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Published on 1 November 2007

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New health directive proposed

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Brian Edwards

CBE

Emeritus Professor of Healthcare Development
University of Sheffield
UK

President
HOPE (European ­Hospital and Healthcare ­Federation)

The European Commission has published proposals for a new directive on safe, high-quality, efficient crossborder care.[1] The directive builds on judgements in the European Court and seeks to clarify rules for patients. In essence, it will let patients seek any healthcare abroad that they would have been provided at home and be reimbursed up to the amount that would have been paid had they obtained that treatment at home, but bear the financial risk of any additional costs arising. The directive will prohibit patients making a profit by securing treatment at a rate lower than the reimbursable cost in their home country.

There are qualifications to this right and several practical consequences. In some countries it is unclear what a citizen’s entitlement at home might be, particularly if costly new technologies and treatments are involved. If a service is not provided at home citizens cannot secure it abroad and send the bill home. Health and social security systems remain firmly in national governments’ hands. The EU may lay down general rules, but that is as far as its powers go. The directive will neither lay down minimum European healthcare standards, nor change rules on co-payment if that is a part of a national system’s entitlement structure.

However, the directive will lay down principles. First, each state must ensure systems are in place to secure quality and patient safety. How this is done is up to individual states. The second principle relates to patients’ ability to make informed choices. Free movement requires that patients can access medical, financial and practical data relevant to the healthcare they seek, plus knowledge about entitlements and procedures for gaining recompense. Citizens’ level of understanding about their rights is low. Each country will set up a contact point to support patients and ensure out-of-court procedures are available for settling crossborder disputes.

Other principles govern what will happen if things go wrong (requiring that patients have ways to challenge poor care, with the duty of quality assurance lying firmly with the state providing treatment), and transfer of patients’ records − a sensitive issue in view of confidentiality and data-protection laws.

Individual states can opt to institute systems requiring prior authorisation for reimbursement of care in another state. This may include price charged. But member states must co-operate in border regions. There is also a requirement to set time limits within which requests for treatment authorisation in another state must be given, and to specify who is authorised to decide on this. Inpatient care is defined as admission for longer than one night, but the exclusion of daycase surgery and many procedures undertaken on an ambulatory-care basis means exceptions will arise. There will be an EU list of reimbursable treatments. Prescription drugs have always complicated crossborder care. There is significant variation in the extent to which scripts written in one state will be accepted in another. Member states will have to lay down pro­cedures to handle uncertainty.

In two further steps the Commission begins to build EU-level health systems. The first provides for developing European rare-disease reference networks and setting up a community network for health technology assessment. The latter move may have great significance for the pharmaceutical industry if technology assessments are to have EU-wide impact. Excellent for products that get endorsed, but catastrophic for those that do not.

As this draft directive winds its way through legislative processes, many will question whether the bureaucratic consequences and costs are worth the gain, given how few citizens appear to want to exercise crossborder rights. Informal collaboration has progressed reasonably well in recent years. Legal certainty may prove costly and will certainly complicate business for healthcare providers, whether in the public or private sectors.

1. European Commission. Proposal for a directive of the European Parliament and of the Council on safe, high-quality and efficient cross-border care. Brussels: EC; 2007.



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