The impact of human gene patents on genetic testing in the United Kingdom.

Purpose: This article reports the results of an empirical study examining the impact of human gene patents on the development and delivery of genetic tests in the public sector in the United Kingdom.

Methods: Semi-structured qualitative interviews.

Results: The study found that, despite the potential for gene patents to have significant negative consequences for genetic testing, in fact, human gene patents have little or no impact on practice for those developing genetic tests in the public sector in the United Kingdom. This is not because patents are managed optimally; rather, gene patents are essentially ignored. This article reports the factors that motivate this behavior.

Conclusions: At least insofar as there seems to be no apparent problem of lack of patient access, there is no significant public health problem. However, there is divergence between the legal and the practical situation. Complacency about the lack of impact of patents on access to diagnostics is risky, and concerns about patents should be addressed proactively, rather than reactively.