Working Group of Enforcement Officers (WGEO)
Introduction/Overview/Mandate
The Working Group of Enforcement Officers (WGEO) was established in 2007 by the HMA to contribute to the protection of human and animal health and welfare. The primary aim of WGEO is to:
- Promote liaison and co-operation between Member States and agencies with the purpose of sharing information.
- Identify emerging threats to the legal manufacturing and distribution chain.
- Coordinate communications and initiatives, exchanging information with relevant working parties/groups and organisations.
- Provide a valuable network for European counterparts to build trust, share experience, best practice and expertise relating to pharmaceutical crime.
- Deliver a practical training platform – largely related to the four work-streams: wholesale and distribution; Internet (illegal supply of medicines); falsified medicines and training and education.
Mandate | pdf
Members and Representatives
- Representatives from both human and veterinary national medicines agencies, other national regulatory agencies and law enforcement agencies, all of whom are engaged in medicines enforcement in the respective Member States.
- Representatives from bodies across the NCAs, EFTA states and the European Medicines Agency, including Police and Customs authorities by agreement of the Member State and/or WGEO. The European Commission and the European Medicines Agency are invited to all meetings.
- Other Observers are permitted by agreement of HMA-WGEO, from other working parties/groups and organisations.
- WGEO has its own Management Committee with Chair, Vice Chair, Secretariat and Recurrent Members, with an election every three years.
- Chair: Martin Burman, Medical Products Agency (Läkemedelsverket), Sweden
- Meeting cycle: two times per year, once per EU-presidency organised by the Presidency holding country where possible.
- The members of the WGEO are appointed on the basis of their expertise and experience in medicines enforcement in the field of human or veterinary medicines. Members are designated by the National Competent Authorities.
Contact Point
Contact Point:
Activities and Achievements
The WGEO has created a network of single points of contact (SPOC) within their membership, including the observer countries and nine partner agencies. The main purpose of this is to facilitate the WGEO Rapid Alert System. The WGEO Rapid Alert system is mainly used to inform the SPOC network about discoveries of products containing undeclared content of medicines and to send out warnings when large amounts of medicines are reported stolen. Through this process, information between members can be shared speedily and confidentially. The alerts are used by the recipients in a number of ways: by Customs to identify products coming in at borders; by Drug Regulatory Authorities so that they can evaluate the risk and raise awareness on their websites or through media channels and by law enforcement to conduct investigations.
Over the years, a number of important issues and initiatives have been discussed and acted on. For example, the WGEO initiated and conducted joint surveillance of the illegal sale of H1N1 products during the influenza pandemic and, on another occasion, products containing Sibutramine after the withdrawal of goods with this ingredient from the EU market. This provided important information to DRAs and enforcement officers enabling them to prevent the importation, distribution and sale of the products identified during surveillance. Membership of the WGEO (v) group also enabled several enforcement bodies to work closely together in successfully tackling a high profile case concerning the importation of illegal veterinary medicines into the UK. Some 20 tonnes of illegal medicine was seized and destroyed.
The work streams have produced a variety of documents that delegates have found to be useful and that have had a practical use in the workplace. A non-exhaustive list of examples follows:
Internet work-stream
The items produced included the following: a guidance document on removing websites advertising and selling unlawful medical products from the Internet, complemented by a draft ‘registrar’ contact process. Guidance on conducting open-source Internet investigations was also completed as well as a survey on Internet threats. This work-stream contributed towards a greater communal understanding of enforcement challenges and risks posed to the public from illegal online trading of medicines and created a strong network involved in combating this ever increasing threat to public health enabling the day to day emerging cases to be resolved and shared correctly and effectively.
Wholesale and distribution work-stream
A concept paper on wholesale dealing was produced together with a report looking at the different interpretations and implementation of wholesale dealing across the EU. A due diligence, question and answer, document was also produced to assist suppliers together with a survey report on licences, status and inspections of bonded warehouses.
Falsified medicines work-stream
A number of documents were produced including a best practice paper on the handling of analytical samples and a product threat assessment template and guidance. They also undertook a survey of counterfeit product recalls between 2005 and 2010 and a survey on active pharmaceutical ingredient and controls in place by medicines regulators and industry.
Training workgroup
This group delivered a range of educational sessions as follows:
2009
Introduction of WGEO training as part of the Presidency meeting schedule
- Crisis Training for enforcement on discovery of falsified medicines and medical devices
- Evidence handling
- Searching premises
- Intelligence gathering and use
- Administration of an enforcement investigation case
2010
Incident Decision making
- Planning and executing an enforcement search
- Computer seizures
- Joint interagency operations
- Exercise on crisis management for enforcement managers
2011
Operational briefing and debriefing, crisis management, interviewing
- Conflict and the enforcement manager
- Incident decision making validation
- Moving from Inspection to Enforcement activities
2012
Critical incident handling for Enforcement Managers
- Impact of the media on enforcement operations - How to manage Media
- Crisis management handling exercise for enforcement officers
2013
Vet training, customs and DRA
- Crisis handling exercise
- Interagency approach to enforcement investigations – working together seminar
- Operation PANGEA investigations – back to basics
2014
Customs documents – tracing distribution of falsified medicinal products
- Cooperation with customs
- How to use customs documentation to trace the actors involved in the distribution of falsified medicinal products.
- 2014 – Fakeshare Training delivered by AIFA - A European Commission funded project for the sharing of intelligence at EU level via a shared, secure e-platform. This is in relation to Directive 2011/62/EU - supply of medicines at a distance
2015
WGEO Delegation visit to Beijing and Hong Kong, China
- The purpose of the visit is to introduce the WGEO and delegate members, to counterparts in the Chinese Food and Drugs Administration (CFDA) and Law Enforcement Agencies (LEA). To build effective lines of communication leading up to building functional working relationships with a common purpose of combating falsified medicines and devices.
Objectives
- Introduce members of the WGEO delegation and their respective roles.
- Introduce the WGEO to the Chinese Authorities and explain its role in coordinating a standard response to enforcement across the European Union.
- Open lines of communication for WGEO members with CFDA and LEAs.
- Develop a mutual understanding of enforcement roles within China and EU.
- Develop a mutual understanding of enforcement issues impacting on China and the EU.
Develop future lines of communication where information and intelligence can be shared with a view to advancing operational activity.
Agencies Visited Beijing:
- EU Delegation Office
- Ministry of Public Security
- CFDA Head Offices
- Wan Hui Law Firm Intellectual Property Agency for Pharma Companies
- Beijing Food & Drug Administration
Agencies Visited in Hong Kong:
- The Pharmaceutical Security Institute
- Hong Kong Customs
- Department of Health Drug Office
- Hong Kong Association of the Pharmaceutical Industry
2016
- New Awareness Strategies – Cartoon Based Teaching Concept
- Financed By EDQM CoE
- Co-ordinators WGEO Members Domenico Di Giorgio AIFA and Pavle Zelić ALIMS
- Operation Volcano – The Herceptin Case
- Story, Lessons learnt and Proposals.
- WGEO Members involved: AIFA, AEMPS, AGES, IGZ and MHRA
- Launch of Fakeshare.eu Platform - Sharing intelligence and Science about Fake Medicines and Illegal Websites
- Website aimed at the General Public offering:
- News and Documents
- Search tools for evaluating e-pharmacies and Products
- A Reporting form
- Website aimed at the General Public offering:
- Tips & Tricks
- Contracting Registrars/ Registries and Registrants
2017
- Dr Lorraine Nolan assumes the Role of HMA Mentor to WGEO.
- Facebook Social Media - presents to the WGEO network.
- Policy in relation to the Advertising and Sale of Pharmaceuticals on the platform
2018
- MEDSAFE
- Combating Falsified Medicines in Eastern and Central Africa
2019
- European Association of Euro- Pharmaceutical Companies – Parallel Trade
- Formed in 1998
- Over 120 members in 22 EU Member States
- All companies are EU Licensed Wholesalers subject to GMP
- Objective – Bring Europeans affordable Medicines.
- Counterfeit and Falsified Medicines in the EU: Key Challenges
- Dr. Vishv Priya Kohli, Assistant Professor, Copenhagen Business School.
2020
Online Meeting – COVID -19 Pandemic restrictions
- UNODC initiatives to combat Falsified Medical Product-related crime.
- Ms Karen Kramer Senior Drug Control and Crime Prevention Officer
- https://www.unodc.org/documents/treaties/publications/19-00741_Guide_Falsified_Medical_Products_ebook.pdf
- Counterfeit and Sub- Standard medicines during the COVID-19 Pandemic – EUROPOL
- Main Transit Routes identified
- Monitoring of Social Media Platforms
- Criminals adapt their illegal activities to exploit the COVID-19 Pandemic
- Falsified Pharmaceutical Products identified
Face Masks, Test Kits, and Latex Gloves
Sanitisers and Disinfectants
- THEFT OF MEDICINES
- Trend of the Phenomenon - Domenico Di Giorgio AIFA
2021
Online Meeting – COVID -19 Pandemic restrictions
- COVID -19 Activities – OLAF European Anti-Fraud Unit
- Falsified and Counterfeit products entered the EU Market
- Unproven treatments
- Test Kits
- Medical equipment – Ventilators, Masks, Gloves
- Falsified and Counterfeit products entered the EU Market
- Victims of the Scams
- Individual
- Pharmacies
- Care Homes
- Large Institutional buyers – Hospitals and Schools
- COVID – 19 Manufacturers
- COVID – 19 Presentations from:
- Pfizer – BioNTech - David Shore, Senior Director Pfizer Global Security – EMEA
- Astra Zeneca – Katie Silk, Global Head of Corporate Security
- Moderna – Dean Geribo, Global Head of Corporate Security
- COVID – 19 Presentations from:
- COVID -19 Experience - The Pharmaceutical Security Institute
- Footsteps of the Pandemic – Pharmaceutical Companies Viewpoint
2022
- Medical Devices – The Legislative Framework
- Thomas Wejs Møller, DMA & Chair of CMAD
- MEDI – THEFT Project
- Domenico Di Giorgio AIFA
- Technology Solution to Combat Falsified Medicinal Products – TrueMed AI Training
- TrueMed Oy SVP & Co-founder Olli Paloheimo
2023
- One Pill Can Kill
- How falsified prescription opioids fuel the new and lethal wave of the opioid epidemic in the US – and its reflection in Europe – Pavle Zelić ALIMS
- MediCrawl – a Search Engine on Medicines - New Software for Surveillance
- Robert Kummer, Enforcement Officer, Swissmedic
- MEDICRIME Convention 24/7 Network
- Dr. Oscar Alarcón-Jiménez Committee of the Parties to MEDICRIME Convention.
- BEST Practices Managing Cases of Thefts of Medicines in the EU
- Domenico Di Giorgio AIFA