(Mar. 2, 2010) Taiwan's President promulgated the Statute on Human Biological Database Management on February 3, 2010. (Statute for Human Body Biological Database Management, THE GAZETTE OF THE OFFICE OF THE PRESIDENT 34-44 (Feb. 3, 2010), http://content.glin.gov/summary/227862.) A major aim of the new law is to protect Taiwan citizens who provide biomedical samples, particularly in the wake of a “storm of protest” that arose in 2007 in response to a local hospital's use, without their consent, of saliva samples collected from an aboriginal community for research purposes. (Draft Bill for Human Biological Databases Approved, TAIWAN TODAY, July 17, 2009 [from the LIBERTY TIMES], available at http://taiwantoday.tw/ct.asp?xitem=55050&ctnode=445&mp=9.) Some highlights of the Statute are:
- Database operators are limited to government agencies, medical or academic institutions, research institutions, and legal persons, and they must be licensed by the authority in charge. That authority will also determine applicant qualifications, application procedures, conditions for licensing, and other matters (art. 4). Those who establish a database without a license are subject to fines of between NT$2 million and 10 million (about US$62,325 to $311,624) and will have their collected samples and data destroyed (art. 23).
- Database operators should establish an ethics committee of 9 to 15 persons, for examination and supervision of matters such as management of the database. At least half of the committee members must be legal experts, social workers, and other disinterested members of society; at least two-thirds should not be personnel of the organization itself (art. 5).
- Database operators must “inform participants of their rights and benefits, how the data may be collected, possible complications during data gathering and the possible impact the genetic information would have on participants and their communities” (art. 7). (Flora Wang, Political Donation Amendment Passes, TAIWAN TODAY, Jan. 8, 2010, at 4, available at http://www.taipeitimes.com/News/taiwan/archives/2010/01/08/2003462931.)
- Participants must be told relevant information in an understandable manner (e.g., the legal basis for establishment of the database and its content; the database operators; the reason why the participant was selected), this information is also set forth in a letter of consent, and data may be collected only after the participant's written consent has been obtained. Participants must be at least 20 years of age and must also have the capacity to act, with certain exceptions (arts. 6 & 7).
- For children aged seven or younger, data may only be collected with the consent of a parent or guardian; for those between seven and 20, the consent must be obtained from both the child and the guardian (art. 6).
- The genetic information providers can ask to stop providing biological samples, withdraw from participation, or change the scope of application of their consent, and the operators cannot refuse (art. 8).
- Operators must keep confidential all pieces of genetic information on the participants (art. 18).
- Biological samples in the database, with the exception of derivatives, may not be sent to other countries (art. 15).
- Database samples, derivatives, and related material and information can only be used for biomedical research, with the exception of medical research approved by the Ethics Committee and the outside select group of legal experts and others (art. 20). (Statute for Human Body Biological Database Management & Wang, supra.)
When legislators approved the law in early January 2010, they reportedly “also resolved to ban the judiciary from forcing operators to provide biological information for judicial purposes.” (Wang, supra, at 4; see also Making a Deposit in Taiwan Biobank: How Safe Are Your Secrets, TAIWAN PANORAMA, Jan. 2008, at 26, available at http://www.sino.gov.tw/en/show_issue.php?id=2008019701026E.TXT&cur_p