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Brussels, 2 July 2008

Questions and Answers on the draft Directive on the application of patients' rights in cross-border healthcare

What does this proposal mean for citizens and patients?

This draft Directive clarifies the rights of patients to seek healthcare in another Member State as recognised by the European Court of Justice and simplifies their application in practice. Once the proposed Directive is implemented by the Member States, it will have the following practical benefits for citizens:

  • As long as a treatment is covered under their national healthcare system, patients will be allowed to receive that treatment in another EU country and be reimbursed without prior authorisation. For hospital care however, under certain circumstances, a Member State may decide to introduce a system in which patients require an administrative prior authorisation before seeking care abroad.
  • The patient will have to pay the costs to the healthcare provider abroad up front, but will have those costs afterwards reimbursed up to the level of reimbursement for the same or similar treatment in their national health system.
  • Patients will be guaranteed fair and quick procedures, including for the actual reimbursement of costs, and will have the right to ask for a review of any administrative decision regarding cross-border healthcare.
  • Patients will have easier access to all relevant information about cross-border healthcare, in particular through national contact points, so that they can make informed decisions about using cross-border healthcare.
  • Patients will be guaranteed access to their medical records and the protection of their personal data will also be guaranteed in the cross-border healthcare setting.
  • It will be easier for patients to have a prescription they received abroad obtained after their return to their home Member State. This will to ensure appropriate follow-up to the healthcare provided in another Member State.
  • As a result of European cooperation in fields such as the European reference networks, patients will have access to highly specialised healthcare that they otherwise may not have.
  • Patients can be confident about the quality and safety standards of healthcare abroad, which are guaranteed in the same way as they are for domestic patients. The country where treatment is provided is responsible for clinical oversight. This is the case regardless of how this treatment is paid for.
  • If something goes wrong, patients will be guaranteed redress and compensation and will be provided with assistance by national contact points for cross-border healthcare.
  • Patients coming from another EU country to benefit from cross-border healthcare will be treated in a non discriminatory way and enjoy equal treatment with the nationals of the country in which they are treated.

Why a specific initiative on cross-border healthcare?

In 2003, Health ministers and other stakeholders invited the Commission to explore how legal certainty could be improved following the European Court of Justice (ECJ) jurisprudence concerning the right of patients to benefit from medical treatment in another Member State.

The Commission’s proposal for a Directive on services in the internal market in early 2004 included provisions codifying the rulings of the ECJ in applying free movement principles to healthcare. This approach, however, was rejected by the European Parliament and the Council. It was felt that the specificities of cross-border healthcare were not sufficiently taken into account.

The Commission, therefore, undertook to explore how best to develop a policy initiative specifically targeting cross-border healthcare as a separate issue.

What are the Directive's reimbursement rules?

  • The Directive reflects the following principles: Any non-hospital care to which citizens are entitled in their own Member State, they may also seek in any other Member State without prior authorisation, and be reimbursed up to the level of reimbursement provided by their own system.
  • Any hospital care that the citizens are entitled to in their own Member State, they may also seek in any other Member State, and also be reimbursed up to the level of reimbursement provided by their own system. If an unpredictable surge of cross-border healthcare risks becoming a serious problem, the proposal provides for a specific safeguard clause. Indeed, in accordance with case law of the ECJ, it allows a Member State to put in place a system of prior authorisation for hospital care, to safeguard its overall system if necessary.

In any event, the Member States may impose the same conditions on seeking cross-border care as they apply domestically, such as the requirement to consult a general practitioner before consulting a specialist or before receiving hospital care.

This proposal does not change the right of Member States to define the benefits that they choose to provide. If a Member State does not include a particular treatment as part of the entitlement of their citizens at home, this directive does not create any new entitlement for patients to have such treatment abroad and be reimbursed.

How does the proposal ensure the quality and safety of cross-border healthcare?

For the moment, there are no clear rules at Community level about how the requirements of appropriate information, quality, safety and continuity of healthcare should be met for cross-border healthcare, or who is responsible for ensuring that they are. This is the case no matter how the care is paid for – whether it is paid for publicly or privately, whether it is undertaken through the regulation on coordination of social security systems or whether it is in relation to the free movement rights described above. Without such clarity, there is the risk of confusion leading to difficulties in ensuring quality and safety of healthcare in cross-border cases.

The proposed directive, therefore, sets out:

  1. that the safety and quality standards that apply are those of the Member States where the care is provided
  2. that such standards should be based on the Council conclusions on "Common values and principles in European Union Health Systems" adopted in June 2006
  3. that it should be for the authorities of the Member State of treatment to ensure correct and continuing application of such standards..

What is the role of the national contact points?

Appropriate information for patients is a necessary precondition for improving patients' confidence in cross-border healthcare as well as achieving a high level of health protection. Often, clear information is felt to be missing. The Directive, therefore, sets out the requirements for information, on all essential aspects of cross-border healthcare, to be provided through national contact points. The form and the numbers of these national contact points are to be decided by the Member States. The Member States should have appropriate facilities to provide information on possibilities for cross-border healthcare and the applicable processes, and to provide practical assistance to patients if needed.

What is the aim of the European reference networks?

This initiative supports the further development of the European reference networks, which will bring together, on a voluntary basis, specialised centres in different Member States. This collaboration has great potential to bring benefits to patients through easier access to highly specialised care. It can also be useful to health systems as it would facilitate the efficient use of resources, for example by pooling resources to tackle rare conditions.

How does e-Health relate to this initiative?

Activities in the field of "e-Health" would be strengthened with this initiative. Information and communication technologies have enormous potential to improve the quality, safety and efficiency of healthcare. The Commission already supports existing e-health projects covering areas such as remote provision of specialist support from large hospitals to smaller local facilities and monitoring of chronic diseases to enable people with chronic conditions to remain active. What is lacking, however, are shared formats and standards that can be used between different systems and different countries. The directive will assist these to be put in place, thus strengthening and enhancing cooperation in e-Health.

What are the existing rules for cross-border health care?

The first discussions about “patient mobility” at EU level were prompted in 1998 after judgements of the European Court of Justice (ECJ). Until then, the only EU mechanism enabling patients to receive treatment abroad (other than patients paying for such treatment privately) was the Regulation on the coordination of social security schemes (1408/71). This regulation entitles patients, whose treatment becomes necessary during a stay in another Member State (for example people travelling, studying or working abroad), to the same benefits as patients insured in the host Member State. It also provides for planned treatment in other Member States, subject to prior authorisation.

In 1998, the ECJ established additional principles through its rulings in the cases of Kohl and Decker. In these rulings, the Court made clear that as healthcare is provided for remuneration, it must be regarded as a service within the meaning of the EU Treaty and thus relevant provisions on free movement of services apply.

The Court also ruled that measures making reimbursement of costs incurred in another Member State subject to prior authorisation, are barriers to freedom to provide services, although such barriers may be justified by overriding reasons of general interest. These reasons include a risk of seriously undermining the financial balance of social security systems; the need to ensure provision of a balanced medical and hospital service accessible to all; or the maintenance of a treatment facility or medical service on national territory which is essential for public health.

If the EJC has already addressed this issue, why do we need a new proposal?

The rulings on the individual cases are clear in themselves. However, uncertainty has remained over how to apply their principles more generally. Moreover, there are no Community rules about how quality and safety of cross-border healthcare should be ensured. In many areas uncertainty continues to exist over how the principles established by the ECJ can be applied in practice by patients, health professionals and Member State regulators. These include:

  • uncertainty about the quality and safety of healthcare provided abroad;
  • uncertainty about which country is responsible for clinical oversight for cross-border healthcare;
  • uncertainty about authorisation and reimbursement of cross-border healthcare;
  • uncertainty about whether Member States have the possibility to regulate and plan their own systems without creating unjustified barriers to free movement;
  • uncertainty for patients and professionals in trying to identify, compare or choose between providers in other countries;
  • uncertainty about what happens if patients suffer harm from cross-border healthcare.

This proposal aims to address these concerns and bring legal clarity to all stakeholders.

Why would someone want to receive healthcare abroad?

Citizens usually prefer to receive healthcare close to where they live. However, in specific situations it may be more efficient or beneficial to receive healthcare abroad. This may be the case for patients who live in border regions as the healthcare provided abroad is just closer to their home.

Sometimes there is more capacity or expertise available in another Member State, such as for certain highly specialised treatments, or healthcare can be provided faster due to spare capacity of healthcare providers abroad. And for some Europeans it is more convenient to receive care away from their home country because their family and friends live in another Member State.

Whatever the reason, the European Court of Justice has recognised that patients have the right to receive healthcare in another Member State and be reimbursed for that healthcare for up to the amount they would have received in their own country.

How common is cross-border health care?

On average 1% of public healthcare budgets is spent on cross-border healthcare annually. That is about €10 billion per year. Cross-border health care is more frequent:

  • in border regions
  • smaller Member States
  • for the treatment of rare diseases
  • in areas attracting large amounts of tourists.

Even in these instances, cross-border care still represents only a very small fragment of total healthcare spending. The aim of this initiative is not to encourage cross-border healthcare as such. Most of the time healthcare is best provided close to where the patient lives. People prefer to have healthcare as close to home as possible, and our surveys show that the vast majority of patients throughout the EU are content with the care provided by their domestic system – over 90% across the EU as a whole.

Most of those who state they are not content still prefer to have their healthcare within their own country. But when receiving healthcare abroad is beneficial it should be possible, safe and of good quality. Procedures for reimbursement should be clear and responsibilities should be clearly defined and allocated.

How will this directive be implemented?

The proposed Directive provides a general framework for the application of cross-border healthcare patient rights, which the Member States will then implement as fits best with their systems, at national, regional or local level. This proposal will be sent to both the European Parliament and the Council of Ministers of the European Union for adoption. After adoption a Comitology committee will be established to further specify the measures necessary for the implementation of this Directive.

Further technical implementation measures may also be adopted at Community level (in agreement with the Member States), for example to define, for the purposes of this Directive a list of treatments, other than those requiring overnight accommodation, which would be subject to the same regime as hospital care.

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