The European Union (EU) policy challenge Contact: openmedicine@empirica.com www.open-medicine.eu USA-EU Workshop Towards a trans-Atlantic solution to univocally identify medicinal products FDA, Silver Spring, MD, June 20-21, 2016 is a project funded by the in the context of

Contents Healthcare policy context in Europe Regulation of cross-border healthcare Pilot projects on ePatient Summary & ePrescription Vision for eHealth interoperability

Health service delivery is a national responsibility Treaty on the Functioning of the European Union (TFEU) - Treaty of Lisbon (2007) Article 168 (Public Health) 7. “Union action... fully respect the responsibilities of the Member States for the delivery of health services...” “Charter of Fundamental Rights”, Title IV Solidarity, Article 35 Healthcare “Everyone has the right to benefit from medical treatment under the conditions established by national laws and practices” Health services excluded from the Directive 2006/123/EC on Services in the Internal Market (Bolkestein Directive) [Recital (22); Article 2 2.(f)]

Diversity of Member States 24 official languages, 6 semi-official ones Countries with 2, 3 & 4 official languages (Finland, Belgium, [Switzerland]) 3 alphabets (Ελληνικού, Кирилица, Latin) National (United Kingdom: 4 home countries) or regional health systems (Spain 17, Italy 20, ...) Sometimes responsibilities for healthcare shared by central/provincial/local governments (Germany, Northern Europe, ...) Diverse financial base (taxes, mandatory solidary insurance, private)

Cross-border healthcare defined Definition (Directive 2011/24/EU on cross-border healthcare): “Healthcare provided or prescribed in a Member State other than the Member State of affiliation” [Art. 3 Definitions (e)] With respect to medicinal products, “the definition of cross-border healthcare should cover both the situation in which a patient purchases such medicinal products ... in a Member State other than the Member State of affiliation and the situation in which the patient purchases such medicinal products ... in another Member State than that in which the prescription was issued” [Recital 16]

Cross-border healthcare: the openMedicine mandate “Where medicinal products ... have been prescribed in a Member State ..., it should, in principle, be possible for such prescriptions to be medically recognised and for the medicinal products to be dispensed in another Member State ...” [Recital 53] “The Commission shall adopt... measures to facilitate the correct identification of medicinal products... in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross border healthcare where the legislation of the dispensing Member State permits such substitution.” [Article 11 2. (c)]

Member State cooperation on eHealth interoperability Large Scale Pilots on cross border interoperability (epSOS = Smart Open Services for European patients) 23 European States, € 48 m funding from the European Commission, 2008-2014 Cross-border services – safe treatment for citizens when in another MS Electronic Patient Summary (emergency treatment, unplanned care) ePrescription (continuity of care) Service delivery across borders is limited (less than 1 % of overall turnover) But: Strong driver for co-operation on eHealth interoperability

The eHealth Network A mandated body of Member State representatives to support countries in implementing cross-border services

The vision for eHealth interoperability The eHealth Digital Services Infrastructure (DSI) to be implemented by Member States under the Connecting Europe Facility (CEF) 2015 work programme Initial incentive funding by the European Commission will support the implementation of the cross border ePatient Summary and the ePrescription services The CEF-supported services will also establish the basic infrastructure, governance and interoperability framework needed to enable the exchange of health data based on a clear legal basis, and within a secure and trusted environment

eHealth Digital Service Infrastructure Source: Giovanni Patella SANTE D3 – eHealth and HTA Unit

Drivers for pan-European & transatlantic information and knowledge sharing Cross-border health care emergency care planned care, specialist referral transfers for care consistent application of care pathways and standards of care Population health public health measures: prevention, immunisations etc. pharmacovigilance, monitoring for other safety signals detecting and tracking critical events: antibiotic resistance, infectious outbreaks, bio- terrorism etc. Comparisons/benchmarking treatment effectiveness clinical outcomes Research epidemiology multi-national clinical studies big data analytics Common products and services collaboration on standards, specifications, tools, common services consistent quality labeling and certification standards for products and assets