COMMISSION REGULATION (EU) 2021/1901

of 29 October 2021

implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council as regards statistics on health care expenditure and financing

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (1), and in particular Article 9(1) and Annex II, point (d), thereof,

Whereas:

(1) It follows from Regulation (EC) No 1338/2008 that the data and metadata on health care expenditure and financing should be set out by implementing measures.

(2) In accordance with Article 6(2) of Regulation (EC) No 1338/2008, the Commission carried out a cost-benefit analysis, taking into account the benefits of the availability of data on health care expenditure and financing. Variables on health care expenditure and financing should be collected to ensure the availability of EU-wide data for decisions relating to health and social policy.

(3) The Commission (Eurostat) produced jointly with the Organisation for Economic Cooperation and Development and the World Health Organization a statistical reference manual, the System of Health Accounts 2011 (2), to ensure relevance and comparability of the data. This manual, which sets out the concepts, the definitions and the methods for data processing relating to health care expenditure and financing should form the basis for the detailed questionnaire together with the guidelines accompanying the joint annual data collection exercise.

(4) The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee established by Article 7 of Regulation (EC) No 223/2009 of the European Parliament and of the Council (3),

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation lays down rules for the development and production of European statistics in the area of health care expenditure and financing, one of the subjects for statistics on health care listed in Annex II to Regulation (EC) No 1338/2008.

Article 2

For the purpose of this Regulation, the definitions set out in Annex I shall apply.

Article 3

Member States shall provide data for the areas and at the level of aggregation specified in Annex II.

Article 4

1. Member States shall provide the required data and the associated standard reference metadata on an annual basis. The reference period shall be the calendar year. The first reference year shall be 2021.

2. Data and reference metadata for the reference year N shall be transmitted by 30 April N+2.

3. Data and reference metadata shall be provided to the Commission (Eurostat) using the single entry point services, or be made available for retrieval by the Commission (Eurostat) by electronic means.

Article 5

Member States shall provide the necessary reference metadata, in particular concerning:

(a) the data sources and their coverage;

(b) the compilation methods used;

(c) information on features of national health care expenditure and financing specific to the Member States and deviations from the definitions listed in Annex I;

(d) references to national legislation where it forms the basis for health care expenditure and financing;

(e) information on any changes to the statistical concepts mentioned in Annex I.

Article 6

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 October 2021.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 354, 31.12.2008, p. 70

(2) OECD, Eurostat and World Health Organization, A System of Health Accounts 2011

(3) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (

OJ L 87, 31.3.2009, p. 164

ANNEX I

Definitions

‘Health care’ means all activities with the primary purpose of improving, maintaining and preventing the deterioration of the health status of persons and mitigating the consequences of ill-health through the application of qualified health knowledge;

‘Current expenditure on health care’ means the final consumption expenditure of resident units on health care goods and services, including the health care goods and services provided directly to individual persons as well as collective health care services;

‘Health care functions’ means the type of need that health care goods and services aim to satisfy or the kind of health objective pursued;

‘Inpatient curative and rehabilitative care’: ‘Inpatient care’ means the treatment and/or care provided in a health care facility to patients formally admitted and requiring an overnight stay; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

‘Day curative and rehabilitative care’: ‘Day care’ means the planned medical and paramedical services delivered in a health care facility to patients who have been formally admitted for diagnosis, treatment or other types of health care and are discharged on the same day; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

‘Outpatient curative and rehabilitative care’: ‘Outpatient care’ means the medical and ancillary services delivered in a health care facility to a patient who is not formally admitted and does not stay overnight; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

‘Home-based curative and rehabilitative care’: ‘Home-based care’ means the medical, ancillary and nursing services that are consumed by patients at their home and involve the providers’ physical presence; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

‘Inpatient long-term care (health)’: ‘Inpatient care’ means the treatment and/or care provided in a health care facility to patients formally admitted and requiring an overnight stay; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

‘Day long-term care (health)’: ‘Day care’ means the planned medical and paramedical services delivered in a health care facility to patients who have been formally admitted for diagnosis, treatment or other types of health care and are discharged on the same day; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

10.

‘Outpatient long-term care (health)’: ‘Outpatient care’ means the medical and ancillary services delivered in a health care facility to a patient who is not formally admitted and does not stay overnight; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

11.

‘Home-based long-term care (health)’: ‘Home-based care’ means the medical, ancillary and nursing services that are consumed by patients at their home and involve the providers’ physical presence; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

12.

‘Ancillary services (non-specified by function)’ means the health care or long-term care related services non-specified by function and non-specified by mode of provision, which the patient consumes directly, in particular during an independent contact with the health system and that are not integral part of a care service package, such as laboratory or imaging services or patient transportation and emergency rescue;

13.

‘Pharmaceuticals and other medical non-durable goods (non-specified by function)’ means pharmaceutical products and non-durable medical goods intended for use in the diagnosis, cure, mitigation or treatment of disease, including prescribed medicines and over-the-counter drugs, where the function and mode of provision are not specified;

14.

‘Therapeutic appliances and other medical goods (non-specified by function)’ means medical durable goods including orthotic devices that support or correct deformities and/or abnormalities of the human body, orthopaedic appliances, prostheses or artificial extensions that replace a missing body part, and other prosthetic devices including implants which replace or supplement the functionality of a missing biological structure and medico-technical devices, where the function and the mode of provision are not specified;

15.

‘Preventive care’ means any measure that aims to avoid or reduce the number or the severity of injuries and diseases, their sequelae and complications;

16.

‘Governance and health system and financing administration’ means services that focus on the health system rather than direct health care, direct and support health system functioning, and are considered to be collective, as they are not allocated to specific individuals but benefit all health system users;

17.

‘Other health care services not elsewhere classified (n.e.c.)’ includes any other health care services not classified in HC.1 to HC.7;

18.

‘Health care financing schemes’ means types of financing arrangements through which people obtain health services, including both direct payments by households for services and goods and third-party financing arrangements;

19.

‘Government schemes’ means health care financing schemes whose characteristics are determined by law or by the government and where a separate budget is set for the programme and a government unit that has an overall responsibility for it;

20.

‘Social health insurance schemes’ means a financing arrangement to ensure access to health care for specific population groups through mandatory participation determined by law or by the government, and eligibility based on the payment of health insurance contributions by or on behalf of the individuals concerned;

21.

‘Compulsory private insurance schemes’ means a financing arrangement to ensure access to health care for specific population groups through mandatory participation determined by law or by the government and eligibility based upon the purchase of a health insurance policy;

22.

‘Voluntary health insurance schemes’ means schemes based upon the purchase of a health insurance policy, which is not made compulsory by government and where insurance premiums may be directly or indirectly subsidised by the government;

23.

‘Non-profit institutions financing schemes’ means non-compulsory financing arrangements and programmes with non-contributory benefit entitlement that are based on donations from the general public, the government or corporations;

24.

‘Enterprise financing schemes’ means primarily arrangements where enterprises directly provide or finance health services for their employees without the involvement of an insurance-type scheme;

25.

‘Household out-of-pocket payment’ means a direct payment for health care goods and services from the household primary income or savings, where the payment is made by the user at the time of the purchase of goods or the use of the services;

26.

‘Rest of the world financing schemes’ means financial arrangements involving or managed by institutional units that are resident abroad, but who collect, pool resources and purchase health care goods and services on behalf of residents, without transiting their funds through a resident scheme;

27.

‘Health care providers’ means the organisations and actors that deliver health care goods and services as their primary activity, as well as those for which health care provision is only one among a number of activities;

28.

‘Hospitals’ means the licensed establishments that are primarily engaged in providing medical, diagnostic and treatment services that include physician, nursing and other health services to inpatients and the specialised accommodation services required by inpatients and which may also provide day care, outpatient and home health care services;

29.

‘Residential long-term care facilities’ means establishments that are primarily engaged in providing residential long-term care that combines nursing, supervisory or other types of care as required by the residents, where a significant part of the production process and the care provided is a mix of health and social services with the health services being largely at the level of nursing care in combination with personal care services;

30.

‘Providers of ambulatory health care’ means establishments that are primarily engaged in providing health care services directly to outpatients who do not require inpatient services, including both offices of general medical practitioners and medical specialists and establishments specialising in the treatment of day-cases and in the delivery of home care services;

31.

‘Providers of ancillary services’ means establishments that provide specific ancillary type of services directly to outpatients under the supervision of health professionals and not covered within the episode of treatment by hospitals, nursing care facilities, ambulatory care providers or other providers;

32.

‘Retailers and other providers of medical goods’ means establishments whose primary activity is the retail sale of medical goods to the general public for individual or household consumption or utilisation, including fitting and repair done in combination with sale;

33.

‘Providers of preventive care’ means organisations that primarily provide collective preventive programmes and campaigns/public health programmes for specific groups of individuals or the population-at-large, such as health promotion and protection agencies or public health institutes as well as specialised establishments providing primary preventive care as their principal activity;

34.

‘Providers of health care system administration and financing’ means establishments that are primarily engaged in the regulation of the activities of agencies that provide health care and in the overall administration of the health care sector, including the administration of health financing;

35.

‘Rest of the economy’ means other resident health care providers not elsewhere classified, including households as providers of personal home health services to family members, in cases where they correspond to social transfer payments granted for this purpose as well as all other industries that offer health care as a secondary activity;

36.

‘Rest of the world’ means all non-resident units providing health care goods and services as well as those involved in health-related activities.

ANNEX II

Subjects to be covered and their characteristics, cross-classification data and breakdowns

(1) Cross-classification current expenditure on health care by health care functions (HC) and financing schemes (HF)

All data shall be transmitted in millions of national currency.

	Financing schemes	HF.1.1	HF.1.2.1	HF.1.2.2	HF.2.1	HF.2.2	HF.2.3	HF.3	HF.4
Health care functions		Government schemes	Social health insurance schemes	Compulsory private insurance schemes	Voluntary health insurance schemes	Non-profit institutions financing schemes	Enterprise financing schemes	Household out-of-pocket payment	Rest of the world financing schemes	Current expenditure on health care HF.1-HF.4
HC.1.1; HC.2.1	Inpatient curative and rehabilitative care
HC.1.2; HC.2.2	Day curative and rehabilitative care
HC.1.3; HC.2.3	Outpatient curative and rehabilitative care
HC.1.4; HC.2.4	Home-based curative and rehabilitative care
HC.3.1	Inpatient long-term care (health)
HC.3.2	Day long-term care (health)
HC.3.3	Outpatient long-term care (health)
HC.3.4	Home-based long-term care (health)
HC.4	Ancillary services (non-specified by function)
HC.5.1	Pharmaceuticals and other medical non-durable goods (non-specified by function)
HC.5.2	Therapeutic appliances and other medical goods (non-specified by function)
HC.6	Preventive care
HC.7	Governance and health system and financing administration
HC.9	Other health care services not elsewhere classified (n.e.c.)
	Current expenditure on health care HC.1-HC.9

(2) Cross-classification current expenditure on health care by health care functions (HC) and health care providers (HP)

All data shall be transmitted in millions of national currency.

	Health care providers	HP.1	HP.2	HP.3	HP.4	HP.5	HP.6	HP.7	HP.8	HP.9
Health care functions		Hospitals	Residential long-term care facilities	Providers of ambulatory health care	Providers of ancillary services	Retailers and other providers of medical goods	Providers of preventive care	Providers of health care system administration and financing	Rest of the economy	Rest of the world	Current expenditure on health care HP.1-HP.9
HC.1.1; HC.2.1	Inpatient curative and rehabilitative care
HC.1.2; HC.2.2	Day curative and rehabilitative care
HC.1.3; HC.2.3	Outpatient curative and rehabilitative care
HC.1.4; HC.2.4	Home-based curative and rehabilitative care
HC.3.1	Inpatient long-term care (health)
HC.3.2	Day long-term care (health)
HC.3.3	Outpatient long-term care (health)
HC.3.4	Home-based long-term care (health)
HC.4	Ancillary services (non-specified by function)
HC.5.1	Pharmaceuticals and other medical non-durable goods (non-specified by function)
HC.5.2	Therapeutic appliances and other medical goods (non-specified by function)
HC.6	Preventive care
HC.7	Governance and health system and financing administration
HC.9	Other health care services not elsewhere classified (n.e.c.)
	Current expenditure on health care HC.1-HC.9

(3) Cross-classification current expenditure on health care by health care providers (HP) and financing schemes (HF)

All data shall be transmitted in millions of national currency.

	Financing schemes	HF.1.1	HF.1.2.1	HF.1.2.2	HF.2.1	HF.2.2	HF.2.3	HF.3	HF.4
Health care providers		Government schemes	Social health insurance schemes	Compulsory private insurance schemes	Voluntary health insurance schemes	Non-profit institutions financing schemes	Enterprise financing schemes	Household out-of-pocket payment	Rest of the world financing schemes (non-resident)	Current expenditure on health care HF.1-HF.4
HP.1	Hospitals
HP.2	Residential long-term care facilities
HP.3	Providers of ambulatory health care
HP.4	Providers of ancillary services
HP.5	Retailers and other providers of medical goods
HP.6	Providers of preventive care
HP.7	Providers of health care system administration and financing
HP.8	Rest of the economy
HP.9	Rest of the world
	Current expenditure on health care HP.1-HP.9