DIRECTIVE OF THE EUROPEAN
PARLIAMENT AND THE COUNCIL
on the application of patients' rights in
CROSS-BORDER HEALTHCARE
voted 01.2011
Karleen De Rijcke
Hamburg 06.2011
Goals
• to establish an EU framework
to ensure cross-border access
to healthcare services
– in another country in the EU
• to provide clarity and legal
certainty as well as support for
co-operation between national
health systems
John Dalli, EC for Health and
Consumer Policy
• “the Directive will help patients who need
specialised treatment, for example those
who are seeking a diagnosis or treatment
for a rare disease”.
• “some rare diseases are not even
recognised in some countries, let alone
treated... small countries often can’t
offer the same medical services as
bigger nations.”
SOUNDS GOOD
BUT… IS IT ?!?
•
•
•
•
Headlines for CF
Opportunities
Drawbacks
What can we , you do?
HEADLINES
•The new
directive in
short
•What’s in it for
you
•The traps
•Next steps
•Who to lobby
Freedom of each MS
•
Member States retain responsibility for providing safe,
high quality, efficient and quantitatively adequate
healthcare to citizens on their territory
•
Furthermore, the transposition of this Directive into
national legislation and its application should not result
in patients being encouraged to receive treatment
outside their Member State of affiliation.
•
This Directive respects and is without prejudice to the
freedom of each Member State to decide what type of
healthcare it considers appropriate.
•
the Member State of affiliation may choose to limit the
reimbursement of cross-border healthcare for reasons
relating to the quality and safety of the healthcare
provided, where this can be justified by overriding
reasons of general interest relating to public health.
Reimbursing the costs
What?
• healthcare in another EU country - “MS”
• the prescription, dispensation and provision of
medicinal products and medical devices
How much?
• up to costs reimbursed in your own country
• MS may decide to reimburse the full cost.
• MS may decide to reimburse other related costs,
such as accommodation and travel costs
•
How?
• reimbursed or paid directly by the Member State
Prescriptions
• Prescriptions issued in
another Member State have to
be recognised in every
country
Prior authorisation
You may have to ask prior authorisation
from your country before you can get
care in another MS!
Prior authorisation
limited to healthcare with:
• overnight hospital accommodation;
• use of highly specialised and costintensive medical infrastructure or
equipment;
Prior authorisation
• “ascertain whether the conditions laid
down in Regulation (EC) No 883/2004
have been met”
• “When a patient affected, or suspected
of being affected, by a rare disease
applies for prior authorisation, a clinical
evaluation may be carried out by experts
in that field (< Member State )”
Prior authorisation
• Member States shall notify the
categories of healthcare needing prior
autorisation to the Commission
• MS shall make publicly available which
healthcare is subject to prior
authorisation
• MS must clearly inform on system of
prior authorisation.
Prior authorisation
MS may not refuse to grant prior authorisation
“...when this healthcare cannot be provided
on its territory within a time-limit which is
medically justifiable, based on an objective
medical assessment of the patient's medical
condition, the history and probable course
of the patient's illness, the degree of the
patient's pain and/or the nature of the
patient's disability at the time when the
request for authorisation was made or
renewed.”
Prior authorisation
MS may refuse to grant prior authorisation...
“if this healthcare can be provided on its
territory within a time-limit which is
medically justifiable, taking into account
the current state of health and the
probable course of the illness of each
patient concerned.”
Info & contact point
• Contact point in each MS
• Help to make an informed choice
– Own country
– Other country
Info & contact point
receive on request the relevant information on
• safety and quality standards enforced in country
• healthcare providers subject to these standards
• availability, quality and safety of the healthcare
they provide
• provisions on supervision and assessment of
healthcare providers
• healthcare services and on treatment options
• prices
• authorisation, registration status, insurance cover
Article 13 - Rare diseases
• The Commission shall support Member States in
cooperating in the development of diagnosis and
treatment capacity in particular by aiming to:
– make health professionals aware of the tools
available to them at Union level to assist them
in the correct diagnosis of rare diseases, in
particular the Orphanet database, and the
European reference networks;
– make patients, health professionals and those
bodies responsible for the funding of
healthcare aware of the possibilities offered
by Regulation (EC) No 883/2004 for referral of
patients with rare diseases to other Member
States even for diagnosis and treatments
which are not available in the MS.
Opportunities
of the directive?!
opportunities
• creates a legal framework
• offering some aspects to be built upon,
to achieve better quality care for all
patients
Opportunities
• National contact/info point
Focus on accessible, clear and reliable
information to make an informed choice:
– know/claim quality care (providers) in
your own country
– get info if looking for care in other
country
• sets a basis for future European
cooperation (HTA, quality and safety,
eHealth and rare diseases)
• Recognition of prescriptions issued in
another Member State
Drawbacks
& Limits
Limits
• Prior autorisation:
– it remains unclear under what criteria
Member States shall judge what is
necessary and proportionate
– What are reasonable time limits?
– Problem with RD care: countries claim
they have quality specialised care,
even if they’re not up to European
standards – how can you ‘prove’ there
is a gap between theoretical claims
and practice?
Limits
• reimbursement:
– Patients will only be reimbursed at
home-country rates;
if a treatment costs more in another
country the patient will have to pay the
difference
– What if care is not provided/
reimbursed at all in your own country?
– Prepay can be needed
•The new
directive in short
•What’s in it for
you
•The traps
•Next steps
•Who to lobby
Limits
• access to and the allocation of organs for
the purpose of organ transplants falls
outside the scope of this Directive
Limits
• Risk of “health tourism”
favouring rich patients...and
insurances:
– Patients from richer countries will be
able to travel to less expensive,
poorer, countries: threat that care
standards for locals will deteriorate to
make room for profitable health
tourism
– insurers could drive patients abroad
in search of cheaper treatment
– If prepayment is needed
Compromise on RD
• “MS are encouraged to cooperate in developing
diagnosis and treatment capacity
• creation of European Reference Networks
with special focus on RD
• Exploit possibilities offered by Orphanet
and the existing Social Security Regulation
for patient referrals abroad”
 limited content
 entirely voluntary for MS
 no stakeholder involvement
What can, should
we, you do
?!?
•The new
directive in short
•What’s in it for
you
Follow-up on next steps
• Implementation
• Feedback
•The traps
•Next steps
•Who to lobby
involvement of all stakeholders in
implementation and monitoring
• Enforce provision that the contact points
will consult with stakeholders, incl PO
– ensure that the information provided meets
patients’ real-life needs
– is provided in patient-friendly formats
• Ask for info on standards of care,
providers, reimbursement etc
• Gather experiences from CF patients
seeking CBHC
=> Inform patients
=> lobby on national & European level
• Eurordis
CONCLUSION
• Some opportunities, but
involvement of PO needed
• Much now depends on the way the
Directive is implemented by
Member States;
• Full impact on patients will only
become clear in the course during
the coming years