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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.

 

Reference:

[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.

※Legal Analysis of the U.S. BIOSECURE Act: Implications for Taiwanese Biotechnology Companies,STLI, https://stli.iii.org.tw/en/article-detail.aspx?no=105&tp=2&i=168&d=9274 (Date:2026/05/20)
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Augustine Chu
 Advanced Legal Researcher

Release： 2024/11
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Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials

Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials 2023/12/15 The development of digital tools such as the internet, apps, and wearable devices have meant major breakthroughs for clinical trials. These advances have the potential to reduce the frequency of trial subject visits, accelerate research timelines, and lower the costs of drug development. The COVID-19 pandemic has further accelerated the use of digital tools, prompting many countries to adopt decentralized measures that enable trial subjects to participate in clinical trials regardless of their physical location. In step with the transition into the post-pandemic era, the Taiwan Food and Drug Administration (TFDA) issued the Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials in June, 2023[1]. The Guidelines are intended to cover a wide array of decentralized measures; they aim to increase trial subjects’ willingness to participate in trials, reduce the need for in-person visits to clinical trial sites, enhance real-time data acquisition during trials, and enable clinic sponsors and contract research organizations to process data remotely. I. Key Points of Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials The Guidelines cover primarily the following matters: General considerations for implementing decentralized measures; trial subject recruitment and electronic informed consent; delivery and provision of investigational medicinal products; remote monitoring of trial subject safety; trial subject reporting of adverse events; remote data monitoring; and information systems and electronic data collection/processing/storage. 1. General Considerations for Implementing Decentralized Measures (1) During clinical trial execution, a reduction in trial subject in-person visits may present challenges to medical observation. It is recommended that home visits for any given trial subject be conducted by the principal investigator, sub-investigator, or a single, consistent delegated study nurse. (2) Sponsors must carefully evaluate all of the trial design’s decentralization measures to ensure data integrity. (3) Sponsors must conduct risk assessments for each individual trial, and must confirm the rationality of choosing decentralized measures. These decentralized measures must also be incorporated into the protocol. (4) When electronically collecting data, sponsors must ensure information system reliability and data security. Artificial intelligence may be considered for use in decentralized clinical trials; sponsors must carefully evaluate such systems, especially when they touch on determinations for critical data or strategies. (5) As the design of decentralized clinical trials is to ensure equal access to healthcare services, it must provide patients with a variety of ways to participate in clinical trials. (6) When implementing any decentralized measures, it is essential to ensure that the principal investigator and sponsor adhere to the Regulations for Good Clinical Practice and bear their respective responsibilities for the trial. (7) The use of decentralized measures must be stated in the regulatory application, and the Checklist of Decentralized Elements in Medicinal Product Clinical Trials must be included in the submission. 2. Subject Recruitment and Electronic Informed Consent (1) Trial subject recruitment through social media or established databases may only be implemented after the Institutional Review Board reviews and approves of the recruitment methods and content. (2) Must comply with the Principles for Recruiting Clinical Trial Subjects in medicinal product trials, the Personal Data Protection Act, and other regulations. (3) Regarding clinical trial subject informed consent done through digital software or devices, if it complies with Article 4, Paragraph 2 of the Electronic Signatures Act, that is, if the content can be displayed in its entirety and continues to be accessible for subsequent reference, then so long as the trial subject agrees to do so, the signature may be done via a tablet or other electronic device. The storage of signed electronic Informed Consent Forms (eICF) must align with the aforementioned Principles and meet the competent authority’s access requirements. 3. Delivery and Provision of Investigational Medicinal Products (1) The method of delivering and providing investigational medicinal products and whether trial subjects can use them on their own at home depends to a high degree on the investigational medicinal product’s administration route and safety profile. (2) When investigational medicinal products are delivered and provided through decentralized measures to trial subjects, this must be documented in the protocol. The process of delivering and providing said products must also be clearly stated in the informed consent form; only after being explained to a trial subject by the trial team, and after the trial subject’s consent is obtained, may such decentralized measures be used. (3) Investigational products prescribed by the principal investigator/sub-investigator must be reviewed by a delegated pharmacist to confirm that the investigational products’ specific items, dosage, duration, total quantity, and labeling align with the trial design. The pharmacist must also review each trial subject’s medication history, to ensure there are no medication-related issues; only then, and only in a manner that ensures the investigational product’s quality and the subject’s privacy, may delegated and specifically-trained trial personnel provide the investigational product to the subject. (4) Compliance with relevant regulations such as the Pharmaceutical Affairs Act, Pharmacists Act, Regulations on Good Practices for Drug Dispensation, and Regulations for Good Clinical Practice is required. 4. Remote Monitoring of Subject Safety (1) Decentralized trial designs involve trial subjects performing relatively large numbers of trial-related procedures at home. The principal investigator must delegate trained, qualified personnel to perform tasks such as collecting blood samples, administering investigational products, conducting safety monitoring, doing adverse event tracking, etc. (2) If trial subjects receive protocol-prescribed testing at nearby medical facilities or laboratories rather than at the original trial site, these locations must be authorized by the trial sponsor and must have relevant laboratory certification; only then may they collect or analyze samples. Such locations must provide detailed records to the principal investigator, to be archived in the trial master file. (3) The trial protocol and schedule must clearly specify which visits must be conducted at the trial site; which can be conducted via phone calls, video calls, or home visits; which tests must be performed at nearby laboratories; and whether trial subjects have multiple or single options at each visit. 5. Subject Reporting of Adverse Events (1) If the trial uses a digital platform to enhance adverse event reporting, trial subjects must be able to report adverse events through the digital platform, such as via a mobile phone app; that is, the principal investigator must be able to immediately access such adverse event information. (2) The principal investigator must handle such reports using risk-based assessment methods. The principal investigator must validate the adverse event reporting platform’s effectiveness, and must develop procedures to identify potential duplicate reports. 6. Remote Data Monitoring (1) If a sponsor chooses to implement remote monitoring, it must perform a reasonability assessment to confirm the appropriateness of such monitoring and establish a remote monitoring plan. (2) The monitoring plan must include monitoring strategies, monitoring personnel responsibilities, monitoring methods, rationale for such implementation, and critical data and processes that must be monitored. It must also generate comprehensive monitoring reports for audit purposes. (3) The sponsor is responsible for ensuring the implementation of remote monitoring, and must conduct risk assessments regarding the implementation process’ data protection and information confidentiality. 7. Information Systems and Electronic Data Collection, Processing, and Storage (1) In accordance with the Regulations for Good Clinical Practice, data recorded in clinical trials must be trustworthy, reliable, and verifiable. (2) It must be ensured that all organizations participating in the clinical trial have a full picture of the data flow. It is recommended that the trial protocol and trial-related documents include data flow diagrams and additional explanations. (3) Define the types and scopes of subject personal data that will be collected, and ensure that every step in the process properly protects their data in accordance with the Personal Data Protection Act. II. A Comparison with Decentralized Trial Regulations in Other Countries Denmark became the first country in the world to release regulatory measures on decentralized trials, issuing the “Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products” in September 2021[2]. In December 2022, the European Union as a whole released its “Recommendation Paper on Decentralized Elements in Clinical Trials”[3]. The United States issued the draft “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” document in May 2023[4]. The comparison in Table 1 shows that Taiwan’s guidelines a relatively similar in structure to those of Denmark and the EU; the US guidelines also cover medical device clinical trials. Table 1: Summary of Decentralized Clinical Trial Guidelines in Taiwan, Denmark, the European Union as a whole, and the United States Taiwan Denmark European Union as a whole United States What do the guidelines apply to? Medicinal products Medicinal products Medicinal products Medicinal products and medical devices Trial subject recruitment and electronic informed consent Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc. Covers informed consent process; informed consent interview; trial subject consent form signing; etc. Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc. Covers informed consent process; informed consent interview; etc. Delivery and provision of investigational medicinal products Delegated, specifically-trained trial personnel deliver and provide investigational medicinal products. The investigator or delegated personnel deliver and provide investigational medicinal products. The investigator, delegated personnel, or a third-party, Good Distribution Practice-compliant logistics provider deliver and provide investigational medicinal products. The principal investigator, delegated personnel, or a distributor deliver and provide investigational products. Remote monitoring of trial subject safety Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits. Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. Trial subject reporting of adverse events Trial subjects may self-report adverse events through a digital platform. Trial subjects may self-report adverse events through a digital platform. Trial subjects may self-report adverse events through a digital platform. Trial subjects may self-report adverse events through a digital platform. Remote data monitoring The sponsor may conduct remote data monitoring. The sponsor may conduct remote data monitoring. The sponsor may conduct remote data monitoring (not permitted in some countries). The sponsor may conduct remote data monitoring. Information systems and electronic data collection, processing, and storage The recorded data must be credible, reliable, and verifiable. Requires an information system that is validated, secure, and user-friendly. The recorded data must be credible, reliable, and verifiable. Must ensure data reliability, security, privacy, and confidentiality. III. Conclusion The implementation of decentralized clinical trials must be approached with careful assessment of risks and rationality, with trial subject safety, rights, and well-being as top priorities. Since Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials were just announced in June of this year, the status of decentralized clinical trial implementation is still pending industry feedback to confirm feasibility. The overall goal is to enhance and optimize the clinical trial environment in Taiwan. Reference: [1] 衛生福利部食品藥物管理署，〈藥品臨床試驗執行分散式措施指引〉，2023/6/12，https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=43548（最後瀏覽日：2023/11/2）。 [2] [DMA] DANISH MEDICINES AGENCY, The Danish Medicines Agency’s guidance on the Implementation of decentralised elements in clinical trials with medicinal products (2021),https://laegemiddelstyrelsen.dk/en/news/2021/guidance-on-the-implementation-of-decentralised-elements-in-clinical-trials-with-medicinal-products-is-now-available/ (last visited Nov. 2, 2023). [3] [HMA] HEADS OF MEDICINES AGENCIES, [EC] EUROPEAN COMMISSION & [EMA] EUROPEAN MEDICINES AGENCY, Recommendation paper on decentralised elements in clinical trials (2022),https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en (last visited Nov. 2, 2023). [4] [US FDA] US FOOD AND DRUG ADMINISTRATION, Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft, 2023),https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices (last visited Nov. 2, 2023).

An Analysis of the Recusal Mechanism in the Latest Revision of the Government Procurement Act and Regulations Governing Procurements for Scientific and Technological Research and Development

An Analysis of the Recusal Mechanism in the Latest Revision of the Government Procurement Act and Regulations Governing Procurements for Scientific and Technological Research and Development 1. Introduction 　　Article 1 of the Government Procurement Act (hereinafter referred to as the Act) reveals that “This Act is enacted to establish a government procurement system that has fair and open procurement procedures, promotes the efficiency and effectiveness of government procurement operation, and ensures the quality of procurement.” Therefore, a recusal mechanism for reviewing qualification/disqualification of tenders and bidders is highly essential, for example, the head of the agency or its related persons should disclose the conflict of interests. After amended and promulgated on May 22, 2019 (Presidential Decree Hua-tzung-1 Yi No. 10800049691), the Act was revised with the identical legislative principle of the Act on Recusal of Public Servants Due to Conflicts of Interest. In other words, a more flexible and transparent mechanism has been adopted, which is more advanced and ideal for both procurement authority and external supervisors. 2. The New Recusal Mechanism of the Act Enhances the Flexibility and Transparency 　　The revision struck out the Paragraph 4, Article 15 of the Act, and the regulation related to the recusal mechanism shall be comply with the Act on Recusal of Public Servants Due to Conflicts of Interest, especially the qualification/disqualification provision of the “related persons.” The new government procurement procedure adopted a more flexible and transparent practice, “disclosure in advance and publication afterwards.” The detailed analysis is as follows. (1) Before the Act amended, the personnel of a procuring entity and its related persons shall withdraw themselves from the procurement. 　　Before the Act amended, the personnel of a procuring entity and its related persons shall withdraw themselves from the procurement. According to the previous Paragraph 4 of Article 15 (4), “Suppliers or persons in charge shall not participate in the procurement if they have connections with the agency’s head described in Paragraph 2. However, if the implementation of this paragraph is against fair competition or public interest, the exclusion can be exempted with the authority’s approval.” The Paragraph 2 mentioned specified, “The personnel of a procuring entity shall withdraw themselves from procurement and all related matters thereof if they or their spouses, relatives by blood or by marriage within three degrees, or family members living together with them have interests involved therein.” Simply put, legislators considered that suppliers or persons in charge shall not participate in an agency's procurement if they have conflict of interests with its head. For instance, the spouses, all the relatives within the third degree by consanguinity (blood) or by affinity (marriage), or family members living together with the head of the agency, cannot involve in the procurement of the agency. Furthermore, if a legal entity or an organization is directed by the relatives of the head of a government agency mentioned, it is disqualified from the procurement. (2) After the Act amended, the recusal of related persons substituted by self-disclosure and information publication norms 　　According to the Amendment, the Act was amended because the content of the article is existed in Article 9 of Act on Recusal of Public Servants Due to Conflicts of Interest; thus, Article 15 of the Act is hereby deleted. Recalling Article 9 of the previous Act on Recusal of Public Servants Due to Conflicts of Interest, “A public servant and his related persons shall not conduct transactions such as subsidizing, sales, lease, contracting, or other transactions conducted with consideration with the organ with which the public servant serves or the organs under his supervision.” For this reason, the amendment to Article 15 of Government Procurement Act is to regulate the mechanism of withdrawal of relevant parties by Article 14 of the existing Act on Recusal of Public Servants Due to Conflicts of Interest. However, the amendment of this article is greatly affected by the interpretation of judicial court no. 716, so it is necessary to briefly describe its key points as follows. 　　On the basis of the Judicial Yuan Justice Interpretation No. 716 [Transactions between public officials and their associates and service agencies shall be prohibited), adopting a constitutional interpretation of Article 9 of Act on Recusal of Public Servants Due to Conflicts of Interest, grand justice agreed this article does not contradict the proportion principle of article 23 of Constitution of the Republic of China (Taiwan), and it does not violate Article 15 “The right of existence, the right of work, and the right of property shall be guaranteed to the people” and Article 22 “All other freedoms and rights of the people that are not detrimental to social order or public welfare shall be guaranteed under the Constitution”, either. However, for public officials, if they are not allowed to participate in trading competition, it will result in the monopoly of other minority traders, which is not conducive to the public interest. Therefore, this interpretation holds that if the agency has conducted open and fair procedures in the transaction process, and there is sufficient anti-fraud regulation, whether there is still a risk of improper benefit transmission or conflict of interest, and it is necessary to prohibit the transaction of public officials' associates, the relevant authorities should make comprehensive review and improvement as soon as possible. 　　Accordingly, following interpretation no. 716, Act on Recusal of Public Servants Due to Conflicts of Interest was amended and published with 23 articles on 13 June, 2018. The withdrawal of interested parties is provided for in Article 14 and an additional six exceptions are provided, including: (1) The procurement carried out by public notice under the Government Procurement Act or pursuant to Article 105 of the same Act. (2) The property right in interest created for the procurement, sale by tender, lease by tender or tender solicitation carried out by public notice in a fair competitive manner pursuant to laws. (3) Subsidy requested in the legal capacity under laws; the subsidy to the public servant’s related person in an open and fair manner pursuant to laws, or the subsidy which might be against the public interest if it is prohibited and is granted subject to the competent authority’s approval. (4) The subject matter of the transaction is provided by the organ with which the public servant serves or the organs under his supervision, and traded at the official price. (5) The lease, acquisition, discretionary management, improvement and utilization of national non-public real estate requested by the state-owned enterprise in order to execute the national construction projects or public policies, or for the purpose of public welfare. (6) The subsidy and transaction under the specific amount. 　　The above amendments make the transactions between public officials and related parties that should be avoided in the past partially flexible now. In accordance with Paragraph 2 of the same article, in the case of the first three paragraphs of the proviso of Paragraph 1, the applicant or bidder shall voluntarily state his/her identity in the application or tender documents. After the subsidy or transaction is established, the agency shall disclose it together with its identity. That is to say, the self-disclosure is required beforehand and the information will go public afterwards to meet public expectations of transparency. This is also conducive to the supervision of all sectors, and conforms to the intention of the grand justice’s interpretation. 　　The reason why there is no need for government procurement to withdrawal is that the announcement process of the procurement is made in accordance with Government Procurement Act (including open tendering, selective tendering and restricted tendering through the announcement). There are strict procedures to follow and there is no conflict between the conflict of interest of public officials and the spirit of legislation. As to Paragraph 2 of other legal orders, the property right in interest created for the procurement, sale by tender, lease by tender or tender solicitation carried out by public notice in a fair competitive manner pursuant to laws. The legislative explanations are exemplified by the procurement (e.g. procurements for scientific and technological research and development) handled by the announcement in accordance with Fundamental Science and Technology Act. 3. Conclusion: It is suggested that relevant withdrawal regulations should be amended as soon as possible in procurements for scientific and technological research and development 　　The strike-out of the recusal provision of the Act does not mean that government procurement stoke out the recusal mechanism. The recusal mechanism is still stated in Article 14 of Act on Recusal of Public Servants Due to Conflicts of Interest. In addition to the advantages of the same regulations on the prohibition of transactions between related parties, it also enables the regulators with open and fair procedures and sufficient prevention of fraud, such as government procurement, to avoid evading so as not to harm the public interest. At the same time, supplemented by open and transparent disclosure, the amendment is a positive change of legislation. 　　Meanwhile, this paper believes that Government Procurement Act has adopted the mechanism of flexibility and transparency requirements for the procurement object avoidance regulations, and procurements for scientific and technological research and development should revise relevant withdrawal regulations as soon as possible. In accordance with Paragraph 4 of Article 6 of Fundamental Science and Technology Act and the authorization, Regulations Governing Procurements for Scientific and Technological Research and Development (hereinafter referred to as the regulatory regulations) is established. According to Article 8 (2) and (3) of the regulation, a responsible person, partner, or representative of the public school, public research institute (organization), or juristic person or entity performing the scientific research procurement may not serve as a responsible person, partner, or representative of the supplier. The supplier and the juristic person or entity performing the scientific research procurement may not at the same time be affiliated with each other, or affiliated to the same other enterprise. From the perspective of the article structure, the withdrawal regulation for scientific research procurement is within the norm of Article 15 of Government Procurement Act before the amendment, but it includes regulations for affiliated enterprises, which is not included in Article 15. The amendment to Article 14 of Act on Recusal of Public Servants Due to Conflicts of Interest also states that the proviso of Paragraph 1 of scientific research procurement “other procurements that are regulated by fair competition and by means of an announcement procedure” can also prove that the mechanism for scientific research procurement should adopt this provision. Therefore, it is recommended that the original procurements for scientific and technological research that is independent from Government Procurement Act should be amended by the competent authority as soon as possible in order to comply with the relevant provisions of Article 8 of Regulations Governing Procurements for Scientific and Technological Research and Development and to comply with the original intention of the Regulations Governing Procurements for Scientific and Technological Research and Development, and to avoid stricter regulations on scientific procurement than government procurement. Meanwhile, it is in accordance with the spirit of the grand justice’s interpretation No. 716.

The EU's New Legal Framework for European Research Infrastructure

Recognized that Research infrastructures (RIs) are at the centre of the knowledge triangle of research, education and innovation and play an increasingly important role in the advancement of knowledge and technology, the EU began to finance for the establishments of RIs by its Framework Programmes (FPs) since the start of FP2 of 1987. On the other hand, the EU also assigned the European Strategy Forum on Research Infrastructures (ESFRI) to develop a coherent and strategy-led approach to policy-making on RIs between Member States and to facilitate the better use and development of RIs at EU and international level. Based on those efforts, the European Commission understood that a major difficulty in setting up RIs between EU countries is the lack of an adequate legal framework allowing the creation of appropriate partnerships and proposed a legal framework for a European research infrastructure adapted to the needs of such facilities. The new legal framework for a European Research Infrastructure Consortium (ERIC) entered into force on 28 August 2009. An successfully-set-up ERIC will have the legal personality based on EU law, and can benefit from exemptions from VAT and excise duty in all EU Member States and may adopt its own procurement procedures to get rid of the EU's public procurement procedures. It is predicted that the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) will apply to become a BBMRI-ERIC in the near future. The EU also seeks to lead in Energy, Food and Biology through the reforms of ERICs to assist the high quality of activities of European scientists and attract the best researchers from around the world. Besides, in order to connect the knowledge triangle effectively, the European Commission also established the European Institute of Innovation and Technology (EIT) on March 2008. It hopes through the research development partnership network to gather all the advantages from the science and technology chains of multiple areas, and make an effort for the strategy of EU innovation development jointly；Meanwhile, extends its roadmap to the objectives and practices of the Knowledge and Innovation Communities (KICs) of the EIT. Contrast with the EU's advance, it is necessary to our government to concentrate and contemplate whether it is the time to reconsider if our existing legal instruments available to domestic research facilities and infrastructures are sufficient enough to reach our science and technology development goals.

The opening and sharing of scientific data- The Data Policy of the U.S. National Institutes of Health

The opening and sharing of scientific data- The Data Policy of the U.S. National Institutes of Health Li-Ting Tsai 　　Scientific research improves the well-being of all mankind, the data sharing on medical and health promote the overall amount of energy in research field. For promoting the access of scientific data and research findings which was supported by the government, the U.S. government affirmed in principle that the development of science was related to the retention and accesses of data. The disclosure of information should comply with legal restrictions, and the limitation by time as well. For government-sponsored research, the data produced was based on the principle of free access, and government policies should also consider the actual situation of international cooperation[1]Furthermore, the access of scientific research data would help to promote scientific development, therefore while formulating a sharing policy, the government should also consider the situation of international cooperation, and discuss the strategy of data disclosure based on the principle of free access. 　　In order to increase the effectiveness of scientific data, the U.S. National Institutes of Health (NIH) set up the Office of Science Policy (OSP) to formulate a policy which included a wide range of issues, such as biosafety (biosecurity), genetic testing, genomic data sharing, human subjects protections, the organization and management of the NIH, and the outputs and value of NIH-funded research. Through extensive analysis and reports, proposed emerging policy recommendations.[2] At the level of scientific data sharing, NIH focused on "genes and health" and "scientific data management". The progress of biomedical research depended on the access of scientific data; sharing scientific data was helpful to verify research results. Researchers integrated data to strengthen analysis, promoted the reuse of difficult-generated data, and accelerated research progress.[3] NIH promoted the use of scientific data through data management to verify and share research results. 　　For assisting data sharing, NIH had issued a data management and sharing policy (DMS Policy), which aimed to promote the sharing of scientific data funded or conducted by NIH.[4] DMS Policy defines “scientific data.” as “The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens.”[5] In other words, for determining scientific data, it is not only based on whether the data can support academic publications, but also based on whether the scientific data is a record of facts and whether the research results can be repeatedly verified. 　　In addition, NIH, NIH research institutes, centers, and offices have had expected sharing of data, such as: scientific data sharing, related standards, database selection, time limitation, applicable and presented in the plan; if not applicable, the researcher should propose the data sharing and management methods in the plan. NIH also recommended that the management and sharing of data should implement the FAIR (Findable, Accessible, Interoperable and Reusable) principles. The types of data to be shared should first in general descriptions and estimates, the second was to list meta-data and other documents that would help to explain scientific data. NIH encouraged the sharing of scientific data as soon as possible, no later than the publication or implementation period.[6] It was said that even each research project was not suitable for the existing sharing strategy, when planning a proposal, the research team should still develop a suitable method for sharing and management, and follow the FAIR principles. 　　The scientific research data which was provided by the research team would be stored in a database which was designated by the policy or funder. NIH proposed a list of recommended databases lists[7], and described the characteristics of ideal storage databases as “have unique and persistent identifiers, a long-term and sustainable data management plan, set up metadata, organizing data and quality assurance, free and easy access, broad and measured reuse, clear use guidance, security and integrity, confidentiality, common format, provenance and data retention policy”[8]. That is to say, the design of the database should be easy to search scientific data, and should maintain the security, integrity and confidentiality and so on of the data while accessing them. 　　In the practical application of NIH shared data, in order to share genetic research data, NIH proposed a Genomic Data Sharing (GDS) Policy in 2014, including NIH funding guidelines and contracts; NIH’s GDS policy applied to all NIHs Funded research, the generated large-scale human or non-human genetic data would be used in subsequent research. [9] This can effectively promote genetic research forward. 　　The GDS policy obliged researchers to provide genomic data; researchers who access genomic data should also abide by the terms that they used the Controlled-Access Data for research.[10] After NIH approved, researchers could use the NIH Controlled-Access Data for secondary research.[11] Reviewed by NIH Data Access Committee, while researchers accessed data must follow the terms which was using Controlled-Access Data for research reason.[12] The Genomic Summary Results (GSR) was belong to NIH policy,[13] and according to the purpose of GDS policy, GSR was defined as summary statistics which was provided by researchers, and non-sensitive data was included to the database that was designated by NIH.[14] Namely. NIH used the application and approval of control access data to strike a balance between the data of limitation access and scientific development. 　　For responding the COVID-19 and accelerating the development of treatments and vaccines, NIH's data sharing and management policy alleviated the global scientific community’s need for opening and sharing scientific data. This policy established data sharing as a basic component in the research process.[15] In conclusion, internalizing data sharing in the research process will help to update the research process globally and face the scientific challenges of all mankind together. [1]NATIONAL SCIENCE AND TECHNOLOGY COUNCIL, COMMITTEE ON SCIENCE, SUBCOMMITEE ON INTERNATIONAL ISSUES, INTERAGENCY WORKING GROUP ON OPEN DATA SHARING POLICY, Principles For Promoting Access To Federal Government-Supported Scientific Data And Research Findings Through International Scientific Cooperation (2016), 1, organized from Principles, at 5-8, https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/NSTC/iwgodsp_principles_0.pdf (last visited December 14, 2020). [2]About Us, Welcome to NIH Office of Science Policy, NIH National Institutes of Health Office of Science Policy, https://osp.od.nih.gov/about-us/ (last visited December 7, 2020). [3]NIH Data Management and Sharing Activities Related to Public Access and Open Science, NIH National Institutes of Health Office of Science Policy, https://osp.od.nih.gov/scientific-sharing/nih-data-management-and-sharing-activities-related-to-public-access-and-open-science/ (last visited December 10, 2020). [4]Final NIH Policy for Data Management and Sharing, NIH National Institutes of Health Office of Extramural Research, Office of The Director, National Institutes of Health (OD), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html (last visited December 11, 2020). [5]Final NIH Policy for Data Management and Sharing, NIH National Institutes of Health Office of Extramural Research, Office of The Director, National Institutes of Health (OD), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html (last visited December 12, 2020). [6]Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan, Office of The Director, National Institutes of Health (OD), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html (last visited December 13, 2020). [7]The list of databases in details please see：Open Domain-Specific Data Sharing Repositories, NIH National Library of Medicine, https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html (last visited December 24, 2020). [8]Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research, Office of The Director, National Institutes of Health (OD), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-016.html (last visited December 13, 2020). [9]NIH Genomic Data Sharing, National Institutes of Health Office of Science Policy, https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/ (last visited December 15, 2020). [10]NIH Genomic Data Sharing Policy, National Institutes of Health (NIH), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html (last visited December 17, 2020). [11]NIH Genomic Data Sharing Policy, National Institutes of Health (NIH), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html (last visited December 17, 2020). [12]id. [13]NIH National Institutes of Health Turning Discovery into Health, Responsible Use of Human Genomic Data An Informational Resource, 1, at 6, https://osp.od.nih.gov/wp-content/uploads/Responsible_Use_of_Human_Genomic_Data_Informational_Resource.pdf (last visited December 17, 2020). [14]Update to NIH Management of Genomic Summary Results Access, National Institutes of Health (NIH), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html (last visited December 17, 2020). [15]Francis S. Collins, Statement on Final NIH Policy for Data Management and Sharing, National Institutes of Health Turning Discovery Into Health, https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-final-nih-policy-data-management-sharing (last visited December 14, 2020).

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