openMedicine at EXPAND project final conference

01/12/2016

The European EXPAND project organised a comprehensive conference and Expandathon on 9 December 2015 in Lisbon. The conference built upon the project’s work on European interoperable, cross border eHealth services based on the legal basis provided by the EU “Patient Rights Directive” relating to their access to planned healthcare in other member states. The goal of the project was to support and facilitate the passage of results and interoperability assets from research to pilots, and from pilots to deployment. It endeavoured to build trust in outcomes and develop capacities for their continued maintenance and support; and cooperation across EU member states.

At this meeting, openMedicine was represented by its scientific coordinator Prof. Dr. Karl A. Stroetmann, empirica. In a session of handing over of results across EU projects and future cooperation, he presented the achievements to-date of openMedicine and explored its anticipated impacts and benefits for patient safety, pharmacovigilance and cross-border healthcare across the European Union and beyond.

openMedicine focuses on 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 this and various related use cases.

The envisaged solution will be based on the ISO IDMP (Identification of Medicinal Products) suite of standards. Close cooperating 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 prescript 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.