On 18 November 2008, the Public Health Committee of the Belgian House of Representatives pre-approved a new bill on the use of cells and tissues or human corporal material, including stem cells. The bill is expected to be ratified by the full House shortly. It is intended to transpose into Belgian law Directive 2004/23 of 31 March 2004 setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells and its implementing Directives 2006/17 of 8 February 2006 and 2006/86 of 24 October 2006 (the "Directives").
In implementing the Directives, Belgium adopted an extensive approach. The bill indeed goes further than the Directives, for example by covering research and development without direct human applications.
Existing legal framework
Previously, the use of human cells and tissues was scarcely regulated in Belgium. The existing legislation is mainly the Act of 13 June 1986 on the collection and transplantation of organs and its implementing Royal Decree of 15 April 1988 on tissue banks and the collection, conservation, preparation, import, transport, distribution and delivery of cells and tissues, the Act of 5 July 1994 on blood and blood derivatives of human origin and the Act of 6 July 2007 on medically assisted procreation and the use of gametes and supernumerary embryos.
Main rules under the Bill
The bill currently covers the donation, collection, control (testing), processing, preservation, storage, distribution and use of human corporal material for human use and/or research and development. This scope may be extended to other applications by means of a royal decree. However, certain applications such as organ transplantation and use for exclusively diagnostic purposes limited to the donor, are excluded.
Four new organisations
In general, the bill aims to safeguard the permanence, confidentiality, security, quality and traceability of human corporal material. In this respect, the bill creates four different types of bodies, each playing a role in the use of cells and tissues: (i) banks for human corporal material (BHCM), (ii) intermediate structures (IS), (iii) production establishments (PE) and (iv) biobanks (BB) . In view of the bill's purpose, such organisations will need to be officially accredited and obtain a positive opinion from an ethics committee in order to operate.
In general, the bill aims to safeguard the permanence, confidentiality, security, quality and traceability of human corporal material. In this respect, the bill creates four different types of bodies, each playing a role in the use of cells and tissues: (i) banks for human corporal material (BHCM), (ii) intermediatestructures (IS), (iii) production establishments (PE) and (iv) biobanks (BB) . In view of the bill's purpose, such organisations will need to be officially accredited and obtain a positive opinion from an ethics committee in order to operate.
Human corporal material shall be extracted at certified hospitals by medical doctors. Once extracted, the material shall be collected by a BHCM, which shall be operated by a certified hospital and will further monitor use of the human corporal material. The import and export of human corporal material are restricted to BHCMs or PEs for the industrial production of advanced therapy medicinal products (ATMPs), including somatic cellular therapy, gene therapy and tissue engineering products.
In general, only BHCMs and intermediary structures (in collaboration with a BCHM) will be entitled to process, preserve, store and distribute cells and tissues for further use, such as the preparation of medicinal products including cellular therapy products or vaccines.
Production establishments or PEs can perform almost all operations (excluding testing) with regard to the industrial production of products related to ATMPs, without the approval of a BHCM being required, provided such use is exclusively autologous. The production of advanced therapy allogenic medical products is thus excluded for the time being.
The biobanks’ role, although still unclear, is to stock and make available human corporal material for scientific research without any direct human application. This role and the conditions for establishment (as well as for the other organisations) will be clarified in future royal decrees.
The bill further provides that no material benefits, other than to cover costs, can be given or advertising made with regard to, respectively, the donation and extraction of human corporal material.
Donor consent and information
The bill contains a detailed set of rules on donor consent and information.
The bill also regulates the secondary use of cells and tissues, i.e. use which differs from that originally agreed by the donor. Normally, a favourable opinion of an ethics committee and the donor's consent are required in this respect, except for research using residual human corporal material collected to diagnose or treat the donor. In that case, the donor need only be informed beforehand.
No delayed use
Finally, the bill prohibits the keeping of cells and tissues for future autologous use, unless it can be demonstrated that the cells and tissues can be used to treat an existing pathology which the recipient is at a particularly high risk of developing or if the cells and tissues are put at the disposal of the community in order to satisfy a proven need and are registered.
Entry into Force
The bill is scheduled to enter into force on a date to be determined by the king but, in any event, no later than 14 July 2009. Until that time, royal decrees further implementing certain provisions of the bill will be passed. During the parliamentary discussions, Minister of Health Onkelinx promised that members of Parliament would have an opportunity to be heard during the drafting of these decrees. Interested parties are advised to follow this matter closely.
Finally, it should be kept in mind that, as from 30 December 2008, any new ATMP as well as all intermediate structures and production establishments must comply with the provisions of Community Regulation 1394/2007 of 13 November 2007 on advanced therapy medicinal products.