EU Directive on patients' rights to cross-border healthcare

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.

History

A significant event that supposed a great advance in the field was the judgment of the European Court of Justice in the case of Kohl and Decker in 1998. Thanks to it, there was established an alternative procedure for which patients who have received treatment in another country member, without previous authorization, can demand the reimbursement to the Social Security System of their origin country. One of the last ECJ judgments that caused reactions against and in favor among the member countries was the case of the British citizen Yvonne Watts in 2006. In it, it is established that one of the reasons to request the reimbursement of an intervention outside the origin country, is the existence of a waiting list.

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.

Law listed in the European Journal on April 4th 2011

The directive on cross border healthcare was voted on in January 2011 and ratified by the European Council in February 2011. The directive became a law on April 4th 2011 when it was listed in the European Jounal. Member states have until October 2013 to implement the Directive and the Commission has indicated that it will be closely monitoring this process to ensure that it is implemented fully across the EU by the deadline agreed.

Public Health: Commission proposes effective measures to better protect citizens from a wide range of cross-border health threats

Brussels, 8 December 2011. To better protect Europeans from a wide range of health threats, and provide for a fully co-ordinated response in the event of a crisis, the European Commission adopted today a legislative proposal on the means to address serious cross border health threats. Building on lessons learned with recent crises such as the H1N1 pandemic in 2009, the volcanic ash cloud in 2010 and the outbreak of E. coli in 2011, the Commission is proposing to beef up the means to prepare for and to address such crises. The main measures proposed include:

• to extend the existing co-ordination mechanism for communicable diseases to all heath threats caused by biological, chemical or environmental causes;

• to reinforce the mandate of the Health Security Committee;

• to strengthen preparedness for crises e.g. by enabling joint purchasing of vaccines;

• to provide the means to recognise a European "health emergency situation" for the purpose of making medicines available faster;

• and to agree on European wide emergency cross border measures when a crisis results in large scale mortality and national measures fail to stop the disease from spreading.

European Commissioner for Health and Consumer Policy, John Dalli said: "In today's globalised society, people and goods move across borders and illnesses can spread around Europe – and the globe - within hours. This is why the European Union and its Member States must be prepared to act together in a fully co-ordinated manner to stop a disease from spreading. The proposal we adopted today gives us the means and the structures to effectively protect our citizens across Europe from a wide range of health threats".

Biological, chemical or environmental factors can trigger serious cross border health threats. Such threats can materialise as diseases that spread from person-to-person such as flu, food and water-borne diseases such as botulism, infections with E. coli or result from extreme weather conditions like heat waves or cold spells. In recent years, the European Union has gone through various crises of this kind. Building on the Early Warning and Response System for communicable diseases created in 1998, the Commission's proposal puts forward measures to strengthen the response to serious cross-border threats in the EU.

The present proposal builds on existing structures and further strengthens them through the following:

1. Extends the assessment of risks and the co-ordination of measures from communicable diseases to all heath threats caused by biological, chemical or environmental causes.

During a health crisis it is essential to know the nature of the threat, how it is spreading, how fast and widely, to be able to limit the spread and health effects, and to provide up-to-date information and advice to citizens. There is already a network in place for the epidemiological surveillance of communicable diseases composed of the European Commission, the European Centre for Disease Prevention and Control (ECDC) and national authorities. With the new proposal, this expertise is extended to other serious cross-border health threats. Should such a threat occur, networks can be set up on an ad hoc basis to exchange information, assess the risks involved, pooling scientists and expertise.

2. Strengthens the role of the Health Security Committee to better co-ordinate measures to fight a health crisis

In 2001, after the terrorist attacks and deliberate release of anthrax toxins in the United States, the EU Health Security Committee was set up by EU Health Ministers. Since then, the committee has supported the coordination of responses to public health crises at EU level by coordinating risk assessment and management of serious cross-border health threats. The proposal formalises and gives a broader mandate to the Committee which includes providing advice to Member States and the Commission on both policy and technical issues relating to health security.

3. Beefs up preparedness to fight a crisis

Having a preparedness plan in place on what do to when a health crisis strikes is essential to halt the crisis. The Commission's proposal foresees that every Member State coordinates its efforts to develop, strengthen and maintain its national preparedness and response plan, in consultation with other Member States. Such plans include e.g. measures to improve access to medical countermeasures, and co-ordination with other key sectors. Member States also respect guidelines put forward by the Commission, which will co-ordinate the process. Such guidelines may relate to health measures or communication with the public. The proposal also provides a basis for joint voluntary purchasing of vaccines and other medical countermeasures for the Member States that are interested.

4. Provides the means to recognise a European "health emergency situation" for the purpose of making medicines (needed to curb a crisis) available faster

The proposal foresees that, when a life threatening disease that can be prevented by vaccines or cured by medicines is spreading rapidly in Europe and the World Health Organisation has not yet declared the "emergency" situation, the EU can recognise a European health emergency, for the sole purpose of authorizing new medicines faster or changing the indication of a medicine. Under existing EU legislation, the European Commission needs to wait for the WHO to declare an international emergency across continents. This provision seeks to address situations where a disease is spreading across Europe (not on a world scale) and lives can be saved with pharmaceuticals.

5. European emergency cross border measures

The proposal foresees that, in very specific emergency situations, resulting in people dying or hospitalised in a large scale, and when Member States' measures prove insufficient to control the spread across borders, the Commission adopts emergency cross border measures e.g. related to containment of an outbreak, or the screening of infected citizens.

Commision of the European Communities Consultation

In 2007, EHFCN commented on the European Communities Consultation. Comments included the  current impact of cross-border healthcare on accessibility, quality and financial sustainability of healthcare systems, what practical information is required to enable safe, high-quality and efficient cross-border healthcare and in what ways should European action help to support the health systems of the Member States and the different actors within them. EHFCN welcomed the opportunity to cooperate with the High Level Group of the European Commission, concerning the issues raised the consultation report, in order to bring grater quality in healthcare sectors across Europe.

Accordingly, EHFCN was invited by the Council of Europe´s Committee of Experts on Good Governance in Healthcare to assist and advice on matters of healthcare fraud and corruption with the objective to reach a recommendation for good governance in the sector. The Recommendation CM/Rec (2010)6 of the Committee of Ministers on Good Governance in Health Systems was adopted by the Council of Europe Minister Deputies at their 1081st meeting. This new instrument will aim to highlight the importance of good governance in health systems to the 47 member states of the Council of Europe.

More information regarding the recommendation can be found here.

Related news

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