openMedicine at ETSI meeting

On the 20th of November 2015, the European Telecommunications Standards Institute (ETSI) organised an eHealth Open Meeting on Health and the Internet of Things (HIT) - Use Cases for Standards in Patient-Driven Medicine, in Sophia Antipolis, France. openMedicine was represented by its scientific coordinator, Prof. Dr. Karl A. Stroetmann. Via telecom facility he gave a talk on “Meeting the cross-border challenge of unique identification of medicinal products.” It explored the business case of the project – the univocal identification of a medicine in the prescription of another member state by the dispensing pharmacist. A core challenge is to define the different “sets of identifying attributes” of a medicinal or a pharmaceutical product for various use cases.

The envisaged solution will be based on the ISO IDMP (Identification of Medicinal Products) suite of standards. The close cooperation with the European Medicines Agency (EMA), national regulatory authorities and stakeholders is assured. Article 57 of Regulation (EC) 726/2004 requires EMA to create and maintain a database of all authorized medicinal products for human use; this DB will adopt and develop upon ISO IDMP standards.

Furthermore, European and global standards development organisations (SDOs) like ISO, CEN, GS1, HL7 and a wide diversity of experts are directly involved in openMedicine work.

Expected benefits include safe dispensation to patients of a medicine at least equivalent to the one prescribed in another country; a better understanding by clinicians of the medicinal therapy information contained in foreign patients’ summaries; the simplification and speeding up of the registration of new medicinal products by pharmaceutical companies; and improved, easier pharmacovigilance.