Release date: 2016-07-05
One thousand
Such a future world is described in the sci-fi movie Gattaca, which was released in 1997:
In the near future, human beings are bred by artificial matching genes to eliminate bad genes. People born without artificial screening of genes are considered "patients." The potential of a person is determined from birth and will be tailored to suit the potential of the gene. The protagonist is the so-called "patient" who pretends to be the genetic identity of elite members in order to participate in the Gattaca company's space program.
The future described in "Millennium" is close at hand, and the commercial use of gene sequencing has been rolled out. It can even be said that the future in the movie has arrived.
In fact, research on genetic sequencing that may lead to legal and social problems has been proposed as early as the completion of the Human Genome Project. Professor Wang Qian, who is well-known in the field of intellectual property, was the title of "Digital Discrimination" and its Legal Countermeasures.
Now, the cost of gene sequencing is getting lower and lower, not even more expensive than a physical examination, and has reached a level that the public can afford. In the United States, companies like 23andMe provide individual genetic sequencing services that can determine a person's ethnic origin information, health risks, genetic disease information, and athletic talent. In China, companies like WeGenge, Gene Cat, and 360 Gene provide similar services, and even WeGenge can support the import of 23andMe data. Therefore, gene sequencing has become a pressing legal and social issue.
Restricted gene sequencing
In the United States, the Food and Drug Administration once banned gene sequencing company 23andMe in 2013 to conduct consumer-oriented gene sequencing services. The FDA believes that because 23andMe provides medical equipment, it is subject to FDA supervision before listing. In December 2015, the FDA agreed that 23andMe will directly conduct gene sequencing services for consumers without the doctor's consent.
In 2014, the China Food and Drug Administration and the Health Planning Commission jointly issued the “Notice on Strengthening the Management of Products and Technologies Related to Clinical Use of Gene Sequencingâ€, which restricted the use of products and technologies for gene sequencing in clinical practice, although Gene sequencing technology belongs to the field of contemporary cutting-edge products and technologies, but it believes that this technology involves "ethics, privacy and protection of human genetic resources, biosafety, and medical institutions to carry out genetic diagnosis service technology management, price, quality supervision and other issues."
Therefore, in the notice, it is required that the genetic sequencing diagnostic products belong to medical device products, and the genetic sequencing diagnostic products should be registered in accordance with the relevant regulations of the Medical Device Supervision and Administration Regulations. The prevention, diagnosis, monitoring, treatment monitoring, health status evaluation and hereditary disease predictions for diseases are subject to approval by the food and drug regulatory authorities and approved by the health and family planning administrative department for technical access. The Notice also establishes a regulatory correspondence:
"Medical Device Registration Management Measures" - clinically detected gene sequencer, diagnostic software products
"In vitro diagnostic reagent registration management method (trial)" - related in vitro diagnostic reagents
Medical Device Clinical Trial Regulations - Conduct clinical trials in medical institutions for application for product registration
According to the experience provided by Dacheng Law Firm, there are often two ways for domestic enterprises to carry out genetic sequencing services:
According to the "Notice" of the Food and Drug Administration and the Health Planning Commission, the clinical trials will be submitted. If approved, the business including non-invasive prenatal gene sequencing will be legally carried out.
Cooperate with foreign equipment manufacturers to apply for registration of new gene sequencing equipment to CFDA.
Southern Weekend quoted the relevant person's point of view: "If the government department only regulates the product registration of the genetic enterprise in accordance with the Regulations on the Supervision and Administration of Medical Devices and the registration of related products, this is the simplest and most mechanical method, without considering genomic medicine. And the characteristics and status quo of the development of gene sequencing."
Whose gene?
Compared with the qualification problem of gene sequencing, a more difficult problem is the preservation, utilization and interpretation of gene sequencing results. In the final analysis, it is the "ownership" problem of gene sequencing results. This issue is important because it involves security risks, social risks, and legal risks.
For individuals, genetic information is a more personal identifier than the ID number (identity card and heavy number). The information contained in the ID card number is just the birthplace of the person, the date of birth, and the photo, which is enough to make the leakage of the ID card information a weapon that can sting the user's nerves. The personal information contained in the genetic information far exceeds the identity card information, and all the information is sensitive information. The value contained in it is self-evident, and of course it will be embarrassed by all parties.
The results of gene sequencing are stored in a storage device in the form of data. I don’t know about the use and sharing of data. Internet companies have been raging. Public comment and Baidu, Sina and the pulse are playing because of the user data. For more valuable genetic information, other parties will be stunned. Pharmaceutical companies, scientific research institutions, insurance companies, Internet companies, and hackers will all realize the value of genes and try to obtain them. The user corresponding to the genetic data, in the whole process of data use, transaction, and mining, basically has no right to speak and lacks control over the genetic data.
From a legal perspective, the ownership of genetic data is full of uncertainty. Taking the traditional medical record data as an example, the right to the medical record belongs to the doctor. The doctor as the employee of the hospital causes the medical record to belong to the job, and the content in the medical record is directly related to the privacy of the patient, and various rights are mixed. This is especially true for genetic information, which is an extremely sensitive issue for the processing and use of genetic information in the detection process. Even if the genetic sequencing service organization does not take the initiative to use the genetic data at hand, once a hacking incident occurs, it is enough to trap itself in the ocean of public opinion.
Wegene's privacy policy is:
The storage of genomic data is basically based on HIPAA rules, such as full-site HTTPS encryption, data access logs are stored separately from separate servers, genomic data and user information are stored separately, genomic data is stored in the cloud database, cloud storage and local backup multiple times, etc. .
Another gene sequencing company, the gene cat promises:
Gene cats use sophisticated technology to protect their genetic and personal information. Gene cats regularly check all safety systems. No third party will receive the user's genetic and personal information without the user's permission.
360 Gene Commitment:
The 360° gene uses sophisticated technology to protect the user's genetic and personal information. The 360° gene regularly checks all safety systems. No third party will receive the user's genetic and personal information without the user's permission.
To be frank, commitments like this don't have any credibility. I don't believe in the character of these business operators. I hope that companies with profit-oriented goals have a moral obligation.
curiosity
Human curiosity about our own destiny is our nature. We have pinned our hopes on such illusory methods as hand, constellation, and divination. We have also used psychological tests, even MBTI professional personality tests. This is all about understanding ourselves more objectively and comprehensively. At present, gene sequencing is the most scientific way to understand oneself, with a large amount of data and paper support.
I actually understand the various risks faced by gene sequencing, including the possibility that genetic information may be abused or leaked. The interpretation of genetic information may not be accurate, and even there may be a virus for editing specific genetic information. Risk (worrying people), but still can't stand the curiosity of myself, want to know more about their own characteristics, buy a genetic testing service, the process of testing is very simple, and soon after the payment, I received the testing kit - saliva The collector puts the saliva in it and sends it to the designated address. After more than a month, there will be a feedback test report.
Part of my genetic test results
From my experience, the impact on me after seeing the genetic test report is huge, even if I am mentally prepared:
Genetic testing is a scientific means of understanding oneself;
Interpretation of genetic test results has limitations;
Genes are only a part of the factors affecting traits, and the living environment and lifestyle will affect traits.
However, when I look at my own genetic test report, there is a feeling that my innate condition is so conclusive. Before reading the report, I will also imagine that I may be very good at one aspect, but I have not discovered it, and the test results will ruthlessly expose this fantasy. On the other hand, there will be a feeling that "I was still good at this thing." In addition, my test results show that I have “difficulty reading, general reading ability†and “not high reading abilityâ€. When I saw this paragraph, I found an excuse for not wanting to read the literature. I also felt that I could read the doctor’s all the way. It is really "the body is ruined by the mind" and "being against the sky".
The future has come
I once thought that perhaps at some point in the future, blind date, insurance, and job search need to provide their own genetic sequences, but never imagined that this is already a reality. Genetic testing companies have already reached a cooperation with marriage and love websites, "incorporating genetic testing into dating and dating, providing a more scientific and responsible mate selection method for singles, and improving the success rate of marriage and love matching." The world described by the film Gattaca It is already in sight.
The use of genetic testing reports will sooner or later spread like a flood. Once someone gains an advantage by providing genetic testing reports in the marriage and marriage market, the job market, and the insurance market, someone will follow. Once the demand side has tasted the "sweetness" brought about by the review of genetic testing reports, genetic testing will sooner or later be mandatory. Imagine that in the future, when people look for a job, they not only need to hold their resumes and degree certificates, but also have their own genetic test reports to prove that they are suitable for the job, such as “hard work†or “leadershipâ€. Gene (the name I edited). When looking for an object, you need to use genetics to prove that you have a "loyalty" gene (the name is still edited by me) and that there is no risk of genetic disease. When purchasing insurance, the rate is determined directly based on the genetic test report.
In this way, the consequences will surely be "genetic discrimination." We have seen too much discrimination, geographical discrimination, gender discrimination, academic discrimination... In the chain of discrimination, there is always one for you. In the genetic testing report, there is more content that can be discriminated against, even if the "three-point day is doomed, seven points rely on hard work", everyone knows. Of course, the use of genetic testing reports is reasonable in various activities, but the boundaries between rationality and discrimination still require legal delineation.
We are always curious about our own destiny. It is too easy, too easy, and tempting to predict our future through genetic testing reports rather than relying on self-struggling and considering historical processes. The cheapness of genetic testing allows genetic testing to enter the homes of ordinary people. It not only allows us to know ourselves more clearly, prevent disease risks, but also causes a series of changes in society to enter an era of unprecedented "knowing ourselves." Even the three ultimate questions of "Who am I?", "Where am I from", and "Where am I going?", genetic testing can provide answers.
Source: Tiger Sniff Network
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