The Club Inter Pharmaceutique (CIP) proposes a new VIP Code as a national product code for medicines in France that are subject to verification using the European Medicines Verification System (EMVS). Today, CIP issues national product numbers and collaborates with GS1 France to embed these into globally unique NTINs (National Trade Item Numbers) that adhere to GS1 standards. CIP proposes that, in future, pharmaceutical manufactures should move away from GS1 standards and, instead, use an internationally recognised ANSI standard when printing the new VIP codes in barcodes for medicine packs destined for the French market.
I have two broad reservations. The first concerns adoption of the ANSI standard, both in comparison to the GS1 standard and in terms of the impact this would have in a market that uses GS1 standards today. The second has to do with the current modalities of the CIP proposal which must be modified before France could adopt the VIP code successfully and legally.
I consider it unwise for France to move away from GS1 standards for medicine verification. Every other EMVS country has adopted GS1 standards, including Germany which, alone in Europe, allows manufacturers to optionally use the ANSI standard. This is for historic reasons. When Germany joined the EMVS, it amended its rules, allowing manufacturers to adopt the GS1 standard. CIP proposes that France moves in the opposite direction, transitioning away from the GS1 standard altogether. This would make France an outlier, both within the European and global pharmaceutical supply chains where GS1 standards dominate the unique identification of medicinal products.
The proposed approach will force France to adapt and maintain pharmacy and wholesale systems that support both types of barcodes. It will have to maintain this dual approach for an indefinite period because older GS1-encoded packs may remain in the supply chain until they expire and GS1-encoded multi-market packs will continue to enter the French market. These packs must be verifiable using the EMVS.
Changes to pharmacy software and automated wholesale and hospital processes will be costly and disruptive. Users may need to select different modes to verify the two barcode types, causing confusion and delay. Manufacturers will need to change their printing and barcode testing processes and equipment to provide and validate the new barcodes – again incurring additional costs. Packs bearing the VIP code may appear in other European markets (e.g., multi-market packs), causing additional disruptions and costs in those countries – something that could be interpreted as a barrier to free trade in the EU.
CIP suggests that the transition period can be extended to accommodate this change. However, this is unrealistic. Manufacturers, pharmacists, hospitals and wholesalers must complete all necessary changes before any new VIP-encoded packs enter the European market. As soon as a manufacturer commissions and places VIP-encoded packs into the supply chain, pharmacists and wholesalers must be able to verify these new packs. France and other affected countries must therefore introduce all necessary changes by a given date. Only then can France allow manufacturers to print the new barcode type. Otherwise, pharmacists and wholesalers will be unable to meet their legal obligations.
France may experience other disadvantages over time beyond additional costs and disruptions. Although the CIP proposals can be supported across the EMVS during interchange with other national systems, any future extension of the European system – e.g., detection of medicine shortages, introduction of deeper track & trace capabilities or support for patient information leaflets – will require specific adaptation to support France. This could make it difficult or even impossible for France to interact with or benefit from future enhancements and evolution.
The European supply chain is part of the global pharmaceutical supply chain which is increasingly adopting GS1 standards. GS1 standards provide a better, more democratised, integrated and flexible approach than the ANSI standard for unique identification and verification of medicinal products. GS1 minimises ambiguity, promotes best practices, ensures rigorous global uniqueness, supports complex issues such as merger, acquisition and divestiture, and provides an integrated approach with better support for global traceability.
Another issue close to my heart is the impact that the CIP proposal may have on Francophone low- and middle-income countries that source a large volume of essential medicines from France. These countries are moving steadily towards the adoption of stronger protections against substandard and falsified medicines. The fragmentation of global unique identification standards will adversely impact their plans, making it harder for national governments to protect the people most at risk from falsified medicinal products.
The modalities of the CIP proposal imply practical and technical disadvantages which should be considered carefully. In its current form, it also undermines some essential requirements of the EMVS to the point of non-conformance with EU law.
The GS1 standard minimises the size of barcodes to a greater extent than the ANSI standard. This, combined with CIP’s proposal to use five, rather than four, data elements, means that VIP-encoded barcodes will be larger than equivalent GS1-encoded barcodes. Size is an important consideration for manufacturers who must print their barcodes in a suitable location on each pack, even where the packaging is very small or non-rectangular. This issue is further compounded if France implements best practice by requiring an additional emblem printed next to the barcode to indicate that it contains a VIP code, rather than a GS1 product code. The emblem allows users or automated machinery to determine the correct mode when scanning different barcode types. An existing example is the ‘PPN’ emblem printed on German non GS1-encoded packs.
The more acute problem, however, concerns the detailed application of the ANSI standard itself. Medicine pack identifiers should be globally unique. European regulations require the adoption of internationally-recognised standards to ensure that this is the case. CIP proposes an approach involving an additional (fifth) element that specifies that the barcode contains a VIP Code. However, the current proposal violates the semantics of the ANSI standard. CIP proposes to use the additional element in a way that does not conform to its stated purpose (its ‘semantics’). This introduces confusion and ambiguity and undermines any guarantee of global uniqueness. More importantly, any manufacturer that applies the current CIP proposal will directly contravene Article 5 (4) of the EU Delegated Regulation governing the EMVS.
If France decides to adopt the CIP proposal, this issue can be addressed easily by applying the ANSI standard correctly. There are a couple of options, but my advice would be to adopt the same approach used in Germany and request that a CIP-specific semantic identifier is added to the ANSI standard. In addition to being legal, this will also reduce the size of VIP barcodes.
The documented CIP proposal currently lacks a complete and unambiguous description of the full requirements. It needs to mandate the appropriate technical barcode encoding (termed ‘Format 06’) to avoid any confusion. It needs to represent expiry dates consistently throughout the document (currently, it states one approach but provides illustrations using a different approach) and it should define the use of an appropriate emblem to conform to best practice. Another issue is that the proposal currently limits the entire barcode entry to 50 characters. This is an unnecessary limitation that may cause issues for manufacturers.
In my view, France is best advised to adopt GS1 standards. I believe there would be benefit in adopting GTINs, but at the very least, France could consider retaining NTINs. I do not believe that the adoption of the ANSI standard is in the best interests of France or the EU. If France does decide to adopt the ANSI standard, care should be taken to ensure full compliance with EU law and to provide a clear and comprehensive technical description of the approach.
While the opinions in this blog article are my own, I have, with Solidsoft Reply’s agreement, written a whitepaper that describes the issues discussed in this article in greater detail. Solidsoft Reply is well placed to offer an informed response on technical aspects of the CIP guidelines, and to provide an assessment of the impact on the EMVS and other medicine verification systems used beyond Europe. This matter is of concern to our customers globally.
There are two downloadable editions of the whitepaper. In addition to English, we’ve translated the document into French which I hope will help some readers. We have also sent abridged versions of these documents as direct feedback to CIP.
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