Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and...

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

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Page 1: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

Cross-border healthcare Cross-border healthcare Directive: latest newsDirective: latest news

John Rowan

First Secretary (Health and Pharmaceuticals),

Permanent Representation of the United Kingdom to the European Union

Page 2: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

Why do we have a Directive?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.

Page 3: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

The ECJ has established the following The ECJ has established the following principles: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.

Page 4: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

Commission’s original proposal: 3 Commission’s original proposal: 3 pillarspillars

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).

Page 5: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

European Parliament’s first reading European Parliament’s first reading texttext

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 co-

operation.

Page 6: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

Council’s first reading textCouncil’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.

Page 7: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

So what happens now?So what happens now? EP 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.

Page 8: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

Main outstanding issuesMain outstanding issues

quality and safety – reasons for refusal?

rare diseases; direct payments; prior authorisation; eHealth.

Page 9: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

If we ever get there: what will happen?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)

Page 10: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

Implications for supervising Implications for supervising organisations?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.

Page 11: Cross-border healthcare Directive: latest news John Rowan First Secretary (Health and Pharmaceuticals), Permanent Representation of the United Kingdom.

More information:www.ukrep.be

UK Permanent Representation to the EUAvenue d’Auderghem 10, B-1040 Brussels

[email protected]: 0032 2 287 8270

Fax: 0032 2 287 8397