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Royal Decree 590/2005 Of 20 May, Amending The Statute Of The Institute Of Health "carlos Iii", Approved By The Royal Decree 375/2001 Of 6 April.

Original Language Title: Real Decreto 590/2005, de 20 de mayo, por el que se modifica el Estatuto del Instituto de Salud «Carlos III», aprobado por el Real Decreto 375/2001, de 6 de abril.

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TEXT

Royal Decree 1555/2004, of 25 June, for which the basic organic structure of the Ministry of Health and Consumer Affairs is developed, carried out a rearrangement of the department to adapt the existing organic structure to the new ones. The Court of the Court of State held that the Court of State held that the Court of Law, in its judgment of 17 April, held that the Court of Law of the Court of State held that the Court of ministerial, whose object was to develop the political program of the government. In accordance with the provisions of Article 3 and the only derogating provision of the said Royal Decree 1555/2004 of 25 June 2004, the Institute of Health "Carlos III" is hereby assigned to the Ministry of Health and Consumer Affairs, through its holder, and its structure and organisation is regulated in accordance with Article 16 of Royal Decree 1087/2003 of 29 August establishing the organic structure of the Ministry of Health and Consumer Affairs. For this royal decree, a restructuring and organization of the Institute of Health "Carlos III" is carried out; these modifications are introduced into the current statute of the public body, approved by Royal Decree 375/2001, of April 6. This restructuring allows to strengthen the planning functions in scientific policy related to the health sciences, coordination with the autonomous communities and other agents of the National System of Science and Technology, the promotion of the biomedical research of excellence carried out in the National Health System and in the system of science and technology, the potentiation of the research and the reference services carried out by the institutions of the Institute and the increase in the participation of the Institute and the rest of the system in the biomedicine of the Sixth Framework Programme of the European Union. The consolidation of Spain as an open country to the future, contributing to the scientific world production in the field of biomedical research, to the improvement of the relationship between basic and clinical research, to the scientific-technical support to the planning in scientific policy related to health sciences and decision making to respond to health problems, make it necessary to redefine the "Carlos III" Health Institute, for which a new structure is addressed and the organisation which allows these objectives and the result of which is the dynamisation of their scientific fabric and health. The "Carlos III" Health Institute was created by Law 14/1986 of 25 April, General of Health. It is a public body of investigation with a character of autonomous body as provided for in article 43.1.a) of Law 6/1997, of 14 April, of the Organization and the Functioning of the General Administration of the State, the purpose of which is to provide Scientific and technical support to the Ministry of Health and Consumer Affairs and to the various health services of the Autonomous Communities and the collaboration, in the field of their functions, with other public administrations. The main modification of this royal decree is the addition to the "Carlos III" Health Institute of the General Subdirectorate of Cell Therapy and Regenerative Medicine of the autonomous agency National Center for Transplantation and Regenerative Medicine. created by Law 45/2003 of 21 November, amending Law 35/1988 of 22 November on Assisted Reproduction Techniques, to which the name is amended, which becomes that of the Subdirectorate-General for Research in Cell Therapy and Regenerative Medicine, to achieve greater adequacy of the functions planned for she. In addition, other changes are included with regard to the attachment of existing organs or units, which respond to the need to achieve an improvement in management that will allow greater efficiency in the delivery of the service than to the Institute corresponds. In its virtue, at the initiative of the Minister for Health and Consumer Affairs, on a proposal from the Ministers of Public and Economic Affairs and Finance and after deliberation by the Council of Ministers at its meeting on 20 May 2005,

D I S P O N G O:

Single item. Amendment of the Statute of the Institute of Health "Carlos III", approved by Royal Decree 375/2001, of 6 April.

The Statute of the Institute of Health "Carlos III", approved by Royal Decree 375/2001 of 6 April, is amended in the following terms: One. Article 1 (1) and (2) shall be worded as follows:

" 1. The Institute of Health "Carlos III" is a public body of research with a self-governing body, as provided for in article 43.1.a) of Law 6/1997, of April 14, of the Organization and the Functioning of the General Administration of the State, attached to the Ministry of Health and Consumer Affairs through its holder, whose mission is to develop and offer scientific-technological services of the highest quality directed to the National Health System and to the whole of society. 2. The Ministry of Health and Consumer Affairs corresponds to the strategic direction, evaluation and control of the results of the activity of the Health Institute "Carlos III", through its holder, without prejudice to the competencies attributed to the General intervention of the State Administration regarding the evaluation and control of the results of the public bodies in the state public sector. "

Two. Article 2 is worded as follows:

" Article 2. Legal framework.

The Institute of Health '' Carlos III '' is governed by the provisions contained in Law 13/1986 of April 14, of promotion and general coordination of scientific and technical research; by Law 14/1986, of April 25, General By Law 16/2003, of 28 May, of Cohesion and Quality of the National Health System; by Law 6/1997, of April 14, of the Organization and the Functioning of the General Administration of the State; by Law 30/1992, of 26 November, of Legal status of public administrations and the common administrative procedure; by the text recast of the Law of Contracts of Public Administrations, approved by the Royal Legislative Decree 2/2000 of 16 June; by Law 47/2003, of November 26, General Budget; by Law 33/2003, of 3 November, of the Article 61 of Law 50/1998 of 30 December 1998 on fiscal, administrative and social measures; by this statute, and, in general, by the rules implementing the provisions cited above and by those of other ones that are applicable. "

Three. Article 7 is worded as follows:

" Article 7. Composition of the Governing Council.

The Governing Council will be composed as follows: a) President: the Minister of Health and Consumer Affairs. (b) Vice-President: the Director of the Health Institute '' Carlos III ''. (c) Six vowels, with a category of director general, of which two will represent the Ministry of Education and Science, one will be appointed among the top posts of the Secretariat of State of Universities and Research and the other will be the President of the Scientific Research Council; the other representatives will be appointed by the ministers of the Ministries of Foreign Affairs and Cooperation; Tourism and Trade; Agriculture, Fisheries and Food, and the Environment. d) Four vowels representing the autonomous communities, chosen from among its members by the Interterritorial Council of the National Health System. It shall be renewed every two years. e) Three vowels appointed by the Minister of Health and Consumer Affairs: two, among professionals of recognized scientific or sanitary prestige, whose mandate will be three years, and one, with a category of director general, representing the Secretariat. f) Secretary: the Secretary General of the Health Institute "Carlos III". "

Four. The last paragraph of Article 10 is worded as follows:

"In case of absence, vacancy or illness, the Director shall be replaced by the Secretary General."

Five. Paragraph 10 of Article 11 shall become paragraph 12. The following paragraphs shall also be added to that Article:

" 10. To promote quality in the procedures and activities of the Institute. 11. Evaluate the activity of the institutions and units of the Institute. "

Six. Articles 14, 15, 16, 17, 18, 19 and 20 are worded as follows:

" Article 14. Sub-Directorates-General and other bodies.

1. As the immediate responsible bodies dependent on the Director, in the competences assigned to them, the following units with an organic level of general subdirección are determined: (a) The General Secretariat. (b) The Subdirectorate-General for Applied Services, Training and Research. (c) The Subdirectorate-General for Evaluation and Promotion of Research. d) The General Subdirectorate of Networks and Cooperative Research Centers. e) The General Subdirectorate of Research in Cell Therapy and Regenerative Medicine. (f) The Deputy Director-General for International Research and Institutional Relations 2. The Director will depend on the level of organic level to be determined in the employment relationship, the Quality and Planning Unit, whose function is to coordinate the various institutions and units of the Institute in the evaluation activities to promote their accreditation and to promote a culture of quality of services, and the Support Unit, which will provide advice and assistance direct to the Director.

Article 15. General Secretariat.

1. It is for the General Secretariat, without prejudice to the powers of other departments of the department, to exercise the following functions: (a) The Institute's general administration. (b) the management of staff and the general services of the body. (c) Economic and financial management and budgetary management. (d) the management of internal arrangements, assets, works and infrastructure and technical maintenance services. e) The dissemination and corporate image of the Institute. (f) The design, development and implementation of the agency's management software, as well as the provision and management of equipment and computer resources, and the provision and management of both voice and data communications; study, preparation and proposal of supplies of equipment and computer equipment and of the technical services and assistance necessary for the exercise of the tasks entrusted to it. (g) The impetus in the use of new technologies by the institutions of the Institute, which will allow for the processing of telematics; likewise, to promote the use of new technologies in cooperation with other public administrations and agencies International and supranational. (h) The report of draft regulatory provisions. (i) Relations and coordination, in relation to the processing of normative provisions, with the units or centres of the Institute and with the other bodies of the department. (j) The examination and processing of motions for resolutions on administrative appeals against acts and provisions of the Institute and procedures for the review of trade in relation to those, in the case of complaints prior to the (a) civil and/or employment judicial proceedings and claims for patrimonial liability, as well as the corresponding relations with the organs of the administration of justice. (k) The processing of proposals for draft agreements and agreements in matters falling within the competence of the Institute. l) The elaboration of the editorial program and the management of the official publications of the Institute. (m) The actions related to the promotion and protection of occupational health that are of the competence of the Institute, in accordance with the Law 31/1995, of 8 November, of Prevention of Occupational Risks. (n) The management of the Museum of Health. 2. The General Secretariat shall act as coordinator between the Institute and the foundations in which it participates, in the exercise of the activity resulting from the fulfilment of the provisions of Article 129.3 of the Law 47/2003 of 26 November, General Budget.

Article 16. Sub-Directorate General for Applied Services, Training and Research.

Corresponds to the Subdirectorate General of Applied Services, Training and Research, without prejudice to the privileges of other departments of the department and the competences of the Inter-Ministerial Commission of Science and Technology and the Ministry of Education and Science, the exercise of the following functions: (a) The research, characterization and evaluation of environmental risks as health conditions, and those which may be the laboratory of reference in the field. (b) microbiological research, characterization and diagnosis and those which may be the reference laboratory. c) The development of technical actions for compliance with the provisions of Royal Decree 2210/1995 of 28 December, establishing the National Network of Epidemiological Surveillance. (d) Research based on the epidemiological method with application to the health problems of the populations and the risk factors. e) The planning, coordination, monitoring, management and evaluation of the intramural research of the Institute of Health '' Carlos III ''. f) Other research activities and the development of new technologies in relation to research health information and public health. g) The training of professionals in the field of public health through the organs and units of the Institute of Health '' Carlos III '' and especially the National School of Health. (h) To promote the creation of training, multidisciplinary and interdisciplinary networks, consisting of training centres or groups. i) Develop and promote online training. (j) Promote and collaborate in the development of studies and research in the field of public health and the management of services and to perform national and international advisory functions in these areas of activity. (k) The development of the resources and functions attributed to the National School of Work Medicine, which shall be assigned the teaching-assistance programmes entrusted to it, in accordance with the provisions of the second provision of Law 31/1995, of 8 November, on the Prevention of Occupational Risks. (l) Develop training and innovation programmes in occupational health.

Article 17. Sub-Directorate-General for Evaluation and Promotion of Research.

1. It is the responsibility of the Subdirectorate-General for Evaluation and Promotion of Research, without prejudice to the powers of other departments of the department, the exercise of the following tasks: (a) The promotion, management, evaluation and monitoring of the extramural research in health sciences. (b) The coordination of research activities in the health sciences, in relation to the National Plan for Scientific Research, Technological Development and Innovation and the Framework Programmes for Research and Development of the European Union, without prejudice to the powers of the Inter-Ministerial Science and Technology Commission. c) The actions that favor and consolidate research in the National Health System. d) The implementation and management of an accreditation system for biomedical research. e) The dissemination of research tasks. (f) the identification and assessment of new or established technologies which require evaluation and which makes it possible to technically base the selection, incorporation and dissemination in the health system and the development of prospective studies on the new and emerging health technologies. (g) The production, review, evaluation and synthesis of scientific information and the establishment on these bases of the medical, ethical, social and economic impact, determined by the use of different technologies, both new technologies and The European Commission has been responsible for the implementation of the programme for the implementation of the programme. 2. It is assigned to the Subdirectorate General for Evaluation and Promotion of Research, with the organic level to be determined in the relations of the working positions, the Agency for the Evaluation of Health Technologies.

Article 18. Deputy Director General of Networks and Cooperative Research Centers.

1. It corresponds to the General Subdirectorate of Networks and Cooperative Research Centres, without prejudice to the powers of other departments of the department, the exercise of the following functions: (a) Coordination, evaluation, monitoring and potentiation of the network research structures in the National Health System in connection with the other agents of the National System of Science and Technology. b) The management of network research structures, based on the thematic networks of cooperative research. (c) the dissemination of resources and results for their joint use in the IT network. d) Promote mixed units and associated research centers. e) To foster and coordinate translational and multidisciplinary research in health problems, in nursing and in strategic aspects for the National Health System. f) The coordination of all the libraries of the Institute. (g) The development of activities to disseminate and provide documentary services to the National Health System as a whole. h) The management of the virtual library communications network. 2. The General Subdirectorate of Networks and Cooperative Research Centres correspond to the activities of planning, coordination, monitoring and scientific evaluation of the foundations in which the Institute participates.

Article 19. General Subdirectorate of Research in Cell Therapy and Regenerative Medicine.

1. It corresponds to the Subdirectorate General of Research in Cell Therapy and Regenerative Medicine, without prejudice to the competencies of the National Center for Transplants and Regenerative Medicine, of the Spanish Agency for Medicines and Health Products. and the duties of other departments of the department, the exercise of the following functions: (a) The promotion, evaluation, coordination and monitoring of research in cell therapy and regenerative medicine performed in the System National Health and the rest of the science and technology system. b) Representation in national, community and international institutions and the coordination of actions related to the protection of the fundamental rights of individuals and ethical postulates affecting biomedical research. c) The coordination of research centers on cell therapy and regenerative medicine in which the Institute participates. d) Registration and follow-up of authorized research projects on cell therapy and regenerative medicine. e) The direction of the National Bank of cell lines, as well as the coordination of the different nodes that compose it. 2. The Secretariat of the Commission for the Monitoring and Control of the Donation and Use of Human Embryonic Cells and Cells is the responsibility of the General Subdirectorate for Research in Cell Therapy and Regenerative Medicine.

Article 20. Sub-Directorate-General for International Research and Institutional Relations Programmes.

corresponds to the Subdirectorate General of International Programs of Research and Institutional Relations, without prejudice to the privileges of other departments of the department, the exercise of the following functions: a) To maintain institutional relations with national, Community and international administrations and bodies competent in the Institute's own matters. (b) The management of international relations and participation in Community and international bodies. (c) The implementation and development of initiatives taken by the European Union in the field of the Institute, in coordination with the Autonomous Communities. (d) The promotion of the effective incorporation of Spanish research resources into the European Union's scientific programmes and policies, in order to maximise the opportunities offered to researchers in the European Union. Member States of the Union. e) Assistance to the National Health System's centers and researchers on how to access services, procedures, aids and grants in relation to the research and training activities of the Institute and projects " f) Promote joint action plans with the autonomous communities and coordinate with their health services actions related to the activities of the Institute, without prejudice to the competencies attributed to other Subdirectorates General. (g) Promote, promote and develop relations with other bodies of Spanish public administrations, as well as with public or private entities, and participate in the forums that refer to them, in which they sponsor and organize autonomous communities, without prejudice to the powers conferred on other Subdirectorates-General. h) The direction and coordination of the activity of transferring the results of the research through the Office of Transfer of the Research Results. "

Additional disposition first. Removal of organs.

The following units with organic level of Subdirectorate General: (a) From the Directorate of the Health Institute "Carlos III" are deleted: 1. The Subdirectorate General for Health Research.

2. The Subdirectorate-General for Training and Dissemination of Health Research. 3. The Subdirectorate-General for Coordination of National Centres for Research and Services Applied to Public Health. 4. Assessment of Sanitary Technologies.

b) From the autonomous organism National Center for Transplantation and Regenerative Medicine, the General Subdirectorate of Cell Therapy and Regenerative Medicine.

Additional provision second. No increase in public spending.

The application of this royal decree, including the creation and modification of units with no organic level of general subdirection provided for in its articles, will be done without an increase in the cost of operation and will not increase the public expenditure.

First transient disposition. Governing Council.

The current Governing Council will continue in the performance of its functions until the new Rector Council is established in this royal decree. In any case, the elected members of the Council whose composition and characteristics would not have suffered any variation in this royal decree will remain until further appointments.

Second transient disposition. Units and jobs with lower organic level than general sub-direction.

Units and jobs with an organic level below the general sub-directorate will continue to remain and will be paid from the same budgetary appropriations until the employment relations of the Member States are approved. work adapted to the organic structure of this royal decree, which under no circumstances will be able to increase public expenditure.

The units and posts which are affected by the changes in the competence laid down in it shall be assigned to the relevant management and sub-directorates-General in accordance with the tasks assigned to them. each in this royal decree and until the new relations of jobs are approved.

Transitional provision third. Statutory staff of Social Security attached to the National Transplant Organization.

The staff who provide services or access or join positions corresponding to the staff of the statutory staff of Social Security, attached to the National Transplant Organization, will maintain its current status. the legal regime and will continue to receive its remuneration from the credits allocated to the National Institute of Health Management, until the legal instruments that allow its incorporation into the organic structure of the National Transplant and Regenerative Medicine Center.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed, they are contrary to the provisions of this royal decree and, in particular, the following: (a) Article 16 of Royal Decree 1087/2003 of 29 August, establishing the organic structure of the Ministry of Health and Consumer Affairs.

b) Royal Decree 176/2004 of 30 January approving the Statute of the National Centre for Transplantation and Regenerative Medicine, and the second paragraph of the Order of the Ministry of Health and Consumer Affairs of 27 December 2001, on the creation of centers in the Institute of Health "Carlos III", in everything that opposes the provisions of this royal decree.

Final disposition first. Amendment of Royal Decree 223/2004 of 6 February.

Article 9 (2) of Royal Decree 223/2004 of 6 February, which regulates clinical trials with medicinal products, is worded as follows:

"The Center for Clinical Research Ethics Committees is attached to the Ministry of Health and Consumer Affairs, through the Directorate General of Pharmacy and Health Products."

Final disposition second. Powers of development.

The Minister of Health and Consumer Affairs is authorized to adopt the measures necessary for the development and implementation of this royal decree.

Final disposition third. Entry into force.

This royal decree will enter into force on the day of its publication in the "Official State Gazette".

Given in Madrid, on May 20, 2005.

JOHN CARLOS R.

First Vice-President of the Government and Minister of the Presidency, MARIA TERESA FERNÁNDEZ DE LA VEGA SANZ