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Order Ssi/1833/2013, October 2, Which Creates And Regulates The Council Network Spanish Of Agencies Of Assessment Of Health Technologies And Benefits Of The National Health System.

Original Language Title: Orden SSI/1833/2013, de 2 de octubre, por la que se crea y regula el Consejo de la Red Española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del Sistema Nacional de Salud.

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TEXT

The Quality Plan for the National Health System provided for in Law 16/2003, of 28 May, of cohesion and quality of the National Health System, articulated by the then Ministry of Health and Consumer Affairs in 2006, contemplated the elaboration of a Plan for the Evaluation of Health Technologies and Procedures, considered to be a priority for the National Health System, based on the proposals made by the Agency for the Evaluation of Health Technologies of the Institute of Health Carlos III and the rest of the agencies and health technology assessment units of the Autonomous communities, in particular, from the Basque Country's Health Technology Assessment Service, the then Health Technology Assessment Unit of the Lain Entresdo Agency of the Community of Madrid (the current Evaluation Unit of the European Community). Health Technologies of the Community of Madrid), the Agency for the Evaluation of Sanitary Technologies of Galicia, the Agency of Quality and Health Assessment of Catalonia, the Agency for the Evaluation of Sanitary Technologies of Andalusia, the Service of Evaluation and Planning of the Canarian Health Service and the Aragones Institute of Science of the Health.

On the other hand, the Carlos III Health Institute, through the Agency for the Evaluation of Health Technologies, developed an electronic shared knowledge platform in 2007 to ensure the networking of all the health technology assessment agencies and units of the Autonomous Communities in order to facilitate the access of healthcare professionals to databases, methodological tools, technology assessment reports health, emerging technologies reports, training resources, resource maps, links national and international assessment networks and other projects related to the work carried out by these agencies and units.

In this way, the network work of all the agencies and health technology assessment units of the National Health System has been facilitated so far.

On February 29, 2012, the National Health System's Interterritorial Council plenary addressed the development and updating of the National Health System's service portfolio with the creation of a network of national health agencies. assessment of health technologies in charge of assessing medical techniques and procedures for the inclusion, exclusion and modification of the conditions of use in this portfolio.

The creation of this Spanish Network of Health Technology Assessment Agencies and the National Health System (National Health System) has been collected in Royal Decree-Law 16/2012 of 20 April, of urgent measures to guarantee the sustainability of the National Health System and improve the quality and safety of its benefits, by amending Articles 20 and 21 of Law 16/2003, of 28 May, of cohesion and quality of the National Health System.

In these articles, for the first time, the figure of the "Spanish Network of Health and National Health System Assessment Agencies" is collected, which will participate in the development of the common portfolio of services of the National Health System through the evaluation of new techniques, technologies or procedures, with a preceptive character and prior to their use in the National Health System.

The Spanish Network of Health Technology Assessment Agencies and National Health System (National Health System) has the task of generating, disseminating and facilitating the implementation of information intended to support the decisions in the National Health System, thus contributing to the increase in quality, equity, efficiency and cohesion in the system.

The Network's inspiring principles are those of safety, effectiveness, quality, equity and efficiency, which are manifested in various aspects, such as consistency with the priorities of the National Health System; the rigorous nature of the various jobs and reports to be drawn up and based on the most up-to-date and robust scientific knowledge; independence in the absence of conflicts of interest that can mediate their work; transparency throughout the process Prioritization, identification, synthesis and critical assessment of scientific knowledge available; and collaboration, as an articulator principle, both among scientific disciplines, actors and participants in the healthcare system, and especially among the health technology assessment units and agencies.

It is intended, based on the synthesis of rigorous and quality scientific information, to guarantee equity and improve the efficiency of the National Health System by facilitating decision-making regarding incorporation. and exclusion of benefits, the modification of the conditions of use, the increase in quality and the decrease in variability in clinical practice through the use of assessment reports and clinical practice guidelines.

For these purposes, in order to manage and coordinate the aforementioned Network, it is created by this order, as a collegiate body of those provided for in Chapter IV of Title II of Law 6/1997, of 14 April, of the and Operation of the General Administration of the State, and attached to the Directorate-General for Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality, through the Subdirectorate-General for Quality and Cohesion, the Council of the Spanish Network of Agency for the Evaluation of Health Technologies and Benefits of the National Health System.

At the same time, it should be recalled that, under the powers conferred on the Directorate-General for Public Health, Quality and Innovation by Article 11 of the Royal Decree 200/2012 of 23 January, the Commission is developing the the basic organic structure of the Ministry of Health, Social Services and Equality and the Royal Decree 1887/2011 of 30 December 2011, establishing the basic organic structure of the ministerial departments, this Directorate General should act as a driver and responsible for the management, financing, monitoring and dissemination of the reports developed by the Spanish Network of Health Technology Assessment Agencies and National Health System (National Health System), in collaboration with the General Directorate of the Basic Portfolio of Services of the National Health System and Pharmacy, with the Interterritorial Council of the National Health System, and with the Departments of Health and/or Health of the Autonomous Communities of the agencies and units of the Network.

In the process of drawing up this provision, the autonomous communities have been consulted, having informed the plenary of the Interterritorial Council of the National Health System and its Advisory Committee. The Spanish Data Protection Agency has also issued a mandatory report.

In its virtue, with the prior approval of the Minister of Finance and Public Administrations, I have:

Article 1. Creation and attachment.

1. This order aims at the creation and regulation of the Council of the Spanish Network of Health Technology Assessment Agencies and the National Health System (hereinafter referred to as the Network Council), as a collegiate body of the in Chapter IV of Title II of Law 6/1997 of 14 April of the Organization and the Functioning of the General Administration of the State.

2. The Board of the Network is attached to the Directorate-General for Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality through the General Quality and Cohesion Subdirectorate.

Article 2. Finnish.

The Network Council aims at the management and coordination of the Spanish Network of Health Technology Assessment Agencies and National Health System Pristations.

Article 3. Functions.

The functions of the Board of the Network are:

a) Establish the work procedures of the Spanish Network of Health Technology Assessment Agencies and National Health System Pristations.

b) Ensuring a common quality methodological framework in the evaluation and elaboration of the work of the Spanish Network of Health Technology Assessment Agencies and National Health System Pristations.

c) Manage and coordinate the development of health technology assessment reports by the Spanish Network of Health Technology Assessment Agencies and National Health System Prostations.

Article 4. Composition and operation.

1. The following are members of the Council of the Network: persons who hold the addresses of the following agencies or assessment units:

a) Agency for the Evaluation of Health Technologies (AETS) of the Carlos III Health Institute.

b) Health Technology Assessment Service-Osteba. Department of Health, Basque Government.

c) Unit for the Evaluation of Health Technologies (UETS) in the Community of Madrid.

d) Agency for the Evaluation of Sanitary Technologies of Galicia (Avalia-t).

e) Sanitary Evaluation and Quality Agency of Catalonia (AQuAS).

f) Agency for the Evaluation of Sanitary Technologies of Andalusia (AETSA).

g) Evaluation and Planning Service of the Canarian Health Service (SESCS).

h) Aragones Institute of Health Sciences (IACS).

i) General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality.

j) Directorate-General for Public Health, Quality and Innovation, Ministry of Health, Social Services and Equality.

2. They are bodies of the Network Council, the Presidency, the Vice-Presidency and the Technical Secretariat.

3. The Council of the Network may operate in plenary and in the Permanent Commission, and may also constitute Working Groups that will have the composition and functions that will be determined in each case.

Article 5. Presidency.

1. The Presidency, which shall be renewed annually, shall be held on a rotating basis by persons holding the addresses of the agencies or assessment units which are part of the Network Council, by the order of the date of approval of the Statutes of Autonomy of their respective Autonomous Communities, ending each cycle with the chairmanship of the person holding the address of the Health Institute of Health Institute of Health Institute Carlos III.

2. The Presidency is responsible for the following tasks:

a) Ostend the representation of the Council of the Network.

b) Convocation the meetings of the plenary and the Standing Committee, setting the agenda.

c) Chair, lead and moderate the meetings of the plenary and the Standing Committee.

d) Vising the minutes and certifications of the organ agreements.

e) Vellar for compliance with the Network Council's operating regulations.

Article 6. Vice Presidency.

1. The Vice-Presidency shall be exercised by the person who holds the address of the agency or unit of assessment which, according to the date of approval of the Statutes of Autonomy of their respective autonomous communities, shall be the case at any time. exercises the presidency, according to the order of designation set out in the previous article.

The renewal of the Vice Presidency will be annual, with each Vice President taking over the Presidency, in order to ensure continuity in the management of the Council of the Network.

2. It is up to the Vice-Presidency to exercise the functions delegated to it by the holder of the Presidency.

Article 7. Technical Secretariat.

1. The Technical Secretariat shall be the head of the General Secretariat for Quality and Cohesion of the Directorate-General for Public Health, Quality and Innovation, with the support of its staff.

2. In case of vacancy, absence or illness and, in general, where there is a justified cause, the Secretary shall be replaced by an official of the Directorate-General for Public Health, Quality and Innovation, designated by its holder.

3. The Technical Secretariat is responsible for the following functions:

a) Develop the Annual Health Technology Assessment Plan to be reported by the National Health System's Interterritorial Council plenary.

b) Develop the Network Council's operating regulations.

c) Prepare the meetings of the plenary and the Standing Committee, bringing the proposal of the agenda to the Presidency.

d) Attend the meetings of the plenary and the Standing Committee, as well as write, sign and safeguard the minutes of the meetings.

e) Coordinate the operation of the Web page of the Network.

Article 8. Full.

1. The plenary session shall be composed of the members of the Network Council, including the persons holding the Presidency and the Vice-Presidency, as well as the head of the Technical Secretariat.

In the event of absence or illness and, in general, where there is a justified cause, the members of the Network Council belonging to the agencies or bodies referred to in Article 4 (a), (i) and (j) shall be replaced by officials of the agency or body to which the holder belongs and is designated by it.

The autonomous communities to which the members of the agencies or units referred to in paragraphs (b), (c), (d), (e) (f), (g) and (h) of Article 4 belong shall designate their respective alternates.

2. The functions of the plenary session shall be as follows:

a) Establish the Network Council's general lines of action.

b) Approve the Annual Plan for the Evaluation of Health Technologies, prepared by the Technical Secretariat, which will be submitted to the plenary session of the Interterritorial Council of the National Health System.

c) Approve the Network Council's operating regulations.

(d) To propose, by means of the procedure laid down in the Rules of Procedure referred to in Article 10, the incorporation of new members into the Council of the Network.

e) Approve the creation of Working Groups, on a proposal from the Permanent Commission.

f) Any other function that is not entrusted to another organ of the Network Council.

3. The operation of the plenary session shall, in any event, comply with the following rules:

(a) The plenary session shall meet at least three times a year, and sessions may be held in non-face-to-face terms.

(b) Calls for meetings shall be held by the Presidency in good time, and in any case, with seven working days and shall be accompanied by an agenda.

c) For the valid constitution of the plenary session, for the purposes of holding sessions, deliberations and agreements, the presence of the President and the Secretary or, where appropriate, of those who replace him, and of the half, shall be required. less, of its members.

(d) The agreements shall be adopted by consensus of the present and, failing that, by the majority of the assistants.

e) A record will be issued for the meetings to be approved at the next session.

Article 9. Standing Committee.

1. The Standing Committee shall be composed of the holders of the Presidency, the Vice-Presidency and the Directorate-General for Public Health, Quality and Innovation.

In case of absence or illness and, in general, where there is a justified cause to prevent their attendance from the Standing Committee, the components of the Permanent Commission will be replaced in the same way as the plenary session.

2. The Standing Committee shall carry out the following tasks:

(a) Monitor and monitor compliance with the agreements adopted by the plenary.

(b) Adopt decisions which, for reasons of urgency, cannot be submitted to the plenary session, bearing in mind the agreement or decision at the first meeting it holds.

c) Propose to the plenary the creation of specific working groups for the implementation of the various activities of the Council of the Network.

3. The functioning of the Standing Committee shall in any case be adjusted to the following rules:

(a) The Standing Committee shall meet, at least, prior to the meetings of the plenary session, which may be held in non-face-to-face form.

(b) Calls for meetings shall be held by the Presidency in good time and, in any case, seven working days and shall be accompanied by an agenda.

(c) The agreements shall be adopted by consensus of the present and, failing that, by the majority of the assistants.

d) A record will be issued for the meetings to be approved at the next session.

Article 10. Operating Regulation.

1. The Network Council shall draw up its own Rules of Procedure without other limitations than those referred to in the previous Articles.

2. The Council of the Network shall, as far as is not covered by the Rules of Procedure, adjust to the provisions of Chapter II of Title II of Title II of Law No 30/1992 of 26 November 1992 on the legal system of public and public administrations. Common Administrative Procedure.

Single additional disposition. No increase in public spending.

The operation of the Board of the Network does not imply an increase in public expenditure and will be attended with the personal and technical means available in the Directorate General of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality.

Single end disposition. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, 2 October 2013. -Minister for Health, Social Services and Equality, Ana Mato Adrover.