EDQM traceability pilot moves towards live demo phase

The European Directorate on the Quality of Medicines is on course to start a lab-scale pilot of its medicine traceability system shortly which should be ready for demonstration to stakeholders in the latter half of 2011, according to project leader Francois-Xavier Lery.

Lery told the IQPC Pharma Serialisation and Traceability conference last month that the technical partners for the project have been largely identified and the 'live demo' phase of the project should be completed in the second quarter of 2011.

EDQM's system will rely on the application of a UMI (unique medicine identifier) in a 2D datamatrix code that is added onto a medicine's secondary packaging. The unique item-level code will be used to trace and verify the pack through the supply chain and finally to verify again at the point of dispensing by the pharmacist - and also potentially by the patients themselves - to ensure that only genuine, safe product is taken. The codes used will be based on standards developed by GS1.

"We are in the process of inviting pharmaceutical manufacturers to participate in the pilot by providing sample packs and possibly interfacing the system with their own IT systems," Lery told delegates, adding that discussions are also ongoing to identify pharmacy partners to trial the point-of-dispensing verification.

The application itself is now under development and, once the live demo is ready, EDQM plans to run a series of stakeholder workshops in the second half of next year to gain feedback on the system. Thereafter, phase 3 of the project will get underway with the development of a full-scale implementation.

EDQM itself is proposing to serve as the gatekeeper to the vast quantity of data generated by the traceability system by operating a centralised directory which could carry the UMI information - assuming manufacturers were happy to share this information.

Alternatively, EDQM could direct transaction queries between independent databases or repositories, allowing a separation of the data which could potentially solve some of the issues surrounding data ownership.

The system stops short of being a full pedigree approach, because while any actor in the supply chain can query the centralised directory, there is no transfer of information between them. GS1 has developed a number of traceability models, of which the Information Sharing Model 3 (see image below) is closest to the EDQM proposal.

That effectively means the EDQM is developing a pilot that is broader in scope than other systems in use or trialled in Europe, for example by including intermediaries in the distribution network such as wholesalers and customs but also legitimate Internet and mail-order pharmacies.

It remains unclear what will come out of the European Parliament's deliberations on the proposed falsified medicines directive, which contains a mention of traceability requirements for at least some yet-to-be-determined products and is due to be debated shortly.

Rather than second guess the EU's verdict, the EDQM is asking for the involvement of a range of licensed manufacturers - including prescription and over-the-counter drugmakers as well as branded and generic medicine producers - as well as registered wholesalers and pharmacies.

Cost considerations

Meanwhile, there are a number of other uncertainties to consider whilst drawing up the scheme, not least of which is cost, according to Lery.

"Cost is likely to be a major constraint, as the scale of the project is huge" Lery told the meeting, pointing out that around 20 billion medicine packs are shipped every year in the EU alone, while for all Council of Europe members states the number is closer to 30 billion.

According to an impact assessment undertaken on behalf of the European Commission, there are around 15,000 pharmaceutical packaging lines in the EU which would have to be upgraded with the marking and vision systems required to add and verify 2D datamatrix codes to packs at an estimated cost of €11.5bn.

That said, many of the larger drugmakers have already started to upgrade their systems in order to meet the requirements of the French CIP batch-level traceability system and Turkey's ITS scheme, so the assessment is already out-of-date.

"Having a harmonised, coordinated and phased approach to serialisation at a European level may allow balancing out of the cost via economies of scale," said Lery. 

Meanwhile, the traceability features may provide manufacturers with some return on investment from greater standardisation of coding across Europe, and improved control and visibility over the supply chain, although much of the benefit is for the public health and as a result fairly intangible.

"We are talking about preventing something from happening, because fortunately the occurrence of counterfeits in the European supply chain has so far been fairly rare," he noted.

"The aim is to propose a harmonised, pan-European solution and avoid a situation in which manufacturers have to deal with multiple different national standards, but clearly we will have to identify which parties will share the funding for the scheme before progressing to a full-scale implementation," concluded Lery.


Related articles:

EDQM launches track-and-trace pilot for medicines