The recent sequencing of two human genomes exemplifies the current pace of development in the field of genomics. Newer technology is making it much cheaper and quicker to carry out this process, which raises the possibility that its use will eventually become more widespread by researchers, such that the genomes of consumers and patients may become readily available for sharing by means of a simple electronic transfer. Research into one’s genetic makeup can, among other things, reveal individual pre-disposition to various physical or mental conditions, aid in further correlating genotypes with traits, and give insight into new treatment options for current diseases. As is often the case with emerging industries, new regulations may be required by amending or supplementing current law. The issues of privacy and ownership of the massive amounts of data that are compiled will no doubt be at the core of a preliminary policy debate, since such information can be both extremely useful and personal.
Currently it is the standard practice that medical professionals own the records that they create and maintain, but that patients have the right to privacy and access to the data. Though on the surface one’s genotype may be seen as a mere extension of standard medical information, the scope of use of this type of information and its level of intimate disclosure are both to such a greater degree that they can be said to warrant special consideration. Medical records are typically governed by rules created by medical associations in compliance with the law, and they will naturally focus on providing patients quality health care, such as Policy #5-05 of the College of Physicians and Surgeons of Ontario. However, it is important to realize that the companies offering sequencing services are not traditional health care providers and those who obtain these services will not always be traditional patients. The data itself can have multiple purposes, such as for plain personal interest, large-scale social benefits, and pure economic gains, in addition to individual patient health care. Regulation of such a conglomerated industry may need to go beyond that of current statutes such as the Personal Information Protection and Electronic Documents Act of Canada.
Current forms of personal medical information about patients are traditionally used for studies of the efficacy of various treatments. Patient A with a particular blood-sugar level responds partially to a treatment for migraines, whereas Patient B with the same blood-sugar level responds poorly. The difficulty with making certain causal claims on the macroscopic level lies in the fact that the influence of all other pertinent conditions is sometimes impossible to take into account. A human genome can reveal a more reliable type of evidence about the likelihood of reaction to treatments. Thus, medical treatments can be much more personally tailored than they are today, and theoretically, much more successful. With the potential for such an approach, the right to keep information about one’s personal genome private may be outweighed. In an essay that appears in Nature, Harvard Medical School’s Patrick Taylor argues that perhaps even consent should not be required for a scientist to use a personal genome since it would hinder the advances of research aiming to help those suffering from disease.
As mentioned earlier, one’s genetic makeup has the potential to disclose intimate medical details since it is much more unique and personal to a specific individual. Current information in a patient’s medical record about cholesterol, blood pressure, and other standard medical data, may in fact add up to an overall medically defining picture, but it perhaps cannot be said to be as defined and detailed a picture as can be obtained by understanding that same patient’s genome. With information that is so much more related to a specific individual, it can be argued that the current social value placed on privacy will be heightened in this case. Additionally, personal genomes may not remain very anonymous, since according to Patrick Taylor, “translating genomic research into health care improvements will require linking genotypes with medical information that has long been considered private.” These implications suggest that stringent regulation should be put in place with respect to who is allowed to own genomic data and their rights as owners. However, another essay in Nature suggests that the industry should be allowed to develop first so that policy makers can first see how the information is actually being used before any regulations are put in place. This in fact may be the wisest way to go about regulation since there is currently no widespread sequencing of personal genomes. Premature controls can easily end up being too broad so as to unnecessarily prevent the benefits that can come about with this technology.
4 Responses
The development in genomics is very interesting. I agree with George that it is too early to start regulating the ownership and transfer of personal genomes. Early regulation could have a chilling effect on future research in that field. However, we should be cautious not to delay regulations since the impact on privacy, as George has pointed out, could be tremendous. Furthermore, this new research could have an important impact on hiring practices, for example. If the personal genome information is not regulated and could be freely transferred, employers might acquire such information. As a result, they might avoid hiring workers who have certain medical predisposition in order to keep down the medical benefits they pay to their employees. It will be interesting to see whether advances in genomics will add ‘personal genome’ as one of the analogous grounds in s.15 of the Charter.
I feel that the ramifications associated with the mishandling of massive amount of data on a person’s genetic makeup can be huge, for instance the employment and insurance related discrimination (as pointed out by Anna). I also acknowledge that the sequencing of genomes is a new territory, and premature controls can be too broad (as George pointed out). But it is the combiation of these two factors- potential significant negative consequences, and the newness of the nature of developments in the field, that compells me to seek some kind of regulation in this field. I belive that it will be a lot more comforting to know that my genetic makeup information is safe and cannot be used against me negatively, at least relatively than having no regulation in place at all. It has been pointed out that the currently existing regulations are not enough, and so I think what is required is some foresight, in addition to some inspiration from the past experiences, on the behalf of the policy makers to start the process of drafting regulations in this field before it is too late.
Ryan Calo has a very interesting post regarding the privacy policies of companies in the consumer genomics industry here: http://cyberlaw.stanford.edu/node/5922
It appears that at least one company, Navigenics, has committed in their privacy policy online to use reasonable efforts to limit the scope of any disclosure they make in response to court orders, requests for information, etc.
I agree with both of you, Anna and Reshika, that we should avoid moving toward a society where knowledge of our genome dictates what we’re allowed to do, as depicted in the movie Gattaca (which I highly suggest you see if you haven’t already done so). This summer the U.S. passed the Genetics Information Nondiscrimination Act (see: http://www.genome.gov/10002328), which prevents employers and insurance companies from using genetic information to predict their chances of getting diseases in order to make decisions on offers. After a quick search I couldn’t find any Canadian statutes of a similar nature.
But leave aside for now the issue of how one’s personal genome can be misused. I think that having one lose their privacy and anonymity, with respect to their genetic information, is a major issue on its own, even if this information could not be used against then. The article that Rex pointed out is somewhat promising, but the fact that the information from these genome banks can still potentially be handed over to authorities by a court order, despite their internal policies, is a bit concerning. I’m also skeptical that all companies within this industry will have a similar privacy policy as Navigenic, and the ones that currently do won’t ever sell out.
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