Pharma In Brief - Overview Of Select Legal Issues Facing The Future Of Personalized Medicine


In the last decade, the expansion of research in genetics, genomics and other personalized healthcare approaches has allowed physicians to customize medical treatment according to patients' genetical, anatomical and physiological characteristics, their environment and their interactions with such environment. While the evolution of "personalized medicine" will continue to be influenced by developments in science, its commercial success will largely depend upon the legislative framework governing such treatments, and more particularly the regulation over: the concept of "medically required services", the protection of personal information, the administration of medical files, the communication of genetic information, genetic testing, genetic discrimination and insurance contracts. Keeping in mind the tremendous significance and complexity of this topic, this article intends to provide a brief introduction to some legal issues pertaining to genetic testing, privacy and human rights issues associated with genetic information.

Genetic tests

One concern raised by genetic tests is that at-home test kits are neither prohibited by nor subject to federal regulation. Accordingly, patients can purchase such kits online and undertake - without supervision or assistance - tests that could reveal sensitive information regarding their health. While some may attempt to interpret their own test results (giving rise to the risk of misinterpretation), others wishing to have a better understanding could consult a physician. Such consultations could then lead to various duties on the physicians' part, for example, to provide the medical follow-up required by the patient's condition. However, due to the potential dubious quality of unregulated tests (and results), the duty to provide assistance and follow up could be difficult for physicians to determine.

Another concern raised by genetic tests concerns the ability for patients to control the information added to their medical records, once the results of these tests are analysed by a physician. Canadian law generally provides that patients may request the rectification of their medical file if the information contained therein is inexact, incomplete, ambiguous, outdated or unjustified. Provided that the genetic test information is accurate, and is in fact included in the patient's medical record, a patient will not be able to request the removal of all (or part) of such information. Likewise, medical...

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