Improving Access to Medicines in Low‐Income Countries: A Review of Mechanisms

• Author: Daniel Gervais,Andrew Christie,Ellen Wright Clayton,Cindy Bors
• DOI: http://doi.org/10.1111/jwip.12032
• Date: 01 March 2015
• Published date: 01 March 2015

Improving Access to Medicines in Low-Income

Countries: A Review of Mechanisms

Cindy Bors

Kliger Partners, Australia

Andrew Christie

Melbourne Law School, Australia

Daniel Gervais

Vanderbilt Law School, Tennessee

Ellen Wright Clayton

Vanderbilt University, Tennessee

Individuals in low-income countries (“LICs”) often lack access to appropriate medicines. The multi-disciplinary

nature of this problem requires a holistic approach. Whereas, other writings on the topic tend to focus on one or a small

number of issues, often from the perspective of a single discipline, this paper seeks to consider the major issues from a

multi-disciplinary perspective. It f‌irst considers mechanisms for improving the availability of medicines in LICs,

through grants, prizes, treaties, advance market commitments, priority review and product development partnerships

to incentivize and fund R&D for neglected diseases. The paper then assesses mechanisms for improving affordability

of medicines in LICs, such as differential pricing mechanisms, monopsonies, patent law f‌lexibilities and human rights

obligations. Next, the paper reviews mechanisms for improving the eff‌icacy of medicines in LICs, including

authentication, criminalization, international and national enforcement and communication and education. Finally, the

paper examines mechanisms for improving the obtainability of medicines in LICs, through low-cost intervention,

task-shifting, eff‌icient regulation, grass-roots service provision and education. The paper concludes by identifying

areas warranting further research.

Keywords TRIPS; WHO; Africa; Caribbean

On the 24th and 25th of July 2013, the University of Melbourne and Vanderbilt University held the

Melbourne–Vanderbilt Roundtable on Access to Medicines (the “Roundtable”) at the University of

Hawaii. In attendance were ten participants

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with expertize in a variety of disciplines, including

intellectual property law, health policy, medical ethics, medicine, genetics, public health, economics,

pharmaceutical markets and development. The Roundtable was moderated by Andrew Christie and Daniel

Gervais, being representatives of the University of Melbourne and Vanderbilt University, respectively.

The participants were brought together to contribute to a group discussion on one of the most important

global public health issues: improving access to medicine in low-income countries (LICs)

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(Commission

on Intellectual Property Rights 2002; Commission on Intellectual Property Rights, Innovation and Public

Health, 2006; Lanjouw, 2005; Watal, 2000; World Bank, 2013, 2014; World Health Organization (WHO)

Commission on Macroeconomics and Health, 2001).

The multi-disciplinary nature of the problem of access to medicines in LICs requires a holistic

approach, especially one that identif‌ies and examines the areas where cross-disciplinary collaboration is

valuable. The need for such a discussion was the primary reason for convening the Roundtable. The

Roundtable proceedings included presentations on all participants’areas of expertize, ref‌lections across

©2015 John Wiley & Sons Ltd 1

The Journal of World Intellectual Property (2015) Vol. 18, no. 1–2, pp. 1–28

doi: 10.1111/jwip.12032

disciplines on the various access issues, a consolidation of the major factors that contribute to access and

suggestions for further research.

This paper provides an overview of the various issues considered at the Roundtable, and contains

further research and analysis undertaken following the Roundtable. Whereas, other writings on the topic

tend to focus on one or a small number of issues, often from the perspective of a single discipline, this paper

seeks to consider the major issues from a multi-disciplinary perspective. Its signif‌icance, therefore, lies in

its breadth.

Individuals in LICs often live in situations of inadequate food, shelter and sanitation. In addition to

these obstacles, they lack appropriate healthcare and access to medicines. As a result, it is not surprising

that these individuals suffer from high rates of illness and premature death from diseases that would

otherwise be preventable and/or treatable (Orach, 2009). Access to medicines in LICs is inf‌luenced by a

combination of interlocking factors. For diseases and illnesses that are prevalent in LICs but which have no

presence in high-income countries, there are often no effective medicines in existence. Such medicines

have not been developed due to a lack of suff‌icient incentive for private sector investment in the necessary

R&D. For those medicines that do exist, their accessibility in LICs is reduced when they are priced to make

a prof‌it, thereby often putting them out of reach of the majority of the population. Access to available and

affordable medicines is also reduced by purveyors of substandard medicines, who expose millions of

patients in LICs to harmful and even deadly concoctions. For those medicines that are available, affordable

and eff‌icacious, access in LICs is dependent upon the medicine being obtainable. Obtainability is reduced

due to a number of impediments to distribution: inadequate health systems, a lack of physical (incl.

transport) infrastructure and social barriers.

Part II of this paper considers mechanisms for improving the availability of medicines in LICs. It

provides an overview of pharmaceutical R&D, its impact on the treatment of neglected tropical diseases

(NTDs), current methods to incentivize and fund R&D, and options for further incentives. Part III

considers mechanisms for improving affordability of medicines in LICs. It discusses patients’ability to

pay for medicines in LICs, methods to reduce the cost of R&D and the price of medicines, and other

approaches to reducing prices. Part IV considers mechanisms for improving the eff‌icacy of medicines in

LICs. It examines the proliferation of substandard medicines internationally, their disproportionate effect

upon poor nations, current structures to reduce their existence, and additional preventative means. Part V

considers mechanisms for improving the obtainability of medicines in LICs. It reviews impediments to

distribution of medicines in poor nations, existing methods to increase supply to patients, and further

possibilities for enhancing distribution. The Annex identif‌ies areas warranting further research.

Improving Availability

Medicine availability is satisf‌ied when medicines specif‌ic to the largest disease burden of LICs, namely

NTDs,

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are in existence (News Medical, 2011; WHO, 2013). While there are thousands of medicines on

the market, the overwhelming majority are designed for the needs of high-income countries. This results

from a lack of incentive for R&D of medicines for NTDs.

Pharmaceutical companies function within a system incentivized by attaining prof‌its through the

intellectual property rights (IPR) regime. The IPR system incentivizes innovation through the extension of

market exclusivity via patents. A benef‌it of this system is its sustainability: the patent system runs within a

market whereby consumers (instead of governments) “choose”by providing the incentive for production

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(Vacca, 2013). However, in LICs the population is largely unable to provide an incentive for production as

their ability to pay is minimal if not non-existent.

Furthermore, the government purchase of medicines for the public sector is restricted due to limited

funds. The cost of medicines is substantial, accounting for 60% of health spending in some developing and

Cindy Bors et al. Improving Access to Medicines in Low-Income Countries

©2015 John Wiley & Sons Ltd

2The Journal of World Intellectual Property (2015) Vol. 18, no. 1–2