Summary
Pharmaceutical counterfeiting is widely accepted to be a serious, global problem. No longer just a scourge on the developing world, counterfeit drugs now affect industrialised nations including the member states of the European Union (EU). This issue must be faced by businesses worldwide.
Today, it is estimated that up to 10% of all drugs may be counterfeit. But international and national organisations, as well as governmental authorities, appear to be unanimous in their assertion that it is extremely difficult to establish reliable statistics regarding the size of the phenomenon - or even to determine what constitutes counterfeiting. So, as well as discussing the extent of the problem, this report explores the definitions - in itself an indication of the many and varied forms counterfeiting can take.
The report also pays special attention to how counterfeit medicines breach intellectual property rights (IPR) as the problem is compounded by originator companies' needs to protect their IPR.
Even in the EU, where protection of IPR is rigorously enforced, data gathered by EU medicines enforcement officers (EMEO) have revealed a startling number of fake drugs in the legal supply chain. And figures presented by the EU's Directorate general for Tax and Customs show that in 2005, customs officers seized more than 500,000 counterfeit medicines.
As the counterfeiting of drugs in Europe threatens to spiral out of control, the European Commission (EC) has implemented stringent measures to deter and combat this type of fraud. Moreover, the European Medicines Agency and the Heads of Medicines Agencies have launched their own approaches to the problem, all of which are discussed in detail here.
In addition, this report contains a series of exclusive commentaries from selected EU countries which outline their opinions on the extent of the problem. This section details national measures that have been introduced to combat counterfeiting and highlights the efforts of the member states to move the fight onto an international stage.
And this report does not ignore the global scale of this problem. It gives an overview of the nature of the problem in countries around the world.
Businesses also have a role to play in the ongoing battle against counterfeit medicines. A number of large pharmaceutical companies have launched their own initiatives to combat counterfeiting. This report presents the solutions employed by some of pharma's biggest players.
Also in the frame is the role of parallel traders and whether their actions truly contribute to the proliferation of counterfeit medicines.
Finally, the report presents a range of practical options open to companies looking to combat the counterfeiting menace. It focuses on radio frequency identification (RFID), often viewed as the most promising technology in this sector.
A comprehensive guide to one of pharma's biggest concerns, this study explores the problem from numerous angles and highlights the biggest threats facing the industry. It also explains what is being done to tackle the issue and suggests what companies themselves can do. It is essential reading for anyone concerned with the safe provision of medicines.
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