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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;

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Cross border healthcare directive latest news

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
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
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
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
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 co-operation.

Council s first reading text
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
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.

Main outstanding issues
Main outstanding issues

  • quality and safety – reasons for refusal?

  • rare diseases;

  • direct payments;

  • prior authorisation;

  • eHealth.

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)

Implications for supervising organisations
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:

UK Permanent Representation to the EU

Avenue d’Auderghem 10, B-1040 [email protected]

Tel: 0032 2 287 8270

Fax: 0032 2 287 8397