Introduction to Tax Incentive Regime for SMEs

Introduction to Tax Incentive Regime for SMEs

I. Introduction

  The developments of SMEs (small-and-medium enterprises) plays an important pillar of development of industries and creation of jobs in Taiwan. In 2017, the total number of SMEs in Taiwan was 1,437,616. They offer 8,904,000 jobs, accounting for 78.44% of the workforce[1]. However, SMEs have difficulties in entering international supply chains because of their weakness in finance. Therefore, how to enhance the global competitiveness of SMEs is an important issue for the concerned authority. Chapter 4 of the Act for Development of Small and Medium Enterprises prescribes the tax incentive regime based on the financial capability of SMEs and characteristics of industries in order to facilitate the development of SMEs, especially the globalization of SMEs. This paper will review the importance of tax incentives to SMEs and introduces the tax incentive regime under the Act for Development of Small and Medium Enterprises In order to help SMES have an understanding of such regime.

II. SME Tax Incentives Scheme

  As the gatekeeper of the market, the government may intervene the market with various policies or tools to reallocate and improve the soundness of the market environment when the market competitions is impaired due to information asymmetry or externalities. At this juncture, preferential tax rates or tax deductions can be offered to specific taxpayers through legal institution. This allows these taxpayers to retain higher post-tax earnings so that they are incentified to invest more resources in the legally defined economic activities. Tax incentives targeting at risky or spillover investments to create benefits to specific economic activities will help the development of industries and markets.

  Whilst Article 10 of the Statute for Industrial Innovation has provided tax cuts for R&D expenditures, these incentives are not focus on SMEs and hence not supportive to their research and innovations. This was the reason for the 2016 amendment of the Act for Development of Small and Medium Enterprises added Article 35 to offer tax incentives in order to encourage R&D and innovative efforts and Article 35-1 to activate intellectual properties via licensing. These articles aim to accelerate the momentum of innovations and transformations which promoting investments for SMEs. OthersTo assist SMEs to cope with change of the business environment, the Article 36-2 added the tax incentives for salary or headcount increases, to contribute to the sustainability of SMEs and stabilize the labour market and industrial structures. Following is an explanation of the applicability of these schemes and the requirements to qualify such incentives.

III. Tax Incentives to Promote Investments

(I) Tax deductions for R&D expenditures

  Governments around the world seek to encourage corporate R&D activities, that Tax incentives are put in place to reduce R&D costs and foster a healthy environment of investment for more R&D initiatives. Neighboring countries such as Japan, Korea and Singapore are frequently practicing belowing tax burdens to encourage R&D efforts. Article 35 of the Act for Development of Small and Medium Enterprises in Taiwan allows accelerated depreciation and offers tax cuts[2] to stimulate R&D and innovations and create an investment friendly environment for SMEs.

1. Taxpaying Entities and Requirements

(1) Qualifications for SMEs

  Article 35 of the Act is applicable to qualified SMEs and individual taxpayers, which are (1) from manufacturing, construction & engineering, mining and quarrying industries, with paid-in capital below or equal to NT$80 million or with the number of full-time employees less than 200 people; (2) from other industries with the sales of the previous year below or equal to NT$100 million or with the number of full-time employees less than 100 people. Thus, the qualifications of Small and Medium Enterprises are based on either paid-in capital/sales or number of employees under the Act[3].Meanwhile, SMEs may not have an independent R&D department due to the limit of size or operating cost.Therefore, if the taxpayers hiring full-time R&D personnel that can provide records of job descriptions and work logs to R&D activities, the SMEs can access the tax incentives provided that the R&D functions. The recognized by government agencies is increasingly flexibility for SMEs seeking policy support.  

2. Taxpayers and requirements

(1) A certain degree of innovativeness

  As the tax incentive regime strives to promote innovations, the R&D expenses should be used to fund innovative developments. According to the official letters from the Small and Medium Enterprise Administration, Ministry of Economic Affairs, there is no high bar as forward-looking, risky and innovative as usually” required for other incentives previously, which is considering the size of SMEs and their industry characteristics. The “certain degree” of innovativeness shall be based on industry environments and SME businesses as determined by competent authorities in a flexible manner.

(2) Flexibility in the utilization of business income tax reductions

  To encourage regular R&D activities, The case that SMEs may not have R&D undertakings each year due to funding constraints, or start-up company may have incurred R&D expenditures but are not yet profitable and hence have no tax liabilities during the year, Corporate taxpayers were able to choose beside deduct the payable taxes during a single year, and reduce the payable taxes during the current year over three years starting from the year when tax incentives are applicable.

3. Tax incentive effects

  As previously mentioned, Article 35 of the Act for Development of Small and Medium Enterprises accommodates the characteristics of SMEs by allowing reductions of corporate business taxes for up to 15% R&D expenditures during the current year, or spreading the tax reductions by spreading up to 10% of the R&D expenditures over three years from the first year when the incentives are applicable. It is worth noting that the tax deductions shall not exceed 30% of the payable business income taxes during a single year.

  If the instruments and equipment for R&D, experiments or quality inspections have a lifetime over two years or longer, it is possible to accelerate the depreciation within half of the years of service prescribed by the income tax codes for fixed assets. However, the final year less than 12 months over the shortened service years shall not be counted. Accelerated depreciation brings in tax benefits for fixed asset investments during the initial stage, that meets the requirements for new technologies and risk management by frontloading the equipment depreciation and creates a buffer for capital utilization.

(II) Deferred taxations on licensing/capitalization of intellectual properties

  The deferral of tax payments under the Act for Development of Small and Medium Enterprises is meant to avoid any adverse effect on the application of technological R&Ds by SMEs. As the equity stakes via capitalization of intellectual properties by inventors or creators are not cashed out yet and the subsequent gains may not be at the same valuation as determined at the time of capitalization, the immediate taxation may hinder the willingness to transfer intellectual properties. Therefore, assisting SMEs to release intellectual properties with potential economic value, the licensing and capitalization of intellectual properties is strongly encouraged. The tax expenses shall be deferred within SME or an individual acquires stakes on a non-publicly-listed company by transferring their intellectual properties.

  This is to stimulate the applications and sharing of relevant manufacturing technologies. When an SME or an individual acquires stakes on a non-publicly-listed company by transferring their intellectual properties, their tax expenses shall be deferred.

1. Taxpayers and requirements

(1) Qualifications for individuals or SMEs

  Article 35-1 of the Act for Development of Small and Medium Enterprises is applicable to SMEs and individual taxpayers. This is to foster the growth of SMEs and enhancement of industry competitiveness by encouraging R&D and innovations from individuals and start-ups. To promote the commercialize of intellectual properties in different ways, the Act for Development of Small and Medium Enterprises provides income tax incentives to individuals and SMEs transferring intellectual properties. The purpose is to encourage different paths to industry upgrades.

(2) Ownership of intellectual properties

  To ensure that the proceeds of intellectual property is linked to the activity of intellectual properties which perform by individuals or SMEs. Only the owners of the intellectual properties capitalized and transferred can enjoy the tax benefits.

  Intellectual properties referred to in the Act for Development of Small and Medium Enterprises are the properties with value created with human activities and hence conferred with legal rights. These include but are not limited to copyrights, patent rights, trademarks, trade secrets, integrated circuit layouts, plant variety rights and any other intellectual properties protected by laws[4].

(3) Acquisition of stock options

  The abovementioned tax incentives are offered to the individuals or SMEs who transfer intellectual properties to non-listed companies in exchange of their new shares. The income taxes on the owners of intellectual properties are deferred until acquisition of shares. These shares are not registered with the book-entry system yet. Before the transferrers of intellectual properties dispose or offload these shares, immediate taxations will impose economic burdens and funding challenges given the unknown prices of the eventual cash-out. Therefore, this legislation is only applicable to taxpayers who obtain options for new shares.

2. Taxpayers and requirements

(1) Transfer of intellectual properties

  According to Article 36 of the Copyright Act as interpreted by official letters issued by the Ministry of Finance, the transfer of intellectual properties is the conferring of intellectual properties to others, and the transferees access these intellectual properties within the scope of the transfer. In terms “transfer” of the first and second paragraphs of Article 36 does not include licensing[5], but such as granting, licensing and inheritance.

(2) Timing of income tax payments

  In general, the particular time that calculation of taxes payable is based on when the taxpayers acquire the incomes, less relevant expenses or costs. The taxes payable timing should be depending on when the taxpayers obtain the newly issued shares by transferring intellectual properties. However, the levy of income taxes at the time of intellectual property transfers and new share acquisitions may cause a sudden jump in taxes payable in the progressive system and thus a burden on the economics of SMEs and individuals concerned. Thus, to avoid disruptions to company operations or personal finance planning, Article 36 makes the exception for the incomes earned by subscribing to new shares as a result of transferring intellectual properties. Such incomes are not subject to taxes during the year when the shares are acquired, in order to mitigate the tax barriers concerned.

  In sum, the taxes shall be paid when such shares are transferred, gifted or distributed.

3. Tax incentive effects

  Article 35-1 of the Act for Development of Small and Medium Enterprises provides tax incentives to stimulate the mobilization of intellectual properties by smoothing out the impact of income taxes payable. This is applicable to (1) SMEs who can postpone the business income taxes payable from the year when they acquire new shares of non-listed companies by transferring the intellectual properties they own; (2) individuals who can postpone the individual income taxes payable from the year when they acquire new shares of non-listed companies by transferring the intellectual properties they own.

IV. Tax incentives aiming to improve the business environment

(I) Tax reductions for wages to additional headcounts

  SMEs are vital to the Taiwan, making uo 90% of the companies accounting in Taiwan, who employ more than 6.5 million people or 72.8% of the total workforce. Any economic recession may make it difficult for SMEs to maintain their labor costs given their smaller funding size and external challenges. This will cause higher unemployment rates and hurt the economy, which may cause impairment of the capacity or create a labor gap for SMEs, eventually shrink the industry scale. To lower the burden of operational and investment costs and learn from the legislatives in Japan and the U.S.[6], tax incentives are put in place as a buffer for adverse effects of external environments. The first paragraph of Article 36-2 of the Act for Development of Small and Medium Enterprises provide tax incentives for employee salaries of new headcounts based on the assessment on the economy over a time period. This is intended to encourage domestic investments and avoid the pitfall of direct government subsidies distorting salary structures. It is hoped that investments from SMEs can stimulate the momentum of economic growth.

1. Taxpayers

  The tax incentives under Article 36-2 of the Act for Development of Small and Medium Enterprises aim to assist SMEs through difficult times in an economic downturn. The threshold of the period time is based on the unemployment rate has been below the economic indicator predetermined for six consecutive months, which calculated by the Directorate General of Budget, Accounting and Statistics, Executive Yuan. In number of the unemployment rate has been below the economic indicator predetermined for six consecutive months, it is deemed that the business environment is not friendly to SMEs. In this instance, the Regulations for the Tax Preferences Provided to Small and Medium-sized Enterprises on Additional Wage Payment will trigger the tax incentives. The abovementioned economic indicator shall be published by the competent authorities once every two years.

  Moreover, to qualify for the tax incentives for new employees, SMEs should investing new ventures or instill new capital by at least $500,000[7] or hiring workforce at least two full-time headcounts compared with the previous fiscal year, that constitute at the Article 36-2 of the Act for Development of Small and Medium Enterprises, which aims to encourage SMEs investments.

2. Taxpayers

(1) Qualifications of additional headcounts

  As the dispatched human resource services typically meet temporary or short-term requirements and contractors do not enjoy employment security, this is not consistent with the spirit of the legislation to create jobs and reduce unemployment. Therefore, to avoid the one-time increase of headcounts from accessing the tax reductions during the year and the deterioration of labor relations in Taiwan. Tax incentive is not offered to the additional recruitment of part-time or contracted workers.

  Meanwhile, the tax incentives are only applicable to the additional employment of Taiwanese nationals, above or below 24 years old. A tax deduction of 50% based on annual wages is provided for the hiring of people below 24 years old. The extra tax deduction will stimulate young employment.

(2) Definition of additional employment

  The number of additional headcounts is based on permanent hires and calculated as the difference between the average number of Taiwanese employees covered by labor insurance per month throughout a single fiscal year or before and after the incremental increase of workforce. The conversion of regular contracts to indefinite employment in writing or signing up for indefinite R&D headcounts under the military service scheme can also be deemed as additional employment. It is worth noting, however, the new headcounts resulted from M&A activities or transfer between affiliated companies are excluded in this legislation.

(3) Calculation of wages

  Companies are also required to increase employment as well as the Comparable Wages. The comparable wages are estimated with the summation of 30% of the wages for the year before and after additional employment that based on the aggregate of the new hires comparable wages compared to the prior year. In other words, if the aggregate wages paid out are higher than comparable wages during the year, the companies concerned have indeed incurred higher personnel expenses. Tax incentives are thus granted because it improves the business environment and it is the purpose of this legislation.

3. Tax incentive effects

  The first paragraph of Article 36-2 of the Act for Development of Small and Medium Enterprises provides deductions of business income taxes during the year to qualified SMEs at an amount equivalent to 130% of the incremental wages paid to new headcounts who are Taiwanese nationals. The deductible amount is equivalent to 150% of the incremental wages if new headcounts are Taiwanese nationals below 24 years old.

(II) Tax incentives for companies that increase salaries

  Companies are subject to the effect of changes in the external factors such as global supply and demand on the international market, as well as the domestic business environment as a result of risk aversion from investors and expectation from customers. These uncertainties associated with investments and the rising prices for consumers will suppress the wage levels in Taiwan. This the reason why the second paragraph of Article 36-2 of the Act for Development of Small and Medium Enterprises grants tax deductions for the companies who increase salaries, to encourage companies share earnings with employees and enhance private-sector consumption. SMEs may deduct their business income taxes payable during the year up to 30% of salary increase for existing entry-level employees who are Taiwanese nationals, not as a result of statutory requirement for basic wage adjustments.

1. Taxpayers

  The tax incentives are applicable to SMEs as defined by the Regulations for the Tax Preferences Provided to Small and Medium-sized Enterprises on Additional Wage Payment and based on the same economic indicators previously mentioned.

2. Qualification for tax incentives

(1) Definition of entry-level employees

  The object of taxation under this act is the enterprise's average wage payment to the entry-level employees. The entry-level employees referred to in this act are authorized by the "Small and medium-sized enterprise employee salary increase, salary deduction act " that refers to employees of local nationality with an average monthly recurring salary below nt $50,000[8] whose were entered into indefinite employment contracts with SMEs. Through such conditions, the effect of tax concessions will be concentrated on promoting the salary level of grassroots staff and helping enterprises to cope with changes in the industrial environment.

(2) Average salaries

  The salaries to entry-level employees refer to the basic salaries, fixed allowances and bonuses paid on a monthly basis. Payment-in-kind shall be discounted based on the actual prices and included into the regular salaries. Meanwhile, regular salaries should be calculated with annualized averages, as this legislation seeks to boost salary levels. The regular salaries to entry-level employees during the year are estimated with the monthly number of entry-level employees during the same year. Only when the average basis salaries during the year are higher than those in the prior year can the tax incentives be applicable.

3. Tax incentive effects

  Applying this article, SMEs can deduct their business income taxes each year up to 130% of salary increase for existing entry-level employees who are Taiwanese nationals, which are not as a result of statutory requirement for basic wage adjustments. However, it is not allowed to double count the increased personnel expenses for new headcounts applicable to the first and second paragraphs of the same article.

V. Conclusions

  The funding scales and relatively weak financial structures are the factors that led SMEs be susceptible influenced by supply change dynamics and business cycles. To the extent that is suppressing the flexible in capital utilization for SMEs, also influencing on the sustainability of SMEs. Differ from government subsidies require budgeting, reviewing and implementations, there are complications regarding the allocation of administrative resources. Therefore, it is important to plan for tax incentives in order to stimulate R&D, innovation and job creation by SMEs and ultimately make SMEs more competitive.

  The tax incentives to SMEs amended in 2016 by the Small and Medium Enterprise Administration are known for the following:

(I) The lowering of thresholds for tax reductions of R&D expenses in order to encourage SMEs to invest in R&D activities with a “certain degree” of innovativeness and enhance the momentum for SMEs to upgrade and transform themselves;  

(II) Deferral the income taxations on the transfer of intellectual properties for equity, in order to encourage application and utilization of such intellectual properties, provide incentives for R&D programs or innovations by individuals and SMEs. This also creates a catalyst for industry upgrade;

(III) Tax deductions for the employment of new headcounts or the increase of employee wages during the time the economic indicators have reached a certain threshold and based on the health of the investment environment. This is to encourage company investments and capital increases in Taiwan and mitigate the volatility of economic cycles, in order to get ready for business improvement.

  The above tax incentive programs, i.e. tax deductions for R&D and innovations; deferral of taxations on the transfer of intellectual properties for equity; tax deductions for the hiring of new headcounts and the increase of employee salaries, are meant to boost the investment from SMEs and the competitiveness of SMEs. The Act for Development of Small and Medium Enterprises seeks to reduce tax burdens of SMEs actively investing for their future and competitive advantages. Tax incentives help to mitigate the adverse effect of the economy on the business environment. It is also the fostering of the sources of business income tax revenues for the government. This is the very purpose of the Act for Development of Small and Medium Enterprises.

 

 

[1]White Paper on Small and Medium Enterprises in Taiwan, 2018, p21 (November 9, 2018)
published by the Ministry of Economic Affairs

[2]Pursuant to the authorization conferred by Article 35 of the Act for Development of Small and Medium Enterprises, the Ministry of Economic Affairs has announced the Regulations Governing the Reduction of Expenditures for Small and Medium Enterprises Research and Development as Investment.

[3]Article 2 on the definition of SMEs. The abovementioned criterion is universally applicable to the Act for Development of Small and Medium Enterprises. It also applies to the eligibility of tax incentives to be introduced in this paper unless otherwise specified.

[4]Official Letter Economic-Business No. 10304605790, Ministry of Economic Affairs

[5]Official Letter Taiwan-Finance No. 10300207480, Ministry of Finance

[6]“Assessment of the Taxations under Article 35, Article 35-1, the first paragraph and the second paragraph of Article 36-2, the Act for Development of Small and Medium Enterprises” published by the Small and Medium Enterprise Administration, Ministry of Economic Affairs, pages 15-17, https://www.moeasmea.gov.tw/files/2670/93B9AF54-84E2-4293-A5CA-EA7DD9FAA05A(most recently browsed date September 9, 2019).

[7]Order of Interpretation Economics-Business No. 104004602510 from the Ministry of Economic Affairs: “Second, on the day when the economic indicator has reached the threshold, the paid-in capital of the new business should be at least NT$500,000 and there is no need to instill additional capital during the period when tax incentives are applicable. For existing businesses, there is no limitation on the number of capital increases during the applicable period. So long as the cumulative increase in capital reaches NT$500,000 and new employees are hired during the same fiscal year or during the prior fiscal year.”

[8]Paragraph 1, Article 2 of the Regulations for the Tax Preferences Provided to Small and Medium-sized Enterprises on Additional Wage Payment

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※Introduction to Tax Incentive Regime for SMEs,STLI, https://stli.iii.org.tw/en/article-detail.aspx?no=105&tp=2&i=168&d=8483 (Date:2024/02/27)
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Impact of Government Organizational Reform to Scientific Research Legal System and Response Thereto (1) – For Example, The Finnish Innovation Fund (“SITRA”) I. Foreword   We hereby aim to analyze and research the role played by The Finnish Innovation Fund (“Sitra”) in boosting the national innovation ability and propose the characteristics of its organization and operation which may afford to facilitate the deliberation on Taiwan’s legal system. Sitra is an independent organization which is used to reporting to the Finnish Parliament directly, dedicated to funding activities to boost sustainable development as its ultimate goal and oriented toward the needs for social change. As of 2004, it promoted the fixed-term program. Until 2012, it, in turn, primarily engaged in 3-year program for ecological sustainable development and enhancement of society in 2012. 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Most studies still indicate positive impact, primarily as a result of the market failure. Some studies indicate that the impact of the public sector’s investment of resources may be observable at least from several points of view, including: 1. The direct output of the investment per se and the corresponding R&D investment potentially derived from investees; 2. R&D of outputs derived from the R&D investment, e.g., products, services and production methods, etc.; 3. direct impact derived from the R&D scope, e.g., development of a new business, or new business and service models, etc.; 4. impact to national and social economies, e.g., change of industrial structures and improvement of employment environment, etc. Most studies indicate that from the various points of view, the investment by public sector all produced positive impacts and, therefore, such investment is needed definitely[3]. The public sector may invest in R&D in diversified manners. Sitra invests in the “market” as an investor of corporate venture investment market, which plays a role different from the Finnish Funding Agency for Technology and Innovation (“Tekes”), which is more like a governmental subsidizer. Nevertheless, Finland’s characteristics reside in the combination of multiple funding and promotion models. Above all, due to the different behavior model, the role played by the former is also held different from those played by the general public sectors. This is why we choose the former as the subject to be studied herein. Data source: Jari Hyvärinen & Anna-Maija Rautiainen, Measuring additionality and systemic impacts of public research and development funding – the case of TEKES, FINLAND, RESEARCH EVALUATION, 16(3), 205, 206 (2007). Fig. 1 Phased Efforts of Resources Invested in R&D by Public Sector (2) Two Sided f Role Played by Sitra in Boosting of Finnish Innovation Policies   Sitra has a very special position in Finland’s national innovation policies, as it not only helps successful implementation of the innovation policies but also acts an intermediary among the relevant entities. Sitra was founded in 1967 under supervision of the Bank of Finland before 1991, but was transformed into an independent foundation under the direction of the Finnish Parliament[4].   Though Sitra is a public foundation, its operation will not be intervened or restricted by the government. Sitra may initiate any innovation activities for its new organization or system, playing a role dedicated to funding technical R&D or promoting venture capital business. Meanwhile, Sitra also assumes some special function dedicated to decision-makers’ training and organizing decision-maker network to boost structural change. Therefore, Sitra may be identified as a special organization which may act flexibly and possess resources at the same time and, therefore, may initiate various innovation activities rapidly[5].   Sitra is authorized to boost the development of innovation activities in said flexible and characteristic manner in accordance with the Finland Innovation Fund Act (Laki Suomen itsenäisyyden juhlarahastosta). According to the Act, Finland established Sitra in 1967 and Sitra was under supervision of Bank of Finland (Article 1). Sitra was established in order to boost the stable growth of Finland’s economy via the national instrument’s support of R&D and education or other development instruments (Article 2). The policies which Sitra may adopt include loaning or funding, guarantee, marketable securities, participation in cooperative programs, partnership or equity investment (Article 3). If necessary, Sitra may collect the title of real estate or corporate shares (Article 7). Data source: Finnish innovation system, Research.fi, http://www.research.fi/en/innovationsystem.html (last visited Mar. 15, 2013). Fig. 2 Finnish Scientific Research Organization Chart   Sitra's innovation role has been evolved through two changes. Specifically, Sitra was primarily dedicated to funding technical R&D among the public sectors in Finland, and the funding model applied by Sitra prior to the changes initiated the technical R&D promotion by Tekes, which was established in 1983. The first change of Sitra took place in 1987. After that, Sitra turned to focus on the business development and venture capital invested in technology business and led the venture capital investment. Meanwhile, it became a partner of private investment funds and thereby boosted the growth of venture capital investments in Finland in 1990. In 2000, the second change of Sitra took place and Sitra’s organization orientation was changed again. It achieved the new goal for structural change step by step by boosting the experimental social innovation activities. Sitra believed that it should play the role contributing to procedural change and reducing systematic obstacles, e.g., various organizational or institutional deadlocks[6].   Among the innovation policies boosted by the Finnish Government, the support of Start-Ups via governmental power has always been the most important one. Therefore, the Finnish Government is used to playing a positive role in the process of developing the venture capital investment market. In 1967, the Government established a venture capital company named Sponsor Oy with the support from Bank of Finland, and Sponsor Oy was privatized after 1983. Finland Government also established Kera Innovation Fund (now known as Finnvera[7]) in 1971, which was dedicated to boosting the booming of Start-Ups in Finland jointly with Finnish Industry Investment Ltd. (“FII”) established by the Government in 1994, and Sitra, so as to make the “innovation” become the main development force of the country[8] .   Sitra plays a very important role in the foundation and development of venture capital market in Finland and is critical to the Finnish Venture Capital Association established in 1990. After Bank of Finland was under supervision of Finnish Parliament in 1991, Sitra became on the most important venture capital investors. Now, a large portion of private venture capital funds are provided by Sitra[9]. Since Sitra launched the new strategic program in 2004, it has turned to apply smaller sized strategic programs when investing young innovation companies, some of which involved venture capital investment. The mapping of young innovation entrepreneurs and angel investors started as of 1996[10].   In addition to being an important innovation R&D promoter in Finland, Sitra is also an excellent organization which is financially self-sufficient and tends to gain profit no less than that to be generated by a private enterprise. As an organization subordinated to the Finnish Parliament immediately, all of Sitra’s decisions are directly reported to the Parliament (public opinion). Chairman of Board, Board of Directors and supervisors of Sitra are all appointed by the Parliament directly[11]. Its working funds are generated from interest accruing from the Fund and investment income from the Fund, not tax revenue or budget prepared by the Government any longer. The total fund initially founded by Bank of Finland amounted to DEM100,000,000 (approximately EUR17,000,000), and was accumulated to DEM500,000,000 (approximately EUR84,000,000) from 1972 to 1992. After that, following the increase in market value, its nominal capital amounted to DEM1,400,000,000 (approximately EUR235,000,000) from 1993 to 2001. Obviously, Sitra generated high investment income. Until 2010, it has generated the investment income amounting to EUR697,000,000 .   In fact, Sitra’s concern about venture capital investment is identified as one of the important changes in Finland's national technical R&D polices after 1990[13]. Sitra is used to funding businesses in three manners, i.e., direct investment in domestic stock, investment in Finnish venture capital funds, and investment in international venture capital funds, primarily in four industries, technology, life science, regional cooperation and small-sized & medium-sized starts-up. Meanwhile, it also invests in venture capital funds for high-tech industries actively. In addition to innovation technology companies, technical service providers are also its invested subjects[14]. 2. “Investment” Instrument Applied by Sitra to Boost Innovation Business   The Starts-Up funding activity conducted by Sitra is named PreSeed Program, including INTRO investors’ mapping platform dedicated to mapping 450 angel investment funds and entrepreneurs, LIKSA engaged in working with Tekes to funding new companies no more than EUR40,000 for purchase of consultation services (a half thereof funded by Tekes, and the other half funded by Sitra in the form of loan convertible to shares), DIILI service[15] dedicated to providing entrepreneurs with professional sale consultation resources to integrate the innovation activity (product thereof) and the market to remedy the deficit in the new company’s ability to sell[16].   The investment subjects are stated as following. Sitra has three investment subjects, namely, corporate investments, fund investments and project funding. (1) Corporate investment   Sitra will not “fund” enterprises directly or provide the enterprises with services without consideration (small-sized and medium-sized enterprises are aided by other competent authorities), but invest in the businesses which are held able to develop positive effects to the society, e.g., health promotion, social problem solutions, utilization of energy and effective utilization of natural resources. Notwithstanding, in order to seek fair rate of return, Sitra is dedicated to making the investment (in various enterprises) by its professional management and technology, products or competitiveness of services, and ranging from EUR300,000 to EUR1,000,000 to acquire 10-30% of the ownership of the enterprises, namely equity investment or convertible funding. Sitra requires its investees to value corporate social responsibility and actively participate in social activities. It usually holds the shares from 4 years to 10 years, during which period it will participate the corporate operation actively (e.g., appointment of directors)[17]. (2) Fund investments   For fund investments[18], Sitra invests in more than 50 venture capital funds[19]. It invests in domestic venture capital fund market to promote the development of the market and help starts-up seek funding and create new business models, such as public-private partnerships. It invests in international venture capital funds to enhance the networking and solicit international funding, which may help Finnish enterprises access international trend information and adapt to the international market. (3) Project funding   For project funding, Sitra provides the on-site information survey (supply of information and view critical to the program), analysis of business activities (analysis of future challenges and opportunities) and research & drafting of strategies (collection and integration of professional information and talents to help decision making), and commissioning of the program (to test new operating model by commissioning to deal with the challenge from social changes). Notwithstanding, please note that Sitra does not invest in academic study programs, research papers or business R&D programs[20]. (4) DIILI Investment Model Integrated With Investment Absorption   A Start-Up usually will not lack technologies (usually, it starts business by virtue of some advanced technology) or foresighted philosophy when it is founded initially, while it often lacks the key to success, the marketing ability. Sitra DIILI is dedicated to providing the professional international marketing service to help starts-up gain profit successfully. Owing to the fact that starts-up are usually founded by R&D personnel or research-oriented technicians, who are not specialized in marketing and usually retains no sufficient fund to employ marketing professionals, DILLI is engaged in providing dedicated marketing talents. Now, it employs about 85 marketing professionals and seeks to become a start-up partner by investing technical services.   Notwithstanding, in light of the characteristics of Sitra’s operation and profitability, some people indicate that it is more similar to a developer of an innovation system, rather than a neutral operator. Therefore, it is not unlikely to hinder some work development which might be less profitable (e.g., establishment of platform). Further, Sitra is used to developing some new investment projects or areas and then founding spin-off companies after developing the projects successfully. The way in which it operates seems to be non-compatible with the development of some industries which require permanent support from the public sector. The other issues, such as INTRO lacking transparency and Sitra's control over investment objectives likely to result in adverse choice, all arise from Sitra’s consideration to its own investment opportunities and profit at the same time of mapping. Therefore, some people consider that it should be necessary to move forward toward a more transparent structure or a non-income-oriented funding structure[21] . Given this, the influence of Sitra’s own income over upgrading of the national innovation ability when Sitra boosts starts-up to engage in innovation activities is always a concern remaining disputable in the Finnish innovation system. 3. Boosting of Balance in Regional Development and R&D Activities   In order to fulfill the objectives under Lisbon Treaty and to enable EU to become the most competitive region in the world, European Commission claims technical R&D as one of its main policies. Among other things, under the circumstance that the entire R&D competitiveness upgrading policy is always progressing sluggishly, Finland, a country with a population of 5,300,000, accounting for 1.1% of the population of 27 EU member states, was identified as the country with the No. 1 innovation R&D ability in the world by World Economic Forum in 2005. Therefore, the way in which it promotes innovation R&D policies catches the public eyes. Some studies also found that the close relationship between R&D and regional development policies of Finland resulted in the integration of regional policies and innovation policies, which were separated from each other initially, after 1990[22]. Finland has clearly defined the plan to exploit the domestic natural resources and human resources in a balanced and effective manner after World War II. At the very beginning, it expanded the balance of human resources to low-developed regions, in consideration of the geographical politics, but in turn, it achieved national balanced development by meeting the needs for a welfare society and mitigation of the rural-urban divide as time went by. The Finnish innovation policies which may resort to technical policies retroactively initially drove the R&D in the manners including upgrading of education degree, founding of Science and Technology Policy Council and Sitra, establishment of Academy of Finland (1970) and establishment of the technical policy scheme, et al.. Among other things, people saw the role played by Sitra in Finland’s knowledge-intensive society policy again. From 1991 to 1995, the Finnish Government officially included the regional competitiveness into the important policies. The National Industrial Policy for Finland in 1993 adopted the strategy focusing on the development based on competitive strength in the regional industrial communities[23].   Also, some studies indicated that in consideration of Finland’s poor financial and natural resources, its national innovation system should concentrate the resources on the R&D objectives which meet the requirements about scale and essence. Therefore, the “Social Innovation, Social and Economic Energy Re-building Learning Society” program boosted by Sitra as the primary promoter in 2002 defined the social innovation as “the reform and action plan to enhance the regulations of social functions (law and administration), politics and organizational structure”, namely reform of the mentality and cultural ability via social structural changes that results in social economic changes ultimately. Notwithstanding, the productivity innovation activity still relies on the interaction between the enterprises and society. Irrelevant with the Finnish Government’s powerful direction in technical R&D activities, in fact, more than two-thirds (69.1%) of the R&D investment was launched by private enterprises and even one-thirds launched by a single enterprise (i.e., Nokia) in Finland. At the very beginning of 2000, due to the impact of globalization to Finland’s innovation and regional policies, a lot of R&D activities were emigrated to the territories outside Finland[24]. Multiple disadvantageous factors initiated the launch of national resources to R&D again. The most successful example about the integration of regional and innovation policies in Finland is the Centres of Expertise Programme (CEP) boosted by it as of 1990. Until 1994, there have been 22 centres of expertise distributed throughout Finland. The centres were dedicated to integrating local universities, research institutions and enterprise for co-growth. The program to be implemented from 2007 to 2013 planned 21 centres of expertise (13 groups), aiming to promote the corporate sectors’ cooperation and innovation activities. CEP integrated local, regional and national resources and then focused on the businesses designated to be developed[25]. [1] Sitra, http://www.sitra.fi/en (last visited Mar. 10, 2013). [2] Jari Hyvärinen & Anna-Maija Rautiainen, Measuring additionality and systemic impacts of public research and development funding – the case of TEKES, FINLAND, RESEARCH EVALUATION, 16(3), 205, 208 (2007). [3] id. at 206-214. [4] Charles Edquist, Tterttu Luukkonen & Markku Sotarauta, Broad-Based Innovation Policy, in EVALUATION OF THE FINNISH NATIONAL INNOVATION SYSTEM – FULL REPORT 11, 25 (Reinhilde Veugelers st al. eds., 2009). [5] id. [6] id. [7] Finnvera is a company specialized in funding Start-Ups, and its business lines include loaning, guarantee, venture capital investment and export credit guarantee, etc. It is a state-run enterprise and Export Credit Agency (ECA) in Finland. Finnvera, http://annualreport2012.finnvera.fi/en/about-finnvera/finnvera-in-brief/ (last visited Mar. 10, 2013). [8] Markku Maula, Gordon Murray & Mikko Jääskeläinen, MINISTRY OF TRADE AND INDUSTRY, Public Financing of Young Innovation Companies in Finland 32 (2006). [9] id. at 33. [10] id. at 41. [11] Sitra, http://www.sitra.fi/en (last visited Mar. 10, 2013). [12] Sitra, http://www.sitra.fi/en (last visited Mar. 10, 2013). [13] The other two were engaged in boosting the regional R&D center and industrial-academy cooperative center programs. Please see Gabriela von Blankenfeld-Enkvist, Malin Brännback, Riitta Söderlund & Marin Petrov, ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT [OECD],OECD Case Study on Innovation: The Finnish Biotechnology Innovation System 15 (2004). [14] id. at20. [15] DIILI service provides sales expertise for SMEs, Sitra, http://www.sitra.fi/en/articles/2005/diili-service-provides-sales-expertise-smes-0 (last visited Mar. 10, 2013). [16] Maula, Murray & Jääskeläinen, supra note 8 at 41-42. [17] Corporate investments, Sitra, http://www.sitra.fi/en/corporate-investments (last visited Mar. 10, 2013). [18] Fund investments, Sitra, http://www.sitra.fi/en/fund-investments (last visited Mar. 10, 2013). [19] The venture capital funds referred to herein mean the pooled investment made by the owners of venture capital, while whether it exists in the form of fund or others is not discussed herein. [20] Project funding, Sitra, http://www.sitra.fi/en/project-funding (last visited Mar. 10, 2013). [21] Maula, Murray & Jääskeläinen, supra note 8 at 42. [22] Jussi S. Jauhiainen, Regional and Innovation Policies in Finland – Towards Convergence and/or Mismatch? REGIONAL STUDIES, 42(7), 1031, 1032-1033 (2008). [23] id. at 1036. [24] id. at 1038. [25] id. at 1038-1039.

Experiences about opening data in private sector

Experiences about opening data in private sector Ⅰ. Introduction   Open data is the idea that data should be available freely for everyone to use and republish without restrictions from copyright, patents or other mechanisms of control. The concept of open data is not new; but a formalized definition is relatively new, and The Open Definition gives full details on the requirements for open data and content as follows:   Availability and access: the data must be available as a whole with no more than a reasonable reproduction cost, preferably by downloading over the internet. The data must also be available in a convenient and modifiable form.   Reuse and redistribution: the data must be provided under terms that permit reuse and redistribution including the intermixing with other datasets. The data shall be machine-readable.   Universal participation: everyone must be able to use, reuse and redistribute the data— which by means there should be no discrimination against fields of endeavor or against persons or groups. For example, “non-commercial” restrictions that would prevent “commercial” use, or restrictions of use for certain purposes are not allowed.   In order to be in tune with international developmental trends, Taiwan passed an executive resolution in favor of promoting Open Government Data in November 2012. Through the release of government data, open data has grown significantly in Taiwan and Taiwan has come out on top among 122 countries and areas in the 2015 and 2016 Global Open Data Index[1].   The result represented a major leap for Taiwan, however, progress is still to be made as most of the data are from the Government, and data from other territories, especially from private sector can rarely be seen. It is a pity that data from private sector has not being properly utilized and true value of such data still need to be revealed. The following research will place emphasis to enhance the value of private data and the strategies of boosting private sector to open their own data. Ⅱ. Why open private data   With the trend of Open Government Data recent years, countries are now starting to realize that Open Government Data is improving transparency, creating opportunities for social and commercial innovation, and opening the door to better engagement with citizens. But open data is not limited to Open Government Data. In fact, the private sector not only interacts with government data, but also produces a massive amount of data, much of which in need of utilized.   According to the G20 open data policy agenda made in 2014, the potential economic value of open data for Australia is up to AUD 64 billion per annum, and the potential value of open data from private sector is around AUD 34 billion per annum. Figure 1 Value of open data for Australia (AUD billion per annum) Source: McKinsey Global Institute   The purpose for opening data held by private entities and corporations is rooted in a broad recognition that private data has the potential to foster much public good. Openness of data for companies can translate into more efficient internal governance frameworks, enhanced feedback from workers and employees, improved traceability of supply chains, accountability to end consumers, and with better service and product delivery. Open Private Data is thus a true win-win for all with benefiting not only the governance but environmental and social gains.   At the same time, a variety of constraints, notably privacy and security, but also proprietary interests and data protectionism on the part of some companies—hold back this potential. Ⅲ. The cases of Open Private Data   Syngenta AG, a global Swiss agribusiness that produces agrochemicals and seeds, has established a solid foundation for reporting on progress that relies on independent data collection and validation, assurance by 3rd party assurance providers, and endorsement from its implementing partners. Through the website, Syngenta AG has shared their datasets for agricultural with efficiency indicators for 3600 farms for selected agro-ecological zones and market segments in 42 countries in Europe, Africa, Latin America, North America and Asia. Such datasets are precious but Syngenta AG share them for free only with a Non-Commercial license which means users may copy and redistribute the material in any medium or format freely but may not use the material for commercial purposes. Figure 2 Description and License for Open data of Syngenta AG Source: http://www.syngenta.com   Tokyo Metro is a rapid transit system in Tokyo, Japan has released information such as train location and delay times for all lines as open data. The company held an Open Data Utilization Competition from 12 September to 17 November, 2014 to promote development of an app using this data and continues to provide the data even after the competition ended. However, many restrictions such as non-commercial use, or app can only be used for Tokyo Metro lines has weakened the efficiency of open data, it is still valued as an initial step of open private data. Figure 3 DM of Tokyo Metro Open data Contest Source: https://developer.tokyometroapp.jp/ Ⅳ. How to enhance Open Private Data   Open Private Data is totally different from Open Government Data since “motivation” is vital for private institutions to release their own data. Unlike the government data can be disclosed and free to use via administrative order or legislation, all of the data controlled by private institutions can only be opened under their own will. The initiative for open data therefore shall focus on how to motivate private sectors releasing their own data-by ensuring profit and minimizing risks.   Originally, open data shall be available freely for everyone to use without any restrictions, and data owners may profit indirectly as users utilizing their data creating apps, etc. but not profit from open data itself. The income is unsteady and data owners therefore lose their interest to open data. As a countermeasure, it is suggested to make data chargeable though this may contradict to the definition of open data. When data owners can charge by usage or by time, the motivation of open data would arise when open data is directly profitable.   Data owners may also worry about many legal issues when releasing their own data. They may not care about whether profitable or not but afraid of being involved into litigation disputes such as intellectual property infringement, unfair competition, etc. It is very important for data owners to have a well protected authorization agreement when releasing data, but not all of them is able to afford the cost of making agreement for each data sharing. Therefore, a standard sample of contract that can be widely adopted plays a very important role for open private data.   A data sharing platform would be a solution to help data owners sharing their own data. It can not only provide a convenient way to collect profit from data sharing but help data owners avoiding legal risks with the platform’s standard agreement. All the data owners have to do is just to transfer their own data to the platform without concern since the platform would handle other affairs. Ⅴ. Conclusion   Actively engaging the private sector in the open data value-chain is considered an innovation imperative as it is highly related to the development of information economy. Although many works still need to be done such as identifying mechanisms for catalyzing private sector engagement, these works can be done by organizations such as the World Bank and the Centre for Open Data Enterprise. Private-public collaboration is also important when it comes to strengthening the global data infrastructure, and the benefits of open data are diverse and range from improved efficiency of public administrations to economic growth in the private sector. However, open private data is not the goal but merely a start for open data revolution. It is to add variation for other organizations and individuals to analyze to create innovations while individuals, private sectors, or government will benefit from that innovation and being encouraged to release much more data to strengthen this data circulation. [1] Global Open Data Index, https://index.okfn.org/place/(Last visited: May 15, 2017)

Israel’s Technological Innovation System

I.Introduction Recently, many countries have attracted by Israel’s technology innovation, and wonder how Israel, resource-deficiency and enemies-around, has the capacity to enrich the environment for innovative startups, innovative R&D and other innovative activities. At the same time, several cross-border enterprises hungers to establish research centers in Israel, and positively recruits Israel high-tech engineers to make more innovative products or researches. However, there is no doubt that Israel is under the spotlight in the era of innovation because of its well-shaped national technology system framework, innovative policies of development and a high level of R&D expenditure, and there must be something to learn from. Also, Taiwanese government has already commenced re-organization lately, how to tightly connect related public technology sectors, and make the cooperation more closely and smoothly, is a critical issue for Taiwanese government to focus on. Consequently, by the observation of Israel’s national technology system framework and technology regulations, Israel’s experience shall be a valuable reference for Taiwanese government to build a better model for public technology sectors for future cooperation. Following harsh international competition, each country around the world is trying to find out the way to improve its ability to upgrade international competitiveness and to put in more power to promote technology innovation skills. Though, while governments are wondering how to strengthen their countries’ superiority, because of the differences on culture and economy, those will influence governments’ points of view to form an appropriate national innovative system, and will come with a different outcome. Israel, as a result of the fact that its short natural resources, recently, its stunning performance on technology innovation system makes others think about whether Israel has any characteristics or advantages to learn from. According to Israeli Central Bureau of Statistics records, Israel’s national expenditures on civilian R&D in 2013 amounted to NIS 44.2 billion, and shared 4.2% of the GDP. Compared to 2012 and 2011, the national expenditure on civilian R&D in 2013, at Israel’s constant price, increased by 1.3%, following an increase of 4.5% in 2012 and of 4.1% in 2011. Owing to a high level of national expenditure poured in, those, directly and indirectly, makes the outputs of Israel’s intellectual property and technology transfer have an eye-catching development and performance. Based on Israeli Central Bureau of Statistics records, in 2012-2013, approximately 1,438 IP invention disclosure reports were submitted by the researchers of various universities and R&D institutions for examination by the commercialization companies. About 1,019 of the reports were by companies at the universities, an increase of 2.2% compared to 2010-2011, and a 1% increase in 2010-2011 compared to 2008-2009. The dominant fields of the original patent applicants were medicines (24%), bio-technology (17%), and medical equipment (13%). The revenues from sales of intellectual property and gross royalties amounted to NIS 1,881 million in 2012, compared to NIS 1,680 million in 2011, and increase of 11.9%. The dominant field of the received revenues was medicines (94%). The revenues from sales of intellectual property and gross royalties in university in 2012 amounted to NIS 1,853 million in 2012, compared to NIS 1,658 million in 2011, an increase of 11.8%. Therefore, by the observation of these records, even though Israel only has 7 million population, compared to other large economies in the world, it is still hard to ignore Israel’s high quality of population and the energy of technical innovation within enterprises. II.The Recent Situation of Israel’s Technology Innovation System A.The Determination of Israel’s Technology Policy The direction and the decision of national technology policy get involved in a country’s economy growth and future technology development. As for a government sector deciding technology policy, it would be different because of each country’s government and administrative system. Compared to other democratic countries, Israel is a cabinet government; the president is the head of the country, but he/she does not have real political power, and is elected by the parliament members in every five years. At the same time, the parliament is re-elected in every four years, and the Israeli prime minister, taking charge of national policies, is elected from the parliament members by the citizens. The decision of Israel’s technology policy is primarily made by the Israeli Ministers Committee for Science and Technology and the Ministry of Science and Technology. The chairman of the Israeli Ministry Committee for Science and Technology is the Minister of Science and Technology, and takes charge of making the guideline of Israel’s national technology development policy and is responsible for coordinating R&D activities in Ministries. The primary function of the Ministry of Science and Technology is to make Israel’s national technology policies and to plan the guideline of national technology development; the scope includes academic research and applied scientific research. In addition, since Israel’s technology R&D was quite dispersed, it means that the Ministries only took responsibilities for their R&D, this phenomenon caused the waste of resources and inefficiency; therefore, Israel government gave a new role and responsibility for the Chief Scientists Forum under the Ministry of Science and Technology in 2000, and wished it can take the responsibility for coordinating R&D between the government’s sectors and non-government enterprises. The determination of technology policy, however, tends to rely on counseling units to provide helpful suggestions to make technology policies more intact. In the system of Israel government, the units playing a role for counseling include National Council for Research and Development (NCRD), the Steering Committee for Scientific Infrastructure, the National Council for Civil Research and Development (MOLMOP), and the Chief Scientists Forums in Ministries. Among the aforementioned units, NCRD and the Steering Committee for Scientific Infrastructure not only provide policy counseling, but also play a role in coordinating R&D among Ministries. NCRD is composed by the Chief Scientists Forums in Ministries, the chairman of Planning and Budgeting Committee, the financial officers, entrepreneurs, senior scientists and the Dean of Israel Academy of Sciences and Humanities. NCRD’s duties include providing suggestions regarding the setup of R&D organizations and related legal system, and advices concerning how to distribute budgets more effectively; making yearly and long-term guidelines for Israel’s R&D activities; suggesting the priority area of R&D; suggesting the formation of necessary basic infrastructures and executing the priority R&D plans; recommending the candidates of the Offices of Chief Scientists in Ministries and government research institutes. As for the Steering Committee for Scientific Infrastructure, the role it plays includes providing advices concerning budgets and the development framework of technology basic infrastructures; providing counsel for Ministries; setting up the priority scientific plans and items, and coordinating activities of R&D between academic institutes and national research committee. At last, as for MOLMOP, it was founded by the Israeli parliament in 2002, and its primary role is be a counseling unit regarding technology R&D issues for Israel government and related technology Ministries. As for MOLMOP’s responsibilities, which include providing advices regarding the government’s yearly and long-term national technology R&D policies, providing the priority development suggestion, and providing the suggestions for the execution of R&D basic infrastructure and research plans. B.The Management and Subsidy of Israel’s Technology plans Regarding the institute for the management and the subsidy of Israel’s technology plans, it will be different because of grantee. Israel Science Foundation (ISF) takes responsibility for the subsidy and the management of fundamental research plans in colleges, and its grantees are mainly focused on Israel’s colleges, high education institutes, medical centers and research institutes or researchers whose areas are in science and technical, life science and medicine, and humanity and social science. As for the budget of ISF, it mainly comes from the Planning and Budgeting Committee (PBC) in Israel Council for Higher Education. In addition, the units, taking charge of the management and the subsidy of technology plans in the government, are the Offices of the Chief Scientist in Ministries. Israel individually forms the Office of the Chief Scientist in the Ministry of Agriculture and Rural Development, the Ministry of Communications, the Ministry of Defense, the Ministry of National Infrastructures, Energy and Water Resources, the Ministry of Health and the Ministry of Economy. The function of the Office of the Chief Scientist not only promotes and inspires R&D innovation in high technology industries that the Office the Chief Scientist takes charge, but also executes Israel’s national plans and takes a responsibility for industrial R&D. Also, the Office of the Chief Scientist has to provide aid supports for those industries or researches, which can assist Israel’s R&D to upgrade; besides, the Office of the Chief Scientists has to provide the guide and training for enterprises to assist them in developing new technology applications or broadening an aspect of innovation for industries. Further, the Office of the Chief Scientists takes charge of cross-country R&D collaboration, and wishes to upgrade Israel’s technical ability and potential in the area of technology R&D and industry innovation by knowledge-sharing and collaboration. III.The Recent Situation of the Management and the Distribution of Israel’s Technology Budget A.The Distribution of Israel’s Technology R&D Budgets By observing Israel’s national expenditures on civilian R&D occupied high share of GDP, Israel’s government wants to promote the ability of innovation in enterprises, research institutes or universities by providing national resources and supports, and directly or indirectly helps the growth of industry development and enhances international competitiveness. However, how to distribute budgets appropriately to different Ministries, and make budgets can match national policies, it is a key point for Israel government to think about. Following the Israeli Central Bureau of Statistics records, Israel’s technology R&D budgets are mainly distributed to some Ministries, including the Ministry of Science and Technology, the Ministry of Economy, the Ministry of Agriculture and Rural Development, the Ministry of National Infrastructures, Energy and Water Resources, the Israel Council for Higher Education and other Ministries. As for the share of R&D budgets, the Ministry of Science and Technology occupies the share of 1.7%, the Ministry of Economy is 35%, the Israel Council for Higher Education is 45.5%, the Ministry of Agriculture and Rural Development is 8.15%, the Ministry of National Infrastructures, Energy and Water Resources is 1.1%, and other Ministries are 7.8% From observing that Israel R&D budgets mainly distributed to several specific Ministries, Israel government not only pours in lot of budgets to encourage civilian technology R&D, to attract more foreign capitals to invest Israel’s industries, and to promote the cooperation between international and domestic technology R&D, but also plans to provide higher education institutes with more R&D budgets to promote their abilities of creativity and innovation in different industries. In addition, by putting R&D budgets into higher education institutes, it also can indirectly inspire students’ potential innovation thinking in technology, develop their abilities to observe the trend of international technology R&D and the need of Israel’s domestic industries, and further appropriately enhance students in higher education institutes to transfer their knowledge into the society. B.The Management of Israel’s Technology R&D Budgets Since Israel is a cabinet government, the cabinet takes responsibility for making all national technology R&D policies. The Ministers Committee for Science and Technology not only has a duty to coordinate Ministries’ technology policies, but also has a responsibility for making a guideline of Israel’s national technology development. The determination of Israel’s national technology development guideline is made by the cabinet conference lead by the Prime Minister, other Ministries does not have any authority to make national technology development guideline. Aforementioned, Israel’s national technology R&D budgets are mainly distributed to several specific Ministries, including the Ministry of Science and Technology, the Ministry of Economy, the Ministry of Agriculture and Rural Development, the Ministry of National Infrastructures, Energy and Water Resources, the Israel Council for Higher Education, and etc. As for the plan management units and plan execution units in Ministries, the Office of the Chief Scientist is the plan management unit in the Ministry of Science and Technology, and Regional Research and Development Centers is the plan execution unit; the Office of the Chief Scientist is the plan management unit in the Ministry of Economy, and its plan execution unit is different industries; the ISF is the plan management units in the Israel Council for Higher Education; also, the Office of the Chief Scientist is the plan management unit in the Ministry of Agriculture, and its plan execution units include the Institute of Field and Garden Corps, the Institute of Horticulture, the Institute of Animal, the Institute of Plan Protection, the Institute of Soil, Water & Environmental Sciences, the Institute for Technology and Storage of Agriculture Products, the Institute of Agricultural Engineering and Research Center; the Office of the Chief Scientist is the plan management unit in the Ministry of National Infrastructures, Energy and Water Resources, and its plan execution units are the Geological Survey of Israel, Israel Oceanographic and Limnological Research and the Institute of Earth and Physical. As for other Ministries, the Offices of the Chief Scientist are the plan management units for Ministries, and the plan execution unit can take Israel National Institute for Health Policy Research or medical centers for example.

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).

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