Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Measures for industry, government and public authorities in Europe in the combat against counterfeit medicines. What is being done and what can yet be done.

Lars-Peter Frohn (Abschlußjahr: 2010)

Summary
Counterfeit medicines are a global problem costing patientʼs their health and the pharmaceutical industry and governmental organisations millions of dollars per year. Although there is no preventative strategy, there are several measures that can be employed simultaneously to reduce the risk of fake medicines entering the pharmaceutical supply chain.
According to the World Health Organisation:

• 50% of medicines purchased over the internet from sites that conceal their physical address are counterfeit;
• 10% of medicines sold in developing countries are fakes;
• 1% of medicines sold in developed markets, such as the European Union, are counterfeit.

While it is generally suspected that the 1% figure in the EU is now much higher, it is still highly significant. Even the 1% figure would mean that in 2009 over 7 million UK and 16 million German prescriptions may have been filled with counterfeit medicines.
The production of substandard and fake drugs is a vast and underreported problem, particularly affecting poorer countries. It is an important cause of unnecessary morbidity, mortality, and loss of public confidence in medicines and health structures. The prevalence of counterfeit drugs appears to be rising and there is only weak cooperation among the various key players at national, regional and global level, while a strong collaboration would be required to effectively combat counterfeit medical products.
From 2010 onwards, success in the pharmaceutical anti-counterfeiting sector will be characterised by the launch of new solutions with superior performance as well as the coordinated measures by industry, government and public authorities.