Within the General European OMCL Network (GEON)
For many OMCLs in the GEON, there has been a significant shift over the last few years from planned market surveillance testing (with products selected according to risk-based criteria) to the analysis of counterfeit and illegal medicines on behalf of other authorities such as customs, police, enforcement / food inspectors, courts and forensic laboratories.
This additional task involves a wide variety of analytical techniques for authenticity testing (comparison of a suspected counterfeit sample with the original product) and screening for unknown products (e.g. in a suspicious "white powder" confiscated by the police). Over the last few years, the OMCL Network and the EDQM have responded to the increasing number of potentially counterfeit 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 counterfeit and illegal medicines.This information platform is used by the OMCLs on a voluntary basis to make test reports available in a standardised format; it is reserved for Network members and allows rapid exchange of information on testing activities in the area of falsified medicines. In March 2014 the data repository was replaced by a more advanced database (KnowX) which now collates test reports from OMCLs and reports issued by customs, police and health authorities on closed falsified medicine cases in Council of Europe member states. Access to the information is restricted to the authorities mentioned.
Following an initiative of the Network, since 2007 the EDQM has been organising a programme on the testing of Suspicious Unknown Products (SUP). This programme aims to evaluate whether OMCLs of the Network 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's website. This document provides an overview of the contributions of the OMCL Network in supporting the implementation of the MEDICRIME Convention of the Council of Europe and is aimed at raising awareness of the essential value of the work of OMCLs in fighting against counterfeit and other illegal medicines.
These concerted efforts of the Network also led to the organisation of the first symposium for OMCLs focusing on all aspects of testing of falsified medicines, which was held on 29-31 March 2011 at the EDQM in Strasbourg.
During the Annual Meeting of GEON 2011 in Düsseldorf, Germany, the Network members agreed to establish a working group dealing with relevant aspects regarding the testing of counterfeit and illegal medicines.
Work plan of the Counterfeit/Illegal Medicines Working Group
The first meeting of the Counterfeit/Illegal Medicines Working Group of the OMCL Network took place on 2 November 2011 and preceded the Centrally Authorised Product (CAP) Annual Meeting of the EEA OMCL Network at the premises of INFARMED in Lisbon, Portugal. In total, 14 representatives from 13 member states accepted the invitation to present their ideas about strengthening collaboration between OMCLs in the field of the testing of falsified medicines and similar products and to draw up a work programme for the Group.
It was decided that the scope of the Group should not be limited to medicines for human use at potential risk of falsification, but should also extend to veterinary medicines and designer drugs.
A number of subjects on which a co-ordinated approach should be fostered were identified at the meeting and have been taken further over recent years:
- Internal information exchange between the OMCLs using existing IT platforms (e.g. the OMCL inventory database) and other forms of communication such as Annual Reports. The exchange of data should not be restricted solely to information about testing activities in connection with laboratory control of suspicious products confiscated by customs and/or the police at the request of the prosecution/court, but should also extend to scientific discussions highlighting new trends in the field of falsified medicines. For this purpose focus topics at the Annual Meeting of the GEON or dedicated symposia should be organised on a regular basis.
- Identification of training needs on technical subjects relevant to the testing of falsified medicines and the development of appropriate training programmes. In this respect, the principle of peer assistance (training of OMCL technical personnel by partner OMCLs experienced in conducting certain techniques) would apply.
- More information about previous Technical OMCL Counterfeit Trainings
- Development of joint market surveillance programmes on counterfeit and illegal products to cover a large part of the European market in a co-ordinated campaign targeted on defined product groups.
- Assistance with the establishment, maintenance and further development of an effective, user-friendly database holding records relating to testing activities on falsified medicines and similar products in the Network. This computer application should allow information exchange with other stakeholders such as the police, customs officers and regulators
Meanwhile the group is meeting biannually to follow-up the decisions taken at its first meeting.
Gradually a number of general internal documents have been developed by the Network covering different aspects of counterfeit/illegal medicine testing by OMCLs. The position paper An “aide-mémoire” for the testing of suspected illegal and counterfeit medicines, PA/PH/OMCL (06) 81 R6 has been made publicly available in December 2016.
Market Surveillance Studies on Suspected Illegal Products (MSSIP) within the Network
Since 2012, the OMCL Network is developing joint market surveillance programmes on suspected counterfeit and illegal products (MSSIP) to cover a large part of the European market in a co-ordinated campaign targeted to defined product groups.
Twenty one OMCLs participated in the first study (MSSIP001), focused on Slimming Dietary Supplements. 370 products from the legal and the illegal supply chain were analysed for the presence of undeclared active ingredients.
Twenty OMCLs from 17 European countries participated in the second study (MSSIP002), focused on Dietary Supplements advertised as Sexual Potency Enhancers. More than 500 samples from the legal and the illegal supply chain were analysed for the presence of undeclared active ingredients.
Summaries of the study reports are now available.