Table 1.

Proposed specific technical working groups with the trilateral working group

Area of focus	Description	Existing models/tools	Goals
Global surveillance, pharmacovigilance, and data collection	Specialized technical group to develop a global, centralized, and harmonized surveillance system for counterfeit medicine detection, reporting, and data sharing. Would also work to develop process for global report on counterfeit medicines	Pharmaceutical Security Institute Counterfeit Incident System. WHO Pilot SSFFC Global Surveillance and Monitoring Project	Establish an active an internationally agreed upon and scientifically validated system for reporting and detection of counterfeit medicines from various sources, including drug regulatory agencies, customs officials, public health agencies, consumers and clinicians, and law enforcement. Would allow for development of data collection from multiple stakeholders that would inform evidence-based policy-making both domestically and globally. Also possibly develop globally harmonized tracking and tracing system, development of e-pedigree/m-pedigree technologies, or best practices from regional or country-level initiatives
Regulatory, legal and policy development	Would work to harmonize criminal legal frameworks against counterfeit medicines, harmonize pharmacovigilance activities for counterfeit detection, engage in regulatory capacity building and strengthen pharmaceutical good governance	UNTOC: Application of counterfeit medicines trade as 'serious crime’ under UNTOC existing framework and transnational enforcement tools, Council of Europe MEDICRIME Convention: First International Counterfeit Medicines treaty, UN Environmental Programme Basel Convention on transboundary movement and management of hazardous waste for pharmaceuticals	Aim to develop and implement public policy, laws, and regulations at local, national, regional, and potentially global levels to combat the criminal trade in dangerous counterfeit medicines. Also aim to strengthen pharmaceutical governance to address corruption in health systems associated with drug supply delivery. Should explore existing regulations, laws, legislation, and treaty instruments for possible expansion or immediate application. This specifically includes application of international treaty instruments such as UNTOC, MEDICRIME, and the Basel Convention
Public outreach and education	Development of a unified and effective public outreach and education campaign tailored and aimed at a diverse group of stakeholders including consumers/patients, healthcare professionals, law enforcement, drug regulators, customs agents, policymakers, civil society, and other interested parties. Use of multimedia channels and mediums to obtain broadest coverage sensitive to target audience	Interpol Counterfeit Medicines Awareness Campaign 2010, US Food and Drug Administration: BeSafeRx Campaign, National Agency for Food, Drug Administration and Control (Nigeria) educational campaigns, Hong Kong Consumer Council outreach and awareness program on pharmacies establishments detected as selling counterfeit medicines	Fund initiatives to increase global awareness among all interested parties regarding the public health and patient safety dangers of counterfeit medicines. These efforts would attempt to address the demand side of counterfeit medicines from end users, increase engagement on prevention from healthcare professionals, and enable all stakeholders to better report suspect medicines to the relevant authorities
Information technology and cybercrime	Special technical working group composed of specialists in information technology, cybersecurity, public health, and law enforcement, with a mandate to specifically address ties between transnational cybercrime and illicit online pharmacies	Interpol Pangea I-VI Multistakeholder Operations.	Development of specific information technology tools to detect and shut down illicit online pharmacies and affiliated third-party enabling technologies. Exploration of existing web monitoring technologies for Internet content surveillance, utilization of tools for technical blocking of violating websites, suspension of financial transactions/processing, and use of other fraud detection tools. Systems that enable verification and certification of legitimate online pharmacies with education of the consumer should also be pursued
		Public-private partnerships: US Alliance for Safe Online Pharmacies; Center for Safe Internet Pharmacies, Integration with current global efforts of the Internet Governance Forum to promote online safety