Serialisation and seals
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For the research-based industry, the rising tide of counterfeits calls for a "combination of robust measures" to protect patients, suggested John Ricketts, associate director, government affairs for Lilly Europe. This should start with a compulsory minimum standard of "serialisation and seals". Medicines seen as particularly at risk will need to layer on additional security features.
The EFPIA preference for a 2D data-matrix barcode, backed up by end-to-end authentication, provides not only a secure and unique identifier for every pack but also the possibility of quicker batch recalls and ancillary benefits in minimising dispensing errors or reimbursement fraud, Ricketts said. There also needs to be a mandatory level of tamper-evident security to protect the contents of the pack.
The "simplest" way to preserve a safety feature is to ban repackaging, Ricketts added. Failing that, equivalent safety features should be applied whenever the originals are removed or covered up by repackagers, while all manufacturing authorisation holders (which would include parallel importers) should have a common duty of care that spreads liability throughout the supply chain.
Carradinha insisted, though, that technical solutions should be considered only as a secondary line of defence, and then according to risk assessment based on past incidence of counterfeiting and product price.
That risk profile could feasibly change as more premium-priced generics, such as biosimilars, feed into the European market. Moreover, a number of top-selling pharmaceutical brands - some of which (e.g., Zyprexa, Seretide, Lipitor) have already fallen prey to counterfeits - will be coming off patent over the next two to four years. Arguably the sheer size of these franchises, even at discounted generic prices, will continue to prove an attractive target for the counterfeit trade.
Clearly the potential costs of mass serialisation and other safety features are an unsettling prospect for a relatively low-margin sector such as generics. That also applies to contract manufacturers like Ursapharm.
Meeting the technical requirements of mass serialisation would require at least two cameras and readers for each packaging line, Glasow said. Manufacturers would also need to install software capable of handling the serialisation codes and quality control.
That amounts to minimum costs of €120,000 per packaging line. For a medium-sized company such as Ursapharm who operates 15 packaging lines, Glasow noted, this would mean investing at least €1.8 million to comply with the technical requirements for mass serialisation.
That is not to mention the logistical difficulties of applying a 2D barcode with minimum dimensions of 43mm x 18mm to smaller packs with insufficient flap space. Putting the safety feature on the front or the side of the pack would make it difficult to satisfy the seven-point type requirement in the EU's readability guideline for drug labelling and packaging, Glasow said.