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Good morning, everyone. I’m Mark Abdoo, the FDA’s associate commissioner for global policy and strategy.
On behalf of the U.S. Food and Drug Administration, I welcome all of you to this two-day workshop exploring a whole-of-governments approach to combatting the illicit trade in health products.
Before we begin, I’d like to thank the Organization for Economic Co-operation and Development for hosting this meeting and for partnering with FDA under the auspices of their Task Force on Countering Illicit Trade. Special thanks also to the OECD leadership in attendance, Deputy Secretary General, Kerri-Ann Jones, in addition to Elsa Pilichowski (from whom you’ve just heard). I also want to thank the US OECD Ambassador the Honorable Jack Markell for joining us this morning, and to Director Pranab Das, of the World Customs Organization, who will provide a keynote speech on the WCO’s Operation Stop II and will also participate in a panel on international collaborations.
Finally, I want to acknowledge the many U.S. government officials, their European counterparts, and colleagues from multilateral organizations, who have been actively engaged in conceptualizing, planning, and preparing for this workshop. We appreciate your efforts and recognize it’s been quite a lift.
FDA’s Office of Global Policy and Strategy or OGPS, which I lead, is a multicultural, multidisciplinary staff working across four continents to carry out the FDA’s global public health mission. We manage the FDA’s foreign offices in six countries – Belgium, Chile, China, Costa Rica, India and Mexico, with an additional person at the European Medicines Agency in the Netherlands. OGPS also serves as a point of contact for many of FDA’s bilateral interactions, and strategically addresses multilateral diplomacy and partnerships and multiple trade, international arrangement and mutual recognition agreements spearheaded by the agency. You might say we’re a microcosm of a whole-of-government effort!
What you’ll be hearing about over the next two days marks the culmination of several months’ long effort – led by the FDA’s Office of Criminal Investigation and our Europe Office partnering with the OECD’s Task Force - to systematically explore a whole-of-governments approach to protecting consumers against illicit products.
Let me explain what I mean by whole-of-governments and why we find that approach to be so compelling. Today, criminal networks are increasingly sophisticated, capable of exploiting regulatory, legal, and other gaps to ship and/or transship illicit and potentially dangerous health products. When criminals are intent on probing for potential weaknesses, there’s a risk they’ll succeed, and products will slip through. However, these gaps are less likely to occur if multiple countries and their arsenals of authorities that crosscut multiple sectors of government coordinate their efforts in what we call a whole-of-governments approach.
To ensure the richest possible discussion today, the FDA and the OECD fleshed out some of these ideas in two earlier discussions over the last few months with government officials in the fields of public health, customs, intellectual property and law enforcement.
Our first meeting, in May, was reserved for government agencies only and focused on a successful whole-of-government’s case study - Operation Lascar, with the United Kingdom. Operation Lascar is the FDA’s first bilateral initiative focused on the movement of illicit FDA-regulated products. Since the FDA and the UK established Operation Lascar in 2017 there have been five joint Initiatives with the UK, that variously involved the FDA’s Office of Criminal Investigations, the U.S. Customs and Border Protection, the U.S. Patent and Trademark Office, the U.S. Embassy in London, the United Kingdom’s Revenue and Customs, the UK Border Force, the Medicines and Healthcare products Regulatory Agency and the UK Intellectual Property Office.
Taken together these five initiatives were responsible for the initiation of more than 80 new FDA criminal investigations and the identification of more than 3,000 violative shipments of illicit medicines intended for the United States. You will hear more about this from our U.S. and UK colleagues this morning.
The FDA’s and OECD’s second meeting, in July, expanded the discussion and delved further into the issue of illicit transshipped products, highlighting the trends of such products transiting through the EU and neighboring regions. In addition, experts from multilateral institutions shared their perspectives on the feasibility of an international framework or coalition, considering the ongoing efforts within their own portfolios.
For the FDA, developing an effective strategy against illicit products has become all the more urgent in light of the unprecedented proliferation of fraudulent products related to COVID-19, with the Internet and small informal mail shipments being used as the primary vehicles for marketing and distributing these unproven products.
Like most regulatory authorities, the FDA protects the supply chain in two equally critical ways: first, we help ensure safe products are coming in; and second, we help prevent illegal, dangerous, and fraudulent products from ever entering our borders. These efforts include partnering with U.S. Customs and Border Protection (CBP) in establishing satellite laboratories at selected International Mail Facilities (IMFs) where scientists using state-of-the-art screening tools can rapidly identify many illicit products.
In the course of this work, the FDA has been seeing over the last two years increasing shipments of illicit and counterfeit medicines, adulterated food products, and other violative FDA-regulated products intended for the U.S. marketplace – including shipments transiting through Europe.
The UK was initially a critical node for transshipments of illicit products through Europe. However, as our detentions of products from the UK decreased, likely in thanks to Operation Lascar, we began seeing a worrisome trend of new ‘hubs’ for illicit trade appearing in EU member states.
In addition to the two meetings that laid the foundation for this workshop and our work in the UK, FDA has initiated targeted outreach with our European counterparts. An FDA special agent, Kerry Mannion, worked in our Brussels Office throughout the summer and together with our policy experts visited counterparts in the EU, EU member states, and multilateral organizations to better understand the European landscape and to help us identify the gaps and potential solutions to addressing this growing problem of transshipments from Europe to the United States.
What we repeatedly came away with is that criminal networks are agile and adept at exploiting weaknesses and adapting to new circumstances, as this current shift in their supply chains demonstrates. These discussions have further convinced us the threat posed by illicit trade has become too complex to be adequately addressed by any single government entity. A whole-of-governments approach - and more - is needed, relying on coordinated efforts across multiple sectors of the government, multilateral organizations, and the private sector.
Over the next two days we hope to get a better collective understanding of the ongoing efforts to combat illicit trade in health products at the national, regional, and global level specific to each of our mandates and missions.
We know many multilateral international organizations are already working in this area – besides the OECD, that includes the WCO, the World Health Organization, the World Trade Organization, the Universal Postal Union, Interpol, Europol, and others. Recognize that our intent is not to duplicate or reinvent the wheel – but to learn from these efforts, build on existing initiatives, and find synergies to address a common public health problem. We hope to share what we are all seeing so we have a better handle on the scope and extent of these illicit trade networks; how they are organized, including source facilities and their nodes in the supply chain; and to get a better handle on what gaps or weaknesses in our systems these bad actors are exploiting.
Ultimately, our purpose is to build on these discussions to create a global coalition that can explore opportunities for collaboration and identify concrete solutions, including at the policy-level.
As we begin our discussions, I suggest you ask yourself, what might such opportunities for cooperation look like – given our limited resources and our shared responsibilities. Is it leveraging data analytics and interoperable/integrated data platforms for real-time information exchanges? Is it joint enforcement operations or coordinated training exercises similar but larger in scope to Operation Lascar? Perhaps we may look into further leveraging capacity building and lab testing, with an emphasis on frontline capacities, to empower national or regional authorities. Or strengthen our regulatory policies and address implementation shortfalls? And we can’t discount the role of effective public education and engagement efforts, turning the focus away from initial purchase price to consumer safety. Finally, we made sure to expand our discussions to include industry and the private sector. What is their role in these efforts? These are some areas we hope this expert group will explore.
I hope that when we wrap up our discussions tomorrow, we will have begun building and strengthening our strategic alliances and identified the best practices reported by the diverse groups represented here.
The fact is - the stakes are high. Illicit trade is a severe threat that not only damages economic growth but also undermines good governance, the rule of law and trust in government. And for FDA and our regulatory counterparts, illicit goods that enter our marketplaces can pose serious health and safety consequences, including death.
So, let’s “put on our thinking caps” and get started. I look forward to rich and thought-provoking discussions over the next two days.