Biobanks as a Tissue and Information Semicommons: Balancing Interests for Personalized Medicine, Tissue Donors and the Public Health

- J. Health Care L. & Pol'y
Author/s: -Gatter, Ken
Journal: J. Health Care L. & Pol'y
Year: 2012
Volume: 15
Issue: 303
Pages: 303-348
Start Page: 303
Abstract:

Personalized medicine’s promise is tantalizing. Match a patient’s specific genetic characteristics with a specific therapeutic intervention and people will be treated more effectively and with fewer side effects. It is the future of medicine, and medical centers, pharmaceutical companies and others are heavily investing in the promise. Critical to realizing this promise is patient tissue and the information derived from patient tissue. Tissue information is essential for research and for routine clinical care in personalized medicine. The most valuable tissue, whether in the research or clinical setting, includes treatment and outcomes information. Tissue also increases in value as it becomes part of a larger collection and benefits increase with collection size. The most valuable tissue collections have large sample numbers, which allow greater statistically power. Unlike tissue repositories in the past, biobanks are more than archived remnants of excised human tissue. They are organized, searchable, data rich entities that, like commercial banks, make lending decisions to qualified researchers or organizations.

Biobanking has a green light, but it is forging ahead with many unsettled ethical and legal issues associated with the collection, maintenance, control and use of tissue and the information derived from tissue. This essay will examine the advantages and shortcomings of the current state of legal rights describing human tissue, and then offer a new way that better recognizes the distinction and interdependence of tissue and tissue information, while balancing important interests and maintaining incentives to realize the potential of personalized medicine. The new way begins by recognizing the unique attributes of human tissue, namely its similarity to clinical health information, and continues, with the help of Henry Smith’s and Michael Heller’s work, by examining and describing biobanks as a liberal semi-commons.