Law 45/2003, of 21 November, amending Law 35/1988 of 22 November on Assisted Reproduction Techniques, created the National Center for Transplant and Regenerative Medicine, as a public body with the nature of a self-employed body, in accordance with paragraph 4 of its unique additional provision that such a centre would have a National Bank of Cell Lines which would be responsible for the production, storage, conservation and management of cell lines of different types, in accordance with the standards and standards determined by the legislation national and international.

Subsequently, the fifth additional provision of Royal Decree 176/2004, of January 30, approving the Statute of the National Center for Transplant and Regenerative Medicine, and which is currently repealed under the terms of the Royal Decree 2132/2004, of 29 October, laying down the requirements and procedures for requesting the development of research projects with stem cells obtained from leftover preembryos, established that the Supernumerary preembryos cryopretained prior to the entry into force of the Law 45/2003, of 21 November, which were to be used for the production of human embryonic cells and tissues, for research purposes, would be made available to the National Center for Transplant and Regenerative Medicine and would constitute the The National Bank of Cell Lines, although these would remain in the pre-embryo banks of assisted reproduction centers until the National Center established one or more sites for their storage.

Royal Decree 2132/2004, dated October 29, established in its unique additional provision that the National Bank of Cellular Lines would be organized through a network structure, articulated around a central registry whose management it is the responsibility of the Ministry of Health and Consumer Affairs, to which it is responsible to fix its location, and in its final disposition the third has enabled the Minister of Health and Consumer Affairs to regulate the organization and operation of the National Bank of Cellular Lines.

Recently, Royal Decree 590/2005 of 20 May, amending the Statute of the Institute of Health "Carlos III", approved by Royal Decree 375/2001, of 6 April, adscribe the General Subdirectorate of Cell Therapy and Regenerative Medicine of the autonomous agency Centro Nacional de Transplantations y Medicina Regenerativa, to the Institute of Health "Carlos III", modifying its name that becomes Subdirectorate General of Research in Cell Therapy and Medicine Regenerative, as set out in Article 19.1.e) corresponding to this Subdirection address of the National Bank of Cell Lines, as well as the coordination of the different nodes that compose it.

In the preparation of this order, the Autonomous Communities have been consulted and the Commission has issued a report on the monitoring and control of the donation and use of human tissues and cells.

The purpose of this provision, which is dictated in accordance with the enabling provision in the final provision of Royal Decree 2132/2004 of 29 October, is to establish the organisation and operation of the National Bank. Cell lines and fix their location.

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

Article 1. Object.

This order regulates the organization and operation of the National Bank of Cellular Lines provided for in the single additional provision of Law 45/2003 of 21 November, amending Law 35/1988 of 22 November, on Assisted Reproduction Techniques, and lays down the minimum conditions for the deposit of adult and embryonic human stem cell lines for biomedical research and the minimum conditions for access to such lines from of biomedical research.

Article 2. Structure and procedure for incorporation into the National Bank of Cellular Lines.

1. The National Bank of Cellular Lines is configured as a network structure, which will aim to guarantee the availability of embryonic and adult human stem cell lines for research throughout the national territory. biomedical. As a network structure, the National Bank will be configured by several nodes coordinated by a central node.

2. The National Bank of Cellular Lines will be attached to the General Subdirectorate of Research in Cell Therapy and Regenerative Medicine of the "Carlos III" Health Institute.

3. The central node will be designated by the Director of the Health Institute "Carlos III" among the nodes of the network in which the National Bank is structured in focus on the special responsibility of its functions and for a maximum period of four renewable years.

4. The incorporation of nodes into the National Bank of Cellular Lines will be authorized by the Director of the Health Institute "Carlos III", prior to the report of the Technical Commission of the aforementioned National Bank and on the proposal of its director.

5. The application for the incorporation of nodes into the network, addressed to the Director of the Health Institute "Carlos III", shall be made by the competent authority in the field of health research of the Autonomous Community concerned or by the representative the legal centre or entity of public ownership concerned. In the latter case the application must be endorsed by the competent authority in the field of health research in the Autonomous Community where the applicant public ownership centre or entity is located.

6. Applicants shall have sufficient technical and human resources for the development of the functions provided for in Article 5.2 of this order and shall demonstrate this at the time of the application.

In addition to the application and the documentation supporting the provision of technical and human resources, it will be accompanied by descriptive memory of the objectives pursued by the requesting node with the incorporation of the National Bank of Cell lines and their organization, with the express indication of who will exercise the direction of the node.

Article 3. Principles.

The National Bank of Cellular Lines will act in accordance with the ethical principles enshrined in the international conventions on biomedicine and human rights of which Spain is a party and in accordance with the principles of objectivity, collaboration, integration and solidarity.

Article 4. Objectives.

The National Bank of Cellular Lines will promote the quality and safety of the procedures on which it exercises its competence, maintain the confidentiality of the data and other ethical requirements regarding the actions that carry out, in accordance with the provisions of Law 35/1988, of 22 November, on Assisted Reproduction Techniques, in Law 45/2003, of 21 November, amending Law 35/1988, and in Organic Law 15/1999, of December 13, the protection of personal data, and shall include in its actions the precautionary principles, proportionality and non-profit.

Article 5. Functions of the National Cell Lines Bank.

1. The National Cell Lines Bank will have the following functions:

a) Coordinate the operation of the network and the different nodes that make up the National Bank of Cellular Lines, according to the guidelines issued by the Technical Commission.

b) Manage the centralized recording of data relating to the cell lines transferred and deposited in the various nodes of the Bank.

c) Approve the technical procedures of network operation.

d) Approve the requirements of the deposit of cell lines in the Bank and access by researchers or research centers to the cell lines deposited or elaborated in the Bank.

e) Ensuring that all the work procedures followed in the various nodes of the network comply with the ethical principles enshrined in the international conventions on biomedicine and human rights and legislation in the case of confidentiality of information.

f) Manage the registration of incidents and biosecurity in research projects using biological material provided by the Bank.

g) Approve the quality and safety standards of human stem cell lines for research, which must include at least: phenotyping and chromosomal characterization, microbiological analysis and typing HLA.

h) Approve internal training plans and advice to research groups in the areas of their competence.

2. In addition, the National Bank of Cellular Lines and each of the various nodes of the network, coordinated by the central node, will have the following functions:

a) Develop, characterize, store, preserve, and make available the human stem cell lines of embryonic and adult origin.

b) Apply the standards of quality and safety of human stem cells for research.

c) Approve requests for access to cell lines and supply them to each of the authorized research projects.

d) Perform internal training and advisory functions to authorized research groups, in the areas of their competence.

3. The duties referred to in paragraph 1 of this Article shall be carried out by the Director of the National Bank of Cellular Lines, but the functions referred to in points (b) and (f) of this Article may be regulated by agreement between the entities or bodies of the network.

Article 6. Organs of the National Bank of Cell Lines.

They are organs of the National Bank of Cell Lines:

(a) Of a single-person nature: the Director and the Technical Subdirector of the National Cell Lines Bank.

b) Collegiate: the Technical Commission.

Article 7. The Director of the National Cell Lines Bank.

1. He will serve as Director of the National Bank of Cellular Lines, the Assistant Director of Cell Therapy Research and Regenerative Medicine of the "Carlos III" Health Institute.

2. They are the functions of the Director of the National Cell Lines Bank:

a) Ostend the representation of the National Bank of Cellular Lines.

b) Lead the development of the functions assigned to the National Bank of Cell Lines.

c) Present the annual activity report to the Director of the Health Institute "Carlos III" for his transfer and report to the Board of Directors of the Institute.

d) Approve the strategic plan of the National Bank of Cellular Lines.

Article 8. The Technical Deputy Director of Cell Lines Bank.

1. The Director of the Institute of Health "Carlos III" will appoint as Technical Assistant to the National Bank of Cellular Lines to the Director of the central node of the network.

2. It will be the role of the Technical Subdirector of the National Bank of Cellular Lines to coordinate the technical activities of all the Bank's nodes, under the supervision of the Bank's Director.

Article 9. The Technical Commission.

1. The Technical Commission shall be composed of the following members:

a) The President, who will be the Deputy Director General of Research in Cell Therapy and Regenerative Medicine of the "Carlos III" Health Institute, as Director of the National Bank of Cellular Lines. In case of vacancy, absence or illness, the President shall be replaced by the Vice-President.

b) The Vice President, who will be the Technical Subdirector of the National Cellular Lines Bank, as Director of the central node.

c) The Vocals, which will be the following: a representative of the "Carlos III" Health Institute, a representative proposed by the National Transplantation Organization, the Directors of the nodes of the National Bank of Cellular Lines, with the exception of the Director of the central node acting as vice-president, and at least two researchers of recognized prestige in the field of cell therapy and regenerative medicine research and a bioethics expert.

d) The Secretary, who will be an official of the General Subdirectorate of Research in Cell Therapy and Regenerative Medicine, who will speak with voice, but without a vote.

2. With the exception of the Directors of the nodes that will be vocal in the role of the Director of the same, the rest of the vowels and the secretary will be appointed by the Director of the Institute of Health "Carlos III", for a period of four years.

3. The appointment of the vowels and the secretary of the Technical Commission may be freely revoked by the Director of the Health Institute "Carlos III", except in the case of the vowels who are for the purpose of the charge.

4. It is for the President of the Technical Commission:

a) The representation of the Commission.

b) Agree to the convening of ordinary and extraordinary meetings and the setting of the agenda for meetings.

(c) The other functions inherent in the chair of a collegiate body.

5. Corresponds to the Secretary of the Technical Commission:

(a) Call for meetings at the order of its President.

(b) Assistance to the President in the exercise of his duties.

c) The coordination of the different presentations and working groups that, if any, are constituted.

(d) The other functions inherent in the secretariat of a collegiate body.

6. The Technical Commission shall operate in full and on a permanent basis, and shall also constitute working groups which shall have the composition and functions to be determined in each case.

7. The plenary session, convened by its President, will meet at least twice a year, coinciding with the natural semesters.

The President may agree to hold extraordinary meetings of the Commission in plenary as many times as necessary, on his own initiative or at the request of at least a quarter of the vowels for the development of the tasks assigned to them and in particular those referred to in points (b), (c), (d), (g), (h), (j) and (k) of paragraph 10 of this Article.

The standing committee shall be composed of the President of the Commission, the Secretary and four Vocals appointed by the President, including at least one of those who have the status of voice for the purpose of the position. The appointment of the members of the standing committee shall be for a period of two years, renewable, and may be freely revoked by the President of the Commission.

The standing committee shall prepare the meetings of the plenary session and shall exercise the functions assigned to it in the rules of procedure of the Technical Commission, and in particular those referred to in points (a), (e), (f), (i) and (l) of paragraph 10 thereof. Article.

Papers and working groups, which may be part of experts from outside the Technical Commission, will meet when necessary for the development of specific tasks.

8. The Technical Commission shall draw up its own rules of procedure for internal arrangements and shall in any event adjust its operation to the provisions of Chapter II of Title II of Law No 30/1992 of 26 November 1992 on the legal framework of the Public administrations and the Common Administrative Procedure, with the peculiarities provided for in this order.

9. The members of the Technical Commission shall not receive any remuneration for the performance of their duties, but may receive the compensation which, for the purpose of the service, corresponds to them in accordance with the rules in force.

10. They are functions of the Technical Commission, in addition to the advice to the director of the National Bank of Cellular Lines in all aspects related to its best functioning, the following:

a) Develop a mandatory report on research projects that request cell lines.

b) Report requests for node incorporation to the network in which the National Cell Lines Bank is structured.

c) Develop the technical procedures of network operation.

d) Propose quality and safety standards for adult or embryonic human stem cell lines, present in the Bank and intended for research or regenerative medicine, which must include at least: phenotyping and chromosomal characterization, microbiological analysis and HLA typing.

e) Propose the internal training programme and advice to research groups, in matters of their competence.

f) Develop the annual activity memory.

g) Propose the strategic plan of the National Cell Lines Bank.

h) Propose the requirements to be able to deposit cell lines in the National Bank of Cellular Lines and the requirements of access, by researchers or research centers, to the cell lines deposited in the or made by him.

i) Evaluate and analyze the incidences and biosecurity of research projects using biological material provided by the Bank.

j) To advise on the strategic policy of relations of the National Bank and the different nodes that make it up with other banks of a similar nature in order to build international networks.

k) Establish the bases according to which the different nodes of the National Bank of Cell Lines will be able to pass on to the researchers and centers an economic compensation for the cession of cell lines.

(l) Inform the work procedures to be followed in the different nodes of the Bank, in order to ensure that they comply with the ethical principles enshrined in the international conventions on biomedicine and rights (a) human rights and human rights, and are consistent with the provisions of the law in force regarding the confidentiality of information.

Article 10. Information, communication and dissemination of results.

The National Bank of Cellular Lines will have a website, with information on available cell lines, working protocols, related national and international legislation and any other information of interest. for the research groups.

The annual memory of the National Bank of Cellular Lines will be disseminated through its website.

In any publication, information or documentation carried out with cell lines obtained from the National Bank of Cellular Lines, the origin of the cell line and the collaboration with the National Bank must be stated.

Article 11. Duty of deposit of stable lines of stem cells and their disposal to the Bank.

In order for the National Bank of Cellular Lines to meet its objective, all public or private institutions that at national level obtain stable lines of human embryonic or adult stem cells they must, in accordance with the procedures established for this purpose, in addition to declaring their existence to the competent authorities, deposit a sample of the same in the National Bank for their storage and transfer to any other a researcher who requests it through established legal channels.

Article 12. Minimum deposit conditions for adult and embryonic human stem cell lines for research and minimum conditions for access to adult and embryonic human stem cell lines from research biomedical.

In Annexes I and II of this order, the minimum conditions for the deposit of adult and embryonic human stem cell lines for research and the minimum conditions for access to cell lines are indicated in Annexes I and II. adult and embryonic human stem from biomedical research.

Without prejudice to the foregoing paragraph, it is the function of the National Bank of Cellular Lines, in accordance with the provisions of Article 5.1.d) of this order, to establish the requirements for the deposit of the cell lines. adult and embryonic human stem cells for research and the requirements for access to adult and embryonic human stem cell lines from biomedical research.

Article 13. Absence of profit.

The bases referred to in article 9.10.k) will guarantee equality and equity in access to cell lines by all researchers and centers in the national territory. The economic impact to be established should be designed to compensate for the costs incurred by the node in relation to that line, without in any case being due to profit.

Article 14. Location of the National Cell Lines Bank.

The location for administrative purposes of the National Bank of Cellular Lines will be that of the General Subdirectorate of Research in Cell Therapy and Regenerative Medicine of the "Carlos III" Health Institute.

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, 8 February 2006.

SALGADO MENDEZ

ANNEX I

Minimum deposit conditions for adult and embryonic human stem cell lines in the National Cell Lines Bank for biomedical research

1. Requests for the deposit of cell lines shall be authorized by the legal representative of the institution where the lines have been derived.

2. The requesting institution will protect the identity of the donors in the strictest secrecy, in accordance with the provisions of the Organic Law 15/1999, of December 13, of Protection of Personal Data, donors have been informed of the extremes contained in Article 5.1 of this Law, providing the necessary biological data to determine the traceability and typing of cells so that the identity of the donors is not disclosed.

3. The application shall contain detailed information on the viability, potential and security of the line, in order to assess whether the line meets the standards established by the Bank for subsequent disposal.

4. The cell shunt performed must ensure the safety of the line, as well as its traceability.

ANNEX II

Minimum conditions for access to the adult and embryonic human stem cell lines of the National Bank of Cell Lines from biomedical research

Applications for cell lines must be carried out from research projects that demonstrate that they have been duly approved, as provided for in the legislation in force by the competent authority.

1. The request will contain information about the project to be developed.

2. The application must be accompanied by an explicit commitment from the applicant centre and/or from the researchers involved in the project not to use the requested material for a different use of the project.

3. The amount of material requested shall be the minimum quantity to be used for the investigation.