• * The center of assisted medical procreation of the CHU St Pierre is specialised in reproductive medicine. Reference center: quality label ISO 9001 obtained in 2008 and accredited by the AFMPS (Agence Fédérale des Médicaments et Produits de Santé).

 legislatif

 

Legislation

InBelgium, the area of Assisted Reproduction is supported by a whole series of legal texts featured below in chronological order.

Every centre must therefore prove to the various auditing institutions that the law is being properly respected.

 

In concrete terms, we are currently audited by:

 

  • theCollegeofPhysiciansfor the annual  registration of the centre’s results with BELRAP, the “Belgian Register for Assisted Procreation”
  • the ‘Brussels-Capital commune’  community commission to obtain our ‘category B centre for reproductive medicine’ certificate
  • the independent quality system auditing company VERITAS to obtain our ISO 9001:2008 certification
  • FAMHP (the Federal Agency for Medicines and Health Products) to obtain our approval as a human tissue bank 

  

 

Law of 19 December 2008 and its eight RD“Law relating to obtaining and using human tissue for the purpose of human medical applications or for the purposes of scientific research”.

  • Assisted reproduction centres are placed in the same class as human tissue banks and are controlled by the Federal Agency for Medication and Health Products.

 

RD of October 2008“RD establishing the reimbursement of a flat-rate for female infertility treatments” 

  • The aims of this RD are to make consultants aware of their responsibilities, control fertility treatment costs and spread solidarity between female patients.

 

Law of 6 July 2007“Law relating to Assisted Reproduction and the disposition of supernumerary embryos and gametes”

  • A legal framework set up for AR

 

RD of 1 October 2006“RD relating to gonadotropins

  • Limitation of the quantity of gonadotropins during ovarian stimulation.
  • Limitation of the distribution of gonadotropins to hospital dispensaries in B centres for in vitro fertilization.

 

RD of 4 June 2003“RD establishing the reimbursement of laboratory costs for in vitro fertilization”

  • Since 1 July 2003, authorised “Reproductive Medicine B” care programmes have received financing for laboratory costs for IVF (+/- EUR 1200) providing that the conditions in terms of age, number of attempts and the number of embryos deposited are respected.
  • The aim of this law is to make AR treatments available to everyone and to limit the number of multiple pregnancies. 

 

Law of 11 May 2003“Law relating to research on in vitro embryos”

  • Sets out the conditions according to which research may be authorised
  • Research placed under the control of the ‘Commission Fédérale pour la recherche médicale et scientifique sur les embryons in vitro’ (Federal commission for medical and scientific research into in vitro embryos), (14 members appointed by the king)
  • Ban on reproductive cloning, sex selection for convenience, eugenics, commercialisation, etc.

 

Law of 15 February1999“Royal decree setting out the standards which “reproductive medicine” care programmes must meet to be authorised”

  • This text defines “reproductive medicine” care programmes A and B.
  • A centres (14 inBelgium) à gamete retrieval and transport to a B centre.
  • B centres (17 inBelgium) à gamete retrieval and in vitro fertilization laboratory.
  • Every centre is obliged to register the data online (BELRAP) allowing an external qualitative assessment of its activity. This registration is controlled by the College of Physicians, “Reproductive Medicine”.

 

N.B.: Most of this legislation is available on the FAMHP website: www.fagg-afmps.be

“human use → human body material → legislation”

 

 

 

Plan du site CHU Saint Pierre - Bâtiment 200, 5è étage . Département de Gynécologie-Obstétrique

Centre de Fécondation In vitro - 322, Rue Haute - Bruxelles Tel +32(0)2 535 3406 Fax +32(0)2 535 3409