The regulation of biobanks in Spain.
On 3 July 2007 the Spanish parliament approved the Biomedical Research Act. This article discusses the provisions of the Biomedical Research Act that are directly relevant for the regulatory framework of biobanks in Spain. This means that we are not only interested in the procedural and administrative dispositions governing biobanks. Our main preoccupation relates to the substantial provisions governing the collection, the research use and the conservation of biological samples. Our contribution starts in the second part with a brief description of the definition of "biobank" in the Spanish Act. Subsequently, in the third part, we deal extensively with the legal conditions for the collection, use and conservation of biological samples and accompanying data for biomedical research purposes. In the fourth part we examine the specific legal framework of research biobanks in Spain, with a special focus on the source's right to know or not to know, his right to privacy and his right to non-discrimination. A discussion of the main characteristics of the Act and some conclusions finalise this article. In stead of summarising these conclusions in our own words, we prefer to cite the legislator who stated in the preamble to the Act the following: "The regulation on the obtaining, conservation, use and assignment of biological samples is likewise object of a detailed regulation. As is logical, the legal framework turns once again on the consent of the source of the samples and on the previous information that must be provided to this respect. In so far as the disjunctive on the possibility to grant a completely generic or a specific consent on the use or latter uses of the sample, the Law has chosen an intermediate and flexible regulation, in that the initial consent may provide coverage, if in the information previously provided to the subject source there has been a provision about later researches related with the initial, including the researches that may be undertaken by third parties and the assignment of the data or of identified or identifiable samples to them".
Nys
Herman
H
Centre of Biomedical Ethics and Law, Catholic University of Leuven, Leuven, Belgium. herman.nys@med.kuleuven.be
Fobelets
Geraldine
G