Legislator Huang Guoshu (left) questioned that Academia Sinica's "Taiwan Precision Medicine Plan" may not comply with relevant laws and regulations, leading to the risk of leakage of medical records and genetic information of Chinese people.

(Provided by Huang Guoshu's office)

[Reporter Chen Zhengyu/Taipei Report] In response to the commercial technology transfer of the "Taiwan Precision Medicine Initiative (TPMI)" of the Institute of Biomedical Sciences of the Academia Sinica, non-party legislator Huang Guoshu pointed out today (10) that the plan covers the genetic data of 600,000 Chinese people , but there are five legal doubts. If the human genetic data is not handled carefully, it is more likely to generate national security concerns. We call on the Ministry of Health and Welfare and Academia Sinica to understand it thoroughly.

Whether it violates the relevant laws and regulations of genetic research, clarify the dispute as soon as possible and do a good job in the security protection of genetic data.

Huang Guoshu held a press conference with lawyer Chen Weixiang today. He pointed out that with the advancement of genetic technology in recent years, genetic data not only has huge commercial benefits, but also has an impact on national security. All countries have strengthened the protection of their own genetic data.

As far as Taiwan is concerned, any collection of human body specimens, derivatives, or related data for medical research and other purposes shall be in accordance with the "Regulations on the Administration of Human Biological Databases", obtain the consent of the provider, and include them in the National Human Biological Database for storage , and the approval of medical equipment shall apply for permission in accordance with the "Medical Equipment Management Law".

Please read on...

Based on this, Huang Guoshu questioned that the "Taiwan Precision Medicine Plan" presided over by Guo Peien, director of the Institute of Biomedical Sciences of the Academia Sinica in 2019, may not comply with relevant laws and regulations, leading to the risk of leakage of medical records and genetic information of Chinese people.

First, have the participants signed the "Human Biological Database Participant Consent" and the right to withdraw has been obtained in accordance with the law?

Second, has nearly 600,000 huge genetic and clinical data been applied to set up a biological database for storage and use in accordance with the regulations?

Program host Guo Peien may have a backup at the same time, is it legal?

He said that thirdly, although the project is of an academic research nature, the genetic testing chips and instruments used, without the permission of the competent authority, provided the test reports for clinical use, and let patients download and use them. people at medical risk?

Does the Ministry of Health and Welfare know about it?

Fourth, genetic and clinical data have not actually been de-identified, let alone de-linked. Is there a risk of breaking the law?

Fifth, does the project accept funding from foreign companies?

Is it possible that the leakage of human genetic data may lead to national security risks?

Chen Weixiang added that the genetic data project is full of many possibilities and unknowns, causing huge harm and creating huge commercial benefits. The whole world is also alert to the fact that genetic data involves national security and competition for commercial interests. This has become an international consensus, and these data are increasingly protected , but the country is relatively backward in this respect.

Such information should comply with the "Regulations on the Management of Human Biological Databases" to apply for establishment, use and storage. However, the program not only obtains blood samples from participants, but the database also contains medical records. Observing foreign experience, these two Data is in an unregulated database.

Chen Weixiang also emphasized that the consent of the participants should be obtained first. In particular, the implied huge commercial interests must be informed. In the future, patents may be applied for through research and development. Do you want to give back to the participants?

Or simply as a research object?

If the participant wants to withdraw midway, he must also inform him of his right to withdraw.