Serialisation concepts: Why a global strategy should be the ultimate goal

During his keynote presentation to be made at NEXUS '17, Jean-Marc Bobée, former director, industrial anti-counterfeiting strategy at Sanofi, will outline global and local traceability concepts and their individual ‘security to cost’ ratios, highlighting the need for a standardised global serialisation.

Unsecured global supply chains and rising internet sales have led to a proliferation of counterfeit drugs. In an era of growing supply chain complexity and globalisation, pharmaceutical companies and governments are increasingly recognising that serialisation can help reduce fraudulent medicines from entering the market.

A global concept for serialisation

Most traceability concepts are based on the use of a serialised data matrix code at the medicine pack level, combined with a database that is accessible by all relevant parties in the supply chain to verify product information. Automated systems at the point-of-dispense can confirm the identity of a medicine, while also detecting expired products and instigating batch recalls. Legislation based on the global concept follows two scenarios – the “serialisation-only” concept and the “serialisation and aggregation” concept. Let’s explore these further.

The “serialisation only” concept

Serialisation only is the approach outlined in the EU Falsified Medicines Directive (FMD). Data matrix barcodes that contain the medicine unique identifier (product code and serial number) as well as batch number and expiry date need to be included on every medicine pack. All barcode information must be transferred into a database repository and verified when dispensed by a pharmacy.

The serialisation only concept is recognised for its simplicity. It requires no aggregation between logistic units and involves no systematic control at the manufacturer distribution centre or at the wholesaler level, which significantly reduces costs. It does, however, demand that pharmacists invest in verification technology.

In weighing up the pros and cons, the serialisation only approach demonstrates a very high ‘security to cost’ ratio. Codes are verified before products are handed to patients, without the need for multiple verification steps throughout the supply chain.

The “serialisation and aggregation” concept

This approach requires more data to be recorded at more points along the supply chain. Adopted by many countries such as Turkey and Argentina, it requires serialising and tracking using 2D technology (data matrix) for all individual medicine packs, cases and pallets. Unlike the serialisation only concept, it requires systematic control by wholesalers and distributors.

As all parties in the supply chain must report data, the approach requires a more sophisticated approach to data exchange. The extra requirements placed on packaging lines and distribution centres to manage serialisation and aggregation of all logistic units also have the potential to increase complexity and reduce productivity. The main advantage of this concept is that it enables a high level of product visibility which makes it possible to track a product at any point in the supply chain based on distribution history data, therefore adding multiple layers of security. That being said, higher costs and greater complexity mean that it represents a lower ‘security to cost’ ratio compared to the serialisation only concept.

Mobile Authentication System (MAS): A local concept

Local supply chains are subject to specific challenges, which have created the need for localised regulations in some regions.

In Africa, for example, counterfeit medicines are a major problem, fuelled by unsecure supply chain infrastructures, limited dispensing points and tight budgets. The MAS used in Nigeria and Ghana enables patients to verify the identity of their medicines using their mobile phones. A code is assigned to each individual pack that is revealed by scratching off a coating on the label of the packaging. The code can be sent to a free SMS number to verify the identity of the medication.

The MAS is most suited to a non-mature supply chain where the illegal selling of drugs is high, giving patients a tool to verify the safety of their own medicines. The approach is based on serialisation only without any traceability information data, so packs are unable to be tracked in the supply chain.

Despite the benefit of saving a life when the serial number does not exist in the database, the approach demonstrates challenges in motivating patients to use the system. To date, only 5 to 10% of the population have taken advantage of the service. Therefore, the answer provided by the MAS server to the patient is not 100% secure as the controlled product can still be the first pack of a series of fakes.

The service is funded by the participating pharmaceutical companies which are required to make a significant investment in producing and applying labels, associated activation (link for each pack between product batch and pin code and serial number of each label) and the transmission of serial numbers to the central database.

Therefore, considering the high cost for the manufacturers and the low level of patient control and security, the MAS system offers a low ‘security to cost’ ratio when compared to the other concepts previously described.

Final thought

The next step for the industry is to work to harmonise its different approaches to serialisation. The industry must continue its work with government authorities to deploy the global traceability concept worldwide, in association — when possible — with systematic control at the point of dispense. This includes, of course, the challenge of moving the MAS concept towards an efficient and affordable solution based on the serialised data matrix.

Another challenge will be to secure the distribution of pharmaceutical products sold over the internet, by developing an efficient solution based on the global traceability concept.

This has the potential to not only bring substantial patient safety benefits, but could considerably reduce total healthcare costs.

Jean-Marc Bobée will be leading a speaking session on global and local traceability concepts at NEXUS 2017. The event takes place in Barcelona, 7–8 June.

More information from this event will be highlighted in EPM's upcoming June issue.