Our current legislation on assisted reproduction allows, with due controls and under certain conditions, to use for research purposes cryopconserved preembryos which are left over from the techniques of assisted reproduction.

The authorisation of this use, met with the remaining requirements, is one of the most effective measures to address the problem of the existence of numerous cryopconserved preembryos in the structures and lines banks. cell. The possibility of such a use is, in turn, part of the specification of different possible destinations for frozen preembryos, the indetermination of which has already been revealed by the National Commission of Assisted Human Reproduction, in its prior reports, as one of the reasons for the accumulation of frozen preembryos.

On the other hand, the possibilities of research with human preembryos have been developed in particular in certain lines, in particular those related to stem cells from those, on whose Various perspectives have been opened in recent years for development and therapeutic possibilities. This accelerated development also determines that this royal decree tries to facilitate, fulfilled all necessary guarantees, the development in the shortest possible time of the corresponding projects that can be promoted in our country, in a way that the options that can assist Spanish research teams in a field that at the present time seems so promising will not be missed.

Facilitating the development of the relevant research projects in the shortest possible time should not, in any case, imply the renunciation or adequate control of the existence of consent for the dedication of the In order to ensure that the European Community is not a Member State, it is not a matter for the European Parliament to be involved in the development of the European Community, but it is also a matter for the European Parliament. concerning the application of the results obtained. All of which makes them susceptible and tax-minded for specific control and coordination, which is the same as similar projects are being submitted in other countries where the corresponding investigations have been initiated.

Finally, in order for the control bodies and procedures already in place to be able to develop their function properly, it is necessary to ensure that the projects to be submitted to the relevant authorisation, which they may be of different character and extent, whether or not the clinical field is understood, have a certain structure and minimum content that will facilitate their assessment prior to their authorization.

This royal decree has been informed by the National Commission of Assisted Human Reproduction.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, with the prior approval of the Minister of Public Administration, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of the October 29, 2004,

DISPONGO:

Article 1. Object.

This royal decree regulates the fate of supernumerary human preembryos that have been cryopreserved prior to the entry into force of Law 45/2003, of 21 November, amending Law 35/1988, of 22 In November, on assisted reproduction techniques, it is intended to determine the specific conditions for biological structures obtained at the time of their defrosting to be used for research purposes within the the limits and under the conditions laid down in the first provision of that law.

The procedure also provides for the procedure whereby assisted human reproduction centres which have pre-embryos which have been cryopreserved prior to the entry into force of that law shall apply for the informed consent of the parents, or of the woman where appropriate, for such a destination.

Article 2. Consent of progenitors for the use of preembryos for research purposes.

1. In those cases where it is established in a feisty and accredited manner prior to the entry into force of Law 45/2003 of 21 November of the informed consent of the progenitors of frozen preembryos for their donation to other potential recipients, without the fact that since the signature of the document the implantation of the aforementioned preembryos has occurred, neither in the couple itself nor in another recipient, may be requested from those parents or the woman, where appropriate, the authorization for the use of the corresponding preembryos for research purposes in projects concrete, on which the parent couple will be specified the characteristics and purpose of those, as well as their expected potential outcomes.

2. The informed consent forms for the use of the preembryos, which, together with the conditions laid down in Law 45/2003, of 21 November, will be used for research purposes in the concrete projects which are They must inform the donors that, in accordance with the provisions of the first provision of the law, they may exercise other options. The forms shall, in any event, include a clause specifying the waiver of the donors to any right of an economic, patrimonial or potestative nature on the results which may be derived directly or indirectly. indirect investigations to be carried out.

Article 3. Project report.

Research projects that develop with human preembryos left over from the techniques of assisted human reproduction, in the terms and conditions provided for in the final provision of Law 45/2003, of On 21 November, they will require a mandatory and favourable report by the Commission on the monitoring and control of the donation and use of human tissues and cells, a body under the National Centre for Transplant and Regenerative Medicine, provided for in the Single additional provision of Law 45/2003 of 21 November.

The health authority to which the authorisation should be granted shall forward the projects to the Commission for the purpose of issuing the relevant report. Once issued, it will be forwarded to the consulting body

The commission may request clarifications or extensions of information that it deems necessary for the issuance of the relevant report.

Article 4. Project conditions.

The research projects that include in their development the use of frozen human preembryos left over from the assisted human reproduction techniques to be submitted for authorization to the health authority The following conditions must be met:

a) Identity and professional qualification of the principal investigator and all participants in the project.

b) In cases where the projects involve or include the development of cell lines from embryonic stem cells, specification of the number, provenance and origin of the pre-embryos donated to those purposes which are to be used in the project, including the informed consent form of the parent concerned, both for the intended use and for other uses or possible destinations of among those provided for in the final provision of Law 45/2003, of 21 November.

c) Indication of the existing common interests and relationships of any nature, or absence thereof, between the team and center that have carried out each of the assisted reproduction processes that have been generated by the preembryos to be included in the project.

d) Material and human resources, as well as resources available for project development.

e) General information and current state of scientific knowledge in the field of research project.

f) Justification and objectives of the project, including among them the accreditation of their relevance and scientific excellence, as well as the impossibility of developing the research foreseen in the animal model.

g) Description of the project and its phases and deadlines, including the specification of its restriction to the basic scope or its extension to the clinical scope of application.

h) Description of the financial conditions of the project and its budget, as well as a declaration and commitment to the absence of its lucrative character.

i) Report of the ethical research committee of the relevant center in the event that the project includes this development phase.

j) A commitment to supply the relevant public authority with the data to identify and understand the conservation of the cell lines that could be obtained as a result of the project's development, effects of the constitution of a cell line registry.

k) Commitment to transfer free of charge of the cell lines that can be obtained in the development of the project for the development of other projects, according to the criteria of distribution of the coordinating center corresponding.

Single additional disposition. National Cell Lines Bank.

The National Bank of Cellular Lines referred to in the additional provision of Law 45/2003 of 21 November 2003 is organised by means of a network structure, articulated around a central register whose management is responsible for to the Ministry of Health and Consumer Affairs, which shall fix its physical location.

Single repeal provision. Regulatory repeal.

As this royal decree enters into force, the following provisions are repealed:

(a) The fifth additional provision of Royal Decree 176/2004, of 30 January, approving the Statute of the National Centre for Transplantation and Regenerative Medicine.

(b) Paragraphs 1, 2, 2, 4, and 5. of Article 5.b) of the Statute of the National Center for Transplantation and Regenerative Medicine, approved by Royal Decree 176/2004 of 30 January 2004.

Final disposition first. Amendment of the Statute of the National Center for Transplantation and Regenerative Medicine.

In the first paragraph of Article 12 (2) of the Statute of the National Center for Transplantation and Regenerative Medicine, approved by Royal Decree 176/2004, of January 30, the sentence " is deleted by the National Center of Transplantation Transplants and Regenerative Medicine. "

Final disposition second. Competence title.

This royal decree is issued under the terms of Article 149.1.15. and 16. of the Spanish Constitution, which attribute to the State exclusive competence in the field of the promotion and general coordination of scientific and technical research and on the basis of the general principles and coordination of health, and on the application and development of the provisions of the first provision of Law 45/2003 of 21 November, amending Law 35/1988 of 22 November on technical assisted reproduction.

Final disposition third. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to regulate the organization and operation of the National Bank of Cellular Lines, which refers to the unique additional provision of this royal decree.

Final disposition fourth. Entry into force.

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

Given in Madrid, 29 October 2004.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

ELENA SALGADO MENDEZ