© empirica – Information provided ‘Commercial in Confidence’ Horizon 2020 (H2020) EU Research & Innovation Funding Programme TOPIC ID SC1-DTH-09-2019: “Scaling up the univocal Identification of Medicinal Products” Up-scaling the global univocal identification of medicines (UNICOM) Pre-proposal notes August 19, 2018 Predecessor project: www.open-medicine.eu © empirica – Information provided ‘Commercial in Confidence’

© empirica –Commercial in Confidence Contents Background/Context Objectives Challenges and outcomes Financial aspects, time frame © empirica –Commercial in Confidence

© empirica –Commercial in Confidence Background and Context implementation of the IDMP standards by EMA and in Member States drug databases to improve patient safety (also in crossborder healthcare) © empirica –Commercial in Confidence

© empirica –Commercial in Confidence ISO IDMP standards The ISO IDMP standards establish definitions and concepts and describe data elements and their structural relationships that are required for the unique identification of: Medicinal products (MPID/PCID) - ISO 11615 Pharmaceutical products (PhPID) - ISO 11616 Substances (Substance ID) - ISO 11238 Pharmaceutical dose forms, units of presentation, routes of administration and packaging - ISO 11239 Units of measurement (UCUM) - ISO 11240 ISO IDMP standards apply to both authorised and developmental medicinal products for human use © empirica –Commercial in Confidence

The solution (…continue): 29 October 2019 The solution (…continue): Standardised attributes for medicinal and pharmaceutical products The ISO IDMP (ID of medicinal products) suite of standards defines a set of attributes and their relations to identify different levels of medicines It harmonizes the concepts and the data elements (attributes) EMA & FDA will adopt it and maintain codes Pharmaceutical manufacturers will implement it (summary of product characteristics [SmPC]; pharmacovigilance) ePrescriptions may identify a package, a medicinal product, or an active substance plus further attributes as needed Pharmaceutical Product (PhP) Identifier = PhPID Active substance(s) (INN, ATC ...) Strength(s) Dose form Route of administration “Is produced as” Medicinal Product (MP) Identifier= MPID Country Marketing Authorisation Holder (MAH) Originator or generic brand name ... “Is packaged as” Package (PC) Identifier=PCID PCID (e.g. GTIN) Quantity ... Source: © openMedicine/empirica © empirica –Commercial in Confidence

xBorder ePrescription & dispensation Common level is usually pharma-ceutical product, i.e. substitution or selection Phar. Product Identifier = PhPID PhP Identifier = PhPID Product is further specified, thanks to standardised attributes Same medicinal product (if available) Medicinal Product Identifier= MPID MP Identifier= MPID Product is specified at any of the IDMP levels in an ePrescription Package Identifier=PCID Package Identifier=PCID Source: © openMedicine/empirica © empirica –Commercial in Confidence

© empirica –Commercial in Confidence Objectives of this H2020 Call http://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020/topics/sc1-dth-09-2019.html Topic identifier: SC1-DTH-09-2019 “Scaling up the univocal Identification of Medicinal Products” Publication date: 27 October 2017   Planned opening date: 16 October 2018 Deadline: 24 April 2019 © empirica –Commercial in Confidence

© empirica –Commercial in Confidence Objectives of Call This innovation action should support two goals: (i) The cross-border mobility of European patients by facilitating ePrescription and supporting safer eDispensations across borders, (ii) The implementation of the IDMP standards in Member States drug databases (including linkage to the EMA Medicinal Products/ Pharmacovigilance data base) in support of improved patient safety, thereby facilitating the safe identification of locally available medicinal products which are equivalent to the one identified in a foreign prescription (same pharmaceutical product – PhP) © empirica –Commercial in Confidence

Challenges and Expected Outcomes © empirica –Commercial in Confidence

© empirica –Commercial in Confidence Specific Challenges: Medicinal products display differences in names, variations in strength or their package size The unavailability of a specific product may necessitate substitution in many instances, if a patient is to be timely served in a pharmacy at home or abroad Moreover, due to differences in marketing authorisation procedures, not every medicinal product is available in each Member State It is not unusual that the same product may have different names across Member States The same name may identify a different product in another Member State   It follows that safe identification of a medicinal product specified in a foreign prescription and substitution (in line with national regulation) are regularly necessary to indeed dispense a foreign (e)Prescription © empirica –Commercial in Confidence

© empirica –Commercial in Confidence European Commission Implementing Regulation (EU) No 520/2012 on “the performance of pharmacovigilance activities.” The implementation of “terminology set out in the ISO IDMP suite of standards” is binding for “Member States, marketing authorisation holders and the [European Medicines] Agency.” It concerns “internationally agreed terminology” applied “for the classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of pharmacovigilance and medicinal product information.” This implementation process is currently under way by EMA and the EU Medicines Regulatory Network With respect to the use of formats and standards, the application of ISO IDMP is not mandatory. However, it is suggested that “national competent authorities, marketing authorisation holders and the Agency may also apply” the IDMP suite of standards for these aspects. © empirica –Commercial in Confidence

Alternative 1: Alternative 2: Potential options for implementing ISO IDMP by National Competent Authorities, (Commercial) Data Base Producers and in Clinical Software Alternative 1: Existing data base and prescribing systems continue to use national identifiers. A conversion service (automatically) matches the set of national attributes or identifiers into the set of IDMP attributes or identifiers when and as required, e.g. by linking to the EMA Art. 57 Medicinal Products DB This will allow national systems to adapt to the IDMP requirements at their own path, but nevertheless already facilitate the reliable identification of (equivalent) medicinal products in another Member State This would be the least invasive approach Alternative 2: Implementation of the full IDMP data set at once, removing the need for a conversion service (The national IDs may still exist and be used for other processes like reimbursement) This could be facilitated through linking to the EMA Data Base as the central reference node and having identifiers/ identifying attributes automatically included into software systems for prescribing and other clinical applications

Staggered participation of countries Countries/agencies participating in this longer-term project do not all need to follow the same path at the same time. Rather, depending on their readiness and ability to become involved, they may vote for one of two (or further) alternatives to participate in wave one of the project in wave two or participate only in a more observational role to learn from the experience of other countries and actors

Expected outcomes/results: According to the Call text, this action aims at enabling and fostering the Usage of a common EU Medicinal Product repository (ISO IDMP compliant) Facilitation of the use case of ePrescription/ eDispensation in a cross-border setting Improvement of patient safety © empirica –Commercial in Confidence

A variety of stakeholder groups may become involved : National Competent Authorities (National Drug Agencies…) National organisations of the eHealth Network Organisations involved in delivering cross-border ePrescription services/CEF Pharmaceutical industry (Commercial) medicinal products/pharma data base producers Clinical software producers Healthcare professionals (pharmacists, physicians…) Other stakeholder groups (as consortium partners, in an advisory role, as observers…) © empirica –Commercial in Confidence

Financial and Time Frame © empirica –Commercial in Confidence

Financial and time frame Overall funding foreseen for this Call is presently EUR 19 m (for one or several projects). Giving the complexity and multitude of tasks required, and depending on the number of countries and organisations participating, it may be advisable to plan for a project with a volume of between EUR 10 m and 19 m Funding instrument: “Innovation Action” implies a 70% EC- contribution to eligible costs of consortium partners; however, for public authorities and institutions, NGOs and other not-for-profit organisations 100 % of costs will be reimbursed (100% of extra personnel cost and 25% overhead contribution) Time frame: 3 (-4) years © empirica –Commercial in Confidence

© empirica –Commercial in Confidence Preparatory Face-to-Face Meeting planned for the 42nd Week of 2018 (October 15 – 19) perhaps in Brussels or Lisbon with all organisations potentially interested to participate in such a project proposal © empirica –Commercial in Confidence

Contacts: empirica Communication & Technology Research Oxfordstr. 2, D-53111 Bonn, Germany T: (+49) 2 28 9 85 30-0 http://empirica.com Prof. Dr. Karl A. Stroetmann karl.stroetmann@empirica.com Dr. Veli Stroetmann veli.stroetmann@empirica.com Henrique Manuel Gil Martins Presidente do Conselho de Administração SPMS – Serviços Partilhados do Ministério da Saúde, EPE Avenida da República, n.º 61 PT-1050-189 Lisboa T: (+3 51) 2 11 54 56 00 http://spms.min-saude.pt/ henrique.m.martins@spms.min-saude.pt