Impact of Government Organizational Reform to Research Legal System and Response Thereto (2) – Observation of the Swiss Research Innovation System
Impact of Government Organizational Reform to Research Legal System and Response Thereto (2) – Observation of the Swiss Research Innovation System
I. Foreword
Switzerland is a landlocked country situated in Central Europe, spanning an area of 41,000 km2, where the Alps occupy 60% of the territory, while it owns little cultivated land and poor natural resources. In 2011, its population was about 7,950,000 persons[1]. Since the Swiss Federal was founded, it has been adhering to a diplomatic policy claiming neutrality and peace, and therefore, it is one of the safest and most stable countries in the world. Switzerland is famous for its high-quality education and high-level technological development and is very competitive in biomedicine, chemical engineering, electronics and metal industries in the international market. As a small country with poor resources, the Swiss have learnt to drive their economic and social development through education, R&D and innovation a very long time ago. Some renowned enterprises, including Nestle, Novartis and Roche, are all based in Switzerland. Meanwhile, a lot of creative small-sized and medium-sized enterprises based in Switzerland are dedicated to supporting the export-orientation economy in Switzerland.
Switzerland has the strongest economic strength and plentiful innovation energy. Its patent applications, publication of essay, frequencies of quotation and private enterprises’ innovation performance are remarkable all over the world. According to the Global Competitiveness Report released by the World Economic Forum (WEF), Switzerland has ranked first among the most competitive countries in the world for four years consecutively since 2009[2]. Meanwhile, according to the Global Innovation Index (GII) released by INSEAD and the World Intellectual Property Organization (WIPO) jointly, Switzerland has also ranked first in 2011 and 2012 consecutively[3]. Obviously, Switzerland has led the other countries in the world in innovation development and economic strength. Therefore, when studying the R&D incentives and boosting the industrial innovation, we might benefit from the experience of Switzerland to help boost the relevant mechanism in Taiwan.
Taiwan’s government organization reform has been launched officially and boosted step by step since 2012. In the future, the National Science Council will be reformed into the “Ministry of Science and Technology”, and the Ministry of Economic Affairs into the “Ministry of Economy and Energy”, and the Department of Industrial Development into the “Department of Industry and Technology”. Therefore, Taiwan’s technology administrative system will be changed materially. Under the new government organizational framework, how Taiwan’s technology R&D and industrial innovation system divide work and coordinate operations to boost the continuous economic growth in Taiwan will be the first priority without doubt. Support of innovation policies is critical to promotion of continuous economic growth. The Swiss Government supports technological research and innovation via various organizations and institutions effectively. In recent years, it has achieved outstanding performance in economy, education and innovation. Therefore, we herein study the functions and orientation of the competent authorities dedicated to boosting research and innovation in Switzerland, and observe its policies and legal system applied to boost the national R&D in order to provide the reference for the functions and orientation of the competent authorities dedicated to boosting R&D and industrial innovation in Taiwan.
II. Overview of Swiss Federal Technology Laws and Technology Administrative System
Swiss national administrative organization is subject to the council system. The Swiss Federal Council is the national supreme administrative authority, consisting of 7 members elected from the Federal Assembly and dedicated to governing a Federal Government department respectively. Switzerland is a federal country consisting of various cantons that have their own constitutions, councils and governments, respectively, entitled to a high degree of independence.
Article 64 of the Swiss Federal Constitution[4] requires that the federal government support research and innovation. The “Research and Innovation Promotion Act” (RIPA)[5] is dedicated to fulfilling the requirements provided in Article 64 of the Constitution. Article 1 of the RIPA[6] expressly states that the Act is enacted for the following three purposes: 1. Promoting the scientific research and science-based innovation and supporting evaluation, promotion and utilization of research results; 2. Overseeing the cooperation between research institutions, and intervening when necessary; 3. Ensuring that the government funding in research and innovation is utilized effectively. Article 4 of the RIPA provides that the Act shall apply to the research institutions dedicated to innovation R&D and higher education institutions which accept the government funding, and may serve to be the merit for establishment of various institutions dedicated to boosting scientific research, e.g., the National Science Foundation and Commission of Technology & Innovation (CTI). Meanwhile, the Act also provides detailed requirements about the method, mode and restriction of the government funding.
According to the RIPA amended in 2011, the Swiss Federal Government’s responsibility for promoting innovation policies has been extended from “promotion of technology R&D” to “unification of education, research and innovation management”, making the Swiss national industrial innovation framework more well-founded and consistent[8] . Therefore, upon the government organization reform of Switzerland in 2013, most of the competent authorities dedicated to technology in Swiss have been consolidated into the Federal Department of Economic Affairs, Education and Research.
Under the framework, the Swiss Federal Government assigned higher education, job training, basic scientific research and innovation to the State Secretariat for Education, Research and Innovation (SERI), while the Commission of Technology & Innovation (CTI) was responsible for boosting the R&D of application scientific technology and industrial technology and cooperation between the industries and academy. The two authorities are directly subordinate to the Federal Department of Economic Affairs, Education and Research (EAER). The Swiss Science and Technology Council (SSTC), subordinate to the SERI is an advisory entity dedicated to Swiss technology policies and responsible for providing the Swiss Federal Government and canton governments with the advice and suggestion on scientific, education and technology innovation policies. The Swiss National Science Foundation (SNSF) is an entity dedicated to boosting the basic scientific R&D, known as the two major funding entities together with CTI for Swiss technology R&D. The organizations, duties, functions and operations of certain important entities in the Swiss innovation system are introduced as following.
Date source: Swiss Federal Department of Economic Affairs, Education and Research official website
Fig. 1 Swiss Innovation Framework Dedicated to Boosting Industries－Swiss Federal Economic, Education and Research Organizational Chart
1. State Secretariat of Education, Research and Innovation (SERI)
SERI is subordinate to the Department of Economic Affairs, Education and Research, and is a department of the Swiss Federal Government dedicated to managing research and innovation. Upon enforcement of the new governmental organization act as of January 1, 2013, SERI was established after the merger of the State Secretariat for Education and Research, initially subordinate to Ministry of Interior, and the Federal Office for Professional Education and Technology (OEPT), initially subordinated to Ministry of Economic Affairs. For the time being, it governs the education, research and innovation (ERI). The transformation not only integrated the management of Swiss innovation system but also unified the orientations toward which the research and innovation policy should be boosted.
SERI’s core missions include “enactment of national technology policies”, “coordination of research activities conducted by higher education institutions, ETH, and other entities of the Federal Government in charge of various areas as energy, environment, traffic and health, and integration of research activities conducted by various government entities and allocation of education, research and innovation resources. Its functions also extend to funding the Swiss National Science Foundation (SNSF) to enable SNSF to subsidize the basic scientific research. Meanwhile, the international cooperation projects for promotion of or participation in research & innovation activities are also handled by SERI to ensure that Switzerland maintains its innovation strength in Europe and the world.
The Swiss Science and Technology Council (SSTC) is subordinate to SERI, and also the advisory unit dedicated to Swiss technology policies, according to Article 5a of RIPA[9]. The SSTC is responsible for providing the Swiss Federal Government and canton governments with advice and suggestion about science, education and innovation policies. It consists of the members elected from the Swiss Federal Council, and a chairman is elected among the members.
2. Swiss National Science Foundation (SNSF)
The Swiss National Science Foundation (SNSF) is one of the most important institutions dedicated to funding research, responsible for promoting the academic research related to basic science. It supports about 8,500 scientists each year. Its core missions cover funding as incentives for basic scientific research. It grants more than CHF70 million each year. Nevertheless, the application science R&D, in principle, does not fall in the scope of funding by the SNSF. The Foundation allocates the public research fund under the competitive funding system and thereby maintains its irreplaceable identity, contributing to continuous output of high quality in Switzerland.
With the support from the Swiss Federal Government, the SNSF was established in 1952. In order to ensure independence of research, it was planned as a private institution when it was established[10]. Though the funding is provided by SERI, the SNSF still has a high degree of independence when performing its functions. The R&D funding granted by the SNSF may be categorized into the funding to free basic research, specific theme-oriented research, and international cooperative technology R&D, and the free basic research is granted the largest funding. The SNSF consists of Foundation Council, National Research Council and Research Commission[11].
Data source: prepared by the Study
Fig. 2 Swiss National Science Foundation Organizational Chart(1) Foundation Council
The Foundation Council is the supreme body of the SNSF[12], which is primarily responsible for making important decisions, deciding the role to be played by the SNSF in the Swiss research system, and ensuring SNSF’s compliance with the purpose for which it was founded. The Foundation Council consists of the members elected from the representatives from important research institutions, universities and industries in Swiss, as well as the government representatives nominated by the Swiss Federal Council. According to the articles of association of the SNSF[13], each member’s term of office should be 4 years, and the members shall be no more than 50 persons. The Foundation Council also governs the Executive Committee of the Foundation Council consisting of 15 Foundation members. The Committee carries out the mission including selection of National Research Council members and review of the Foundation budget.
(2) National Research Council
The National Research Council is responsible for reviewing the applications for funding and deciding whether the funding should be granted. It consists of no more than 100 members, mostly researchers in universities and categorized, in four groups by major[14], namely, 1. Humanities and Social Sciences; 2. Math, Natural Science and Engineering; 3. Biology and Medical Science; and 4. National Research Programs (NRPs）and National Centers of Competence in Research (NCCRs). The NRPs and NCCRs are both limited to specific theme-oriented research plans. The funding will continue for 4~5years, amounting to CHF5 million~CHF20 million[15]. The specific theme-oriented research is applicable to non-academic entities, aiming at knowledge and technology transfer, and promotion and application of research results. The four groups evaluate and review the applications and authorize the funding amount.
Meanwhile, the representative members from each group form the Presiding Board dedicated to supervising and coordinating the operations of the National Research Council, and advising the Foundation Council about scientific policies, reviewing defined funding policies, funding model and funding plan, and allocating funding by major.
(3) Research Commissions
Research Commissions are established in various higher education research institutions. They serve as the contact bridge between higher education academic institutions and the SNSF. The research commission of a university is responsible for evaluating the application submitted by any researcher in the university in terms of the school conditions, e.g., the school’s basic research facilities and human resource policies, and providing advice in the process of application. Meanwhile, in order to encourage young scholars to attend research activities, the research committee may grant scholarships to PhD students and post-doctor research[16].
~to be continued~
[1] SWISS FEDERAL STATISTICS OFFICE, Switzerland's population 2011 (2012), http://www.bfs.admin.ch/bfs/portal/en/index/news/publikationen.Document.163772.pdf (last visited Jun. 1, 2013).
[2] WORLD ECONOMIC FORUM [WEF], The Global Competiveness Report 2012-2013 (2012), http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2012-13.pdf (last visited Jun. 1, 2013); WEF, The Global Competiveness Report 2011-2012 (2011), http://www3.weforum.org/docs/WEF_GCR_Report_2011-12.pdf (last visited Jun. 1, 2013); WEF, The Global Competiveness Report 2010-2011 (2010), http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2010-11.pdf (last visited Jun. 1, 2013); WEF, The Global Competiveness Report 2009-2010 (2009),. http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2009-10.pdf (last visited Jun. 1, 2013).
[3] INSEAD, The Global Innovation Index 2012 Report (2012), http://www.globalinnovationindex.org/gii/GII%202012%20Report.pdf (last visited Jun. 1, 2013); INSEAD, The Global Innovation Index 2011 Report (2011), http://www.wipo.int/freepublications/en/economics/gii/gii_2011.pdf (last visited Jun. 1, 2013).
[4] SR 101 Art. 64: “Der Bund fördert die wissenschaftliche Forschung und die Innovation.”
[5] Forschungs- und Innovationsförderungsgesetz, vom 7. Oktober 1983 (Stand am 1. Januar 2013). For the full text, please see www.admin.ch/ch/d/sr/4/420.1.de.pdf (last visited Jun. 3, 2013).
[6] Id.
[7] Id.
[8] CTI, CTI Multi-year Program 2013-2016 7(2012), available at http://www.kti.admin.ch/?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDeYR,hGym162epYbg2c_JjKbNoKSn6A-- (last visited Jun. 3, 2013).
[9] Supra note 5.
[10] Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/Pages/default.aspx (last visited Jun. 3, 2013).
[11] Id.
[12] Foundation Council, Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/Pages/foundationcouncil.aspx (last visited Jun. 3, 2013).
[13] See Statutes of Swiss National Science Foundation Art.8 & Art. 9, available at http://www.snf.ch/SiteCollectionDocuments/statuten_08_e.pdf (last visited Jun. 3, 2013).
[14] National Research Council, Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/researchcouncil/Pages/default.aspx (last visted Jun.3, 2013).
[15] Theres Paulsen, VISION RD4SD Country Case Study Switzerland (2011), http://www.visionrd4sd.eu/documents/doc_download/109-case-study-switzerland (last visited Jun.6, 2013).
[16] Research Commissions, Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/Pages/researchcommissions.aspx (last visted Jun. 6, 2013).
Adopting Flexible Mechanism to Promote Public Procurement of Innovation—the Amendment of Article 27 of the Statute for Industrial Innovation I.Introduction To further industrial innovation, improve industrial environment, and enhance industrial competitiveness through a systematic long-term approach, the Statute for Industrial Innovation (hereinafter referred to as the Statute) has been formulated in Taiwan. The central government authority of this Statute is the Ministry of Economic Affairs, and the Industrial Development Bureau of the Ministry of Economic Affairs (henceforth referred to as the IDB) is the administrative body for the formulation of this Statute. Since its formulation and promulgation in 2010, the Statute has undergone four amendments. The latest amendment, passed by the Legislative Yuan on November 3, 2017, on the third reading, is a precipitate of the international industrial development trends. The government is actively encouraging the investment in industrial innovation through a combination of capital, R&D, advanced technologies and human resources to help the promotion of industrial transformation, hence this large scale amendment is conducted. The amendment, promulgated and enacted on November 22, 2017, focuses on eight key points, which include: state-owned businesses partaking in R&D (Article 9-1 of the amended provisions of the Statute), the tax concessions of the limited partnership venture capital businesses (Article 2, Article 10, Article 12-1 and Article 23-1 of the amended provisions of the Statute), the tax concessions of Angel Investors (Article 23-2 of the amended provisions of the Statute), applicable tax deferral of employees' stock compensation (Article 19-1 of the amended provisions of the Statute), tax deferral benefit of stocks given to research institution creators (Article 12-2 of the amended provisions of the Statute), the promotion of flexible mechanism for innovation procurement (Article 27 of the amended provisions of the Statute), the establishment of evaluation mechanism for intangible assets (Article 13 of the amended provisions of the Statute), and forced sale auction of idled land for industrial use (Article 46-1 of the amended provisions of the Statute). This paper focuses on the amendment of Article 27 of the Fourth Revision of the Statute, which is also one of the major focuses of this revision—promoting flexible mechanism for innovation procurement, using the mass-market purchasing power of the government as the energetic force for the development of industrial innovation. II.Explanation of the Amendment of Article 27 of the Statute 1.Purposes and Descriptions of the Amendment of Article 27 of the Statute The original intent of Article 27 (hereinafter referred to as the Article) of the Statute, prior to the latest amendment (content of the original provisions is shown in Table 1), was to encourage government agencies and enterprises to give a priority to using green products through the "priority procurement" provisions of Paragraph 2, which allow government agencies to award contracts to green product producers using special government procurement procedures, so as to increase the opportunities for government agencies to use green products, and thereby promote the sustainable development of the industry. In view of the inherent tasks of promoting the development of industrial innovation, and considering that, using the large-scale government procurement demand to guide industrial innovation activities, has become the policy instrument accepted by most advanced countries, the IDB expects that, with the latest amendment of Article 27, the procurement mechanism policy for software, innovative products and services, in addition to the original green products, may become influential, and that "innovative products and services" may be included in the scope of "Priority Procurement" of this Article namely, make “priority procurement of innovative products and services” as one of the flexible mechanisms for promoting innovation procurement. A comparison of the amended provisions and the original provisions is shown in Table 1, and an explanation of the amendment is described as follows:[1] Table 1 A Comparison of Article 27 Amendment of the Statute for Industrial Innovation Amended Provisions Original Provisions Article 27 (I) Each central government authority in charge of end enterprises of a specific industry shall encourage government organizations (agencies) and enterprises to procure software, innovative and green products or services. (II) To enhance the procurement efficiencies, as effected by supply and demand, the central government authority shall offer assistance and services to the organizations (agencies) that handle these procurements as described in the preceding paragraph; wherein, Inter-entity Supply Contracts that are required for the aforesaid procurements, the common requirements shall be decided, in accordance with policy requirements, upon consultation between the central government authority and each central government authority in charge of end enterprises of a specific industry. (III) Where the software, innovative and green products or services, as described in Paragraph 1, must be tested, audited, accredited and certified, their associated fees and charges may be reduced, exempted, or suspended. (IV) Government organizations (agencies) may specify in the tender document the priority procurement of innovative and green products or services that have been identified to meet the requirements of paragraph 1. However, such a specification shall not violate treaties or agreements that have been ratified by the Republic of China. The measures concerning specifications, categories, and identification procedures of software, innovative and green products or services as prescribed in Paragraph 1; the testing, auditing criteria, accreditation and certification as prescribed in paragraph 3; and the Priority Procurement in paragraph 4 and other relevant items, shall be established by each central government authority in charge of end-enterprises of a specific industry. Article 27 (I) Each central government authority in charge of end enterprises shall encourage government agencies and enterprises to give priority to green products that are energy/resources recyclable/renewable, energy and water saving, non-toxic, less-polluting, or able to reduce the burden on the environment. (II) Agencies may specify in the tender documents that priority is given to green products meeting the requirement set forth in the preceding Paragraph. (III) The regulations governing the specifications, categories, certification procedures, review standards, and other relevant matters relating to the green products as referred to in the preceding Paragraph shall be prescribed by the central government authorities in charge of end enterprises. Source: The Ministry of Economic Affairs (I).Paragraph 1 In order to compel each central government authority in charge of end enterprises of a specific industry to motivate industrial innovation activities and sustainable development on the basis of requirements, and to support the development of the software industry in Taiwan, the provision, that such an authority should encourage government organizations (agencies) and enterprises to procure software and innovative products and services, is added in paragraph 1. (II).Paragraph 2 This procurement, as described in paragraph 1, is different from the property or services procurement of general affairs as handled by various organizations. To enhance procurement efficiencies, as effected by supply and demand, the central government authority, i.e., the Ministry of Economic Affairs, shall provide relevant assistance and services to organizations (agencies) handling these procurements, hence the added provisions in paragraph 2. For purchases using inter-entity supply contracts, which are bound by the requirements of this Article, due to their prospective nature, and that the common demand of each organization is difficult to make an accurate estimate by using a demand survey or other method, the Ministry of Economic Affairs shall discuss the issues with each central government authority in charge of end-enterprises of a specific industry, who consult or promote policies, and are in charge of end enterprises of a specific industry, and then make decisions in accordance with the policy promotion requirements. (III).Paragraph 3 The fee schedule for testing, auditing, accrediting and certifying software, innovative and green products or services is covered by Article 7, Administrative Fees of the Charges And Fees Act. The authorities in charge should determine relevant fee standards.However, considering that the test, audit, accreditation and certification may be conducted during a trial or promotional period, or circumstances dictate that it is necessary to motivate tenderer participation, the fee may be reduced, waived or suspended; hence, paragraph 3 is added. (IV).Paragraph 4 Paragraph 2 of the original provision is moved to paragraph 4 with the revisions made to paragraph 1, accordingly, and the provision for using Priority Procurement to handle innovative products or services is added. However, for organizations covered by The Agreement on Government Procurement (GPA), due to Taiwan's accession to the WTO, ANZTEC, and ASTEP, their procurement of items covered in the aforesaid agreements with a value reaching the legislated threshold, shall be handled in accordance with the regulations stipulated in the aforesaid agreements; hence the stipulation in the proviso that the procurement must not violate the provisions of treaties or agreements ratified by the Taiwan government. (V).Paragraph 5 Paragraph 3 of the original Article is moved to paragraph 5 with the revisions made to paragraph 1, accordingly, and the provision, that authorizes each central government authority in charge of end enterprises of a specific industry to determine appropriate measures concerning the methods of defining software, innovative and green products and services, as well as matters relating to test, accreditation, certification and priority procurement, is added. 2.The Focus of the Amendment of Article 27 of the Statute—Promoting a Flexible Mechanism for Innovation Procurement As previously stated, the amendment of this Article aims to stimulate activities of industrial innovation by taking advantage of the huge demand from government agencies. With the government agencies being the users of the innovative products or services, government's procurement market potential is tapped to support the development of industrial innovation. The original intention of amendment is to incorporate the spirit of Public Procurement of Innovation[2] into this Article, and to try to introduce EU's innovation procurement mechanism[3] into our laws. So that, a procurement procedure, that is more flexible and not subject to the limitation of procurement procedures currently stipulated by the Government Procurement Act, may be adopted to facilitate government sector action in taking the lead on adopting innovative products or services that have just entered their commercial prototype stage, or utilizing the demand for innovation in the government sector to drive industry's innovative ideas or R&D (that can not be satisfied with the existing solutions in the marketplace). However, while it is assessing the relevant laws and regulations of our government procurement system and the practice of implementation, the use of the current government procurement mechanism by organizations in the public sector to achieve the targets of innovation procurement is still in its infancy. It is difficult to achieve the goal, in a short time, of establishing a variety of Public Procurement of Innovation Solutions (PPI Solutions) as disclosed in the EU's Directive 2014/24 / EU, enacted by the EU in 2014, in ways that are not subject to current government procurement legislation. Hence, the next best thing: Instead of setting up an innovative procurement mechanism in such a way that it is "not subject to the restrictions of the current government procurement law", we will focus on utilizing the flexible room available under the current system of government procurement laws and regulations, and promoting the "flexible mechanism for innovation procurement” paradigm. With the provisions now provided in Article 27 of the Statute for Industrial Innovation, the government sector is authorized to adopt the "Priority Procurement" method on innovative products and services, thus increasing the public sector's access to innovative products and services. With this amendment, in addition to the "green products" listed in the original provisions of paragraph 1 of the Statute, "software" and "innovative products or services"[4] are now incorporated into the target procurement scope and each central government authority in charge of end enterprises of a specific industry should now encourage government organizations and enterprises to implement; however, the provisions of this paragraph do not have the specific effect of law, they are declaratory provisions. Two priorities are the１ primary focus of the provisions of paragraph 2 and paragraph 4 of this Article for promoting flexible mechanism for innovation procurement: (I)The procurement of software, innovative and green products or services that uses Inter-entity Supply Contracts may rely on the "policy requirement" to establish the common demand. According to the first half of the provisions of paragraph 2 of this Article, the Ministry of Economic Affairs, being the central government authority of the Statute, may provide assistance and services to organizations dealing with the procurement of software, innovative and green products and services.This is because the procurement subjects, as pertaining to software, products or services that are innovative and green products (or services), usually have the particularities (especially in the software) of the information professions; different qualities (especially in innovative products or services), and are highly profession-specific. They are different from the general affairs goods and services procured by most government agencies. Hence, the Ministry of Economic Affairs may provide assistance and service to these procurement agencies, along with the coordination of relevant organizations, in matters relating to the aforesaid procurement process in order to improve procurement efficiency as relates to supply and demand. Pursuant to the second half of Paragraph 2 of this Article, if the inter-entity supply contract method is used to process the procurement of software, innovative products and services, green products (or services) and other related subjects, there could be "Commonly Required" by two or more organizations concerning the procurement subjects, so in accordance with the stipulations of Article 93 of the Government Procurement Act, and Article 2 of the Regulations for The Implementation of Inter-entity Supply Contracts[5], an investigation of common requirements should be conducted first. However, this type of subject is prospective and profession-specific (innovative products or services in particular), and government organizations are generally not sure whether they have demand or not, which makes it difficult to reliably estimate the demand via the traditional demand survey method[6], resulting in a major obstacle for the procurement process. Therefore, the provisions are now revised to allow the Ministry of Economic Affairs to discuss procurement with each central government authority in charge of end enterprises of a specific industry, who consult or promote policies (such as the National Development Council, or central government authority in charge of end enterprises of a specific industry relevant to the procurement subjects), and then make decisions based on the quantities of goods and services of common requirements in accordance with the demand for promoting the policy. The provisions explicitly stipulate such flexibility in adopting methods other than the "traditional demand survey" method, as is required by laws for the common demand of Inter-entity Supply Contracts. Thus, agencies currently handling procurement of prospective or innovative subjects using inter-entity supply contracts, may reduce the administrative burden typically associated with conducting their own procurement. In addition, with a larger purchase quantity demand, as generated from two or more organizations, the process can more effectively inject momentum into the industry, and achieve a win-win situation for both supply and demand. (II)Government organizations may adopt "Priority Procurement" when handling procurement of innovative and green products or services. Prior to the amendment, the original provision of paragraph 2 of this Article stipulates that organizations may specify in the tender document Priority Procurement of certified green products; Additionally, a provision of paragraph 3 of the original Article stipulates that each central government authority in charge of end enterprises of a specific industry is authorized to establish the specifications, categories and other relevant matters of the green products[7] (according to the interpretation of the original text, it should include "Priority Procurement" in paragraph 3 of the Article).After the amendment of the Article, paragraph 2 of the original Article is moved to paragraph 4. In addition to the original green products, "innovative products or services" are included in the scope of "Priority Procurement" that organizations are permitted to adopt (but, the "software" in paragraph 1 was not included[8]). However, for organizations covered by The Agreement on Government Procurement (GPA), due to Taiwan's accession to the WTO, ANZTEC, and ASTEP, their procurement of items covered by the aforesaid agreements with a value reaching the stated threshold, shall be handled in accordance with the regulations stipulated in the aforesaid agreements; hence the stipulation in the proviso that the procurement must not violate the provisions in treaties or agreements ratified by the Taiwan government. Additionally, paragraph 3 of the original Article is moved to paragraph 5. Each central government authority in charge of end enterprises of a specific industry is authorized to use their own judgment on matters concerning the specifications, categories, certification processes of software, innovative and green products or services and the method for Priority Procurement of paragraph 4. In accordance with the authorization in paragraph 5 of the amended provision of this Article, each central government authority in charge of end enterprises of a specific industry may, depending on the specific policy requirement that promotes innovation development of its supervised industry, establish methods of identification and the processes of Priority Procurement for “Specific categories of innovative products or services", especially on products or services fitting the requirements of the method of using the demands of government organizations to stimulate industrial innovation. The established "Regolations for priority procurement of Specific categories of innovative products or services" is essentially a special regulation of the government procurement legislation, which belongs to the level of regulations, that is, it allows the organizations to apply measures other than the government procurement regulations and its related measures to the procurement process, and adopt "Preferential Contract Awarding" for qualified innovative products or services. Any government agency that has the need to procure a particular category of innovative product or service may, in accordance with the provisions of paragraph 4 of this Article, specify the use of Priority Procurement in the tender document, and administer the procurement, in accordance with the process of this particular category of innovative products, or priority procurement. The agency is now enabled to follow a more flexible procurement process than that of the government procurement regulations to more smoothly award contracts for qualified innovative products or services. Citing two examples of this applied scenario: Example one, "innovative information services": The central government authority in charge of information services is IDB. Thus, IDB may, according to the authorization provided for in paragraph 5 of the Article, establish the identification methods for innovative information services (the purpose of which is to define the categories and specifications of innovative services covered in the scope of priority procurement) and priority procurement processes, pertaining to emerging information services that are more applicable to the requirements of government agencies, such as: cloud computing services, IoT services, and Big Data analysis services.Example two, "Innovative construction or engineering methods": The central government authority in charge of construction affairs is the Construction and Planning Agency of the Ministry of the Interior. Since the agency has already established the "Guidelines for Approval of Applications for New Construction Techniques, Methods, Equipment and Materials", the agency may establish a priority procurement process for new construction techniques, methods or equipment, in accordance with the stipulations in paragraph 5 of the Article. Government agencies may conduct procurement following any of these priority procurement practices, if there is a requirement for innovative information services, or new construction techniques, methods or equipment. In addition to the two aforementioned flexible mechanisms for innovation procurement, where government agencies are granted flexible procedures to handle the procurement of innovative products or services via the use of the flexible procurement mechanism, paragraph 3, concerning the incentive measures of concessionary deductions, is added to the Article to reduce the bidding costs for tenderers participating in the tender. For the Procurement of software, innovative and green products or services encouraged by each central government authority in charge of end-enterprises of a specific industry (not limited to those handled by the authorities themselves, using inter-entity supply contracts or priority procurement methods), if the procurement subjects are still required to be tested, audited, accredited and certified by the government agencies, such a process falls under the scope of administrative fees collection, pursuant to paragraph 1 Article 7 of the Charges And Fees Act. However, considering that the item subject to test, audit, accreditation and certification may be in a trial or promotional period, or that it may be necessary to motivate tenderer participation, the provisions of paragraph 3 are thusly added to the Article to reduce, waive, or suspend the collection of aforementioned fees. Executive authorities in charge of collecting administrative fees shall proceed to reduce, waive, or suspend the collection pursuant to the stipulations of paragraph 3 of the Article and Article 12 subparagraph 7 of the Charges And Fees Act.[9] III.The direction of devising supporting measures of flexible mechanism for innovation procurement The latest amendment of the Statute for Industrial Innovation was promulgated and enacted on November 22, 2017, it is imperative that supporting measures pertaining to Article 27 of the Statute be formulated. As previously stated, the flexible mechanism for innovation procurement, as promoted in this Article, is designed specifically for the products or services that are pertinent to the government procurement requirements and are capable of stimulating industrial innovation, and providing a more flexible government procurement procedure for central authorities in charge of a specific industry as a policy approach in supporting industry innovation. Thus, the premise of devising relevant supporting measures is dependent on whether the specific industry, as overseen by the particular central authority, has a policy in place for promoting the development of industrial innovation, and on whether it is suitable in promoting the flexible mechanism for innovation procurement as described in this Article. The purpose of this Article is to promote the flexible mechanism for innovation procurement. Supporting measures pertaining to this Article will focus on the promotion of devising an "Innovation Identification Method", and of the "Priority Procurement Process" of the innovative products or services of each industry that central government authorities oversee. The former will rely on each central government authority in charge of a specific industry to charter an industry-appropriate and profession-specific planning scheme; while, for the latter, the designing of a priority procurement process, in accordance with the nature of the various types of innovative products or services, does not have to be applicable to all. However, regardless what type of innovative products or services the priority procurement process is designed for, the general direction of consideration should be given to - taking the different qualities of innovative products or services as the core consideration. Additionally, the attribute of the priority procurement procedures focusing specifically on the different qualities of the innovative subjects relates to the special regulation relevant to the government procurement regulations. Thus, the procurement procedures should follow the principle that if no applicable stipulation is found in the special regulation, the provisions of the principal regulation shall apply. The so-called "Priority Procurement" process refers to the "Preferential Contract Awarding" on tenders that meet certain criteria in a government procurement procedure. The existing Government Procurement Act (GPA, for short) and its related laws that have specific stipulations on "Priority Procurement" can be found in the "Regulations for Priority Procurement of Eco-Products" (Regulations for Eco-Products Procurement, for short), and the "Regulations for Obliged Purchasing Units / Institutions to Purchase the Products and Services Provided by Disabled Welfare Institutions, Organizations or Sheltered Workshops" (Regulations for Priority Procurement of Products or Services for Disabled or Shelters, for short). After studying these two measures, the priority procurement procedures applicable to criteria-conformed subjects can be summarized into the following two types: 1.The first type: Giving preferential contract awarding to the tenderer who qualifies with "the lowest tender price”, as proposed in the tender document, and who meets a certain criteria (for example, tenderers of environmental products, disabled welfare institutions, or sheltered workshops). There are two scenarios: When a general tenderer and the criteria-conformed tenderer both submit the lowest tender price, the criteria-conformed tenderer shall obtain the right to be the "preferential winning tender" without having to go through the Price Comparison and Reduction Procedures. Additionally, if the lowest tender price is submitted by a general tenderer, then the criteria-conformed tenderers have the right to a "preferential price reduction” option, that is, the criteria-conformed tenderers can be contacted, in ascending order of the tender submitted, with a one time option to reduce their bidding prices. The first tenderer who reduces their price to the lowest amount shall win the tender. Both the Regulations for Eco-Products Procurement[10] and Regulations for Priority Procurement of Products or Services for Disabilities or Shelters[11] have such relevant stipulations. 2.The second type: It is permitted to give Preferential Contract Awarding to a criteria-conformed tenderer, when the submitted tender is within the rate of price preference. When the lowest tenderer is a general tenderer, and the tender submitted by the criteria-conformed tenderer is higher than the lowest tender price, the law permits that if the tender submitted is "within the rate of price preference ", as set by the procuring entity, the procuring entity may award the contract preferentially to "the tender submitted by the criteria-conformed tenderer." The premise for allowing this method is that the tender submitted by the criteria-conformed tenderer must be within the preferential price ratio. If the submitted tender is higher than the preferential price ratio, then the criteria-conformed tenderer does not have the right to preferential contract awarding. The contract will be awarded to theother criteria-conformed tenderer, or to a general tenderer. This method is covered in the provisions of the Regulations for Eco-Products Procurement[12]. However, the important premise for the above two priority procurement methods is that the nature of the subject matter of the tender is suitable for adopting the awarding principle of the lowest tender (Article 52, Paragraph 1, Subparagraphs 1 and 2 of the Procurement Act), that is, it is difficult to apply these methods to the subjects if they are different qualities. Pursuant to the provisions of Article 66 of the Enforcement Rules of the Government Procurement Act, the so-called "different qualities" refers to the construction work, property or services provided by different suppliers that are different in technology, quality, function, performance, characteristics, commercial terms, etc. Subjects of different qualities are essentially difficult to compare when based on the same specifications. If just looking at pricing alone it is difficult to identify the advantages and disadvantages of the subjects, hence, the awarding principle of the lowest tender is not appropriate. The innovative subjects are essentially subjects of different qualities, and under the same consideration, they are not suitable for applying the awarding principle of the lowest tender. Therefore, it is difficult to adopt the lowest-tender-based priority procurement method for the procurement of innovative subjects. In the case of innovative subjects with different qualities, the principle of the most advantageous tender should be adopted (Article 52 Paragraph 1 Subparagraph 3 of the Procurement Act) to identify the most qualified vender of the subjects through open selection. Therefore, the procedure for the priority procurement of innovative subjects with different qualities should be based on the most advantageous tender principle with focus on the "innovativeness" of the subjects, and consideration on how to give priority to tenderers, who qualify with the criteria of innovation. Pursuant to the provisions of Article 56 Paragraph 4 of the Procurement Act, the Procurement and Public Construction Commission has established the "Regulations for Evaluation of the Most Advantageous Tender". The tendering authorities adopting the most advantageous tender principle should abide by the evaluation method and procedures delineated in the method, and conduct an open selection of a winning tender. According to the Regulations for Evaluation of the Most Advantageous Tender, in addition to pricing, the tenderers' technology, quality, function, management, commercial terms, past performance of contract fulfillment, financial planning, and other matters pertaining to procurement functions or effectiveness, maybe chosen as evaluation criteria and sub-criteria. According to the three evaluation methods delineated in the provisions of Article 11 of the Regulations for Evaluation of the Most Advantageous Tender (overall evaluation score method, price per score point method, and ranking method), pricing could not been included in the scoring. That is, "the prices of the subjects" is not the absolute criterion of evaluation of the most advantageous tender process. The priority procurement procedures designed specifically for innovative subjects with different qualities may adopt an evaluation method that excludes "pricing" as part of the scoring criterion so as to give innovative subject tenderers the opportunity to be more competitive in the bidding evaluation process, and due to the extent of their innovativeness, obtain the right to preferential tenders. If it must be included in the scoring, the percentage of the total score for pricing should be reduced from its usual ratio[13], while stipulating explicitly that "innovation" must be included as part of the evaluation criteria. In addition, its weight distribution should not be less than a ratio that highlights the importance of innovation in the evaluation criteria. Furthermore, when determining how to give preference to tenderers who meet certain innovation criteria in the contract awarding procedures, care should be taken to stay on focus with the degree of innovation of the subject (the higher the degree of innovation, the higher the priority), rather than giving priority to arbitrary standards. In summary, with consideration of priority procurement procedures designed specifically for innovative subjects with different qualities, this paper proposes the following preliminary regulatory directions: 1.Adopt the awarding principle of the most advantageous tender. 2.Explicitly stipulate the inclusion of "innovation" in the evaluation criteria and sub-criteria, and its ratio, one that indicates its importance, should not be less than a certain percentage of the total score (for example 20%). 3.Reduce the distributed ratio of "price" in the scoring criteria in the open selection. 4.After the members of the evaluation committee have concluded the scoring, if more than two tenderers have attained the same highest overall evaluated score or lowest quotient of price divided by overall evaluated score, or more than two tenderers have attained the first ranking, the contract is awarded preferentially to the tenderer who scores the highest in the "innovation" criterion. 5.When multiple awards (according to Article 52 Paragraph 1 Subparagraph 4 of the Procurement Act) are adopted, that is, there is more than one final winning tender, the procuring entity may select the tenderers with higher innovation scores as the price negotiation targets for contract awarding, when there are more than two tenderers with the same ranking. Using the above method to highlight the value of innovative subjects will make these suppliers more competitive, because of their innovativeness ratings in the procurement procedures, and not confine them to the limitation of price-determination. So that, subject suppliers with a high degree of innovation, may attain the right to the preferential contract awarding that they deserve due to their innovativeness, and the procuring entity can purchase suitable innovative products in a more efficient and easy process. It also lowers the threshold for tenderers with innovation energy to enter the government procurement market, thus achieving the goal of supporting industrial innovation and creating a win-win scenario for supply and demand. [1] Cross-reference Table of Amended Provisions of the Statute for Industrial Innovation, The Ministry of Economic Affairs, https://www.moea.gov.tw/MNS/populace/news/wHandNews_File.ashx?file_id=59099 (Last viewed date: 12/08/2017). [2] According to the Guidance for public authorities on Public Procurement of Innovation issued by the Procurement of Innovation Platform in 2015, the so-called innovation procurement in essence refers to that the public sector can obtain innovative products, services, or work by using the government procurement processes, or that the public sector can administer government procurement with a new-and-better process. Either way, the implementation of innovation procurement philosophy is an important link between government procurement, R & D and innovation, which shortens the distance between the foresighted emerging technologies/processes and the public sector/users. [3] The EU's innovative procurement mechanism comprises the "Public Procurement of Innovation Solutions" (PPI Solutions) and "Pre-Commercial Procurement" (PCP). The former is one of the government procurement procedures, explicitly regulated in the new EU Public Procurement Directive (Directive 2014/24 / EU), for procuring solutions that are innovative, near or in preliminary commercial prototype; The latter is a procurement process designed to assist the public sector in obtaining technological innovative solutions that are not yet in commercial prototype, must undergo research and development process, and are not within the scope of EU Public Procurement Directive. [4] The "software, innovative and green products or services", as described in paragraph 1 of Article 27 of the amended Statute for Industrial Innovation, refers to, respectively, "software", "innovative products or services", and "green products or services" in general. There is no co-ordination or subordination relationship between the three; the same applies to "innovative and green products or services" in paragraph 4. [5] Article 93 of the Government Procurement Act stipulates: "An entity may execute an inter-entity supply contract with a supplier for the supply of property or services that are commonly needed by entities." Additionally, Article 2 of the Regulations for The Implementation of Inter-entity Supply Contracts stipulates: "The term 'property or services that are commonly needed by entities' referred to in Article 93 of the Act means property or services which are commonly required by two or more entities. The term 'inter-entity supply contract (hereinafter referred to as the “Contract”)' referred to in Article 93 of the Act means that an entity, on behalf of two or more entities, signs a contract with a supplier for property or services that are commonly needed by entities, so that the entity and other entities to which the Contract applies can utilize the Contract to conduct procurements." Therefore, according to the interpretation made by the Public Construction Commission, the Executive Yuan (PCC, for short), organizations handling inter-entity supply contracts should first conduct a demand investigation. [6] In general, organizations in charge of handling the inter-entity supply contracts will disseminate official documents to applicable organizations with an invitation to furnish information online about their interests and estimated requirement (for budget estimation) at government's e-procurement website. However, in the case of more prospective subjects (such as cloud services of the emerging industry), it may be difficult for an organization to accurately estimate the demand when filling out the survey, resulting in a mismatch of data between the demand survey and actual needs. [7] In accordance with the authorization of paragraph 3 of the Article, the IDB has established "Regulations Governing Examination and Identification of Advanced Recycled Products by Ministry of Economic Affairs" (including an appendix: Identification Specification for Resource Regenerating Green Products), except that the priority procurement process was not stipulated, because the Resource Regenerating Green Products, that meet the requirements of the Ministry of Economic Affairs, are covered by the "Category III Products" in the provisions of Article 6 of the existing "Regulations for Priority Procurement of Eco-Products", set forth by the PPC and The Environmental Protection Administration of the Executive Yuan. Hence, organizations that have the requirement to procure green products, may proceed with priority procurement by following the regulations in the "Regulations for Priority Procurement of Eco-Products". [8] After the amendment of the Article, the "software" in the provisions of paragraph 1 was excluded in paragraph 4, because the objective of paragraph 4 is to promote industry innovation and sustainable development with the use of a more flexible government procurement procedure. Thus, the subjects of the priority procurement mechanism are focused on "innovative" and "green" products or services, which exclude popular "software" that has a common standard in the market. However, if it is an "innovative software", it may be included in the "innovative products or services" in the provisions of paragraph 4. [9] According to the provisions of Article 12 of the Charges And Fees Act: "In any of the following cases, the executive authority in charge of the concerned matters may waive or reduce the amount of the charges and fees, or suspend the collection of the charges and fees: 7. Waiver, reduction, or suspension made under other applicable laws." [10] Refer to Article 12, Paragraph 1, Subparagraphs 1 and Article 13, Paragraph 1 and 2 of Regulations for Priority Procurement of Eco-Products. [11] Refer to Article 4 of Regulations for Obliged Purchasing Units / Institutions to Purchase the Products and Services Provided by Disabled Welfare Institutions, Organizations or Sheltered Workshops. [12] Refer to Article 12, Paragraph 1, Subparagraphs 2 and Article 13, Paragraph 3 of Regulations for Priority Procurement of Eco-Products. [13] The provisions of paragraph 3 Article 16 of the Regulations for Evaluation of the Most Advantageous Tender stipulates: Where price is included in scoring, its proportion of the overall score shall be not less than 20% and not more than 50%.
The Research on ownership of cell therapy productsThe 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).
The opening and sharing of scientific data- The Data Policy of the U.S. National Institutes of HealthThe 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).
Hard Law or Soft Law? –Global AI Regulation Developments and Regulatory ConsiderationsHard Law or Soft Law? –Global AI Regulation Developments and Regulatory Considerations 2023/08/18 Since the launch of ChatGPT on November 30, 2022, the technology has been disrupting industries, shifting the way things used to work, bringing benefits but also problems. Several law suits were filed by artists, writers and voice actors in the US, claiming that the usage of copyright materials in training generative AI violates their copyright.[1] AI deepfake, hallucination and bias has also become the center of discussion, as the generation of fake news, false information, and biased decisions could deeply affect human rights and the society as a whole.[2] To retain the benefits of AI without causing damage to the society, regulators around the world have been accelerating their pace in establishing AI regulations. However, with the technology evolving at such speed and uncertainty, there is a lack of consensus on which regulation approach can effectively safeguard human rights while promoting innovation. This article will provide an overview of current AI regulation developments around the world, a preliminary analysis of the pros and cons of different regulation approaches, and point out some other elements that regulators should consider. I. An overview of the current AI regulation landscape around the world The EU has its lead in legislation, with its parliament adopting its position on the AI ACT in June 2023, heading into trilogue meetings that aim to reach an agreement by the end of this year.[3] China has also announced its draft National AI ACT, scheduled to enter its National People's Congress before the end of 2023.[4] It already has several administration rules in place, such as the 2021 regulation on recommendation algorithms, the 2022 rules for deep synthesis, and the 2023 draft rules on generative AI.[5] Some other countries have been taking a softer approach, preferring voluntary guidelines and testing schemes. The UK published its AI regulation plans in March, seeking views on its sectoral guideline-based pro-innovation regulation approach.[6] To minimize uncertainty for companies, it proposed a set of regulatory principles to ensure that government bodies develop guidelines in a consistent manner.[7] The US National Institute of Standards and Technology (NIST) released the AI Risk Management Framework in January[8], with a non-binding Blueprint for an AI Bill of Rights published in October 2022, providing guidance on the design and use of AI with a set of principles.[9] It is important to take note that some States have drafted regulations on specific subjects, such as New York City’s Final Regulations on Use of AI in Hiring and Promotion came into force in July 2023.[10] Singapore launched the world’s first AI testing framework and toolkit international pilot in May 2022, with the assistance of AWS, DBS Bank, Google, Meta, Microsoft, Singapore Airlines, etc. After a year of testing, it open-sourced the software toolkit in July 2023, to better develop the system.[11] There are also some countries still undecided on their regulation approach. Australia commenced a public consultation on its AI regulatory framework proposal in June[12], seeking views on its draft AI risk management approach.[13] Taiwan’s government announced in July 2023 to propose a draft AI basic law by September 2023, covering topics such as AI-related definition, privacy protections, data governance, risk management, ethical principles, and industrial promotion.[14] However, the plan was recently postponed, indicating a possible shift towards voluntary or mandatory government principles and guidance, before establishing the law.[15] II. Hard law or soft law? The pros and cons of different regulatory approaches One of the key advantages of hard law in AI regulation is its ability to provide binding legal obligations and legal enforcement mechanisms that ensure accountability and compliance.[16] Hard law also provides greater legal certainty, transparency and remedies for consumers and companies, which is especially important for smaller companies that do not have as many resources to influence and comply with fast-changing soft law.[17] However, the legislative process can be time-consuming, slower to update, and less agile.[18] This poses the risk of stifling innovation, as hard law inevitably cannot keep pace with the rapidly evolving AI technology.[19] In contrast, soft law represents a more flexible and adaptive approach to AI regulation. As the potential of AI still remains largely mysterious, government bodies can formulate principles and guidelines tailored to the regulatory needs of different industry sectors.[20] In addition, if there are adequate incentives in place for actors to comply, the cost of enforcement could be much lower than hard laws. Governments can also experiment with several different soft law approaches to test their effectiveness.[21] However, the voluntary nature of soft law and the lack of legal enforcement mechanisms could lead to inconsistent adoption and undermine the effectiveness of these guidelines, potentially leaving critical gaps in addressing AI's risks.[22] Additionally, in cases of AI-related harms, soft law could not offer effective protection on consumer rights and human rights, as there is no clear legal obligation to facilitate accountability and remedies.[23] Carlos Ignacio Gutierrez and Gary Marchant, faculty members at Arizona State University (ASU), analyzed 634 AI soft law programs against 100 criteria and found that two-thirds of the program lack enforcement mechanisms to deliver its anticipated AI governance goals. He pointed out that credible indirect enforcement mechanisms and a perception of legitimacy are two critical elements that could strengthen soft law’s effectiveness.[24] For example, to publish stem cell research in top academic journals, the author needs to demonstrate that the research complies with related research standards.[25] In addition, companies usually have a greater incentive to comply with private standards to avoid regulatory shifts towards hard laws with higher costs and constraints.[26] III. Other considerations Apart from understanding the strengths and limitations of soft law and hard law, it is important for governments to consider each country’s unique differences. For example, Singapore has always focused on voluntary approaches as it acknowledges that being a small country, close cooperation with the industry, research organizations, and other governments to formulate a strong AI governance practice is much more important than rushing into legislation.[27] For them, the flexibility and lower cost of soft regulation provide time to learn from industries to prevent forming rules that aren’t addressing real-world issues.[28] This process allows preparation for better legislation at a later stage. Japan has also shifted towards a softer approach to minimize legal compliance costs, as it recognizes its slower position in the AI race.[29] For them, the EU AI Act is aiming at regulating Giant Tech companies, rather than promoting innovation.[30] That is why Japan considers that hard law does not suit the industry development stage they’re currently in.[31] Therefore, they seek to address legal issues with current laws and draft relevant guidance.[32] IV. Conclusion As the global AI regulatory landscape continues to evolve, it is important for governments to consider the pros and cons of hard law and soft law, and also country-specific conditions in deciding what’s suitable for the country. Additionally, a regular review on the effectiveness and impact of their chosen regulatory approach on AI’s development and the society is recommended. [1] ChatGPT and Deepfake-Creating Apps: A Running List of Key AI-Lawsuits, TFL, https://www.thefashionlaw.com/from-chatgpt-to-deepfake-creating-apps-a-running-list-of-key-ai-lawsuits/ (last visited Aug 10, 2023); Protection for Voice Actors is Artificial in Today’s Artificial Intelligence World, The National Law Review, https://www.natlawreview.com/article/protection-voice-actors-artificial-today-s-artificial-intelligence-world (last visited Aug 10, 2023). [2] The politics of AI: ChatGPT and political bias, Brookings, https://www.brookings.edu/articles/the-politics-of-ai-chatgpt-and-political-bias/ (last visited Aug 10, 2023); Prospect of AI Producing News Articles Concerns Digital Experts, VOA, https://www.voanews.com/a/prospect-of-ai-producing-news-articles-concerns-digital-experts-/7202519.html (last visited Aug 10, 2023). [3] EU AI Act: first regulation on artificial intelligence, European Parliament, https://www.europarl.europa.eu/news/en/headlines/society/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence (last visited Aug 10, 2023). [4] 中國國務院發布立法計畫 年內審議AI法草案，經濟日報(2023/06/09)，https://money.udn.com/money/story/5604/7223533 (last visited Aug 10, 2023). [5] id [6] A pro-innovation approach to AI regulation, GOV.UK, https://www.gov.uk/government/publications/ai-regulation-a-pro-innovation-approach/white-paper (last visited Aug 10, 2023). [7] id [8] AI RISK MANAGEMENT FRAMEWORK, NIST, https://www.nist.gov/itl/ai-risk-management-framework (last visited Aug 10, 2023). [9] The White House released an ‘AI Bill of Rights’, CNN, https://edition.cnn.com/2022/10/04/tech/ai-bill-of-rights/index.html (last visited Aug 10, 2023). [10] New York City Adopts Final Regulations on Use of AI in Hiring and Promotion, Extends Enforcement Date to July 5, 2023, Littler https://www.littler.com/publication-press/publication/new-york-city-adopts-final-regulations-use-ai-hiring-and-promotionv (last visited Aug 10, 2023). [11] IMDA, Fact sheet - Open-Sourcing of AI Verify and Set Up of AI Verify Foundation (2023), https://www.imda.gov.sg/-/media/imda/files/news-and-events/media-room/media-releases/2023/06/7-jun---ai-annoucements---annex-a.pdf (last visited Aug 10, 2023). [12] Supporting responsible AI: discussion paper, Australia Government Department of Industry, Science and Resources,https://consult.industry.gov.au/supporting-responsible-ai (last visited Aug 10, 2023). [13] Australian Government Department of Industry, Science and Resources, Safe and responsible AI in Australia (2023), https://storage.googleapis.com/converlens-au-industry/industry/p/prj2452c8e24d7a400c72429/public_assets/Safe-and-responsible-AI-in-Australia-discussion-paper.pdf (last visited Aug 10, 2023). [14] 張璦，中央通訊社，AI基本法草案聚焦隱私保護、應用合法性等7面向 擬設打假中心，https://www.cna.com.tw/news/ait/202307040329.aspx (最後瀏覽日：2023/08/10)。 [15] 蘇思云，中央通訊社，2023/08/01，鄭文燦：考量技術發展快應用廣 AI基本法延後提出，https://www.cna.com.tw/news/afe/202308010228.aspx (最後瀏覽日：2023/08/10)。 [16] supra, note 13, at 27. [17] id. [18] id., at 28. [19] Soft law as a complement to AI regulation, Brookings, https://www.brookings.edu/articles/soft-law-as-a-complement-to-ai-regulation/ (last visited Aug 10, 2023). [20] supra, note 5. [21] Gary Marchant, “Soft Law” Governance of Artificial Intelligence (2019), https://escholarship.org/uc/item/0jq252ks (last visited Aug 10, 2023). [22] How soft law is used in AI governance, Brookings,https://www.brookings.edu/articles/how-soft-law-is-used-in-ai-governance/ (last visited Aug 10, 2023). [23] supra, note 13, at 27. [24] Why Soft Law is the Best Way to Approach the Pacing Problem in AI, Carnegie Council for Ethics in International Affairs,https://www.carnegiecouncil.org/media/article/why-soft-law-is-the-best-way-to-approach-the-pacing-problem-in-ai (last visited Aug 10, 2023). [25] id. [26] id. [27] Singapore is not looking to regulate A.I. just yet, says the city-state’s authority, CNBC,https://www.cnbc.com/2023/06/19/singapore-is-not-looking-to-regulate-ai-just-yet-says-the-city-state.html#:~:text=Singapore%20is%20not%20rushing%20to,Media%20Development%20Authority%2C%20told%20CNBC (last visited Aug 10, 2023). [28] id. [29] Japan leaning toward softer AI rules than EU, official close to deliberations says, Reuters, https://www.reuters.com/technology/japan-leaning-toward-softer-ai-rules-than-eu-source-2023-07-03/ (last visited Aug 10, 2023). [30] id. [31] id. [32] id.
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