Regulatory Focus™ > News Articles > Gates Foundation Says New Efforts Needed to Bolster Pharmacovigilance Systems in Developing World

Gates Foundation Says New Efforts Needed to Bolster Pharmacovigilance Systems in Developing World

Posted 27 February 2014 | By Alexander Gaffney, RAC

A new report just released by the Bill and Melinda Gates Foundation calls for an expansion of pharmacovigilance efforts in low- and middle-income countries (LMICs) to ensure the safety of healthcare products around the world.


Pharmacovigilance refers to systems put in place to keep track of the safety of pharmaceutical products. While the systems can detect pharmaceutical counterfeiting and substandard drugs, they are primarily put in place (in developed countries) to track adverse events and other safety issues inherent to the product itself.

In more developed regulatory regions, such as the US and EU, regulators have set up robust and multi-layered pharmacovigilance systems that rely on massive amounts of data obtained from manufacturers, hospitals, patients, healthcare providers, government agencies and outside research. US regulators are also looking for new ways to conduct pharmacovigilance, such as the use of registries, social media, electronic medical records, and other "big data"-driven approaches.

But as with all things, these efforts cost money-lots and lots of money. While most developed nations can afford to conduct pharmacovigilance, low- and middle-income nations may not have resources available to do the same.

Many of those countries rely on outside help, such as from the World Health Organization (WHO), which maintains a Programme for International Drug Monitoring to collect individual case safety reports (ICSRs) from around the world. The underlying principle of sharing pharmacovigilance data is that if a drug is harming patients in one country, it's likely doing so in others as well.

A Need for New Models

But, as the Gates Foundation says in a new report, international efforts have largely fallen short to date. For one, it explains, the funding behind these initiatives is often scarce. Second, the range of drugs present in LMICs is massive: new drugs, generic drugs, traditional medicines, substandard and spurious medicines, falsified and counterfeit medications, and falsely labeled medications.

While adverse event monitoring may work well in places where a regulator can be sure of the quality and identity of a medication, the effectiveness of that monitoring breaks down as assurances do.

And that, the report explains, does not bode well for LMICs in desperate need of drugs and vaccines to fight off communicable diseases long since conquered in more developed nations.

What is needed, then, is a new emphasis on postmarket safety surveillance in LMICs, writes Trevor Mundel, president of Global Health at the Gates Foundation.

"Historically, developing countries relied upon post-market surveillance in developed countries to identify the risks and benefits of drugs and vaccines," he wrote in an accompanying article on the report. "This is understandable because few drugs and vaccines were developed to specifically address the health needs of poor countries.  But as access to treatment and immunization has increased in developing countries … improvements in post-market safety surveillance have not kept pace."

What are needed are new capacity-building efforts, innovative pharmacovigilance systems based on resource constraints, and more support for the WHO's existing pharmacovigilance efforts, the report says. The report calls for pharmacovigilance systems to focus on the needs of each locale, rather than on what the institutions should look like. The systems should "reflect local capabilities" and be "scalable to address broader health needs," it adds.

Regional cooperation between LMIC regulators and established regulators will be key, allowing benefits to be shared among regions, the report states. Other approaches, such as pilot programs and regional technical facilities, were also advanced as being models of improving pharmacovigilance systems.


Strengthening Post-Market Safety Surveillance in Low- and Middle-income Countries

Want Better Medicines? Demand Better Safety Surveillance

GHTC Article on the Report

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