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 Sequencing”, 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. .

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