Pharmacogenetics--legal, ethical and regulatory considerations.

The overall objective of pharmacogenetics is to determine the genetic basis of variability in drug efficacy and safety, and to use this information to benefit the patient. Genetics can be used to develop drugs that are suitable for the majority of patients and to help identify those patients for whom a certain drug may not be the most appropriate. This review will cover some background to pharmacogenetics and various issues including confidentiality, data protection, coding of samples and genetic data, informed consent, and drug development guidelines. International, national and regional variation in the legal and regulatory basis for pharmacogenetics presents challenges for researchers attempting to increase scientific understanding in the field. Examples of national and international regulations and guidelines will be given. It is clear that pharmacogenetics today is a long way from the 'personalised medicine' advocated by some individuals in recent years. The aim of pharmacogenetic research should always be to make sure that patients have the best treatment available and that patients are not exposed to drugs to which they are genetically unable to respond. This vision must continue to inspire researchers and regulators who are working together to make it a widespread reality.

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