Abstract
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.
| 
View Cart
