Provenance and risk in transfer of biological materials.

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

Access to tangible research materials in biomedical research: conditions of access and their effect on research.

Biomedical discoveries often provide the basic tools for research. Such discoveries may be patentable or non-patentable products or processes, as well as the materials necessary for further research. Without rapid access to these materials on reasonable terms, there is concern that the progress of science will suffer. In 1995, the National Institutes of Health in the United States published a Master Uniform Biomaterial Transfer Agreement (UBMTA) to improve access to biomedical materials. Guidelines for transfers were published in 1999. This article analyses a survey that the author conducted in the Faculty of Medicine, Nursing and Health Science, Monash University. It observes that a significant minority of respondents experience frustration and/or adverse effects upon their research as a result of restrictions imposed upon their access to materials. It concludes that the extensive experience and precedent material in the United States provides an immediate resource to help improve access to biological materials in Australian universities.