Brussels, 21 November 2013

1. Brussels, 21 November 2013 Directive on patients’ rights in cross-border healthcare DG SANCO Unit D2 Healthcare systems

2. Headline messages • - Patients' rights to choose care abroad increased and clarified • - Increase in information to patients on cross-border rights and on health systems more generally • - Minimum set of patient rights established for all treatment delivered in the EU

3. Background • - Cross-border healthcare not new – both unplanned care (EHIC) and planned care covered in social security Regulations since 1970s • - ECJ jurisprudence 1997 – 2006 developed additional rights based on free movement • - Initial attempt to codify via Services Directive – separate piece of legislation required • - Contentious negotiations 2008 - 2011

4. Provisions of Directive 1: patient entitlements • - Patients have right of reimbursement when they receive healthcare in another EU MS • - Level of reimbursement up to cost of treatment at home • - Quality and safety standards / legislation of MS of treatment applies

5. Provisions of Directive 2: prior authorisation • - Prior authorisation possible for a) overnight stay; b) highly specialised healthcare ("hospital care") • - Authorisation may be refused if no "undue delay" • - Authorisation processes must be reasonable, "properly reasoned"

6. Provisions of Directive 3: National Contact Points • - Each MS must set up a National Contact Point (NCP) • - NCPs tell outgoing patients about: rights; entitlements; reimbursement; appeal processes • - NCPs tell incoming patients about: quality and safety standards and systems; complaints and redress procedure • - NCPs have obligation to consult with patient organisations, healthcare providers, healthcare insurers

7. NATIONAL CONTACT POINTSFunctioning

8. Provisions of Directive 4: prices, access, information, prescriptions • - Healthcare providers must provide information on: treatment options; quality and safety; prices; authorisation status; insurance / liability cover • - Patients should have access to care on basis of non- discrimination; providers must apply same scale of fees as for domestic patients • - Directive introduces cross-border prescriptions to help patients moving across borders

9. Provisions of Directive 5: Mutual assistance and co-operation • - Assistance on invoices • - Cross-border co-operation • - Exchange of info on health professionals via IMI • - Permanent co-operation on: Health Technology Assessment; eHealth; European Reference Networks

10. IMI clause – Article 10.4 • - Where does this come from? • - How could it be used? • - Future uses? Links to NCPs?

11. Challenges in implementation • Transparency for patients: entitlements; pricing; reimbursement • Management of patient flows • National Contact Points: who and how? • Political pressure within MS (for and against)

12. Next steps: • Transposition deadline and transposition check • Reflection between COM and NCPs on functioning of NCPs • Regular reporting by COM (to include data requests to Member States) • Monitoring of transposition by individuals and stakeholders • IMI: monitoring and consideration of potential future uses?

13. Thank you! Further information: http://ec.europa.eu/health/cross_border_care/policy/index_en.htm

14. IMI clause – Article 10.4 "Member States of treatment shall ensure that information on the right to practise of health professionals listed in national or local registers established on their territory is, upon request, made available to the authorities of other Member States, for the purpose of cross-border healthcare, in accordance with Chapters II and III and with national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC, and the principle of presumption of innocence. The exchange of information shall take place via the Internal Market Information system established pursuant to Commission Decision 2008/49/EC of 12 December 2007 concerning the implementation of the Internal Market Information System (IMI) as regards the protection of personal data"