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Taiwan's Approach to AI Governance

Taiwan's Approach to AI Governance

2024/06/19

In an era where artificial intelligence (AI) reshapes every facet of life, governance plays a pivotal role in harnessing its benefits while mitigating associated risks. Taiwan, recognizing the dual-edged nature of AI, has embarked on a comprehensive strategy to ensure its development is both ethical and effective. This article delves into Taiwan's AI governance framework, exploring its strategic pillars, regulatory milestones, and future directions.

I. Taiwan's AI Governance Vision: Taiwan AI Action Plan 2.0

Taiwan has long viewed AI as a transformative force that must be guided with a careful balance of innovation and regulation. With the advent of technologies capable of influencing democracy, privacy, and social stability, Taiwan's approach is rooted in human-centric values. The nation's strategy is aligned with global movements towards responsible AI, drawing lessons from international standards like those set by the European Union's Artificial Intelligence Act.

The "Taiwan AI Action Plan 2.0" is the cornerstone of this strategy. It is a multi-faceted plan designed to boost Taiwan's AI capabilities through five key components:

1. Talent Development: Enhancing the quality and quantity of AI professionals while improving public AI literacy through targeted education and training initiatives.

2. Technological and Industrial Advancement: Focusing on critical AI technologies and applications to foster industrial growth and creating the Trustworthy AI Dialogue Engine (TAIDE) that communicates in Traditional Chinese.

3. Supportive Infrastructure: Establishing robust AI governance infrastructure to facilitate industry and governmental regulation, and to foster compliance with international standards.

4. International Collaboration: Expanding Taiwan's role in international AI forums, such as the Global Partnership on AI (GPAI), to collaborate on developing trustworthy AI practices.

5. Societal and Humanitarian Engagement: Utilizing AI to tackle pressing societal challenges like labor shortages, an aging population, and environmental sustainability.

II. Guidance-before-legislation

To facilitate a gradual adaptation to the evolving legal landscape of artificial intelligence and maintain flexibility in governance, Taiwan employs a "guidance-before-legislation" approach. This strategy prioritizes the rollout of non-binding guidelines as an initial step, allowing agencies to adjust before any formal legislation is enacted as needed.

Taiwan adopts a proactive approach in AI governance, facilitated by the Executive Yuan. This method involves consistent inter-departmental collaborations to create a unified regulatory landscape. Each ministry is actively formulating and refining guidelines to address the specific challenges and opportunities presented by AI within their areas of responsibility, spanning finance, healthcare, transportation, and cultural sectors.

III. Next step: Artificial Intelligence Basic Act

The drafting of the "Basic Law on Artificial Intelligence," anticipated for legislative review in 2024, marks a significant step towards codifying Taiwan’s AI governance. Built on seven foundational principles—transparency, privacy, autonomy, fairness, cybersecurity, sustainable development, and accountability—this law will serve as the backbone for all AI-related activities and developments in Taiwan.

By establishing rigorous standards and evaluation mechanisms, this law will not only govern but also guide the ethical deployment of AI technologies, ensuring that they are beneficial and safe for all.

IV. Conclusion

As AI continues to evolve, the need for robust governance frameworks becomes increasingly critical. Taiwan is setting a global standard for AI governance that is both ethical and effective. Through legislation, active international cooperation, and a steadfast commitment to human-centric values, Taiwan is shaping a future where AI technology not only thrives but also aligns seamlessly with societal norms and values.

※Taiwan's Approach to AI Governance,STLI, https://stli.iii.org.tw//en/article-detail.aspx?no=105&tp=2&i=168&d=9199 (Date:2025/03/20)
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Tsai, Yi-Jen
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Release： 2024/07
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Previous After the European Union's Artificial Intelligence Law, the draft of AI Basic Law is announced in Taiwan. Next Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials
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Research on Policies for building a digital nation in Recent Years (2016-2017)

Research on Policies for building a digital nation in Recent Years (2016-2017) 　　Recent years, the government has already made some proactive actions, including some policies and initiatives, to enable development in the digital economy and fulfill the vision of Digital Nation. Those actions are as follows: 1. CREATING THE “FOOD CLOUD” FOR FOOD SAFETY CONTROLS 　　Government agencies have joined forces to create an integrated “food cloud” application that quickly alerts authorities to food safety risks and allows for faster tracing of products and ingredients. The effort to create the cloud was spearheaded by the Executive Yuan’s Office of Food Safety under the leadership of Vice Premier Chang San-cheng on January 12, 2016. 　　The “food cloud” application links five core systems (registration, tracing, reporting, testing, and inspection) from the Ministry of Health and Welfare (MOHW) with eight systems from the Ministry of Finance, Ministry of Economic Affairs, Ministry of Education (MOE), Council of Agriculture and Environmental Protection Administration. 　　The application gathers shares and analyzes information in a methodical and systematic manner by employing big data technology. To ensure the data can flow properly across different agencies, the Office of Food Safety came up with several products not intended for human consumption and had the MOHW simulate the flow of those products under import, sale and supply chain distribution scenarios. The interministerial interface successfully analyzed the data and generated lists of food risks to help investigators focus on suspicious companies. 　　Based on these simulation results, the MOHW on September 2, 2015, established a food and drug intelligence center as a mechanism for managing food safety risks and crises on the national level. The technologies for big data management and mega data analysis will enable authorities to better manage food sources and protect consumer health. 　　In addition, food cloud systems established by individual government agencies are producing early results. The MOE, for instance, rolled out a school food ingredient registration platform in 2014, and by 2015 had implemented the system across 22 countries and cities at 6,000 schools supplying lunches for 4.5 million students. This platform, which made school lunch ingredients completely transparent, received the 2015 eAsia Award as international recognition for the use of information technology in ensuring food safety. 2. REVISING DIGITAL CONVERGENCE ACTS 　　On 2016 May 5th, the Executive Yuan Council approved the National Communications Commission's (NCC) proposals, drafts of “Broadcasting Terrestrial and Channel Service Suppliers Administration Act”, “Multichannel Cable Platform Service Administration Act”, “Telecommunications Service Suppliers Act”, “Telecommunications Infrastructure and Resources Administration Act”, “Electronic Communications Act”, also the five digital convergence laws. They will be sent to the Legislature for deliberation. But in the end, this version of five digital convergence bills did not pass by the Legislature. 　　However, later on, November 16, 2017, The Executive Yuan approved the new drafts of “Digital Communication Act” and the “Telecommunication Service Management Act”. 　　The “Digital Communication Act” and the “Telecommunication Service Management Act” focused summaries as follows: 　　1. The digital communication bill 　　A. Public consultation and participation. 　　B. The digital communication service provider ought to use internet resource reasonability and reveal network traffic control measures. 　　C. The digital communication service provider ought to reveal business information and Terms of Service. 　　D. The responsibility of the digital communication service provider. 　　2. The telecommunication service management bill 　　A. The telecommunication service management bill change to use registration system. 　　B. The general obligation of telecommunications to provide telecommunication service and the special obligation of Specific telecommunications. 　　C. Investment, giving, receiving and merging rules of the telecommunication service. 　　Telecommunications are optimism of relaxing rules and regulations, and wish it would infuse new life and energy into the market. Premier Lai instructed the National Communications Commission and other agencies to elucidate the contents of the two communication bills to all sectors of society, and communicate closely with lawmakers of all parties to build support for a quick passage of the bills. 3. FOCUSING ON ICT SECURITY TO BUILD DIGITAL COUNTRIES 　　Ｔhe development of ICT has brought convenience to life but often accompanied by the threat of illegal use, especially the crimes with the use of new technologies such as Internet techniques and has gradually become social security worries. Minor impacts may cause inconvenience to life while major impacts may lead to a breakdown of government functions and effects on national security. To enhance the capability of national security protection and to avoid the gap of national security, the Executive Yuan on August 1st 2016 has upgraded the Office of Information and Communication Security into the Agency of Information and Communication Security, a strategic center of R.O.C security work, integrating the mechanism of the whole government governance of information security, through specific responsibility, professionalism, designated persons and permanent organization to establish the security system, together with the relevant provisions of the law so that the country's information and communication security protection mechanism will become more complete. The efforts to the direction could be divided into three parts: 　　First, strengthening the cooperation of government and private sectors of information security: In a sound basis of legal system, the government plans to strengthen the government and some private sectors’ information security protection abilities ,continue to study and modify the relevant amendments to the relevant provisions, strengthen public-private collaborative mechanism, deepen the training of human resources and enhance the protection of key information infrastructure of our country. 　　Second, improving the information and communication security professional capability: information and communication security business is divided into policy and technical aspects. While the government takes the responsibility for policy planning and coordination, the technical service lies in an outsourcing way. Based on a sound legal system, the government will establish institutionalized and long-term operation modes and plan appropriate organizational structures through the discussion of experts and scholars from all walks of life. 　　Third, formulating Information and Communication Safety Management Act and planning of the Fifth National Development Program for Information and Communication Security: The government is now actively promoting the Information and Communication Safety Management Act as the cornerstone for the development of the national digital security and information security industry. The main content of the Act provides that the applicable authorities should set up security protection plan at the core of risk management and the procedures of notification and contingency measures, and accept the relevant administrative check. Besides the vision of the Fifth National Development Program for Information and Communication Security which the government is planning now is to build a safe and reliable digital economy and establish a safe information and communication environment by completing the legal system of information and communication security environment, constructing joint defense system of the national Information and Communication security, pushing up the self-energy of the industries of information security and nurture high-quality human resources for elite talents for information security. 4. THE DIGITAL NATION AND INNOVATIVE ECONOMIC DEVELOPMENT PLAN 　　The Digital Nation and Innovative Economic Development Plan (2017-2025) known as “DIGI+” plan, approved by the Executive Yuan on November 24, 2016. The plan wants to grow nation’s digital economy to NT $ 6.5 trillion (US$205.9 billion), improve the digital lifestyle services penetration rate to 80 %, increase broadband connections to 2 Gbps, ensure citizens’ basic rights to have 25 Mbps broadband access, and put our nation among the top 10 information technology nations worldwide by 2025. 　　The plan contains several important development strategies: DIGI+ Infrastructure: Build infrastructure conducive to digital innovation. DIGI+ Talent: Cultivate digital innovation talent. DIGI+ Industry: Support cross-industry transformation through digital innovation. DIGI+ Rights: Make R.O.C. an advanced society that respects digital rights and supports open online communities. DIGI+ Cities: Build smart cities through cooperation among central and local governments and the industrial, academic and research sectors. DIGI+ Globalization: Boost nation’s standing in the global digital service economy. 　　The plan also highlights few efforts: 　　First is to enrich “soft” factors and workforce to create an innovative environment for digital development. To construct this environment, the government will construct an innovation-friendly legal framework, cultivate interdisciplinary digital talent, strengthen research and develop advanced digital technologies. 　　Second is to enhance digital economy development. The government will incentivize innovative applications and optimize the environment for digital commerce. 　　Third, the government will develop an open application programming interface for government data and create demand-oriented, one-stop smart government cloud services. 　　Fourth, the government will ensure broadband access for the disadvantaged and citizens of the rural area, implement the participatory process, enhance different kinds of international cooperation, and construct a comprehensive humanitarian legal framework with digital development. 　　Five is to build a sustainable smart country. The government will use smart network technology to build a better living environment, promote smart urban and rural area connective governance and construction and use on-site research and industries innovation ecosystem to assist local government plan and promote construction of the smart country. 　　In order to achieve the overall effectiveness of the DIGI + program, interdisciplinary, inter-ministerial, inter-departmental and inter-departmental efforts will be required to collaborate with the newly launched Digital National Innovation Economy (DIGI +) Promotion Team. 5. ARTIFICIAL INTELLIGENCE SCIENTIFIC RESEARCH STRATEGY 　　The Ministry of Science and Technology (MOST) reported strategy plan for artificial intelligence (AI) scientific research at Cabinet meeting on August 24, 2017. Artificial intelligence is a powerful and inevitable trend, and it will be critical to R.O.C.’s competitiveness for the next 30 years. 　　The ministry will devote NT$16 billion over the next five years to building an AI innovation ecosystem in R.O.C. According to MOST, the plan will promote five strategies: 　　1. Creating an AI platform to provide R&D services 　　MOST will devote NT$5 billion over the next four years to build a platform, integrating the resources, providing a shared high-speed computing environment and nurturing emerging AI industries and applications. 　　2. Establishing an AI innovative research center 　　MOST will four artificial intelligence innovation research centers across R.O.C. as part of government efforts to enhance the nation’s competitiveness in AI technology. The centers will support the development of new AI in the realms of financial technology, smart manufacturing, smart healthcare and intelligent transportation systems. 　　3. Setting up AI robot maker spaces 　　An NT$2 billion, four-year project assisting industry to develop the hardware-software integration of robots and innovative applications was announced by the Ministry of Science and Technology. 　　4. Subsidizing a semiconductor “moonshot” program to explore ambitious and groundbreaking smart technologies 　　This program will invest NT$4 billion from 2018 through 2021 into developing semiconductors and chip systems for edge devices as well as integrating the academic sector’s R&D capabilities and resources. the project encompasses cognitive computing and AI processor chips; next-generation memory designs; process technologies and materials for key components of sensing devices; unmanned vehicles, AR and VR; IoT systems and security. 　　5. Organizing Formosa Grand Challenge competitions 　　The program is held in competitions to engage young people in the development of AI applications. 　　The government hopes to extend R.O.C.’s industrial advantages and bolster the country’s international competitiveness, giving R.O.C. the confidence to usher in the era of AI applications. All of these efforts will weave people, technologies, facilities, and businesses into a broader AI innovation ecosystem. 6. INTELLIGENT TRANSPORTATION SYSTEM PLANS 　　Ministry of Transportation and Communications (MOTC) launched plans to develop intelligent transportation systems at March 7th in 2017. MOTC integrates transportation and information and communications technology through these plans to improve the convenience and reduce the congestion of the transportation. These plans combine traffic management systems for highways, freeways and urban roads, a multi-lane free-flow electronic toll collection system, bus information system that provides timely integrated traffic information services, and public transportation fare card readers to reduce transport accidence losses, inconvenience of rural area, congestion of main traffic arteries and improve accessibility of public transportation. 　　There are six plans are included: 1. Intelligent transportation safety plan; 2. Relieve congestion on major traffic arteries; 3. Make transportation more convenient in Eastern Taiwan and remote areas; 4. Integrate and share transportation resources; 5. Develop “internet-of-vehicles” technology applications; and 6. Fundamental R&D for smart transportation technology. 　　These plans promote research and development of smart vehicles and safety intersections, develop timely bus and traffic information tracking system, build a safe system of shared, safe and green-energy smart system, and subsidize the large vehicles to install the vision enhancement cameras to improve the safety of transportation. These plans also use eTag readers, vehicle sensors and info communication technologies to gather the traffic information and provide timely traffic guidance, reduce the congestion of the traffic flow. These plans try to use demand-responsive transit system with some measures such as combine public transportation and taxi, to improve the flexibility of the public traffic service and help the basic transportation needs of residents in eastern Taiwan and rural areas to be fulfilled. A mobile transport service interface and a platform that integrating booking and payment processes are also expected to be established to provide door-to-door transportation services and to integrate transportation resources. And develop demonstration projects of speed coordination of passenger coach fleets, vehicle-road interaction technology, and self-driving car to investigate and verify the issues in technological, operational, industrial, legal environments of internet-of-vehicles applications in our country. Last but not least, research and development on signal control systems that can be used in both two and four-wheeled vehicles, and deploy an internet-of-vehicles prototype platform and develop drones traffic applications. 　　These plans are expected to reduce 25% traffic congestion, 20% of motor vehicle incidence, leverage 10% using rate of public transportation, raise 20% public transportation service accessibility of rural area and create NT$30 billion production value. After accomplishing these targets, the government can establish a comprehensive transportation system and guide industry development of relating technology areas. 　　Through the aforementioned initiatives, programs, and plans, the government wants to construct the robust legal framework and policy environment for digital innovation development, and facilitate the quality of citizens in our society.

Executive Yuan Promotes Free Economic Demonstration Zone

I.Background To promote more liberal and internationalized development of Taiwan economy, Premier of Executive Yuan approved the “Free Economic Demonstration Zone Plan” on April 26, 2013. Meanwhile, an Executive Yuan Working Group on Promotion of Economic Demonstration Zone is set up to accelerate the mapping out of the promotion programs as well as detailed action plans. The first phase of the Free Economic Demonstration Zone is to be officially initiated in July. According to the “Free Economic Demonstration Zone Plan”, the relevant laws and provisions regarding the flowing of human and financial capitals, and of logistics, will be loosen up to a great degree, based on the core ideas of liberalization, internationalization, and forwardness. Other related measures such as offering of lands and taxation would also be made, in order to attract capitals from both the inside and outside of the country. In addition, the Free Economic Demonstration Zone will first develop economic activities such as intelligent computing, international medicine services, value-added agriculture and cooperation among industries, to accelerate the transformation of the industrial structure of Taiwan. In order to construe an excellent environment for business of full liberalization and internationalization, the promotion strategies will be focused on “break-through of legal frameworks and innovations of management mechanisms”. II.Content of the Plan To accelerate the promotion process, the Free Economic Demonstration Zone will be conducted in two phases. The first phase is centered on the existing free trade port areas, including five ports and one airport, incorporated with the nature of “being inside the country border but outside the tariff zone”. All the industrial parks in the near counties and cities will also be integrated. The promotion will be set out simultaneously in the north, middle and south of Taiwan. The effects of the promotion are expected to be magnified by fully utilizing the resources and the unique characters of industries of each region. Moreover, the promulgation of a special legislation on the Free Economic Demonstration Zone would be facilitated in the future. After this special legislation is passed, the set-ups of demonstration zones can be applied by authorities either of central or of local government and the related promotion works of the second phase will be unfolded immediately. According to the Executive Yuan, the Free Economic Demonstration Zone will be beneficial in terms of creating positive conditions for Taiwan to participate in regional trade organizations and attract both local and foreign investment, injecting new movement into the economic growth of Taiwan. III.Recent Development In addition, on August 8, 2013, relevant discussions on “Furtherance Plan for Free Economic Demonstration Zone Phase One” are further unfolded in the Executive Yuan conference. In addition, the Premier also indicates, that the furtherance of the Free Economic Demonstration Zone (hereafter: FEDZ) is divided into two phases. The first phase starts from the moment that the Plan is approved till the related special legislation is passed and promulgated. In this phase, the relevant tasks can be achieved through the ways of promulgation of administrative orders. On the other hand, the tasks concerning taxation benefits and other parts that involve legislation will not able to be initiated till the second phase of the Plan. For those tasks, the Council for Economic Planning and Development is asked to complete the drafting of this special legislation and related procedures for registering it into the Executive Yuan, together with the Ministry of Economic Affairs and other concerned agencies, in the hope that the related legislation works of the Executive Yuan can be completed before the end of this year. In respect of “Furtherance Plan for Free Economic Demonstration Zone Phase One”, Premier Jiang further points out, that FEDZ is a model incorporates the concept of “being inside the country border but outside the tariff zone” and the idea of “combining the stores upfront and the factories behind, outsourcing manufactures”. In this way, the hinterland of a port can be expended and magnified effects to be achieved through using the resources provided by the factory in behind. Under this pattern, the expansion effects that cities and counties such as New Taipei City and Changhua Country fight for, can be further extended by this concept of “factories in the back”. As for Port of Anping, over which Tainan City government has proactively fought for, can be listed as a demonstration zone once the Executive Yuan approved it as free trade port zone. In the future, other places that are with forward-looking industry and suitable can still be enlisted. Premier Jiang further expresses that, there are four demonstration industries in the first phase, including intelligent computing, international medicine services, value-added agriculture and cooperation among industries. Yet, he also points out that the demonstration of liberalized economy is a concept of “4+N”. It means that the demonstration will not be limited to the scope of these four industries. Other industries that match up with the idea of liberalization, internationalization and foresight can all be incorporated into FEDZ through continuing examination. Moreover, Premier Jiang later mentions on August 14th, that FEDZ is a crucial task for the government at this moment. He thus requests the Ministry of Economic Affairs, Ministry of Transportation and Communications, Ministry of Health and Welfare, and the Council of Agriculture, to enhance the training and service quality of staffers of the single service window of furtherance of FEDZ. Moreover, Premier Jiang additionally indicated in November, that the scope of the FEDZ will include Pingtung Agricultural Biotechnology Park and Kaohsiung Free Trade Port Area. The combination of the two will facilitate adding value to the agriculture in Taiwan and put momentum into quality agriculture, making the high-quality agricultural products of our country being sold to all over the world with swift logistic services. Premier Jiang also mentioned, that in order to avoid Taiwan being marginalized amid regional integrations of global economies, the government is facilitating industries of potentials by proactively promote the FEDZ. The current approach is to expend the original free trade port area with legislative bases, creating the demonstration zones of free economy by combing original establishments such as Pingtung Agricultural Biotechnology Park. If this approach and system is proved feasible, the next step would be promoting it to island-wide, making the whole nation open-up. IV.Conclusion In the past decade, the economic development in Taiwan, compared to neighboring economic zones such as Hong Kong, Korean or Singapore, was indeed stagnant. It is thus a positive move for the government to put great efforts in promoting FEDZ, in the hope that the liberalization and internationalization of the economy of this country can therefore be significantly improved. Yet, some commentators are of slightly more skeptical opinions, reminding that in terms of the tax relaxation in the Plan, similar approach was already taken by the government before, which did not lead to the expected outcome. In sum, it still remains as a continuing task for us and for the administration as well, to ponder on how Taiwan can find out its own unique strength in the face of global competition. How we can attract more international partners, to create mutual economic benefits. The FEDZ is undoubtedly a first step. Nevertheless, challenges are still ahead of the government, as to how to take many more steps in the future, in order to make Taiwan to march on the stage of the world again.

The Research on ownership of cell therapy products

The Research on ownership of cell therapy products 1. Issues concerning ownership of cell therapy products 　　Regarding the issue of ownership interests, American Medical Association(AMA)has pointed out in 2016 that using human tissues to develop commercially available products raises question about who holds property rights in human biological materials[1]. In United States, there have been several disputes concern the issue of the whether the donor of the cell therapy can claim ownership of the product, including Moore v. Regents of University of California(1990)[2], Greenberg v. Miami Children's Hospital Research Institute(2003)[3], and Washington University v. Catalona(2007)[4]. The courts tend to hold that since cells and tissues were donated voluntarily, the donors had already lost their property rights of their cells and tissues at the time of the donation. In Moore case, even if the researchers used Moore’s cells to obtain commercial benefits in an involuntary situation, the court still held that the property rights of removed cells were not suitable to be claimed by their donor, so as to avoid the burden for researcher to clarify whether the use of cells violates the wishes of the donors and therefore decrease the legal risk for R&D activities. United Kingdom Medical Research Council(MRC)also noted in 2019 that the donated human material is usually described as ‘gifts’, and donors of samples are not usually regarded as having ownership or property rights in these[5]. Accordingly, both USA and UK tends to believe that it is not suitable for cell donors to claim ownership. 2. The ownership of cell therapy products in the lens of Taiwan’s Civil Code 　　In Taiwan, Article 766 of Civil Code stipulated: “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Accordingly, many scholars believe that the ownership of separated body parts of the human body belong to the person whom the parts were separated from. Therefore, it should be considered that the ownership of the cells obtained from the donor still belongs to the donor. In addition, since it is stipulated in Article 406 of Civil Code that “A gift is a contract whereby the parties agree that one of the parties delivers his property gratuitously to another party and the latter agrees to accept it.”, if the act of donation can be considered as a gift relationship, then the ownership of the cells has been delivered from donor to other party who accept it accordingly. 　　However, in the different versions of Regenerative Medicine Biologics Regulation (draft) proposed by Taiwan legislators, some of which replace the term “donor” with “provider”. Therefore, for cell providers, instead of cell donors, after providing cells, whether they can claim ownership of cell therapy product still needs further discussion. 　　According to Article 69 of the Civil Code, it is stipulated that “Natural profits are products of the earth, animals, and other products which are produced from another thing without diminution of its substance.” In addition, Article 766 of the Civil Code stipulated that “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Thus, many scholars believe that when the product is organic, original substance and the natural profits thereof are all belong to the owner of the original substance. For example, when proteins are produced from isolated cells, the proteins can be deemed as natural profits and the ownership of proteins and isolated cells all belong to the owner of the cells[6]. 　　Nevertheless, according to Article 814 of the Civil Code, it is stipulated that “When a person has contributed work to a personal property belonging to another, the ownership of the personal property upon which the work is done belongs to the owner of the material thereof. However, if the value of the contributing work obviously exceeds the value of the material, the ownership of the personal property upon which the work is done belongs to the contributing person.” Thus, scholar believes that since regenerative medical technology, which induces cell differentiation, involves quite complex biotechnology technology, and should be deemed as contributing work. Therefore, the ownership of cell products after contributing work should belongs to the contributing person[7]. Thus, if the provider provides the cells to the researcher, after complex biotechnology contributing work, the original ownership of the cells should be deemed to have been eliminated, and there is no basis for providers to claim ownership. 　　However, since the development of cell therapy products involves a series of R&D activities, it still need to be clarified that who is entitled to the ownership of the final cell therapy products. According to Taiwan’s Civil Code, the ownership of product after contributing work should belongs to the contributing person. However, when there are numerous contributing persons, which person should the ownership belong to, might be determined on a case-by-case basis. 3. Conclusion 　　The biggest difference between cell therapy products and all other small molecule drugs or biologics is that original cell materials are provided by donors or providers, and the whole development process involves numerous contributing persons. Hence, ownership disputes are prone to arise. 　　In addition to the above-discussed disputes, United Kingdom Co-ordinating Committee on Cancer Research(UKCCCR)also noted that there is a long list of people and organizations who might lay claim to the ownership of specimens and their derivatives, including the donor and relatives, the surgeon and pathologist, the hospital authority where the sample was taken, the scientists engaged in the research, the institution where the research work was carried out, the funding organization supporting the research and any collaborating commercial company. Thus, the ultimate control of subsequent ownership and patent rights will need to be negotiated[8]. 　　Since the same issues might also occur in Taiwan, while developing cell therapy products, carefully clarifying the ownership between stakeholders is necessary for avoiding possible dispute. [1]American Medical Association [AMA], Commercial Use of Human Biological Materials, Code of Medical Ethics Opinion 7.3.9, Nov. 14, 2016, https://www.ama-assn.org/delivering-care/ethics/commercial-use-human-biological-materials (last visited Jan. 3, 2021). [2]Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990) [3]Greenberg v. Miami Children's Hospital Research Institute, 264 F. Suppl. 2d, 1064 (SD Fl. 2003) [4]Washington University v. Catalona, 490 F 3d 667 (8th Cir. 2007) [5]Medical Research Council [MRC], Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines, 2019, https://mrc.ukri.org/publications/browse/human-tissue-and-biological-samples-for-use-in-research/ (last visited Jan. 3, 2021). [6]Wen-Hui Chiu, The legal entitlement of human body, tissue and derivatives in civil law, Angle Publishing, 2016, at 327. [7]id, at 341. [8]Okano, M., Takebayashi, S., Okumura, K., Li, E., Gaudray, P., Carle, G. F., & Bliek, J. UKCCCR guidelines for the use of cell lines in cancer research.Cytogenetic and Genome Research,86(3-4), 1999, https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC2363383&blobtype=pdf (last visited Jan. 3, 2021).

Legal Analysis of the U.S. BIOSECURE Act: Implications for Taiwanese Biotechnology Companies

Legal Analysis of the U.S. BIOSECURE Act: Implications for Taiwanese Biotechnology Companies 2024/11/15 I.Introduction The U.S. BIOSECURE Act (H.R.8333)[1](hereunder, "BIOSECURE Act" or "Act") is a strategic legislative measure designed to protect U.S. biotechnology technologies and data from potential exploitation by foreign entities deemed to be threats to national security. Passed by the House of Representatives on September 9, 2024, with a vote of 306-81[2], the Act demonstrates robust bipartisan support to limit foreign influence in critical U.S. sectors. Passed during the legislative session known as "China Week[3]," the Act imposes restrictions on government contracts, funding, and technological cooperation with entities classified as "Biotechnology Companies of Concern" (hereunder, "BCCs") that are affiliated with adversarial governments. Given Taiwan's prominent role in biotechnology and its strong trade ties with the U.S., Taiwanese companies must examine the implications of the BIOSECURE Act, specifically in regard to technology acquisition from restricted foreign companies and compliance obligations for joint projects with U.S. partners. This analysis will delve into three core aspects of the BIOSECURE Act: (1) the designation and evaluation of BCCs, (2) prohibitions on transactions involving BCCs, and (3) enforcement mechanisms. Each section will evaluate potential impacts on Taiwanese companies, focusing on how the Act might influence technology transfers, compliance obligations, and partnership opportunities within the U.S. biotechnology supply chain. II.Designation and Evaluation of Biotechnology Companies of Concern A central element of the BIOSECURE Act is the process of identifying and evaluating foreign biotechnology companies considered potential threats to U.S. national security.[4] Under Section 2(f)(2) of the Act, a "Biotechnology Company of Concern" is defined as any entity associated with adversarial governments—specifically, China, Russia, North Korea, and Iran[5]—that engages in activities or partnerships posing risks to U.S. security[6]. These risks may include collaboration with foreign military or intelligence agencies, involvement in dual-use research, or access to sensitive personal or genetic information of U.S. citizens. Companies already designated as BCCs include BGI, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics, all of which have substantial ties to China and the Chinese government or military[7]. Under Section 2(f)(4) of the Act, the Office of Management and Budget (OMB) is required to continuously evaluate and update the BCC list in consultation with agencies such as the Department of Defense, Department of Commerce, and the National Intelligence Community to reflect evolving security concerns[8]. The designation process presents significant challenges for Taiwanese companies, particularly those that have connections with BCCs or rely on BCC technologies for their products, diagnostics, or research initiatives. For instance, if a Taiwanese company uses gene sequencing technology or multiomics tools sourced from one of the designated BCCs, it may face restrictions when pursuing contracts with U.S. entities or seeking federal funding. To proactively address these challenges, Taiwanese companies should establish compliance protocols that verify the origin of their technology and data sources. Moreover, developing new supply chain relationships with U.S. or European suppliers may not only reduce reliance on BCC-affiliated technology but also enhance Taiwanese companies' reputation as secure and reliable partners in the biotechnology industry. By adapting proactively to the BCC designation process, Taiwanese companies can anticipate and respond to future regulatory shifts more effectively. Diversifying their technology base away from BCCs positions these companies to better align with U.S. biosecurity standards, thereby becoming more attractive collaborators for U.S.-based biotechnology and life sciences companies. Given the rapid pace of regulatory and security developments, staying informed about changes in BCC designations will enable Taiwanese companies to operate with greater agility, adjusting suppliers and adopting new compliance measures as needed. Such proactive alignment can strengthen their resilience and reinforce their status as stable and secure participants in the global biotechnology landscape. III.Prohibition on Government Contracts and Funding A core component of the BIOSECURE Act is its stringent restrictions on contracting and funding involving entities linked to BCCs, as detailed in Section 2(a) of the act[9]. These restrictions extend beyond direct federal interactions to include any recipients of federal funds, prohibiting them from using such funds to procure biotechnology products or services from BCCs[10]. By curtailing federal support and preventing indirect financial benefits to these companies, the U.S. aims to mitigate national security risks posed by adversarial governments. The wide-reaching scope of these prohibitions makes the BIOSECURE Act one of the most comprehensive legislative efforts to secure the biotechnology sector and address concerns over foreign technologies potentially compromising U.S. security interests. For Taiwanese biotechnology companies, these prohibitions introduce substantial compliance demands, particularly for companies that utilize BCC technology within their supply chains. For example, a Taiwanese company engaged in a joint research project with a U.S. government contractor may be required to demonstrate that none of its technology or data sources originate from BCCs. Compliance could necessitate rigorous supply chain audits and operational adjustments, potentially increasing short-term costs. However, aligning with U.S. regulatory standards preemptively can position Taiwanese companies as more desirable partners for U.S. entities that are increasingly prioritizing security and regulatory adherence. The BIOSECURE Act also incentivizes Taiwanese companies to explore alternative technology providers that meet U.S. biosecurity criteria, including secure data management practices, compliance with federal regulations, and the absence of connections to adversarial governments. By sourcing technology from approved U.S. or European biotechnology companies, Taiwanese companies can enhance their market access and collaborative prospects in the U.S. biotechnology and life sciences sectors. This strategy may also foster long-term stability in partnerships and mitigate risks associated with supply chain disruptions, particularly if more companies are designated as BCCs in the future[11]. Establishing partnerships with U.S.-aligned suppliers can also provide Taiwanese companies with a competitive edge in securing government contracts and research funding, as U.S.-based entities increasingly prefer suppliers that comply with national biosecurity requirements. IV.Enforcement Mechanisms, Transition Periods, and Taiwanese Considerations The BIOSECURE Act outlines key enforcement mechanisms and transitional provisions designed to facilitate the adjustment process for companies affected by its restrictions. Specifically, Section 2(c) of the Act provides an eight-year grandfathering period for contracts established prior to the Act’s effective date involving existing BCCs, allowing these agreements to continue until January 1, 2032[12]. This provision is intended to provide companies that are dependent on BCC-supplied biotechnology ample time to transition to compliant suppliers. In addition, the Act includes a "safe harbor" provision[13], which clarifies that equipment previously produced by a BCC but now sourced from a non-BCC entity will not be restricted. This allows companies to re-source components without the risk of penalties for past procurement decisions. For Taiwanese companies, this transition period presents a critical opportunity to adapt to the new regulatory environment without facing immediate disruptions to business operations. Companies dependent on BCC technology for essential biotechnological functions can leverage the eight-year window to gradually phase out such suppliers, thereby minimizing the impact on operations while ensuring future compliance. For example, a Taiwanese company that relies on a BCC’s sequencing technology for genomic research can use this period to forge partnerships with compliant technology suppliers, thereby avoiding sudden disruptions in research or production. Additionally, the Act includes a waiver provision[14] that allows case-by-case exemptions under specific conditions, particularly when compliance is infeasible, such as in instances where critical healthcare services abroad are at risk[15]. By making strategic use of the phased enforcement and waiver provisions, Taiwanese companies can restructure their supply chains to align fully with U.S. requirements. Those that plan these transitions carefully not only ensure regulatory compliance but also enhance their appeal as resilient and trustworthy partners in the U.S. market. Exploring new collaborations with U.S.-approved biotechnology suppliers can further bolster supply chain resilience against future geopolitical or regulatory uncertainties. The transition period[16] and waiver options[17] reflect the BIOSECURE Act's balanced approach between immediate security needs and pragmatic implementation, which Taiwanese companies can capitalize on to build robust, compliant biotechnological operations. V.Conclusion The U.S. BIOSECURE Act[18] presents both significant challenges and strategic opportunities for Taiwanese biotechnology companies. The Act’s restrictions on contracts with designated BCCs and funding constraints necessitate a reassessment of technology acquisition strategies and a reinforcement of compliance practices. Taiwanese companies seeking deeper integration into U.S. and global biotechnology markets will benefit from aligning their procurement approaches with non-BCC suppliers, particularly those in the U.S. or allied countries. This proactive alignment will not only mitigate potential compliance risks but also enhance Taiwanese companies’ reputations as reliable global partners in biotechnology. The phased enforcement and waiver provisions of the BIOSECURE Act[19] provide Taiwanese companies with a clear pathway to navigate the evolving regulatory landscape, allowing them to establish stronger, more resilient supply chains that meet U.S. standards. Such alignment positions these companies as competitive players in the biotechnology sector, contributing to secure and innovative progress in an increasingly interconnected world. By actively engaging with the BIOSECURE Act’s compliance demands, Taiwanese biotechnology companies can leverage the Act's phased implementation to ensure sustained, secure access to the U.S. market and foster strategic biotechnology partnerships. [1] U.S. CONGRESS, H.R. 8333 – U.S. BIOSECURE Act (2024), https://www.congress.gov/bill/118th-congress/house-bill/8333 (last visited Nov. 1, 2024). [2] OFFICE OF THE CLERK, U.S. HOUSE OF REPRESENTATIVES, Roll Call Vote No. 402 on H.R. 8333 (Sept. 9, 2024), https://clerk.house.gov/Votes?RollCallNum=402&BillNum=H.R.8333 (last visited Nov. 1, 2024). [3] JANINE LITTLE, U.S. House Of Representatives Passes The BIOSECURE Act During “China Week”, Global Supply Chain Law Blog (Sept. 13, 2024), https://www.globalsupplychainlawblog.com/supply-chain/u-s-house-of-representatives-passes-the-biosecure-act-during-china-week/ (last visited Nov. 1, 2024). [4] SABINE NAUGÈS & SARAH L. ENGLE, BIOSECURE Act: US Target on Chinese Biotechnology Companies, NAT'L L. REV. (Sept. 13, 2024), https://natlawreview.com/article/biosecure-act-us-target-chinese-biotechnology-companies (last visited Nov. 1, 2024). [5] 10 U.S.C. § 4872(d) (2024), https://www.law.cornell.edu/uscode/text/10/4872 (last visited Nov. 1, 2024). [6] U.S. CONGRESS, H.R. 8333 – U.S. BIOSECURE Act (2024), https://www.congress.gov/bill/118th-congress/house-bill/8333 (last visited Nov. 1, 2024). [7] id. [8] id. [9] id. [10] id. [11] JANINE LITTLE, U.S. House Of Representatives Passes The BIOSECURE Act During “China Week”, Global Supply Chain Law Blog (Sept. 13, 2024), https://www.globalsupplychainlawblog.com/supply-chain/u-s-house-of-representatives-passes-the-biosecure-act-during-china-week/ (last visited Nov. 1, 2024). [12] U.S. CONGRESS, H.R. 8333 – U.S. BIOSECURE Act (2024), https://www.congress.gov/bill/118th-congress/house-bill/8333 (last visited Nov. 1, 2024). [13] id. [14] id. [15] id. [16] id. [17] id. [18] id. [19] id.

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