Directive 2011/24/EU on the application of patients' …...Directive 2011/24/EU on the application...
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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
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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 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 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)
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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