Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products

Type: Consensus Study
Topics: Global Health
Board: Board on Global Health

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Activity Description

The IOM is requested to convene an ad hoc consensus committee of diverse experts to gather information and deliberate on approaches to mitigating the global problem of substandard, falsified, and counterfeit pharmaceuticals and products used in their manufacture.  It will begin by developing among the committee members and for this context consensus working definitions for the terms “substandard”, “falsified”, and “counterfeit.” The committee will carefully distinguish between the application of these terms to meet public health and legal needs.  Then focusing specifically on the public health aspects of the problem, the IOM committee will address the following issues:

  • TRENDS: Using available literature, identify high-level, global trends in substandard, falsified, and counterfeit medicines (SFC) including differences and similarities in different global regions. Identify gaps in the evidence that complicate the analysis of these trends. This is intended to provide context to the study, but not serve as an in-depth analysis.
  • RISKS IN THE SUPPLY CHAIN: Identify the weaknesses in the supply chain that allow falsified, substandard, and counterfeit drugs to circulate.  
  • HEALTH EFFECTS: Explain the public health consequences, to patients and at the population level, of SFC drugs and how to measure this. 
  • STANDARDS:  Identify areas where convergence of standards could contribute to stronger regulatory actions.
  • IDENTIFICATION:  Describe global regulatory processes, e.g. track and trace, authentication, that distinguish genuine and high quality drugs from fake or substandard drugs and identify what factors could be used for additional scrutiny of the genuineness of the product. 
  • TECHNOLOGY:  Identify detection, sampling methods, and analytical techniques used to identify counterfeit, falsified, and substandard drugs. Explain how these technologies can be best used and implemented in a system to stop the circulation of harmful drugs. 
  • COLLABORATION:  Assess effectiveness of regulatory approaches around the globe including prevention, detection, track and trace systems, compliance, and enforcement actions. 
    • Based on such an assessment, identify areas where collective action among government regulatory authorities is most relevant and sustainable;
    • Identify ways government, industry, and other stakeholders can work together to strengthen supply chains and fight counterfeit, falsified, and substandard drugs;
    • Identify areas where industry or other stakeholders are best equipped to act; and
    • Recommend a collaborative path forward. This includes recommending definitions for the products in question that would be sensitive to the needs of drug regulators around the world and focuses on the public health. It also includes recommending how various regulators could collaborate on a global and regional level to best address the problem.

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