The Patients’ Directive The final countdown?

Christian Horemans Expert International Affairs Union Nationale des Mutualités Libres christian.horemans@mloz.be www.mloz.be The Patients’ DirectiveThe final countdown?

The European landscape The directive: a SWOT-analysis Conclusion Structure

The European landscape (1) • Cross-border health care has different “faces”: • Regulations 883/2004 and 987/2009 • Reimbursements according to the decisions of European Court of Justice • Cross-border projects: • To facilitate patient mobility • To facilitate collaboration between hospitals

The European landscape (2) • Lack of transparency! • No complete data about: • How many patients travel to other Member States for treatment? • For which treatment? • For which reasons? • … • Today: development of policy in patient mobility without fact & figures

The European landscape (3) • And now: the Patients’ Directive… • July 2008: presentation proposal of directive by European Commission • April 2009: vote in EP (first reading) • June 2010: compromise in European Council • September 2010: • Communication from the Commission to the EP • EP ENVI committee discussion on the draft report of Ms Grossetête on cross-border healthcare • October 2010: vote in the ENVI committee • January 2011: vote in EP (second reading) SWOT-analysis

SWOT – Strengths (1) • Codification of European jurisprudence • BUT: different opinion of definition between Commission, council, EP • Commission: only authorisation for hospital care • Council & EP: authorisation for hospital & some non-hospital care • European reference networks • Mutual recognition of prescriptions • EU prescription template (EP) • Interoperability of ePrescriptions (EP)

SWOT – Strengths (2) • Data collection for statistical and monitoring purposes • Necessary to have a clear idea of what cross border care represents in Europe • Council: deleted the article from the initial proposal • EP: introduced a new article (art. 19a) • National points of contact • EP: explicit role for health insurance funds (!), patient organisations, healthcare providers • EP: too ambitious concerning the medical information • More collaboration around eHealth and health technology assessment • Commission: role for Commission in establishment and management of network on HTS • Council: no way => the network may receive EU aid

SWOT – Weaknesses (1) • Complexity • New procedure of authorisation makes the legal framework even more complex • Difficult for the patients AND for the health insurance funds • To avoid legal uncertainty: • EP: need for “closed” lists (Council: open lists) • List of health care for which the patient needs an authorisation • List of reasons to refuse an authorisation • EP: No possibility to limit the application of the rules of reimbursement (Council: possibility to limit) • Risk of new jurisprudence? => Still uncertainty about: • Prior authorisation for non-hospital care? • Commission vs Council & EP • Motivation of authorisation procedure? • Commission vs Council & EP

SWOT – Weaknesses (2) • Unrealistic proposals: • The “voucher” (art. 7a - EP): • Written confirmation of maximum amount that will be paid • Sounds good, but impossible to organize • Rare diseases (art. 8, 6c – EP): • No authorisation needed + reimbursement according tariffs in member state of affiliation or in member state of treatment • Better solution: more flexible conditions based on regulation 883/2004, decided by Administrative Commission • Clearing house (art. 9, §3b – EP): • A European platform to facilitate reimbursements under Directive • Reimbursement is a task of the national competent institution!

SWOT - Opportunities • More transparency and legal security for the patients • Uniform rules for all Member States • Information about procedures and treatments • Awareness on patient mobility in Member States • May lead to a discussion based on “facts & figures” • In BE: creation of Observatory on Patient Mobility • Support for cooperation in cross-border healthcare at regional and local level • To stimulates cross-border projects • BUT: a bit of a paradox if it serves to avoid the complexity of directive/regulation…

SWOT - Threats • Directive could create high expectations, feeling of “everything is possible”, BUT: • Big risk of no or limited reimbursement • Legal framework of cross-border healthcare becomes too complex • Only specialists see “clear” • Risk of new cases for the European Court • Member States will look for ways to simplify • Proposals that has not been thought trough (like the “voucher”) • Risk for frustration for the patient and/or the insurers • Bad PR for Europe – “it doesn’t work – it’s too complicated”

The next step • Search for compromise during last months of Belgian Presidency • The last big points of discussion: • Authorisation procedure • Quality & safety standards • Role of European Commission • They expect that Belgium will succeed…

Conclusions • Positive evolution for the patient, but risks • Legal framework becomes more complicated • 2 parallel systems: regulation - directive • Unrealistic proposals should be removed from the final text • “Voucher” • Rare diseases • Clearing house • Transposition to national legislation by 2014 • new source of legal problems?

christian.horemans@mloz.be

The Patients’ Directive The final countdown?