Belgium

Legislation

• Law 19th December 2008 regulating the procurement and use of human bodily material for medical application to humans and for scientific research (implements and extends EC Directive 2004/25/EC on human tissues and cells). Repeals part of Law of 13th June 1986 on the removal and transplantation of organs. Not applicable to organ tranplantation or use of blood. (French official version)
• Law of December 8, 1992 on Privacy Protection in relation to the Processing of Personal Data as modified by the law of December 11, 1998 implementing Directive 95/46/EC and implemented by Royal Decree of 12 Feb 2001. (Unofficial English translation).
• Loi relative aux expérimentations sur la personne humaine (7 May 2004) (French official version), amended by Law of 27 December 2004, implements and extends EC Clinical Trials Directive 2001/20.
• Law of 5 July 1994 concerning blood and blood derivatives of human origin.
• Law of 22 August 2004 on the Rights of Patients will apply to any intervention by a health professional.
• Other laws also apply to research using embryos:
  • Law of 6 July 2007 on medically assisted reproduction and the destination of supernumerary emrbyos and gametes

Guidance

• Federaal Raadgevend Comité voor Bio-ethiek
  • Opinion n° 45 (19 Janvier 2009) on biobanks for research (in French)
  • Opinion n° 43 (10 December 2007) on commercialisation of human body parts (in French) 
  • Opinion No. 42 (April 16, 2007) on umbilical cord blood banks  (in French)(in English)