“Health tourism”

To recall, the Commission adopted, in 2008, a proposal for a Directive on the application of patient’s rights in cross-border healthcare which has been considered to promote “health tourism.” The proposal aims to help patients exercise their rights to cross border 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 EU Member States have been 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 and 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. Hence, Member States have been stressing that they should be able to make the use of cross-border healthcare subject to prior authorization. Last June, the Council agreed on the draft directive on the basis of a compromise proposal by the Spanish presidency. The Council adopted, today, its common position, at first reading, by qualified majority and the European Parliament’s second reading is scheduled for December.

The main aim of the draft directive is to establish “a general framework for provision of safe, high quality and efficient cross-border healthcare” as well as to remove obstacles to patients’ freedom of movement. It contains, therefore, provisions on prior authorisation and reimbursement of healthcare provided in another Member State. The Commission has said that “the Directive fully respects the differences of national health-care systems and the Member States' responsibilities for organisation and delivery of health services and medical care.” According to the Commission, the draft proposal will not endanger the financial balance of Member States' healthcare and social security systems. However, the wording of the Commission’s draft proposal could not guarantee that. The Council and the European Parliament have tried to enhance this idea. Both the European Parliament and the Council believe that it should be specified in the draft directive that it “establishes cooperation mechanisms on healthcare between Member States, whilst fully respecting national competencies in the organisation and delivery of healthcare.” The Council also included a provision which provides that the proposal “shall not affect laws and regulations in Member States relating to the organisation and financing of healthcare in situations not related to cross-border healthcare.” Moreover, the Council and the MEPs included in the proposal that the draft directive recognises member states freedom to organise their healthcare and social security systems including that entitlement for treatment can be decided at regional or local level. Hence, with this amendment to the Commission proposal, the de-centralised healthcare in the UK would be recognised. Nevertheless, one could wonder whether the legislative proposal respects the responsibilities and competences of the Member States with regard to the organisation and planning of national health systems.

The Council and the MEPs have broadened the scope of the directive. Both specified that for the purpose of reimbursing cross-border healthcare, the present draft Directive not only covers situations where the patient receives healthcare provided in another Member State but also health goods, including prescriptions, dispensation and provision of medicinal products and medical devices when provided in the context of a health service. In the other hand, the European Parliament as well as the Council amended the Commission proposal in order to specify that the directive shall not apply to health services in the field of long-term care, including services provided over an extended period of time whose purpose is to support people in need of assistance in carrying out daily routines. Moreover, the European Parliament introduced a provision stating that the Directive does not apply to organ transplants. The Council has also included the exclusion of public vaccination programmes against infectious diseases.

The Commission has defined "Member State of treatment" as the Member State on where cross-border healthcare is actually provided. The Council has stressed that under Article 168(7) TFEU the organisation and delivery of health services and medical care is Member States’ responsibility. In order to ensure the freedom to provide and obtain cross border healthcare Member States' authorities must ensure that all patients are treated equitably on the basis of their healthcare need. The draft proposal provides that Member States patients shall enjoy equal treatment with the nationals of the Member State of treatment. The Council takes the view that it should be possible for the Member State of treatment, where justified by overriding reasons of general interest, to adopt measures on the access to treatment meant to fulfil its responsibility to guarantee sufficient and permanent access to healthcare within its territory.
The European Parliament and the Council both specified in the proposal that the legislation of the Member State of treatment shall apply to cross-border healthcare which shall be provided according to that Member State defined standards and guidelines on quality and safety.

According to the MEPs and the Council the Member State of treatment shall ensure that patients receive, if requested, information on standards and guidelines as well as information on which healthcare providers are subject those standards. Moreover, patients shall get information by healthcare providers on the healthcare availability that they provide, including information on prices. Patients shall also be provided with information on the healthcare providers’ authorisation or registration status and their insurance cover. The Council specified that healthcare provides are not obliged to provide more information to patients from another member state than they are already providing to patients resident in the Member State of treatment. Moreover, according to the Council compromise text, Member States are not obliged to provide information in other languages than those which are official languages in the concerned Member State. In the other hand, the MEPs believe that information on the quality and safety standards of the Member State of treatment should be published “in a language and format that is clear and accessible to all citizens.”

Under the draft proposal, the member states of treatment would be required to put in place systems and mechanisms for making complaints, according to their legislation, for patients to seek remedies, in case of harm arising from the healthcare they receive. Both the European Parliament and the Council positions on the draft proposal provide that patients who have received treatment should be entitled to a written or electronic medical record of the treatment. Moreover, according to the European Parliament, Member States shall put in place a mechanism for the calculation of costs for the charges for the healthcare provided which shall be based on objective, non discriminatory criteria.

Under the Commission 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. The European Scrutiny Committee has expressed doubts over the home State ability to ensure that the patient is not prevented from receiving the treatment in question. The Council has not included this provision in the draft proposal.

The Council common position specifies that the Member State of affiliation is responsible for determining the conditions, criteria and formalities relating to entitlements to healthcare. Nevertheless, conditions, criteria and formalities related to clinical circumstances, including considering patient safety risks in performing a specific procedure, might be imposed by the Member State of treatment.

The Commission’s proposal would allow patients to seek healthcare in another Member State which would have been provided at home and then be reimbursed the costs of anything up to the full amount that would have been paid if they have had received 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 Commission draft proposal there is no requirement of prior authorisation for reimbursement by the statutory social security system of a Member State of affiliation for healthcare considered as non-hospital care. The Commission has asserted 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. 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.
Hence, under the draft proposal the Member State of affiliation shall not make subject to prior authorisation the reimbursement of the costs of non-hospital care provided in another Member State if the cost of that care, if it had been provided in its territory, would have been paid for by its social security system. The European Parliaments includes in the provision the purchase of goods connected with healthcare which are purchased in another Member State if they had been purchased in its territory, would have been paid for by its social security system.

Under the Council common position the Member State of affiliation shall be the one to determine, whether at a local, regional or national level healthcare for which an insured person is entitled to reimbursement of costs and the level of reimbursement of those costs, regardless of where it is provided.
Moreover, under the council compromise “as a general rule”, the Member State of affiliation shall reimbursed he costs of cross-border healthcare up to the level of costs that would have been assumed by it, had this healthcare been provided in its territory without exceeding the actual costs of healthcare received. However, the Council recall that the concept of “overriding reasons of general interest” has been developed by the ECJ. The Council text provides that the Member State of affiliation may limit the reimbursement of cross-border healthcare if this can be justified by overriding reasons of general interest such as the risk of seriously undermining the financial balance of a social security system, or the objective of maintaining a balanced hospital service open to all. But, such restriction on the reimbursement of costs shall be limited to what is necessary and proportionate and cannot constitute arbitrary discrimination. The European Parliament has not introduced, at first reading, these restrictions.

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. Nevertheless, as a general rule the Member state of affiliation meaning the member state of residence should reimburse the cost of cross-border healthcare for pensioners if they receive healthcare in a third Member state.

The European parliament has added a new provision whereby the member state may decide to cover other related costs. 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.”
The MEPS also introduced the requirement that if a Member State of affiliation rejects the reimbursement of a treatment it must give a medical justification for its decision. The European Parliament first reading position also provides that the member state of affiliation should reimbursed patients affected by rare diseases for healthcare in another Member State even if that treatment is not among the benefits provided for by its legislation. Moreover, according to the MEPs “If there are several methods available for treating a certain disease or injury, the patient should have the right to reimbursement for all methods of treatment that are sufficiently tried and tested by international medical science, even if they are not available in the patient’s Member State of affiliation.”

Member States would be required to put in place a mechanism for calculation of costs that are to be reimbursed for healthcare provided in another Member State to the insured person by the statutory social security system of the Member State of affiliation, which shall be based on objective, non-discriminatory criteria. According to the European Parliament and the Council “The mechanism shall be applied at the relevant administrative level in cases where the Member State of affiliation has a decentralised healthcare system.”
The Member State of affiliation may impose on a patient seeking healthcare provided
in another Member State its general conditions as well as its criteria for eligibility and regulatory and administrative formalities for receipt of healthcare and reimbursement of healthcare costs providing that “such conditions are necessary, proportionate to the aim and are not discretionary and discriminatory.”  This may include the requirement to consult a general practitioner before consulting a specialist or before receiving hospital care, if this is necessary for determining the individual patient’s entitlement to healthcare.

Under the drat proposal, the Member State of affiliation shall put in place mechanisms to provide patients with information, if requested, on their rights as regards cross-border healthcare, particularly with regard to procedures for accessing those entitlements as well as conditions for reimbursement of costs and systems of appeal and redress.
Under the draft proposal, the Member State of affiliation is required to ensure that patients who travel to another Member State for seeking or receiving healthcare have access to their medical records. The MEPs have stressed that patient or patient’s relatives shall give express consent in writing before data is transmitted.
In what concerns hospital care Member States would be allowed to introduce a prior authorisation scheme for reimbursement.

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, for the purposes of reimbursement of healthcare provided in another Member State, 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 or involves treatments presenting a particular risk for the patient or the population. The Commission would, through the comitology procedure, define a regularly updated technical list of such treatments. In fact, under the draft proposal a lot of room is left to comitology, a process which will diminish Member State control over the content of such measures.
The MEPs voted for the definition for hospital care to come from the Member State of affiliation and not from the Commission. The Council does not provide for a definition of hospital care but it provides, as the European Parliament, that shall be limited to, the cases abovementioned.
Consequently, 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 European Parliament has supported the Commission proposal under which patients will have the right to seek healthcare abroad but the Member State of affiliation may, nevertheless, introduce a system requiring prior authorisation for the reimbursement of hospital costs if its social security system financial balance could be seriously undermined. 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, that there is the risk of seriously undermining the financial balance of a social security system as well as the objective of keeping on grounds of public health a balanced medical and hospital service open to all and the objective of maintaining treatment capacity or medical competence on the territory of the concerned Member State, essential for the public health. The Council stressing the Member States responsible for establishing rules on management, requirements, quality and safety standards and the organisation and delivery of healthcare, took the view that it is for the Member States to decide whether it is necessary to introduce the system of prior authorisation, and to identify the healthcare requiring prior authorisation in the context of their system according to the criteria defined by this Directive and in the light of the case law of the Court of Justice, including the abovementioned cases. Moreover, the Council pointed out the impact of patient mobility on national health systems varies between Member States or between regions within a Member State. Hence, it should be for every Member State to establish proportionate criteria for refusing prior authorisation taking into account different regions or other relevant administrative levels for the organisation of healthcare.
According to the Council compromise text a prior authorisation may be refused by the Member State of affiliation for different reasons including: no entitlement to the treatment in question, the healthcare can be provided on national territory within a time-limit which is medically justifiable, if according to a clinical evaluation, the patient or the general public will be exposed to a safety risk as a result of the cross-border healthcare in question and if the healthcare providers meant to provide treatment raise serious concerns as regard the respect of standards and guidelines on quality of care and patient safety, established by the Member State of Treatment. The compromise text specifies that the reasons for refusal are not limited to these cases.
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 shall be reimbursed by the Member State of affiliation up to the level of costs that would have been taken had the same treatment been provided at home.
The systems of prior authorisation shall be, under the draft directive, limited to what is necessary and proportionate and not constitute arbitrary discrimination.

Member States would be required when establishing time limits to deal with requests for the use of healthcare in another Member State to take into account the specific medical condition, individual circumstances, and the nature of the patient's disability. The Commission proposal would require member states to specify in advance and in a transparent way the criteria for refusal of the prior authorisation.

The Member States are required to make publicly available all relevant information on the prior authorisation systems.
The European Parliament has introduced, at first reading, a new provision under which Member States shall made available, at the level appropriate for the administration of their health service, prior authorisation application systems.

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. Hence, according to the MEPs, if prior authorisation has been given, the Member State of affiliation would be required to ensure that patients who have received prior authorisation for the use of healthcare in another member state will only be required to make advance or top-up payments to the Member State of treatment healthcare providers, to the extent that such payments would be required in the Member State of affiliation itself. The Council has rejected this amended as it deems it contrary to the Member States competence to organise their health systems, particularly as regards regulating “upfront payments.” Moreover, according to the Council such idea is “unfeasible in practice as the healthcare that a patient might receive abroad and its cost cannot be known beforehand.”

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.”

Under the draft proposal administrative procedures regarding the use of healthcare in another Member State related to any prior authorisation shall be ensured by the Member State of affiliation and shall be “based on objective, non-discriminatory criteria” which shall be published in advance, and “necessary and proportionate to the objective to be achieved.”

Member States national authorities are required to take their decisions related to cross-border healthcare, including reimbursement of costs, in a timely manner and respecting the principles of objectivity, non-discrimination and transparency, as well as the circumstances of the case. The proposal provides that in general a decision regarding the cross-border healthcare should take fifteen days, but such period should be shorter taking into account the urgency of the treatment in question.
Under the draft directive any administrative decisions regarding the use of healthcare in another Member State shall be subject to administrative review as well as being capable of challenged in judicial proceedings. The European Parliament has added medical decisions to this provision whilst the Council has added decisions regarding reimbursement of costs of healthcare incurred in another Member State.

The European Parliament has called upon the Commission to carry out a study on the viability of establishing a clearing house to facilitate the reimbursement of costs across borders, healthcare systems and currency zones and, if necessary, to present a legislative proposal. The Council has rejected this amendment.

The European Parliament also proposed, at first reading, the creation of a European Patients Ombudsman to take care of patients' complaints regarding prior authorisation, reimbursement of costs or harm. In fact, the MEPs have asked the Commission to put forward a legislative proposal on this regard. As the European Scrutiny Committee has pointed a European Patients Ombudsman cannot have power
to investigate 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.”

Member States would be required to establish national contact points for cross-border healthcare to provide patients with information on aspects of cross-border healthcare as well as practical assistance. Such contact points for cross border health care shall be designated by Member States. Member States may decide on the form of those national contact points for cross-border healthcare as well as the number of them. The Commission has specified in the preamble that these contact points may be incorporated into Member States existing centres. The European Parliament believes that this should be included in the directive provisions in order to avoid “placing additional administrative burdens on the Member States in connection with the implementation of the directive.”
According to the European Parliament and Council the national contact points shall also provide information on health professionals. The European Parliament has added the requirement for Member States to provide “information in accessible formats and to potential sources of additional assistance for vulnerable patients, disabled people and people with complex needs.” According to the Council the abovementioned information must be provided in any of the official languages of the Member State in which the contact points are placed but member states are not obliged to provide such information in other languages.
Moreover, the national contact points shall also help patients to seek appropriate redress in case of harm caused by the use of healthcare in another Member State. They would be required to provide the patient with information on “the options available to settle any dispute, help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monitor their dispute where necessary.” Moreover, the Commission proposal provides that the national contact points shall “facilitate the development of international out-of-court settlement scheme for disputes arising from cross-border healthcare.” The Council compromise text does not provide for this requirement.
The Commission will adopt measures to implement this provision including measures necessary for the management of the network of national contact points, the nature and type of data to be collected and exchanged as well as guidelines on information to patients.

Although the Commission proposal specifies that it is for the member stated to decide the nature of the mechanisms for the protection of patients and the compensation for harm, they are required to ensure that such mechanisms are in place for healthcare provided on their territory and that they are suitable to the nature and extent of the risk. The Member States of affiliation are, therefore, required to put in place mechanisms to provide patients on request with information on receiving healthcare in another Member State as well as on the applicable terms and conditions where harm is caused as a result of healthcare received in another Member State. Such information shall be easily accessible, including by electronic means. Moreover, it shall include information on patients' rights, on procedures for having access those entitlements and on systems of appeal and redress. According to the European Parliament such information shall be published in formats accessible to persons with disabilities.
The European Parliament also believes that member states shall made available information of registered health professionals and healthcare providers. The MEPs have not backed the Commission provision which would have empowered itself to develop, through the comitology procedure, a standard Community format for the abovementioned information.

The draft proposal also provides for the recognition of prescriptions issued in another Member State. Hence, Member States are required to recognised prescriptions issued by an authorised person in another Member State for a named patient. Moreover, they must ensure that any restrictions on recognition of individual prescriptions are forbidden except they are not discriminatory and limited to what is necessary and proportionate to safeguard human health and based on legitimate and justified doubts about the authenticity of an individual prescription.
According to the European Parliament and the Council the recognition of prescriptions shall not affect national rules governing dispensing as well as rules governing generic drugs. Moreover, they believe rules on reimbursement of medicinal products shall not be affected.

The Council common position specifies that Member States are not obliged to reimburse an insured person for a medicinal product prescribed in the Member State of treatment if it is not amongst the benefits provided to that insured person by the Member State of affiliation’s statutory social security system.
In order to implement this provision the Commission would adopt measures, through the comitology procedure, which would enable the health professional to verify the authenticity of the prescription.

Whereas the Commission has proposed to develop a Community prescription template, the Council believes that this can be achieved “through developing a non-exhaustive list of elements to be included in the prescriptions.” 

The European Commission has proposed one year after the entry into force of the draft directive for the member states to transpose it into national law whereas the Council has proposed three years.

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 Commission draft proposal, endorsed by the European Parliament, limits the circumstances in which prior authorisation for treatment abroad would be allowed, restricting, in this way, the Member States responsibility for deciding entitlement to healthcare. 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 rights of patients who seek/receive cross-border healthcare should be protected but one could wonder if the draft directive would protect those rights whilst ensuring the Member States’s responsibility for the organisation and delivery of health services and medical care.

The Council and the MEPs have agreed on the wording of several provisions. Nevertheless, the Council has rejected several amendments proposed by the European Parliament. Particularly, the Council has not taken on board the European Parliament position on reimbursement of costs, particularly the reimbursement of hospital treatment. It remains to be seen what will come out from the negotiations with the European Parliament but it is noteworthy that the UK cannot veto the proposal as QMV is required at the Council.