ACCESS TO AFFORDABLE ESSENTIAL MEDICINES AND VACCINES IN

DEVELOPING AND LEAST DEVELOPED COUNTRIES: TO WHAT EXTENT

SHOULD HUMAN RIGHTS TAKE PRECEDENCE OVER INTELLECTUAL
PROPERTY WHERE THE RIGHTS OF CHILDREN ARE CONCERNED?.

HAZEL MUGUMBATE

Dissertation submitted in partial fulfilment of the requirements of the degree

LLM Health Law

NOTTINGHAM TRENT UNIVERSITY

LAW SCHOOL

SEPTEMBER 2013
Abstract

Millions of people in developing and least developed countries (LDCs) lack access to the
most basic healthcare services which includes safe and effective medicines. This represents
the global healthcare crisis were treatable and preventable diseases are rampant in countries
that are not equipped to deal with these problems. Access to pharmaceuticals including
vaccines is one of the key pillars of a healthcare system. The World Health Organization
(WHO) introduced the term “Essential Medicines” in 1977 to refer to medicines that are
considered vital to saving lives and improving health. Access to essential medicines is widely
accepted as a core component of access to health care and is recognised as realising the
human right to health. However huge disparities exist in the health status of people between
the developed and developing world as well as within countries. While advances in the
development of medicines for adults have been made globally, this has not occurred at the
same rate in the area of medicines for children. A large proportion of medicines used to treat
children are not licensed or approved for use in this population group. The lack of child
specific medicines which leads to the use of medicines that have not been tested or authorised
for use in children, is a global problem but affects poor countries the most .The WHO Model
List of Essential Medicines (EML) was published in 1977 and it took 30 years for the first
Essential Medicines List for Children (EMLc) to be introduced. The lack of interest and
focus on treatable and preventable diseases claiming the lives of children in the developing
and LDCs such as Sub-Saharan Africa had led to a deficit in the knowledge, research and
developments in their treatment. The term LDCs will be used as defined by the United
Nations (UN) and adopted by the World Trade Organisation (WTO). The following terms
“drugs,” “medicines,” and “pharmaceuticals” will be used interchangeably in this study and
do not refer to vaccines. The terms” children” and “paediatrics” will also be used
interchangeably.

1. Introduction
Access to medicines is fundamental for both adults and children to achieve their right to
health. Lack of paediatric formulations of medicines or child specific medicines is a global
problem but mostly affects developing and LDCs. While public health devastations such as
HIV/AIDS have received increased worldwide attention, the impact of other diseases
affecting children has not received as much. Malaria, diarrhoeal disease, pneumonia and
vaccine-preventable diseases such as measles are major diseases that claim the lives of
children under the age of five in developing and LDCs. Safe and effective medicines
specifically developed for use in children are not as widely available as adult medicines. A
limited number of drugs are developed to specifically cater for the child or paediatric
population and within this group neonates are the most neglected. The burden of many global
diseases is disproportionately shouldered by LDCs who lack access to effective medicines
and vaccines, yet most of these products are available and manufactured in developed
countries.

Children in developing and LDCs are dying from treatable and preventable diseases because
the market for paediatric medicines and vaccines is not viewed as financially viable,
medicines are priced out of reach for most families and there is lack of research and
development (R&D) for diseases prevalent in children in tropical areas such as the Sub-
Saharan African (SSA) region. The extent of the HIV/AIDS crisis has highlighted the plight
of millions in developing and LDCs who are unable to access essential medicines. Global
interest and unprecedented amounts of funding have been mobilized to fight the HIV/AIDS
epidemic. The lack of paediatric medicines is a global problem leading to the use of off label
and medicines that are not licensed for children and this practice can expose children to risks.
Research in children is therefore required to generate data on the safety and efficacy of
medicines. However obstacles pose a challenge in conducting research in children.

International organisations and Non-Governmental Organisations (NGOs) have advocated

for the pharmaceutical industry to develop paediatric formulations of antiretroviral (ARV)
and progress has been made in this area. However the lack of paediatric formulations of
medicines is an issue not limited to ARVs but affects most of the medication used in the
treatment of the paediatric population. The lack of interest and focus on other treatable and
preventable diseases claiming the lives of children in LDCs such as SSA has led to a deficit
in the knowledge, research and developments in their treatment. Significant advances have
been made in treatments for children in developed countries but this is yet to be felt in the
treatment of children in LDCs and some developing countries.

1.2 Objectives of the study

This study looks at broadening access to medicines in developing and LDCs with a focus on
paediatric medicines and vaccines using the SSA region as a case study. The SSA region
presents the world’s most serious health problem with inequalities and lack of access to
health care yet this region is ill equipped to tackle these problems. An examination of the
needs of children in terms on access to essential medicines and their right to access medicine
under the international human rights framework will be carried out in order to determine
whether the human rights of children should take precedence over intellectual property rights
under such a framework. An assessment of initiatives to solve the problem of lack of
availability and access to essential medicines for children and vaccines will be discussed.

The implications of trade agreements on public health, such the 1994 WTO Trade Related
Aspects of Intellectual Property Rights Agreement (TRIPS or TRIPS Agreement), on access
to essential medicines, has been one the most debated topics in the recent years. TRIPS has
been heavily criticised for hindering access and availability of medicines in poor countries
and consequently disregarding the right to health. This study emphasises that the TRIPS
regime does not necessarily end this right but provides an opportunity to realise the right to
health. This study also identifies other opportunities within and outside the TRIPS agreement
and subsequent Doha Declaration for realising the right to health for children.

Although this study acknowledges the fact that other factors unrelated to patents restrict
access to essential medicines in developing and LDCs These can be socio-economic factors
such as extreme poverty, poor health systems with lack of skilled health professionals and
lack of commitment to disease prevention, the impact of intellectual property rights (IPR)
such as patented medicines either being unavailable in the developing world or being priced
out of reach for many patients will be the main focus of this discussion.

1.3 Significance of the Study

One of the most pressing global health issues is the lack of access to essential medicines in
developing and LDCs. The lack of access to medicines impacts on both adults and children
yet for the latter child friendly medicines are not available simply because they have not yet
been developed. The situation facing children in developing and LDCs is lack of access to
essential treatment because suitable paediatric formulations are not available or are
unaffordable. Although international agreements give children the right to medicines that
fulfil the same criteria of quality, safety and efficacy, children`s medicines are not available
to the same extent as a adult medicines. The paediatric population is being treated with
medicines that have not been tested in children but in adults with the efficacy and safety of
these medicines assumed to be the same as in adults and not based on sound evidence.
Vaccines represent an exceptional success story in modern medicine and play a key role in
the reduction in morbidity and mortality worldwide. Vaccines are relevant to this study
because of their success as a public health intervention and the fact that they are
predominately used in the paediatric population.

In any society an effective health system should be a core institution but unfortunately the
failing health systems in many developing countries give rise to human rights problems .The
focus on SSA is due to the fact that the health of the majority of the population, especially
children, remains in jeopardy due to lack of access to essential medicines and the region’s
health system`s failure to meet basic standards of care. Most SSA countries fall under the UN
designation of LDCs and of the 34 LDCs who are currently WTO members, most of these are
SSA countries. The SSA region has the highest level of mortality of children under the age
of five than any other region. The SSA countries as participants in the multilateral trade
system have viewed the TRIPS Agreement as favouring developed countries while their
interests are ignored and at worst harmed. TRIPS has been criticised for creating a “one-size-
fits-all” system for all WTO members despite their different levels of development.
Additionally, concerns that developed countries are pushing for the acceptance of IP
protection that is more than what is mandated by TRIPS, referred to as TRIPS-Plus, poses an
obstacle for developing and LDCs in using TRIPS to meet their public health needs.