Philosophiae Doctor - PhD / The concepts of availability, affordability, accessibility and acceptability otherwise known as the 4As of ATM are key factors that influence access to essential medicines in any given health system. However, the exact scale and extent to which these 4As affect various populations in Nigeria remains unknown. This study investigates the Nigerian healthcare system with special focus on access to quality and affordable essential medicines in three Nigerian States; Abuja, Kaduna and Nassarawa, by drawing upon primary data, using qualitative and quantitative research methods.

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Since the last century, many wars and violations of Human Rights were direct reasons that set the pace to develop Human Rights laws, especially after the end of World War II and the holocausts associated with it. One of the critical Human Rights is that ‘to life’, relating to the right ‘to health’, hence the fundamental accessibility to healthcare services and products. Nonetheless, the last decades have witnessed a significant growth in pharmaceutical patents leading to increased drug prices. Overshoots in prices prohibit access to medicine. Disputes between States, pharmaceutical corporations, patients, and investors have occurred, some of which were not purely related to monetary aspects but also to Human Rights, such as the right to ‘access to medicine’. These disputes are controversial. The applicable legal regimes are patent laws (e.g., the TRIPS Agreement) and International Human Rights Law (IHRL) including the European Convention on Human Rights (ECHR), European Social Charter, and more. However, it is up to the courts to decide on whether to consider IHRL in the legal decision process. The question turns to whether they consider the two regimes to be intersecting or independent. This thesis tackles the area of intersection between patent law and the right to ‘access to medicine’ in cases of pandemics such as inter alia HIV/AIDS and COVID-19. It investigates whether the right to ‘access to medicine’ exists as a human right by law, to jump to examine whether solutions like Compulsory Licenses (CLs) and patent exceptions are suitable. Then it answers the question whether there should be defragmentation of laws or not. The work analyzes available caselaw to seek a balance between patent laws and the human right to ‘access to medicine’ during pandemics. Caselaw shows that the conflict makes the overlap of laws confusing and in need of determining the set of relevant provisions in the applicable norms. The question on defragmentation in answered by focusing on Section 5 of the TRIPS Agreement and some provisions in IHRL instruments. The thesis proposes a defragmentation of applicable laws that aids in looking at previous solutions to reach the sought balance, and it sheds the light to give recommendations. The work finally recommends being proactive, for times of pandemics like the COVID-19 outbreak, and working on the realization of a unified and harmonized EU patent law to keep up to the objective of delivering quality vaccines/antivirals, on time, within budget, and with supporting applicable laws.

This thesis aims to provide a framework for analyzing the moral responsibilities of global agents in what I call the Global Health Crisis (GHC), with special attention devoted to the moral responsibilities of pharmaceutical companies. The main contribution of this thesis is to provide a general account of the moral responsibilities of different global players, mapping the different kinds of duties they have, their content and force, and their relation to the responsibilities of other relevant actors in the GHC. I also apply this account to current debates surrounding the need for reforms to the international legal rules addressing the GHC, notably the TRIPs regime. In doing so, this thesis will discuss the allocation of responsibilities for the GHC among different global players, such as state and non-state actors, the latter including pharmaceutical companies. In order to investigate the allocation of duties, I will first analyze the object of such allocation which constitutes the object of the current GHC (Part A); then the agents responsible for addressing this crisis (Part B); and finally, existing institutional alternatives to reform the international legal rules addressing the GHC, such as the TRIPs regime (Part C).

"The thesis of this study is that the flexibility within the exceptions to patent rights protecton under the TRIPS Agreement has not sufficiently been exploited at the national level. The study conceptualises the regimes for the protection of the right to health and IPRs not as mutually exclusive but as potentially reinforcing. The contention is therefore that the obligations in respect to the right to health limit the manner in which states can exercise the flexibilty within the patent regime of the TRIPS Agreement. Eventually the study seeks to answer the question: Where does the guarantee for the right to health lie in light of the TRIPS regime? ... The study is divided into three chapters preceded by an introduction. The introduction lays the background for te discussion. Chapter one deals with the definition of important concepts and provides the context in which the study is set. The chapter also discusses the background to the creation of the TRIPS Agreement, with an emphatic discussion on the involvement or lack thereof of Africn and other least developed and developing countries in this process. Chapter two discusses the patent rights exceptions clause under the TRIPS Agreement. Against this background, compuslory licensing, government use and parallel importing as means of making accessibility to drugs a reality under the TRIPS Agreement will be discussed. Chapter three identifies other means of making drugs more accessible and identifying places where they have worked well. In this chapter, generic substitution, establishemnt of a pricing committee, therapeutic value pricing, pooled procurement, negotiated procurement and planned donations will be discussed. Finally a conclusion will be drawn from the discussion and recommendations will be advanced." -- Chapter 1. / Prepared under the supervision of Riekie Wandrag at the Community Law Centre, University of Western Cape, South Africa / Thesis (LLM (Human Rights and Democratisation in Africa)) -- University of Pretoria, 2002. / http://www.chr.up.ac.za/academic_pro/llm1/dissertations.html / Centre for Human Rights / LLM

"The implementation of the TRIPS Agreement, within the wider context of globalisation, has brought about a conflict between the obligation of states to promote and protect health and the achievement of economic goals pursued under the WTO regime. Since trade is the driving engine of globalisation, it is imperative that, at the very least, rules governing it do not violate human rights but rather promote them. The problem of IP and the right to health therefore lies in ensuring that the integration of economic rules and institutional operations in relation to IPRs coincide with states’ obligations to promote and protect public health. ... This study centres on the specific debate about health and IPRs in the context of the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the WTO rules on IP protection. In terms of a human rights approach to the TRIPS Agreement, the ICESCR has been chosen for several reasons. First, the ICESCR specifically recognises both the right to health and the right to the protection of inventions in clearer terms than any other human rights instrument. Secondly, at least 111 of the state parties to the ICESCR are also members of the WTO including a large number of developing countries. Thirdly, if one sees the ICESCR as a vehicle for the fulfilment of the obligation to promote and protect human rights under the United Nations Organisation’s (UN) Charter, it can be argued that in line with article 103, the implementation and interpretation of TRIPS by all UN members states must take into account basic human rights. However, even with primary focus being on the ICESCR, most of the discussion on practical issues will focus on the experiences in Sub-Saharan Africa because the inequalities and problems of access to health care are most dramatically played out in this part of the world. The objective of the study is to examine the relationship between the obligation of states to progressively realise and guarantee the right to health, and the IP rules under the TRIPS Agreement. The specific objective is to examine the relationship between the exceptions under the TRIPS Agreement and the obligation to protect health and the identification of a consistent way of achieving a convergence between the implementation and interpretation of the rules of the two regimes in the area of health." -- Chapter 1 / Mini Dissertation (LLM)--University of Pretoria, 2001. / http://www.chr.up.ac.za/academic_pro/llm1/dissertations.html / Centre for Human Rights / LLM