Belgian legislation

Law on research on embryos in vitro (11/05/2003)

Embryo research

Art. 3

Research on embryos in vitro is allowed if all conditions imposed by this law are fulfilled and more specifically if:

1. the research has a therapeutic purpose or contributes to a better knowledge about fertility, infertility, organ and tissue transplantation, prevention or treatment of diseases.
2. the research is founded on the most recent scientific findings and is conform the requirements of correct scientific methodology.
3. the research is conducted in a licenced laboratory that is linked to an academic programme for assisted reproduction or human genetics and is performed in appropriate technical and material conditions; …
4. the research is conducted under the supervision of a specialist or a qualified person.
5. the research is performed on embryos during the first 14 days of development, the period of freezing not included.
6. There is no other research method that is equally efficient.

Art. 4

§ 1. The creation of embryos in vitro for research purposes is forbidden, except if the goal of the research cannot be achieved by research on supernumerary embryos and insofar the conditions of this law are respected.

§ 2. Oocyte [ovarian] stimulation is allowed if the women is of age, has given written consent and if the stimulation is scientifically justified.

Art. 5

It is forbidden:

1. to place human embryos in animals or to create chimaera or hybrids;
2. to replace embryos on which research has been conducted in humans, except when the research had a therapeutic benefit for the embryo itself or when it concerns an observation method that does not harm the embryo’s integrity;
3. to use embryos, gametes and embryonic stem cells for commercial purposes;
4. to conduct research or treatment for eugenic purposes, i.e. directed at the selection or enhancement of non-pathological characteristics of the human species;
5. to conduct research or treatment directed at sex selection, except when selection is performed to prevent sex linked diseases.

Art. 6

Reproductive cloning of humans is prohibited.

Art. 7

§ 1. Each research project on embryos in vitro should be brought before the local ethics committee of the academic institute that is involved and before the Federal Commission for medical and scientific research on embryos in vitro. …

§ 2. The local ethics committee gives its advice within a period of two months. …

Art. 8

The persons involved, after being appropriately informed, give written consent for the use of their gametes or embryos for research. Consent can only be given after the persons involved have received all necessary information regarding:

the provisions of the law;

the technology to obtain the gametes;

the purpose, method and time period of the research or treatment;

the advice of the local ethics committee, and, if applicable, of the Federal Commission.

The researcher informs the persons involved that they have the right to refuse to donate gametes or embryos for research or treatment and that they can withdraw their consent until the start of the research.

No research is allowed on embryos that already exist on the date of commencement of the law without the consent of the persons involved.

Art. 9

§ 1. A Federal Commission for medical and scientific research on embryos in vitro will be established. …

Art. 10

§ 1. The Federal Commission should:

1. collect and centralise information on the different projects on embryos in vitro, including those for which the local ethics committee issued a negative advice;
2. prevent scientifically unjustified research projects involving identical research;
3. evaluate the application of this law;
4. issue recommendations for future legislative initiatives or other measures;
5. issue recommendations regarding the adaptation of the law for the local ethics committees.

§ 2. The Commission should evaluate all research projects that are submitted to her.

§ 3. The Commission decides with a two third majority.

§ 4. Every year the Commission reports to the legislative chambers.

Art. 11

Every researcher sends a report on the progress of his/her research to the Commission. This report includes:

1. the purpose, methodology and time period of the research;
2. the manner in which the provisions of the law were respected;
3. the advice of the local ethics committee
4. the progress of the research.

Art. 12 Persons who do not send the yearly report will be punished with a fine of 50 to 5000 euro.

Art. 13 Persons who perform acts prohibited in articles 3, 5°, 4, 5 and 6 of this law will be punished with a prison sentence of one to five years and a fine of 1000 to 10000 euro.

Art. 14 Every condemnation for facts mentioned in article 6 may include a prohibition of conducting any medical or research activity during a period of five years.