cristina ceccarini: spanish regulation on biomedical research

The Spanish regulation of biomedical reserch on embryos for therapeutic and research purposes

The Spanish regulation of biomedical research on embryos and pre-embryos

Dr. Cristina Ceccarini

(PhD Administrative Comparative Law)School of Law Complutense University of Spain

Current legal position on biomedical reserch on embryon and pre-embryos dictated by Human Assisted Reproduction Act 2006 (HARA) and Biomedical Reserch Act 2007 (BRA)

The pillars of this legal frame work ( HARA + BRA ) are:

Possibility to use for reserch purposes of pre-embryos and embryos.

Creation a new stage of development that ranks first embryo: pre-embrionyc stage.

The Article 1.2 HARA create an autonomous category so-called pre-embryo (constituted in vitro and formed by the group of cells that are the result of the progressive division of the oocyte from the time it is fertilized until 14 days after).

Possibility to make Preimplantation Genetic Diagnosis (PGD), therapeutic techniques in the pre-embryos and research during the pregnancy.

Institution of Biobanks for storage biological samples that we can use for some biomedical research.

Expressly forbids reproductive human cloning and surrogated motherhood.

1)Donation and use of human embryos and foetuses, their cells, or organs for research and therapeutic purpose

-> The donation is possible prior informed express and written consent (Article 4.1 BRA);

-> the consent can be revoke at any moment, in according with the limitations provided in the BRA (Article 4.3 BRA);

-> the donation and use of human biological samples shall be gratuitous. Commercial nature is prohibited.

Likewise, the donation implies the waiver by the donor to any right, of an economic nature or other, on the results that could be directly or indirectly obtained through the research that takes place with these biological samples (Article 7 BRA);

-> the research is possible when the human embryos have lost their capacity for biological development, as well as dead human embryos or fetuses, may be donated for biomedical research or other diagnostic, therapeutic, pharmacological, clinical or surgical purposes (Article 28.1-2 BRA);

-> the fetuses that are prematurely and spontaneously expelled shall be clinically treated while they remain biologically viable with the sole purpose to favour their development and vital autonomy . In the event that the persons from whom the embryos or fetuses come from are deceased, it is necessary that there is no record of their express opposition to donation for research purposes (Article 28.3 and 29.2 BRA).

->conditions for biomedical research with human embryos and foetuses in utero: utero research with live embryos and fetuses can only be conducted for diagnostic or therapeutic purposes in the interest of the embryo or fetus, without prejudice to legal provisions for the voluntary interruption of pregnancy (Article 30 BRA);

-> the project detailing the use to be made of the embryos or fetuses must be approved by the Committee for Donations and Use of Human Cells and Tissue, as well as the corresponding state or autonomous community authorities (Article 31 BRA);

-> the creation of human pre-embryos and embryos exclusively for experimentation purposes is prohibited

While the use of any technique for obtaining human stem cells for therapeutic or research purposes is allowed, always when it does not entail the creation of a pre-embryo or an embryo exclusively for this purpose including the activation of oocytes through nuclear transfer (Article 33 BRA);

-> the donation of human embryos or fetuses or their biological structures for research purposes must be subsequent to specific written consensus of the donor (Article 29 BRA).

2) Donation and use of human gametes and pre-embryo for research and therapeutic purpose

-> donation for research or experimentation with surplus oocytes or preembryos from assisted reproduction techniques, or their biological structures, for purposes related with the obtaining, development and use of embryonic stem cell lines, shall be undertaken in accordance with that provided by HARA (Articles 32.2 and 33 BRA).

In according with the article 11.4 HARA the options for use of supernumerary cryopreserved pre-embryos, oocyte, male gamete and ovarian tissue, are:

- use for the couple or patient;

- donation to other couples or single women;

- donation for research;

- discard

-> Donation of oocyte and pre-embryo for research is allowed under some condition:

informed consent writing by donor. Likewise dead human embryos or foetuses, may be donated for biomedical research;

the donation of gametes and pre-embryos is a free contract (Article 5.1 HARA);

The donation will never have lucrative or commercial nature, except for the financial compensation for damages that can be fixed only be strictly offset the physical discomfort and travel expenses (Article 5.3 HARA);

The contract is formalized in writing between the donor and the authorized center (Article 5.4 HARA);

The donation will be anonymous (Article 5.5 HARA);

The donation can be revoked in any moment without affecting the research undertaken (Article 32.1 BRA) and if biological samples are available. A revocation shall be refunded by the donor of the expenses incurred for the revocation (Article 5.2 HARA);

the pre-embryo has not developed in vitro beyond 14 days after fertilization of the oocyte (Article 15.1.b) HARA);

Implementation of the project in authorized centre (Article 15.1.c) HARA);

The scientific project must be approved by National Assisted Reproduction Committee or in alternative by Guarantees Commission for the Donation and Use of Human Cells and Tissues (Article 15.1.d) HARA)

3) Other techniques permitted by HARA and BRA

-> A) Preimplantation genetic diagnosis (PGD - article 12 HARA) when:

the genetic hereditary conditions are considered serious, early-onset and for which no treatment exist;

to detect the alterations that may affect negatively the viability of the embryos;

In any case the application of techniques of preimplantation diagnosis for this and any other purpose require the express authorization, case by case, by regional authorities and prior favorable report of the National Commission on Assisted Human Reproduction.

-> B) Therapeutic techniques in the pre-embryo (article 13 HARA). This treatment is possible with the aim of treating a disease and preventing transmission, and under the following condition:

informed consent by the couple or single woman;

severe or serious diseases;

severe prognosis and adequate chances of success;

no modification of no pathologic traits (avoid eugenics);

It is possible only in authorized centers of vitro fertilization by competent regional authority;

specific authorization for this specific purpose by competent regional authority and National Assisted Reproduction Committee.

-> C) Research during pregnancy (article 19 BRA)

Any research in which a pregnant woman participates, which shall not produce a direct benefit for her, or embryo, foetus or the child after his birth shall only be authorized if the following conditions are met:

that the aim of the research is to contribute to produce results that are for the benefit of other women, embryos, foetuses or children;

that research of similar efficacy is not possible to be undertaken in non-pregnant women;

the research entails a minimum risk and damage for the woman and, in its case, for the embryo and foetus;

That the pregnant woman, or the legal representatives, provides their consent in the terms provided in the BRA.

4) Biobank

(Article 63 and following BRA)

The BRA introduces for the first time in Spain the possibility of storing the samples in a common platform: Biobank.

The Royal Decree defines the basic requirements for authorization and operation of Biobanks for biomedical research and also creates a National Registry of Biobanks.

Nowdays the Spanish regulation foresees three possible ways in which samples for research are to be handled:

Gathering for use in a specific project;

Storage in a collection;

Storage in a biobank.

The difference between storage in a collection and storage in a biobank is:

biological sample storage in a collection

used only for single research project or clinical trial;

biological sample storage in a biobank

used for any biomedical research;

possibility of transfer to third parties the biological sample for the same purposes for which the donor has consented to sampling.

5) National Control Authorities on biomedical research:

In Spain there are two separate commissions with different functions in relation to human biological sample research:

National Assisted Reproduction Committee (Comisin Nacional de Reproduccin Humana Asistida CNRHA) created in 1997 and now regulated by Article 20 and following HARA.

Guarantees Commission for the Donation and Use of Human Cells and Tissues (Comisin de Garantas para la Donacin y Utilizacin de Clulas y Tejidos Humanos) Article 37 and following BRA

6) Sanctions

Failure to comply with the obligations contained in both laws - BRA and HARA - will be subject to administrative sanctions, without prejudice to any civil, criminal or other liability which the non-compliant may incur.

The sanctioning authority regulated in those Laws they must be exercised, in the cases not provided in those Laws, in accordance with that provided in Law 30/1992 of the Legal regulation of Public Administrations and the Common Administrative Procedure.

Haga clic para modificar el estilo de ttulo del patrn

Editar el estilo de texto del patrn

Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel

6/1/2016

Click to edit Master text stylesSecond level

Third level

Fourth level

Fifth level


Haga clic para editar el estilo de subttulo del patrn

6/1/2016


Third level

Fourth level

Fifth level


Haga clic para editar el estilo de subttulo del patrn

click to

6/1/2016


Third level

Fourth level

Fifth level



Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel

6/1/2016


Third level

Fourth level

Fifth level



Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel

6/1/2016


Third level

Fourth level

Fifth level



Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel


Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel

6/1/2016


Third level

Fourth level

Fifth level




Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel



Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel

6/1/2016


Third level

Fourth level

Fifth level


6/1/2016


Third level

Fourth level

Fifth level

6/1/2016


Third level

Fourth level

Fifth level

6/1/2016


Third level

Fourth level

Fifth level



Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel

6/1/2016


Third level

Fourth level

Fifth level



Segundo nivel

Tercer nivel

Cuarto nivel

Quinto nivel


6/1/2016


Third level

Fourth level

Fifth level

white rectangle.pngClick to edit Master title style

Click to edit Master text styles

Second level

Third level

Fourth level

Fifth level

6/1/2016


Third level

Fourth level

Fifth level

white rectangle.pngClick to edit Master title style

Click to edit Master text styles

Second level

Third level

Fourth level

Fifth level

6/1/2016


Third level

Fourth level

Fifth level