Patients to be able to check authenticity of medicine under new Council of Europe scheme

Strasbourg, 31.01.2012 – The Council of Europe and its European Directorate for the Quality of Medicines & HealthCare (EDQM) have launched “eTACT”, an IT-based traceability service which will allow patients to check the authenticity of their medicines using smartphones or the internet.

“eTACT”– part of the Council of Europe’s global strategy to counter fake drugs - is a publicly governed service which covers all medicines in the legal supply chain and will be open to the 36 member states of the European Pharmacopoeia Commission and beyond.

Coming at a critical stage in the development of anti-counterfeiting systems in Europe, “eTACT” will make a major contribution by providing a secure, inter-operable, efficient, cost-effective and flexible traceability service to protect public health.

Consultations, technical workshops and a series of webinars for the relevant European authorities and patient organisations are to be organised in the coming months to help users understand the project, and to gather ideas to create an optimum traceability environment for medicines.

Background

On 26 and 27 January 2012, the EDQM organised a workshop to bring together key stakeholders (business stakeholders such as EFPIA, EGA, PGEU and EAHP, together with regulatory authorities and patient organisations, e.g. the International Alliance of Patients' Organizations IAPO), to present the project and create a forum for the international exchange of experiences and views. Eighty-five participants from 22 countries from Europe and beyond attended the meeting in Strasbourg.

The aim of the workshop was to provide stakeholders with a better understanding of the project, thanks to a demonstration of the IT tool that showed the flexibility and inter-operability of eTACT with existing national systems. In addition, a lot of time was dedicated to discussing technical and political issues, such as costing, and to gather feedback that would facilitate further fine-tuning of the model.

The workshop was a success with a demonstration of the robustness of the eTACT service run over the entire supply-chain, integrating various stakeholder systems, and a number of crucial questions were discussed over the two days. Regarding the strategic question of cost, the results of a first scalability study for eTACT were presented. eTACT is an efficient, cost-effective tool; nevertheless, benchmarking will be feasible once other stakeholders are able to share transparent and concrete cost figures for their different approaches.

As a pan-European inter-governmental organisation, the EDQM is well placed to act as a trusted third party for the independent governance of a service open to all stakeholders, thereby ensuring data protection. The International Alliance of Patients' Organizations specifically welcomed the EDQM’s initiative to open the service to patients and underlined the importance of value to patients versus costs.