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:2025/12/16)
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[1]〈政院通過「人工智慧基本法」草案 建構AI發展與應用良善環境 打造臺灣成為AI人工智慧島〉,行政院,https://www.ey.gov.tw/Page/9277F759E41CCD91/5d673d1e-f418-47dc-ab35-a06600f77f07(最後瀏覽日期︰2025/09/15)。 [2] United States Office of Management and Budget (OMB), M-25-21 Accelerating Federal Use of AI through Innovation, Governance, and Public Trust, https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-21-Accelerating-Federal-Use-of-AI-through-Innovation-Governance-and-Public-Trust.pdf (last visited Sept 15, 2025). [3] 蘇文彬,〈行政院通過AI基本法草案,將不設立AI專責機關〉,iThome,https://www.ithome.com.tw/news/170874(最後瀏覽日期︰2025/09/15)。 [4] Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act), https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1689 (last visited Sept 15, 2025). [5] 인공지능발전과신뢰기반조성등에관한기본법안,https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%B8%EA%B3%B5%EC%A7%80%EB%8A%A5%20%EB%B0 %9C%EC%A0%84%EA%B3%BC%20%EC%8B%A0%EB%A2%B0%20%EA%B8%B0%EB%B0%98%20%EC%A1%B0 %EC%84%B1%20%EB%93%B1%EC%97%90%20%EA%B4%80%ED%95%9C%20%EA%B8%B0%EB%B3%B8%EB%B2 %95/(20676,20250121) (last visited Sept 15, 2025).

Taiwan's Approach to AI Governance

Taiwan's Approach to AI Governance 2024/06/19 In an era where artificial intelligence (AI) reshapes every facet of life, governance plays a pivotal role in harnessing its benefits while mitigating associated risks. Taiwan, recognizing the dual-edged nature of AI, has embarked on a comprehensive strategy to ensure its development is both ethical and effective. This article delves into Taiwan's AI governance framework, exploring its strategic pillars, regulatory milestones, and future directions. I. Taiwan's AI Governance Vision: Taiwan AI Action Plan 2.0 Taiwan has long viewed AI as a transformative force that must be guided with a careful balance of innovation and regulation. With the advent of technologies capable of influencing democracy, privacy, and social stability, Taiwan's approach is rooted in human-centric values. The nation's strategy is aligned with global movements towards responsible AI, drawing lessons from international standards like those set by the European Union's Artificial Intelligence Act. The "Taiwan AI Action Plan 2.0" is the cornerstone of this strategy. It is a multi-faceted plan designed to boost Taiwan's AI capabilities through five key components: 1. Talent Development: Enhancing the quality and quantity of AI professionals while improving public AI literacy through targeted education and training initiatives. 2. Technological and Industrial Advancement: Focusing on critical AI technologies and applications to foster industrial growth and creating the Trustworthy AI Dialogue Engine (TAIDE) that communicates in Traditional Chinese. 3. Supportive Infrastructure: Establishing robust AI governance infrastructure to facilitate industry and governmental regulation, and to foster compliance with international standards. 4. International Collaboration: Expanding Taiwan's role in international AI forums, such as the Global Partnership on AI (GPAI), to collaborate on developing trustworthy AI practices. 5. Societal and Humanitarian Engagement: Utilizing AI to tackle pressing societal challenges like labor shortages, an aging population, and environmental sustainability. II. Guidance-before-legislation To facilitate a gradual adaptation to the evolving legal landscape of artificial intelligence and maintain flexibility in governance, Taiwan employs a "guidance-before-legislation" approach. This strategy prioritizes the rollout of non-binding guidelines as an initial step, allowing agencies to adjust before any formal legislation is enacted as needed. Taiwan adopts a proactive approach in AI governance, facilitated by the Executive Yuan. This method involves consistent inter-departmental collaborations to create a unified regulatory landscape. Each ministry is actively formulating and refining guidelines to address the specific challenges and opportunities presented by AI within their areas of responsibility, spanning finance, healthcare, transportation, and cultural sectors. III. Next step: Artificial Intelligence Basic Act The drafting of the "Basic Law on Artificial Intelligence," anticipated for legislative review in 2024, marks a significant step towards codifying Taiwan’s AI governance. Built on seven foundational principles—transparency, privacy, autonomy, fairness, cybersecurity, sustainable development, and accountability—this law will serve as the backbone for all AI-related activities and developments in Taiwan. By establishing rigorous standards and evaluation mechanisms, this law will not only govern but also guide the ethical deployment of AI technologies, ensuring that they are beneficial and safe for all. IV. Conclusion As AI continues to evolve, the need for robust governance frameworks becomes increasingly critical. Taiwan is setting a global standard for AI governance that is both ethical and effective. Through legislation, active international cooperation, and a steadfast commitment to human-centric values, Taiwan is shaping a future where AI technology not only thrives but also aligns seamlessly with societal norms and values.

The Study of Estonian Human Genes Database

I. Introduction The human genes database or human genome project, the product under the policy of biotechnology no matter in a developed or developing country, has been paid more attention by a government and an ordinary people gradually. The construction of human genes database or human genome project, which is not only related to a country’s innovation on biotechnology, but also concerns the promotion of a country’s medical quality, the construction of medical care system, and the advantages brought by the usage of bio-information stored in human genes database or from human genome project. However, even though every country has a high interest in setting up human genes database or performing human genome project, the issues concerning the purposes of related biotechnology policies, the distribution of advantages and risks and the management of bio-information, since each country has different recognition upon human genes database or human genome project and has varied standards of protecting human basic rights, there would be a totally difference upon planning biotechnology policies or forming the related systems. Right now, the countries that vigorously discuss human genes database or practice human genome project include England, Iceland, Norway, Sweden, Latvia and Estonia. Estonia, which is the country around the Baltic Sea, has planned to set up its own human genes database in order to draw attention from other advanced countries, to attract intelligent international researchers or research groups, and to be in the lead in the area of biotechnology. To sum up, the purpose of constructing Estonian human genes database was to collect the genes and health information of nearly 70% Estonia’s population and to encourage bio-research and promote medical quality. II. The Origin of Estonian Human Genes Database The construction of Estonian human genes database started from Estonian Genome Project (EGP). This project was advocated by the professor of biotechnology Andres Metspalu at Tartu University in Estonia, and he proposed the idea of setting up Estonian human genes database in 1999. The purposes of EGP not only tried to make the economy of Estonia shift from low-cost manufacturing and heavy industry to an advanced technological economy, but also attempted to draw other countries’ attention and to increase the opportunity of making international bio-researches, and then promoted the development of biotechnology and assisted in building the system of medical care in Estonia. EGP started from the agreement made between Estonian government and Eesti Geenikeskus (Estonian Genome Foundation) in March, 1999. Estonian Genome Foundation was a non-profit organization formed by Estonian scientists, doctors and politicians, and its original purposes were to support genes researches, assist in proceeding any project of biotechnology and to set up EGP. The original goals of constructing EGP were “(a) reaching a new level in health care, reduction of costs, and more effective health care, (b) improving knowledge of individuals, genotype-based risk assessment and preventive medicine, and helping the next generation, (c) increasing competitiveness of Estonia – developing infrastructure, investments into high-technology, well-paid jobs, and science intensive products and services, (d) [constructing] better management of health databases (phenotype/genotype database), (e) … [supporting]… economic development through improving gene technology that opens cooperation possibilities and creates synergy between different fields (e.g., gene technology, IT, agriculture, health care)”1. III. The Way of Constructing Estonian Human Genes Database In order to ensure that Estonian human genes database could be operated properly and reasonably in the perspectives of law, ethics and society in Estonia, the Estonian parliament followed the step of Iceland to enact “Human Genes Research Act” (HGRA) via a special legislative process to regulate its human genes database in 2000. HGRA not only authorizes the chief processor to manage Estonian human genes database, but also regulates the issues with regard to the procedure of donation, the maintenance and building of human genes database, the organization of making researches, the confidential identity of donator or patient, the discrimination of genes, and so on. Since the construction of Estonian human genes database might bring the conflicts of different points of view upon the database in Estonia, in order to “avoid fragmentation of societal solidarity and ensure public acceptability and respectability”2 , HGRA adopted international standards regulating a genes research to be a norm of maintaining and building the database. Those standards include UNESCO Universal Declaration on the Human Genome and Human Rights (1997) and the Council of Europe’s Convention on Human Rights and Biomedicine (1997). The purpose of enacting HGRA is mainly to encourage and promote genes researches in Estonia via building Estonian human genes database. By means of utilizing the bio-information stored in the database, it can generate “more exact and efficient drug development, new diagnostic tests, improved individualized treatment and determination of risks of the development of a disease in the future”3 . In order to achieve the above objectives, HGRA primarily puts emphasis on several aspects. Those aspects include providing stronger protection on confidential identity of donators or patients, caring for their privacy, ensuring their autonomy to make donations, and avoiding any possibility that discrimination may happen because of the disclosure of donators’ or patients’ genes information. 1.HERBERT GOTTWEIS & ALAN PETERSEN, BIOBANKS – GOVERNANCE IN COMPARATIVE PERSPECTIVE 59 (2008). 2.Andres Rannamae, Populations and Genetics – Legal and Socio-Ethical Perspectives, in Estonian Genome Porject – Large Scale Health Status Description and DNA Collection 18, 21 (Bartha Maria Knoppers et al. eds., 2003. 3.REMIGIUS N. NWABUEZE, BIOTECHNOLOGY AND THE CHALLENGE OF PROPERTY – PROPERTY RIGHTS IN DEAD BODIES, BODY PARTS, AND GENETIC INFORMATION, 163 (2007).

Taiwan Recent Regulatory Development- Promoting Biotech and New Pharmaceuticals Industry

Over the past twenty years, the Government has sought to cultivate the biopharmaceutical industry as one of the future major industry in Taiwan. Back in 1982, the Government has begun to regard biotechnology as a key technology in Technology Development Program, demonstrated that biotechnology is a vital technology in pursuit of future economic growth. Subsequently, the Government initiated national programs that incorporated biotechnology as a blueprint for future industrial development. In order to enhance our competitiveness and building an initial framework for the industry, The Executive Yuan has passed the Biotechnology Industry Promotion Plan. As the Government seeks to create future engines of growth by building an environment conducive for enterprise development, the Plan has been amended four times, and implemented measures focused on the following six areas: related law and regulations, R&D and applications, technology transfer and commercialization, personnel training, investment promotion and coordination, marketing information and marketing service. In 2002, the Executive Yuan approved the Challenge 2008, a six-year national development plan, pointing out biotechnology industry as one of the Two Trillion, Twin Stars industries. The Government planned for future economic growth by benefiting through the attributes of the biotechnology: high-tech, high-reward and less pollution. Thus, since 1997 the Strategic Review Board (SRB) under the Executive Yuan Science and Technology Advisory Panel has taken action in coordinating government policies with industry comments to form a sound policy for the biotechnology industry. Additionally, a well-established legal system for sufficient protection of intellectual property rights is the perquisite for building the industry, as the Government recognized the significance through amending and executing related laws and regulations. By stipulating data exclusivity and experimental use exception in the Pharmaceutical Affair Act, tax benefits provided in Statute for Upgrading Industries , Incentives for Production and R&D of Rare Disease Medicine, Incentives for Medical Technology Research and Development, provide funding measures in the Guidance of Reviewing Programs for Promoting Biotechnology Investment. Clearly, the government has great expectation for the industry through establishing a favorable environment by carrying out these policies and revising outdated regulations. Thus, the Legislative Yuan has passed the “Act for The Development of Biotechnology and New Pharmaceuticals Industry” in June, 2007, and immediately took effect in July. The relevant laws and regulations became effective as well, driving the industry in conducting researches on new drugs and manufacturing new products, increasing sales and expanding the industry to meet an international level. For a biopharmaceutical industry that requires long-term investment and costly R&D, incentive measures is vital to the industry’s survival before the product launches the market. Accordingly, this article will be introducing the recent important regulation that supports the biopharmaceutical industry in Taiwan, and analyzing the government’s policies. Biotechnology is increasingly gaining global attention for its potential in building future economic growth and generating significant profits. In an effort to support the biotechnology industry in Taiwan, the Government has made a step forward by enacting the “Act for the Development of Biotech and New Pharmaceutical Industry”. The biopharmaceutical industry is characterized as high-risk and high-reward, strong government support and a well-developed legal system plays a vital role from its establishment throughout the long term development. Therefore, the Act was enacted tailor to the Biotech and New Pharmaceutical Industry, primarily focuses on tax benefits, R&D activities, personnel recruitment and investment funding, in support of start-up companies and attracting a strong flow of funding worldwide. To pave the way for promoting the biopharmaceutical industry and the Biotech and New Pharmaceutical Company, here the article will be introducing the incentive measures provided in the Act, and supporting development of the industry, demonstrating the efforts made by the Government to build a “Bio-tech Island”. Reference “Act for Development of Biotech and New Pharmaceutical Industry”, webpage of Law and Regulations Database of the Republic of China. 4 July, 2007. Ministry of Justice, Taiwan. 5 Nov. 2008 http://law.moj.gov.tw/Eng/Fnews/FnewsContent.asp?msgid=3180&msgType=en&keyword=undefined

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