The pharmaceutical industry is making increasing use of human genetic databases created by the integration of genetic data obtained from human biological material and other data, such as personal lifestyle and medical information, in order to study the relationship between genes and disease. The chapter examines the several methods that pharmaceutical companies use to access human tissue samples and related genetic information (commonly known as genetic databases) and assesses the size and extent of such activity. It also explores the reasons why the industry is interested in tissue collections and genetic information and why investment in human biological material and related bioinformatics products has been expanding dramatically and is likely to continue to do so.
Four models of pharmaceutical industry access are identified: "in-house"
collections established by drug companies themselves; the use of corporate intermediaries in the form of clinical genomics companies; collaborations with existing public collections, such as hospital pathology collections, and other, research-based, tissue banks; and industry use of newly built public collections incorporating public health records and other personal information, such as the UK Biobank, the Icelandic Health Sector Database, and similar initiatives in other countries.
The second of these routes, access via clinical genomics companies, is the most significant at this point in time, apart from pharmaceutical companies' own internal efforts at building genetic databases, and the activities of a number of such companies are discussed. Two other important trends examined are the commercialisation of existing public collections, often through academic-industry collaborations; and the creation of new national biobanks - large population-based collections that incorporate well-defined samples and related patient information obtained through health care delivery systems. The chapter concludes with a brief discussion of the policy issues raised by these various developments.
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