On a European level, collaboration in the fight against counterfeit medicines comes in several forms. There is law enforcement collaboration in different settings and possibilities.
4.3.3.1 Europol
Currently, the intellectual property crime unit of Europol facilitates investigations with law enforcement and private sector partners, to protect consumers and identify the criminals behind the networks of the counterfeiting industry.69 This unit, operating from the headquarters in The Hague has several ways of facilitating collaboration. One of these ways is through their online platform, the Europol Platform for Experts
69 Europol (2016) Retrieved from: https://www.europol.europa.eu/content/page/mandate-119 (last visited 22-03-2016)
(EPE), which facilitates the sharing of best practices, documentation, innovation, knowledge and non-personal data on intellectual property crime, including counterfeit medicines with professionals from the public and private sector.70
Another way is facilitating a Joint Investigation Team (JIT). A JIT is an investigation team set up for a fixed period, based on an agreement between two or more EU Member States and/or competent authorities, for a specific purpose. Non EU Member States may participate in a JIT with the agreement of all other parties. The aim of a JIT is per definition to investigate a specific case. For example, an organized crime group that is active in selling counterfeit cancer medicines online in two EU member states and one non-member state. These three countries can decide to set up a JIT, using Europol facilities for a fixed period to tackle this common problem. However, after this case is closed, the JIT is finished as well. It is not possible to establish a generically competent task force for a certain type of crime, nor is it possible to set up a permanent operational team by using the JIT setup and concept.71
4.3.3.2 Working Group Enforcement Officers (WGEO)
The Working Group Enforcement Officers (WGEO) is an initiative by Heads of Medicine (HMA) and was established in 2007. It is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area.72
The mission of the WGEO is to contribute to the protection of public and animal health and welfare through ensuring adherence to the regulation of the manufacturing and distribution chains of medicinal products, the disruption of illegal activities and the information sharing.73 A respondent about the collaboration on a European level:
“Well, there are different forms of collaboration. If one takes only law enforcement collaboration, then there is the Working Group Enforcement Officers, which has been
70 Europol (2016) Retrieved from: https://www.europol.europa.eu/content/page/europol-platform- experts-1851 (last visited 8-8-2016)
71 Europol (2016) Retrieved from: https://www.europol.europa.eu/content/page/joint-investigation- teams-989 (last visited 8-8-2016)
72 HMA (2016) Retrieved from: http://www.hma.eu/wgeo.html (last visited 6-6-2016)
73 WGEO (2016) Retrieved from: https://medregeu2016.nl/calendar/working-group-of-enforcement- officers-wgeo/ (last visited 23-7-2016)
around for quite a while. In this group several agencies are represented. Including pharmaceutical agencies and for several countries the national customs and/or police. There are 2 meetings a year. The meaning is to create a platform where people can share best practices, and because of contacts and setting up a network, improving the collaboration between the police and agencies.” (Interview 1, Manager Counterfeiting Europol, 2-6-2016)
These contacts improve because of such meetings, according to the current Chair of the WGEO:
“The Working Group Enforcement Officers (WGEO), which is a working group that falls under the Heads of Medicines Agencies, which is part of the EU, where law enforcement officials and some observers are unified and discuss law enforcement methods, best practices, on-going cases, trends, topics, new legislation and more (Interview 2, Chair WGEO, 26-7-2016).”
4.3.3.3 Single Points of Contact (SPOCs)
The WGEO has created a network of single points of contact (SPOC) within their membership, including the observer countries and nine partner agencies. A SPOC is a single point of contact within a country on a specific issue. A respondent described it as a positive development for the coordination within Europe:
“The coordination within Europe is good. And there are some countries with which we have close contacts. Within this group of countries, there are so called SPOCs, which means Single Points of Contacts. So on the moment that there is a case study going on, the SPOC is contacted with the information on the illegal or counterfeit medicines and where the products were found and how to recognize it (Interview 2, Chair WGEO, 26-7-2016).”
The main purpose of these SPOCs 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 procedure, information between members can be shared speedily and confidentially. The alerts are used by the recipients in a number of methods: by Customs to identify products coming in at borders; by Drug Regulatory Authorities (DRAs) so that they
can evaluate the risk and raise awareness on their websites or through media channels and by law enforcement to conduct investigations.74
4.3.3.4 Results and work streams
Over the years, a number of significant issues and initiatives have been discussed and acted upon. For instance, the WGEO had initiated and conducted joint surveillance of the illegal sale of the so-called H1N1 (better known as swine-flu) products during the influenza pandemic in 200975 and, on another occasion, products containing Sibutramine (Sibutramine-containing medicines are used in the management of obesity) after the withdrawal of goods with this ingredient from the EU market.76 This provided important information to DRAs and enforcement officers enabling them to prevent the importation, distribution and sale of the products identified during surveillance.
Furthermore, the WGEO has work streams that have produced a variety of that delegates have found to be useful and practical for day-to-day management. An example of this is the Internet work-stream. The items produced during this work stream included; a guidance document on removing websites advertising and selling unlawful medical products from the Internet, completed by a “draft registrar contact process”, guidance on conducting open-source Internet investigations and a survey on Internet threats. Furthermore, there have been yearly educational sessions and trainings on practical issues in the fight against counterfeit pharmaceutical products.77