Scaling up the univocal Identification of Medicinal Products
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:
- Define the additional quality criteria, processes, actors, risk minimisation measures and safety nets to be applied to the data coming from the EU SPOR database to ensure that the data can be safely used by the ePrescription/eDispensing systems and any harm to patient is avoided;
- Define and implement APIs or use the ones that will be provided by the SPOR system) for data retrieval/view;
- Ensure the quality of data, usability of data for national agencies, determine and support the implementation and validation of adaptations needed at national or regional levels;
- Support integration with existing cross-border ePrescription services, such as implemented under the Connecting Europe Facility[[https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL/CEF+Digital+Home]];
- Improved pharmacovigilance, inclusion of pharmacovigilance modules capable of reporting adverse drug reactions to relevant regulators using the format defined by the ISO ICSR (Individual Case Safety Report) standard into clinical software systems, validation and diffusion;
- Establish a Working Group of European medicinal products database producers to support the implementation of the IDMP standard;
- Raise awareness and ensure coordination of pre-competitive activities, cooperation with EMA and the EU Regulatory Network (e.g. national competent authorities), and other relevant stakeholders (producers of ePrescribing, clinical record systems);
- Raise awareness and explore benefits for both regulatory and clinical contexts, use cases for public health, big data;
- Disseminate to clinical actors (prescribers, physicians, nurses) the ISO IDMP data base contents, usage, value generation and relevance for integrated care;
- Contribute to EU-US Trans-Atlantic cooperation and trans-border medicinal products data access and exchange (semantic interoperability);
- Ensure compliance with relevant EU legislation, in particular REGULATION (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data;
- Contribute, where relevant, to the sustainability and diffusion of European eHealth services, such as implemented under the CEF.
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.
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.
The proposal should provide appropriate indicators to measure its progress and specific impact in the following areas:
- Design and implementation of an IT solution based on the EU SPOR database to support ePrescribing/eDispensing in a cross-border setting is designed and implemented, open for integration with existing cross-border ePrescription and electronic health record services, such as under CEF[[https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL/CEF+Digital+Home]] or H2020
- Better address adverse events/effects and safety issues by enhanced development of standard vocabulary for the related reporting;
- Better health data access across Europe for patients and healthcare providers;
- Improved quality of care resulting in enhanced patient safety;
- Improved efficiency gains in term of timeliness of intervention;
- Extended healthcare continuum across borders;
- Collection and re-use of a data set that is sufficiently large to detect (statistically) significant findings;
- Provision of medicinal products information for under-resourced stakeholders.