DIRECTIVE OF THE EUROPEAN PARLIAMENT AND THE COUNCIL

on the application of patients' rights in

CROSS-BORDER HEALTHCARE

voted 01.2011

Karleen De RijckeHamburg 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

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.

•The new directive in short

•What’s in it for you

•The traps

•Next steps

•Who to lobby

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 cost-

intensive 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 authorisationMS 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 authorisationMS 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.

Opportunitiesof 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 pointFocus 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

Limits

• access to and the allocation of organs for the purpose of organ transplants falls outside the scope of this Directive

•The new directive in short

•What’s in it for you

•The traps

•Next steps

•Who to lobby

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 contententirely voluntary for MSno stakeholder involvement

What can, should we, you do

?!?

Follow-up on next steps

• Implementation

• Feedback

•The new directive in short

•What’s in it for you

•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