Masterarbeit

Evaluierung der deutschen und europäischen Rechtsprechung hinsichtlich des Risikos für Arzneimittelfälschungen

Dr. Janina Julia Bielefeldt (2008)

Language: German

Due to several publications counterfeit medicines has attracted notice of the experts and the public during the last years. A long time there was the conviction that it is primarily a problem of developing countries which do not have adequate systems for drug approval and do not have enough control over the distribution chain of the medicinal products. But since there have been batch recalls in the United States and the United Kingdom due to the occurrence of counterfeit medicines in the legal distribution chain, it has become clear that the developed industrial nations will not remain spared by these problems.

One of the main entry routes for counterfeiters in the distribution chain is the mail order of medicines over the Internet. Online trading with medicinal products can be done by a legal Internet pharmacy, an illegal (but for the consumer supposedly legal) Internet pharmacy or through direct shipment to the mostly through spam e-mails recruited clients. The purchase of prescription medicines from uncertain sources of Internet leads with a probability of more than 60% to a fake, defective or non-approved medicinal product. A serious-looking Web presence can easily be created. Even certificates on the homepage of the online pharmacy can easily be imitated.

Meanwhile, there are numerous initiatives against drugs counterfeiters and counterfeiting. The planned database of DIMDI seems to be an opportunity to provide consumers with more certainty in the selection of an online pharmacy.

The biggest risk for counterfeit medicines has not been through the adjudications, but by the change of the German Drug Act which allows online trading with medicinal products since January 1st, 2004. Currently jurisdiction has very little influence on the risk of counterfeit medicines. However, the judgement of the European Court of Justice leaves the possibility for the legislature to reduce online trading with medicinal products to OTC medicines due to the reasons of drug safety. This would lead to a reduced risk for counterfeit medicine trough online pharmacies. However, the chances of success of the requests of some federal states and parties for changing the law accordingly seam to be rather low.

Pages: 41