Commission Européenne: Directive droit des patients et frontières ou tourisme médical et e-santé

Après avoir annoncé diverses décisions depuis 10 ans, la Commission Européenne a émis hier une directive concernant la liberté des patients d'aller dans un autre pays  chercher un service, et être remboursés.Ceci entraîne des considérations de transmission de l'information médicale prérequis, pour que ce "tourisme médical" puisse avoir lieu.

L'e-santé avancera-t-elle plus vite, facilitant la traduction de résultats d'examens, imagerie, etc...? ou les patients seront-ils obligés de chercher et transporter leurs dossiers personnellement pendant encore de longues années, voire de partir sans...? Cliquer pour lire un briefing paper sur la directive européenne.

Rédigé par le Dr Petra Wilson:

Today  the European Commission announced new policy initiatives on Patients' Rights as part of the Social Package. Commissioner Vassiliou introduced the 'Directive on the application of patients’ rights in cross-border Healthcare '. The  purpose of the Directive is to codify into a Directive the rulings on cross-border healthcare which have been handed down by the European Court of Justice in the past decade. 

This Directive is to a large extent a repackaging of the Health Services Directive, which was delayed amid controversy over the creation of new burdens upon national health systems through 'health tourism' in December 2007. Most of the re-working of the Directive is cosmetic, emphasizing that this is a limited provision which doesn't step on the Member States' toes too much, but simply puts in place a legislative framework which is in line with the existing case-law.

Purpose of the Directive
The  purpose of the Directive is to codify into a Directive the rulings on cross-border healthcare which have been handed down by the European Court of Justice in the past decade. In particular these are that the freedom to provide services includes the freedom of recipients of medical treatment to go to another Member Sate in order to receive those services.

The Directive sets out the following key points:
·   European citizens are entitled to travel to any Member State to receive non-hospital care. Where such care would have been paid for or reimbursed in the State in which they are insured, the costs of the care they receive in another State shall be reimbursed. No prior authorisation of the home State will be required.

·   For hospital based care, (meaning broadly anything which is either highly specialised or requires one overnight stay), Member States may put in place a procedure for prior authorisation.  Such prior authorisation may be required in cases where the implementation of the Directive could seriously undermine the financial balance of the social security system and/or the outflow of patients could seriously undermine the planning and rationalisation carried out in the hospital sector. In such cases the introduction of a prior authorisation scheme must be proportionate and justifiable.

·   The Directive provides that whether the care is in-hospital or non-hospital, the healthcare professional  will be subject to the rules governing the practice of healthcare applicable in the country in which the care is delivered.

·   The Directive sets out requirements for appropriate systems of information provision on cross-border so that citizens can easily inform themselves of care available in other Member States

·   The Directive calls for the establishment of reference networks to promote and facilitate sharing of knowledge and skills across Member States.

·   The Directive provides for further work on eHealth standardisation and Interoperability

eHealth and ICT in the Proposed Directive
The new Directive contains measures to promote eHealth, going beyond what was proposed in previous version, noting in particular that the ‘Provision of cross-border healthcare does not necessary require either the patient or the professional to physically change countries, but may be provided through information and communication technologies’.
The Directive clearly recognises eHealth as a key element in the growing cross-border health services market. And gives the Commission a mandate to take stronger action on interoperability.
The eHealth Article (Art. 16)  specifically gives the Commission the power to specify 'standards and terminologies for interoperability' of eHealth technologies. The earlier draft did not specifically mention establishing standards.
In an attempt to assuage the fears of Member States about an erosion of their eHealth decision-making powers, the explanatory note to this article clearly states that, ‘the proposal does not oblige any introduction of e-health systems or services, but aims at ensuring interoperability once the choice of introducing such systems is done by Member States’
Nevertheless,  the new text of Article 16 clearly gives the Commission a mandate to create standards for eHealth technologies where necessary. Note that the announcement of 2nd July 2008 includes also the publication of the Commission’s Recommendation on Interoperability in Electronic Health Records.
The two reasons cited for why such standards are ‘necessary’ are health protection, and promoting the internal market in eHealth. The impact on the eHealth market of such standards could be enormous – compare with the Commission’s role in establishing the GSM standard for mobile phones in Europe, which had a huge market impact, and also the current attempts to establish a ‘voluntary’ standard for mobile TV, which are also likely to have a major impact.
The Directive  also proposes the creation of a network to connect national authorities responsible for new health technology assessment (Art. 18). This will be a vehicle for exchanges of information about the effectiveness of new health technologies. Most of the work of the network will be concerned with considering whether new pharmaceutical drugs are cost effective, rather than looking at eHealth solutions.

Opportunities for  engagement
eHealth is not the most controversial aspect of the Directive - what will grab the headlines will be the concept of 'health tourism' – and therefore eHealth issues will not automatically take the spotlight in this discussion. However, the directive clearly opens the door for continued engagement at European policy level on a number of issues:
·   To become law the Directive  has to be adopted by the European Parliament, it will therefore play a much bigger role in comparison to previous eHealth initiatives (such as the eHealth Action Plan).  The process will provide an excellent opportunity to engage with  MEPs, and to seek to reinforce the eHealth provisions of the Directive during its progress through the Parliament.
·   Based on the Directive the Commission will step up its work on EU-wide interoperability standards for eHealth. It will be increasingly important to  work with the Commission in order to shape the debate around terminology and standards, bringing a clear view from the eHealth industry about how standards should emerge (market-driven or regulatory) and which technical standards are appropriate.
·   The proposed network of national authorities responsible for new health technology assessment could provide a forum for discussion over the implementation of new eHealth technologies.
· Finally, the strong commitment to reference networks for sharing knowledge and expertise provides an ideal opportunity to promote the use of eHealth Networks, building on such examples as the Baltic eHealth Exchange.

Cisco IBSG has a strong history of engaging with the European Commission and Parliament on all these issues and will continue to engage actively as we move into a new phase of Health and eHealth policy in Europe. Petra Wilson, Cisco, Internet Business Solutions Group

Today  the European Commission announced new policy initiatives on Patients' Rights as part of the Social Package. Commissioner Vassiliou introduced the 'Directive on the application of patients’ rights in cross-border Healthcare '. The  purpose of the Directive is to codify into a Directive the rulings on cross-border healthcare which have been handed down by the European Court of Justice in the past decade.