Last summer, the European Commission put forward a proposal for a Directive on the application of patient’s rights in cross-border healthcare as part of the Renewed Social Agenda. The proposal aims to help patients exercise their rights to crossborder health care in order to codify the case law of the EU Court of Justice and seeks to promote cooperation between the national health systems.
The ECJ has been ruling that patients have the right, under the EC Treaty, to seek healthcare within the EU and be reimbursed of healthcare costs received abroad that they would have been entitled to receive at the Member State of affiliation meaning where the patient is an insured person. According to the ECJ the requirement of prior authorisation for reimbursement of a patient’s costs for treatment received in another Member State represents a barrier to the freedom to provide services.
The Commission has pointed out that “the uncertainty about the general application of rights to reimbursement for healthcare provided in other Member States is creating obstacles to the free movement of patients and of health services more generally in practice.” Consequently, the Commission has addressed the issue of reimbursement of the cost of healthcare provided in other Member States in its draft proposal.
The EU Member States are widely divided on the need for such legislative proposal and on how this area should be regulated. Several Member states fear loss of national sovereignty over healthcare, that such proposal could have a negative impact on their ability to organise their respective national health systems or on the safety and security of patients. The Commission proposal might put the NHS financial stability at risk.
Member States have stressed that they should be able to make the use of cross-border healthcare subject to prior authorization. The main outstanding issues concern the definition of 'hospital' and 'non-hospital' care and 'specialised' care, as well as the principle of prior authorisation for care reimbursement and the management of incoming patient flows from outside their jurisdiction.
On 23 April, the European Parliament adopted a first-reading report on patients’ rights in cross-border health care. The European Parliament underlined that the prior authorisation requirement must not create an obstacle to the freedom of movement of patients.
The Commission proposal would allow patients to seek healthcare in another Member State which would have been provided at home and be reimbursed up to the amount that would have been paid if they have had that treatment at home. Under Article 6 (1) of the draft proposal the Member States of affiliation would be required to ensure that their patients seeking to receive healthcare provided in another Member State would not be prevented from receiving it.
However, it is not clear what it would be the scope of such duty of the home state or whether it is enforceable. According to the European Scrutiny Committee “(…) it is not apparent that the duty is limited to events within the home State, or that the home State has any power to require healthcare providers in another State to treat a patient.” The ESC has doubts concerning home State ability to ensure that the patient is not prevented from receiving the treatment in question.
The Commission has stressed that a prior authorisation requirement on cross-border non-hospital care represents an obstacle to the free movement of health services which is not justified. The Commission has pointed out that the absence of a prior authorisation requirement will not undermine the financial equilibrium of social security systems or the organisation, planning and delivery of health services if the reimbursement of cross-border non-hospital care is within the limits of the cover guaranteed by the sickness insurance scheme of the Member State of affiliation.
Under the Commission draft proposal patients would be allowed to seek non-hospital care in another Member State and Member States would no longer be able to require prior authorization. A Member State would not be obliged to reimburse treatment provided in another Member State which is not offered by its own national health system.
The European Parliament agreed with the rule that patients are to be reimbursed up to the level they would have received in their home country. Whereas the Commission has proposed that the member state of affiliation would be obliged to reimburse only “the actual cost of treatment,”, the MEPs added that “Member States may decide to cover other related costs, such as therapeutic treatment and accommodation and travel costs.”
On the question of patients paying in advance and get reimbursed latter the European Parliament included a new provision under which Member States would be allowed to offer their patients a system of voluntary prior notification. Hence, citizens travelling abroad for treatment would obtain approval from their health authority in advance. In return, for such notification, reimbursement would be made directly by the Member State of affiliation to the hospital of treatment.
The European Parliament proposes therefore the creation of a system where the social security system of the member state of afiliation will make a direct payment to the hospital of treatment, either through a central clearing house or through a “bilateral voucher system” for the patient to take to the hospital and guaranteeing payment to the hospital by the member state of affiliation.
The European Parliament called on the Commission to carry out a study on the viability of establishing a clearing house to facilitate the reimbursement of costs under the draft Directive across borders, within two years of the directive’s entry into force and, if necessary, to present a legislative proposal.
The MEPs support the Commission proposal under which patients will have the right to seek healthcare abroad but Member States may nevertheless introduce a system requiring prior authorisation for the reimbursement of hospital costs if their social security system financial balance could be seriously undermined.
In what concerns hospital care Member States would be allowed to introduce a prior authorisation scheme for reimbursement. However, Member States must provide evidence that due to the directive implementation the outflow of patients is likely or seriously undermines the financial balance of the social security system or the planning of hospital capacity. Nevertheless, if a Member State has established a system of prior authorisation for assumption of costs of hospital care provided in another Member State, the costs of such care should also be reimbursed by the home Member State up to the level of costs that would have been taken had the same treatment been provided at home.
MEPs agreed upon the possibility of introducing a system of prior authorization for the reimbursement of the costs of hospital care, but they voted for the definition for hospital care to come from the member states and not from the Commission, as was initially proposed.
The Commission believes that the absence of a common definition of what constitutes hospital care throughout the different health systems in the EU represents an obstacle to the freedom for patients to obtain healthcare services. Hence, unsurprisingly, the Commission has introduced a Community definition of hospital care which is “treatment that requires at least one night of stay in a hospital or clinic” and treatment that requires the use of highly specialised and cost-intensive medical infrastructure or medical equipment. The Commission will, through the comitology procedure, define a regularly updated technical list of such treatments.
In fact, under the drat proposal a lot of room is left to comitology which will diminish Member States control over the content of such measures.
It is clear that the Draft Directive would make more difficult for the member states to require prior authorisation for reimbursement of hospital treatment provided in another Member State.
The European Parliament also voted to introduce special rules for patients with rare diseases and disabilities who may need special treatment. These patients would have the right to access healthcare in another Member State not subject to prior authorisation and to reimbursement “even if the treatment in question is not among the benefits provided for by the legislation of the Member State of affiliation.”
The MEPs have excluded long-term care and organ transplants from the directive scope.
Under the draft proposal the home state is allowed to impose on a patient seeking healthcare provided in another Member State its general requirements, criteria for eligibility and administrative formalities for receipt of healthcare and reimbursement of healthcare costs, as it would impose if the same treatment was provided at home providing that such conditions are necessary, proportionate and are not discretionary and discriminatory.
Member States would be required to establish national contact points for cross-border healthcare to provide patients information on their right to seek care within the EU. The European Parliament also proposes the creation of a European Patients Ombudsman to take care of patients' complaints regarding prior authorisation, reimbursement of costs or harm. According to the European Scrutiny Committee any “European” Ombudsman should solely have the power to investigate the actions of the European Institutions but not the actions of national or regional governments. The ESC is concerned that the European Ombudsman could be a “court of appeal against the findings and conclusions of the national ombudsmen for health services.”
The draft directive creates further bureaucratic and administrative burdens for health systems. According to Euractiv a member state representative has said "It is justifiable to ask how big the administrative burden will be compared to the number of people actually crossing borders to seek care and to calculate how much tax payers' money is spent on maintaining an administration to serve those few.”
The draft directive will be discussed by ministers at the Employment, Social Affairs, Health and Consumer Affairs Council in June 2009. It remains to be seen what will come out from the negotiations but it should be noticed that the UK cannot veto the proposal as QMV is required at the Council. Long and fierce discussions at the Council and with the European Parliament are foreseen.
On 8 June the Health and Consumer Affairs Council reached an agreement on the draft directive concerning the application of patient’s rights in cross-border healthcare.
The Commission proposal would allow patients to seek healthcare in another Member State and be reimbursed up to the amount that would have been paid if they have had that treatment at home.
The Council and the European Commission have different views on the issue of prior authorisation for reimbursement of health care costs. Member States have been stressing that they should be able to make the use of cross-border healthcare subject to prior authorization.
Under the Spanish Presidency’s compromise text, “as a general rule”, patients would be allowed to seek health care in another Member State and be reimbursed up to the level of costs that would have been taken had the same treatment been provided at home. If due to the directive implementation the outflow of patients is likely or seriously undermines the financial balance of the social security system the Member State of affiliation may restrict the application of the rules on reimbursement for cross-border healthcare.
Moreover, Member States would be allowed to make the reimbursement of costs of cross-border healthcare subject to prior authorisation, if the treatment requires at least one night stay in a hospital, requires the use of highly specialised and cost-intensive medical infrastructure or medical equipment, or raises “serious and concrete concerns related with the quality or safety of the care.”
The main controversial issue has been the cross-border health care coverage for pensioners. The Council has agreed that if pensioners live abroad but return to their country of origin to health treatment this country should bear the costs.
It remains to be seen what will come out from the negotiations with the European Parliament.
Dear Ms. Vasconcelos,
May I have your e-mail address? I would be grateful if you send me an e-mail on account of the importance of the subject of your articles for my master thesis.
Yours sincerely,
Luciana Santos
My apologies for the delayed response. Thank you very much for your interest in my articles. You can reach me at the following email address: vasconcelos@e-f.org.uk
On 1 December, the Health Council has reached no political agreement on a draft directive concerning the application of patients’ rights in cross-border healthcare.
The main outstanding issue is the reimbursement of costs with regard to non-contractual healthcare providers. Nine Member States, including Spain, Hungary, Portugal and Italy, could not accept having private, non-contracted health care treatment within the scope of the directive.
According to the EuropeanVoice, Androulla Vassiliou, the European commissioner for health, has said “The next European Commission will take time to think about this failure and honestly I do not exclude the possibility of withdrawing this proposal (…).”
The draft directive was discussed by the EU’s Health Ministers on 9 June. The Czech Presidency compromise proposal was generally welcomed but it still needs to be further amended as there are some crucial outstanding issues.
Member States have different understanding of key terms used in the proposal related to the different organisation of health systems in Europe. There are Member States which have a system of health insurance whereas others have a national health system (NHS).
The actual content of key terms is an outstanding issue. The definition of “healthcare” still needs to be finalised. Moreover, more clarification is needed for terms such as “statutory social security/ public health system” and “long-term care.”
Several Member States want to limit the scope of the Directive to health care providers contracted to provide services to public health insurance or otherwise recognized by the public system whereas other Member States favour the Presidency proposal that the Directive should incorporate all healthcare regardless of the status of the healthcare provider.
Moreover, a considerable number of Member States requested for long term care to be excluded from the scope of the Directive.
The Member States could not agree yet on “reasons for refusal to grant prior authorisation,” the reimbursement of prescriptions and the legal basis of the directive.