Directive 2011/24/EU on the application of patients' right in

cross-border healthcare – implications on patient safety and

quality

Katja NeubauerDeputy Head

Healthcare Systems UnitDG SANCO

1.Directive 2011/24/EU on patient rights in X border care

2.Council Recommendation 2009/C 151/01 on patient safety including HCAI

Directive on patients’ rights in cross-border healthcare

provisions on safety and quality

4

The 3 Aims of this DirectiveThe 3 Aims of this Directive

1.

Help patients to exercise their rights to reimbursement

for healthcare received in

another EU country

2.

Provide assurance about quality and safety

of cross- border healthcare

3.

Establish formal cooperation

betweenhealth systems

Information to patients by NCP Information to patients by NCP in the MS of treatmentin the MS of treatment

Patients receive from the NCP information on standards and guidelines, including provisions on supervision and assessment of healthcare

providers and information on which healthcare providers are subject to these standards and guidelines. 4(2)(a)

NCPs shall provide patients with information on a specific provider's right to provide services

or any restriction on its practice. 3(3)

NCP shall provide information on patients' rights, complaint procedures and mechanisms for seeking remedies 6(3)

Information to patients by healthcare Information to patients by healthcare provider in the MS of treatmentprovider in the MS of treatment

In order to help individual patients to make an informed choice healthcare providers gives information to patients on quality and safety of the healthcare they provide, as well as on their authorisation and registration status. 4(2)(b)

Cooperation of Member StatesCooperation of Member States

Member States shall render mutual assistance as is necessary for the implementation of the Directive, including cooperation on standards and guidelines on quality and safety

and the exchange of information,

especially between their national contact points. 10(1)

•

Art. 12:

enhanced cooperation of Member States

in the area of European reference networks

(ERN).

•

Main goal: facilitate improvements in the diagnosis and treatment

across the EU:

•

By delivery of high-quality, accessible and cost- effective healthcare

•

For Medical conditions requiring:

•

Concentration

of expertise or resources, •

In medical domains

where expertise is rare.

Context & main GoalContext & main Goal

European Reference Networks

European Reference Networks

• Commission

Support MS in the development of ERNAdopt Delegated & Implementing Acts

• Member States

Connecting providers & Centres of Expertise at national levelFostering participation in the ERN.

• Voluntary participation of providers:

Fulfilling all required conditions and criteria

Context, tasks and responsibilities

European Reference Networks

European Reference Networks

EU added value

ERN should guarantee:

–

Appropriated scope: relevant conditions and diseases

–

Prerequisites and criteria for healthcare providers acting as centres of expertise, including criteria on safety and quality

–

That EU co-operation is cost-effective

–

The development/disemination of best practices to the advantages of Member States.

European Reference Networks

European Reference Networks

Pilot networks of cooperation under Directive 2011/24/EU (Public Health WP 2013)

Network of Paediatric Oncology Centres dealing with low prevalence and rare solid tumours:

Retinoblastoma (04/100.000), Wilms tumour (0,8/100.000), soft tissues (1/100.000) , bone sarcoma (06/100.000) and other rare cancers

Highly specialised neurological diseases and procedures:

refractory epilepsy (6/100.000) ,, brachialis plexus injuries (0,6/100.000), hereditary ataxia (3/100.000) refractory neuropathic pain, severe craniofacial conditions , and other rare conditions.

complex neurosurgery, movement disorders surgery, and brain neuro-modulation Examples

ExamplesEuropean Reference Networks

European Reference Networks

Council Recommendation on patient safety, including HCAI

COUNCIL RECOMMENDATION 2009/C 151/01

•

Actions for Member States:

Develop national policies on patient safetyInform and empower patientsEstablish reporting and learning systems on adverse eventsPromote education and training for health workersAdopt and implement a strategy to prevent and control HCAI

COUNCIL RECOMMENDATION 2009/C 151/01

•

Actions for Member States and EU:

Classify and measure patient safetyShare knowledge and experienceDevelop and promote research

IMPLEMENTATION REPORT

Published 15 November 2012Based on information from 27 MS and NorwayAccompanied by a Commission staff working document – detailed analysis from countries and regions

Implementation Report Summary of actions implemented by countries

Implementation Report Main messages

Patient safety widely embedded in public health policiesProgress made in setting up reporting and learning systems but no information about the actual useRoom for improvement in the areas of patient empowerment and education of health workersInitiatives need to cover also non-hospital careProgress to be made on EU classification on PS24 countries would welcome a guideline on patient safety standard

Implementation Report Next steps

Two work strands within the Commission working group on patient safety and quality of care:

Reporting and learning systems on adverse eventsEducation and training of healthcare workers

Objective: to produce recommendations on how to effectively implement provisions of the Recommendation

Timeline: first half of 2014

Useful links:Patient safety:

http://ec.europa.eu/health/patient_safety/policy/index_en.htm

Cross-border healthcare Directive:http://ec.europa.eu/health/cross_border_care/policy/index_en.htm

Delegated Acts(Art. 17)

leg

islative

pro

cess

leg

islative

pro

cess

criteria for establishing

and evaluating ERNArt. 12.4(b)

Adoption of a list of criteria and conditions for the CR & ERN to fulfil

Art. 12.5

Implementing acts (Art. 16)

Committee

Milestones and timeline for the implementation

Exchange of information and expertise for ERN

Art. 12.4(c)

20

11

-

20

15

Deployment ProcessEstablishment of ERNsDeployment ProcessEstablishment of ERNs

European Reference Networks

European Reference Networks

Work on progress

Cross-border Healthcare Expert

Group

SANCO

Advise

Technical Brainstorming &

workshops

•Step-by-step approach (rigorous and best practice-ba

Looking at best practices: MS and

Centres visits

Meeting with Stakeholders

Public Consultation

Adoption of Delegated Act

Adoption of Implementing Act

Vote of Committee

Reports and technical papers

Draft Report

and outcomes

I. Workshop

on European

Reference

Networks

Directive on the application

of patients' rights in cross-

border healthcare Brussels,

30-31

January

2012

Draft Report

and outcomes II. Workshop

on European Reference

NetworksDirective on the application of

patients' rights in cross-border

healthcare

Brussels, 24 April 2012

European Reference Networks

European Reference Networks