Karleen De Rijcke Hamburg 06.2011

1. DIRECTIVE OF THE EUROPEAN PARLIAMENT AND THE COUNCILon the application of patients' rights incross-border healthcarevoted 01.2011 Karleen De Rijcke Hamburg 06.2011

2. 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

3. 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.”

4. SOUNDS GOOD BUT… IS IT ?!? • Headlines for CF • Opportunities • Drawbacks • Whatcanwe , you do?

5. HEADLINES

6. 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.

7. 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

8. Prescriptions • Prescriptions issued in another Member State have to be recognised in every country

9. Prior authorisation You may have to ask prior authorisation from your country before you can get care in another MS!

10. Prior authorisation limited to healthcare with: • overnight hospital accommodation; • use of highly specialised and cost-intensive medical infrastructure or equipment;

11. 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 )”

12. 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.

13. 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.”

14. 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.”

15. Info & contact point • Contact point in each MS • Help to make an informed choice • Own country • Other country

16. 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

17. 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.

18. Opportunitiesof the directive?!

19. opportunities • creates a legal framework • offering some aspects to be built upon, to achieve better quality care for all patients

20. 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

21. Drawbacks & Limits

22. 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?

23. 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

24. 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

25. 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

26. 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

27. What can, should we, you do?!?

28. The new directive in short • What’s in it for you • The traps • Next steps • Who to lobby Follow-up on next steps • Implementation • Feedback

29. 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

30. 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