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? ECJ cases from 1998 onwards established certain rights for patients; confusion over interaction of these rights and existing legal instruments for: referral of patients abroad; tourists; pensioners etc.; exclusion of healthcare from the Services Directive. The ECJ has established the following principles: patients have a right to receive healthcare abroad they would be entitled to at home; they should be reimbursed the cost – but only up to the cost of that treatment in their home system; Member States may limit this right in order to manage impact of patient outflow on their systems; but: large number of unanswered questions. Commission’s original proposal: 3 pillars Common principles in EU health care systems (attempt to have minimal requirements of quality and safety); Rules for accessing cross-border healthcare (reimbursement, prior authorisation and so on); EU co-operation on healthcare (eHealth; European Reference Networks; Health Technology Assessments). European Parliament’s first reading text essentially supported the Commission on quality and safety; some useful clarifications on the reimbursement rules (e.g. gatekeeping); but some very unhelpful additions (e.g. rare diseases; disabilities); introduction of ‘direct payments’ concept; duty on regulators to pro-actively exchange information on professionals; greater stakeholder engagement in areas of cooperation. Council’s first reading text did not agree with Cion / EP on quality and safety – although agreed to transparency about systems; much more restrictive text on patient’s rights – greater use of prior authorisation; more reasons to refuse authorisation; importantly: ability to refuse because of quality and safety concerns; some important points added e.g. patient inflow; clarity that co-operation does not equal harmonisation; limited role for secondary legislation. So what happens now? now in second reading phase – vote in the ENVI Committee next week; final plenary vote in January; three months to reconcile EP and Council position… …or we’re in conciliation. EP Main outstanding issues and safety – reasons for refusal? rare diseases; direct payments; prior authorisation; eHealth. quality If we ever get there: what will happen? Impact on numbers of patients travelling: large, small, or negligible? mechanisms for determining healthcare entitlements will need to become more transparent [NB Elchinov]; problems of planning capacity? greater impact on poorer MS? greater impact (probably) for certain treatments and certain geographic regions; greater competition and choice (including from private providers in other MS) Implications for supervising organisations? depends on the text on quality and safety… …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… …and for providers outside any accreditation schemes to be given opportunity to show they meet those standards. More information: www.ukrep.be UK Permanent Representation to the EU Avenue d’Auderghem 10, B-1040 Brussels john.rowan@fco.gov.uk Tel: 0032 2 287 8270 Fax: 0032 2 287 8397