1. The European Union (EU) policy challenge
Contact:
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

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

3. 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)]

4. 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)

5. 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]

6. 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 (c)]

7. 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,
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

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

9. 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

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

11. 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