The Biotechnology Industry Organization developed Guidelines for BIO Members Engaging in Bioprospecting (Guidelines) in 2005 to educate BIO Members about the relevant issues that could arise in the conduct of bioprospecting activities and to provide assistance to those Members seeking guidance.
These Guidelines envisioned that BIO Members would enter into a “Bioprospecting Agreement” before collecting physical samples of “regulated genetic resources” in situ or accessing such resources maintained ex situ. That Agreement would include the grant of prior informed consent as well as enumerate the terms and conditions governing the collection and use of the regulated genetic resources including benefit-sharing. Depending on the manner of collection, the Agreement could also include provisions that would transfer the collected physical samples of regulated genetic resources from the Providing Party to the BIO Member. Alternatively, a separate agreement to transfer the regulated genetic resources could be concluded after the physical samples were identified or collected.