11:10 - 11:30 amSaturday, September 17
LK 120
Blockchain: The new frontier in the fight against counterfeit medicines?
LK 120
Blockchain: The new frontier in the fight against counterfeit medicines?
Assistant Professor/UC San Diego - School of Medicine
The 21st-century global pharmaceutical supply chain is complex, fragmented, and involves multiple actors from countries all over the world. This complexity introduces vulnerabilities that allow the infiltration... Read more

Description

The 21st-century global pharmaceutical supply chain is complex, fragmented, and involves multiple actors from countries all over the world. This complexity introduces vulnerabilities that allow the infiltration of substandard/spurious/falsified/falsely-labelled/counterfeit medicines, now an urgent public health and patients safety problem valued in the billions of dollars. Even in high-income countries, such as the US, where robust regulatory controls exist, counterfeit medicines can still enter the drug supply chain and endanger patients. As an example, in 2012, the U.S. Food and Drug Administration sent letters to close to 1,000 clinical practices in 48 different states warning that they may have purchased a counterfeit version of the anti-cancer drug Avastin. The Avastin incident was a sentinel event, however, to this day the exact number of patients negatively impacted remains unknown. This continuing deficiency in the security of the drug supply demands innovative solutions, such as the promise of blockchain technology. Specifically, blockchain technology can be used to strengthen the integrity of the supply chain by ensuring that pharmaceutical products are subject to robust “track and trace” as now mandated by the Federal 2013 Drug Quality and Security Act (DSCSA.) Blockchain can also be integrated into existing anti-counterfeiting technology, such as linking to product authentication technologies (such as barcodes and forensic markers), RFID tracking, and e-pedigree and m-pedigree solutions. Beyond these uses, blockchain technology should also be explored for its application in other critical policy areas including: (1) enhancing public health surveillance of counterfeit drugs; (2) developing algorithms (e.g. machine learning protocols) that can detect risk patterns associated with medicine diversion/theft or counterfeit penetration; and (3) ensuring reimbursement is tied to quality drugs that are not expired or otherwise adulterated. In summary, blockchain can serve as the technology backbone and accelerate efforts to ensure that DSCSA requirements for track and trace, pedigree, and exchange of transaction documentation is harmonized and provides drug safety information that can be of value to all stakeholders.

Timothy Ken Mackey is the Director of the Global Health Policy Institute (www.ghpolicy.org) and an Assistant Professor of Anesthesiology and Global Public Health at University of California, San Diego School of Medicine. He is also the Associate Director for the UC San Diego MAS Program in Health Policy & Law. He earned his BA in Political Science-International Relations from the UC San Diego, a Masters Degree from UC San Diego MAS Program in Health Policy & Law, and his PhD in the Joint Global Public Health program with UC San Diego and San Diego State University. He has also completed an Executive Course in Global Health Diplomacy at the Graduate Institute, Geneva.  His work focuses on a broad array of multidisciplinary topics in domestic and global public health research. This includes cross-cutting research in disciplines of public health, medicine, international relations, public policy, law, technology, economics and intellectual property, technology environmental health, eHealth, crime, and global governance. He has extensive professional working experience in the private sector and has worked for the World Health Organization and the US Department of State among others.

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