Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom to the European Union

Why do we have a Directive? l ECJ cases from 1998 onwards established certain rights for patients; l confusion over interaction of these rights and existing legal instruments for: referral of patients abroad; tourists; pensioners etc.; l exclusion of healthcare from the Services Directive.

The ECJ has established the following principles: l patients have a right to receive healthcare abroad they would be entitled to at home; l they should be reimbursed the cost – but only up to the cost of that treatment in their home system; l Member States may limit this right in order to manage impact of patient outflow on their systems; l but: large number of unanswered questions.

Commission’s original proposal: 3 pillars l Common principles in EU health care systems (attempt to have minimal requirements of quality and safety); l Rules for accessing cross-border healthcare (reimbursement, prior authorisation and so on); l EU co-operation on healthcare (eHealth; European Reference Networks; Health Technology Assessments).

European Parliament’s first reading text l essentially supported the Commission on quality and safety; l some useful clarifications on the reimbursement rules (e.g. gatekeeping); but some very unhelpful additions (e.g. rare diseases; disabilities); l introduction of ‘direct payments’ concept; l duty on regulators to pro-actively exchange information on professionals; l greater stakeholder engagement in areas of co- operation.

Council’s first reading text l did not agree with Cion / EP on quality and safety – although agreed to transparency about systems; l much more restrictive text on patient’s rights – greater use of prior authorisation; more reasons to refuse authorisation; l importantly: ability to refuse because of quality and safety concerns; l some important points added e.g. patient inflow; l clarity that co-operation does not equal harmonisation; limited role for secondary legislation.

So what happens now? l EP now in second reading phase – vote in the ENVI Committee next week; l final plenary vote in January; l three months to reconcile EP and Council position… l …or we’re in conciliation.

Main outstanding issues l quality and safety – reasons for refusal? l rare diseases; l direct payments; l prior authorisation; l eHealth.

If we ever get there: what will happen? l Impact on numbers of patients travelling: large, small, or negligible? l mechanisms for determining healthcare entitlements will need to become more transparent [NB Elchinov]; l problems of planning capacity? greater impact on poorer MS? l greater impact (probably) for certain treatments and certain geographic regions; l greater competition and choice (including from private providers in other MS)

Implications for supervising organisations? l depends on the text on quality and safety… l …but my guess is that there will be a requirement for each MS to publish a list of those organisations it considers to meet quality and safety standards… l …and for providers outside any accreditation schemes to be given opportunity to show they meet those standards.

More information: UK Permanent Representation to the EU Avenue d’Auderghem 10, B-1040 Brussels Tel: Fax: