Unintended Consequences and Hidden Obstacles in Medicine Access in Sub-Saharan Africa.

Iain Barton,Ravi Anupindi,Nevashini Gounden,Anton L V Avanceña

doi:10.3389/fpubh.2019.00342

Iain Barton, Ravi Anupindi + Show 2 more

Open Access

https://doi.org/10.3389/fpubh.2019.00342

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Abstract

Many life-saving drugs are still inaccessible and unaffordable in low- and middle-income countries, particularly in Sub-Saharan Africa. This contributes to poor health outcomes, wider health and socioeconomic inequities, and higher patient spending on healthcare. While resource limitations facing national regulatory authorities (NRAs) contribute to the problem, we believe that (1) fragmented and complex drug regulations, (2) suboptimal enforcement of existing regulations, and (3) poorly designed disincentives for non-compliance play a larger role. These “unintended consequences” that are a direct result of our current regulatory regimes limit competition, keep drug costs high, and lead to shortages and the proliferation of illegitimate and unregistered drugs. While NRAs can gain a lot from increased investment in their work, regulatory harmonization and innovation can arrest and reverse the regulatory failures we still see today and improve medicine access in Africa. Unfortunately, harmonization initiatives in Sub-Saharan Africa have made modest impact and have done so slowly. We encourage greater attention and investment in harmonization and other downstream functions of NRAs. We also urge increased participation of national governments–particularly executive agencies in health and the treasury—and patient advocacy groups in advancing harmonization across the subcontinent.

Highlights

In most countries, a national regulatory agency (NRA) ensures that medicines are safe, effective, affordable, and are high-quality [1,2,3,4]
We propose a framework that explains how [1] fragmented and complex drug regulations, [2] suboptimal enforcement of regulations, and [3] poor disincentives for non-compliance create unintended consequences that lead to poor health outcomes and health inequities
We argue that some of the issues around drug availability, affordability, and quality result not from poor NRA capacity but from the misguided belief that each Low- and middle-income countries (LMICs) must establish its own NRA with its own standalone regulations

Summary

INTRODUCTION

A national regulatory agency (NRA) ensures that medicines are safe, effective, affordable, and are high-quality [1,2,3,4]. Low- and middle-income countries (LMICs), Sub-Saharan African (SSA) countries, have made great strides in establishing their own NRAs and drug regulatory regimes; the availability, affordability, and quality of life-saving drugs are still not guaranteed [6] In this perspective article, we propose a framework that explains how [1] fragmented and complex drug regulations, [2] suboptimal enforcement of regulations, and [3] poor disincentives for non-compliance create unintended consequences that lead to poor health outcomes and health inequities. Harmonization will result in streamlined regulations and processes, which can reduce redundancy and drug registration times, leading to increased access to new and effective treatments [5, 23]. As of 2017, 12 African countries have adapted the AU Model Law on Medical Products Regulation which aims to establish common pharmaceutical laws throughout the continent [6]

A Path Forward

Findings

CONCLUSION