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Cross-border Healthcare Directive

Under the treaties of the European Union, healthcare systems and healthcare expenditure are normally the sole responsibility of individual Member States. However, in recent years the European Court of Justice (ECJ) has been asked to rule as to who should pay for treatment in cases where citizens have sought treatment in EU Member States outside their country of residence. Such a situation may occur because a treatment is not available in the home country, or is better managed elsewhere, or in border areas where the nearest care may actually be in another Member State. Currently, these events account for approximately 1% of the overall EU public health spending – around €10 billion per annum.

To clarify the management of such situations, the European Commission has proposed a Cross-border Healthcare Directive, to set out a legal framework for citizens who seek and receive their healthcare in a member state other than their own. By 2013, this legislation will be transposed into national law, allowing citizens to seek safe, high quality healthcare in the most appropriate member state for them. This would be in addition to the existing coordination between national social security schemes.

The medical technology industry believes the Cross-border Healthcare Directive can bring many benefits to European citizens. Currently, there are differences in how member states use information and conduct their appraisals. The Directive provides, amongst others, a legal basis for an improved exchange of HTA-related information between member states, and the principles of good governance and appropriate stakeholder consultations are a significant step forward. The medical technology industry particularly favours strong stakeholder participation, and looks forward to continuing to provide relevant expertise. The key elements in developing adequate HTA policies and methodologies will be transparency in both the objectives and work of the HTA network, alongside an open dialogue with all stakeholders. However, the role of the member states in properly implementing these principles will be vital.

Through the Cross-border Healthcare Directive, the European Commission will also set up networks to foster EU and member states cooperation on eHealth. Although the network is voluntary, this initiative will have a positive impact on the prevalence and accessibility of innovative solutions such as telemonitoring devices.

The medical technology industry is very aware of the potential that eHealth offers. Eucomed and its members are fully committed to supporting appropriate policies, legislation and pilot programmes which will assist eHealth in reaching its full potential.