Directive 2011/24 - Application of patients’ rights in cross-border healthcare
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official title
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 healthcareLegal instrument | Directive |
---|---|
Number legal act | Directive 2011/24 |
Original proposal | COM(2008)414 ![]() |
CELEX number185 | 32011L0024 |
Document | 09-03-2011 |
---|---|
Publication in Official Journal | 04-04-2011; OJ L 88, 4.4.2011,Special edition in Croatian: Chapter 15 Volume 014 |
Effect | 24-04-2011; Entry into force Date pub. +20 See Art 22 |
Deadline | 25-10-2027; See Art 20.1 |
End of validity | 31-12-9999 |
Transposition | 25-10-2013; See Art 21 |
4.4.2011 |
EN |
Official Journal of the European Union |
L 88/45 |
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
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1) |
According to Article 168(1) of the Treaty on the Functioning of the European Union (TFEU), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. This implies that a high level of human health protection is to be ensured also when the Union adopts acts under other Treaty provisions. |
(2) |
Article 114 TFEU is the appropriate legal basis since the majority of the provisions of this Directive aim to improve the functioning of the internal market and the free movement of goods, persons and services. Given that the conditions for recourse to Article 114 TFEU as a legal basis are fulfilled, Union legislation has to rely on this legal basis even when public health protection is a decisive factor in the choices made. In this respect, Article 114(3) TFEU explicitly requires that, in achieving harmonisation, a high level of protection of human health is to be guaranteed taking account in particular of any new development based on scientific facts. |
(3) |
The health systems in the Union are a central component of the Union’s high levels of social protection, and contribute to social cohesion and social justice as well as to sustainable development. They are also part of the wider framework of services of general interest. |
(4) |
Notwithstanding the possibility for patients to receive cross-border healthcare under this Directive, Member States retain responsibility for providing safe, high quality, efficient and quantitatively adequate healthcare to citizens on their territory. Furthermore, the transposition of this Directive into national legislation and its application should not result in patients being encouraged to receive treatment outside their Member State of affiliation. |
(5) |
As recognised by the Council in its Conclusions of 1-2 June 2006 on Common values and principles in European Union Health Systems (4) (hereinafter the ‘Council Conclusions’) there is a set of operating principles that are shared by health systems throughout the Union. Those operating principles are necessary to ensure patients’ trust in cross-border healthcare, which is necessary for achieving patient mobility as well as a high level of health protection. In the same statement, the Council recognised that the practical ways in which these values and principles become a reality vary significantly between Member States. In particular, decisions about the basket of healthcare to which citizens are entitled and the mechanisms used to finance and deliver that healthcare, such as the extent to which it is appropriate to rely on market mechanisms and competitive pressures to manage health systems, must be taken in the national context. |
(6) |
As confirmed by the Court of Justice of the European Union (hereinafter the ‘Court of Justice’) on several occasions, while recognising their specific nature, all types of medical care fall within the scope of the TFEU. |
(7) |
This Directive respects and is without prejudice to the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a... |
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- 1.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 2.10173/06 SAN 168 SOC 302 MI 132
- 3.A6-0129/2005 final
- 4.B6-0098/2007
- 5.A6-0173/2007 final
- 6.The last Open Health Forum attracted around 380 participants from a wide range of health organisations. The Forum recommended during its conference in November 2005 that the Commission should address the potential of targeted healthcare legislation, because subsidiarity is not a sufficient guarantee of meeting the promise of universal access to high quality healthcare. The Forum also confirmed the need for strong and fully implemented safeguards of patient safety at EU level whilst respecting for the capacity of national rules guaranteeing quality and safety. The Forum also recommended to establish an internet portal for the free exchange of data, evidence and practice to foster continuous learning and innovation, Final Report of the Open Health Forum, Health challenges and future strategy, European Public Health Alliance (2005).
- 7.All EU Member States are represented in the High Level Group on Health Services and Medical Care, observers from the EEA/EFTA states as well as representatives from civil society have also been involved in the work of this group; Report on the work of the High Level Group on Health Services and Medical Care in 2006, European Commission (2006).
- 8.Commission Communication, Consultation regarding Community action on health services, SEC (2006) 1195/4, 26 September 2006.
- 9.Commission document, Summary report of the responses to the consultation regarding 'Community action on health services' (2007)
- 11.Wismar M, Palm W, Figueras J, Ernst K and Van Ginneken E, Cross-Border Healthcare: Mapping and Analysing Health Systems Diversity, European Observatory on Health Systems and Policies, 2007.
- 12.Council Regulation (EC) No 1408/71 of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community. OJ L 149, 5.7.1971, p.2.
- 13.OJ L 255, 30.9.2005, p. 22.
- 14.OJ L 281, 23.11.1995, p.31.
- 15.OJ L 201, 31.7.2002, p. 37.
- 16.OJ L 178, 17.7.2000, p. 1.
- 17.See in particular Case C-158/96 Kohll, paragraphs 35-36.
- 18.See in particular Case C-368/98 Vanbraekel, paragraph 45.
- 19.Flash Eurobarometer Series
- 20.A6-0129/2005 final
- 21.A6-0173/2007 final
- 22.See Case C-372/04 Watts, paragraph 147.
- 23.See the impact assessment, and the results of the Europe 4 Patients research project referred to above.
- 24.See in particular Case C-158/96 Kohll
- 25.See in particular Kohll , paragraphs 35-36.
- 26.See in particular Vanbraekel , paragraph 45.
- 27.See in particular Kohll , paragraph 42.
- 28.See in particular Müller-Fauré and van Riet , paragraph 93.
- 29.See in particular Smits and Peerbooms , paragraphs 76-80.
- 30.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 31.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 32.See again in particular Smits and Peerbooms , paragraphs 76-80.
- 34.Flash Eurobarometer Series
- 35.For more information and the text of the report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union, see europa.eu.int/comm/health/ph_overview
- 36.OJ C
- 37.OJ C
- 38.OJ C
- 39.OJ C , , p. .
- 40.OJ C
- 41.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 42.A6-0129/2005 final
- 43.OJ L 376, 27.12.2006, p.36.
- 44.OJ C 146, 22.6.2006, p.1.
- 45.OJ C 146, 22.6.2006, p. 1.
- 46.OJ L 255, 30.9.2005, p. 22.Directive as last amended by Council Directive 2006/100/EC (OJ L 363, 20.12.2006, p.141)
- 47.OJ L 281, 23.11.1995, p.31.
- 48.OJ L 149, 5.7.1971, p.2. Regulation as last amended by Regulation (EC) No 1992/2006, (OJ L 392, 30.12.2006, p. 1).
- 49.OJ L 166, 30.4.2004, p. 1.
- 50.10173/06 SAN 168 SOC 302 MI 132
- 51.A6-0173/2007 final
- 52.10173/06 SAN 168 SOC 302 MI 132
- 53.OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ L 378, 27.12.2006, p. 1).
- 54.OJ L L 271, 9.10.2002, p. 1.
- 55.OJ L 142, 30.4. 2004, p.1.
- 56.OJ L 184, 17.7.1999, p.23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p.11).
- 57.OJ L 201, 31.7.2002, p. 37. Directive as last amended by Directive 2006/24/EC (OJ L 105, 13.4.2006, p.54).
- 58.OJ L 136, 30.4.2004, p.1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).
- 59.OJ L 121, 1.5.2001, p.34.
- 60.OJ L 18, 21.1.1997, p. 1.
- 61.OJ L 149, 5.7.1971, p.2. Regulation as last amended by Regulation (EC) No 1992/2006, (OJ L 392, 30.12.2006, p. 1).
- 62.OJ L 166, 30.4.2004, p. 1.
- 63.OJ L 210, 31.7.2006, p. 19.
- 64.10173/06 SAN 168 SOC 302 MI 132
- 65.OJ L 178, 17.7.2000, p. 1.
- 66.A6-0129/2005 final
- 67.A6-0129/2005 final
- 68.A6-0129/2005 final
- 69.A6-0129/2005 final
- 70.10173/06 SAN 168 SOC 302 MI 132
- 71.10173/06 SAN 168 SOC 302 MI 132
- 72.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 73.10173/06 SAN 168 SOC 302 MI 132
- 74.A6-0129/2005 final
- 75.10173/06 SAN 168 SOC 302 MI 132
- 76.A6-0129/2005 final
- 77.10173/06 SAN 168 SOC 302 MI 132
- 78.10173/06 SAN 168 SOC 302 MI 132
- 79.10173/06 SAN 168 SOC 302 MI 132
- 80.The last Open Health Forum attracted around 380 participants from a wide range of health organisations. The Forum recommended during its conference in November 2005 that the Commission should address the potential of targeted healthcare legislation, because subsidiarity is not a sufficient guarantee of meeting the promise of universal access to high quality healthcare. The Forum also confirmed the need for strong and fully implemented safeguards of patient safety at EU level whilst respecting for the capacity of national rules guaranteeing quality and safety. The Forum also recommended to establish an internet portal for the free exchange of data, evidence and practice to foster continuous learning and innovation, Final Report of the Open Health Forum, Health challenges and future strategy, European Public Health Alliance (2005).
- 81.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 82.B6-0098/2007
- 83.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 84.OJ L 166, 30.4.2004, p.1.
- 85.Non-differentiated appropriations hereafter referred to as NDA
- 86.Non-differentiated appropriations hereafter referred to as NDA
- 87.Expenditure within article xx 01 04 of Title xx.
- 88.Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05.
- 89.As described under Section 5.3
- 90.Cost of which is NOT covered by the reference amount
- 91.Cost of which is NOT covered by the reference amount
- 92.Reference should be made to the specific legislative financial statement for the Executive Agency(ies) concerned.
- 93.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 94.10173/06 SAN 168 SOC 302 MI 132
- 95.A6-0129/2005 final
- 96.B6-0098/2007
- 97.A6-0173/2007 final
- 98.The last Open Health Forum attracted around 380 participants from a wide range of health organisations. The Forum recommended during its conference in November 2005 that the Commission should address the potential of targeted healthcare legislation, because subsidiarity is not a sufficient guarantee of meeting the promise of universal access to high quality healthcare. The Forum also confirmed the need for strong and fully implemented safeguards of patient safety at EU level whilst respecting for the capacity of national rules guaranteeing quality and safety. The Forum also recommended to establish an internet portal for the free exchange of data, evidence and practice to foster continuous learning and innovation, Final Report of the Open Health Forum, Health challenges and future strategy, European Public Health Alliance (2005).
- 99.All EU Member States are represented in the High Level Group on Health Services and Medical Care, observers from the EEA/EFTA states as well as representatives from civil society have also been involved in the work of this group; Report on the work of the High Level Group on Health Services and Medical Care in 2006, European Commission (2006).
- 100.Commission Communication, Consultation regarding Community action on health services, SEC (2006) 1195/4, 26 September 2006.
- 101.Commission document, Summary report of the responses to the consultation regarding 'Community action on health services' (2007)
- 103.Wismar M, Palm W, Figueras J, Ernst K and Van Ginneken E, Cross-Border Healthcare: Mapping and Analysing Health Systems Diversity, European Observatory on Health Systems and Policies, 2007.
- 104.Council Regulation (EC) No 1408/71 of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community. OJ L 149, 5.7.1971, p.2.
- 105.OJ L 255, 30.9.2005, p. 22.
- 106.OJ L 281, 23.11.1995, p.31.
- 107.OJ L 201, 31.7.2002, p. 37.
- 108.OJ L 178, 17.7.2000, p. 1.
- 109.See in particular Case C-158/96 Kohll, paragraphs 35-36.
- 110.See in particular Case C-368/98 Vanbraekel, paragraph 45.
- 111.Flash Eurobarometer Series
- 112.A6-0129/2005 final
- 113.A6-0173/2007 final
- 114.See Case C-372/04 Watts, paragraph 147.
- 115.See the impact assessment, and the results of the Europe 4 Patients research project referred to above.
- 116.See in particular Case C-158/96 Kohll
- 117.See in particular Kohll , paragraphs 35-36.
- 118.See in particular Vanbraekel , paragraph 45.
- 119.See in particular Kohll , paragraph 42.
- 120.See in particular Müller-Fauré and van Riet , paragraph 93.
- 121.See in particular Smits and Peerbooms , paragraphs 76-80.
- 122.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 123.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 124.See again in particular Smits and Peerbooms , paragraphs 76-80.
- 126.Flash Eurobarometer Series
- 127.For more information and the text of the report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union, see europa.eu.int/comm/health/ph_overview
- 128.OJ C
- 129.OJ C
- 130.OJ C
- 131.OJ C , , p. .
- 132.OJ C
- 133.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 134.A6-0129/2005 final
- 135.OJ L 376, 27.12.2006, p.36.
- 136.OJ C 146, 22.6.2006, p.1.
- 137.OJ C 146, 22.6.2006, p. 1.
- 138.OJ L 255, 30.9.2005, p. 22.Directive as last amended by Council Directive 2006/100/EC (OJ L 363, 20.12.2006, p.141)
- 139.OJ L 281, 23.11.1995, p.31.
- 140.OJ L 149, 5.7.1971, p.2. Regulation as last amended by Regulation (EC) No 1992/2006, (OJ L 392, 30.12.2006, p.
1).
- 141.OJ L 166, 30.4.2004, p. 1.
- 142.10173/06 SAN 168 SOC 302 MI 132
- 143.A6-0173/2007 final
- 144.10173/06 SAN 168 SOC 302 MI 132
- 145.OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ L 378, 27.12.2006, p.
1).
- 146.OJ L L 271, 9.10.2002, p. 1.
- 147.OJ L 142, 30.4. 2004, p.1.
- 148.OJ L 184, 17.7.1999, p.23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p.11).
- 149.OJ L 201, 31.7.2002, p. 37. Directive as last amended by Directive 2006/24/EC (OJ L 105, 13.4.2006, p.54).
- 150.OJ L 136, 30.4.2004, p.1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p.
1).
- 151.OJ L 121, 1.5.2001, p.34.
- 152.OJ L 18, 21.1.1997, p. 1.
- 153.OJ L 149, 5.7.1971, p.2. Regulation as last amended by Regulation (EC) No 1992/2006, (OJ L 392, 30.12.2006, p.
1).
- 154.OJ L 166, 30.4.2004, p. 1.
- 155.OJ L 210, 31.7.2006, p. 19.
- 156.10173/06 SAN 168 SOC 302 MI 132
- 157.OJ L 178, 17.7.2000, p. 1.
- 158.A6-0129/2005 final
- 159.A6-0129/2005 final
- 160.A6-0129/2005 final
- 161.A6-0129/2005 final
- 162.10173/06 SAN 168 SOC 302 MI 132
- 163.10173/06 SAN 168 SOC 302 MI 132
- 164.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 165.10173/06 SAN 168 SOC 302 MI 132
- 166.A6-0129/2005 final
- 167.10173/06 SAN 168 SOC 302 MI 132
- 168.A6-0129/2005 final
- 169.10173/06 SAN 168 SOC 302 MI 132
- 170.10173/06 SAN 168 SOC 302 MI 132
- 171.10173/06 SAN 168 SOC 302 MI 132
- 172.The last Open Health Forum attracted around 380 participants from a wide range of health organisations. The Forum recommended during its conference in November 2005 that the Commission should address the potential of targeted healthcare legislation, because subsidiarity is not a sufficient guarantee of meeting the promise of universal access to high quality healthcare. The Forum also confirmed the need for strong and fully implemented safeguards of patient safety at EU level whilst respecting for the capacity of national rules guaranteeing quality and safety. The Forum also recommended to establish an internet portal for the free exchange of data, evidence and practice to foster continuous learning and innovation, Final Report of the Open Health Forum, Health challenges and future strategy, European Public Health Alliance (2005).
- 173.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 174.B6-0098/2007
- 175.See the Report of the High Level Process of Reflection on patient mobility and healthcare developments in the European Union and the Commission Communication on the follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM (2004) 301 final, 20 April 2004.
- 176.OJ L 166, 30.4.2004, p.1.
- 177.Non-differentiated appropriations hereafter referred to as NDA
- 178.Non-differentiated appropriations hereafter referred to as NDA
- 179.Expenditure within article xx 01 04 of Title xx.
- 180.Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05.
- 181.As described under Section 5.3
- 182.Cost of which is NOT covered by the reference amount
- 183.Cost of which is NOT covered by the reference amount
- 184.Reference should be made to the specific legislative financial statement for the Executive Agency(ies) concerned.
- 185.Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
- 186.EUR-lex provides an overview of the proposal, amendments, citations and legality.