Directive 2011/24/EU on patients’ rights in cross-border healthcare Advisory Committee, 24.10.2013 Directive 2011/24/EU on patients’ rights in cross-border healthcare DG SANCO Unit D2 Healthcare systems

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 of services - Initial attempt to codify via Services Directive – separate piece of legislation required - Contentious negotiations 2008 - 2011

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

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"

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; rights as a patient; provider's right to practice

NATIONAL CONTACT POINTS Functioning 6 6

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

Main differences Directive / Regulations - Regulations only cover public-sector or contracted providers: Directive covers all providers in EU for planned and unplanned care (but not long-term care) - Planned care – prior authorisation is the norm under Regulations, but the exception (if used at all) under Directive - Regulations cover patient cost at level of MS of treatment; Directive at level of MS of affiliation ("home" MS) - Regulations primarily direct payment; Directive primarily reimbursement

Interaction between two instruments - Where terms of Regulations are met, Regulations should be used… - …unless patient specifically requests otherwise - Patients should not be deprived of rights under Regulation where this is more beneficial for them

Transposition process - Bilateral engagement with MS capitals - Formal committee meetings in Brussels - Discussions in Administrative Commission - Regular informal workshops on transposition - Guidance note on Regulation / Directive - Working party on Regulation / Directive - "Europa" website to be updated shortly

Thank you! Further information: http://ec.europa.eu/health/cross_border_care/policy/index_en.htm 11