A major step towards a Europe for HealthA major step towards a Europe for Health

Directive on patients’ rights in Directive on patients rights in cross-border healthcare

DG SANCODG SANCO

The 3 Aims of this DirectiveThe 3 Aims of this DirectiveThe 3 Aims of this DirectiveThe 3 Aims of this Directive

11 Help patients to exerciseHelp patients to exercise their rights totheir rights to1.1. Help patients to exercise Help patients to exercise their rights to their rights to reimbursementreimbursement for healthcare received in for healthcare received in another EU countryanother EU country

2.2. Provide assurance about Provide assurance about safety and qualitysafety and quality of crossof cross--b d h lthb d h lthborder healthcare border healthcare

33 E t bli hE t bli h f l tif l ti b tb t3.3. Establish Establish formal cooperationformal cooperation betweenbetweenhealth systemshealth systems

2

Scope

Provision of all types of healthcare to patients regardless h i i d d li d fi dhow is organized, delivered or financed

Exceptions:Exceptions:

Long term care (supportive services to everyday tasks)

Allocation of and access to organs for the purpose of organ transplantsg p

Public vaccination programmes

1.1. Helping patients (1/2)Helping patients (1/2)1.1. Helping patients (1/2)Helping patients (1/2)

•• Information to patientsInformation to patients

National Contact PointsNational Contact PointsNational Contact PointsNational Contact Points

Patients will have access them to getPatients will have access them to get all relevantall relevantPatients will have access them to get Patients will have access them to get all relevant all relevant information information to cross-border healthcare in order to make an informed choice

1.1. Helping patients (2/2)Helping patients (2/2)

Rules of reimbursementRules of reimbursementClarification of rules Clarification of rules -- patients will knowpatients will know: :

(1) need for prior authorisation; (1) need for prior authorisation; (2) reasons for refusal; (2) reasons for refusal; ( )( )(3) level of reimbursement, (3) level of reimbursement, (4) need for up(4) need for up--front paymentfront payment

P d lP d lProcedural guaranteesProcedural guaranteesPatients will benefit from:Patients will benefit from:

(1) clarification of responsibilities; (1) clarification of responsibilities; (2) clear rules if something goes wrong; (2) clear rules if something goes wrong; (3) right to review of administrative decisions;(3) right to review of administrative decisions;(3) right to review of administrative decisions; (3) right to review of administrative decisions; (4) right to judicial proceedings(4) right to judicial proceedings

1. Information to patients1. Information to patients

Conditions of reimbursementConditions of reimbursement

pp

-- ONLY for treatments included in the national benefits;ONLY for treatments included in the national benefits;

-- Payment up to the same amount as it would pay for at home.Payment up to the same amount as it would pay for at home.

Maintaining of national rulesMaintaining of national rulesNational rules applicable on their territoryNational rules applicable on their territory-- National rules applicable on their territory.National rules applicable on their territory.

-- Conditions and formalities required in MS can also be imposed for Conditions and formalities required in MS can also be imposed for treatments abroad.treatments abroad.t eat e ts ab oadt eat e ts ab oad

Prior authorisation systemPrior authorisation system-- Member States can introduce a system of prior authorisation.Member States can introduce a system of prior authorisation.

General General safeguard safeguard

1. The System of Prior Authorisation1. The System of Prior Authorisation (1/2)(1/2)

Scope for prior authorisation (PA)Scope for prior authorisation (PA)

Healthcare that:

is subject to planning requirements:is subject to planning requirements:

one overnight stay in a hospital; use of highly specialised or cost intensive medical infrastructures oruse of highly specialised or cost-intensive medical infrastructures or equipments;

involves a particular risk to patients or population;involves a particular risk to patients or population;

is provided by a healthcare provider who raises concerns over quality and safety of careand safety of care.

1. The System of Prior Authorisation1. The System of Prior Authorisation (2/2)(2/2)

Obligation of granting PA Obligation of granting PA

If the healthcare in question cannot be provided within a reasonable time limit(undue delay).

Reasons to refuse a PAReasons to refuse a PA

- Safety risk for patient or for population;

Healthcare is provided by a healthcare provider that raises concerns over- Healthcare is provided by a healthcare provider that raises concerns over quality and safety of care;

- Healthcare can be provided within a reasonable time limit.Healthcare can be provided within a reasonable time limit.

22 Q lit d f t (1/3) Q lit d f t (1/3)22. Quality and safety (1/3). Quality and safety (1/3)

The Directive highlights that Quality and safety should be the cornerstone of the healthcare to be provided to citizens across Europeacross Europe

Provides some rules and provisions for facilitating the access to safe and high-quality cross-border healthcare and promotes cooperation on in this respect.

Quality is consider an horizontal issue that affects different chapters and articles (no specific article on this topic)

Responsibilities of Members States on Q & S

22. Quality and safety (2/3). Quality and safety (2/3)

Transparency and accountability

• Patients right to information about quality and safety framework and standardssafety framework and standards

• To provide information to patients on national criteria/system related with quality and safetyy q y y

• Explicit and publicly available national standards / criteria

• To provide Information on Health Care Providers with compliance, "

22 Q lit d f t (3/3) Q lit d f t (3/3)22. Quality and safety (3/3). Quality and safety (3/3)

Member States responsibility

Refusal of prior authorisation if doubts over quality and safety of a p q y yhealthcare provider

Continuity of care: di l f ll i h lthContinuity of care: same medical follow-up as in healthcare provided locally & access to clinical records

Cooperation of Member States

Exchange of information on standards and guidelines for quality andExchange of information on standards and guidelines for quality and safety through national contact points

3. 3. Cooperation between health systems Cooperation between health systems (1/2)(1/2)(1/2)(1/2)

Recognition of prescriptionsRecognition of prescriptions

A prescription issued in another EU country will bemore effectively recognised

European ReferenceEuropean Reference NetworksNetworks

They will bring together specialised centres accross EuropeThey will bring together specialised centres accross Europe helping citizens to better access highly specialized and complex healthcare and to disseminate information and expertise

3. 3. Cooperation between health systems (2/2)Cooperation between health systems (2/2)3. 3. Cooperation between health systems (2/2)Cooperation between health systems (2/2)

The eHealth NetworkThe eHealth Network

A first step towards "interoperability" of ICT for health at EU level for safety and quality of care continuity of care and health researchsafety and quality of care, continuity of care, and health research

- Adoption of the Commission Decision setting up the network: 22 December 2011- 1st discussion: 8 May 2012

TheThe Network onNetwork on Health Technology AssessmentHealth Technology Assessment

A permanent EU structure of cooperation to help decision-makers to make the right decisions on health investment and spending

The transposition processThe transposition processp pp p

• Entry into force: 24 April 2011

Transposition period: 30 months (25 October 2013)

Bilateral discussions with 27 Member States (MS):• COM questionnaire on the transposition of the measures provided 

for in the Directive (May October 2011)for in the Directive (May – October 2011)

• COM bilateral visits in all 27 MS (2011 – 2012) to discuss particular issues related to transpositionp

Committee on Cross‐Border Healthcare• Formal forum created by the Directive where all 27 MS will meet• Formal forum created by the Directive where all 27 MS will meet 

regularly to vote on implementing acts (Cooperation chapter).

Thank you!Thank you!yy

Further information:Further information:Further information:Further information:http://ec.europa.eu/health/cross_border_care/policy/index_en.htm