In the first decade of the 21st century, many OMCLs of the GEON began to shift away from planned market surveillance testing (with products selected according to risk-based criteria) towards the analysis of falsified and illegal medicines on behalf of other authorities such as customs, police, enforcement/food inspectors and courts.
These OMCLs began to carry out authenticity testing (comparison of a suspected falsified sample with the genuine product) and screening for unknown products (e.g. in a suspicious "white powder" confiscated by the police) using a wide variety of analytical techniques. Over the last two decades, the OMCL Network and the EDQM have responded to the increasing number of potentially falsified and illegal medicines through a series of measures outlined below.
In October 2006, the EDQM set up a data repository for Network members involved in the testing of falsified and illegal medicines. This information platform was used by OMCLs on a voluntary basis to make test reports available in a standardised format; it was reserved for Network members and enabled the rapid exchange of information on testing activities in the field of falsified medicines. In March 2014, the data repository was replaced by a more advanced database, Know-X, which collates OMCL test reports and reports issued by customs, police and health authorities on falsified medicine cases in Council of Europe member states and member states of the GEON. Access to Know-X is restricted to the authorities mentioned above. A more intuitive and user-friendly version of the database was then rolled out in July 2018. A new module for Rapid Alert management was developed at the same time.
Since 2007 and at the request of the Network, the EDQM has organised a programme on the testing of Suspicious Unknown Products (SUP). The aim is to evaluate whether the Network’s OMCLs are able to identify (and, where possible, quantify) unknown active pharmaceutical ingredients (APIs) in a selected sample.
At its Annual Meeting in Split, Croatia, in 2010, the Network decided to publish the first document covering this field of activity on the EDQM website. This document provides an overview of how the OMCL Network contributes to supporting the implementation of the Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health (or MEDICRIME Convention) and is aimed at raising awareness of the essential value of the work of OMCLs in the fight against falsified and other illegal medicines.
The EDQM regularly organises scientific symposia covering all aspects of falsified medicines testing, such as:
- the different types of falsified medicines, including medicines in disguise (dietary supplements, cosmetics, medical devices, etc. containing undeclared APIs);
- new trends in the falsification of medicines and the use of established and advanced techniques for the detection of falsification;
- possibilities for collaboration with different partners active in the same field.
These symposia are excellent occasions to bring together stakeholders working in this field, including OMCLs, health authorities, police, forensic laboratories, customs authorities, customs laboratories and the European Commission. The symposia facilitate scientific interaction between the different groups and the exchange of information on new developments and trends with respect to the phenomenon of falsified medicines.
For more information please read available Press Releases which have been issued in context with these event.