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Paul Huleatt, Ph.D., is the Chair of the Steering Committee for the World Health Organization Member State Mechanism on Substandard and Falsified Medical Products. Dr. Huleatt represents Australia and the WHO Western Pacific Region on the Steering Committee.
He also is the First Secretary and Strategic Partnerships and Program Implementation Lead at the Program Implementation and Regulatory Strengthening Section in the International Regulatory Branch of the Therapeutic Goods Administration, within Australia’s Department of Health.
The WHO estimates that more than one in 10 medicines in low- and middle-income countries are substandard or falsified (SF). To address this crisis, in October 2012 the World Health Assembly established the World Health Organization’s Member State Mechanism on Substandard and Falsified Medical Products (the Mechanism). The Mechanism is a unique governance forum that brings together the 194 Member States of the WHO to develop strategies for mitigating the public health risk and harm caused by substandard or falsified medical products.
On January 25, staff from the FDA’s Office of Global Policy and Strategy’s Communications Team spoke with Dr. Huleatt regarding the Member State Mechanism and his work as Chair of the Mechanism’s Steering Committee.
Dr. Huleatt, I understand that the Mechanism has been around for 10 years, what do you see as the continued value of its work?
Effectively, the Member State Mechanism was established in order to protect public health through the prevention and control of Substandard and Falsified (SF) medical products and associated activities. We still need to address the problem of SF medical products, so I think the continued value of its work is in continuing to address the problem it was established to deal with. It hasn't gone away and it's not going away anytime soon. So, from my perspective I think we need to be pragmatic and realistic about the issue and understand that it's going to be an ongoing fight for the foreseeable future.
The Mechanism also had initiatives like IMPACT [International Medical Products Anti-Counterfeiting Taskforce] that predated it so I think that there will be something in the future. It may be a continuation of the Mechanism as it exists today, it might be a variation thereof, or it might be something completely new that has been adapted to continue the fight as the problem evolves and the world changes.
What do you think is the most important contribution of the Mechanism?
I think it's difficult to distill down to a single thing as there were a few that stood out early in my chairmanship. Simply agreeing that substandard and falsified medical products are an issue to be dealt with in a global forum is one. Then bringing a great number of Member States together and agreeing on the definitions related to SF medical products and bringing the issue into focus in fine detail is another. I think that getting the key definitions of “unregistered/unlicensed,” “falsified,” and “substandard,” amongst others, was important — and this achievement was highlighted in the outcome of a review of the Mechanism in 2017 as well. I think we've seen another example of this at the last plenary meeting (MSM11 2022) when we got agreement on a working definition for “informal markets.”
Implementation of the WHO Global Surveillance and Monitoring System (GSMS) and development of the Global Focal Point Network — the network of individuals [appointed by a Member State's national regulatory authority] who report incidents to GSMS — are inextricably linked with the Mechanism, and this has also been an amazing achievement though still a work in progress.
Establishing focal points in Member States and connecting them with each other and the WHO through technologies allows countries to effectively communicate and deal with incidents of substandard falsified medical products as they emerge. In recent times, such incidents have included falsified COVID-19 vaccines, falsified COVID-19 treatments like remdesivir, and the pediatric liquid dosage medicines contaminated with ethylene glycol and diethylene glycol found in multiple WHO regions.
 How does this forum help governments better protect its citizens when SF medical products are found in multiple countries?
Firstly, as you point out, infiltration of SF medical products into a country’s supply chain is not a confined, domestic issue in the majority of cases. So, the forum helps governments to rapidly respond when an incident is identified. Timely information sharing between Member States and the WHO through the Global Focal Point Network allows coordination on prevention, detection, and response to the emerging threat. This is critical for minimizing harm and eliminating the problem in multiple countries.
Secondly, the Mechanism is the global forum at which Member States convene, coordinate, decide, and organize activities to address SF medical products. Country representatives come together and work through a variety of issues at plenary meetings, and there are currently eight Member State Mechanism working groups addressing such topics as internet sales, informal markets, detection technologies, and risk communication. So, the forum also helps governments hone elements of their prevention, detection, and response strategies in order to be prepared for future threats as they emerge.
What is the role of the Mechanism in substandard (contaminated) medical product issues such as the tragic deaths of children in Gambia and Indonesia linked to pediatric cough syrups?
This is an incident, or series of incidents, that have warranted a lot of attention because of the emergence of these substandard products in disparate locations and the devastating impact they have had in a relatively short space of time. In his recent media briefing, the Director General of the WHO outlined that three countries have seen over 300 deaths, mainly in children under the age of five, and that at least seven countries have been affected.
The Mechanism was established in 2012 by the World Health Assembly to facilitate tackling issues in a collegiate, inclusive, transparent way from a public health perspective, so it is, in theory, the most appropriate vehicle for dealing with an issue like this. What that requires is trust, transparency, and openness from all Member States, i.e., those immediately affected, those that may be affected but whose authorities are as yet unaware, or those that may be affected by the issue in the future. In addition, I am sure that there has been a prompt response from the WHO Secretariat and an in-depth investigation so a permissive environment where that information can be shared rapidly is essential.
Now, obviously saying that comes with the understanding that investigations need to be carried out very thoroughly, and certainly there are sensitivities involved, but carrying out a root cause analysis and then communicating the outcome to other stakeholders who will have to deal with the issue is incredibly important. At this point in time, the Member States and WHO Secretariat have the opportunity to demonstrate the value of the Mechanism by effectively addressing specific cases like this one.
What impact did COVID-19 have on the prevalence of substandard and falsified medical products globally?
This is difficult to quantify. We know that there is extensive underreporting of SF incidents in general, so it is difficult to gauge their true penetration and prevalence in normal times, let alone during a pandemic. The picture is also different across the WHO regions where we observe profound differences in the reporting rates of SF medical products. What is clear though is that COVID-19 vaccines and therapeutics have been attractive targets for falsification by nefarious entities. There were a number of medical product alerts that the ISF (Incidents and Substandard/Falsified Medical Products) team in the WHO published on falsified COVID vaccines in 2021, and these affected multiple WHO regions. There were also medical product alerts for remdesivir last year and in 2021 as well.
Frankly, I think the COVID-19 pandemic, as it has done on numerous fronts and not just on SF medical products, has magnified problems that already existed, brought them to the fore, and made them worse. There has been disruption of global supply chains, and medicine shortages can result. When supply chains are compromised in this way, then they’re certainly open to infiltration by SF medical products, and I think we've seen that in a number of cases — as, for example, early on in the pandemic when falsified chloroquine products were found in Africa and Europe.
You've mentioned these alerts — if you could explain where they go to, and are they being distributed to everyone who should be able to see them or needs to see them?
Yes, they are published and distributed by the WHO, and they appear on the WHO website. These alerts are also published after investigation and verification of an incident and agreement with the affected Member States. The alerts contain detailed information and images of the products.
What we've seen in cases like the ethylene glycol and diethylene glycol contamination of cough syrups is that the news of the incidents reaches the public domain a lot faster than the medical product alerts can come out. If you look at the example of the recent cases in Uzbekistan, they were published by media outlets late in December 2022. I think the WHO medical product alert was published on January 11, 2023. You can see that there is a lag in disclosure of information but I’m not sure there is any way around that. This is another reason why building and maintaining robust communication channels through the Global Focal Point Network, leveraging the GSMS, is so important for Member States.
The United States is chairing a new topic in this forum concerning informal markets for medical products — the market stalls, push carts, and small retail shops that dispense medicines when pharmacies or health care facilities aren’t available. What was the genesis of this work stream, and what are you trying to accomplish?
Well, I think this is probably one of those issues which over time has come more to the fore. As other issues related to SF have been defined and addressed, it has become apparent that SF medical product penetration and distribution through informal markets needs to be dealt with.
This is certainly something that Member States, often but not always low and middle-income countries, can grapple with. There can be hesitancy — perhaps from national regulatory authorities — on how to deal with the issue in the absence of a clear definition of the problem.
Formal and informal markets may be perceived differently in different countries and different parts of the world. This shows another challenge with a global approach to combating SF medical products in that there are nuanced differences, in each Member State and across regions as well. Therefore, an important first step was to get the definition of informal markets agreed upon. This was successfully achieved on the back of the work of Working Group H and was a great outcome from MSM11 in October 2022. Next steps will involve establishing a knowledge base and identifying knowledge gaps, gathering evidence to address the gaps, and then to work towards developing strategies and policy recommendations on the issue.
Now, on the genesis of the work I can speak in broad terms. At the March 2021 Member State Mechanism Steering Committee meeting, the U.S. expressed an intention to propose a new Member State Mechanism working group and activities related to addressing informal markets. This was ultimately progressed and included in the draft list of prioritized activities to implement the Member State Mechanism workplan for the 2022/23 biennium at MSM10 in October 2021.
What you see as the main challenge facing the Mechanism?
With my relatively fresh eyes, I think one of the things that struck me is, the work plan of the Mechanism is quite open-ended. As a result, the ‘actions’ of the Mechanism, though planned on a 2-year cycle, also tend to be open-ended, meaning that successful completion (or otherwise) isn’t always linked to the planning cycle and some actions roll over to the next cycle. Having clear time frames for measuring progress and success in completing tasks is useful, especially when they feed into bigger pieces of work that are ongoing or at least extend beyond the biennial cycle. To expand on this theme, one of the challenges looking forward, is to set a longer-term strategic plan for the Mechanism and then plot tactically how we go about realizing it. [That means asking] what metrics will we need to put in place to measure our performance and progress? How, at a very granular level within the working groups, will we go about agreeing on activities and goals for each biennium, that are specific, measurable, and achievable within that period?
Moreover, in order to develop a good strategic plan, we need to have pictures of the future to reference. So, we also need to consider a number of scenarios that might play out. We can then plan with flexibility to ensure we can adapt as the future unfolds. Now, it's very difficult to do that effectively on a 2-year planning cycle so the strategic plan needs to go out much further. Some people might say five years— I would say more like 10 years or even further into the future. Planning in this way would be very different for the Mechanism. It would necessitate greater participation from Member States and potentially an evolution in the role of the Steering Committee and the WHO Secretariat. If the Mechanism decides to work in this way it will be a big challenge, but it would be a significant development.
I assume that's sort of what you as the chair would hope to propose and push forward in the future?
Definitely. In addition, one of the fundamental requirements for setting a good strategic plan for the future is to have a good understanding of where the Mechanism and its operations are currently placed and how it has arrived at this point since its inception in 2012. What have been the successes, failures, and lessons learned? To me, having this foundation is critical and one of the driving forces behind pushing for an independent evaluation of the Mechanism. At the last plenary meeting, the proposed evaluation was positively received by Member States, and I should acknowledge that the United States has been a champion of this idea.
And has that begun yet?
There are some procedures that need to be followed, of course, but things are progressing in a positive manner. Following the paper put forward by the United States at the end of 2021, through initial discussions with the Member State Mechanism Steering Committee in 2022, and agreement by the Mechanism at MSM11 in October, last year — hopefully we can progress this through the Executive Board and World Health Assembly. I would like to think that's one of the things we can have realized before the end of my chairmanship after MSM12 this year.
Now, I think that's a very formal approach. We can also take a less procedurally constrained approach, and there are certainly things that can happen ahead of any evaluation. For example, the Secretariat and appropriate working groups might well look back over 10 years’ worth of achievements of the Mechanism too. If another publication was developed like the brochure on the Mechanism produced in 2020 or the report on the GSMS produced in 2017, it would be a persuasive tool for showcasing the valuable work of the Mechanism and its successes. It could be used to pique Member States’ interest. If for example, a Steering Committee vice chair was advocating for a Member State’s participation in their region, they could very easily show key stakeholders in that Member State, particularly their national regulatory authorities, that engagement would be very helpful for their country.
So, I think there's a range of things that can be done in the near term which span the spectrum of retrospective analysis and documenting success all the way through to the formal independent evaluation of the Mechanism.
What you are saying is that there is a variety of participation by Member States that you apparently would like to get greater buy-in across the world for the Member State Mechanism and that some are just not as locked into the idea as others?
I think that's absolutely the case, and it's not simply because there's not an appreciation of the problem. I am heavily involved in several Australian Government, Department of Foreign Affairs and Trade funded, TGA-led, development assistance programs in the Indo-Pacific region that focus on regulatory systems strengthening and support activities. Through this work, I see the issue of combating SF medical products come up time and time again. But effectively linking the fight in some countries to the work of the Mechanism remains a challenge with both Member State and WHO stakeholders, though at the regional level there are some really positive steps being taken. For example, combating SF medical products and the work of the Mechanism is addressed by both the Western Pacific Regional Alliance of NRAs (WPRA) and the South-East Asia Regulatory Network (SEARN).
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