Abstract
In order to ensure that the Biobank management and operation are confirmed to ethical, legal and social implications (ELSI), appropriate strategies have been established in different countries, including contractual agreements, or enacting laws which is specifically for Biobank. In Taiwan, The Human Biobank Management Act (Biobank act), enacted in 2010, was designed to suggest governances for “Taiwan Biobank”, which is subordinate to Academia Sinica. However, the Biobank act was later applied to biobanks which are satisfied to Biobank act. Is it suitable that the regulation framework originally for single biobank to expand the scope to all objects? For the application of Human Biobank Management Act to Biobanks, there are discussions about poorly defined, resulting in that the institutes which collect biological specimen and related data are difficult to avoid falling within the scope of control. In addition, we were adopted to strict regulatory standards, is it appropriate and will it cause any impacts？Further discussion is expected for improving the situation. This article will firstly clarify the management scope of Human Biobank Management Act in Taiwan, and compare the biobank definition and management of the countries which are also through enacting law, including Iceland, Norway and Estonia. In general, there are typical biobanks that is suitable for traditional biobank act. However, there are also atypical biobanks, which meet the definition but legislators are reluctantly to administrate, which might cause doubts in application. In addition, are the policies that biological specimens would not be exported, and biological specimens which not meet the definition should be destroyed appropriate? Will it cause any impact to the institutions which collect biological specimens and information? Secondly, this article will analysis the definition and policies of Human Biobank Management Act through principle of clarity and definition of law, principle of proportionality and principle of equality. To sum up, examples from other countries and consider of the actual situation in Taiwan, we try to offer adjusted direction and suggestions by clarifying the scope, rationalization of regulations and hierarchization of regulations.