Presentation at Israel Bar Association of Tel Aviv - 1st June 2016

1. The Spanish regulation ofThe Spanish regulation of
biomedical research on embryosbiomedical research on embryos
and pre-embryosand pre-embryos
Dr. Cristina Ceccarini
(PhD Administrative Comparative Law)
School of Law
Complutense University of Spain

2. CurrentlegalpositiononbiomedicalreserchonCurrentlegalpositiononbiomedicalreserchon
embryonandpre-embryosdictatedbyHumanembryonandpre-embryosdictatedbyHuman
AssistedReproductionAct2006(HARA)andAssistedReproductionAct2006(HARA)and
BiomedicalReserchAct2007(BRA)BiomedicalReserchAct2007(BRA)
The pillars of this legal frame work ( HARA + BRA )The pillars of this legal frame work ( HARA + BRA )
are:are:
Ø
Possibility to use for reserch purposes of pre-Possibility to use for reserch purposes of pre-
embryos and embryos.embryos and embryos.
Ø
Creation a new stage of development that ranksCreation a new stage of development that ranks
first embryo: pre-embrionyc stage.first embryo: pre-embrionyc stage.
The Article 1.2 HARA create an autonomous category so-calledThe Article 1.2 HARA create an autonomous category so-called
pre-embryo (constituted in vitro and formed by the group of cellspre-embryo (constituted in vitro and formed by the group of cells
that are the result of the progressive division of the oocyte fromthat are the result of the progressive division of the oocyte from
the time it is fertilized until 14 days after)the time it is fertilized until 14 days after)..

3. Ø
Possibility to make Preimplantation GeneticPossibility to make Preimplantation Genetic
Diagnosis (PGD), therapeutic techniques in theDiagnosis (PGD), therapeutic techniques in the
pre-embryos and research during thepre-embryos and research during the
pregnancy.pregnancy.
Ø
Institution of Biobanks for storage biologicalInstitution of Biobanks for storage biological
samples that we can use for some biomedicalsamples that we can use for some biomedical
research.research.
Ø
Expressly forbids reproductive human cloningExpressly forbids reproductive human cloning
and surrogated motherhood.and surrogated motherhood.

4. 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);

5. -> 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).

6. ->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);

7. -> 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).

8. 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).
-

9. 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

10. -> 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

11. - 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)

12. 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.

13. -> 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.

14. -> 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.

15. 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.

16. 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.

17. 5) National Control Authorities on biomedical5) National Control Authorities on biomedical
research:research:
In Spain there are two separate commissions with
different functions in relation to human biological sample
research:
Ø
National Assisted Reproduction Committee (Comisión
Nacional de Reproducción Humana Asistida –
CNRHA) created in 1997 and now regulated by
Article 20 and following HARA.
Ø
Guarantees Commission for the Donation and Use of
Human Cells and Tissues (Comisión de Garantías
para la Donación y Utilización de Células y Tejidos
Humanos) Article 37 and following BRA

18. 6)Sanctions6)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.
-