*Updated* Crossborder Healthcare Directive adopted

Update February 2011

On 28 February 2011, the Council approved the European Parliament’s amendments on a draft directive. The European Parliament’s amendments reflect a second-reading-compromise reached between the Belgian Presidency and representatives of the European Parliament in an informal trilogue on 15 December 2010. In line with article 294 of the Lisbon Treaty the Crossborder Healthcare Directive has thus been adopted. Member States will have 30 months to transpose the Directive’s provision into national legislation.

Update October 2010

On 27 October, the ENVI Committee adopted the second reading of the report on the Patients` Rights in Cross-border Healthcare Directive. In June 2010, a political agreement was reached in the Council. The rapporteur Francoise Grossetete was concerned that the Council did not take Parliament’s amendments on board.

The objective, therefore, is to introduce a simplified prior authorisation system for patients, which will nevertheless ensure that healthcare managers are given advance warning of any exceptional costs. The ‘quality and safety of healthcare’ criteria proposed by the Council are too vague to be assessed adequately.

As regards ‘e-health’, the Council’s position only makes general statements. The recommendation for second reading seeks to strengthen the potential of ‘e-health’, which should be supervised. The report highlighted the issue of interoperability, access to e-health technology, and seeks to ensure that e-health adhere to the same professional medical quality and safety standards as those in use for non-electronic healthcare provision. In addition e-health should offer adequate protection to patients, notably through the introduction of appropriate regulatory requirements for health professionals similar to those in use for non-electronic healthcare provision. The report also recommends that Member States introduce measures should specify the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high-quality, accessible and efficient provision of cross-border health services.

There are three main differences between the Council and Parliament positions are: prepayment, prior authorisation and rare diseases.

The different political groups agree that to avoid discrimination towards people who have less, the home country shall pay the hospital directly or the country where the care is carried out (payment in advance), without the citizen being obliged to pay the money upfront. If this is not possible, then the patient can expect to be repaid as soon as possible. Regarding prior authorisation, even though Parliament is against it, they can agree to it if the criteria for possible rejection are accurate, objective and limited.

Another very important point for the parliament is that Europeans affected by rare diseases have the opportunity to receive treatment in another State. The Council of Ministers did not take on this point.

In December, the Council is expected to reach a political agreement on position.

In January, the EP will vote on the second reading in plenary.

For more information click here.

Update September 2010

In its position, the Council seeks to facilitate the access to safe and high-quality cross-border healthcare and to promote cooperation on healthcare between member states. In the compromise, the Council acknowledges the case law established by the European Court of Justice on the patients’ rights in cross-border healthcare and seeks to balance this with the member states’ rights to organise their own healthcare systems.

Provisions contained in the Council’s position:

 patients will be allowed to receive healthcare in another member state and be reimbursed up to the level of reimbursement applicable for the same or similar treatment in their national health system;

 in case of overriding reasons of general interest [such as the risk of seriously undermining the financial balance of a social security system] a member state of affiliation may limit the application of the rules on reimbursement for cross-border healthcare;

 member states may manage the outgoing flows of patients also by asking a prior authorisation for certain healthcare [those which involve overnight hospital accommodation, require a highly specialised and cost-intensive medical infrastructure or which raise concerns with regard to the quality or safety of the care] or via the application of the "gate-keeping principle", for example by the attending physician;

 member states of treatment will have to ensure, via national contact points, that patients from other EU countries receive on request information on safety and quality standards on their territory in order to enable patients to make an informed choice;

 the recognition of prescriptions issued in another member state is improved; as a general rule, if a product is authorised to be marketed on its territory, a member state must ensure that prescriptions issued for such a product in another member state can be dispensed in its territory in compliance with its national legislation;

 sales of medicinal products and medical devices via internet, long-term care services provided in residential homes and the access and allocation of organs for the purpose of transplantation fall outside the scope of the draft directive;

 concerning healthcare providers, the Council’s position seeks to ensure that patients looking for a healthcare in another member state will enjoy the quality and safety standards applicable in this country, independently of the type of provider;

 member states may adopt provisions aimed at ensuring that patients enjoy the same rights when receiving cross-border healthcare as they would have enjoyed if they had received healthcare in a comparable situation in the member state of affiliation;

 e-health is concerned, the Council’s position provides for a close collaboration between the member states and the Commission in this field.

Council adopts its position on patient’s rights in cross-border healthcare

Health ministers position - June 2010

European health ministers met on Tuesday 8 June 2010 to finalise a political agreement on the draft directive on cross-border healthcare. Adopted by the European Parliament in April 2009, the dossier was being heavily discussed by ministers. Its new version will now be discussed by the European Parliament in second reading.

The revised text was proposed by the Spanish presidency. Crucially, it addresses issues regarding reimbursement from affiliated countries, as well as providing the Directive with a double legal base in Articles 168 and 114. On 3 June 2010, the UK and Germany circulated an additional proposal to change the provisions concerning eHealth and interoperability (in Article 14 and Recital 38 respectively).

The text was widely approved, with strong opposition coming only from Poland, which issued an alternative text for approval, and from Portugal. Romania chose to abstain after the failure of the Polish text. Sweden, Slovakia, Ireland, Lithuania, France, Austria, Slovenia, Cyprus, Finland, Hungary, Malta, The Netherlands, Bulgaria and Denmark lent their support to the compromise bill and welcomed progress on the dossier.

The UK noted the importance of codifying the mass of European Court of Justice (ECJ) case law that has accumulated on this issue, so as to ensure legislators are setting the rules, rather than the courts. The Italian minister attacked the amendment offered by the UK and Germany, claiming it served only to “water down” the proposal and weaken its implication. Luxembourg and Estonia expressed their concern at the link between the Directive and social services systems in Member States – work would need to be done on the interoperability of these processes so as to retain compliance with social services provision, they said.

The Latvian vice-minister offered his support to the compromise, but noted that Latvia felt that the previous Swedish approach to prior-authorisation was better. The current one may create a disproportionate administration burden. Greece highlighted the overarching need of all Member States to reduce expenditure, and the pressure this puts upon healthcare systems. Emphasising the “public” nature of healthcare, the Greek minister highlighted the danger of turning it into a consumer product ruled by market forces. The Czech Republic noted the possibility to adjust the salient details through negotiations with the European Parliament, whilst the German minister pointed to several “ethical issue” amendments proposed by the Parliament, which the Council might be able to support.

The Polish delegation expressed their recognition at the attempted compromise, but said they could not support it, as it does not go far enough to guarantee equality of access to healthcare for Polish patients. Additionally, Poland asserted that EU law should delegate sovereign responsibility for healthcare systems to the Members States, as in the Polish alternative text. The Portuguese minister concluded that their concerns regarding non-contractual private providers had not been met and they would therefore be supporting the Polish text, whilst submitting a separate written declaration to the Council.

Related EPHA articles:
 Directive on Patients’ Rights in Cross-border Healthcare
 ’Health Professionals Crossing Borders’ - healthcare regulators meet to discuss patients’ rights
 Vassiliou answers questions on cross-border healthcare

For further information:
 European Court of Justice
 Spanish Presidency of the Council of Ministers
 Employment, Social Policy, Health and Consumers Affairs Council