EU Directive on patients' rights to cross-border healthcare

The directive on patient's rights to cross-border healthcare has been proposed by the European Commission. It followed a series of rulings made by the European Court of Justice beginning in 1998, which entitled patients to obtain healthcare in any other EU Member State and to have these healthcare costs reimbursed by their own health systems in their home country. The European Commission began a consultation process on cross-border access to healthcare in 2006, which culminated in the publication of the proposal for a directive on 2 July 2008

Content of the directive

Overall, the directive is set to clarify the right of patients to seek health care in another EU country while being reimbursed by their national system.

The stated aims of the proposal are three-fold:

• To help patients exercise their rights to access cross-border care;
• To give people assurances about safety and quality of cross border care, and;
• To help national health systems cooperate to achieve economies of scale. 

Patients' access to cross-border care:

The proposal, once adopted, would give EU citizens the right to seek non-hospital care, such as dental care, visits to the optician or medical consultations, in another member state without prior authorisation. Patients would be entitled to reimbursement for planned healthcare in other EU Member States if the same or similar healthcare would have been paid for by the social security system in the patient's home country. According to the proposal, reimbursement would be made up to the amount that would have been paid if the same or similar treatment had been provided in the home country, but without exceeding the actual cost of healthcare.

As for hospital care (defined by the European Commission as requiring at least one night of hospitalisation), Member States may introduce a system of prior authorisation for reimbursement in two cases. First, if the care could have been provided and reimbursed in the home country and second, if the outflow of patients is such that it puts in risk either the finances of the national social security systems or the planning of hospital capacity. 

Safety and quality of cross-border healthcare:

The proposal establishes that healthcare is to be provided in accordance with legislation in the Member State of treatment, which in turn will have clear quality and safety standards for healthcare. There shall also be comprehensive liability insurance for providers and possibilities for patients to demand compensation in case of harm arising from healthcare.

The draft directive asks Members States to establish national contact points for cross-border healthcare and to ensure citizens are provided with information on their entitlement to seek healthcare abroad. It also states that non-nationals enjoy the same rights concerning access to care as nationals.

Increased EU cooperation on healthcare:

The draft Directive establishes that the Member States have a general duty of cooperation in matters relating to cross-border healthcare and identifies a number of areas for further cooperation: prescriptions issued in one Member State should be recognized and used in another Member State; European reference networks will be established to allow access to and promote cooperation on highly-specialised healthcare and rare diseases; Member States are expected to cooperate on eHealth by making ICT systems interoperable and send, for example, electronic patient records between countries, and share their efforts regarding the  management of new health technologies, including health technology assessment.

The process at the Council and at the European Parliament

Council of the European Union:

The draft directive was submitted by the Commission to the Member States on 2 July 2008. In December 2008 the proposal was discussed for the first time at the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO). The principles of the proposal were discussed and the positions of the Member States on this issue were checked, on the basis of a progress report on negotiations during the French Presidency. The Czech presidency continued the negotiations during the spring of 2009 and a new progress report was submitted on 9 June 2009 at a Council's meeting. The issues discussed at that meeting included which kind of healthcare should be covered by the Directive, and the forms for future cooperation in healthcare issue (see news).      

European Parliament:

The European Parliament submitted a formal opinion on the Directive on 23 April 2009 and consequently proposed a number of changes or conditions, including:

• Since most patients would only receive reimbursement after they had paid the healthcare costs, Member States should be able to introduce a system of voluntary prior notification with direct payment from the Member States to the provider. Member States must also guarantee that patients with prior authorization only have to pay a fee if this was obligatory in their home country.
• The Commission should check the possibility of setting up a clearing organisation to facilitate reimbursement of costs
• There should be clear rules on the level of reimbursement and the possibility of having the matter reconsidered if problems arise. Central contact points in each Member State and a European patient ombudsman to handle these complaints are advised.  

Future Steps

The directive has to go through a co-decision procedure, where both the European Parliament and the Council must be in agreement in order for the directive to be adopted.

If a political agreement is reached in the upcoming months, the revised proposal will be sent back to Parliament for a second reading. At that point there would probably also be direct negotiations between the Council and the Parliament on the content of the Directive. After the second reading, if the Council and Parliament are not in agreement, a conciliation process would be initiated through a special committee with representatives from the Council and the Parliament. If no agreement is reached between the Council and the Parliament after the conciliation process, there won't be a Directive.

Perceptions of the directive

There are fundamental divisions among European health ministers regarding the directive. Some countries are firmly opposed to the basic principle of the plan. It seems that Spain and Portugal are firmly opposed to the principle of the directive, which could have an impact on how services are planned and funded. Hungary, Poland and Italy also have reservations about what is proposed and may seek to impose limitations on the kinds of treatment that will be reimbursed under the new system. Some smaller member states have consistently expressed concerns that the directive could have a negative impact on their health systems if there is a large outflow of patients or medical specialists to other countries.
Despite this, it seems that the UK, France and Germany could be reaching broad agreement on what the final text could look like.

Proposals have been emitted such as exempting private hospitals and clinics from the directive in certain cases, however this would run contrary to the case law upon which the new legislation is built. A major obstacle can be the circumstances under which countries can refuse to pay for treatment for citizens who have suffered from "undue delays". The definition of this term and the question of who will decide whether a patient has waited too long are yet to be determined.

EPSCO Council discusses Czech presidency compromised text 9 June 2009

In talks on the Czech presidency's text, during the first half of 2009, there was a lack of conformity. Member states tend to favour national competency when it comes to national health systems. The new directive points towards a system of subsidiary. They also wanted to exclude long-term care from the Directive. Comitology did not seem to be the favored way of working out the directive and there was debate on whether the legal basis for the directive should come from article 152, on public health, or from article 95, on internal market.

Council Fail to Reach Agreement December 2009

The Swedish presidency tabled four texts continuing on from the work done by the French and Czech presidencies. During their examination however,  the Permanent Representatives Committee pointed out that "certain issues remain unresolved and the Council is, therefore, invited to examine the major outstanding questions, including the scope of the Directive and the definition of the Member State of affiliation, with a view to reaching a political agreement on a common position." They failed to reach a deal following a blocking majority which included Spain.

Agreement reached in Luxembourg June 2010

Agreement was reached on a draft directive concerning patient mobility by the Council in charge of Employment, Social Policy, Health and Consumer, on the basis of a compromise proposal of the Spanish presidency.

The draft aims to assist the development of safe and high-quality cross-border healthcare as well as to build up cooperation on healthcare between EU member states. The directive creates a balance between respect for the case law of the ECJ, and the right of the member state to organize their own healthcare systems. The directive brings clarity to a previously ambiguous system as well as granting several new rights to citizens hoping to avail of cross boarder healthcare.

More specifically, the draft directive contains the following:

• Patients will be allowed to receive healthcare in another member state. Reimbursement will go as far as the same level of reimbursement applicable for the same or similar treatment in the patient's home state.
• The rules on reimbursement may be limited by the home state in the case of overriding reasons of general interest. The outgoing flow of patients may be managed by requesting prior authorization for certain types of healthcare, or via the application of a “gate-keeping principle”. This involves a referral from a general practitioner who will act as the “gate-keeper”. This will streamline and manage patient flows. This will help keep the system running and control costs.
• In order to manage the inflow of patients and ensure efficient and permanent access, measures may be adopted concerning the access to treatment where this is justified by overriding reasons.
• Member states of treatment are required to ensure that patients from other EU countries receive on request information on safety and quality standards in order to allow them to make an informed choice.
• Cooperation between member states in the area of healthcare is strengthened for example in the field of e-health and through the development of European reference networks.
• Improvements were brought to the recognition of prescriptions from other member states. Generally, if a product is authorized to be marketed on the territory, prescriptions authorized in another member state can be dispensed in that territory, in compliance with national legislation.
• Sales of medical products and medical services via internet, long term services provided in residential homes and the access and allocations of organs for the purposes of transplantation fall outside of the scope of the directive.

Issues discussed at the council meeting included:

• The definition of member state of affiliation in the case of pensioners living abroad
• Reimbursement and prior authorization
• The legal basis
• The provisions on e-health

With regards to the member state of affiliation for pensioners, it was agreed that as a general rule the member state competent to grant a prior authorization is the state of residence. If care is provided in the state of origin, this country would have to cover its own expenses.

The council agreed on a double legal basis, striking a balance between the law of the European court of Justice on the application of Article 114 to health services and the member states competences recognized but the treaty for the organization and provision of health services, according to Article 168 on public health. In the area of e-health, they agreed on a close collaboration between the member states and the Commission.

The draft directive forms a part of the social agenda package of July 2008, which focused on a triple objective: to guarantee that all patients have care that's safe and good quality, to support patients in their right to cross border healthcare, and to promote cooperation between health systems. After the legal-linguistic revision of the draft directive, the Council will adopt its position at first reading and forward it to the European Parliament for its second reading before the end of the year. 

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Council of EU: EU countries discussed cross-border healthcare plans

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