Counterfeiting: EU moves toward mass serialisation

I have recently been engaged in a project exploring the benefits of mass serialisation technology with regards to improving communication between pharmacists and pharmaceutical companies. Here, I outline the potential upside to industry in terms of tackling counterfeit trade. Published on SCRIP in August 2008.

Market Insight – 22 August 2008

Some have likened anti-counterfeiting techniques to the pre-flight checks that pilots routinely perform before taking off. Nobody would ever imagine trusting an airline whose pilots do not comply with this rule. Yet this is analogous to the situation in the pharmaceutical supply chain when the tools currently available to rule out the health and legal risks posed by counterfeit medicines are not used.

a growing trend

There has been a huge upsurge in the number of counterfeit medicines in circulation in recent years, as reflected by the intensifying rate at which fake and substandard products are finding their way into the hands of European patients. Estimates of the market share of counterfeits range from 1% in the West all the way up to 10% in developing countries, and total sales could surpass $75 billion by 2010, according to the WHO. 

The internet is proving to be a particular problem in this regard. In a recent report, the European Alliance for Access to Safe Medicines (EAASM) discovered that more than 62% of its online medicines purchases were fake or substandard. Aside from the internet, the most worrying route of entry is infiltration of the legitimate European distribution system, although counterfeit medicines can reach patients in many other ways.

the potential of mass serialisation

On a recent project, we had the opportunity to learn more about mass serialisation, a method by which a unique number is assigned to each saleable unit of a product, be it a pallet, a case or an individual pack of drugs. This technology can provide the authentication processes needed to validate drugs at critical points in the supply chain, enabling assurance of product quality before dispensing and the opportunity to identify sources where counterfeits may leak in.

Mass serialisation is already used in many other industry sectors, such as food and beverages, timber and alcohol. Yet, just a handful of European countries have fully implemented mass serialisation programmes for medicines, others are still at various stages of the planning process, while Germany, Spain and the UK have yet to take any action. Slow uptake could partly be attributed to debate over the merits of different technologies and concerns over the need for standardised approaches. However, the availability in Belgium, Greece and now Italy of an authentication process that can read and interpret different coding systems indicate that it may be time for this debate to move on.

Anti-counterfeiting schemes currently in use across the world include:

– Simple linear bar coding. In Greece and Italy, products are labelled with two bar codes. The former employs an “EOF Code” (a mass serialised linear bar code plus a second product bar code). In Belgium, meanwhile, a single unique linear bar code is used. These coding structures, although different, have the potential to ultimately provide complete security across the supply and distribution chain, especially if each item is also fitted with tamper-evident technology. Validation of these serialised codes is crucial for there to be any benefit in adding such security features.

– A multi-layered approach. Overt (eg, water marks) and covert labelling and hologram systems have recently been complemented by the use of uniquely-numbered individual sales packs. These programmes, which extend beyond the standard bar code systems, are perhaps the most effective solution to securing the pharmaceutical supply chain.

– Government support. The Nigerian government has initiated a programme due to come into effect this year. Modelled on a similar Malaysian system, the Nigerian scheme will require manufacturers to apply a hologram to packs to help with authentication. This level of governmental support and indeed that of the examples of Belgium, Greece and Italy (where the requirement to add the serialised code has led to the possibility of authenticating every pack in the pharmacy), suggests that for widespread and rapid adoption of a security approach, national or international support is necessary.

The PDF version is here: article-scrip-22-august-2008

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