Background

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:

  1. the different types of falsified medicines, including medicines in disguise (dietary supplements, cosmetics, medical devices, etc. containing undeclared APIs);
  2. new trends in the falsification of medicines and the use of established and advanced techniques for the detection of falsification;
  3. 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.

19th Technical OMCL Falsified Medicines Training
Prague, Czech Republic 3-4 May 2023
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On 3-4 May 2023, a technical training session for OMCLs on the testing of falsified and illegal medicines took place on the premises of the National Health Institute in Prague, the location of the Czech OMCL for human medicines (SÚKL). The objective was to present important techniques for the analysis of falsified, unknown products. The Prague session was a repeat of two training sessions successfully run by the Czech OMCL in 2018. All OMCL hands-on training programmes are co-organised by members of the GEON and the EDQM.

Twelve OMCL trainees from ten European countries attended the course. They were split into two small groups so that technical exchanges with the host OMCL staff were as interactive as possible.

Each of the groups attended two half-day training sessions, during which the following methodologies were presented:

  • Liquid Chromatography – Mass Spectrometry (TOF);
  • Infrared and Raman Spectroscopy.

The aspects covered during the sessions were: principles of each analytical technique, components of the instruments and software, calibration/qualification and quality management requirements, sample preparation, and sample processing and interpretation of results, where applicable with the help of in-house or commercially available libraries/databases. The training course ended with a guided tour of the laboratory given by the staff members.

Hands-on training for OMCLs on the testing of falsified medicines has become a regular offer of the GEON and will be continued thanks to the great interest from Network members and positive feedback received from participants.

Work plan of the OMCL Falsified Medicines Working Group

The first meeting of the Falsified Medicines Working Group of the OMCL Network took place on 2 November 2011 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 testing of falsified medicines and similar products and to draw up a work programme for the group. In 2023, the Falsified Medicines Working Group comprises representatives from 24 OMCLs and usually meets twice face-to-face each year.

It was decided that the scope of the group should not be limited to medicines for human use that are at potential risk of falsification, but should also cover veterinary medicines and other related products (e.g. medicines in disguise, illegally traded medicines including diverted and stolen medicines, designer drugs, doping drugs, new psychoactive substances, etc.).

A number of subjects on which a co-ordinated approach should be fostered were identified at the kick-off meeting and have been taken further over the following 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 include 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, relying on peer assistance (training of OMCL technical personnel by partner OMCLs experienced in conducting certain techniques).

More information about previous Technical OMCL Falsified Medicines Training

  • Development of joint market surveillance programmes on falsified and illegal products covering a large part of the European market in a co-ordinated campaign that targets defined product groups.
  • Assistance with the establishment, maintenance and further development of an effective, user-friendly database holding records relating to testing activities carried out 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 (see Know-X database).

The group meets twice a year, with decisions taken at the first meeting followed up at the second meeting.

A number of general internal documents have been issued over the years by the Network, covering different aspects of falsified/illegal medicine testing by OMCLs. The last updated version of the position paper An “aide-mémoire” for the testing of suspected illegally traded and falsified medicines was made publicly available in November 2019.

Market Surveillance Studies on Suspected Illegal Products (MSSIP) within the Network

Since 2012, the OMCL Network has been developing MSSIPs covering a large part of the European market in a co-ordinated campaign that targets defined product groups. Five of these studies (described below in chronological order) have been carried out to date.

Twenty-one OMCLs participated in MSSIP001 on Slimming Dietary Supplements. About 370 products from the legal and the illegal supply chains were analysed for the presence of undeclared active ingredients.

Twenty OMCLs from 17 European countries participated MSSIP002 on Dietary Supplements advertised as Sexual Potency Enhancers. More than 500 samples from the legal and the illegal supply chains were analysed for the presence of undeclared active ingredients.

Seventeen OMCLs from 16 different European countries participated in MSSIP003 on Illegal Anabolic Steroids. More than 1600 samples, mainly from the illegal supply chain, were analysed for the presence of any declared and undeclared active substances.

Seventeen OMCLs from 16 different European countries and Israel (an associated member of the Network) participated in MSSIP004 on Medicines in disguise with the following profile: non-medicinal products containing undeclared APIs described in the ATC classification system – INN list, in quantities equal to or greater than the quantity of APIs in an authorised medicine. More than 300 samples, mainly from the illegal supply chain, were analysed.

Sixteen OMCLs from 14 different European countries as well as Australia and Israel participated in MSSIP005 on Illegal Products containing “non-INN” APIs. Results from around 1100 samples, mainly drawn from the illegal supply chain, were summarised in the report.

The results of MSSIP005 were published in the following scientific article: The occurrence of non-anatomical therapeutic chemical-international non-proprietary name molecules in suspected illegal or illegally traded health products in Europe: A retrospective and prospective study, doi: 10.1002/dta.3001.

Summaries of the study reports are now available.

OMCL Monoclonal Antibody Testing Group

A new OMCL Network expert group was established in December 2018 in response to the rising number of reports of falsification and theft of biologicals in Europe. Many of the cases reported concerned monoclonal antibody (mAb) and antibody-containing fusion protein (AbFP) preparations, which are typically costly products.

The main objective of the group is to develop strategies for the testing of suspected falsified mAbs and AbFP and to build on the Network’s expertise in the physico-chemical analysis and bioassay of these products by applying some of the key principles of the GEON, namely work sharing, knowledge transfer and mutual recognition of test results.

The group has developed a position paper entitled Aide-Mémoire: How to identify a Falsified Monoclonal Antibody / Antibody containing Fusion Protein dealing with the testing of suspected falsified mAbs and AbFP for use by the OMCL Network.