to promote access to medicine.[18] The Doha Declaration opens the way for developing countries to access essential medicine.  

V. The legal implication of compulsory license of pharmaceutical products in the TRIPS agreement to the protection of the right to heath in developing countries

Foremost amongst these implications is the accessibility and affordability of the essential medicine which are deserved by patients in developing countries, such as Antiviral and Antiretroviral,[19] since the developing countries can use the justification based on the reason of protecting public health and also the developing countries have a freedom to issue the law to determine what emergency situation to justify to implement compulsory license. Thus, the compulsory license enables state to protect the right to health. Second, the developing countries can exercise the compulsory license to support the right to health. However, it is necessary to adopt policy and regulations to take the benefit of the compulsory license to protect the right to health. Indeed, the right to health does not only oblige states to take positive measures to ensure the access to affordable medicine for all, but also requires them to refrain from taking measures that could impede this access.

Consequently, when implementing compulsory license rules, countries have to take the right to health into account, ensuring the access to quality medicines is affordable prices,[20] so that the patients in developing countries will not find difficulty in accessing the medicine. 

Thirdly, access to essential medicine which is protected by patent has already become the important issue in international human rights law. The accessibility and affordability of essential medicine needs to be materialised in order to protect the right to health.[21] It has been noted by the UN Sub-Commission on Human Rights[22] that there are apparent conflicts between the fundamental principles of international human rights and the principles of international intellectual property regime as embodied in the TRIPS Agreement.  Thus, the compulsory license can be used as a legal instrument to justify of producing generic version of essential medicines in developing countries.  Hence, the TRIPs Council made an Amendment of the TRIPs Agreement in November 2005 which permits the parallel import. Finally, international human rights documents cannot serve as a substitute for an explicit recognition of the right to medicine in the TRIPS Agreement. By embodying the right in the TRIPS Agreement, the WTO would help secure the right to medicine by supplying member.[23]

VI. Conclusion/ Recommendation

This article examined the legal issues that may surround the accessibility of a prospective vaccine for the Corona-virus. Dissenting views on the justification of compulsory licenses in pharmaceutical products were examined. This work revealed that compulsory licenses of pharmaceutical products stem from the reference to the right to health. The present Nigerian Constitution appeared to leave the right to health as a mere aspiration while depriving the Courts of any powers to award remedies to anyone who’s right to health has been violated. This makes it imperative to seek that current state of affairs be reviewed in line with international standards. Although the justiciability’s of the right to health will not necessarily translate to adequate health care. The non-justiciability of the right to health care does not also translate to the access to health care. It is recommended that there must be conscious efforts to ensure that Citizens are catered for through programmes or policies that live up to the expectation of the International Treaties to which Nigeria is a signatory.


[1] Emaediong Ofonime Akpan (LL.M) School of Post Graduate Studies University of UyO. She can be reached at  +2348067228485 and  akpanemaediongofonime@gmail.com

[2] Chinonyerem Ini Ememobong, (B.L), Negotiation Skills (Harvard University) Lecturer Akwa Ibom State Polytechnic. A postgraduate student, Faulty of Law University of Uyo. She can be reached at  chinonyereminiememobong07@gmail.com

[3] See Ellen Hoen, ‘Covid-19 and the Comeback of Compulsory Licensing’ (2020) Medicines Law and Policy

[4] The WHO announced a large multi-country clinical trial to test drugs to treat Covid-19. The drugs to be tested include remdesivir, lopinavir and ritonavir in combination; lopinavir/ritonavir plus interferon-beta; and chloroquine and hydroxychloroquine. All are known medicines originally developed for other indications. The products have shown some efficacy in laboratory and animal experiments but unless a large human trial is carried out it is not possible to make an evidence-based recommendation about their use in the treatment of Covid-19.

[5] See Rebeca Harasimowicz, ‘The Global Patent Race for a COVID-19 Vaccine’ (2020) Summa PLLC March 24, 2020.

[6] See Raadhika Gupta, ‘Compulsory Licensing Under Trips and Public Health Concerns in Developing Nations’(2010) 15 Journal of Intellectual Property Rights 357-363.

[7] See Neil George Cherian, ‘Using Compulsory Licenses to Access Pharmaceuticals: A Cross Case Analysis on Outcomes’ (2016) Master Thesis University of Oslo.

[8] See G Julian-Arnold, ‘International Compulsory Licensing: The Rationales and the Reality’ (1993) 33 (2) The Journal of Law and Technology 349.

[9] See Cherian (n.5).           

[10] The Agreement on Trade Related Aspects of Intellectual Property (TRIPS) imbibed Article 5(a) Paris Convention for the protection of Industrial Property March 20 (1883).

[11] Section 14(4) The Constitution of the Federal Republic of Nigeria (1999) as Amended. 

[12] Article 25 (1).

See Tina S. Bhatt, “Amending Trips: A New Hope for Increased Access to Essential Medicines”, (2008) 33 Brooklyn Journal of International Law 600.

[13] See Kojo Yelpaalaa, ‘Quo Vadis WTO? The Threat of Trips and the Biodiversity Convention to Human Health and Food Security’ (2012) 30 Boston University International Law Journal, 65-66.

[14] See Timothy Bazzle, ‘Pharmacy of the Developing World: Reconciling Intellectual Property Rights in India with The Right To Health: Trips, India’s Patent System and Essential Medicines’ (2011) 42 Georgetown Journal of International Law 788.

[15] See Adam Houstona, ‘A Scientific Approach to Intellectual Property and Health: Innovation, Access, and a Forgotten Corner of the Universal Declaration of Human Rights’ (2014)13 John Marshall Review of Intellectual Property Law 800-801.

[16] See Erika Georgea,” The Human Right to Health and HIV/ AIDs: South Africa and South-South Cooperation to Reframe Global Intellectual Property Principles and Promote Access to Essential Medicines”, (2012) 18 Indiana Journal of Global Legal Studies 179-180.

[17] See Chuan-Feng, Wu, ‘Raising the Right to Health Concerns Within the Framework of International Intellectual Property Law’. Asian Journal of WTO & International Health Law & Policy (2010) 5 141-209.

[18] Wu (n. 15).

[19] See Adam Houstona, “A Scientific Approach to Intellectual Property and Health: Innovation, Access, and a Forgotten Corner of the Universal Declaration of Human Rights”, (2014) 13 John Marshall Review of Intellectual Property Law 800-801.

[20] See Center for Health, “Transnational Pharmaceutical Corporations’ Legal and Moral Human Rights Responsibilities in Relation to Access to Medicines”, “Health and Human Rights Resource Guide”. Retrieved from:  https://www.hhrguide.org/2017/06/09/access-tomedicines-and-human-rights/. Accessed on May 4, 2020.

[21] Peter K Yua, “Intellectual Property in International Perspective: Institute for Intellectual Property & Information Law Symposium”, (2009) 46 Houston Law Review 990.

[22] WTO Doha Ministerial Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2 (14 Nov. 2001) [hereinafter Declaration on TRIPS and Public Health]; WTO Council for TRIPS, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/C/W/405 (30 Aug. 2003) [hereinafter WTO, Implementation of Paragraph 6]”. Available on the website: https://www.wto.org/english/res_e/booksp_e/ddec_e.pdf, retrieved on May 7, 2020.

[23] Sri Wartini, ‘The Legal Implication of Compulsory Licence Pharmaceutical Products in The TRIPS’ (2018) 1 (18) 

Jurnal Dinamika Hukum 3.

This article was published as part of NLIPW Trademarks Digest Volume 3 No. 10.

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