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Falsified medicines: ending a global threat

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By Tom Woods, Chairman of the World Bank hosted Global Steering Committee for Quality Assurance, and Chairman of the Wilton Park USA Foundation

Tens of thousands have died during the pandemic and there are no signs that the world has turned the tide. We have no magic cure. Most people do not agree on the origin of the crisis, but not a single country has been spared the ravages. Lower income countries bear the brunt as in many health emergencies.

While the world went on lockdown for months and raced to develop lifesaving vaccines to fight COVID-19, the pandemic that continues its death march is falsified medicines. It is an entirely man made crisis that could be ended in days, but there are powerful forces at work. Vast criminal networks manufacture, supply, and distribute fake medicines at commercial scale. The trade evades law enforcement, medicines regulatory agencies, development agencies, and health care workers.

Ten years to the month after Wilton Park hosted the first ‘Pathways to Safe Medicines’ dialogue, the world continues to confront many of the same challenges posed by falsified and substandard quality medicines. We have supply chain systems that are complex and convoluted.  Criminals thrive. We have corruption that spans continents.  Transnational illicit networks are growing. We have more and better quality medicines to treat more illnesses, but they do not reliably reach patients in need.

The coalition of the willing has many players – public and private sector, regulators and law enforcement, health financing institutions and pharmaceutical manufacturers – but too often these groups remain siloed and lack the coordination needed to combat the threat.

Organized under the auspices of the Global Steering Committee for Quality Assurance (GSC), the second  Pathways to Safe Medicines dialogue will reinvigorate a multi-pronged fight against falsified medicines. The gathering brings together for the first time in many years representatives from leading African medicines regulatory agencies, health financing and development agencies, pharmaceutical companies, and law enforcement. Acting alone, progress is destined to be spotty and slow, but the GSC will help ensure ongoing coordination and avoid duplication of efforts.

High on the agenda for discussions is the need for full-scale national medicines traceability systems. Implementation will enhance supply chain visibility and better integrate Africa’s markets using a globally interoperable standard for monitoring products as they move from manufacturers to patients. It’s an achievable goal and one that Africa has already embraced. Now we need steady progress toward this important effort.

Medicines traceability is complex. Implementation won’t happen overnight, and traceability is not a panacea.  We need a multilayered approach to detect and disrupt illicit medicine flows in poorer countries. We also need to successfully prosecute these cases.  Regulatory agencies are building new capacity and partnerships with development agencies, but more can be done. Law enforcement agencies, both national and international, have a critical role to play. Pharmaceutical manufacturers are key players too as their brand reputations and their very ethos is at stake. Even as efforts progress toward new regional manufacturing in less developed regions, the regulatory systems must race to provide the necessary oversight to enhance the success of these important regional investments. If we build the regional pharmaceutical manufacturing engine without greater supply chain integrity and regulatory capacity to support it, the wheels will quickly come off.

As with many global challenges, bringing the right people together at the right time can achieve critical momentum. Meeting face to face and exchanging views – not by reading institutional talking points over a virtual platform but as individuals with enormous personal experience to share – is a key element that has been missing. Wilton Park’s history of serving as a catalytic off-the-record venue for hard problem solving makes it the ideal gathering place to fight the global pandemic that has not yet ended: the pandemic of falsified medicines.

Wilton Park’s event on pathways to safe medicines takes place on June 7 – 9 2023. Click here to learn more.


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