(028) Overview of regulations for INN prescribing and substitution, with implications for the implementation of crossborder ePrescription and eDIspensation services in countries of the European Union.

Background: The European Union is investing in the development of building blocks for a European Health Data Space (EHDS) which includes getting ready for a roll-out of crossborder ePrescriptions, eDispensations, Medication Lists, and Patient Summaries. , all building blocks for a European Health Data Space. A pPrerequisite for success of the EHDS is the implementation of 5 ISO/CEN standards on Identification of Medicinal Products (IDMP) by the regulatory authorities of Europe (European Medicines Agency (EMA). and 27 National Compentent Authorities (NCAs); as well as the integration of IDMP into national eHealth systems.

Objectives: The aim of this study is to map describe the national regulations for prescribing by International Non-proprietary Name (INN prescribing) and substitution in for the EU countries , involved in the Horizon 2020 Research and Innovation Project UNICOM, to establish nation-specific tools to help pharmacists in one coutry to find suitable equivalents for medicinal products which have been , prescribed in another EU, based on ISO/CEN IDMP standardisation.

Methods: A survey was sent to the NCAs, active in UNICOM, with the request to update information from a previous 2015 survey from Ghent University, Belgium..

Results: Data was collected from 14 EU countries. INN prescribing is mandatory in Greece, Portugal and in Estonia (implemented in prescribing system IIPS). It is allowed in Germany, Belgium (IIPS), Norway (IIPS), Spain, the Netherlands (by professional regulation), and Italy (seldom used). Substitution based on precise substance and dose form is mandatory in Finland and Sweden (Pharmaceutical Product or PhPID prescrbing), and allowed in Ireland (with a positive list). In Austria and Croatia only brand substitution is possible (albeit Croatia’s new regulation is in preparation). In most countries where prescribing by International Nnon-propieraty Nomenclature (INN) or substitution is possible, there are nation-specific lists of exemptions, except for Portugal, Italy, Greece. Mandatory regulations imply the obligation to choose cheap(er)est equivalents (which could be the brand originator or a branded generic, depending on the price setting).

Conclusions: For the countries surveyed here, it is possible to set up rules for a substitution module in the cross-border ePresribing and eDispensing services, with 3 possible levels of equivalent lists: (brand substitution (AT,HRAustria, Kroatia); PhPID Substitution (FI, SE,Finland, Sweden, Norway); INN substitution (ELGE,BE,NL,FI,EE,GR,ITA,ES,PT), with respect for national exemption lists and the possibility of physician’s veto. Harmonisation of national regulations in this area could be beneficial.