Genetic information is set to come under the protection of privacy legislation in Japan, but fears have been raised that this move alone won't keep the information secure. At the same time, there are concerns that overbearing regulations could hamper research efforts.
Not only does genetic information reveal a person's vulnerability to certain diseases, it can also reveal bodily characteristics and how effective medicines would be on a person, as well as information about their offspring. Some fear that genetic data -- dubbed the "ultimate personal information"-- could be used to discriminate against people when deciding on whether to employ them or admit them into an insurance policy.
Genetic data is basically a list of the four bases making up a person's DNA. Human cells contain around 3 billion base pairs, and with current technology a person cannot be identified just from how their bases line up.
Japan's Act on the Protection of Personal Information currently puts a person's genetic information under its protection only if it is paired with identifying information like that person's name or address; there are no clear rules within the act on how to handle genetic information by itself.
In September last year, a revised version of the act was passed, to go in effect within two years. Although this revision does not specifically cover genetic data separated from identifying information, a government task force on genomic therapy chaired by Tsuguya Fukui, head of St. Luke's International Hospital, decided at the end of last year to regulate such data under a government ordinance.
The revised act provides a new classification for identifying sequences of letters and symbols, such as the new social security and tax number, or "My Number," describing them as "individual identification symbols." It also defines delicate information like race and illness histories as "personal information requiring care," which is not allowed to be passed on to third parties or to have the purpose of its use changed without an individual's consent.
The task force categorized the order of a person's DNA bases as "genomic data," and base order coupled with analyzed information as "genomic information." Genes able to be inherited were labeled by the group as "genetic information."
The task force further classified "genomic data" as "individual identification symbols," while both "genomic information" and "genetic information" were classified as "personal information requiring care" -- making all three types subject to regulations.
Expectations for individual genomic therapy and the growth of industries using genomic information have played a part in the government's formulation of new rules on the handling of genetic information. Rules are also being determined in the European Union, and to facilitate the smooth exchange of information with foreign research institutions, Japan must draw clear lines on how it handles such data.
Furthermore, with a jump in the number of gene testing businesses, which provide health and dieting services, there is a need to keep the genetic data they collect from being misused.
Naoya Bessho, head director of the Council for Protection of Individual Genetic Information, to which powerful players in the genetic testing business belong, comments, "When forming contracts, businesses usually obtain agreements that allow (gene) information to be passed on to third parties. There won't be any big problems (under the new regulations.)"
There are almost 1,000 gene therapy-related firms in Japan, including businesses that introduce customers to foreign gene therapy services. Some form contracts with their clients after nothing more than an online explanation. Criticism has been raised that if all that matters is obtaining consent, the new regulations are meaningless.
At the same time, there are concerns that the regulations could stand in the way of research on intractable diseases. Universities and other research institutions currently collect gene information at "bio banks" for medical treatment purposes. Advanced research will be exempted from the regulations, but researchers including professor Kazuto Kato of Osaka University and associate professor Shigeto Yonemura of the University of Tokyo warn that the regulations could prevent the use of previously collected genetic data in joint industrial-academic research, as well as in research at private hospitals. They have suggested reducing the scope of the types of data marked as "requiring care."
Rules governing partial sequences of genomic data or genomic information have yet to be decided in closed meetings of the Personal Information Protection Commission, a third-party organization formed this month, so many such details remain unclear.
Criticism has been raised from within the task force formulating the new regulations that too little time has been spent on debate, and that regulations should be made through a special law, not through a government ordinance.
Due to the large potential impact of the regulations, the government will likely come under pressure to provide a simple and clear explanation to the public.