- To identify the current ethical, legal, and social issues associated with pharmacogenomics and pharmacogenomic testing.
- To understand how genetic discrimination, stigmatization, and privacy and confidentiality impact the implementation of pharmacogenomic testing into clinical practice.
- To understand the legal issues involving pharmacogenomic testing regarding the ownership of data and/or samples and intellectual property.
- To develop a knowledge base involving pharmacogenomic core competencies.
On completion of the Human Genome Project in 2003, the field of pharmacogenetics and/or pharmacogenomics has rapidly developed with the intent of clinical application on individualizing therapy to maximize efficacy and/or minimize toxicity. There are numerous challenges and barriers that impact the implementation of pharmacogenomics into clinical practice. These include ethical, legal, and social issues that highlight risk, benefit, and public and professional acceptance.1 Attempts to establish a framework of accelerating integration of appropriate pharmacogenomic and human genome discoveries into clinical practice have been reported.2,3 Haddow and Palomaki4 first reported the ACCE model for evaluating data on genetic tests. ACCE that takes its name from the four main criteria for evaluating a genetic test—analytic validity, clinical validity, clinical utility, and associated ethical, legal, and social implications—is a model process that includes collecting, evaluating, interpreting, and reporting data about DNA (and related) testing for disorders with a genetic component in a format that allows policy makers to have access to up-to-date and reliable information for decision making. One of the major components for evaluation includes the associated ethical, legal, and social implications. The authors identified challenges and barriers to genetic testing including genetic discrimination, stigmatization, privacy/confidentiality, and personal/family social issues. Additional challenges highlighted legal issues regarding consent, ownership of data and/or samples, patents, licensing, disclosure obligations, and reporting requirements. Although the ethical, legal, and social issues revolve around establishing safeguards in the context of genetic testing, these components are applicable to pharmacogenomic testing.5–7 Several examples in this chapter will highlight these issues in relation to genetic testing to aid in the understanding of specific concepts and application. The purpose of this chapter is to provide a framework of the ethical, legal, and social issues surrounding the rapidly evolving field of pharmacogenomics.
Individuals who obtain pharmacogenomic and/or genetic testing may be exposed to genetic discrimination. Genetic discrimination refers to when an individual, with a known genetic disorder or genetic polymorphism, is treated differently by his or her employer or insurance company.8 Knowledge of genetic and/or pharmacogenomic information may be used to deny, limit, or cancel health insurance. There is suggestion that health insurers should have limited access to such information. Insurers would be able to use pharmacogenomic information for drug formulary management, but should be prohibited from using the same information in determining copayments or premiums, or negotiating contracts.9 Additional concerns regarding genetic discrimination include employers using such information to only employ or retain individuals who do not have the genetic disorder or genetic polymorphism, ...