The Research on ownership of cell therapy products
The Research on ownership of cell therapy products
1. Issues concerning ownership of cell therapy products
Regarding the issue of ownership interests, American Medical Association(AMA)has pointed out in 2016 that using human tissues to develop commercially available products raises question about who holds property rights in human biological materials[1]. In United States, there have been several disputes concern the issue of the whether the donor of the cell therapy can claim ownership of the product, including Moore v. Regents of University of California(1990)[2], Greenberg v. Miami Children's Hospital Research Institute(2003)[3], and Washington University v. Catalona(2007)[4]. The courts tend to hold that since cells and tissues were donated voluntarily, the donors had already lost their property rights of their cells and tissues at the time of the donation. In Moore case, even if the researchers used Moore’s cells to obtain commercial benefits in an involuntary situation, the court still held that the property rights of removed cells were not suitable to be claimed by their donor, so as to avoid the burden for researcher to clarify whether the use of cells violates the wishes of the donors and therefore decrease the legal risk for R&D activities. United Kingdom Medical Research Council(MRC)also noted in 2019 that the donated human material is usually described as ‘gifts’, and donors of samples are not usually regarded as having ownership or property rights in these[5]. Accordingly, both USA and UK tends to believe that it is not suitable for cell donors to claim ownership.
2. The ownership of cell therapy products in the lens of Taiwan’s Civil Code
In Taiwan, Article 766 of Civil Code stipulated: “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Accordingly, many scholars believe that the ownership of separated body parts of the human body belong to the person whom the parts were separated from. Therefore, it should be considered that the ownership of the cells obtained from the donor still belongs to the donor. In addition, since it is stipulated in Article 406 of Civil Code that “A gift is a contract whereby the parties agree that one of the parties delivers his property gratuitously to another party and the latter agrees to accept it.”, if the act of donation can be considered as a gift relationship, then the ownership of the cells has been delivered from donor to other party who accept it accordingly.
However, in the different versions of Regenerative Medicine Biologics Regulation (draft) proposed by Taiwan legislators, some of which replace the term “donor” with “provider”. Therefore, for cell providers, instead of cell donors, after providing cells, whether they can claim ownership of cell therapy product still needs further discussion.
According to Article 69 of the Civil Code, it is stipulated that “Natural profits are products of the earth, animals, and other products which are produced from another thing without diminution of its substance.” In addition, Article 766 of the Civil Code stipulated that “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Thus, many scholars believe that when the product is organic, original substance and the natural profits thereof are all belong to the owner of the original substance. For example, when proteins are produced from isolated cells, the proteins can be deemed as natural profits and the ownership of proteins and isolated cells all belong to the owner of the cells[6].
Nevertheless, according to Article 814 of the Civil Code, it is stipulated that “When a person has contributed work to a personal property belonging to another, the ownership of the personal property upon which the work is done belongs to the owner of the material thereof. However, if the value of the contributing work obviously exceeds the value of the material, the ownership of the personal property upon which the work is done belongs to the contributing person.” Thus, scholar believes that since regenerative medical technology, which induces cell differentiation, involves quite complex biotechnology technology, and should be deemed as contributing work. Therefore, the ownership of cell products after contributing work should belongs to the contributing person[7]. Thus, if the provider provides the cells to the researcher, after complex biotechnology contributing work, the original ownership of the cells should be deemed to have been eliminated, and there is no basis for providers to claim ownership.
However, since the development of cell therapy products involves a series of R&D activities, it still need to be clarified that who is entitled to the ownership of the final cell therapy products. According to Taiwan’s Civil Code, the ownership of product after contributing work should belongs to the contributing person. However, when there are numerous contributing persons, which person should the ownership belong to, might be determined on a case-by-case basis.
3. Conclusion
The biggest difference between cell therapy products and all other small molecule drugs or biologics is that original cell materials are provided by donors or providers, and the whole development process involves numerous contributing persons. Hence, ownership disputes are prone to arise.
In addition to the above-discussed disputes, United Kingdom Co-ordinating Committee on Cancer Research(UKCCCR)also noted that there is a long list of people and organizations who might lay claim to the ownership of specimens and their derivatives, including the donor and relatives, the surgeon and pathologist, the hospital authority where the sample was taken, the scientists engaged in the research, the institution where the research work was carried out, the funding organization supporting the research and any collaborating commercial company. Thus, the ultimate control of subsequent ownership and patent rights will need to be negotiated[8].
Since the same issues might also occur in Taiwan, while developing cell therapy products, carefully clarifying the ownership between stakeholders is necessary for avoiding possible dispute.
[1]American Medical Association [AMA], Commercial Use of Human Biological Materials, Code of Medical Ethics Opinion 7.3.9, Nov. 14, 2016, https://www.ama-assn.org/delivering-care/ethics/commercial-use-human-biological-materials (last visited Jan. 3, 2021).
[2]Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990)
[3]Greenberg v. Miami Children's Hospital Research Institute, 264 F. Suppl. 2d, 1064 (SD Fl. 2003)
[4]Washington University v. Catalona, 490 F 3d 667 (8th Cir. 2007)
[5]Medical Research Council [MRC], Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines, 2019, https://mrc.ukri.org/publications/browse/human-tissue-and-biological-samples-for-use-in-research/ (last visited Jan. 3, 2021).
[6]Wen-Hui Chiu, The legal entitlement of human body, tissue and derivatives in civil law, Angle Publishing, 2016, at 327.
[7]id, at 341.
[8]Okano, M., Takebayashi, S., Okumura, K., Li, E., Gaudray, P., Carle, G. F., & Bliek, J. UKCCCR guidelines for the use of cell lines in cancer research. Cytogenetic and Genome Research, 86(3-4), 1999, https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC2363383&blobtype=pdf (last visited Jan. 3, 2021).
The Tax Benefit of “Act for Establishment and Administration of Science Parks” and the Relational Norms for Innovation “Act for Establishment and Administration of Science Parks” was promulgated in 1979, and was amended entirely in May 15, 2018, announced in June 6. The title was revised from “Act for Establishment and Administration of Science ‘Industrial’ Parks” to “Act for Establishment and Administration of Science Parks” (it would be called “the Act” in this article). It was a significant transition from traditional manufacture into technological innovation. For encouraging different innovative technology enter into the science park, there is tax benefit in the Act. When the park enterprises import machines, equipment, material and so on from foreign country, the import duties, commodity tax, and business tax shall be exempted; moreover, when the park enterprises export products and services, it will have given favorable business and commodity tax free.[1] Furthermore, the park bureaus also exempt collection of land rent.[2] If they have approval for importing or exporting products, they do not need to apply for permission.[3] In the sub-law, there is also regulations of bonding operation.[4] To sum up, for applying the benefit of the act, enterprises approved for establishment in science parks still require to manufacture products. Such regulations are confined to industrial industry. Innovative companies dedicate in software, big data, or customer service, rarely gain benefits from taxation. In other norms,[5] there are also tax deduction or exemption for developing innovative industries. Based on promoting innovation, the enterprises following the laws of environmental protection, laborers’ safety, food safety and sanitation,[6] or investing in brand-new smart machines for their own utilize,[7] or licensing their intellectual property rights,[8] can deduct from its taxable income. In addition, the research creators from academic or research institutions,[9] or employee,[10] can declare deferral of the income tax payable for the shares distributed. In order to assist new invested innovative enterprises,[11] there are also relational benefit of tax. For upgrading the biotech and new pharmaceuticals enterprises, when they invest in human resource training, research and development, they can have deductible corporate income tax payable.[12] There is also tax favored benefits for small and medium enterprises in using of land, experiment of research, technology stocks, retaining of surplus, and additional employees hiring.[13] The present norms of tax are not only limiting in space or products but also encouraging in “research”. In other word, in each steps of the research of innovation, the enterprises still need to manufacture products from their own technology, fund and human resources. If the government could encourage open innovation with favored taxation, it would strengthen the capability of research and development for innovative enterprises. Supporting the innovation by taxation, the government can achieve the goal of scientific development more quickly and encourage them accepting guidance. “New York State Business Incubator and Innovation Hot Spot Support Act” can be an example, [14]the innovative enterprises accepting the guidance from incubators will have the benefit of tax on “personal income”, “sales and use” and “corporation franchise”. Moreover, focusing on key industries and exemplary cases, there are also the norms of tax exemption and tax abatement in China for promoting the development of technology.[15]The benefit of tax is not only in research but also in “the process of research”. To sum up, the government of Taiwan provides the benefit of tax for advancing the competition of outcomes in market, and for propelling the development of innovation. In order to accelerate the efficiency of scientific research, the government could draw lessons from America and China for enacting the norms about the benefit of tax and the constitution of guidance. [1] The Act §23. [2] Id. §24. [3] Id. §25. [4] Regulations Governing the Bonding Operations in Science Parks. [5] Such as Act for Development of Small and Medium Enterprises, Statute for Industrial Innovation, Act for the Development of Biotech and New Pharmaceuticals Industry. [6] Statute for Industrial Innovation §10. [7] Id. §10-1. [8] Id. §12-1. [9] Id. §12-2. [10] Id. §19-1. [11] Id. §23-1, §23-2, §23-3. [12] Act for the Development of Biotech and New Pharmaceuticals Industry §5, §6, §7. [13] Act for Development of Small and Medium Enterprises Chapter 4: §33 to §36-3. [14] New York State Department of Taxation and Finance Taxpayer Guidance Division, New York State Business Incubator and Innovation Hot Spot Support Act, Technical Memorandum TSB-M-14(1)C, (1)I, (2)S, at 1-6 (March 7, 2014), URL：http://www.wnyincubators.com/content/Innovation%20Hot%20Spot%20Technical%20Memorandum.pdf (last visited：December 18, 2019). [15] Enterprise Income Tax Law of the People’s Republic of China Chapter 4 “Preferential Tax Treatments”: §25 to §36 (2008 revised).
Reviews on Taiwan Constitutional Court's Judgment no. 13 of 2022Reviews on Taiwan Constitutional Court's Judgment no. 13 of 2022 2022/11/24 I.Introduction In 2012, the Taiwan Human Rights Promotion Association and other civil groups believe that the National Health Insurance Administration released the national health insurance database and other health insurance data for scholars to do research without consent, which may be unconstitutional and petitioned for constitutional interpretation. Taiwan Human Rights Promotion Association believes that the state collects, processes, and utilizes personal data on a large scale with the "Personal Data Protection Law", but does not set up another law of conduct to control the exercise of state power, which has violated the principle of legal retention; the data is provided to third-party academic research for use, and the parties involved later Excessive restrictions on the right to withdraw go against the principle of proportionality. The claimant criticized that depriving citizens of their prior consent and post-control rights to medical data is like forcing all citizens to unconditionally contribute data for use outside the purpose before they can use health insurance. The personal data law was originally established to "avoid the infringement of personality rights and promote the rational use of data", but in the insufficient and outdated design of the regulations, it cannot protect the privacy of citizens' information from infringement, and it is easy to open the door to the use of data for other purposes. In addition, even if the health insurance data is de-identified, it is still "individual data" that can distinguish individuals, not "overall data." Health insurance data can be connected with other data of the Ministry of Health and Welfare, such as: physical and mental disability files, sexual assault notification files, etc., and you can also apply for bringing in external data or connecting with other agency data. Although Taiwan prohibits the export of original data, the risk of re-identification may also increase as the number of sources and types of data concatenated increases, as well as unspecified research purposes. The constitutional court of Taiwan has made its judgment on the constitutionality of the personal data usage of National Health Insurance research database. The judgment, released on August 12, 2022, states that Article 6 of Personal Data Protection Act(PDPA), which asks“data pertaining to a natural person's medical records, healthcare, genetics, sex life, physical examination and criminal records shall not be collected, processed or used unless where it is necessary for statistics gathering or academic research by a government agency or an academic institution for the purpose of healthcare, public health, or crime prevention, provided that such data, as processed by the data provider or as disclosed by the data collector, may not lead to the identification of a specific data subject”does not violate Intelligible principle and Principle of proportionality. Therefore, PDPA does not invade people’s right to privacy and remains constitutional. However, the judgment finds the absence of independent supervisory authority responsible for ensuring Taiwan institutions and bodies comply with data protection law, can be unconstitutional, putting personal data protection system on the borderline to failure. Accordingly, laws and regulations must be amended to protect people’s information privacy guaranteed by Article 22 of Constitution of the Republic of China (Taiwan). In addition, the judgment also states it is unconstitutional that Articles 79 and 80 of National Health Insurance Law and other relevant laws lack clear provisions in terms of store, process, external transmission of Personal health insurance data held by Central Health Insurance Administration of the Ministry of Health and Welfare. Finally, the Central Health Insurance Administration of the Ministry of Health and Welfare provides public agencies or academic research institutions with personal health insurance data for use outside the original purpose of collection. According to the overall observation of the relevant regulations, there is no relevant provision that the parties can request to “opt-out”; within this scope, it violates the intention of Article 22 of the Constitution to protect people's right to information privacy. II.Independent supervisory authority According to Article 3 of Central Regulations and Standards Act, government agencies can be divided into independent agencies that can independently exercise their powers and operate autonomously, and non- independent agencies that must obey orders from their superiors. In Taiwan, the so-called "dedicated agency"(專責機關) does not fall into any type of agency defined by the Central Regulations and Standards Act. Dedicated agency should be interpreted as an agency that is responsible for a specific business and here is no other agency to share the business. The European Union requires member states to set up independent regulatory agencies (refer to Articles 51 and 52 of General Data Protection Regulation (GDPR)). In General Data Protection Regulation and the adequacy reference guidelines, the specific requirements for personal data supervisory agencies are as follows: the country concerned should have one or more independent supervisory agencies; they should perform their duties completely independently and cannot seek or accept instructions; the supervisory agencies should have necessary and practicable powers, including the power of investigation; it should be considered whether its staff and budget can effectively assist its implementation. Therefore, in order to pass the EU's adequacy certification and implement the protection of people's privacy and information autonomy, major countries have set up independent supervisory agencies for personal data protection based on the GDPR standards. According to this research, most countries have 5 to 10 commissioners that independently exercise their powers to supervise data exchange and personal data protection. In order to implement the powers and avoid unnecessary conflicts of interests among personnel, most of the commissioners are full-time professionals. Article 3 of Basic Code Governing Central Administrative Agencies Organizations defines independent agency as "A commission-type collegial organization that exercises its powers and functions independently without the supervision of other agencies, and operates autonomously unless otherwise stipulated." It is similar to Japan, South Korea, and the United States. III.Right to Opt-out The judgment pointed out that the parties still have the right to control afterwards the personal information that is allowed to be collected, processed and used without the consent of the parties or that meets certain requirements. Although Article 11 of PDPA provides for certain parties to exercise the right to control afterwards, it does not cover all situations in which personal data is used, such as: legally collecting, processing or using correct personal data, and its specific purpose has not disappeared, In the event that the time limit has not yet expired, so the information autonomy of the party cannot be fully protected, the subject, cause, procedure, effect, etc. of the request for suspension of use should be clearly stipulated in the revised law, and exceptions are not allowed. The United Kingdom is of great reference. In 2017, after the British Information Commissioner's Office (ICO) determined that the data sharing agreement between Google's artificial intelligence DeepMind and the British National Health Service (NHS) violated the British data protection law, the British Department of Health and Social Care proposed National data opt-out Directive in May, 2018. British health and social care-related institutions may refer to the National Data Opt-out Operational Policy Guidance Document published by the National Health Service in October to plan the mechanism for exercising patient's opt-out right. The guidance document mainly explains the overall policy on the exercise of the right to opt-out, as well as the specific implementation of suggested practices, such as opt-out response measures, methods of exercising the opt-out right, etc. National Data Opt-out Operational Policy Guidance Document also includes exceptions and restrictions on the right to opt-out. The Document stipulates that exceptions may limit the right to Opt-out, including: the sharing of patient data, if it is based on the consent of the parties (consent), the prevention and control of infectious diseases (communicable disease and risks to public health), major public interests (overriding) Public interest), statutory obligations, or cooperation with judicial investigations (information required by law or court order), health and social care-related institutions may exceptionally restrict the exercise of the patient's right to withdraw. What needs to be distinguished from the situation in Taiwan is that when the UK first collected public information and entered it into the NHS database, there was already a law authorizing the NHS to search and use personal information of the public. The right to choose to enter or not for the first time; and after their personal data has entered the NHS database, the law gives the public the right to opt-out. Therefore, the UK has given the public two opportunities to choose through the enactment of special laws to protect public's right to information autonomy. At present, the secondary use of data in the health insurance database does not have a complete legal basis in Taiwan. At the beginning, the data was automatically sent in without asking for everyone’s consent, and there was no way to withdraw when it was used for other purposes, therefore it was s unconstitutional. Hence, in addition to thinking about what kind of provisions to add to the PDPA as a condition for "exception and non-request for cessation of use", whether to formulate a special law on secondary use is also worthy of consideration by the Taiwan government. IV.De-identification According to the relevant regulations of PDPA, there is no definition of "de-identification", resulting in a conceptual gap in the connotation. In other words, what angle or standard should be used to judge that the processed data has reached the point where it is impossible to identify a specific person. In judicial practice, it has been pointed out that for "data recipients", if the data has been de-identified, the data will no longer be regulated by PDPA due to the loss of personal attributes, and it is even further believed that de-identification is not necessary. However, the Judgment No. 13 of Constitutional Court, pointed out that through de-identification measures, ordinary people cannot identify a specific party without using additional information, which can be regarded as personal data of de-identification data. Therefore, the judge did not give an objective standard for de-identification, but believed that the purpose of data utilization and the risk of re-identification should be measured on a case-by-case basis, and a strict review of the constitutional principle of proportionality should be carried out. So far, it should be considered that the interpretation of the de-identification standard has been roughly finalized. V.Conclusions The judge first explained that if personal information is processed, the type and nature of the data can still be objectively restored to indirectly identify the parties, no matter how simple or difficult the restoration process is, if the data is restored in a specific way, the parties can still be identified. personal information. Therefore, the independent control rights of the parties to such data are still protected by Article 22 of the Constitution. Conversely, when the processed data objectively has no possibility to restore the identification of individuals, it loses the essence of personal data, and the parties concerned are no longer protected by Article 22 of the Constitution. Based on this, the judge declared that according to Article 6, Item 1, Proviso, Clause 4 of the PDPA, the health insurance database has been processed so that the specific party cannot be identified, and it is used by public agencies or academic research institutions for medical and health purposes. Doing necessary statistical or academic research complies with the principles of legal clarity and proportionality, and does not violate the Constitution. However, the judge believes that the current personal data law or other relevant regulations still lack an independent supervision mechanism for personal data protection, and the protection of personal information privacy is insufficient. In addition, important matters such as personal health insurance data can be stored, processed, and transmitted externally by the National Health Insurance Administration in a database; the subject, purpose, requirements, scope, and method of providing external use; and organizational and procedural supervision and protection mechanisms, etc. Articles 79 and 80 of the Health Insurance Law and other relevant laws lack clear provisions, so they are determined to be unconstitutional. In the end, the judge found that the relevant laws and regulations lacked the provisions that the parties can request to stop using the data, whether it is the right of the parties to request to stop, or the procedures to be followed to stop the use, there is no relevant clear text, obviously the protection of information privacy is insufficient. Therefore, regarding unconstitutional issues, the Constitutional Court ordered the relevant agencies to amend the Health Insurance Law and related laws within 3 years, or formulate specific laws.
Research on Taiwan’s Policies of Innovative Industry Development in Recent Years (2015-2016)Research on Taiwan’s Policies of Innovative Industry Development in Recent Years (2015-2016) 1. “Five plus Two” Innovative Industries Policy On June 15, 2016, Premier Lin Chuan met with a group of prominent business leaders to talk about a government project on five innovative industries, which aim to drive the next generation of businesses in R.O.C.. Subsequently the program was expanded to include “new agriculture” and the “circular economy” as the “+2.” The program was then broadened even further to include the Digital Economy and Cultural Innovation, with even Semiconductors and IC Design included, although the name of the policy remains 5+2. Speaking at the Third Wednesday Club in Taipei, Premier Lin said the industries require more investment to drive the next generation of industry growth momentum in R.O.C., create high-quality jobs, and upgrade the industrial competitiveness. Executive Yuan has selected the five innovative industries of Asia Silicon Valley, smart machinery, green energy, biotech & pharmaceutical industry, and national defense, which will be the core for pushing forward the next-generation industrial growth and improve overall environment by creating a cluster effect that links local and global industries, while simultaneously raising wages and stimulating employment. Premier Lin said, regarding industrial competitiveness and investment issues the lackluster economy has stifled investment opportunities, and with limited government budgets, the private sector must play the larger role in investments. Regarding the “Five major Innovative Industries” project, Premier Lin said the National Development Council is currently drafting long-term plan to attract talent, create a thriving working environment, and infuse companies with more innovation, entrepreneurship and young workers. In addition, R.O.C. must also cultivate a strong software industry, without which it would be difficult to build a highly intelligent infrastructure. The National Development Council said the program possess both the capacity of domestic demand and local characteristics, as the core for pushing forward the next-generation industrial growth. The government aims to promote a seamless synergy of investment, technology, and the talent, in order to develop innovative industrial clusters for furthering global linkage and nurturing international enterprises. In the meantime, the government also aims at achieving the enhancement of technology levels, balanced regional development, as well as realizing the benefits of job creation. 2. The Asia Silicon Valley Development Plan In September 2016 the government approved the Asia Silicon Valley Development Plan, which connect Taiwan to global tech clusters and create new industries for the next generation. By harnessing advanced technological research and development results from around the world, the plan hopes to promote innovation and R&D for devices and applications of the internet of things (IoT), and upgrade Taiwan’s startup and entrepreneurship ecosystem. The four implementation strategies are as follows: (1) Building a comprehensive ecosystem to support innovation and entrepreneurship (2) Connect with international research and development capabilities (3) Create an IoT value chain (4) Construct diversified test beds for smart products and services by establishing a quality internet environment Taiwan’s first wave of industrial development was driven by continuous technological innovation, and the wave that followed saw the information industry become a major source of economic growth. 3. Global Hub for Smart Machinery On July 21, 2016, Premier Lin Chuan said at a Cabinet meeting, the government aims to forge Taiwan into a global manufacturing hub for intelligent machinery and high-end equipment parts. Upgrading from precision machinery to intelligent machinery is the main goal of putting intelligent machinery industry into focal execution area expecting to create jobs and to maximize the production of production line as well as to forge central Taiwan into a global manufacturing hub for smart machinery. The Ministry of Economic draws up the Intelligent Machinery Promotion Program to establish the applications of the technology and capacity of services that fit the demand of the market. The program embodies two parts. The first is to accelerate the industrialization of intelligent machinery for building an ecosystem. The second is to improve intelligentization by means of introducing the intelligent machinery into the industries. The execution policy of the Intelligent Machinery Promotion Program is to integrate the intelligent functions such as malfunctions predictions, accuracy compensation, and automatic parameter setting into the machinery industry so as to have the ability to render the whole solutions to the problem. Simultaneously, the program employs three strategies, which are connecting with the local industries, connecting with the future, and connecting with the world, to develop the mentioned vision and objectives. Especially, the way to execute the strategy of connecting with the local industries consists of integrating the capabilities of industry, research organization and the government. At the meantime, the government will encourage the applications of smart vehicles and unmanned aerial vehicles and train the talents as well. The thinking of connecting with the future lies in the goal of deepening the technologies, establishing systematic solutions, and providing a testing areas, which focus on the related applications such as aerospace, advanced semiconductor, smart transportation, green vehicles, energy industry, whole solutions between factories, intelligent man-machine coordination, and robots of machine vision combined with intelligent machinery applications. The government would strengthen the cross-cutting cooperation to develop machines for aerospace and integrate the system of industrial division to form a cluster in order to create Taiwanese IoT technology. Eventually, Taiwan will be able to connect with the world, enhance international cooperation, expand export trade and push industry moving toward the age of information and digital economy and break the edge of industry technology to make the industry feel the goodwill of the government. 4. Green energy innovations The government’s “five plus two” innovative industries program includes a green energy industrial innovation plan passed October 27, 2016 that will focus on Taiwan’s green needs, spur extensive investments from within and outside the country, and increase quality employment opportunities while supporting the growth of green energy technologies and businesses. The government is developing the Shalun Green Energy Science City. The hub’s core in Shalun will house a green energy technology research center as well as a demo site, providing facilities to develop research and development (R&D) capabilities and conduct the requisite certification and demonstration procedures. The joint research center for green energy technologies will integrate the efforts of domestic academic institutions, research institutes, state-run enterprises and industry to develop green energy technologies, focusing on four major functions: creating, conserving and storing energy, as well as system integration. Development strategies include systems integration and finding better ways to conserve, generate and store energy by promoting green energy infrastructure, expanding renewable energy capabilities and cooperating with large international firms. The emergence of the green economy has prompted the government to build infrastructure that will lay the foundation for Taiwan’s green energy sector, transform the nation into a nuclear-free society, and spur industrial innovation. For innovative technology industries, green energy industries can drive domestic economic development by attracting more venture capital and creating more employment opportunities. 5. Biomedical Industry Innovation Program To facilitate development of Taiwan’s biomedical industry, the government proposed a “biomedical industrial innovation promotion program” on November 10, 2016 to serve as the nation’s new blueprint for innovative biomedical research and development (R&D). To facilitate development of the biomedical industry, the government proposed a “biomedical industrial innovation promotion program”. The program centered on the theme of “local, global and future links,” “the biomedical industrial innovation promotion program” includes four action plans: (1) Build a comprehensive ecosystem To address a rapidly ageing global population, Taiwan will enhance the biomedical industry’s capacity for innovation by focusing on talent, capital, topic selection, intellectual property, laws and regulations, and resources. (2) Integrate innovative business clusters Established by the Ministry of Science and Technology and based in Hsinchu Biomedical Science Park, the center will serve as a government think tank on related issues. It is also tasked with initiating and advancing exchanges among local and foreign experts, overseeing project implementation, promoting investment and recruiting talents. Equally important, it will play a central role in integrating resources from other biomedical industry clusters around the country, including Nangang Software Park in Taipei City, Central Taiwan Science Park in Taichung City and Southern Science Park in Tainan City. (3) Connect global market resources Building on Taiwan’s advantages, promote M&A and strategic alliances, and employ buyout funds and syndicated loans to purchase high-potential small and medium-sized international pharmaceutical companies, medical supply companies, distributors and service providers. Use modern mosquito-borne disease control strategies as the foundation of diplomatic cooperation, and promote the development of Taiwan’s public health care and medical services in Southeast Asian countries. (4) Promote specialized key industries Promote niche precision medical services, foster clusters of world-class specialty clinics, and develop industries in the health and wellness sectors. 6. DIGITAL NATION AND INNOVATIVE ECONOMIC DEVELOPMENT PLAN On November 24, 2016, the Executive Yuan promote the Digital Nation and Innovative Economic Development Plan (2017-2025) (DIGI+ program), the plan’s main goals for 2025 are to grow R.O.C.’s digital economy to NT $ 6.5 trillion (US$205.9 billion), increase the digital lifestyle services penetration rate to 80 percent, speed up broadband connections to 2 Gbps, ensure citizens’ basic rights to have 25 Mbps broadband access, and put R.O.C. among the top 10 information technology nations worldwide. In addition to the industrial economy, the program can jump off bottlenecks in the past industrial development, and promote the current Internet of things, intelligent machinery, green energy, medical care and other key national industries, but also attaches great importance to strengthening the digital infrastructure construction, the development of equal active, as well as the creation of a service-oriented digital government. It is also hoped that through the construction of a sustainable and intelligent urban and rural area, the quality of life will be improved and the people will enjoy a wealthy and healthy life. Over the next 8 years, the government will spend more than NT $ 150 billion. The plan contains several important development strategies: DIGI+Infrastructure: Build infrastructure conducive to digital innovation. DIGI+Talent: Cultivate digital innovation talent. DIGI+Industry: Support cross-industry transformation through digital innovation. DIGI+Rights: Make R.O.C. an advanced society that respects digital rights and supports open online communities. DIGI+Cities: Build smart cities through cooperation among central and local governments and the industrial, academic and research sectors. DIGI+Globalization: Boost R.O.C.’s standing in the global digital service economy. The program aims to build a favorable environment for digital innovation and to create a friendly legal environment to complete the draft amendments to the Digital Communications Law and the Telecommunications Act as soon as possible, foster cross-domain digital talents and develop advanced digital technologies, To create a digital economy, digital government, network society, smart urban and rural and other national innovation ecological environment in order to achieve "the development of active network society, promote high value innovation economy, open up rich countries of the policy vision. In order to achieve the overall effectiveness of the DIGI + program, interdisciplinary, inter-ministerial, inter-departmental and inter-departmental efforts will be required to collaborate with the newly launched Digital National Innovation Economy (DIGI +) Promotion Team. 7. “NEW AGRICULTURE” PROMOTION PROJECT At a Cabinet meeting On December 08, 2016, Premier Lin Chuan underscored the importance of a new agricultural paradigm for Taiwan’s economic development, adding that new agriculture is an integral part of the “five plus two” industrial innovation projects proposed by President Tsai Ing-wen. The “new agriculture” promotion project uses innovation technology to bring value to agricultural, and build new agricultural paradigm, agricultural safety systems and promote agricultural marketing. This project also takes resources recycling and environmental sustainability into consideration to promote agricultural transformation, and build a robust new agricultural system. This agricultural project is expected to increase food self-sufficiency rate to 40%, level up agricultural industry value by NT$43.4 billion, create 370,000 jobs and increase portion of total agricultural exports to new overseas markets to 57% by 2020. This project contains three aspects: First is “building new agricultural paradigm”: to protect farmers, agricultural development and ensure sustainability of the environment. Second is “building agricultural safety systems”: Ensuring product safety and quality, and building a certification system which can be trust by the consumers and is consistent with international standards. Last but not least is “leveling up agricultural marketing and promotions”: enhancing promotion, making the agricultural industry become profitable and sustainable. Council of Agriculture’s initiatives also proposed 10 policies to leverage agricultural industry, not only just use the passive subsidies measure of the past. These policies including promoting environmentally friendly farming practices; giving farmers that are beneficial(green) to the land payments; stabilizing farmers’ incomes; increasing the competitiveness of the livestock and poultry industries; using agricultural resources sustainably; ensuring the safety of agricultural products; developing technological innovation; leveling up food security; increasing diversification of domestic and external marketing channels; and increasing agriculture industry added value. In this statutes report, Council of Agriculture said this project will accelerate reforms, create new agricultural models and safety systems, but also build a new sustainable paradigm of agricultural. Premier Lin Chuan also backed this “five plus two innovative industries” program and “new agriculture” project, and asked Council of Agriculture to reviewing the possible legal changes or amendment that may help to enhance the transformation of agricultural sector.
The EU's New Legal Framework for European Research InfrastructureRecognized that Research infrastructures (RIs) are at the centre of the knowledge triangle of research, education and innovation and play an increasingly important role in the advancement of knowledge and technology, the EU began to finance for the establishments of RIs by its Framework Programmes (FPs) since the start of FP2 of 1987. On the other hand, the EU also assigned the European Strategy Forum on Research Infrastructures (ESFRI) to develop a coherent and strategy-led approach to policy-making on RIs between Member States and to facilitate the better use and development of RIs at EU and international level. Based on those efforts, the European Commission understood that a major difficulty in setting up RIs between EU countries is the lack of an adequate legal framework allowing the creation of appropriate partnerships and proposed a legal framework for a European research infrastructure adapted to the needs of such facilities. The new legal framework for a European Research Infrastructure Consortium (ERIC) entered into force on 28 August 2009. An successfully-set-up ERIC will have the legal personality based on EU law, and can benefit from exemptions from VAT and excise duty in all EU Member States and may adopt its own procurement procedures to get rid of the EU's public procurement procedures. It is predicted that the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) will apply to become a BBMRI-ERIC in the near future. The EU also seeks to lead in Energy, Food and Biology through the reforms of ERICs to assist the high quality of activities of European scientists and attract the best researchers from around the world. Besides, in order to connect the knowledge triangle effectively, the European Commission also established the European Institute of Innovation and Technology (EIT) on March 2008. It hopes through the research development partnership network to gather all the advantages from the science and technology chains of multiple areas, and make an effort for the strategy of EU innovation development jointly；Meanwhile, extends its roadmap to the objectives and practices of the Knowledge and Innovation Communities (KICs) of the EIT. Contrast with the EU's advance, it is necessary to our government to concentrate and contemplate whether it is the time to reconsider if our existing legal instruments available to domestic research facilities and infrastructures are sufficient enough to reach our science and technology development goals.
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