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.
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: Maria Morais, INFARMED, Portugal.
- 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.
E-Mail: WGEOSecretariat@ hpra .ie
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:
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.
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.