On a forum entitled "The safe medicine – from the manufacturer via the wholesaler to the patient" hosted by the Berlin daily newspaper "Tagesspiegel" at Berlin on 8 May 2019, Professor Stefan Vieths, vice president of the Paul-Ehrlich-Institut (PEI) explained the different pillars of safety of medicinal products and how to handle medicines counterfeits within the responsibility of the PEI.
Counterfeiting medicines presents a serious threat to the health of the population. Accordingly, all possible efforts are made to stop counterfeiting and the distribution of counterfeit medicines.
On 8 May, experts from different sectors including health and politics met at a professional forum organised by the Berlin daily newspaper "Tagesspiegel" to discuss the safety of the trading chain of medicines, risks presented by counterfeiting medicines, and how to prevent counterfeiting.
What is a counterfeited medicinal product? The term is defined in AMG Section 4 (40). A medicinal product is considered as counterfeited if it is distributed with incorrect data including its identity, composition, origin, and described channels of distribution. Consequently, such counterfeiting also refers to medicinal products which have been stolen and have re-entered the legal trading chain with counterfeited data. The PEI is responsible for vaccines and biomedicines. These also include the group of monoclonal antibodies – a highly priced product group which thus arouses a major interest among medicines counterfeiters. These medicines are primarily used for the treatment of cancer diseases and anti-inflammatory treatments. Counterfeits of these medicines have been uncovered in this product group time and again. As Professor Vieths reported, these counterfeits occurred exclusively in parallel trade.
All stakeholders have learned from the experiences of 2014, when a large number of counterfeit medicines of Italian origin became known in the context of the "Herceptin case". In order to optimise the flow of information in Germany between all participants and to coordinate the measures to be taken in the best possible way, a federal-state working group on counterfeiting of drugs (Bund-Länder Arbeitsgruppe Arzneimittelfälschungen) was founded in 2015.
Among the members of this working party are members of staff of the Federal Ministry of Health (BMG), the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), the PEI, the competent state authorities for the supervision of the marketing of medicines, the Central Office of the Federal States for Health Protection of Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG), the Federal Criminal Police Office (Bundeskriminalamt, BKA) and the German Investigations Office for Customs Crimes (Zollkriminalamt, ZKA).
The increase in counterfeit medicines in the legal chain of trade has led to the implementation of the EU Counterfeiting Directive (Directive 2011/62/EU). The Directive includes a package of measures designed to prevent the entry of counterfeits into the legal chain of trade. Since 9 February 2019, medicinal products for human use covered by this Directive must be labelled with additional security features such as the individual serialisation code and a tamper-evident device for detecting a possible manipulation.
Pharmaceutical companies in many cases market their medicinal products both in Germany and in other member states of the European Union (EU) or the European Economic Area (EEA), as applicable, and as a result, have the appropriate marketing authorisations in many of these member states. In the event of a parallel import, an importing company (which is as a rule specialised in the pharmaceutical sector) buys a medicinal product in another EU/EEA member state, imports it to Germany and then markets it “in parallel” to the original pharmaceutical company. In this context, the parallel importer benefits from the differences in the prices prevailing within Europe.
Updated: 08.05.2019
