The full version of this counterfeiting feature can be read in the July issue of our digital magazine: http://www.pharmtech.com/ptedigital0710
Mark Davison
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The effects of counterfeiting are hard to measure, both in human impact and financial loss. Unless baseline data are established
the effects of an anti-counterfeiting programme are therefore often difficult to demonstrate and it is impossible for a company
to develop a successful and coherent anti-counterfeiting strategy. A baseline can be established using various methods, including
test purchases and market surveys, but these must all be carefully designed to avoid sample bias. Once a baseline has been
found, a company can then decide how best to protect each of its products. This should be done on a rational, objective basis
that takes into account patient safety, revenue defence, legal compliance and cost.
Once anti-counterfeiting strategies have been put in place, one important issue that needs to be considered is communication
between a company's different divisions. Product protection costs are quantifiable and usually paid by manufacturing, but
the benefits are often found elsewhere; for example, in increased sales at a distant subsidiary. As such, anti-counterfeiting
should be controlled by someone senior enough to see the connections across the company.
For authentication that requires consumer involvement, education also needs to be considered. Education and awareness about
the anti-counterfeiting solution are critical because counterfeiters will be quick to exploit any confusion. There is no point
using an overt feature if people don't know exactly what to look for when differentiating your pack from similar-looking copies.
A global problem
Pharmaceutical supply chains are global, but the regulatory environment for anti-counterfeiting is not. Fortunately, this
is slowly changing with the FDA and the EU gearing up for new standards and legislation. In the EU, there is currently a number
of implemented and pending national regulations, such as the French CIP 13 and the Italian Bollino system. However, the forthcoming
EU Pharmaceutical package may eventually help to harmonise the situation within Europe by specifying EU-wide serialisation
standards.
For global track-and-trace to become a reality, a clear international compliance framework based on open technology is a critical
first step. The involvement of GS1 as a neutral, consensus-based standards organisation has helped to keep most governments
on parallel tracks for anti-counterfeiting, albeit they may be travelling at different speeds.
Outside of the EU, there are serialisation regulations in Turkey (which have been slightly delayed) and similar regulations
will also soon come into force in Brazil. Meanwhile, Malaysia already has its long-standing MediTag system of serialised holograms,
while other countries have local labelling requirements that incorporate authentication elements. Some governments who are
net importers of pharmaceuticals are also taking a more active role in their drug supply; for instance, the Nigerian regulator
NAFDAC has opened offices in India and China to try to influence pharmaceutical quality at the source.
Internationally, there has been some controversy over the role of the WHO IMPACT group and its links with pharmaceutical companies.
Developing nations, in particular, would prefer to see a clear separation between intellectual property issues and counterfeiting.
The issues addressed by IMPACT are fundamentally ones of patient safety, but semantics should not be allowed to derail their
attempts to coordinate and harmonise the legal and technical approaches to anti-counterfeiting worldwide.
As the US is the biggest pharmaceutical market, the main driver for a mass rollout of serialisation worldwide will probably
be the FDA, which has adopted the serialised National Drug Code (NDC) as a standard numerical identifier for serialisation.
The data structure of the sNDC is compatible with GS1 standards and the resulting clarity will catalyse some action from drug
companies.
Enforcing track-and-trace fully throughout the supply chain, however, will be a problem because of the inherent difficulty
of reading codes or checking the authentication features for every pack at every transaction. One hundred percent coverage
is impractical with any anti-counterfeiting system, but serialisation is a good start and the wider the net the harder it
is for counterfeiters to evade it. Companies just need to make sure they keep checking for holes.
