Authors: Marie-Paule Kieny and Trevor Mundel
Over the past two decades, health innovations have begun to transform the lives of people in the world’s poorest and most remote communities. Inequities in access to lifesaving tools are gradually shrinking. And thanks to dedicated public and philanthropic funding for research, there is a healthy pipeline of new products – like the Meningitis A vaccine – that have been created specifically to meet the greatest health needs of people in developing countries. But creating products and delivering them quickly isn’t enough. The success of newly introduced innovations hinges on our ability to ensure that they are safe and used responsibly, and that people are getting healthier because of them.
The story of thalidomide shows that completing this final step is not an abstract concern. In the early 1960s, pictures of children with horrific birth defects, particularly underdeveloped legs and arms, began to appear in the media. These birth defects were ultimately linked to the drug thalidomide, which had been widely prescribed throughout the world to prevent morning sickness in pregnant women. But it was only after the public reports of birth defects that researchers discovered that thalidomide could penetrate the placental barrier between mothers and fetuses, causing serious developmental complications in newborns.
The episode showed that a rigorous system to monitor new medical products is essential to public safety. This final step in introducing medical innovations – monitoring new products after they’ve been licensed – is called pharmacovigilance, and it’s central to increasing access to medicines and improving health.
Pharmacovigilance is our safety net if a rigorously tested new product behaves unexpectedly once it’s introduced on a large scale. In addition to ensuring that innovations deliver their intended impact, it reduces the risk of unintended patient harm, prevents resources from being wasted on unsafe products, expedites the introduction of better ones and safeguards patients’ trust in the health systems they rely on. In high-income countries, people now take these systems for granted; in most low- and middle-income countries, they are weak or non-existent. That’s because healthcare providers and patients face barriers reporting adverse events, and the infrastructure and capacity to analyze those reports and act on findings is often limited. As a result, people’s safety and the quality of their health services are at risk.
This issue becomes increasingly urgent as access to lifesaving medicines and vaccines in developing countries improves. Low-income countries have historically relied on developed countries’ surveillance systems because new products were licensed in those countries years before they reached developing-country markets. However, many health products in the pipeline today – like malaria vaccines or tuberculosis treatments – will launch either exclusively in low- and middle-income countries, or simultaneously in developed and developing countries. When they do, low-income countries won’t be able to rely on developed-country surveillance systems.
Pharmacovigilance is especially critical when the approval process for new products is accelerated – for example, when a new vaccine is developed in the midst of an emerging pandemic (as shown by the rapid development of an Ebola vaccine during the West Africa epidemic). When researchers are racing to develop tools that protect against an outbreak, safety data may be limited at the time of emergency approval. Pharmacovigilance will help find potential safety signals that may not have been found before.
So how do we ensure the safety of new products, no matter when or where they’re introduced? It’s a complex challenge that requires resources and political will, but there are clear steps we can take. At the most basic level, countries need local platforms where patients and doctors can report adverse events, and collaboration across affected countries to analyze reports and take appropriate action. Encouragingly, the World Health Organization (WHO), other global organizations and country governments have initiatives underway to tackle this challenge in developing countries, which have led to promising successes. Distressing symptoms, including severe muscle spasms, from a malaria medicine have been reported and kept in check in Burkina Faso thanks to WHO awareness-raising activities and the training of pharmacovigilance professionals. Errors in medicine administration, which could harm or kill patients, are declining in several African countries where WHO works to expand capacity for reporting adverse events by training health workers.
We’re pleased to announce a new partnership between WHO and the Bill & Melinda Gates Foundation to expand this work. The partnership will strengthen, expand and streamline pharmacovigilance systems in low- and middle-income countries, focusing initially on the safety of priority medicines and vaccines that will be introduced in the next few years. Eventually, the strategies that work well will be scaled up to additional countries and products.
We’re optimistic about this effort, but there’s much work to be done to ensure that every country in the world – rich or poor – has access to safe vaccines and medicines. Governments, product developers and the global health community must work together to prioritize and invest in pharmacovigilance. We must act urgently to ensure that brilliant innovations can do what they’re intended to do: save lives. The safety of our communities and integrity of our health services depends on our collective efforts.
Marie-Paule Kieny is Assistant-Director General for Health Systems and Innovation at the World Health Organization; Trevor Mundel is President, Global Health Division, Bill & Melinda Gates Foundation