Complying with the provisions of Law 35/1988 of 22 November on assisted human reproduction techniques, Royal Decree 415/1997 of March 21, created the National Commission of Human Reproduction Assisted- Commission-as a permanent and consultative collegiate body, directed to guide the use of these techniques and to collaborate with the public authorities regarding this matter and its scientific derivations.

Law 14/2006 of 26 May on assisted human reproduction techniques-which repeals the previous one-in Article 20 sets out the object, composition and functions of the Commission.

As a result, Royal Decree 906/2007, dated 6 July, amended Royal Decree 415/1997, introducing new functions as Law 14/2006, assigned to the collegiate body and constituting a Technical Commission to facilitate the work of the plenary session.

The consolidation of the basic techniques of assisted human reproduction has become a practice of routine care, fully incorporated into the collective culture and of enormous social acceptance. However, the development in recent years of new advances in assisted human reproduction techniques, such as preimplantation diagnosis, reproductive genetics, minimally invasive diagnostic techniques, etc., has led to a need to analyse more specialised aspects related to new technical and scientific possibilities.

This fact, together with the new powers granted to the Commission by Law 14/2006 of 26 May, requires the Commission to be more flexible and specialised in order to provide it with more effective functioning, given that certain cases require a greater degree of technical knowledge and discussion at the same time as greater speed in the analysis and in the taking of agreements, despite the technical and scientific complexities involved.

order to improve the operation of the Commission, this royal decree amends its composition by reducing the number of its members, but with strict compliance with the representation provided for in Article 20.2 of the Treaty. Law 14/2006, of May 26.

Also, in order to achieve maximum agility when deemed necessary, the royal decree allows both the plenary and the Permanent Technical Committee to be able to establish and adopt agreements by electronic means, as establishes the first provision of Law 11/2007, of 22 June, on the electronic access of citizens to public services.

This royal decree has been submitted to the Interterritorial Council of the National Health System for prior reporting.

In its virtue, on the proposal of the Minister of Health and Social Policy, with the prior approval of the First Vice-President of the Government and Minister of the Presidency, in accordance with the opinion of the Council of State and deliberation of the Council of Ministers at its meeting on 15 January 2010,

DISPONGO:

Article 1. Nature and purpose.

1. The National Commission for Human Reproduction is a collegiate body, a permanent and consultative body, under the Ministry of Health and Social Policy, attached to the Directorate-General for Advanced Therapies. Transplants, the purposes of which are:

a) Advising and orienting on the utilization of assisted human reproduction techniques.

b) Contribute to the updating and dissemination of scientific and technical knowledge in this field.

c) Develop functional and structural criteria for the centers and services where the techniques are performed.

Article 2. Composition.

1. The Commission shall be composed of the Presidency, the Vice-Presidency, the Vocalias and the Secretariat, as provided for in Article 20.2 of Law 14/2006 of 26 May on assisted human reproduction techniques.

2. The words of the Commission shall be related to one of the different scientific, legal or ethical aspects of assisted human reproduction techniques and shall have the following distribution:

(a) Three representatives appointed by the Government of the Nation, one of them on a proposal from the Ministry of Health and Social Policy, another, on a proposal from the Ministry of Justice and another, on a proposal from the Ministry of Equality.

b) Four representatives appointed by the Interterritorial Council of the National Health System among those proposed by the Autonomous Communities.

c) A Bioethics expert appointed by the Bioethics Committee of Spain.

d) A person designated by the National Transplant Organization.

e) Five representatives appointed by the following scientific societies at the state level, related to human fertility, obstetrics and gynecology, and assisted human reproduction techniques: Spanish Society of Gynecology and Obstetrics (SEGO), Spanish Fertility Society (SEF), Spanish Society of Andrology (ASESA), Association for the Study of Reproduction Biology (ASEBIR) and Spanish Association of Human Genetics (AEGH). Each will designate a representative.

f) Three appointed representatives, one by the General Council of Medical Officers, another by the General Council of the Official Colleges of Biologists, and the other by the General Council of the Advocate General.

g) A representative appointed by the Consumers and Users Council.

3. All vowels shall be appointed by the titular person of the Ministry of Health and Social Policy.

4. The term of office of the vowels shall be renewable for four years for a further four years, subject to the agreement of the person holding the Ministry of Health and Social Policy.

5. The composition of the Commission will seek to fulfil, as far as possible, the principle of a balanced presence of men and women.

Article 3. Functions.

The functions of the Commission are as follows:

1. To report on the development and updating of scientific knowledge, in relation to assisted reproductive techniques referred to in Law 14/2006 of 26 May on assisted human reproduction techniques.

2. Propose criteria and standards for the best guidance in the use of these techniques.

3. Report and propose criteria in relation to the study of donors and users of assisted reproductive techniques.

4. To study, update and propose lists of genetic and hereditary diseases that may be the object of preimplantation genetic diagnosis, have doubts or uncertainties about their inclusion in the cases referred to in Article 12.1 of the Law 14/2006.

5. Inform and propose criteria concerning the technical and functional requirements for approval and approval which, in general, must comply with the centres and services where the technical and the respective equipment are carried out Without prejudice to the fact that the autonomous communities, within the scope of their powers, lay down the specific characteristics that they understand appropriate.

6. Collaborate in the elaboration of standards and protocols of operation of the centers or services where the techniques are applied.

7. Develop and report guidelines for the monitoring and evaluation of the results and complications of these techniques, as well as the centers that perform them.

8. To evaluate the results of approved research and experimentation projects for scientific, diagnostic or therapeutic purposes in the field of assisted reproduction.

9. To advise the relevant administrations, in the elaboration, development and implementation of the legislation on assisted reproduction.

10. To inform and advise the competent health administrations in relation to scientific-technical advertising, advertising campaigns, divulgative or similar, that about assisted reproduction, their centers, services, applications, or their derivations, may occur, regardless of who is the sponsor of the same and the support used for that purpose.

11. To advise on studies aimed at updating existing legislation on assisted human reproduction.

12. Report on a mandatory basis in the following scenarios:

(a) The authorisation of an assisted human reproduction technique on an experimental basis not included in the Annex to Law 14/2006 of 26 May.

(b) The occasional authorisation for specific cases and not provided for in the Preimplantation Diagnostic Techniques Act, as well as in the cases provided for in Article 12.2.

(c) The authorisation of therapeutic practices provided for in Article 13 of the same Law.

d) The authorization of research projects in the field of assisted human reproduction.

e) In the procedure for the elaboration of general provisions covering matters provided for in that Law, or directly related to assisted reproduction.

f) The amounts of the financial compensation compensation to the donors, which guarantee respect for the free character of the donation.

g) In any other legal or regulatory assumption.

13. To advise and guide in research or experimentation on human sterility, gametes and preembryos in the terms outlined in Chapter IV of Law 14/2006.

14. Any other tasks entrusted to it or requested by the competent health authorities.

Article 4. Reports from the Commission.

1. The Government of the Nation or its members and the governing bodies of the Autonomous Communities, as well as the approved commissions which constitute them, may obtain the report or advice from the Commission.

2. For the purpose of channelling the requests for a report, the health centres and services in which assisted human reproduction techniques are applied which require a report from the National Commission shall direct their application to the body. autonomic competent for processing.

Article 5. Organs.

The Commission's bodies are as follows:

1. The Plenary Session.

2. The Presidency.

3. The Vice-Presidency.

4. The Secretariat.

5. The Standing Technical Committee.

Article 6. The Plenary Session.

1. The plenary session shall be composed of the Presidency, the Vice-Presidency, the vocalisations referred to in Article 2.2 and the Secretariat.

2. The plenary session shall be convened by the holder of the Presidency at least twice a year.

Extraordinary meetings may also be convened at the request of at least one-third of its components.

3. The plenary session shall be validly constituted with the presence of the holder of the Presidency, the person occupying the Secretariat and at least half of the vowels referred to in Article 2.2.

Article 7. The Presidency.

The Presidency of the Commission shall be carried out by the titular person of the General Secretariat of Health.

The Presidency is responsible for the tasks referred to in Article 23.1 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure and on the to be assigned to it in the Rules of Procedure of the Commission.

Article 8. The Vice-Presidency.

The Vice Presidency of the Commission will be performed by the head of the Directorate-General for Advanced Therapies and Transplants.

It is established that in cases of vacancy, absence, illness or other legal cause, the person holding the Presidency shall be replaced by the person who holds the Vice-Presidency.

Article 9. The Secretariat.

The person holding the Secretariat shall be appointed by the person holding the Presidency of the Commission. It may be one of its members or a person providing its services in the Ministry of Health and Social Policy. In the first case it will have a voice and vote, in the second it will have a voice but no vote. It shall perform its own functions, both in plenary and in the Standing Technical Committee.

Article 10. The Standing Technical Committee.

A Standing Technical Committee composed of the following members of the Commission shall be established:

1. The holder of the Presidency or person to whom the delegation is delegated.

2. The person occupying the Secretariat.

3. The words designated by the following scientific societies: the Spanish Fertility Society, the Association for the Study of the Biology of Reproduction and the Spanish Association of Human Genetics.

4. The word designated by the Ministry of Justice.

5. The vocalia designated by the National Transplant Organization.

The Committee shall examine, analyse and raise the proposed report in the case referred to in Article 3.12.

Article 11. External advisors.

When the holder of the Presidency of the Commission considers it appropriate and on a temporary basis, external advisors who will collaborate as experts, with a voice but without a voice, will be able to join the plenary and the Standing Technical Committee. vote.

Article 12. Operation.

1. For its operation, the Commission shall adopt its rules of procedure. As not provided for in that regulation and in this royal decree, the regulation on collegiate bodies of Chapter II of Title II of Law 30/1992 of 26 November shall apply.

2. This Regulation shall include at least the following terms:

a) Frequency of meetings.

b) deliberative and decision-making procedures.

c) Extension and limits of the duty of confidentiality of its members.

d) Independence of its members and conflicts of interest.

3. The Commission may, in the performance of its duties, request a report from other bodies of the Public Administration.

4. The plenary session of the Commission and the Standing Technical Committee may constitute and adopt agreements by electronic means, as provided for in the first provision of Law 11/2007, of 22 June, of electronic access of citizens to public services.

5. The members of the Commission shall not receive any remuneration for the performance of their duties. Those who have the status of staff at the service of the General Administration of the State may be entitled to receive compensation as provided for in the rules governing compensation for the purpose of the service.

6. Members of the Commission who do not have the status of staff at the service of the General Administration of the State, as well as the experts referred to in Article 11, shall have the right to be paid the costs incurred as a result of as a result of their attendance at the meetings to which they are convened, in accordance with the provisions of the rules governing the compensation for the service.

7. When the plenary considers it appropriate, technical committees and working groups may be formed for the study of specific subjects. The creation agreement shall contain the composition, purpose and tasks for which the holder of the Presidency of the National Commission will be established and the presidency shall be held by the Chair. The committees and working groups may be incorporated, on a temporary basis, with external advisors who will collaborate as experts, with a voice but without a vote.

Article 13. Headquarters.

The headquarters of the National Commission of Assisted Human Reproduction is established in the Ministry of Health and Social Policy, without prejudice to the possibility of holding meetings in other places and localities.

Article 14. Autonomous regional commissions.

The homologous commissions that are established in the autonomous communities will have the consideration of support commissions and reference of the National Commission of Assisted Human Reproduction, and will collaborate with it in the exercise of their functions.

The National Commission of Assisted Human Reproduction, in collaboration with the autonomous regional commissions, will establish the coordination mechanisms for the elaboration of joint reports.

Single repeal provision. Regulatory repeal.

The Royal Decree 415/1997 of 21 March, for which the National Commission of Assisted Human Reproduction is created, is hereby repealed.

Final disposition first. Enablement for development.

The Minister of Health and Social Policy is enabled to dictate how many provisions are necessary for the development of this royal decree.

Final disposition second. Entry into force.

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

Given in Madrid, on January 15, 2010.

JOHN CARLOS R.

The Minister of Health and Social Policy,

TRINIDAD JIMENEZ GARCIA-HERRERA