Menu

EDQM launches track-and-trace pilot for medicines

EDQMThe European Directorate for the Quality of Medicines (EDQM) is starting a track-and-trace pilot study for pharmaceuticals that aims to go a little further than other systems that have been set up or piloted in Europe.

From this month the EDQM is seeking tenders from vendor companies wishing to participate in the project, which will cover patented pharmaceutical products, generics, veterinary medicines and also over-the-counter products. The call for tender can be reviewed here.

The intention is to develop a serialisation scheme that will provide not only point-of-dispensing verification of medicine packages - as championed by the pilot in Sweden carried out by the EFPIA industry group and schemes already operating in Belgium, Italy and Greece from Aegate - but also optional verification steps within the distribution chain.

Brand owners, contract manufacturers, repackagers, third-party logistics providers, pharmacies and government authorities such as customs would all be included in the scheme, which also has the ambitious objectives of including legal mail-order and Internet pharmacies into its scope and placing the ability to verify packs into the hands of patients.

Presenting the project at the IQPC Global Pharmaceutical Authentication conference in Munich, Germany, last month, EDQM's Hans-Joachim Bigalke explained that the project rests on the concept of serialising each pack with a Unique Medicine Identifier (UMI) that would be printed in a 2D datamatrix code, and potentially also in human-readable form.

The code would conform to the GTIN standard from GS1, but it should also be feasible to use a modified national code if that is already in place.

While the project is still in its early stages, it is anticipated that scanning of the barcode would be carried out at various points in the supply chain, both to verify the product and trace its progress, with the EDQM operating a centralised database to handle the queries.

Manufacturers could either upload their UMIs to the EDQM or operate their own, interlinked repository. In the latter case UMI queries from pharmacies, customs or patients would be routed via the EDQM database, according to Bigalke.

"The patients should be included in the process," he said. "Otherwise it will not be effective in protecting them against potentially counterfeit products purchased in the illegal supply chain."

Data ownership has been a thorny issue for many of the serialisation systems operating around the world, in part because of the transparency it lends to company operations. But Bigalke believes EDQM has demonstrated its ability to act as a guardian of this commercially-sensitive information via its certification of suitability system for pharmaceutical substances.

"EDQM's work on certification over the last 15 years proves that we can hold highly-sensitive data in a secure way," he told the meeting, adding that there are some advantages to placing its governance into the hands of an intergovernmental organisation.

The concept development stage of the project came to a conclusion in March 2010, and the aim is to develop a live demonstration of the system between now and the second quarter of 2011. The third phase - developing it into a fully functional service - would take place from the third quarter of 2011 if there is support for EDQM's proposal.

Looking to the future, Bigalke said that while the initial project will develop serialisation at the secondary packaging, bundle, case and pallet levels, it might be desirable in future to extend verification to the primary packaging, such as blisters, or even the dosage form.

Points of contention

Some delegates at the IQPC conference reacted strongly to the proposal, questioning whether there is value in EDQM running a broader pilot on serialisation and duplicating work already carried out by other stakeholders.

It was also pointed out that point-of-dispensing approaches fulfil the key requirement of protecting patient safety without the extra cost of a full traceability system, and that the latter requires buy-in by multiple stakeholders which raises the complexity of deciding who will shoulder the cost burden.

Bigalke reiterated that this full traceability is considered optional at the moment, but pointed out that - once a traceability system is deployed at the pan-European level - the economy of scale will help balance costs. There will also be some additional return on investment for manufacturers and other stakeholders in terms of operational streamlining, he added, and a single pan-European coding system should make it easier and cheaper for manufacturers to print the codes.

"We need to approach this from a pan-European perspective, not country-by-country," he asserted.

Moreover, "counterfeiting incidents in the legitimate supply chain have always involved weak points in between manufacturers and pharmacies, not these two secure end-to-end points," added Bigalke.

There are some recently-announced national initiatives that go beyond point-of-dispensing identification and lend support to EDQM's decision to explore a traceability solution.

For example, the pilot programme announced in Germany earlier this year by the ABDA pharmacists' body - also supported by Aegate - includes optional verification of medicines by wholesalers. And amendments to Spain's national law at the end of 2009 suggest that laboratories, wholesalers and pharmacies will have to record products coming in and leaving their establishments.

Meanwhile EDQM's approach may also get some support from the EU pharmaceutical package currently working its way through the European Parliamentary and Council co-decision procedure.

At present, the proposed amendments to the draft directive on falsified medicines suggest cover the identification, authentication and traceability of products, and state that pharmacists and wholesale distributors should be able to identify individual packs of medicine if they so choose.

The falsified medicines directive is scheduled to come in front of the European Parliament in October.


Related articles:

Parliamentary plenary on falsified meds set back to October

EFPIA publishes serialisation pilot report

UK pilot shows serialisation and authentication in harmony

EMA 'road map' outlines supply chain security plans

Parliamentary report broadens, accelerates counterfeiting directive

Interim EU measures needed to stem counterfeits





Click here to subscribe to our weekly newsletter

© SecuringIndustry.com


Home  |  About us  |  Contact us  |  Advertise  |  Links  |  Partners  |  Privacy Policy  |   |  RSS feed   |  back to top
© SecuringIndustry.com