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Mark Davison is CEO at Blue Sphere Health Ltd and the author of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs and Pharmaceutical Serialisation: Opportunity or Perfect Storm.www.bluespherehealth.com
The effects of counterfeiting are hard to measure, both in human impact and financial loss.
The full version of this counterfeiting feature can be read in the July issue of our digital magazine: http://www.pharmtech.com/ptedigital0710
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.
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.
Various false starts with different kinds of anti-counterfeiting technologies have led many companies to take a wait-and-see approach. Companies have invested to comply with national drug tracking regulations, such as those in France and Turkey, and have protected key products with targeted authentication initiatives, but many have not implemented serialisation across their entire product range. Most companies are now gearing up to do this, but will need to devote regular Board-level attention to anti-counterfeiting to develop and maintain momentum. Some companies have a person of real power with profit and loss responsibility in direct charge of product protection, but in most companies committed mid-level managers struggle to be heard above corporate background noise.
A core, global, interoperable framework with optional additional layers of local flexibility is key to an anti-counterfeiting solution's success. Ubiquitous technologies tend to be quite long-lived, so once 2D codes become the standard data carrier, we will be using them for a while. The open standards on which serialisation is built will also allow integration of other complementary technologies such as RFID, which has yet to realise its potential, but offers many advantages, such as the ability to read multiple unit codes quickly and without unpacking shipping cartons. Many other technologies, such as on-dose technologies, are also being developed, and the worldwide rise of social networking and mobile telephony also holds interesting potential for the combination of authentication with marketing and customer interaction.
In the future, non-digital authentication will become ever more important; codes can be copied and RFID chips cloned, so we still need methods that can obtain a definitive authentic/fake answer to the question "Is this product real?"
Overt versus covert
Despite the development of covert security technologies, overt solutions are still very important. Overt solutions are easy to locate and check, require no additional verification devices and also involve the consumer in the authentication process. They can also offer a high level of security in terms of how difficult they are to copy. Covert solutions, however, also offer a number of advantages, particularly during product recall situations. As such, it is beneficial to use both solutions when protecting supply chains.
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Richard Burhouse of Payne Security
NIR chemical imaging
Some counterfeit products can be extremely difficult to distinguish from the genuine article with the naked eye. However, near-infrared chemical imaging (NIRCI) can measure the presence of known ingredients to provide assurance that the patient will at least receive the right drug in the right amount. There is a reasonable use of NIRCI for counterfeit analysis in the pharma industry, but the full potential of the technology has not yet been exploited.
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Janie Dubois of Malvern Instruments
Serialisation is here to stay
Although there is a growing trend to introduce serialisation, many companies still do not have serialisation capabilities because they are waiting for legislation to be finalised. Serialisation requirements and methods vary worldwide and it will be difficult to introduce a single global standard. Despite this, serialisation will become very prominent in the industry because it offers numerous benefits — key of which is full traceability.
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Frank Borrmann of Mettler Toledo
Mark Davison is Managing Partner at Pharma Pieces.