A re‐evaluation of the framework for the protection of patents, women’s health in Nigeria and the issue of accessing pharmaceutical innovation in Africa: Designing strategies for medicines

• Author: Jennifer H. Mike
• Date: 01 July 2019
• Published date: 01 July 2019
• DOI: http://doi.org/10.1111/jwip.12123

J World Intellect Prop. 2019;22:162–204.wileyonlinelibrary.com/journal/jwip162

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Received: 6 July 2018

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Revised: 24 February 2019

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Accepted: 23 March 2019

DOI: 10.1111/jwip.12123

ORIGINAL ARTICLE

A re-evaluation of the framework for the

protection of patents, women’s health in Nigeria

and the issue of accessing pharmaceutical

innovation in Africa: Designing strategies for

medicines

Jennifer H. Mike

School of Law, University of Exeter, Exeter,

United Kingdom of Great Britain and

Northern Ireland

Correspondence

Jennifer Heaven Mike, School of Law,

University of Exeter, Exeter, United Kingdom

of Great Britain and Northern Ireland.

Email: Jennifer.mike@aun.edu.ng;

Jennifer2heaven@yahoo.com

Abstract

The objective of this study is to make a case for Nigerian

women to have access essential medicines in light of patent

protection of pharmaceuticals. Consequently, this study argues

for an improvement of women's access to medicines within the

context of patent law and rights, the available flexibilities in

the international IP regime of the Trade Related Aspect of

Intellectual Property Rights (TRIPS) Agreement and Nigeria's

national patent system. Towards this goal, the article makes

the point that patent law and its exclusive rights, both the

TRIPS Agreement and national law of Nigeria, do not exist in a

social welfare vacuum. The legal text of patent law, which

confers rights on inventors when enforced, translates to many

other things outside the sphere of property rights; indeed, it

can be a matter of life and death. It is argued in this regard that

patent right could, in effect, interfere with access to medicines

and therefore, the right to health and prospects for human

development. This study adopts a doctrinal methodology to

examine, analyse, and evaluate the issues that have arisen in

the context of patent protection of pharmaceuticals and its

effect on access medicines. It concludes that while the

hindrances to accessibility of essential drugs in Nigeria are

Health is not everything, but, without health, everything else is nothing. (Joseph, 1991)

© 2019 The Authors. The Journal of World Intellectual Property © 2019 John Wiley & Sons Ltd

multifaceted and demand a multidimensional approach for a

lasting solution, the TRIPS flexibilities are significant means for

addressing the challenges of affordable access to important

health treatments within the context of patent law. However,

it is emphasised that utilising the flexibilities will require that

Nigeria's patent system is strategically designed to take full

advantage of the available exceptions, safeguards, and options.

KEYWORDS

access to medicines, flexibilities, Nigeria, Pharmaceutical patents,

public health, TRIPS, women's right to health

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INTRODUCTION

The concept of access to medicines generally encompasses the idea that everyone should have the equitable

means, facilities, and opportunities to have, obtain, and use safe life‐saving drugs for health treatment purposes

(United Nations, 2008a, p. 35; WHO, 2004a, p. 5).

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Access to a secure, affordable, regular, sustainable, and good

quality supply of life‐saving essential medicines is, however, not adequate, especially in developing countries,

including Nigeria. Access to medicines is not only a public health conundrum; the problem of access also raises

concerns with regard to the patenting of medicines.

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(United Nations, 2008a, p. 35; WHO, 2004c, p. 5; Leach,

Paluzzi, & Munderi, 2005, p. 27). The patenting of pharmaceuticals is often at the forefront of the debate on the

effects of patent rights on the availability of, and affordable access to, life‐saving treatments, mainly for people

living in developing countries.

Against this background, this article examines the issues of access to medicines within the context of patent

rights in Nigeria and the international debate on the relevance of the Trade Related Aspect of Intellectual Property

Rights (TRIPS) Agreement (1994). Particularly, the ways in which the intellectual property (IP) rules in the

Agreement could impact adversely on access to essential medicines. In conducting the analysis, the article mainly

highlights the distinct public health needs and interests of women in their quest for access to essential medicines in

Nigeria. This is borne out of a need to make a case for women's right to health by pointing to a range of legal,

socioeconomic, and other factors, both in Nigeria and within the international trade system that can positively or

negatively influence their health outcomes.

Essentially, this study adds a gendered dimension to the problems of access to medicines within the scope of

patent law.

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Principally, it surmises that, although the problems of access to medicines in Nigeria can be traced to

socioeconomic, cultural and limited infrastructural factors, patent provisions can also potentially bear upon

women's access to important healthcare treatments. This interdisciplinary study therefore, suggest ways in which

Nigeria's patent system can be more human development and human rights friendly in the interest of public health,

particularly, the use of the TRIPS flexibilities to enhance access to life‐saving medicines in Nigeria.

This study is divided into two parts. The first sets the tone for the study by outlining the general challenges of

the Nigerian health care system and also the distinct health needs of its women. In addition, the general health

condition and problems of access to medicines in Nigeria are discussed. This part argues that, although men and

women face similar constraints and difficulties in relation to accessibility to medicines, due in part to socioeconomic

factors, harmful traditional, cultural, and religious practices, the experience of women are exacerbated to varying

degrees. It is, therefore, argued that any national process to improve access to medicines requires multifaceted

efforts. Specifically, in this study, it is argued that these should include a consideration of the ways in which patent

rights could impede women's accessibility to affordable essential medicines.

MIKE

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The second part relates the problems of access medicines to the widespread international debate on the ways

in which patent rights could hinder accessibility to life‐saving medicines. This analysis also explores the unintended

consequences and repercussions of patent rights on the cost of medicines and availability of drugs to women. In

particular, the focus is on the patent provisions in the TRIPS Agreement which extend to pharmaceuticals and the

consequential trickle‐down effect on the price and the availability of medicines. Similarly, it outlines the problems

associated with the patent system's inadequacy on promoting investment in medicinal products for neglected

diseases that affect women and the poor in many parts of the developing world.

The study concludes with suggestions on how the TRIPS‐related flexibilities can ameliorate this challenge of

access.

To put the research in context, this study starts with an examination of the health care system in Nigeria.

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PART I: THE NIGERIAN HEALTHCARE SYSTEM AND THE ISSUE OF

ACCESS TO ESSENTIAL MEDICINES

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The concept of essential medicines: Improving access to life‐saving and important

pharmaceuticals

While medicines are vital to maintaining, improving, and restoring health, as well as preventing and treating

illnesses and diseases, essential medicines

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are important medicinal treatments that can save lives and improve

health when they are available at affordable prices and used appropriately (WHO, 2004b, p. 1). The World Health

Organization (WHO) defined essential medicines as “those that satisfy the priority health care needs of the

population.”

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Accordingly, these are affordable medications that everyone should have appropriate access to, at all

times to improve their health, within a functioning health system. The WHO has also noted that essential medicines

are “of utmost importance, basic and indispensable, and necessary for the healthcare needs of the populations”

(WHO, 2003, p. 14). Importantly, access to essential drugs is recognised as fundamental to the realisation of the

right to health (General Comment no. 14, para 43(d)).

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Essential medicines are selected on the basis of certain criteria. They are selected with due regards to the

“disease prevalence, public health relevance, evidence of clinical efficacy and safety, and comparative costs and

cost‐effectiveness”(WHO, 2003, 2017). There is no universal identification of all essential medicines; however, the

definition of essential medicines by the WHO is widely adopted as the parameter for categorising essential

medicines. The implementation of which is intended to be flexible and adaptable to many different situations

(WHO, 2004b). Furthermore, the WHO states that the medicines to be regarded as “essential”are matters of

national responsibility; although further guidance is provided on how to determine and select essential medicines

(WHO, 2004b).

The WHO publishes a Model List of essential medicines although each country is encouraged to prepare and

publish their own list by taking into account their development, health and national priorities (United Nations,

2008a, p. 36).

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Though the list is not designed as a global standard, it is a guide for countries to adopt and adapt

where necessary in the development of their national and institutional essential medicines list (Kar, Pradhan, &

Mohanta, 2010, pp. 10–13; WHO, 2004b, 2015a; WHO, 2013). The first Model List of Essential Medicines was

launched in 1977 (WHO, 2003). It was designed to serve as a blueprint for the most effective, affordable, and safe

medicine to meet important healthcare needs and priorities (WHO, 2013).

The WHO Essential Model List contains a core list and a complementary list of essential drugs.

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The essential

medicines list (EML) of a country is vital to improving and maintaining health as it gives priority status to safe and

high‐quality medicines that address a country's public health challenges, while also taking into account the cost

effectiveness of the medicinal treatment (Logez, Helene Moller, Ahmed, & Patel, 2011, pp. 62–68; WHO, 2003).

Nigeria's Essential Medicines List (Sixth Revision 2016) was updated “to ensure that essential medicines are

available at all times to its people all over the country as it expands the primary care system to ensure access to

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