The Law and Ethics of Belgian Biobanking: A Reversal for the Logic of Regulation?

On 19 January 2009 the The Belgian Bioethics Consultative Committee published its Opinion No 45 on the banking of human biological materials used for research. In an apparent reversal of the usual regulatory chronology, the 2009 Opinion was preceded one month earlier by the equivalent Belgian law on the procurement and use of biological materials.This article discusses both the 2008 Act and the 2009 Opinion in the light of current biobanking practice in other countries. For the sake of comparison, we believe that a short comment on Belgian law is worthwhile not just in itself, but also because of the strange interplay between the relevant regulatory stakeholders: first the lawmaker regulated, and then the Bioethics Committee delivered its Opinion. Should it not be the other way around?

The Belgian legislature passed a relatively liberal Act that was then followed by the Bioethics Committee's Opinion, which apparently questioned some of the choices made by the parliament. The 2009 Opinion offers no unified answers but lists diverging viewpoints on sensitive topics. It thus illustrates the various factions that exist with regard to the general ethical questions existent in the biobanking debate, but at the same time raises a pertinent question: what is the value of an ethical opinion that offers several answers to one question? It is noteworthy that similar opinions rendered by other ethical committees of European Member States employ different language, and each adopts their own, single and unified view.

In this contribution, we will examine the Belgian approach by analysing the 2008 Act and the 2009 Opinion, focusing on specific areas: the role of local ethics committees; access and the right to know; property rights and commercialisation; and consent. However, we will first lay the foundation for understanding these debates by looking into the definition and legal framework surrounding biobanking.