James Reilly (Dublin North, Fine Gael) | Oireachtas source

I welcome this opportunity provided by Seanad Éireann to discuss the EU directive on the application of patients' rights in cross-border health care. This directive, commonly known as the cross-border directive, aims to provide clarity on the rights of patients to access health care in another member state. It also sets out the grounds on which a patient may claim reimbursement of the eligible costs of treatment from his or her own state's health system and outlines a number of other areas for co-operation between member states. It also supplements the rights that patients already have at EU level through the legislation on the co-ordination of social security schemes, EU Regulation 883/04.

The directive aims to facilitate access to safe, high-quality cross-border health care and to promote co-operation on health care between member states in full respect of national competencies in organising and delivering health care, facilitate efficient transfer of patient information between member states, facilitate reimbursement of the cost of treatment in other member states, and introduce a system of prior authorisation for certain categories of treatment. In essence, the directive provides rules allowing for the provision of information on health care to patients and, where such treatment is availed of in a cross-border context, for the reimbursement to patients of the cost of receiving treatment abroad, where the patient would be entitled to such treatment at home.

Notwithstanding these aims, the vast majority of EU patients receive health care in their own countries and prefer to do so. This can be easily explained by, among other things, the presence in their home country of family and friends, the absence of language and cultural differences, and the absence of need to arrange the more expensive travel and accommodation costs involved in accessing health care in another EEA country. However, in certain circumstances, patients may benefit from receiving their health care in another European country. Examples might include highly specialised care, or health care in centres of particular speciality. Yet, beyond the EU regulation route, which required that the treatment not be available in the patient's home country, no formal mechanisms existed to facilitate such cross-border health care. Bearing these reasons in mind, the need for some formal arrangement for accessing this type of health care became clear, as evidenced by the fact that European citizens have brought a series of cases to the European Court of Justice seeking to assert rights to reimbursement for health care provided in other member states. The directive evolved from calls from both the European Parliament and the Council of Ministers for the Commission to propose a specific initiative on cross-border health care, as it was considered necessary to clarify how the principles established on these specific cases should be applied in general. To this end, and as already stated, the directive seeks to ensure a clear and transparent framework for the provision of cross-border health care within the EU for those occasions on which the care patients seek is provided in a member state other than their home countries.

The following general principles apply to the directive's provisions: there should be no unjustified obstacles; the care should be safe and of good quality; and the procedures for reimbursement of costs should be clear and transparent. This does not negate the fact that the EU recognises that member states are responsible for the organisation and delivery of health services and medical care. They are, in particular, responsible for determining which rules will apply to the reimbursement of patients and to the provision of health care. The directive changes nothing in this respect.

It is important not to forget the EU regulation route for the provision of overseas, or cross-border, health care, which I mentioned at the start of my speech. With the transposition of the directive there will be two potential routes for patients to receive planned health care in another member state which will be paid for by their own member state. These are the established route under EU Regulation 883/2004, otherwise known as the E112 route; and the new route under the cross-border directive. To emphasise this point, the directive makes explicit comment on the fact that patients must be made aware of the existing EU regulation, the E112 form, if and when they make inquiries of the national contact points regarding reimbursement for their cross-border health care. This is because the regulation route may be a more beneficial route in many circumstances - for example, when up-front payment by the patient for the treatment is not required.

There are, nevertheless, differences in the two routes. The key differences between the two routes are that the E112 route relates only to treatment provided in the State health care sector, it is all pre-authorised, the costs are handled between the HSE and the provider - not by the patient - and the treatment must not be available within the Irish system. However, under the directive, patients may seek any health service in another member state that is the same as or equivalent to a service that is available to a patient in his or her own health care system. The patient has the right to have this treatment reimbursed up to the cost of the same, or equivalent, treatment in their own State, or the actual amount, whichever amount is lower. Unlike the E112 route, the patient may also access treatment in another member state in either the state or the private health care sector. Except where the member state opts to have certain treatments subject to prior authorisation - and this provision is limited to particular conditions under the directive - the patient will not be required to receive prior authorisation, but may do so if he or she wishes. In contrast, under the E112 route all treatment must be authorised in advance.

To further explain the obligations under the directive, it can be said that the working of the directive may be broken down into two main areas. First, it addresses a member state's obligations to its own citizens. Second, it sets out a member state's obligation to provide information to any EU citizen on the accessing of treatment in the member state, the cost of such treatment, and the regulation of providers such as institutions and individual professionals.

For our own citizens, we must ensure that administrative procedures regarding the use of cross-border health care and reimbursement of costs of health care incurred in another member state are based on objective, non-discriminatory criteria which are necessary and proportionate to the objective to be achieved. Any administrative procedure must be easily accessible and information relating to such a procedure has to be made publicly available. Such a procedure must be capable of ensuring that requests are dealt with objectively and impartially. We must set out reasonable periods of time within which requests for cross-border health care are dealt with and make them public.

When considering a request for cross-border health care, we must take into account the specific medical condition, the urgency of treatment, and individual circumstances. We must ensure individual decisions regarding the use of cross-border health care and reimbursement of costs of health care incurred in another member State are properly reasoned, can be subject to review on a case-by-case basis and are capable of being challenged in judicial proceedings. We have the option to offer patients a voluntary system of prior notification whereby the patient receives a written confirmation of the amount to be reimbursed on the basis of an estimate. This estimate must take into account the patient's clinical case, specifying the medical procedures likely to apply.

We may choose to pay the providers of the cross-border treatment directly, similar to the situation under EU Regulation 883/2004. However, if we decide not to put such a mechanism in place we must ensure that patients receive reimbursement without undue delay. We must ensure that where a patient has received cross-border health care and where medical follow-up proves necessary, the same medical follow-up is available as would have been available if that health care had been provided in the Irish health system. We must ensure that patients who seek to receive, or do receive, cross-border health care have remote access to or at least a copy of their medical records, in conformity with, and subject to, national measures implementing EU provisions on the protection of personal data.

For citizens of other member states, we must establish a national contact point, NCP, to provide patients with information about their rights and entitlements and practical aspects of receiving cross-border health care in Ireland - for example, information about health care providers, quality and safety, accessibility of hospitals for persons with disabilities, and, to enable patients to make an informed choice, information about health professionals. The NCP will provide information to patients concerning Irish health care providers, the right to provide services, restrictions on its practice, information on standards and guidelines on quality and safety in Ireland for both private and public providers, their rights as patients, complaints procedures, mechanisms for seeking remedies, and legal and administrative options for settling disputes.

NCPs are to co-operate among each other and with the Commission. NCPs will provide patients with contact details of the NCPs in other member states.

In short, the NCP must on request be able to provide patients with information on the rights and entitlements which apply to them in an Irish context relating to receiving cross-border health care. This includes the cost of the treatment in Ireland and procedures for accessing and determining those entitlements, as well as appeal and redress procedures if patients consider that their rights have not been respected. In providing information about cross-border health care, a clear distinction shall be made between the rights that patients have by virtue of this directive and rights arising from Regulation EC 883/2004. Health care providers must also supply patients with a copy of their medical records when they return to their member states.

The directive also states that member states and the Commission should co-operate to strengthen their interactions in the field of health care in a number of areas - for example, in the field of e-health, through the development of a European network which will bring together on a voluntary basis the national authorities responsible for e-health. Another example is rare diseases, in which regard the Commission will support member states in co-operating in the field of diagnosis and treatment capacity. Co-operation in these areas is voluntary but member states are being actively encouraged to do so and my Department has become involved in these voluntary networks.

The directive seeks to ensure a clear and transparent framework for the provision of cross-border health care within the EU for those occasions when the care patients seek is provided in other member states rather than in their home countries, while recognising that member states are responsible for the organisation and delivery of health services and medical care, including in particular for determining which rules will apply to the reimbursement of patients and to the provision of health care. I welcome this directive because it provides a coherent and uniform set of rules for patients throughout the EU and will start a new phase of co-operation between 27 national health systems. I hope the directive will contribute towards reducing inequalities in access to care by helping patients to choose their health care provider across the EU and that patients will have greater and clearer access to information on the quality and safety of the care they receive in whichever member state they decide to access their treatment.