WHAT IS THE AIM OF THE DIRECTIVE?
- It sets out the conditions under which a patient may travel to another EU country to receive safe and high-quality medical care and have the cost reimbursed by their own health insurance scheme.
- It also encourages cooperation between national healthcare systems.
KEY POINTS
- The EU country providing the treatment must ensure that:
- all the information necessary is available for patients to make an informed choice including on treatment options, availability, quality and safety of the healthcare provided, prices, authorisation or registration status;
- transparent complaint procedures exist;
- professional liability insurance or similar guarantees are in place;
- privacy of personal data is respected;
- patients have access to a written or electronic record of the treatment they receive;
- the scale of healthcare fees charged are the same as for domestic patients who are in a comparable medical situation, or the price charged is calculated according to objective, non-discriminatory criteria if there is no comparable price for domestic patients.
- The EU country where the patient is insured must ensure that:
- the cost of the healthcare provided is reimbursed;
- information on patient rights and entitlements is available;
- patients have access to any necessary medical follow-up treatment;
- patients have access to their medical records.
- National contact points exist to provide information and to consult with patient organisations and healthcare providers and insurers.
- Healthcare providers give all the necessary information to patients so they can make an informed decision, including:
- treatment options;
- availability;
- quality and safety of the healthcare they provide;
- prices;
- authorisation or registration status.
- A patient's own country must reimburse the cost of the treatment according to the scales it applies domestically.
- A patient may require prior authorisation from their own country before going abroad for treatment. This may be necessary if the medical care involves at least one night in hospital and/or the use of highly specialised and cost-intensive medical equipment, or if it poses a particular risk for the patient or the population.
- A national authority may refuse to give prior authorisation if it considers that it can provide the patient with the necessary healthcare within a medically justifiable time limit.
- Requests for medical treatment in another EU country must be dealt with within a reasonable period of time.
- Prescriptions issued in one EU country are valid in another.
- National health authorities must cooperate with each other in implementing the legislation and in developing European reference networks between healthcare providers and centres of expertise.
- The cooperation extends to tackling rare diseases, developing eHealth and assessing new health technology.
- The legislation does not cover long-term care or the allocation of and access to organs or vaccinations.
- The directive does not affect how EU countries organise and finance their national health systems for their own citizens.
- The European Commission produces a report every 3 years on the way the system is working and how the directive operates. The first report was adopted in September 2015 and a subsequent one was adopted in September 2018.
The Commission has adopted a number of implementing and delegated acts related to Directive 2011/24/EU. These include:
- Implementing Directive 2012/52/EU on the recognition of medical prescriptions issued in another EU country;
- Implementing Decision 2013/329/EU on the establishment, management and the transparent functioning of the network of national authorities or bodies responsible for health technology assessment;
- Delegated Decision 2014/286/EU on criteria and conditions that European reference networks and healthcare providers wishing to join a European reference network must fulfil;
- Implementing Decision 2014/287/EU on criteria for establishing and evaluating European reference networks and their members and for facilitating the exchange of information and expertise on establishing and evaluating such networks;
- Implementing Decision 2019/1765 on the establishment, management and the functioning of the network of national authorities responsible for e-health, which was subsequently amended by Implementing Decision (EU) 2020/1023, on the cross-border exchange of data between national contact-tracing and contact-warning mobile applications with regard to combatting the COVID-19 pandemic. In particular, amending Implementing Decision (EU) 2020/1023 adds two new annexes to Implementing Decision 2019/1765, which respectively deal with the responsibilities of:
- the participating EU countries as joint controllers for the federation gateway for cross-border processing between national contact-tracing and contact-warning mobile applications; and
- the Commission as data processor for the federation gateway for cross-border processing between national contact-tracing and contact-warning mobile applications.
FROM WHEN DOES THE DIRECTIVE APPLY?
It has applied since 24 April 2011 and had to become law in the EU countries by 25 October 2013.
BACKGROUND
- The reason the rules for cross-border healthcare needed clarifying is that they had been developed based on individual judgments of the Court of Justice of the European Union over a period of more than 10 years. The directive was brought forward specifically to clarify the rights to healthcare which derive from the Court’s rulings based on Article 56 of the Treaty on the Functioning of the European Union and to enable these rights to be used in practice. The directive aims to clarify the relationship between its rules on cross-border healthcare and the existing framework provided by Regulation (EC) No 883/2004 (see summary) on social security coordination.
- For more information, see:
MAIN DOCUMENT
Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, pp. 45-65)
Successive amendments to Directive 2011/24/EU have been incorporated into the original text. See consolidated version.
RELATED DOCUMENTS
Commission Implementing Decision (EU) 2020/1023 of 15 July 2020 amending Implementing Decision (EU) 2019/1765 as regards the cross-border exchange of data between national contact tracing and warning mobile applications with regard to combatting the COVID-19 pandemic (OJ L 227I, 16.7.2020, pp. 1-9)
Commission Implementing Decision 2019/1765 of 22 October 2019 providing the rules for the establishment, the management and the functioning of the network of national authorities responsible for e-health, and repealing Implementing Decision 2011/890/EU (OJ L 270, 24.10.2019, pp. 83-93)
See consolidated version.
Report from the Commission to the European Parliament and the Council on the operation of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (COM(2018) 651 final, 21.9.2018)
Commission Delegated Decision 2014/286/EU of 10 March 2014 setting out criteria and conditions that European reference networks and healthcare providers wishing to join a European reference network must fulfil (OJ L 147, 17.5.2014, pp. 71-78)
Commission Implementing Decision 2014/287/EU of 10 March 2014 setting out criteria for establishing and evaluating European reference networks and their members and for facilitating the exchange of information and expertise on establishing and evaluating such networks (OJ L 147, 17.5.2014, pp. 79-87)
See consolidated version.
Commission Implementing Decision 2013/329/EU of 26 June 2013 providing the rules for the establishment, management and transparent functioning of the network of national authorities or bodies responsible for health technology assessment (OJ L 175, 27.6.2013, pp. 71-72)
Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State (OJ L 356, 22.12.2012, pp. 68-70)
