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Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization

Sunday, 20th of November 2016

Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization

• Vincent Ahonkhai, 
• Samuel F. Martins, 
• Alexandre Portet, 
• Murray Lumpkin, 
• Dan Hartman

 

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• Published: November 16, 2016
• http://dx.doi.org/10.1371/journal.pone.0166515

Abstract below; full text is at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0166515

Background

The United Nations Millennium Development Goals galvanized global efforts to alleviate suffering of the worlds poorest people through unprecedented public-private partnerships. Donor aid agencies have demonstrably saved millions of lives that might otherwise have been lost to disease through increased access to quality-assured vaccines and medicines. Yet, the introduction of these health interventions in low- and middle-income countries (LMICs) continues to face a time lag due to factors which remain poorly understood.

Methods and Findings

A recurring theme from our partnership engagements was that an optimized regulatory process would contribute to improved access to quality health products. Therefore, we investigated the current system for medicine and vaccine registration in LMICs as part of our comprehensive regulatory strategy. Here, we report a fact base of the registration timelines for vaccines and drugs used to treat certain communicable diseases in LMICs. We worked with a broad set of stakeholders, including the World Health Organizations prequalification team, national regulatory authorities, manufacturers, procurers, and other experts, and collected data on the timelines between first submission and last approval of applications for product registration sub-Saharan Africa. We focused on countries with the highest burden of communicable disease and the greatest need for the products studied. The data showed a typical lag of 4 to 7 years between the first regulatory submission which was usually to a regulatory agency in a high-income country, and the final approval in Sub-Saharan Africa. Two of the three typical registration steps which products undergo before delivery in the countries involve lengthy timelines. Failure to leverage or rely on the findings from reviews already performed by competent regulatory authorities, disparate requirements for product approval by the countries, and lengthy timelines by manufacturers to respond to regulatory queries were key underlying factors for the delays.

Conclusions

We propose a series of measures which we developed in close collaboration with key stakeholders that could be taken to reduce registration time and to make safe, effective medicines more quickly available in countries where they are most needed. Many of these recommendations are being implemented by the responsible stakeholders, including the WHO prequalification team and the national regulatory authorities in Sub-Saharan Africa. Those efforts will be the focus of subsequent publications by the pertinent groups.

 

Citation: Ahonkhai V, Martins SF, Portet A, Lumpkin M, Hartman D (2016) Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization. PLoS ONE 11(11): e0166515. doi:10.1371/journal.pone.0166515

Introduction

The United Nations Millennium Development Goals have galvanized global efforts to alleviate suffering of the worlds poorest people [1]. With these major global challenges as a reference, new and unprecedented public-private partnerships were formed. One of the most effective of these coalitions, the GAVI Alliance, has since its inception in 2000 provided vaccines to approximately 440 million of the worlds poorest children [2,3]. Similarly, a focused campaign led by The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), increased funding for malaria elimination by more than 18-fold between 2000 and 2011, contributing to a significant reduction in the incidence of malaria in 34 endemic countries [4]. The continuing efforts of these aid organizations and others such as UNITAID and the U.S. Presidents Emergency Plan for AIDS Relief (PEPFAR) demonstrate that dramatic results can be achieved by increasing healthcare access [5]. Looking to the future, global product development partnerships have accelerated to the point that new interventions for diseases afflicting primarily low- and middle-income countries (LMICs) are ready or nearly ready for use [6].

But reaching populations in need continues to prove challenging as we at the Bill & Melinda Gates Foundation (BMGF) frequently observe working with partners to fulfil our mission. The challenges point to a high degree of complexity in the interplay of stakeholders in the global regulatory and delivery systems. The key stakeholders include global and regional pharmaceutical companies, non-governmental organizations, national medical product regulatory agencies (NRAs), ministries of health and others who make product utilization recommendations. In particular, regulatory and procurement requirements vary widely between countries, creating a system with many inefficiencies and redundancies, only a few of which have been adequately documented [7].

Our intuition was that the resultant drug lag [8] should be addressed in order to improve health for millions in underserved nations. Therefore, we worked with several partners to investigate timelines for the global registration process for both vaccines and medicines intended to prevent or treat communicable diseases. At the project inception in 2012, data on the subject were not available in the public domain except for regulatory agencies in high-income countries (HIC).

We set out to develop the fact base to enable us answer the following key questions:

• What are the registration pathways for global health products reaching LMICs?
• How much time does each step take in the pathways and what is the cumulative end-to-end time?
• Who are the stakeholders involved and what are their responsibilities?
• Where are the biggest bottlenecks, challenges, and gaps?
• What solution options can be synthesized from the fact base?

Here, we present a review of the current LMIC registration system for biopharmaceutical products and propose a framework that could help reduce product registration time. The reduced time could in turn accelerate access to health products and ultimately reduce morbidity and mortality consistent with our philanthropic mission.