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).

※Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials,STLI, https://stli.iii.org.tw/en/article-detail.aspx?no=55&tp=2&i=168&d=9100 (Date:2024/07/20)
Quote this paper
You may be interested
Impact of Government Organizational Reform to Scientific Research Legal System and Response Thereto (1) – For Example, The Finnish Innovation Fund (“SITRA”)

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. The former aimed at the sustainable use of natural resources to develop new structures and business models and to boost the development of a bioeconomy and low-carbon society, while the latter aimed to create a more well-being-oriented public administrative environment to upgrade various public sectors’ leadership and decision-making ability to introduce nationals’ opinion to policies and the potential of building new business models and venture capital businesses[1]. II. Standing and Operating Instrument of Sitra 1. Sitra Standing in Boosting of Finnish Innovation Policies (1) Positive Impact from Support of Innovation R&D Activities by Public Sector   Utilization of public sector’s resources to facilitate and boost industrial innovation R&D ability is commonly applied in various countries in the world. Notwithstanding, the impact of the public sector’s investment of resources produced to the technical R&D and the entire society remains explorable[2]. 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.

Taiwan Announced the Biobanks Regulations and Management Practices

Taiwan Has Passed “Statute of Human Biobank Management” to Maintain Privacy and Improve Medicine Industries Due to lack of regulations, divergent opinions abounded about the establishment of Biobanks and collection of human biological specimen. For example, a researcher in an academic research organization and a hospital-based physician collected biospecimens from native Taiwanese. Although they insisted that the collections were for research only, human rights groups, ethics researchers, and groups for natives´ benefits condemned the collections as an invasion of human rights. Consequently, the Taiwanese government recognized the need for Biobanks regulation. To investigate the relationship between disease and multiple factors and to proceed with possible prevention, The Legislative Yuan Social Welfare and Healthy Environment Committee has passed "the draft statute of human biobank management" through primary reviewing process on December 30, 2009 and subsequently passed through entire three-reading procedure on January 7, 2010. Therefore, the medical and research institute not only can set up optimal gene database for particular disease curing, but also can collect blood sample for database establishment, legally. However, the use of sample collections will be excluded from the use of judiciary purpose. In the light of to establish large scale biobank is going to face the fundamental human right issue, from the viewpoint of biobank management, it is essential not only to set up the strict ethics regulation for operational standard, but also to make the legal environment more complete. For instance, the Department of Health, Executive Yuan had committed the earlier planning of Taiwan biobank establishment to the Academic Sinica in 2006, and planned to collect bio-specimen by recruiting volunteers. However, it has been criticized by all circles that it might be considered violating the Constitution article 8 provision 1 front paragraph, and article 22 rules; moreover, it might also infringe the personal liberty or body information privacy. Therefore, the Executive Yuan has passed the draft statute of human biobank management which was drafted and reviewed by Department of Health during the 3152nd meeting, on July 16, 2009, to achieve the goal of protecting our nation’s privacy and promoting the development of medical science by management biomedical research affairs in more effective ways. Currently, the draft statute has been passed through the primary review procedure by the Legislative Yuan. About the draft statute, there are several important points as following: (1) Sample Definition: Types of collected sample include human somatic cell, tissues, body fluids, or other derivatives; (2) Biobank Establishment: It requires not only to be qualified and permitted, but also to set up the ethical reviewing mechanism to strengthen its management and application; (3)Sample Collection and Participant Protection: In accordance with the draft statute, bio-specimen collecting should respect the living ethics during the time and refer to the "Medical Law" article 64 provision 1; before sample collection, all related points of attention should be kept in written form , the participant should be notified accordingly, and samples can only be collected with the participant’s consent. Furthermore, regarding the restrained read right and setting up participants’ sample process way if there were death or lost of their capacity; (4) Biobank Management: The safety regulation, obligation of active notification, free to retreat, data destruction, confidentiality and obligation, and termination of operation handling are stipulated; and (5) Biobank Application: According to the new draft statute, that the biological data can’t be used for other purposes, for example, the use of inquisition result for the "Civil law", article 1063, provision 2, prosecution for denying the parent-child relationship law suit", or according to the "Criminal law", article 213, provision 6. This rule not only protects the participants’ body information and their privacy right, but also clearly defines application limits, as well as to set up the mechanism for inner control and avoid conflict of interests to prevent unnecessary disputes. Finally, the Department of Health noted that, as many medical researches has shown that the occurrence of diseases are mostly co-effected by various factors such as multiple genes and their living environment, rather than one single gene, developed countries have actively devoted to human biological sample collection for their national biobank establishment. The construction and usage of a large-scale human bank may bring up the critical issue such as privacy protection and ethical problems; however, to meet the equilibrium biomedical research promotion and citizen privacy issue will highly depend on the cooperation and trust between the public and private sectors. Taiwan Department of Health Announced the Human Biobanks Information Security Regulation The field of human biobanks will be governed by the Act of Human Biobanks (“Biobanks Act”) after its promulgation on February 3, 2010 in Taiwan. According to Article 13 of the Biobanks Act, a biobank owner should establish its directive rules based on the regulation of information security of biobanks announced by the competent authority. Thus the Department of Health announced the draft of the Human Biobanks Information Security Regulation (“Regulation”) for the due process requirement. According to the Biobanks Act, only the government institutes, medical institutes, academic institutes, and research institutes are competent to establish biobanks (Article 4). In terms of the collecting of organisms, the participants should be informed of the relevant matters by reasonable patterns, and the collecting of organisms may be conducted after obtaining the written consent of the participants (Article 6). The relative information including the organisms and its derivatives are not allowed to be used except for biological and medical research. After all the protection of biobanks relative information above, the most important thing is the safety regulations and directive rules of the database administration lest all the restrictions of biobanks owners and the use be in vain. The draft Regulation aims to strengthen the safety of biobanks database and assure the data, the systems, the equipments, and the web circumstances are safe for the sake of the participants’ rights. The significant aspects of the draft are described as below. At first, the regulation should refer to the ISO27001, ISO27002 and other official rules. Concerning the personnel management, the security assessment is required and the database management personnel and researchers may not serve concurrently. In case some tasks are outsourced, the contractor should be responsible for the information security; the nondisclosure agreement and auditing mechanism are required. The application system should update periodically including the anti-virus and firewall programs. The biobanks database should be separated physically form internet connection, including the prohibition of information transforming by email or any other patterns through internet. The authorizing protocol of access to the biobanks should be established and all log files should be preserved in a period. The system establishment and maintenance should avoid remote control. In case the database system is physically out of the owner’s control, the authorization of the officer in charge is required. If an information security accident occurred, the bionbanks owner should contact the competent authority immediately and inform the participants by adequate tunnel. The biobanks owner should establish annual security auditing program and the project auditing will be conducted subject to the necessity. To sum up, while the biobanks database security regulation is fully established, the biobanks owners will have the sufficient guidance in connection with the biobank information security to comply with in the future.

The Institutionalization of the Taiwan Personal Data Protection Committee - Triumph of Digital Constitutionalism: A Legal Positivism Analysis

The Institutionalization of the Taiwan Personal Data Protection Committee - Triumph of Digital Constitutionalism: A Legal Positivism Analysis 2023/07/13 The Legislative Yuan recently passed an amendment to the Taiwan Personal Data Protection Act, which resulted in the institutionalization of the Taiwan Personal Data Protection Commission (hereunder the “PDPC”)[1]. This article aims to analyze the significance of this institutionalization from three different perspectives: legal positivism, digital constitutionalism, and Millian liberalism. By examining these frameworks, we can better understand the constitutional essence of sovereignty, the power dynamics among individuals, businesses, and governments, and the paradox of freedom that the PDPC addresses through governance and trust. I.Three Layers of Significance 1.Legal Positivism The institutionalization of the PDPC fully demonstrates the constitutional essence of sovereignty in the hands of citizens. Legal positivism emphasizes the importance of recognizing and obeying (the sovereign, of which it is obeyed by all but does not itself obey to anyone else, as Austin claims) laws that are enacted by legitimate authorities[2]. In this context, the institutionalization of the PDPC signifies the recognition of citizens' rights to control their personal data and the acknowledgment of the sovereign in protecting their privacy. It underscores the idea that the power to govern personal data rests with the individuals themselves, reinforcing the principles of legal positivism regarding sovereign Moreover, legal positivism recognizes the authority of the state in creating and enforcing laws. The institutionalization of the PDPC as a specialized commission with the power to regulate and enforce personal data protection laws represents the state's recognition of the need to address the challenges posed by the digital age. By investing the PDPC with the authority to oversee the proper handling and use of personal data, the state acknowledges its responsibility to protect the rights and interests of its citizens. 2.Digital Constitutionalism The institutionalization of the PDPC also rebalances the power structure among individuals, businesses, and governments in the digital realm[3]. Digital constitutionalism refers to the principles and norms that govern the relationship between individuals and the digital sphere, ensuring the protection of rights and liberties[4]. With the rise of technology and the increasing collection and use of personal data, individuals often find themselves at a disadvantage compared to powerful entities such as corporations and governments[5]. However, the PDPC acts as a regulatory body that safeguards individuals' interests, rectifying the power imbalances and promoting digital constitutionalism. By establishing clear rules and regulations regarding the collection, use, and transfer of personal data, the PDPC may set a framework that ensures the protection of individuals' privacy and data rights. It may enforce accountability among businesses and governments, holding them responsible for their data practices and creating a level playing field where individuals have a say in how their personal data is handled. 3.Millian Liberalism The need for the institutionalization of the PDPC embodies the paradox of freedom, as raised in John Stuart Mill’s “On Liberty”[6], where Mill recognizes that absolute freedom can lead to the infringement of others' rights and well-being. In this context, the institutionalization of the PDPC acknowledges the necessity of governance to mitigate the risks associated with personal data protection. In the digital age, the vast amount of personal data collected and processed by various entities raises concerns about privacy, security, and potential misuse. The institutionalization of the PDPC represents a commitment to address these concerns through responsible governance. By setting up rules, regulations, and enforcement mechanisms, the PDPC ensures that individuals' freedoms are preserved without compromising the rights and privacy of others. It strikes a delicate balance between individual autonomy and the broader social interest, shedding light on the paradox of freedom. II.Legal Positivism: Function and Authority of the PDPC 1.John Austin's Concept of Legal Positivism: Sovereignty, Punishment, Order To understand the function and authority of the PDPC, we turn to John Austin's concept of legal positivism. Austin posited that laws are commands issued by a sovereign authority and backed by sanctions[7]. Sovereignty entails the power to make and enforce laws within a given jurisdiction. In the case of the PDPC, its institutionalization by the Legislative Yuan reflects the recognition of its authority to create and enforce regulations concerning personal data protection. The PDPC, as an independent and specialized committee, possesses the necessary jurisdiction and competence to ensure compliance with the law, administer punishments for violations, and maintain order in the realm of personal data protection. 2.Dire Need for the Institutionalization of the PDPC There has been a dire need for the establishment of the PDPC following the Constitutional Court's decision in August 2022, holding that the government needed to establish a specific agency in charge of personal data-related issues[8]. This need reflects John Austin's concept of legal positivism, as it highlights the demand for a legitimate and authoritative body to regulate and oversee personal data protection. The PDPC's institutionalization serves as a response to the growing concerns surrounding data privacy, security breaches, and the increasing reliance on digital platforms. It signifies the de facto recognition of the need for a dedicated institution to safeguard the individual’s personal data rights, reinforcing the principles of legal positivism. Furthermore, the institutionalization of the PDPC demonstrates the responsiveness of the legislative branch to the evolving challenges posed by the digital age. The amendment to the Taiwan Personal Data Protection Act and the subsequent institutionalization of the PDPC are the outcomes of a democratic process, reflecting the will of the people and their desire for enhanced data protection measures. It signifies a commitment to uphold the rule of law and ensure the protection of citizens' rights in the face of emerging technologies and their impact on privacy. 3.Authority to Define Cross-Border Transfer of Personal Data Upon the establishment of the PDPC, it's authority to define what constitutes a cross-border transfer of personal data under Article 21 of the Personal Data Protection Act will then align with John Austin's theory on order. According to Austin, laws bring about order by regulating behavior and ensuring predictability in society. By granting the PDPC the power to determine cross-border data transfers, the legal framework brings clarity and consistency to the process. This promotes order by establishing clear guidelines and standards, reducing uncertainty, and enhancing the protection of personal data in the context of international data transfers. The PDPC's authority in this regard reflects the recognition of the need to regulate and monitor the cross-border transfer of personal data to protect individuals' privacy and prevent unauthorized use or abuse of their information. It ensures that the transfer of personal data across borders adheres to legal and ethical standards, contributing to the institutionalization of a comprehensive framework for cross-border data transfer. III.Conclusion In conclusion, the institutionalization of the Taiwan Personal Data Protection Committee represents the convergence of legal positivism, digital constitutionalism, and Millian liberalism. It signifies the recognition of citizens' sovereignty over their personal data, rebalances power dynamics in the digital realm, and addresses the paradox of freedom through responsible governance. By analyzing the PDPC's function and authority in the context of legal positivism, we understand its role as a regulatory body to maintain order and uphold the principles of legal positivism. The institutionalization of the PDPC serves as a milestone in Taiwan's commitment to protect individuals' personal data and safeguard the digital rights. In essence, the institutionalization of the Taiwan Personal Data Protection Committee represents a triumph of digital constitutionalism, where individuals' rights and interests are safeguarded, and power imbalances are rectified. It also embodies the recognition of the paradox of freedom and the need for responsible governance in the digital age in Taiwan. [1] Lin Ching-yin & Evelyn Yang, Bill to establish data protection agency clears legislative floor, CNA English News, FOCUS TAIWAN, May 16, 2023, https://focustaiwan.tw/society/202305160014 (last visited, July 13, 2023). [2] Legal positivism, Stanford Encyclopedia of Philosophy, https://plato.stanford.edu/entries/legal-positivism/?utm_source=fbia (last visited July 13, 2023). [3] Edoardo Celeste, Digital constitutionalism: how fundamental rights are turning digital, (2023): 13-36, https://doras.dcu.ie/28151/1/2023_Celeste_DIGITAL%20CONSTITUTIONALISM_%20HOW%20FUNDAMENTAL%20RIGHTS%20ARE%20TURNING%20DIGITAL.pdf (last visited July 3, 2023). [4] GIOVANNI DE GREGORIO, DIGITAL CONSTITUTIONALISM IN EUROPE: REFRAMING RIGHTS AND POWERS IN THE ALGORITHMIC SOCIETY 218 (2022). [5] Celeste Edoardo, Digital constitutionalism: how fundamental rights are turning digital (2023), https://doras.dcu.ie/28151/1/2023_Celeste_DIGITAL%20CONSTITUTIONALISM_%20HOW%20FUNDAMENTAL%20RIGHTS%20ARE%20TURNING%20DIGITAL.pdf (last visited July 13, 2023). [6]JOHN STUART MILL,On Liberty (1859), https://openlibrary-repo.ecampusontario.ca/jspui/bitstream/123456789/1310/1/On-Liberty-1645644599.pdf (last visited July 13, 2023). [7] Legal positivism, Stanford Encyclopedia of Philosophy, https://plato.stanford.edu/entries/legal-positivism/?utm_source=fbia (last visited July 13, 2023). [8] Lin Ching-yin & Evelyn Yang, Bill to establish data protection agency clears legislative floor, CNA English News, FOCUS TAIWAN, May 16, 2023, https://focustaiwan.tw/society/202305160014 (last visited, July 13, 2023).

Finland’s Technology Innovation System

I. Introduction   When, Finland, this country comes to our minds, it is quite easy for us to associate with the prestigious cell-phone company “NOKIA”, and its unbeatable high technology communication industry. However, following the change of entire cell-phone industry, the rise of smart phone not only has an influence upon people’s communication and interaction, but also makes Finland, once monopolized the whole cell-phone industry, feel the threat and challenge coming from other new competitors in the smart phone industry. However, even though Finland’s cell-phone industry has encountered frustrations in recent years in global markets, the Finland government still poured many funds into the area of technology and innovation, and brought up the birth of “Angry Birds”, one of the most popular smart phone games in the world. The Finland government still keeps the tradition to encourage R&D, and wishes Finland’s industries could re-gain new energy and power on technology innovation, and indirectly reach another new competitive level.   According to the Statistics Finland, 46% Finland’s enterprises took innovative actions upon product manufacturing and the process of R&D during 2008-2010; also, the promotion of those actions not merely existed in enterprises, but directly continued to the aspect of marketing and manufacturing. No matter on product manufacturing, the process of R&D, the pattern of organization or product marketing, we can observe that enterprises or organizations make contributions upon innovative activities in different levels or procedures. In the assignment of Finland’s R&D budgets in 2012, which amounted to 200 million Euros, universities were assigned by 58 million Euros and occupied 29% R&D budgets. The Finland Tekes was assigned by 55 million Euros, and roughly occupied 27.5% R&D budgets. The Academy of Finland (AOF) was assigned by 32 million Euros, and occupied 16% R&D budges. The government’s sectors were assigned by 3 million Euros, and occupied 15.2% R&D budgets. Other technology R&D expenses were 2.1 million Euros, and roughly occupied 10.5% R&D. The affiliated teaching hospitals in universities were assigned by 0.36 million Euros, and occupied 1.8% R&D budgets. In this way, observing the information above, concerning the promotion of technology, the Finland government not only puts more focus upon R&D innovation, but also pays much attention on education quality of universities, and subsidizes various R&D activities. As to the Finland government’s assignment of budges, it can be referred to the chart below.   As a result of the fact that Finland promotes industries’ innovative activities, it not only made Finland win the first position in “Growth Competitiveness Index” published by the World Economic Forum (WEF) during 2000-2006, but also located the fourth position in 142 national economy in “The Global Competitiveness Report” published by WEF, preceded only by Swiss, Singapore and Sweden, even though facing unstable global economic situations and the European debt crisis. Hence, observing the reasons why Finland’s industries have so strong innovative power, it seems to be related to the Finland’s national technology administrative system, and is worthy to be researched. II. The Recent Situation of Finland’s Technology Administrative System A. Preface   Finland’s administrative system is semi-presidentialism, and its executive power is shared by the president and the Prime Minister; as to its legislative power, is shared by the Congress and the president. The president is the Finland’s leader, and he/she is elected by the Electoral College, and the Prime Minister is elected by the Congress members, and then appointed by the president. To sum up, comparing to the power owned by the Prime Minister and the president in the Finland’s administrative system, the Prime Minister has more power upon executive power. So, actually, Finland can be said that it is a semi-predisnetialism country, but trends to a cabinet system.   Finland technology administrative system can be divided into four parts, and the main agency in each part, based upon its authority, coordinates and cooperates with making, subsidizing, executing of Finland’s technology policies. The first part is the policy-making, and it is composed of the Congress, the Cabinet and the Research and Innovation Council; the second part is policy management and supervision, and it is leaded by the Ministry of Education and Culture, the Ministry of Employment and the Economy, and other Ministries; the third part is science program management and subsidy, and it is composed of the Academy of Finland (AOF), the National Technology Agency (Tekes), and the Finnish National Fund Research and Development (SITRA); the fourth part is policy-executing, and it is composed of universities, polytechnics, public-owned research institutions, private enterprises, and private research institutions. Concerning the framework of Finland’s technology administrative, it can be referred to below. B. The Agency of Finland’s Technology Policy Making and Management (A) The Agency of Finland’s Technology Policy Making   Finland’s technology policies are mainly made by the cabinet, and it means that the cabinet has responsibilities for the master plan, coordinated operation and fund-assignment of national technology policies. The cabinet has two councils, and those are the Economic Council and the Research and Innovation Council, and both of them are chaired by the Prime Minister. The Research and Innovation Council is reshuffled by the Science and Technology Policy Council (STPC) in 1978, and it changed name to the Research and Innovation Council in Jan. 2009. The major duties of the Research and Innovation Council include the assessment of country’s development, deals with the affairs regarding science, technology, innovative policy, human resource, and provides the government with aforementioned schedules and plans, deals with fund-assignment concerning public research development and innovative research, coordinates with all government’s activities upon the area of science, technology, and innovative policy, and executes the government’s other missions.   The Research and Innovation Council is an integration unit for Finland’s national technology policies, and it originally is a consulting agency between the cabinet and Ministries. However, in the actual operation, its scope of authority has already covered coordination function, and turns to direct to make all kinds of policies related to national science technology development. In addition, the consulting suggestions related to national scientific development policies made by the Research and Innovation Council for the cabinet and the heads of Ministries, the conclusion has to be made as a “Key Policy Report” in every three year. The Report has included “Science, Technology, Innovation” in 2006, “Review 2008” in 2008, and the newest “Research and Innovation Policy Guidelines for 2011-2015” in 2010.   Regarding the formation and duration of the Research and Innovation Council, its duration follows the government term. As for its formation, the Prime Minister is a chairman of the Research and Innovation Council, and the membership consists of the Minister of Education and Science, the Minister of Economy, the Minister of Finance and a maximum of six other ministers appointed by the Government. In addition to the Ministerial members, the Council shall comprise ten other members appointed by the Government for the parliamentary term. The Members must comprehensively represent expertise in research and innovation. The structure of Council includes the Council Secretariat, the Administrative Assistant, the Science and Education Subcommittee, and the Technology and Innovation Subcommittee. The Council has the Science and Education Subcommittee and the Technology and Innovation Subcommittee with preparatory tasks. There are chaired by the Ministry of Education and Science and by the Minister of Economy, respectively. The Council’s Secretariat consists of one full-time Secretary General and two full-time Chief Planning Officers. The clerical tasks are taken care of at the Ministry of Education and Culture. (B) The Agency of Finland’s Technology Policy Management   The Ministries mainly take the responsibility for Finland’s technology policy management, which includes the Ministry of Education and Culture, the Ministry of Employment and Economy, the Ministry of Social Affairs and Health, the Ministry of Agriculture and Forestry, the Ministry of Defense, the Ministry of Transport and Communication, the Ministry of Environment, the Ministry of Financial, and the Ministry of Justice. In the aforementioned Ministries, the Ministry of Education and Culture and the Ministry of Employment and Economy are mainly responsible for Finland national scientific technology development, and take charge of national scientific policy and national technical policy, respectively. The goal of national scientific policy is to promote fundamental scientific research and to build up related scientific infrastructures; at the same time, the authority of the Ministry of Education and Culture covers education and training, research infrastructures, fundamental research, applied research, technology development, and commercialization. The main direction of Finland’s national scientific policy is to make sure that scientific technology and innovative activities can be motivated aggressively in universities, and its objects are, first, to raise research funds and maintain research development in a specific ratio; second, to make sure that no matter on R&D institutions or R&D training, it will reach fundamental level upon funding or environment; third, to provide a research network for Finland, European Union and global research; fourth, to support the research related to industries or services based upon knowledge-innovation; fifth, to strengthen the cooperation between research initiators and users, and spread R&D results to find out the values of commercialization, and then create a new technology industry; sixth, to analyze the performance of national R&D system.   As for the Ministry of Employment and Economy, its major duties not only include labor, energy, regional development, marketing and consumer policy, but also takes responsibilities for Finland’s industry and technical policies, and provides industries and enterprises with a well development environment upon technology R&D. The business scope of the Ministry of Employment and Economy puts more focus on actual application of R&D results, it covers applied research of scientific technology, technology development, commercialization, and so on. The direction of Finland’s national technology policy is to strengthen the ability and creativity of industries’ technology development, and its objects are, first, to develop the new horizons of knowledge with national innovation system, and to provide knowledge-oriented products and services; second, to promote the efficiency of the government R&D funds; third, to provide cross-country R&D research networks, and support the priorities of technology policy by strengthening bilateral or multilateral cooperation; fourth, to raise and to broaden the efficiency of research discovery; fifth, to promote the regional development by technology; sixth, to evaluate the performance of technology policy; seventh, to increase the influence of R&D on technological change, innovation and society; eighth, to make sure that technology fundamental structure, national quality policy and technology safety system will be up to international standards. (C) The Agency of Finland’s Technology Policy Management and Subsidy   As to the agency of Finland’s technology policy management and subsidy, it is composed of the Academy of Finland (AOF), the National Technology Agency (Tekes), and the Finnish National Fund Research and Development (SITRA). The fund of AOF comes from the Ministry of Education and Culture; the fund of Tekes comes from the Ministry of Employment and Economy, and the fund of SITRA comes from independent public fund supervised by the Finland’s Congress. (D) The Agency of Finland’s Technology Plan Execution   As to the agency of Finland’s technology plan execution, it mainly belongs to the universities under Ministries, polytechnics, national technology research institutions, and other related research institutions. Under the Ministry of Education and Culture, the technology plans are executed by 16 universities, 25 polytechnics, and the Research Institute for the Language of Finland; under the Ministry of Employment and Economy, the technology plans are executed by the Technical Research Centre of Finland (VTT), the Geological Survey of Finnish, the National Consumer Research Centre; under the Ministry of Social Affairs and Health, the technology plans are executed by the National Institute for Health and Welfare, the Finnish Institute of Occupational Health, and University Central Hospitals; under the Ministry of Agriculture and Forestry, the technology plans are executed by the Finnish Forest Research Institute (Metla), the Finnish Geodetic Institute, and the Finnish Game and Fisheries Research Institute (RKTL); under the Ministry of Defense, the technology plans are executed by the Finnish Defense Forces’ Technical Research Centre (Pvtt); under the Ministry of Transport and Communications, the technology plans are executed by the Finnish Meteorological Institute; under the Ministry of Environment, the technology plans are executed by the Finnish Environment Institute (SYKE); under the Ministry of Financial, the technology plans are executed by the Government Institute for Economic Research (VATT). At last, under the Ministry of Justice, the technology plans are executed by the National Research Institute of Legal Policy.

TOP