Testing of falsified / illegal medicines
- Work plan of the OMCL Falsified Medicines Working Group
- Market Surveillance Studies on Suspected Illegal Products (MSSIP) within the Network
- OMCL Monoclonal Antibody Testing Group
For many OMCLs in the GEON, there has been a significant shift in the first decade of the 21st century from planned market surveillance testing (with products selected according to risk-based criteria) to the analysis of falsified and illegal medicines on behalf of other authorities such as customs, police, enforcement/food inspectors and courts.
This additional task involves a wide variety of analytical techniques for 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). 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 the 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 area of falsified medicines. In March 2014, the data repository was replaced by a more advanced database (Know-X) which now collates test reports from OMCLs 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 the information is restricted to the authorities mentioned. In July 2018, a new version of the database was implemented. The aim of the changes was to offer a more intuitive and user-friendly IT tool. On the occasion a new module for Rapid Alert management was developed.
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 at evaluating 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 website. This document provides an overview of the contributions of the OMCL Network in 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 fighting against falsified 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 falsified and illegal medicines. Since the first Symposium, two others have taken place, in Strasbourg (France) and in Nicosia (Cyprus). The scope of these symposia was respectively: 1) medicines in disguise (dietary supplements, cosmetics, etc., including undeclared APIs), 2) new phenomena in falsification of medicines and advanced techniques for the detection of falsifications.
The first meeting of the OMCL 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 2019, 28 representatives from 24 OMCLs make up the Falsified Medicines Working Group and there are usually two face-to-face meetings each year.
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 other related products (e.g. illegally traded medicines, designer drugs, doping drugs, new psychoactive substances, medicines in disguise, etc.).
A number of subjects on which a co-ordinated approach should be fostered were identified at the 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 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.
- Development of joint market surveillance programmes on falsified 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 (see Know-X database).
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 falsified/illegal medicine testing by OMCLs. The last updated version of position paper An “aide-mémoire” for the testing of suspected illegally traded and falsified medicines, PA/PH/OMCL (06) 81 R10 has been made publicly available in November 2019.
Since 2012, the OMCL Network has developed joint market surveillance programmes on suspected falsified 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. About 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.
Seventeen OMCLs from 16 different European countries participated in the third study (MSSIP003), focused 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 substance.
Seventeen OMCLs from European countries and Israel (an associated member of the Network) participated in the fourth study (MSSIP004), focused on Medicines in disguise. More than 300 samples, mainly from the illegal supply chain, were analysed.
Summaries of the study reports are now available.
- Download the study report on Illegal Products containing “non-INN” APIs
- Download the study report on Slimming dietary supplements
- Download the study report on Dietary Supplements advertised as Sexual Potency Enhancers
- Download the study report on Illegal Anabolic Steroids
- Download the study report on Medicines in disguise
In December 2018 a new expert group of the OMCL Network has been established in reaction to increasing numbers of reports with respect to falsifications and thefts of biologicals in Europe. In particular monoclonal antibody (mAb) and antibody-containing fusion protein (AbFP) preparations, which typically are high-price products, are involved in many of the reported cases.
The main objective of the group is to develop strategies for testing suspected falsified mAbs and AbFP and to strengthen the expertise in the Network regarding physico-chemical analyses and bioassays for 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 for the OMCL Network dealing with the testing of suspected falsified mAbs and AbFP which can be accessed via the following link.
- MEDICRIME Convention
- Bundesamt für Sicherheit im Gesundheitswesen (BASG), Austria
- Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES) Medizinmarktaufsicht, Austria
- Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain
- Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
- Swedish Medicines Agency, Sweden
- Agence nationale de sécurité du médicament et des produits de santé, France