Millions of human biological samples and associated data are collected each
year for a variety of purposes. These purposes may include basic research, clinical
trials and epidemiological studies. The legal framework that determines access to
biobanks remains presently unclear. The absence of a defined set of applicable rules on
international, European and national level creates legal uncertainty for biobanks and
applicants. This chapter reports on four studies concerning the legal structure
applicable to “Access to Biobanks”. The first study consisted of a comparative analysis
of access arrangements of organizations, biobank networks and biorepositories. The
second study included interviews to gather qualitative data on the different perspectives
held by stakeholders and experts in relation to the rights and obligations of custodians
and applicants with respect to access to HBM and data stored in biobanks. The third
study focused on the analysis of the legal framework applicable to access to biobanks.
The final study (four) analysed the intellectual property rights (IPRs) in biobanking and
the return and sharing of research results. These studies allowed us to formulate
recommendations on the improvement of the legal framework applicable to public and
private biobanks.
Keywords: Access, Biobank, Custodianship, Intellectual property, Legal
framework.