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).

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Finland’s Technology Innovation System

I. Introduction   When, Finland, this country comes to our minds, it is quite easy for us to associate with the prestigious cell-phone company “NOKIA”, and its unbeatable high technology communication industry. However, following the change of entire cell-phone industry, the rise of smart phone not only has an influence upon people’s communication and interaction, but also makes Finland, once monopolized the whole cell-phone industry, feel the threat and challenge coming from other new competitors in the smart phone industry. However, even though Finland’s cell-phone industry has encountered frustrations in recent years in global markets, the Finland government still poured many funds into the area of technology and innovation, and brought up the birth of “Angry Birds”, one of the most popular smart phone games in the world. 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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. [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).

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.

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.

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