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Royal Decree 1893 / 1996, Of 2 August, From Basic Organic Structure Of The Ministry Of Health And Consumption, Its Autonomous Bodies And The National Institutes Of Health.

Original Language Title: Real Decreto 1893/1996, de 2 de agosto, de estructura orgánica básica del Ministerio de Sanidad y Consumo, de sus organismos autónomos y del Instituto Nacional de la Salud.

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TEXT

Royal Decree 839/1996, of 10 May, establishes the new basic organization of the various ministerial departments, among others, in Article 10, the higher organs and management centers of the Ministry of Health and Consumption. In turn, the Royal Decree 1140/1996, of 24 May, gives new structure to the National Institute of Health, managing body of Social Security attached to the Ministry of Health and Consumer Affairs through the General Secretariat of Assistance Health, to whom is the top management of that organ.

In the light of the important changes introduced in the organization of the Department, its autonomous agencies and the National Institute of Health, the Royal Decrees mentioned above, the adaptation of the basic organic structure of the same in the terms provided for in the second and third final provisions of the aforementioned Royal Decree 839/1996.

The new organization of the Ministry, in line with what was established for INHEALTH by Royal Decree 1140/1996, of 24 May, intends to separate as clearly as possible the exercise of the state functions in Health and Consumer Affairs. -including those of general coordination through the Interterritorial Council and the Sectoral Conference of Consumode, the competences assumed by the State in the field of health care in the Autonomous Communities that have not taken over the management in (a) the matter, which shall be exercised through the General Secretariat for Health Care, who is the executive chair of the INHEALTH and the coordination of the Directorates-General in which the Institute is structured.

The Ministry of Health and Consumer Affairs is thus configured, under the direction of the Minister, in two well-defined areas of competence. On the one hand, the Health and Consumer Secretariat, which corresponds to the state functions in these sectors and which assumes, consequently, the support tasks of the Interterritorial Council and the Consumer Sectoral Conference. And on the other hand, the General Secretariat of Health Care, responsible for health care services managed by the State, and which assumes, for operational reasons, some tasks in the field of the National Health System, especially the on state funding.

In this framework, the restructuring takes place, in the present Royal Decree, with the objective of greater efficiency and rationalization of the administrative organization and based on criteria of austerity and limitation of public expenditure, and Among other effects, there is a reduction in the central and peripheral administrative organisation, including the removal of the Department's Territorial Directorates.

In its virtue, at the initiative of the Ministry of Health and Consumer Affairs, and on a joint proposal of the Ministers of Public and Economic Affairs and Finance, after deliberation by the Council of Ministers, at its meeting on August 1996,

D I S P O N G O:

Article 1. General organization of the Department.

1. The Ministry of Health and Consumer Affairs is the body of the General Administration of the State responsible for the proposal and implementation of the Government's general guidelines on health policy, health planning and health care, and consumption.

2. Under the Minister's top management, the Ministry of Health and Consumer Affairs develops the functions that are legally and regulatively corresponding to it, through the following higher bodies:

(a) Health and Consumer Undersecretary.

b) General Secretariat for Health Care.

3. As an immediate assistance agency to the Minister, there is a Cabinet, with an organic level of Directorate General, with the structure set out in Article 12 of Royal Decree 839/1996 of 10 May.

Article 2. Health Advisory Board.

The Health Advisory Board is the advisory and assistance body to the Minister in the formulation of health policy in the terms set out in Royal Decree 858/1992 of 10 July. Its composition and operating system is governed by its specific rules.

Article 3. Deputy Secretary for Health and Consumer Affairs.

1. It is up to the Deputy Secretary for Health and Consumer Affairs to perform the functions that Article 15 of the Law of 26 July 1957, of the Legal Regime of the State Administration, attributes to the Subsecretaries of the Ministries.

2. It also corresponds to the overall coordination of the Department and, in addition, to the direction, impetus and supervision of the functions and activities managed by the management centers and units dependent on it, as well as the agencies that are attached.

3. The Secretariat's institutional relations are attributed to the Secretariat, in particular with the Autonomous Communities, support for the Interterritorial Council of the National Health System, set up in Article 47 of Law 14/1986, General de Health, of 25 April, and the Sectoral Conference of Consumption and the exercise of the functions of High Inspection that correspond to the Department under the provisions of Chapter 4 of Title II of the Law.

4. In addition to the functions set out in the above paragraphs and except for cases reserved for the Minister's decision or the competence of the General Secretariat for Health Care, the following functions are attributed to the Secretariat:

(a) The elaboration of the annual preliminary draft budgets of the Department and its autonomous bodies, and the monitoring of budget implementation. This preliminary draft will be integrated with the one prepared by the General Secretariat of Health Assistance for the state funding of the health care of the National Health System.

b) The development of health programmes and programmes in the field of State competence and, in collaboration with the Autonomous Communities, the development and monitoring of national health plans and the Integrated Plan of Health.

c) The establishment of health information systems, including information initiatives for the management of the General Secretariat for Health Care, and the design of health statistics for purposes state.

d) The proposal for basic management of the insurance, the care activities, resources and benefits of the National Health System, as well as the supervision of the functions of registration, approval, accreditation and inspection which correspond to the State in health matters.

e) The proposal for the basic management of the National Health System, for the regulation of the health professions-without prejudice to the competencies that correspond to other departments-and the management of the functions that The Ministry of Health is responsible for specialized health training.

f) The design, elaboration and management of the IT plan of the Department and its autonomous agencies.

5. The following management centres depend on the Health and Consumer Secretariat:

(a) Technical General Secretariat.

b) Directorate General of Public Health.

c) Directorate General of Pharmacy and Healthcare Products.

They are attached to the Ministry of Health and Consumer Affairs, through the Secretariat, the autonomous bodies Instituto de Salud Carlos III and Instituto Nacional del Consumo.

6. It is up to the Under-Secretary of State to chair the National Commission for the Coordination and Monitoring of AIDS Prevention Programmes, set up by Royal Decree 592/1993 of 23 April.

The National Transplant Organization, established in accordance with the provisions of Royal Decree 426/1980 of 22 February, and the Transplant Advisory Commission, established by Order of 25 August 1980, is hereby assigned to the Secretariat. Also, the National Councils of Medical and Nursing Specialties, regulated, respectively, in Royal Decree 127/1984, of 11 January, and Royal Decree 992/1987, of July 3, are assigned to it.

7. The following units are directly dependent on the Subsecretariat for Health and Consumer Affairs, with an organic level of Subdirectorate General:

(a) The Technical Cabinet of the Secretariat, as a body for immediate assistance to the Undersecretary and for the coordination of the functions and units assigned directly to the Undersecretary, who also assumes the planning proposals basic health insurance, activities, resources and benefits of the National Health System.

b) Subdirectorate General of Institutional Relations and High Inspection, to whom the development of relations with the Autonomous Communities and Local Corporations, as well as the monitoring and analysis of the acts and provisions of the Autonomous Communities and cooperation in the exercise of the functions of the High Inspectorate which assigns to the State the fourth chapter of Title II of the General Law on Health.

c) Secretariat of the Interterritorial Council of the National Health System, which assumes the administrative and technical support, if any, to the Interterritorial Council of the National Health System, to its commissions and working groups and to the Advisory Committee, regulated by Royal Decree 1515/1992 of 11 December, as well as assistance to the Consumer Sectoral Conference and its committees and working bodies.

(d) General Secretariat for Professional Relations, to whom the proposals for basic human resources regulations of the National Health System correspond, as well as the coordination of the exercise of the functions of the Department in relationship with the management of the health professions entitled.

e) General Health Training Subdirectorate, to whom the study of the needs of specialists in the National Health System, the proposals for the regulation of specialized training, the definition of the system training, assessment and accreditation of the health centres and the quality control of such training.

(f) Subdirectorate General for Professional Development, to whom the management of the State information systems on the personnel of the National Health System, the management of the training system and the development of the Role of the Department in continuing health training.

g) General inspection of the Ministry of Health and Consumer Affairs, which exercises the functions of advisory on administrative and health organizations, the proposals to modernize them, the tasks of accreditation that are entrusted and the actions of inspection, audit and control, in the health and administrative fields, which correspond to the Department.

h) Subdirectorate General of Information Systems and Technologies, to whom are the design, elaboration and management of the Information Plan of the Department and its autonomous agencies, and the development and implementation of the computer applications.

8. They are attached to the Secretariat, without prejudice to their functional dependence on the Ministries of Justice and Economy and Finance, respectively, the following units with an organic level of Subdirectorate General:

(a) The Legal Service, with the functions assigned to it by the provisions in force.

b) The Delegated Intervention, with the functions that the current rules attribute to it.

Article 4. Technical General Secretariat.

1. The Technical General Secretariat is the management center that assumes, along with the powers assigned to it in Article 19 of the Law of Legal Regime of the State Administration, the management of the general and common services of consultative support instruments that are determined in this Royal Decree.

2. The following functions are assigned to the Technical General Secretariat:

(a) The examination, report and proposal of the cases to be submitted to the Government, its delegated Commissions and the General Commission of Secretaries of State and Undersecretaries.

b) The report of the general provisions of the Department, as well as the management and elaboration of the own or joint normative projects, including their insertion into the "Official State Gazette", which is expressly entrusts.

c) The report of the draft general provisions of other Departments of the General Administration of the State, in those aspects that may affect the competence of the Ministry of Health and Consumer Affairs.

d) The preparation, compilation and recasting of legal texts and their adaptation to Community law, and the collection of doctrinal and jurisprudential criteria in the field of health and consumption.

e) The relationship and coordination with the other Departments and agencies of the General Administration and the State Advisory Bodies, with respect to the matters of the competence of the Technical General Secretariat.

(f) The study, processing and proposal for the resolution of the resources and review procedures relating to the provisions and acts of the Department and its autonomous bodies, as well as the related relations with the bodies of the administration of justice.

g) Administrative information and attention to the citizen, processing of petition or complaint, as well as the corresponding relations with the Ombudsman.

h) The elaboration of the editorial plan, the management of the official publications of the Department and its autonomous agencies, and the management of the General Library of the Ministry.

i) The management of international relations and development cooperation, as well as the coordination of actions in the European Union and international bodies in the field of health and consumption, according to and in relation to with the Ministry of Foreign Affairs.

(j) The management of human resources, both official and labour staff; the drawing up of employment relations and the preliminary draft public employment offer, as well as the employment plans; calls for the selection and provision of jobs by the Department and its self-employed bodies; training of staff, social assistance and relations with the Staff Board; safety and hygiene at work; the scheme the economic and control of staff expenditure, as well as the empowerment of staff, and, in general, the other arrangements concerning the staff of the Department and its self-employed bodies.

k) Management in the field of internal arrangements, assets and works; technical maintenance, surveillance and security services; supervision of the technical projects of the Department and its autonomous bodies in these areas; and the execution of the contracts.

(l) the economic and administrative management of the Department's budgetary appropriations and their prior accounting; the processing of the files in the firm and the justification; the system of fixed-box advances; the justification for accounts; the provision of appropriations, except those for staff; the coordination of the payment appropriations; the control of health rates; and, in general, the economic and financial management of the Ministry.

(m) Preparation and processing of the preliminary draft budget of the Department and coordination of the budgets of the bodies attached; the changes to be made in the course of the financial year; the report and assistance (i) technical assistance for the budget and, in general, the tasks entrusted to the budget offices.

3. For the performance of its functions, the Technical General Secretariat is structured in the following units with an organic level of Subdirection General:

(a) Subdirectorate General of Regulations, which assumes the development of the functions described in paragraphs 2.a), (b), (c), (d) and (e) of this Article.

b) Subdirectorate General of Resources and Attention to the Citizen, who assumes the development of the functions described in paragraphs 2.f), g) and h) of this article.

(c) Subdirectorate General for International Relations, which assumes the development of the functions described in paragraph 2. (i) of this Article.

(d) General Staff Subdirectorate, which assumes the development of the functions described in paragraph 2.j) of this Article.

e) Major Office, which assumes the development of the functions described in paragraph 2.k) of this article.

(f) Subdirectorate General of Financial Management, which assumes the development of the functions described in paragraph 2. (l) of this Article.

g) Budget Office, which assumes the development of the functions described in paragraph 2.m) of this Article.

Article 5. Directorate-General for Public Health.

1. The Directorate General of Public Health is the executive director responsible for the management of state functions in public health, health, food and environmental health, and information and state health planning.

2. The following functions are the responsibility of the Directorate-General for Public Health:

(a) Those in the field of external health are derived from the provisions of international law, Law 14/1986, General of Health, and Royal Decree 1418/1986 of 13 June. The development and monitoring of national and international programmes to combat anthropozoonoses and, in general, those of the Department of Public Health Veterinary.

b) The proposals on regulations for the health control of food and products specified in the Spanish Food Code and the health risks of other products and services, as well as the management of the food alert network.

c) Those relating to proposals on the regulation of sanitary control of water, chemicals and radiation protection, as well as the management of the environmental monitoring network and the management of specific registers and controls concerning the health aspects of agricultural and environmental products.

(d) The duties entrusted to the Department on the notification of new substances and the classification, packaging and labelling of dangerous substances.

e) The analysis, proposal and, where appropriate, management of disease prevention, health education, occupational health and promotion of healthy habits, especially those involving the development of initiatives taken by the European Union.

f) Technical assistance to the Public Health committees and working groups of the Interterritorial Council of the National Health System.

g) The development of information systems for state planning and evaluation, statistics, surveys and state health indicators, including the National Health Survey and the catalogue, general of health centres, services and establishments.

(h) The elaboration of health programmes and plans in the field of State competence, the implementation and monitoring, in collaboration with the Autonomous Communities, of joint plans and the proposal and follow-up of the Plan of Health of the Ministry and the Integrated Health Plan.

3. They are attached to the Directorate-General for Public Health, the Commission on Social Aid to the People Affected by the Human Immunodeficiency Virus Acquired (CASHIV), scheduled for the Royal Decree-Law 9/1993 of 28 May; the National Commission of Coordination and Monitoring of AIDS Prevention Programmes and the Secretariat of the National Plan on AIDS, both of which are provided for in Royal Decree 592/1993 of 23 April; the Inter-Ministerial Committee on Food Management, regulated by the Royal Decree Decree 1456/1982 of 18 June; the National Commission of Hemotherapy, regulated by the Royal Decree 1945/1985 of 9 October, and the National Commissions of Human Reproduction Assisted, provided for in Law 35/1988, of 22 November.

In general, it is up to the Directorate General of Public Health to address and coordinate the state health plans and programs developed by the Department.

4. For the performance of its functions, the Directorate General of Public Health is structured in the following units with an organic level of Subdirection General:

(a) Subdirectorate-General for Foreign and Veterinary Health, which is responsible for the development of the functions referred to in paragraphs 2 (a) and (2) (f) of this Article.

(b) General Food Hygiene Subdirectorate, which corresponds to the development of the functions referred to in paragraphs 2 (b) and 2 (f) of this Article. The Secretariat of the Inter-Ministerial Food Management Committee is responsible for the Deputy Director-General.

(c) Subdirectorate-General for Environmental Health, which corresponds to the development of the functions referred to in paragraphs 2 (c) and (d) and (2) (f) of this Article.

(d) General Sub-Directorate of Epidemiology, Promotion and Education for Health, which corresponds to the development of the functions referred to in paragraphs 2.e), g) and h) and, in its scope, 2.f) of this article.

Article 6. Directorate-General for Pharmacy and Health Products.

1. The Directorate General of Pharmacy and Health Products is the executive director responsible for the management and development of the pharmaceutical policy of the Department, in the terms indicated in Law 14/1986, of 25 April, General of Health; in the Law 25/1990, of 20 December, of the Medication, and in the Community Directives on implementation.

2. It is up to the Directorate General of Pharmacy and Healthcare products to develop the following functions:

(a) The planning, evaluation and authorization of the new drugs, as well as the review and appropriate adjustments in those already marketed.

(b) Participation in the planning, evaluation and control of medicinal products authorised by the European Union through the European Agency for the Evaluation of Medicinal Products.

c) The evaluation and authorisation of products in clinical research, clinical trials and products in the research phase.

d) The authorization of pharmaceutical laboratories.

e) The granting of authorisations for health guarantees for the external trade in medicinal products.

f) The coordination and planning of pharmaceutical care and the criteria for pricing and margins affecting medicines and effects and accessories.

g) The studies and selection of medicines and medical devices for the purpose of their financing from Social Security funds or state funds assigned to health, within the National Health System.

(h) The supply of medicinal products and medical devices of the State in the terms provided for in the first provision of Law 25/1990 of 20 December of the Medication, as well as the authorization of compassionate use of medicines.

i) Management of aggregated information resulting from the processing of prescriptions from the National Health System.

(j) Promoting the rational use of medicinal products and general information on medicines to health professionals and the public; participation in the regulation and management of pharmaceutical training and the authorization of the advertising of medicinal products for human use, in cases where their grant corresponds to the Ministry of Health and Consumer Affairs.

(k) The processing of the industrial price fixing files for the proprietary medicinal products in the register, as well as those related to the reviews of the existing ones on the market.

l) The issuance of reports and the formulation of proposals on the prices corresponding to the distribution and dispensing of the proprietary medicinal products.

m) The proposal for the fixing and revision of the maximum prices for the effects and accessories for their financing from Social Security funds or state funds affected by health.

n) The management of the Spanish Royal Pharmacopoeia in the terms set out in Royal Decree 294/1995 of 24 February, and the planning, evaluation and development of the Spanish pharmacovigilance system.

n) Inspection and control of medicinal products in their manufacture and production; control of narcotic drugs and psychotropic drugs and the analysis and destruction, if any, of the trade flows from illicit trafficking the same, and the coordination of the activities of the peripheral laboratories of the Ministry of Health and Consumption in this field.

(o) The instruction of the procedures arising from infringements related to medicinal products and medical devices where appropriate to the Ministry of Health and Consumer Affairs.

p) The exercise of functions which, in relation to medical devices, cosmetics, preparations used in personal hygiene and disinfectants of clinical and pharmaceutical material and of clinical and surgical environments, attribute to the Ministry of Health and Consumer Law 14/1986 of 25 April, General of Health; Law 25/1990 of 20 December of the Medicament, and the provisions implementing the Community Directives in these matters.

q) The design of information systems projects related to medicines and medical devices and the maintenance of databases related to information systems in the pharmaceutical field.

r) The study, design and evaluation of management procedures relating to medicinal products and medical devices.

3. They are assigned to the Directorate-General of Pharmacy and Health Products, the National Commissions for the Rational Use of the Drug, created by Royal Decree 1274/1992, of 23 October; of Pharmaceutical Specializations, according to the Royal Decree 2708/1982 of 15 October 1982; Evaluation of Medicinal Products, regulated by Royal Decree 898/1993 of 11 June; Pharmacovigilance, regulated by Order of 25 June 1985; of the Royal Spanish Pharmacopoeia, regulated by Royal Decree 294/1995, of 24 February; the Advisory Committee on Cosmetology, Regulated by Order of 31 May 1990, and the Commission of the Technical Advisory of Orthopaedic Prstation, regulated by Order of 18 January 1996.

4. For the development of its functions, the General Directorate of Pharmacy and Health Products is structured in the following units, with an organic level of Subdirection General:

(a) Subdirectorate-General for the Evaluation of Medicinal Products, to which the development of the functions referred to in paragraphs 2.a), (b), (c), (d) and (e) of this Article corresponds.

(b) General Health Products Subdirectorate, to which the development of the functions referred to in paragraph 2.p. of this Article corresponds.

(c) General Secretariat for Pharmaceutical Control, which is responsible for the development of the functions referred to in paragraphs 2.n), (n) and (o) of this Article.

(d) General Sub-Directorate of Pharmaceutical Planning, which is responsible for the development of the functions referred to in paragraphs (2.f), (g), (h), (i) and (j) of this Article.

(e) Subdirectorate-General for Economic Studies and Pharmaceutical Procedures, which corresponds to the development of the functions referred to in paragraphs 2.k), l), m), q) and r) of this Article.

Article 7. Institute of Health Carlos III.

1. The Carlos III Health Institute is the scientific and technical support organ of the Ministry of Health and Consumer Affairs and the various Health Services of the Autonomous Communities, and of collaboration, in the field of their functions, with other administrations public.

2. It is up to the Carlos III Health Institute to carry out the functions mentioned in Articles 111 and 112 of the General Health Law, in the terms regulated in Royal Decree 10/1988 of 8 January; those of the Health Research Fund -including research on toxic syndrome-in the terms of the Ministerial Orders of 27 June 1980 and 18 October 1985; those of the National School of Health, regulated by Royal Decree 150/1991 of 1 February 1985, and those of the Agency for the Evaluation of Sanitary Technologies, created by Royal Decree 1415/1994, 25 of June.

The Carlos III Health Institute also assumes how many other tasks in the field of public health, research, technical control, teaching, evaluation or health accreditation are entrusted to the other bodies. of the Department or the Interterritorial Council of the National Health System.

3. They are the governing bodies of the Carlos III Health Institute, the Rector Council and the Director, with the rank of Director-General. It is for the Minister of Health and Consumer Affairs of the Rector Council, whose Vice Presidency is exercised by the Undersecretary of the Department; it is up to the Director of the Health Institute Carlos III to the Secretariat of that Council.

In addition to the above charges, the following members are included in the Rector Board:

(a) Four Vocals, with a category of Director-General, representing the Ministries of Education and Culture, Industry and Energy, Agriculture, Fisheries and Food, and the Environment, appointed by the These departments; the representative of the Ministry of Education and Culture appointed among the senior posts of the Secretariat of State for Universities and Research and Development.

b) Four Vocals representing the Autonomous Communities, elected from among its members by the Interterritorial Council of the National Health System.

(c) Three Vocals designated by the Minister of Health and Consumer Affairs; two, among professionals of recognized scientific or health prestige, and one, with a category of Director-General, representing the General Secretariat of Health Care.

4. The following units are dependent on the Director of the Health Institute Carlos III for the organic level of Subdirección General:

1. The General Secretariat, to which it is responsible, in coordination with the units of the Secretariat of the Department, the functions of general administration of the Institute. The Secretary-General replaces the Director in cases of vacancy, absence or illness.

Depend on the Secretary-General on the human resources management units of the Institute, the administrative and financial management units and those of the internal system.

2. The Technical Secretariat, which corresponds to the coordination and interrelation of the various institutions of the Institute, the institutional relations, the follow-up of own research, the dissemination and the corporate image of the Institute and management of the Museum of Health. It also corresponds to the coordination of the Research Units, as well as the Center for Clinical Research and Preventive Medicine, without prejudice to the system of concertation of care services with the National Institute of Health.

3. The Health Research Fund, which is responsible for the promotion of research in health sciences through the evaluation, financing and monitoring of research projects, infrastructure aids and aid for the training of research staff.

4. The National School of Health, which corresponds to the continuous and permanent formation of the staff of the Higher and Media Corps at the service of the State Health Administrations, as well as to promote and collaborate in the development of studies and research in the field of service management and public health.

Of the National School of Health, and similar to that of the research centers, the National Library of Health Sciences, which assumes the direction and coordination of all the libraries of the Institute, depends.

5. The General Sub-Directorate of Epidemiology and Health Information, to which it is responsible to coordinate the activities of the following centers, whose organic level will be determined in the corresponding relations of posts of job:

a) National Center for Epidemiology.

b) National Health Information Center.

c) Research Center on Toxic Oil Syndrome.

6. The General Subdirectorate of Laboratories and Services in Public Health, to which it is responsible to coordinate the activities of the following centers, whose organic level will be determined in the corresponding relations of job:

a) National Center for Pharmacobiology.

b) National Food Center.

c) National Center for Environmental Health.

d) National Center for Microbiology.

e) National Center for Fundamental Biology.

7. The Agency for the Evaluation of Health Technologies, which assumes, in coordination with the Directorate General of Public Health and the Secretariat of the Interterritorial Council, the functions assigned to it by the second provision of the Royal Decree 1415/1994 of 25 June, as well as the functions of evaluation of health benefits in relation to their ordination in the National Health System.

Article 8. Instituto Nacional del Consumo.

1. The National Institute of Consumption is the body that exercises, in accordance with the provisions of Article 51 of the Constitution and Law 26/1984, of July 19, General for the Defense of Consumers and Users, the functions of promotion and promotion of the rights of consumers and users.

2. It is up to the National Consumer Institute to develop the following functions:

(a) Advice, proposal and collaboration in the work of public administrations in the field of consumer protection, as well as the promotion and conduct of research and studies in relation to consumption; the internal arrangements, economic, administrative and budgetary management, and ordinary management of the staff of the body.

b) The implementation, development and dissemination of the Arbitration System for Consumption, in compliance with Royal Decree 636/1993 of 3 May.

c) The development of information, training and education of consumers, as well as the promotion and registration of their associations, and support to the Consumers and Users Council, in terms established in the Royal Decrees 825/1990, of 22 July, and 2211/1995, of 28 December.

(d) The proposal for consumer management, technical support for consumer inspection services of other public administrations, as well as the development of functions related to the smooth functioning of the market for the protection of the consumer and the management of the alert network for non-food products, as provided for in Royal Decree 44/1996 of 19 January.

(e) Research and analysis, testing and testing on the quality and safety of consumer goods and services; training and advice of technical staff, as well as activity aimed at promoting the use of the quality of goods and services for use and consumption.

3. They are the governing bodies of the Institute, the President, whose role the Department's Assistant Secretary assumes, and the Vice President. It is up to the President to address and represent the body, as well as the approval of the Institute's overall activity plans; and to the Vice-President, the implementation of these plans, the management of staff, the recruitment on behalf of the of the body, the provision of expenditure and the management of payments and the general coordination of the Institute's units.

4. The following organic units depend on the President of the Institute, at the level of Subdirectorate General:

(a) General Secretariat, which is assumed by the Vice-Presidency and which also corresponds to the development of the functions provided for in paragraph 2 (a) of this Article.

(b) Subdirectorate-General for Cooperation, which is responsible for the development of the functions referred to in paragraphs 2.b) and c) of this Article.

(c) General Subdirectorate for Management of Consumption, which corresponds to the development of the functions referred to in paragraphs 2.d) and e) of this article, as well as the Research and Quality Control Center.

Article 9. General Secretary for Health Care.

1. The General Secretariat for Health Care, whose head is under the rank of Undersecretary, is the body of the Ministry of Health and Consumer Affairs, which assumes the top management and control of the National Institute of Health.

2. In addition to the functions that correspond to the National Institute of Health, the General Secretariat of Health Care assumes the following competencies:

a) The analysis of the needs of economic resources and the elaboration of the annual budget proposal for the state funding of health care of the National Health System, within the budget of the Ministry of Health and Consumer Affairs.

b) The elaboration and proposal of criteria on the economic-financial relations between the National Health System and public and private insurance entities.

c) The annual distribution of budgetary resources, within the framework of public funding for health care.

d) The analysis, development and maintenance of the clinical information systems for the management of the National Health System.

3. From the General Secretariat of Health Care, the following units depend on the organic level of Subdirección General:

(a) Subdirectorate-General for Financing and Budgets, which assumes the tasks set out in paragraphs (a), (b) and (c) of the previous paragraph.

b) Subdirectorate General of Programs, which assumes the functions provided for in paragraph (d) of the previous paragraph, as well as those for assistance and advice to the Secretary-General for Health Care in its activities in the field of the National Health System, in coordination with the Secretariat of the Interterritorial Council.

Article 10. Instituto Nacional de la Salud (INHEALTH).

1. The National Institute of Health (INHEALTH), the managing body of the health services of Social Security, is attached to the Ministry of Health and Consumer Affairs, through the General Secretariat for Health Care, which is assumed by the Presidency. Executive.

2. It is for INHEALTH, in accordance with the provisions of Article 57 of the Royal Legislative Decree 1/1994 of 20 June, approving the recast text of the General Law of Social Security and the third transitional provision of Law 14/1986, of 25 April, General of Health, the management of the health benefits of Social Security in the territorial area of the Autonomous Communities that have not assumed those powers, as well as in Ceuta and Melilla.

3. INHEALTH is structured in the following organs:

(a) Participation in the control and monitoring of management.

1. The General Council.

2. The Executive Committee.

b) Senior management and management: the Executive Chairman, whose role is assumed by the Secretary-General for Health Care, and who directly depends on the management and management bodies.

c) Address and management, the holders of which have the rank of General Manager:

1. General Directorate of Health Organization and Planning.

2. General Directorate of Primary and Specialized Care.

3. Directorate-General for Budgets and Investments.

4. General Directorate of Human Resources.

4. The composition and functions of the General Council are those attributed to it in the third article of Royal Decree 1855/1979 of 30 July 1979. Its President is the Executive Chairman of INHEALTH.

5. The composition and functions of the Executive Committee are those laid down in the fourth article of Royal Decree 1855/1979 of 30 July 1979. Its President shall be appointed by the Executive Chairman of INHEALTH, from among the Directors-General of the Agency.

6. The Executive Chairman, as the body of senior management and management, has the legal representation of the body, and it is up to him to plan, address and evaluate the Institute and, in general, to exercise the powers legally. attributed to the Directors of the Social Security Management Entities.

The Executive Presidency is attached to the Central Intervention of the National Institute of Health, without prejudice to its dependence on the General Intervention of the State Administration and the General Intervention of the Social Security.

7. As a coordination and advisory body to the Executive Chairman, the Commission of Management is constituted by the study and formulation of proposals in relation to the action plans of the agency and its permanent monitoring, the analysis of the preliminary draft budget and, in particular, the coordination of powers and actions of the management centres of the Institute, as well as any other attributed to it by the Executive Chairman.

The Board of Directors, whose presidency is the executive chairman of the body, is composed of the directors general of the entity, and can be incorporated into it, in the light of the issues to be dealt with, Deputy Directors general, other INHEALTH-dependent personnel or representatives of other bodies or management centres, subject to a summons from the President.

8. The following units are directly dependent on the Executive Chairman, with an organic level of Subdirection General:

(a) Deputy Director-General of Administrative Coordination, to which the technical and administrative assistance to the Executive Chairman correspond, the coordination of all matters affecting the competence of various units, the internal arrangements and technical assistance to the General Council, to which the Secretariat is responsible.

b) Subdirectorate General of Legal Counsel, to which the legal advice and coordination of the legal defense of the Institute correspond.

(c) Subdirectorate General of Health Inspection, which corresponds to the inspection, evaluation and control of health services, centers and services of INHEALTH, as well as the management and elaboration of draft resolutions of the records of patrimonial liability.

(d) General Information Subdirectorate, which corresponds to the design, development and management of the agency's IT plan, and the development and implementation of the Institute's computer applications, without prejudice to the Competence of the Ministerial Commission of Informatics.

9. The Directorate-General for Health Organisation and Planning is the body responsible for the development and maintenance of health information systems, the promotion of new forms of organisation and management of centres and services and health planning in the field of INHEALTH.

The planning, control and monitoring of the international programs related to the planning, organization and management of health services in the field of INHEALTH is also appropriate.

In addition to the ones described above, in the preceding paragraphs, are functions of the General Directorate of Health Organization and Planning, the following:

a) The design, implementation and development of organizational and management models, as well as the impetus of the organizational improvements of the health service providers, in order to give them greater autonomy in their management.

b) The analysis, evaluation and monitoring of healthcare facilities in which new organisational and management models are implemented.

c) The elaboration and development of the Strategic Plan for INHEALTH, as well as its annual monitoring and review, in collaboration with the other Directorates General.

d) The development and implementation of total quality programmes.

e) The development and maintenance of the health information and statistics system and any other information tools affecting the INHEALTH centers and services.

f) The proposal of the minimum conditions and requirements for the accreditation of centers and services, as well as the development of the accreditation device, within the field of INHEALTH.

g) The planning and proposal of the technical needs of the INHEALTH, as well as the training needs of its professionals, according to the organizational and management models.

The General Directorate of Health Organization and Planning is structured in the following units, with an organic level of Subdirection General:

1. The Deputy Director-General of the Organization, to which the execution and development of the functions provided for in paragraphs (a), (b), (c) and (d) correspond.

2. The General Health Planning and Information Subdirectorate, which is responsible for the implementation and development of the functions provided for in paragraphs e), f) and g).

10. The Directorate-General for Primary and Specialized Care is the body responsible for the management and development of health care in the field of primary care, as well as specialized care through the Health and safety at work, the management and management of health concert policies, and the rationalization and management of the pharmaceutical supply.

These are the functions of the Primary and Specialized General Care Directorate:

(a) The definition of health centers ' health care programs and objectives and the proposed allocation of resources necessary for this purpose.

b) The coordination, control and evaluation of health care facilities.

c) The coordination, development and control of continuing training programmes, post-graduate training and research.

d) The development of programs and activities for the improvement of health benefits, especially for the rationalization of the pharmaceutical supply.

e) The analysis of the proposals for the consultation of centers and services, as well as the proposal for the subscription of the corresponding concerts, their monitoring and control.

f) The management of the pharmaceutical delivery.

The General Directorate of Primary and Specialized Care is structured in the following units, with an organic level of Subdirection General:

1. The General Sub-Directorate of Primary Care, which corresponds to the implementation and development, in the field of its level of care, of the functions referred to in paragraphs 10.a), b), c) and d), as well as the paragraph 10.f) of this Article.

2. The Subdirectorate General for Specialized Care, which corresponds to the implementation and development, in the field of its level of care, of the functions referred to in paragraphs 10.a), b), c) and d) of this Article.

3. The General Subdirectorate of Concerts, to which the execution and development of the functions referred to in paragraph 10.e) of this article correspond.

11. The Directorate-General for Budgets and Investments is the body responsible, in general, for the management, implementation and control of the economic and budgetary management of INHEALTH and for the programming and implementation of investment programmes in works, facilities and supplies.

The Directorate-General for Budgets and Investments assumes the following functions:

(a) The elaboration and drafting of the preliminary draft budget of the INHEALTH and its distribution by management centers.

b) The establishment of the bases and guidelines for the economic management of the Institute, as well as carrying out the actions of control and evaluation of the economic and budgetary management of its management centers.

(c) The preparation and processing of proposals for changes in appropriations for the budget and for accounting and budgetary documents.

d) The processing and control of the cash flow and the cash movement of the central bank.

e) The processing of the Institute's expenditure files, which were not the subject of delegation to other bodies.

f) The programming and management of the investments necessary for the operation of the INHEALTH activity, both in physical resources and in equipment.

g) The programming and management of the purchase of supplies and services necessary for the operation of the integrated centers in the INHEALTH network, as well as the establishment of the purchasing policy of the agency.

h) The management of the maintenance of the physical resources of the primary care centers, specialized and administrative care, managed by the Institute.

i) The promotion and development of the functions that correspond to the office of supervision of projects under the law on contracts of public administrations in the field of INHEALTH.

The Directorate-General for Budgets and Investments is structured in the following units, with an organic level of Subdirection General:

1. The Sub-Directorate-General for Economic and Budgetary Control, which is responsible for the implementation and development of the tasks referred to in paragraphs (a), (b), (c) and (d), as well as the one set out in the paragraph (e); refers to the expenditure files of its competence.

2. The Subdirectorate-General for Works, Facilities and Supplies, to which the implementation and development of the functions provided for in paragraphs (f), (g), (h) and (i), as well as the one set out in the paragraph (e) are concerned, refers to the expenditure files of its competence.

12. The Directorate-General for Human Resources is the body responsible, in general, for the management, management and implementation of the staff policy of INHEALTH.

The head of the Directorate-General exercises the powers in matters of public call and resolution of the selective procedures for admission, promotion and transfer, as well as those relating to the disciplinary regime of the staff. at the service of the Health Institutions of Social Security. The Directorate-General for Human Resources exercises the following functions:

(a) The organisation of the staff service delivery scheme and the drafting of its regulatory regulations.

b) Collective bargaining with staff representatives, as provided for in the current regulations, and the development of trade union relations.

(c) The proposal for training, promotion and development of staff programmes, as well as the management of the annual training plan.

(d) Those relating to occupational health, social action and disciplinary staff arrangements.

e) Programming, proposal for management and management in the field of remuneration and the preparation of Chapter I of the preliminary draft budget, its monitoring and monitoring.

f) The proposal for the establishment of the staff templates of the various centers and services, their modifications and the management of the Personnel Registry.

g) The preparation of the offer of public employment and the management of the selective procedures for the entry, promotion and transfer of personnel.

(h) the coordination and, where appropriate, the management of acts arising from the administrative situations of staff and their legal status.

i) The proposal for the relationship of the employees ' jobs, as well as all the acts that arise from the management, management and control of the official and labor personnel of the administrative services of the INHEALTH.

The Human Resources Directorate is structured in the following units, with an organic level of Subdirection General:

1. The Subdirectorate-General for Industrial Relations, which is responsible for the implementation and development of the tasks set out in paragraphs 12.a), b), c) and d).

2. The Deputy Director-General for Personnel Management, which is responsible for the implementation and development of the tasks set out in paragraphs 12.e), f), g), h) and i).

13. In case of vacancy, absence or disease, the holders of the organs shall be replaced as follows:

(a) The Executive Chairman by the Directors-General of the Institute, in the order referred to in paragraph 3.c) of this Article.

(b) The Directors-General by the Deputy Directors-General of them, in the same order as they are in their respective structures.

Additional disposition first. Removal of organs in the Department's Central Services.

In the Department's Central Services scope, the following units are deleted:

a) General Inspection of Services.

b) Technical General ViceGeneral.

(c) Subdirectorate General of High Inspection.

(d) Subdirectorate-General for Inspection and Coordination.

e) Subdirectorate General of Relations with the Autonomous Communities and Local Corporations.

f) General Subdirection of Financing, Cost Analysis and Economic Assessment.

g) General Subdirection of Healthcare Services Recruitment Programs.

h) General Information and Health Statistics Subdirectorate.

i) General Health Planning Subdirectorate.

j) Subdirection General of Assurance.

k) General Administration of Pharmaceutical and Pharmaceutical Assistance.

(l) Deputy Director-General for Economic Affairs.

m) Subdirectorate General for Human Resources Planning and Management.

n) Subdirectorate General for Human Resources Development.

n) Subdirectorate General of Human Resources Organization.

Additional provision second. Elimination and modification of organs in the Carlos III Health Institute.

1. In the field of the Carlos III Health Institute, the following units are deleted, with an organic level of Subdirection General:

(a) Deputy Director-General for the Coordination of Research.

b) Subdirectorate-General for Training and Dissemination of Research.

c) General Health Subdirectorate.

d) Control General Subdirection.

e) General Management Subdirectorate of the National School of Health.

f) Subdirectorate General for Training and Studies of the National School of Health.

2. In the field of the Carlos III Health Institute, the following centers are modified:

a) National Center for Microbiology, Virology and Sanitary Immunology, which is renamed the National Center for Microbiology.

b) National Center for Cell Biology and Retrovirus, which is renamed the National Center for Fundamental Biology.

Additional provision third. Abolition of organs at the National Consumer Institute.

In the scope of the National Consumer Institute, the following units are deleted:

(a) Address of the National Institute of Consumption, with a level of Subdirectorate General.

b) Subdirectorate-General for Information, Promotion and Arbitration.

Additional provision fourth. Removal of organs at the National Institute of Health.

1. In the field of the National Institute of Health, the following units are deleted, with an organic level of Subdirection General:

(a) General Secretariat.

b) Deputy Secretary-General.

c) General Staff Subdirection.

d) Subdirectorate General of Internal Relations.

2. The provincial executive commissions of INHEALTH shall be chaired by the respective provincial directors of the agency.

Additional provision fifth. Removal of peripheral organs from the Department.

1. In the field of peripheral services, the Territorial Directorates of the Ministry of Health and Consumer Affairs are deleted.

2. The functions of the territorial director initially provided for in Article 3 (1), (2), (4) and (5) of Royal Decree 348/93 of 5 March 1993 shall be carried out directly by the Government delegations. Central to the Ministry of Health and Consumer Affairs, the functions initially provided for in paragraphs 3 and 6 (b) and (d), and by the National Institute of Health, the functions initially provided for in paragraphs 6.a) and c) of the same Article.

Additional provision sixth. Collegiate bodies.

Collegiate bodies of the Ministry of Health and Consumer Affairs, whose composition and functions are strictly ministerial in scope, may be regulated, amended or deleted by Order of the Minister for Health and Consumer Affairs, although its rules of creation or modification have the rank of Royal Decree.

Single transient arrangement. Units and jobs with an organic level lower than Subdirección General.

The units and jobs with lower organic level to the General Subdirectorate will continue to remain and will be paid from the same budget appropriations until the relations of posts of adapted to the organic structure of this Royal Decree. Such adaptation, in no case, will be able to generate an increase in public expenditure and, even, the possible decrease in costs that the application of this Royal Decree can entail will not be compensated in future restructurings or to finance changes in the relationship between jobs.

The job positions in the organs deleted in this Royal Decree, or which are affected by the modifications of competences established in the Royal Decree, be they of the structure of the Department, of its agencies Self-employed or the National Institute of Health, shall be provisionally attached, by resolution of the Deputy Secretary, or the Secretary-General of Health Assistance, if any, to the relevant management and sub-directorates-General, with the functions assigned to each one in this Royal Decree and until the new relations of jobs.

Single repeal provision. Regulatory repeal.

The following organic provisions are hereby repealed, in so far as they are contrary to the provisions of this Royal Decree:

(a) Royal Decree 858/1992 of 10 July, determining the basic organic structure of the Ministry of Health and Consumer Affairs.

(b) Royal Decree 1415/1994 of 25 June 1994 amending in part the basic organic structure of the Ministry of Health and Consumer Affairs.

c) Royal Decree 1140/1996 of 24 May, for the restructuring of certain bodies attached to the Ministry of Health and Consumer Affairs.

(d) Royal Decree 348/93 of 5 March on the organisation of the territorial services of the Ministry of Health and Consumer Affairs.

e) Royal Decree 10/1988, of 8 January, determining the structure of the Institute of Health Carlos III.

f) Royal Decree 150/1991, of 1 February, on the structure of the National School of Health.

The provisions of this Royal Decree also have to be repealed.

Final disposition first. Powers of development.

The Minister of Health and Consumer Affairs is hereby authorized to take the necessary measures for the development and implementation of this Royal Decree, after the appropriate legal procedures have been completed.

Final disposition second. Budgetary changes.

The Ministry of Economy and Finance will carry out the necessary budgetary changes for the fulfillment of the provisions of this Royal Decree.

Final disposition third. Entry into force.

This Royal Decree will enter into force on 2 September 1996.

Given in Palma de Mallorca to 2 August 1996.

JOHN CARLOS R.

The Minister of Public Administration,

MARIANO RAJOY BREY