Across the European Union, medicinal products display differences in names, variations in strength or their package size. The unavailability of a specific product may also necessitate substitution in many instances, if a patient is to be timely served in a pharmacy. Moreover, due to differences in marketing authorisation procedures, not every medicinal product is available in each Member State, and it is not unusual that the same product may have different names across Member States or the same name may identify a different product in another Member State. As substitution is regularly necessary to dispense a foreign ePrescription (eDispensation), a univocal identification of medicinal products would enable and enhance the dispensation of a foreign ePrescription and would provide benefits to patient health, patient safety, pharmacovigilance and would also allow better data analysis of clinical records. Most national ePrescription and medicines databases are not currently supporting relevant identification attributes and codes. As the EU-wide implementation of ISO IDMP (identification of medicinal products) standards is currently under way by the European Medicines Agency (EMA) and the EU Regulatory Network to comply with the EU Pharmacovigilance legislation, this action aims at enabling and fostering the use of a common EU medicinal Product repository (ISO IDMP compliant) to fulfil the ePrescription/eDispensation in a cross-border setting use case. This will provide a univocal identification of medicinal products across Europe and potentially beyond.Scope:
This innovation action is expected to support two goals: (i) the cross-border mobility of European patients by offering safer eDispensations across borders, (ii) the implementation of the IDMP standards in Member States drug databases (including a possible linkage to the EU SPOR - Substance, Product, Organisation and Referential master data database) allowing the identification of locally available medicinal products which are equivalent to the one identified in a foreign prescription.
This requires creating an EU ePrescription/eDispensing approach to use the future EU SPOR database. A common approach and operating model needs to be developed, including common processes for validation of contents, error mitigation, linkage of the EU SPOR database with the ePrescription/eDispensing systems, updates and mappings to other systems for at least 5 Member States' organisations. Harmonisation guidelines of prescribing and dispensation practices in a cross-border setting could be a further focus.
The proposal should demonstrate its ability to:
It is expected that Members of the Consortium should include a wide range of relevant stakeholders and experts including inter alia Pharmacists, National Competent Authorities, IT Integrators, producers of ePrescribing, clinical record systems. It should demonstrate its ability to deliver large scale implementation and coordination of European projects. Participation of Industry is encouraged in the most appropriate phases of the project.
The work should also provide an assessment of impacts based on benefits and costs to be anticipated. This should include not only regulatory impact, but also impact on setting global standards and best practice, and impact on clinical data quality and interoperability along with the spill-over effects on pharmaceutical companies, data base producers and competitive advantage of European companies.
Synergies with actions and activities supported by different programmes and policy initiatives of the Commission should be encouraged and resources from previous European projects should be considered.
The Commission considers that proposals requesting a contribution from the EU of between EUR 5 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.Expected Impact:
The proposal should provide appropriate indicators to measure its progress and specific impact in the following areas: