Periodic Reporting for period 1 - UNICOM (Up-scaling the global univocal identification of medicines) Reporting period: 2019-12-01 to 2021-05-31 Summary of the context and overall objectives of the project The accurate identification of medicinal products anywhere in a health system context is a worldwide patient safety issue. It necessitates a collaborative solution. Despite 20 years of efforts by the global health standardisation community, there is a persistent need for agreed and implementable standardised medicinal product attributes, code systems, implementation guides and data exchange infrastructures. The International Organization for Standardization’s (ISO) suite of IDMP (IDentification of Medicinal Products) standards for accurate identification along the full life cycle of drugs was conceived to meet this challenge.IDMP standards are to be used to describe and identify medicinal products, their ingredients as well as their packages in a coherent manner such that the information can be safely recorded, coded, and exchanged between regional, national, and international stakeholders. Receiving IDMP compliant data helps regulatory bodies by facilitating and substantially improving regulatory processes around authorising medical products and managing their full life cycle, in addition to rendering global pharmacovigilance and risk management procedures faster and more reliable. In the clinical domain, IDMP compliant data will support improving processes related to (cross-border) prescription exchange, dispensation reporting, or the reconciliation of medicinal products prescribed by independent healthcare professionals treating the same patient, amongst others.The UNICOM project's main goal is to enhance and implement the ISO IDMP suite of standards for the univocal identification of medicinal products across participating Member States and all stakeholders engaged in the life-cycle data management of medicinal products. As a four-and-a-half year trans-Atlantic semantic interoperability project with a consortium of over forty European and American partners, UNICOM is well situated to provide the collaborative platform needed for such an ambitious goal. UNICOM integrates diverse perspectives and coordinates their activities by bringing together multiple stakeholders such as standard development organizations, national medicines authorities, pharmaceutical industry, national eHealth authorities, medicinal products database providers, cross-border healthcare services, healthcare professionals, patient advocacy groups, and others, into one European Innovation Action focused on IDMP implementation. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Over the course of the first 18-month reporting period, UNICOM has achieved its first Milestone: the analysis of known gaps and new requirements for IDMP standards development. Furthermore, UNICOM has strongly supported the further development and implementation of the European [Medicinal Products] Substance Registration System (EU-SRS), which is expected to be handed over to EMA in 2022. This will be a cornerstone for the implementation of IDMP across the UNION and worldwide. Concerning the IDMP-conformant Common European Submission Platform (CESP) which will allow the electronic submission of applications for the authorisation of new medicinal products by national authorities and EMA, an agreement was reached with EMA; through which the collaborative development and testing of this platform has started successfully. Implementation of IDMP at the 11 participating National Competent Authorities [for Medicinal Products] was furthered through detailed requirements analyses of national medicinal product databases, contributing to the European Medicines Agency’s (EMA) EU-wide IDMP Implementation Guide, and linkages to EMA´s master data management systems for Substances, Products, Organisations and Referentials – SPOR.UNICOM´s objectives concerning the adoption of IDMP in eHealth services have been furthered through work on defining the business and functional requirements for IDMP implementation in the eHealth domain. This entailed an overview of key aspects of ePrescription, eDispensation, and Patient Summary activities to demonstrate how business value flows differ according to the different stakeholder perspectives. Active liaison between UNICOM and the Connecting Europe Facility eHealth Digital Service Infrastructure (CEF eHDSI) and European eHealth Network communities was established so as to align UNICOM work with these key bodies’ ambitions. In terms of the application of IDMP in big data for science, UNICOM has proposed a protocol and statistical analysis plan for subsequent proof of concept studies which include an overview of the common data models utilized by large research networks conducting such studies. Initial work on the link between IDMP implementation and data flows to pharmacotherapeutic groups, and the benefits for medical data in pharmacotherapeutic audits was also successfully started. Also, Medicinal Product Dictionaries (MPDs) as well as community prescribing and dispensing software systems that operate in EU member states were characterised. To assess UNICOM´s impact, an initial socioeconomic impact assessment and cost-benefit analysis framework was developed. The framework implementation will be use-case driven and incorporate multiple stakeholder perspectives.The project management and scientific technical coordination offices were established to ensure that the underlying cross-project technical coordination processes were fully functional, including the submission of 32 deliverables. In addition to the publishing of regular news items and continued social media engagement, outreach efforts, in accordance with the project´s communication and exploitation strategy, included targeted events focused on different stakeholders including regular ‘’community of expertise’’ meetings with IDMP experts, consortium-wide meetings, best-practice sharing ISO IDMP workshops for non-participating National Medicines Authorities, an event focused on end-user engagement, and the first trans-Atlantic cooperation conference, amongst others. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) UNICOM, an Innovation Action, develops, implements, tests and pilots an IDMP-based infrastructure supporting semantic interoperability along the medicines data value chain, as well as across national agencies and EMA, all of which entails significant progress beyond the current status quo. This will facilitate faster and better pharmacovigilance reporting, create economic efficiency gains for industry and service providers, and facilitate the use case of ePrescription/eDispensation in cross-border settings. It will improve safe, reliable recording of medicinal product information in clinical documents (e.g. Patient Summaries, health records) and enable safer communication with and empowerment of patients. Finally, it will improve reuse of medication related data for public health and medical research as well as create new synergies across regulatory, healthcare, public health, and scientific domains.More specifically, by the end of the project, UNICOM will have piloted IDMP compliant data feeds to and among National Competent Authorities for Medicinal Products, eHealth organisations, and medicinal product dictionary providers. ISO IDMP enhanced eHealth Pilot Services at national and cross border level with selected patients are planned to demonstrate the project´s impacts. Continued outreach to Member States outside the UNICOM consortium will push for IDMP implementation across the global medicinal product community.