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EDI - European Association of Dental Implantologists

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46<br />

<strong>EDI</strong><br />

<strong>EDI</strong> News<br />

<strong>European</strong> Commission to strengthen patients’ rights<br />

Are we Threatened by<br />

a New Wave <strong>of</strong> Regulations?<br />

Peter Knüpper, solicitor, Munich/Germany<br />

The <strong>European</strong> Court <strong>of</strong> Justice (ECJ) has passed an<br />

extensive body <strong>of</strong> legal decisions on this topic since<br />

1998. In summary, the court has stated that healthcare<br />

services are covered by the freedom to render<br />

services, which is one <strong>of</strong> the four <strong>European</strong> fundamental<br />

freedoms. The free movement <strong>of</strong> goods, persons,<br />

capital and, not least, services have long been<br />

taken for granted by most <strong>of</strong> us. Nevertheless, only<br />

30 percent <strong>of</strong> all EU citizens know that they can<br />

choose to obtain health services in other EU countries,<br />

where the social security system in the patient’s<br />

home country – whether run directly by the state or<br />

in the form <strong>of</strong> an insurance system – has to reimburse<br />

the patient if those services would have been<br />

<strong>of</strong>fered or reimbursed for in the home country.<br />

No prior authorization required<br />

for outpatient services<br />

This is exactly what the draft Directive codifies, with<br />

the result that EU citizens will no longer have to<br />

approach the ECJ in Luxembourg in order to obtain<br />

reimbursement but can confront their national<br />

administrations or health insurance institutions<br />

directly with the new Directive on patients’ rights. It<br />

states, in unison with ECJ decisions, that outpatient<br />

services do not require prior authorization. The same<br />

is true <strong>of</strong> inpatient health services that require a<br />

patient to be admitted overnight or that are included<br />

on a list <strong>of</strong> specific diseases – unless “the financial<br />

balance <strong>of</strong> the Social Security system” were threat-<br />

The <strong>European</strong> Commission finally presented its proposal for a Directive to facilitate the application<br />

<strong>of</strong> <strong>European</strong> patients' rights in relation to cross-border healthcare on 2 July 2008, as part <strong>of</strong> its<br />

Renewed Social Agenda. The proposal is intended to respond to rapid changes in the social and eco-<br />

nomic fields. It intends to promote citizens’ “social well-being” through a mixture <strong>of</strong> measures and<br />

instruments while at the same time harmonizing and modernizing the existing political armamen-<br />

tarium. The proposed Directive covers cross-border health services that patients may obtain outside<br />

their home country – such as the hip joint surgery that a British patient had had performed in<br />

France, bypassing the long waiting lists <strong>of</strong> the British National Health Service.<br />

ened or the planning and rationalization carried out<br />

in the hospital sector were “seriously undermined”<br />

(Article 8 (3) <strong>of</strong> the draft guideline). The prior authorization<br />

system must be limited to what is necessary<br />

and proportionate to avoid such an impact and must<br />

not constitute a means <strong>of</strong> arbitrary discrimination.<br />

The Member States must act to improve the flow <strong>of</strong><br />

information concerning potential healthcare services<br />

in other EU Member States.<br />

The <strong>European</strong> Commission continues to uphold<br />

the sole responsibility <strong>of</strong> the Member States for the<br />

organization and delivery <strong>of</strong> health services and<br />

medical care. The Directive also demands <strong>of</strong> the<br />

Member States to respect the principles <strong>of</strong> universality,<br />

access to quality care, equity and solidarity and<br />

define observe clear standards for quality and safety<br />

and health care. They also have to ensure that “mechanisms<br />

are in place for ensuring that healthcare<br />

providers are able to meet such standards, taking<br />

into account international medical science and generally<br />

recognized good medical practices”. In addition,<br />

EU Member States are tasked to ensure that the<br />

application <strong>of</strong> such standards in practice is regularly<br />

monitored.<br />

National contact points<br />

Healthcare providers will have to “provide all relevant<br />

information to enable patients to make an informed<br />

choice, in particular on availability, prices and outcomes<br />

<strong>of</strong> the healthcare provided”. This also includes

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