EDQM showcases eTACT traceability system

The European Directorate for the Quality of Medicines (EDQM) has confirmed its intention to continue the development of its eTACT drug traceability system.

The organization recently held a two day workshop in Strasbourg to highlight the latest technical developments in the project, which is being conducted with support from IBM. The large and diverse international audience of industry, regulators, trade associations and other interested parties was given a detailed demonstration of potential system capabilities using a mock-up of transaction flow along a typical supply chain. 

In her introduction, EDQM Director Dr. Susanne Keitel confirmed that EDQM will be using the feedback from the meeting to decide how to proceed beyond the working model stage. eTACT project leader Dr. Francois-Xavier Lery later noted that at the moment EDQM does not have funding in place to finance a pan-European system.

EDQM is a subsidiary of the Council of Europe which at 47 member states has a wider membership than the EU.

The eTACT system is based on globally-compatible GS1 EPCIS standards and uses software and hardware components which will be familiar to anyone working in serialization and supply chain security. The demonstration encompassed potential transaction scenarios involving manufacturers, distributors, hospitals, community pharmacists and regulators.

The EDQM model also explicitly addresses the issues of how to integrate legal Internet pharmacies into a workable framework and how to allow patients to conduct their own verification, unlike other proposals.

There are also some interesting ideas around putting a confidence rating on traceability data.  This might take involve the cumulative pedigree for any given pack gaining a higher 'confidence level' as it passes through more transaction points - perhaps in turn weighted for reliability. Thus, a short path (e.g. direct from manufacturer to pharmacy) might be given a high rating, as might a longer path through regular and well-established supply chain nodes. 

Anything which has ventured 'off-piste' might attract a lower rating. There are potential complications with this approach, but this and several other ideas raised at the workshop merit further discussion.

Although naturally not yet the finished article, the technical achievement of the project given the relatively limited manpower resources available is commendable.

The bigger challenge may be to align the project with other initiatives to avoid any duplication of effort and to promote one harmonised approach to the problem of falsified medicines in Europe. 

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One of the key areas where the EDQM approach differs most markedly from other proposed systems is governance. The model developed and favoured by EDQM sees the ownership and control of the system infrastructure, and the data itself, remaining in public hands.

This contrasts with the framework proposed by a consensus of manufacturers (EFPIA), pharmacists (PGEU), wholesalers (GIRP) and now even repackagers (EAEPC), which favours a not-for-profit, stakeholder-governed approach. The stakeholder-led group argues that it alone has the supply chain knowledge to implement a large-scale system efficiently and at acceptable cost.

As well as a demonstration of eTACT, the symposium also gave an opportunity to share broader views on the next steps for serialization and traceability in Europe. An unusually wide spread of delegates and presenters may for a lively debate.

Christoph Krahenbuhl of AstraZeneca, representing EFPIA, said that a risk-based approach to security ('black listing' and 'white listing' as described in the Directive) may prove difficult. He noted that AstraZeneca sees counterfeits in all product types and therapeutic areas and has seen a rise in detected cases from 171 in 2010 to 358 in 2011 (although some of this may be due to specific vigilance initiatives).

The key issue of cost was discussed at length. Although there are few precedents that can be used for accurate range-finding, the estimates given ranged from 0.5 to 3 Euro cents per pack if system costs are amortized evenly. 

Delegates from Turkey shared their accumulated data from the ITS drug tracking system that has been in place for some time and has accumulated over 50 billion transactions. In their opinion the costs can be kept below one cent per pack.

Groups representing mid-sized companies (EUCOPE) and generics producers (EGA) argued that any costs must be spread not by production volumes but according to risk profile and profit margins. Since generics account for a very low percentage of counterfeits seized, and have narrow profit margins (making counterfeiting less attractive) these groups argued that they should pay less per pack than manufacturers of branded products.

The contributions from regulators were also informative. The delegate from AFSSAPS, the French regulator, restated a position heard several times recently that the CIP13 batch-level traceability system constitutes a pre-existing traceability system as defined by the Directive.  Under the terms of the Directive, this would allow France a further six years beyond the date when other countries will have to comply and could push the adoption date in France out to 2023.

The Directive stipulates that countries eligible for the temporary opt-out must already have a pack-level traceability system. The French position is therefore controversial and received a very mixed reception in the room. It may or may not be upheld by the EU when the final Delegated Act is published, but the exclusion of such a major pharmaceutical market could weaken the credibility of a Europe-wide system.

Italy has a stronger case for a delay, having had a functioning pack-level traceability infrastructure in the shape of the bollini system for a number of years. However, the Italian approach to the six-year breathing space is to use the only as much extra time as is necessary to ensure a smooth transition to the EU system when they are ready. They have already started to print 2D bar codes on bollini as a starting point in this direction.

There was much more consensus than disagreement at the meeting but the clear divide between proponents of public sector projects like eTACT and the private sector’s stakeholder governance philosophy means that this issue will not go away. Dialogue between the various parties is ongoing and mostly good-natured but the future direction of the debate will be interesting and the outcome far-reaching.

One delegate predicted “an intense eighteen months of lobbying in Brussels” ahead of the publication by the EU of the Delegated Act. This will finally describe the details of how the Falsified Medicines Directive will deal with traceability, as well as who pays what and who owns what. 

The meeting was reminded by representatives from patient associations that patient safety must be the first priority whatever the outcome.

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Mark Davison is the founder and CEO of Blue Sphere Health and is helping clients from healthcare, food, drink and other industries to solve global problems in brand defence and consumer protection. He is a well-known independent voice in the field and his book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” is published by Wiley.