There probably aren’t very many scientific conferences whose attendees include former FBI agents, government leaders, customs officials, wildlife geneticists, pharmacists, sociologists, informaticians, isotope geochemists and many, many other experts. But that’s the expertise that you need to gather in order to address the threat of substandard and falsified medical products, estimated to cause around 500,000 deaths every year in sub-Saharan Africa alone, with billions of dollars across the world lost to ineffective treatments.
Substandard and falsified medications are a transnational issue, and the Medicine Quality Research Group (MQRG) brought together over 90 attendees from all over the world at Christ Church in Oxford to discuss, plan and brainstorm over three days from 13th to 15th April.
MQRG is part of the Centre for Tropical Medicine & Global Health, the Infectious Diseases Data Observatory and the MORU Tropical Health Network.
This is not the first time such a disparate group of people have come together: in the mid-2000’s, a unique collaboration between law enforcement agencies, public health bodies and researchers (including MQRG Head Paul Newton) led to arrests and seizures of falsified antimalarials.
But the problem has only continued to grow, with the COVID-19 pandemic bringing falsified COVID-19 vaccines, and recent outbreaks of falsified cough syrups resulting in child deaths, and most recently and horrifyingly, fake rabies vaccines, impacting the most vulnerable.
Unable to access laboratories because of COVID-19 closures, MQRG and collaborators Prof Pavel Matousek, Dr Robert Stokes and Dr Tehmina Bharucha use a car boot to test a device to detect falsified vaccines
With discussions covering everything from low-cost devices to spot falsified medication to understanding why and how consumers buy such medication, researchers covered an incredibly wide variety of topics. But a few key themes emerged over the conference and its many discussions:
- Substandard and falsified medicines and vaccines are public health problems, not (just) a crime problem. substandard products (due to errors in manufacture in factories or supply chains) require regulatory and health-system responses; falsified products (due to criminal fraud) also require criminal investigation. But the lived reality for patients does not separate these factors neatly. This tension was a major thread in many discussions: the problem needs public health, regulatory, customs, police, judicial, and intelligence responses all at once - it is a 'wicked problem'.
- Better sharing of data and information is key. Policymakers such as the World Health Organisation and research organisations such as the Medicine Quality Research Group have already developed tools to share information and alerts about substandard and falsified medical products. But much critical information remains siloed within countries/regions, and within specific organisations, partially because it is confidential, sensitive information. Being able to share such information, with managed access to those who need it, will help everybody from governments to researchers to act on real-world information. Without such sharing, information remains fragmented, and cannot be acted on by regulators, customs, researchers, industry or international bodies.
- Detection technologies that empower inspectors in post-market surveillance are also key. Many different technologies for detecting substandard and falsified medical products in supply chains, are included in the MQRG-led DAFODIL platform, which enables regulators and researchers to compare those available to identify those that are best for their needs. DAFODIL was recognised by the African Medicine Agency, which has agreed to provide a future home for the project. Much discussion centred on how enabling inspectors in low resource settings to undertake post-market surveillance is key to fighting the spread of such products.
- Standardisations matters almost as much as detection. Seizures are often reported in the media as numbers of boxes or containers seized. But just how many doses do these seizures represent? How many patients were potentially protected by these seizures? In the absence of common standards, in can be difficult for on-the-ground actors such as customs to estimate this essential information. Several discussions highlighted the need for shared standards for sampling, reporting, evidence quality, and evaluation of screening devices.
- Forensic scientific tools are advancing, but more research is needed to translate these into action. A major emerging theme was the move from simple authentication toward forensic techniques already used in other fields where science meets criminal investigation, such as wildlife trafficking and narcotics. Techniques such as isotope analysis, packaging analysis, tracking bacterial & plant DNA in falsified medicines can help uncover trade routes and falsified medicine origins. But on their own, they are not enough – they need actionable intelligence.
- Impaired access, poor governance, and limited regulatory capacity are drivers of substandard and falsified products, driving inequity in access to quality-assured medicines and vaccines. While manufacturers of falsified medical products are acting maliciously, some of those trading in substandard and falsified medical products, unaware of their contents, may see themselves as providing an essential good (because otherwise their consumers would have no medication at all). Informal sellers, pharmacists, customers, and local communities do not necessarily fit into simple good/bad binary.
- Public discussions about this issue need to be carefully managed. How do we raise awareness about the issues of substandard and falsified medication, including vaccines, without harming public trust in health care ? The need for media to discuss this with sensitivity was an important point, with the need for alerting but not alarming. Similarly, information needs to be shared so that patients are protected and action is supported, but not so much that falsifiers can adapt faster than the systems can respond.
Paul Newton, who co-leads the MQRG together with Dr Celine Caillet, said “Twelve years ago we published a paper describing a large seizure of falsified antimalarials in Angola, which used a term used in Laos 'NATO: No action, talk only.'
“This described the woeful situation at that time, and the paucity of joined up action.
“The situation has improved somewhat, with more initiatives, but there still remain enormous hurdles to ensure that the terrible inequity of (usually especially vulnerable) people taking much less good quality medicines than those in the wealthier world.'