Steve Kemp
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Counterfeiting continues to be a huge challenge affecting both branded and generic products, which, although a worldwide issue,
is especially prominent in developing countries; some reports suggest that 80% of counterfeit products are now coming out
of China. Regulatory authorities are already working hard to address these issues, and as soon as authorities find counterfeit
medicines, they are destroyed. Some counterfeit packs may have packaging features that state "genuine product" or even have
a hologram, regardless of whether or not this appears on the original product. Though the introduction of the Falsified Medicines
Directive (FMD) in Europe aims to prevent falsified medicines from reaching patients, this won't help those who continue to
self diagnose and source their own drugs via the internet, where there is currently little control.
In terms of technology, although 2D data matrix and serialisation codes are both gaining momentum, it may be the case that
we need a combination of approaches to fully safeguard the pharma supply chain in the future. This is a constantly evolving
situation and one that we are monitoring closely. Brecon complies with what our clients wish to provide to their customers;
we follow their guidelines and work in partnership with them to provide the most effective anti-counterfeiting solution. Common
technologies employed are 2D data matrices, serialisation and covert or overt package features that are embedded into the
graphic artwork, for example the use of micro text and micro characters that cannot be seen by the naked eye.
Packaging can play an important role in the war against counterfeit medicines and it follows the old saying that "prevention
is better than cure". So pharmaceutical packaging should offer features that both protect the product before it reaches the
end user, as well as deterring counterfeiting. Unfortunately, forgers will always find a way to copy, which is the constant
battle facing the industry. The Burgopak, for example, and our new AndersonBrecon compliance packs (IntuiDose) go a long way
to deter counterfeiting because they are patented, so we know which products are packed in this format. Additionally, the
equipment used is typically bespoke and not easy to replicate economically, which acts as another deterrent.
Packaging design needs to be combined with ever-greater lines of traceability through the inclusion of effective coding and
marking, whether that be the use of 2D data matrix codes, QR codes, or linear/numerical codes. In the US, for example, the
approach to track and trace appears to favour a 'chain of provenance,' whereby drugs can be traced from manufacturer to distributor
to retailer and patient. In Europe, under the new FMD, unique and random product coding will enable a drug to be authenticated
by the manufacturer.
The severity of the counterfeiting trade means that industry and regulatory bodies are investing constantly to introduce new
ways to address counterfeiting. I'm sure that sometime in the future, there will be a more universal approach. However, in
the meantime, with the introduction of the EU's Falsified Medicines Directive, which will need to be addressed by 2013, we
are already seeing the foundations of a future unified approach across Europe.
There is also one final question to consider. Has the decision by some pharmaceutical companies to take their production overseas
helped to fuel the opportunity for counterfeiting? In my opinion, by retaining manufacturing in the UK, for example, and distributing
products internationally, we can retain containment and traceability. If manufacturing is moved to China or other low-cost
producing countries, it may open up other channels and access to techniques that allow counterfeiting to be used with little
trace. Is it time to re-consider where manufacturing should be conducted? After all, a company's reputation and brand protection
could be at stake.
Steve Kemp is business development director at Brecon Pharmaceuticals.
