A pilot study looking at a national system for mass serialisation of medicine packs using 2D matrix coding is due to get underway next year in Germany.
The study is the brainchild of the European Federation of Pharmaceutical Industry Associations, which presented the plan at its annual conference last week. The study forms the centrepiece of EFPIA's work in the fight against medicine counterfeiting, which is in turn a key part of its ongoing AIMS strategy (Access, Innovation, Mobilisation and Security).
The rationale is that each medicine pack distributed in the pilot will have a unique identifying code, allowing pharmacists and other healthcare professionals to check if a product is genuine using a simple optical reader. All elements of the supply chain from manufacturer to patient would be included - including wholesalers, distributors and pharmacies, to provide a robut system of traceability. It's hoped that this coding system could eventually roll out across Europe, providing a universal standard that would avoid the problems associated with the plethora of localised coding approaches - at least 10 at present - that are being implemented in some countries.
EFPIA's activities in the area of counterfeiting are being led by Jean-Francois Dehecq, chairman of Sanofi-Aventis, and focus on the related topics of counterfeiting and product traceability in the supply chain. AstraZeneca CEO David Brennan is also playing a role as an official EFPIA 'champion' for the project. "Counterfeits are now starting to appear in the legitimate supply chain, in pharmacies as well as distributors and wholesalers," said Dehecq, estimating that bootleg copies impact sales of Sanofi-Aventis' own products in Europe by around 2 to 3 per cent, a level similar to other European drug manufacturers.
While supplies via the Internet still account for vast majority of counterfeit cases (80 - 90 per cent, data from the UK Medicine and Healthcare products Regulatory Agency (MHRA) have uncovered a steady increase in incidents affecting the regular distribution chain, with counterfeit medicines reaching patients on nine occasions since 2004 and discovered at the wholesale level on a further five occasions. Aside form the risk to human health - which is becoming more acute now that the counterfeiters are increasingly copying life-saving drugs as well as lifestyle medications for erectile dysfunction and overweight - each counterfeiting case imposes a "colossal" cost on the pharmaceutical manufacturer, said Dehecq.
"Of course manufacturers need to recall all affected batches if counterfeit product is discovered, and that in itself carries a high cost in addition to revenues lost from counterfeiting," said Dehecq. The huge scale of Internet traffic of counterfeit medicines also indicates that there is a huge task to be undertaken in educating the public about counterfeits, said Dehecq.
While an encouraging step, there are still a lot of questions to be answered about the role of this type of serialisation effort in safeguarding the pharmaceutical supply chain. For example, at the moment it's not clear who will manage and have ownership of the serialisation data should the principle be applied on an international scale. Parallel efforts in other countries such as the US also need to be considered to avoid adoption of incompatible technologies or approaches. And of course the cost of implementing it may be a barrier to some healthcare systems.
For these and other reasons "the pharmaceutical industry now needs to take a leading role," according to Dehecq, both in funding the development work and implementation of anti-counterfeiting technologies, and in coordinating efforts helping to bring all stakeholders on board. Aside from this technology-based solution, Dehecq and other EFPIA representatives at the conference repeatedly called for a ban on drug repackaging in Europe as the primary strategy for reducing the threat of counterfeits entering the legitimate supply chain.
The issue of repackaging will be discussed in more detail in an article to be published later this week.