XIX Jornadas sobre Derecho y Genoma Humano (18-19 Abril 2012)

1. A major step towards a Europe for Health
Directive on patients’ rights in
patients
cross-border healthcare
DG SANCO

2. The 3 Aims of this Directive
1.
1 Help patients to exercise their rights to
reimbursement for healthcare received in
another EU country
2. Provide assurance about safety and quality of cross-
cross-
border healthcare
b d h lth
3.
3 Establish formal cooperation b t
E t bli h f l ti between
health systems
2

3. Scope
Provision of all types of healthcare to patients regardless
how is organized, delivered or financed
h i i d d li d fi d
Exceptions:
Long term care (supportive services to everyday tasks)
Allocation of and access to organs for the purpose of
organ transplants
g p
Public vaccination programmes

4. 1. Helping patients (1/2)
• Information to patients
National Contact Points
Patients will have access them to get all relevant
information to cross-border healthcare in order to
make an informed choice

5. 1. Helping patients (2/2)
Rules of reimbursement
Clarification of rules - patients will know:
know:
(1) need for prior authorisation;
( )
(2) reasons for refusal;
(3) level of reimbursement,
(4) need for up-front payment
up-
Procedural guarantees
P d l
Patients will benefit from:
(1) clarification of responsibilities;
(2) clear rules if something goes wrong;
(3) right to review of administrative decisions;
(4) right to judicial proceedings

6. 1. Information to patients
p
Conditions of reimbursement
- ONLY for treatments included in the national benefits;
- Payment up to the same amount as it would pay for at home.
Maintaining of national rules
- National rules applicable on their territory
territory.
- Conditions and formalities required in MS can also be imposed for
t eat e ts ab oad
treatments abroad.
Prior authorisation system
- Member States can introduce a system of prior authorisation.
General safeguard

7. 1. The System of Prior Authorisation (1/2)
Scope for prior authorisation (PA)
Healthcare that:
is subject to planning requirements:
one overnight stay in a hospital;
use of highly specialised or cost-intensive medical infrastructures or
cost intensive
equipments;
involves a particular risk to patients or population;
is provided by a healthcare provider who raises concerns over quality
and safety of care.
care

8. 1. The System of Prior Authorisation (2/2)
Obligation of granting PA
If the healthcare in question cannot be provided within a reasonable time limit
(undue delay).
Reasons to refuse a PA
- Safety risk for patient or for population;
- 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.

9. 2. Q lit and safety (1/3)
Quality d f t
The Directive highlights that Quality and safety should be
the cornerstone of the healthcare to be provided to citizens
across 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)

10. Responsibilities of Members States on Q &
S
2. Quality and safety (2/3)
Transparency and accountability
• Patients right to information about quality and
safety framework and standards
• To provide information to patients on national
criteria/system related with q
y quality and safety
y y
• Explicit and publicly available national
standards / criteria
• To provide Information on Health Care Providers
with compliance, "

11. 2. Q lit and safety (3/3)
Quality d f t
Member States responsibility
Refusal of prior authorisation if doubts over q
p quality and safety of a
y y
healthcare provider
Continuity of care: same medicall f ll
di follow-up as i h lth
in healthcare
provided locally & access to clinical records
Cooperation of Member States
Exchange of information on standards and guidelines for quality and
safety through national contact points

12. 3. Cooperation between health systems
(1/2)
Recognition of prescriptions
A prescription issued in another EU country will be
more effectively recognised
European Reference Networks
They will bring together specialised centres accross Europe
helping citizens to better access highly specialized and complex
healthcare and to disseminate information and expertise

13. 3. Cooperation between health systems (2/2)
The 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 research
care, care,
- Adoption of the Commission Decision setting up the network: 22 December 2011
- 1st discussion: 8 May 2012
The Network on Health Technology Assessment
A permanent EU structure of cooperation to help decision-makers to
make the right decisions on health investment and spending

14. The transposition p
p process
• 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
p
issues related to transposition
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).

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