eTACT PROJECT: INTERVIEW WITH DR SUSANNE KEITEL, DIRECTOR OF THE EDQM

Background

In June 2011, the European Parliament and the Council of the European Union adopted an amendment to Directive 2001/83/EC, the Falsified Medicines Directive. One of the key requirements is the introduction of so-called safety features. The authenticity of medicinal products has to be ensured in order to protect European citizens against falsified products. This could be done by a serial number which is encoded in a 2D Datamatrix Code printed on the packaging of medicinal products. However, the Directive does not specify a single coding system. Therefore, industry and regulators are reviewing options in order to implement this new requirement.

The EDQM is well known for the development of quality standards for safe medicines, such as the European Pharmacopoeia and its certification procedure (CEP) for pharmaceutical substances. Why does the EDQM wish to develop a traceability service for medicines?

Dr Keitel: The EDQM has launched the eTACT project as part of the Council of Europe's holistic strategy to combat falsified/counterfeit medicines. It complements the Council of Europe Convention on Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health (Medicrime Convention) and other practical measures. The EDQM's core mission is to contribute to the basic human right of access to good quality medicines and healthcare products. This access is endangered by falsified/ counterfeit medical products entering the legal supplychain, which has prompted the Council of Europe and the EDQM to develop this strategy. On the specific topic of traceability, the EDQM has developed the eTACT project because its position as a public inter-governmental organisation, which promotes public governance and patient involvement and empowerment, endows a significant added value on systems having such a deep impact on the functioning of the medicines supply-chain and the protection they provide against illegitimate sources of medicine supply. This is even more important given that patients are still unaware of the risks, despite the awareness campaigns promoted by national competent authorities and international organisations such as the World Health Organization and the EDQM.

• Can you briefly explain how the system will work and how it will impact pharmaceutical manufacturers?

Dr Keitel: The eTACT service is based on the concept of mass serialisation of packs of medicines. A Unique Medicine Identifier (UMI) is generated at the manufacturer's level. The individual packs of medicines are identified using a 2D Datamatrix barcode (ECC 200) printed onto the secondary packaging. A systematic verification is performed upon dispensing by all registered community, hospital, internet and mail-order pharmacies. There is also the possibility for intermediate stakeholders to perform verifications along the supply-chain and to capture traceability events. These verifications or event captures are performed using scanners that read the code and send the pack information to a lookup-service for databases (EDQM, manufacturer or national/regional database) in order to check whether it matches the original information. eTACT has been designed to allow it to include all the stakeholders within the legal supply-chain, including legal internet pharmacies and patients who can verify the authenticity of their medicine (e.g. with mobile phones).

The impact for manufacturers is the need to upgrade their packaging lines to generate serialised pack identification numbers and to interface their IT systems with eTACT , either for sharing data with eTACT (acting as an external, independent system) or for allowing eTACT to check the accuracy of pack data with the manufacturer's repository. Depending on the agreements formed with wholesale distributors, aggregation information could also be generated by manufacturers to make pack verifications possible at distributor levels downstream in the supply-chain.

• Is there a way of participating in the EDQM's pilot project? If yes, what should manufacturers do if they are interested in participating?

Dr Keitel: Up to now, manufacturers have participated by attending the workshops that are being organised on a regular basis by the EDQM to collect comments on the service, its technicalities and other high-level aspects such as governance and costing. A deeper interaction is possible for manufacturers, distributors and pharmacies that are willing to verify the interfacing of their test or production environment with the eTACT system or pro-actively address specificities of business processes to be covered in the future real-scale system. The eTACT project team regularly contacts relevant operators and associations when a need to fine-tune an eTACT functionality is identified. However, business stakeholders are also welcome to contact the EDQM spontaneously by email (eTACT@edqm.eu).

• In Europe, many countries have already established a coding system for other purposes like cost reimbursement. In addition, some industry organisations like EFPIA and SecurPharm have developed their own coding pilot projects. How are they different from the EDQM project?

Dr Keitel:The national systems already developed in Italy and Turkey are publicly governed, like the EDQM project. They are individualised Track-and-Trace systems that systematically cover distribution within their respective countries. eTACT is a flexible, pan-European system that is adaptable to specific national environments.

The national systems already deployed in some pharmacies in Belgium and Greece are based on a Point-of-Dispensing verification model, without any traceability within the supply-chain and governed by the pharmacists themselves.

Apart from the Turkish system, which uses GS1 standards, all the above-mentioned systems use other standards that are currently not inter-operable within a pan-European architecture.

Regarding the other pilot projects mentioned, the EDQM acknowledges the efforts made by various parties in Europe (e.g. EFPIA, Securpharm) to prepare for the implementation of the upcoming EU requirements, taking into account the various regional, national and business constraints. The different models and projects currently being proposed are all progressively converging towards a technical consensus, and these various other projects are increasingly adopting the flexible approach inherent in eTACT in order to allow for traceability within the supplychain. This includes optional verification by stakeholders other than pharmacies or the use of a product identification number that combines a standard product number with the national identification number where it is different. Key questions remain on cost and governance. It should also be noted that eTACT will be open to the 37 member states of the European Pharmacopoeia Commission and beyond, whereas other projects are only being tailored to national or EU levels. A common approach needs to be found by the time the EU requirements become clearer with the publication (not before 2014) of the delegated acts on the implementation of the EU Directive, and before real-scale systems are developed. The EDQM has been organising workshops specifically to offer a platform for collaboration in order to establish the optimal system for Europe. More than two hundred experts from authorities and operators from the medicines supply chain have participated in these workshops and their contributions have allowed the EDQM to fine tune the concept and validate the technical and conceptual approach for the project.

The crucial difference between the other systems/projects and that of the EDQM is that patients will have access to the eTACT service; although, this is also a feature of the Turkish, publicly-governed Track-and-Trace system. This functionality could be used by a patient once they have received their medicine to verify the Unique Medicine Identifier (UMI) on the pack through the eTACT directory. Verification of medicines by patients is an essential aspect of the project because of the need to maintain and strengthen the confidence of patients in the legal supply-chain and to convince them not to purchase medicines from illegal internet sites. Their inclusion in the eTACT service is consistent with the principle of patient empowerment.

• Do you see a risk if no agreement is reached on a European- wide coding system? Could this lead to many different coding systems in the EU member states?

Dr Keitel: First, it should be stated that, at the level of individual countries, parallel systems will not be deployed. Once a consensus has been found on the technicalities of the system(s) to be adopted and their governance and costing models, any such systems will have to be approved by local authorities.

At the higher European level, there are several implementation scenarios. The ideal one is a unique system, whereby a common agreement exists between all countries on a flexible and inter-operable system that is adaptable to each national environment. Another potential scenario is the adoption of harmonised standards, with several inter-operable systems co-existing through the application of these harmonised standards. In any case, this latter scenario will have to be adopted to some extent in order to integrate the already-existing systems into a pan-European architecture. These systems have been pro-actively developed in some countries due to national specificities and other risks and constraints, mainly to limit reimbursement fraud.

• In the US, there is currently also a discussion about the establishment of a coding system. Are there any efforts to harmonise the system with countries outside the EU?

Dr Keitel: It is obvious that, in an ideal world, a global tool would be beneficial in the fight against counterfeiting. However, operating environments are very diverse in aspects such as IT infrastructure, prescription or reimbursement statuses of medicinal products, dispensing schemes, etc. Even agreeing on a unique European approach is proving to be a challenge. However, the EDQM has non- European observer countries that are following the development of the project and are exchanging information on similar tools. For the moment, this is the only reasonable approach for global harmonisation.

• What about the costs? The system proposed by the Industry is a so-called 'end-to-end' solution, while the EDQM system offers a full Track-and-Trace model. Some generic products will also be covered by the new requirements. Wouldn't a full Track-and-Trace system for generic products prove too expensive?

Dr Keitel: eTACT is not a full Track-and-Trace system, but a flexible service that allows deployment of traceability within the supply-chain at the level of wholesale distributors. The proposals from within the Industry are also progressively moving towards this approach.

Regarding costs, it cannot be denied that increased traceability will incur extra costs. The discussions on the technical developments and on the costing model are being run in parallel. Costs remain in the area of approximately €0.01 per pack of medicines, even if all products (including not only generics, which are in the scope of the Falsified Medicine Directive, but also over-the-counter products) are serialised because the costs will remain unchanged, whatever the finally adopted scope. It is the understanding of the EDQM that costs of this range would not endanger the incentives for using generic medicines in Europe, taking into account a reasonable estimate of a 30-40% price difference between an originator product and its generic product¹ and, therefore, the sustainability of the economic model for European healthcare systems.

Possibilities for returns on investment should also be borne in mind, e.g. due to its inter-operability, the anti-counterfeiting system could be used for other purposes such as prevention of reimbursement fraud or greater efficiencies in the medicines supply-chain. This has been analysed in-depth through the recent McKinsey report² where executive leaders in the Healthcare industry have highlighted that on top of securing the legal supply-chain the development of supply chain traceability with common standards enable healthcare cost reductions of €30-75 billion.

Since, ultimately, the decision on which system will be used lies with national authorities, they will be in a better position to have an overview of the costs, their impact on healthcare systems and the balance between immediate financial costs and overall short- and long-term Public Health benefits.

• One of the main topics under discussion when talking about a coding system is the database in which the serial numbers have to be stored and which connects manufacturers and pharmacies. Who will host and maintain the eTACT service database?

Dr Keitel: This question illustrates the need for an independent, third party to administer and store the data so that there is no risk regarding the confidentiality of sensitive data. Separating data into different databases would, in theory, limit the risk of leakage during data storage. However, the core principle of allowing the verification of a medicine package (at the latest, when being dispensed) against the original data will require an interface between separate databases. Thus, the effort and extra cost in building up different databases that are administered separately would be pointless, unless an independent administrator can guarantee the absence of leakage during transactions(s) and storage of data coming from different parties. In the eTACT project, national authorities will govern the database(s) and could delegate its/their administration to a trusted third party like the EDQM. This will also depend on the level of European centralisation, with national specificities, e.g. on interfacing with reimbursement systems, potentially being strong drivers for national decentralised authorities' databases.

Author:
Dr Susanne Keitel
... has been Director of the European Directorate of the Quality of Medicines & HealthCare (EDQM) since October 2007.

Source:
¹ Note: several European countries impose a price reduction ranging around 30-40%. In France, the price reduction is up to 60% according to a recent document from the French generics industry: http://www.medicamentsgeneriques.info/dossier-de-presse-reponses-du-gemme-au-rapport-de-lacademie-de-medecine/
²http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf