NEW STRATEGIES: THE FIGHT AGAINST COUNTERFEIT MEDICINES

   

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The number of revealed cases of counterfeit medicines has increased substantially since 2004. For one thing, this is due to the constant increase in crime on the world-wide market for medicinal products and for another, to the improved detection rates in the individual countries. At the "Strategies against Counterfeit Medicines"-ECA -Conference which took place in Würzburg last April, representatives of authorities (FDA , WHO, MHRA and IMB), industry and research presented the latest developments in the fight against counterfeit medicines.

According to § 8 AMG (German Drug Law), medicines or APIs are regarded as counterfeit if they are labelled incorrectly with respect to their identity or source. Dr. Christian Tillmanns, a lawyer from Munich, explained that § 4 (17) AMG prohibits them from being put on the market in Germany. In other countries, the definitions and laws are similar to those in Germany. Nevertheless, various adverse events have often occurred in the recent past which could clearly be traced to the criminal counterfeit of medicines. One example is the heparin scandal of 2007/2008 that claimed many deaths, especially in the USA. What's more, so-called lifestyle products, with which huge profits can be made on the illegal market, are often counterfeited. But in the past, there have also been incidents with counterfeit medicines in the sector of analgesics, antibiotics and antidepressants.

Dr. Sabine Kopp states that the WHO defines a counterfeit medicine as one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Hence counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with incorrect quantities of active ingredients or with fake packaging. In the fight against counterfeit medicines the WHO launched IMPACT (International Medical Products Anti-Counterfeiting Taskforce). Since 2006, this taskforce has been working on a voluntary basis on co-ordinating international activities against counterfeit medicines. IMPACT's five working groups focus on the sectors revealing weak spots which, according to WHO, require action at a national and international level. These sectors are legislative and regulatory infrastructure, regulatory implementation, enforcement, technology and communication. These working groups aim to abolish borders and barriers between the authorities and institutions in various countries in order to facilitate a faster and more effective co-operation beyond frontiers and the limits of jurisdiction.

Many activities of the individual countries presenting their concepts at the ECA conference aim towards improving control and transparency of the supply chain as a whole. In this regard, a pilot project was carried out in Brazil from January to July last year. Patricia Blanco explained that in Brazil the implementation of a two-dimensional barcode on each single medicine package is an attempt to make the supply chain more transparent and hence more secure. Apart from the batch number, the production date and the serial number, this barcode also includes the socalled GTIN (Global Trade Item Number) which is an identification number, issued and maintained by GS1 (Global Standards One) that makes it possible to definitively identify each single medicine package world-wide. This should make it impossible to infiltrate illegal items into the supply chain.

Nimo Ahmed and Andy Charvill represented the competent British agency for medicines and healthcare products (MHRA). Ahmed described the threat that medical products crime poses to the economy and public health. The British authority attaches great importance to education by means of an increased public relations effort, including advertising campaigns by the industry. The point is to sensitise the consumer and to convey to him an idea of the danger that emanates from counterfeit medicines. To that end, Pfizer started a campaign which aims at raising the awareness of the consumer by means of shocking, although exaggerated, illustrations (see graphic). This campaign is part of the authority's co-operation with an interest group including representatives of the pharmaceutical industry, pharmaceutical wholesalers, retailers and importers of medicines.

Andy Charvill demonstrated that near- and middle- infrared spectroscopy represents a fast and inexpensive method for the verification of product and packaging. Among other things, the FDA, represented by Frederick Fricke, uses the polarised light microscopy that makes it possible to depict the surface of tablets and capsules three-dimensionally so that fakes can easily be distinguished from the original product. The authenticity of medicines can also be tested by means of Raman spectroscopy. But the authorities are dependent on samples from the pharmaceutical producers since these methods are always in the form of a comparative analysis.

Furthermore, it was discussed at different points how useful the application of certain PCIDs (physical-chemical Identifiers) is. They are added to the product so that it may be distinguished very easily from fakes should the occasion arise. Some companies have already implemented this method in the case of primary and secondary packaging material. Lilly, for example, uses blisters that fluoresce in ultraviolet light.

In the end, all participants at the conference agreed that close and cross-border co-operation by producers of medicinal products and authorities is vital in the fight against counterfeit medicines.

Authors:
Prof Dr Ulrike Holzgrabe
... has a chair in Pharmaceutical Chemistry at the University of Würzburg since April 1999.

The approbated pharmacists Christine Büttner- Merz and Tanja Beyer have been scientific assistants in the working group of Prof. Holzgrabe at the Institute for Pharmacy, Julius-Maximilians-Universität Würzburg, in the sector of pharmaceutical analytics since 2006.

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