Strengthening the WHO Member State Mechanism on Substandard and Falsified Medical Products
FROM A GLOBAL PERSPECTIVE
By Mark Abdoo, FDA Associate Commissioner for Global Policy and Strategy
November 7, 2024
For the last 12 years, the World Health Organization (WHO) Member State Mechanism on Substandard and Falsified Medical Products has served as one of the few bastions against the public health threats of substandard and falsified (SF) medical products. And yet, those of us who work on its committees believe the Mechanism can accomplish much more. To achieve more through the Mechanism, there is a need to consider its history, how it currently functions, and what could be done so it would be more effective in the future.
As defined by the WHO, a substandard product is authorized but fails to meet its quality standards or specifications. A falsified product deliberately or fraudulently misrepresents its identity, composition, or source; it may contain no active ingredient, the wrong active ingredient, or the wrong amount of the correct active ingredient. The presence of such fillers as corn starch, potato starch, or chalk is common. The scope of this problem is vast. The WHO has estimated that more than one in 10 medicines in low- and middle-income countries are substandard or falsified, with as many as two out of 10 medicines in sub-Saharan Africa being substandard or falsified.
The World Health Assembly established the Mechanism in October 2012 to address this problem. Since then, the Mechanism has been charged with collecting information, informing the development of detection tools, making policy recommendations, and working to strengthen regulatory capacity and quality control laboratories, particularly in developing countries. It is governed by a Steering Committee, chaired by one Member State for two years, with the chair rotating through the six official WHO regions; most of its work is conducted by a series of technical work groups. Although the Mechanism has the capacity to mitigate the threats presented by SF medical products, progress can be hindered by the parameters of its current roles. This can be better understood after reviewing the Mechanism’s current functions.
The Mechanism’s Capabilities, and Its Limitations
Firstly, the Mechanism helps governments fortify elements of their prevention, detection, and response strategies so they will be prepared for any future emerging threats. Member States also use the Mechanism to exchange experiences, lessons learned, best practices, and salient information on ongoing activities at national, regional, and global levels. Country representatives convene at plenary meetings and discuss the progress made by the workgroups — these groups address a variety of technical issues, including internet sales, safety of drug excipients, informal markets, detection technologies, and risk communication.
The Mechanism is also aligned with the WHO’s Global Surveillance and Monitoring System (GSMS), which leverages the resources of national regulatory authorities (NRAs) and their trained experts, called “focal points,” who file reports of SF products through a secure web portal using an electronic rapid alert form. Once an incident has been investigated and verified, detailed information and images of the SF medical product are made public on the WHO website and distributed globally via WHO’s Incidents and Substandard/Falsified (ISF) Medical Products Team.
By publicly disseminating WHO medical product alerts to the Member States, the Mechanism hopes to use the power of information to halt further distribution of identified SF products. Although the Mechanism can encourage action by heightening awareness among regulators and the public, the onus is on Member States to determine what interventions are most appropriate for their jurisdictions. Encouragingly, the WHO reported at the Mechanism’s November 2023 meeting that the past two years saw a nearly 60% increase in reported incidents. Nevertheless, reporting remains low due to various barriers including limited awareness, poor detection capacity, inefficient information systems, and concerns over reputational damage. In addition to the problems posed by low reporting, issues exist with the information that is being reported — for example, it can be incomplete, preventing timely action.
As the Mechanism, we should focus on improving the quality, consistency, and breadth of data reported to GSMS while working toward publicly sharing region-level GSMS data to allow Member States to assess risks to their supply chains in real time. Additionally, to reduce the duplication of reporting and improve the quality and breadth of data collected, the Mechanism should work with the Secretariat to ensure that the GSMS uses modern IT-based techniques to periodically pull information from public rapid alert systems run by the Member States — such as recall alerts. This would not only allow GSMS to have a more complete picture of SF products globally, but to also automate higher-quality SF data collection that can then be reviewed by WHO experts for follow up and action.
Addressing the root causes of SF medical product manufacture and distribution is challenging. The Mechanism is reliant on governments across the globe — and their national regulatory agencies — to combat the proliferation of SF medical products. However, many Member States lack resources, are overburdened and understaffed, and have limited capacity to detect and respond to SF medical products. To strengthen SF detection and response, Member States, with the help of the Mechanism and WHO, need to develop efficient administrative procedures, improve procurement and supply chain management, and ensure transparent communication.
Notably, inadequate track and trace systems that limit elucidation of the drug product supply chain — involving suppliers, importers, exporters, procurers, and distributors — can also compromise regulatory authorities from ensuring the quality of circulating medicines. For many governments and authorities, functional postmarket surveillance systems to detect and respond to SF products remain out of reach due to constraints in resources and technical abilities.
We must acknowledge that these detection and response efforts have been arduous, particularly in low-capacity settings. In so doing, we must also ask where the Mechanism needs to go from here, and how it can help Member States strengthen and expand their prevention, detection, and response tactics. We have identified several activities that support this goal.
Building a Better Toolbox: How to Improve the Mechanism
First, improving the technical capacity via trainings and regulatory workforce development of the Member States will be key. Member States must have a strong and qualified regulatory workforce that is trained in the requisite tools and methods to prevent, detect, and respond to SF medical products.
Second, the Secretariat, along with nongovernmental stakeholders, must more actively support the Mechanism’s Member States to implement existing WHO handbooks and guidelines on topics such as track and trace systems and detection technologies, and ensure these materials include advisory guidelines for health ministries and national regulatory agencies to collaborate with other sectors in order to deploy them. Enacting a multisectoral approach to the sale of SF medical products via the internet and/or through informal markets will also be crucial.
Third, developing a holistic, whole-of-governments approach through the inclusion of regional, national, and local officials to prevent, detect, and respond to SF medical products will be necessary. That effort could be bolstered by stepped up engagement by Member States, especially with respect to Steering Committee roles. The fact is, currently only a small percentage of Member States actively participate in the Mechanism and its deliberations. The Mechanism has proposed ways for Steering Committee members to exercise more proactive roles in their countries and regions, which can raise the Mechanism’s global profile and encourage more participation from Member States.
Finally, the Member State Mechanism should reach a consensus on the purpose of the Global Surveillance and Monitoring System reporting by deciding whether it is a tool for incident management or for knowledge generation. Given the limited resources of both Member States and the WHO, the Mechanism and the WHO should consider prioritizing GSMS reporting to ensure maximum impact. This involves developing an algorithmic approach to report high-risk issues (falsified and certain substandard products) that could result in greatest harm to patients, while deferring less risky cases for optional reporting. This could help both Member States and the WHO to better respond to high-risk medical product issues.
Ultimately, when Member States utilize high quality, comprehensive data to reduce the threat of SF medical products, they improve access to safe, effective, and affordable medical products globally.