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).

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Reviews on Taiwan Constitutional Court's Judgment no. 13 of 2022

Reviews 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.

Impact of Government Organizational Reform to Research Legal System and Response Thereto (2) – Observation of the Swiss Research Innovation System

Impact of Government Organizational Reform to Research Legal System and Response Thereto (2) – Observation of the Swiss Research Innovation System I. Foreword   Switzerland is a landlocked country situated in Central Europe, spanning an area of 41,000 km2, where the Alps occupy 60% of the territory, while it owns little cultivated land and poor natural resources. In 2011, its population was about 7,950,000 persons[1]. Since the Swiss Federal was founded, it has been adhering to a diplomatic policy claiming neutrality and peace, and therefore, it is one of the safest and most stable countries in the world. Switzerland is famous for its high-quality education and high-level technological development and is very competitive in biomedicine, chemical engineering, electronics and metal industries in the international market. As a small country with poor resources, the Swiss have learnt to drive their economic and social development through education, R&D and innovation a very long time ago. Some renowned enterprises, including Nestle, Novartis and Roche, are all based in Switzerland. Meanwhile, a lot of creative small-sized and medium-sized enterprises based in Switzerland are dedicated to supporting the export-orientation economy in Switzerland.   Switzerland has the strongest economic strength and plentiful innovation energy. Its patent applications, publication of essay, frequencies of quotation and private enterprises’ innovation performance are remarkable all over the world. According to the Global Competitiveness Report released by the World Economic Forum (WEF), Switzerland has ranked first among the most competitive countries in the world for four years consecutively since 2009[2]. Meanwhile, according to the Global Innovation Index (GII) released by INSEAD and the World Intellectual Property Organization (WIPO) jointly, Switzerland has also ranked first in 2011 and 2012 consecutively[3]. Obviously, Switzerland has led the other countries in the world in innovation development and economic strength. Therefore, when studying the R&D incentives and boosting the industrial innovation, we might benefit from the experience of Switzerland to help boost the relevant mechanism in Taiwan.   Taiwan’s government organization reform has been launched officially and boosted step by step since 2012. In the future, the National Science Council will be reformed into the “Ministry of Science and Technology”, and the Ministry of Economic Affairs into the “Ministry of Economy and Energy”, and the Department of Industrial Development into the “Department of Industry and Technology”. Therefore, Taiwan’s technology administrative system will be changed materially. Under the new government organizational framework, how Taiwan’s technology R&D and industrial innovation system divide work and coordinate operations to boost the continuous economic growth in Taiwan will be the first priority without doubt. Support of innovation policies is critical to promotion of continuous economic growth. The Swiss Government supports technological research and innovation via various organizations and institutions effectively. In recent years, it has achieved outstanding performance in economy, education and innovation. Therefore, we herein study the functions and orientation of the competent authorities dedicated to boosting research and innovation in Switzerland, and observe its policies and legal system applied to boost the national R&D in order to provide the reference for the functions and orientation of the competent authorities dedicated to boosting R&D and industrial innovation in Taiwan. II. Overview of Swiss Federal Technology Laws and Technology Administrative System   Swiss national administrative organization is subject to the council system. The Swiss Federal Council is the national supreme administrative authority, consisting of 7 members elected from the Federal Assembly and dedicated to governing a Federal Government department respectively. Switzerland is a federal country consisting of various cantons that have their own constitutions, councils and governments, respectively, entitled to a high degree of independence.   Article 64 of the Swiss Federal Constitution[4] requires that the federal government support research and innovation. The “Research and Innovation Promotion Act” (RIPA)[5] is dedicated to fulfilling the requirements provided in Article 64 of the Constitution. Article 1 of the RIPA[6] expressly states that the Act is enacted for the following three purposes: 1. Promoting the scientific research and science-based innovation and supporting evaluation, promotion and utilization of research results; 2. Overseeing the cooperation between research institutions, and intervening when necessary; 3. Ensuring that the government funding in research and innovation is utilized effectively. Article 4 of the RIPA provides that the Act shall apply to the research institutions dedicated to innovation R&D and higher education institutions which accept the government funding, and may serve to be the merit for establishment of various institutions dedicated to boosting scientific research, e.g., the National Science Foundation and Commission of Technology & Innovation (CTI). Meanwhile, the Act also provides detailed requirements about the method, mode and restriction of the government funding.   According to the RIPA amended in 2011, the Swiss Federal Government’s responsibility for promoting innovation policies has been extended from “promotion of technology R&D” to “unification of education, research and innovation management”, making the Swiss national industrial innovation framework more well-founded and consistent[8] . Therefore, upon the government organization reform of Switzerland in 2013, most of the competent authorities dedicated to technology in Swiss have been consolidated into the Federal Department of Economic Affairs, Education and Research.   Under the framework, the Swiss Federal Government assigned higher education, job training, basic scientific research and innovation to the State Secretariat for Education, Research and Innovation (SERI), while the Commission of Technology & Innovation (CTI) was responsible for boosting the R&D of application scientific technology and industrial technology and cooperation between the industries and academy. The two authorities are directly subordinate to the Federal Department of Economic Affairs, Education and Research (EAER). The Swiss Science and Technology Council (SSTC), subordinate to the SERI is an advisory entity dedicated to Swiss technology policies and responsible for providing the Swiss Federal Government and canton governments with the advice and suggestion on scientific, education and technology innovation policies. The Swiss National Science Foundation (SNSF) is an entity dedicated to boosting the basic scientific R&D, known as the two major funding entities together with CTI for Swiss technology R&D. The organizations, duties, functions and operations of certain important entities in the Swiss innovation system are introduced as following. Date source: Swiss Federal Department of Economic Affairs, Education and Research official website Fig. 1 Swiss Innovation Framework Dedicated to Boosting Industries-Swiss Federal Economic, Education and Research Organizational Chart 1. State Secretariat of Education, Research and Innovation (SERI)   SERI is subordinate to the Department of Economic Affairs, Education and Research, and is a department of the Swiss Federal Government dedicated to managing research and innovation. Upon enforcement of the new governmental organization act as of January 1, 2013, SERI was established after the merger of the State Secretariat for Education and Research, initially subordinate to Ministry of Interior, and the Federal Office for Professional Education and Technology (OEPT), initially subordinated to Ministry of Economic Affairs. For the time being, it governs the education, research and innovation (ERI). The transformation not only integrated the management of Swiss innovation system but also unified the orientations toward which the research and innovation policy should be boosted.   SERI’s core missions include “enactment of national technology policies”, “coordination of research activities conducted by higher education institutions, ETH, and other entities of the Federal Government in charge of various areas as energy, environment, traffic and health, and integration of research activities conducted by various government entities and allocation of education, research and innovation resources. Its functions also extend to funding the Swiss National Science Foundation (SNSF) to enable SNSF to subsidize the basic scientific research. Meanwhile, the international cooperation projects for promotion of or participation in research & innovation activities are also handled by SERI to ensure that Switzerland maintains its innovation strength in Europe and the world.   The Swiss Science and Technology Council (SSTC) is subordinate to SERI, and also the advisory unit dedicated to Swiss technology policies, according to Article 5a of RIPA[9]. The SSTC is responsible for providing the Swiss Federal Government and canton governments with advice and suggestion about science, education and innovation policies. It consists of the members elected from the Swiss Federal Council, and a chairman is elected among the members. 2. Swiss National Science Foundation (SNSF)   The Swiss National Science Foundation (SNSF) is one of the most important institutions dedicated to funding research, responsible for promoting the academic research related to basic science. It supports about 8,500 scientists each year. Its core missions cover funding as incentives for basic scientific research. It grants more than CHF70 million each year. Nevertheless, the application science R&D, in principle, does not fall in the scope of funding by the SNSF. The Foundation allocates the public research fund under the competitive funding system and thereby maintains its irreplaceable identity, contributing to continuous output of high quality in Switzerland.   With the support from the Swiss Federal Government, the SNSF was established in 1952. In order to ensure independence of research, it was planned as a private institution when it was established[10]. Though the funding is provided by SERI, the SNSF still has a high degree of independence when performing its functions. The R&D funding granted by the SNSF may be categorized into the funding to free basic research, specific theme-oriented research, and international cooperative technology R&D, and the free basic research is granted the largest funding. The SNSF consists of Foundation Council, National Research Council and Research Commission[11]. Data source: prepared by the Study Fig. 2  Swiss National Science Foundation Organizational Chart (1) Foundation Council   The Foundation Council is the supreme body of the SNSF[12], which is primarily responsible for making important decisions, deciding the role to be played by the SNSF in the Swiss research system, and ensuring SNSF’s compliance with the purpose for which it was founded. The Foundation Council consists of the members elected from the representatives from important research institutions, universities and industries in Swiss, as well as the government representatives nominated by the Swiss Federal Council. According to the articles of association of the SNSF[13], each member’s term of office should be 4 years, and the members shall be no more than 50 persons. The Foundation Council also governs the Executive Committee of the Foundation Council consisting of 15 Foundation members. The Committee carries out the mission including selection of National Research Council members and review of the Foundation budget. (2) National Research Council   The National Research Council is responsible for reviewing the applications for funding and deciding whether the funding should be granted. It consists of no more than 100 members, mostly researchers in universities and categorized, in four groups by major[14], namely, 1. Humanities and Social Sciences; 2. Math, Natural Science and Engineering; 3. Biology and Medical Science; and 4. National Research Programs (NRPs)and National Centers of Competence in Research (NCCRs). The NRPs and NCCRs are both limited to specific theme-oriented research plans. The funding will continue for 4~5years, amounting to CHF5 million~CHF20 million[15]. The specific theme-oriented research is applicable to non-academic entities, aiming at knowledge and technology transfer, and promotion and application of research results. The four groups evaluate and review the applications and authorize the funding amount.   Meanwhile, the representative members from each group form the Presiding Board dedicated to supervising and coordinating the operations of the National Research Council, and advising the Foundation Council about scientific policies, reviewing defined funding policies, funding model and funding plan, and allocating funding by major. (3) Research Commissions   Research Commissions are established in various higher education research institutions. They serve as the contact bridge between higher education academic institutions and the SNSF. The research commission of a university is responsible for evaluating the application submitted by any researcher in the university in terms of the school conditions, e.g., the school’s basic research facilities and human resource policies, and providing advice in the process of application. Meanwhile, in order to encourage young scholars to attend research activities, the research committee may grant scholarships to PhD students and post-doctor research[16]. ~to be continued~ [1] SWISS FEDERAL STATISTICS OFFICE, Switzerland's population 2011 (2012), http://www.bfs.admin.ch/bfs/portal/en/index/news/publikationen.Document.163772.pdf (last visited Jun. 1, 2013). [2] WORLD ECONOMIC FORUM [WEF], The Global Competiveness Report 2012-2013 (2012), http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2012-13.pdf (last visited Jun. 1, 2013); WEF, The Global Competiveness Report 2011-2012 (2011), http://www3.weforum.org/docs/WEF_GCR_Report_2011-12.pdf (last visited Jun. 1, 2013); WEF, The Global Competiveness Report 2010-2011 (2010), http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2010-11.pdf (last visited Jun. 1, 2013); WEF, The Global Competiveness Report 2009-2010 (2009),. http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2009-10.pdf (last visited Jun. 1, 2013). [3] INSEAD, The Global Innovation Index 2012 Report (2012), http://www.globalinnovationindex.org/gii/GII%202012%20Report.pdf (last visited Jun. 1, 2013); INSEAD, The Global Innovation Index 2011 Report (2011), http://www.wipo.int/freepublications/en/economics/gii/gii_2011.pdf (last visited Jun. 1, 2013). [4] SR 101 Art. 64: “Der Bund fördert die wissenschaftliche Forschung und die Innovation.” [5] Forschungs- und Innovationsförderungsgesetz, vom 7. Oktober 1983 (Stand am 1. Januar 2013). For the full text, please see www.admin.ch/ch/d/sr/4/420.1.de.pdf (last visited Jun. 3, 2013). [6] Id. [7] Id. [8] CTI, CTI Multi-year Program 2013-2016 7(2012), available at http://www.kti.admin.ch/?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDeYR,hGym162epYbg2c_JjKbNoKSn6A-- (last visited Jun. 3, 2013). [9] Supra note 5. [10] Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/Pages/default.aspx (last visited Jun. 3, 2013). [11] Id. [12] Foundation Council, Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/Pages/foundationcouncil.aspx (last visited Jun. 3, 2013). [13] See Statutes of Swiss National Science Foundation Art.8 & Art. 9, available at http://www.snf.ch/SiteCollectionDocuments/statuten_08_e.pdf (last visited Jun. 3, 2013). [14] National Research Council, Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/researchcouncil/Pages/default.aspx (last visted Jun.3, 2013). [15] Theres Paulsen, VISION RD4SD Country Case Study Switzerland (2011), http://www.visionrd4sd.eu/documents/doc_download/109-case-study-switzerland (last visited Jun.6, 2013). [16] Research Commissions, Swiss National Science Foundation, http://www.snf.ch/E/about-us/organisation/Pages/researchcommissions.aspx (last visted Jun. 6, 2013).

Executive Yuan’s call to action:“Industrial Upgrading and Transformation Action Plan”

I.Introduction Having sustained the negative repercussions following the global financial crisis of 2008, Taiwan’s average economic growth rate decreased from 4.4 percent (during 2000-2007 years) to 3 percent (2008-2012). This phenomenon highlighted the intrinsic problems the Taiwanese economic growth paradigm was facing, seen from the perspective of its development momentum and industrial framework: sluggish growth of the manufacturing industries and the weakening productivity of the service sector. Moreover, the bleak investment climate of the post-2008 era discouraged domestic investors injecting capital into the local economy, rendering a prolonged negative investment growth rate. To further exacerbation, the European Debt Crisis of 2011 – 2012 has impacted to such detriment of private investors and enterprises, that confidence and willingness to invest in the private sector were utterly disfavored. It can be observed that as Taiwan’s industrial core strength is largely concentrated within the the manufacturing sector, the service sector, on the other hand, dwindles. Similarly, the country’s manufacturing efforts have been largely centered upon the Information & Communications Technology (ICT) industry, where the norm of production has been the fulfillment of international orders in components manufacturing and Original Equipment Manufacturing (OEM). Additionally, the raising-up of society’s ecological awareness has further halted the development of the upstream petrochemical and metal industry. Consumer goods manufacturing growth impetus too has been stagnated. Against the backdrop of the aforementioned factors at play as well as the competitive pressure exerted on Taiwan by force of the rapid global and regional economic integration developments, plans to upgrade and transform the existing industrial framework, consequently, arises out as an necessary course of action by the state. Accordingly, Taiwan’s Executive Yuan approved and launched the “Industrial Upgrading and Transformation Action Plan”, on the 13th of October 2014, aiming to reform traditional industries, reinforcing core manufacturing capacities and fostering innovative enterprises, through the implementation of four principal strategies: Upgrading of Product Grade and Value, Establishment of Complete Supply Chain, Setting-up of System Integration Solutions Capability, Acceleration of Growth in the Innovative Sector. II.Current challenges confronting Taiwanese industries 1.Effective apportionment of industrial development funds Despite that Research and Development (R&D) funds takes up 3.02% of Taiwan’s national GDP, there has been a decrease of the country’s investment in industrial and technology research. Currently Taiwan’s research efforts have been directed mostly into manufacturing process improvement, as well as into the high-tech sector, however, traditional and service industries on the other hand are lacking in investments. If research funds for the last decade could be more efficiently distributed, enterprises would be equally encouraged to likewise invest in innovation research. However, it should be noted that Taiwan’s Small and Medium Enterprises (SME) based on their traditional developmental models, do not place research as their top priority. Unlike practices in countries such as Germany and Korea, the research fund input by private enterprises into academic and research institutions is still a relatively unfamiliar exercise in Taiwan. With regards to investment focus, the over-concentration in ICTs should be redirected to accommodate growth possibilities for other industries as well. It has been observed that research investments in the pharmaceutical and electric equipment manufacturing sector has increased, yet in order to not fall into the race-to-the-bottom trap for lowest of costs, enterprises should be continually encouraged to develop high-quality and innovative products and services that would stand out. 2.Human talent and labor force issues Taiwan’s labor force, age 15 to 64, will have reached its peak in 2015, after which will slowly decline. It has been estimated that in 2011 the working population would amount to a meager 55.8%. If by mathematical deduction, based on an annual growth rate of 3%, 4% and 5%, in the year 2020 the labor scarcity would increase from 379,000, 580,000 to 780,000 accordingly. Therefore, it is crucial that productivity must increase, otherwise labor shortage of the future will inevitably stagnate economic growth. Notwithstanding that Taiwan’s demographical changes have lead to a decrease in labor force; the unfavorable working conditions so far has induced skilled professionals to seek employment abroad. The aging society along with decrease in birth rates has further exacerbated the existing cul-de-sac in securing a robust workforce. In 1995 the employment rate under the age of 34 was 46.35%, yet in 2010 it dropped to a daunting 37.6%. 3.Proportional land-use and environmental concerns Taiwan’s Environmental Impact Assessment (EIA) is a time-consuming and often unpredictable process that has substantially deterred investor’s confidence. Additionally, there exists a disproportionate use of land resources in Taiwan, given that demand for its use predominantly stems from the northern and middle region of the country. Should the government choose to balance out the utilization of land resources across Taiwan through labor and tax policies, the situation may be corrected accordingly. III.Industrial Upgrading and Transformation Strategies The current action plan commences its implementation from October 2014 to end of December 2024. The expected industrial development outcomes are as follows: (1) Total output value of the manufacturing sector starting from 2013 at NTD 13.93 trillion is expected to grow in 2020 to NTD 19.46 trillion. (2) Total GDP of the service sector, starting at 3.03 trillion from 2011 is expected to grow in 2020 to 4.75 trillion NTD. 1.Strategy No.1 : Upgrading of product grade and value Given that Taiwan’s manufacturing industry’s rate for added value has been declining year after year, the industry should strive to evolve itself to be more qualitative and value-added oriented, starting from the development of high-end products, including accordingly high-value research efforts in harnessing essential technologies, in the metallic materials, screws and nuts manufacturing sector, aviation, petrochemical, textile and food industries etc. (1) Furtherance of quality research Through the employment of Technology Development Program (TDP) Organizations, Industrial TDP and Academic TDP, theme-based and pro-active Research and Development programs, along with other related secondary assistance measures, the industrial research capability will be expanded. The key is in targeting research in high-end products so that critical technology can be reaped as a result. (2) Facilitating the formation of research alliances with upper-, mid- and downstream enterprises Through the formation of research and development alliances, the localization of material and equipment supply is secured; hence resulting in national autonomy in production capacity. Furthermore, supply chain between industrial component makers and end-product manufacturers are to be conjoined and maintained. National enterprises too are to be pushed forth towards industrial research development, materializing the technical evolution of mid- and downstream industries. (3) Integrative development assistance in Testing and Certification The government will support integrative development in testing and certification, in an effort to boost national competitive advantage thorough benefitting from industrial clusters as well as strengthening value-added logistics services, including collaboration in related value-added services. (4) Establishment of international logistics centre Projection of high-value product and industrial cluster image, through the establishment of an international logistics centre. 2.Strategy No.2 : Establishment of a Complete Supply Chain The establishing a robust and comprehensive supply chain is has at its aim transforming national production capabilities to be sovereign and self-sustaining, without having to resort to intervention of foreign corporations. This is attained through the securing of key materials, components and equipments manufacturing capabilities. This strategy finds its application in the field of machine tool controllers, flat panel display materials, semiconductor devices (3D1C), high-end applications processor AP, solar cell materials, special alloys for the aviation industry, panel equipment, electric vehicle motors, power batteries, bicycle electronic speed controller (ESC), electrical silicon steel, robotics, etc. The main measures listed are as follows: (1) Review of industry gaps After comprehensive review of existing technology gaps depicted by industry, research and academic institutions, government, strategies are to be devised, so that foreign technology can be introduced, such as by way of cooperative ventures, in order to promote domestic autonomous development models. (2) Coordination of Research and Development unions – building-up of autonomous supply chain. Integrating mid- and downstream research and development unions in order to set up a uniform standard in equipment, components and materials in its functional specifications. (3) Application-theme-based research programs Through the release of public notice, industries are invited to submit research proposals focusing on specific areas, so that businesses are aided in developing their own research capabilities in core technologies and products. (4) Promotion of cross-industry cooperation to expand fields of mutual application Continuously expanding field of technical application and facilitating cross-industry cooperation; Taking advantage of international platform to induce cross-border technical collaboration. 3.Strategy No.3 : Setting-up of System Integration Solutions capability Expanding turnkey-factory and turnkey-project system integration capabilities, in order to increase and stimulate export growth; Combination of smart automation systems to strengthen hardware and software integration, hence, boosting system integration solution capacity, allowing stand-alone machinery to evolve into a total solution plant, thus creating additional fields of application and services, effectively expanding the value-chain. These type of transitions are to be seen in the following areas: turnkey-factory and turnkey-project exports, intelligent automated manufacturing, cloud industry, lifestyle (key example: U-Bike in Taipei City) industry, solar factory, wood-working machinery, machine tools, food/paper mills, rubber and plastic machines sector. Specific implementation measure s includes: (1) Listing of national export capability – using domestic market as test bed for future global business opportunities Overall listing of all national system integration capabilities and gaps and further assistance in building domestic “test beds” for system integration projects, so that in the future system-integration solutions can be exported abroad, especially to the emerging economies (including ASEAN, Mainland China) where business opportunities should be fully explored. The current action plan should simultaneously assist these national enterprises in their marketing efforts. (2) Formation of System Integration business alliances and Strengthening of export capability through creation of flagship team Formation of system integration business alliances, through the use of national equipment and technology, with an aim to comply with global market’s needs. Promotion of export of turnkey-factory and turnkey-projects, in order to make an entrance to the global high-value system integration market. Bolstering of international exchanges, allowing European and Asian banking experts assist Taiwanese enterprises in enhancing bids efforts. (3) Establishing of financial assistance schemes to help national enterprises in their overseas bidding efforts Cooperation with financial institutes creating financial support schemes in syndicated loans for overseas bidding, in order to assist national businesses in exporting their turnkey-factories and turnkey-solutions abroad. 4. Strategy No.4 : Acceleration of growth in the innovative sectors Given Taiwan economy’s over-dependence on the growth of the electronics industry, a new mainstream industry replacement should be developed. Moreover, the blur distinction between the manufacturing, service and other industries, presses Taiwan to develop cross-fields of application markets, so that the market opportunities of the future can be fully explored. Examples of these markets include: Smart Campus, Intelligent Transportation System, Smart Health, Smart City, B4G/5G Communications, Strategic Service Industries, Next-Generation Semiconductors, Next-Generation Visual Display, 3D Printing, New Drugs and Medical Instruments, Smart Entertainment, Lifestyle industry (for instance the combination of plan factory and leisure tourism), offshore wind power plant, digital content (including digital learning), deep sea water. Concrete measures include: (1) Promotion of cooperation between enterprises and research institutions to increase efficiency in the functioning of the national innovation process Fostering of Industry-academic cooperation, combining pioneering academic research results with efficient production capability; Cultivation of key technology, accumulation of core intellectual property, strengthening integration of industrial technology and its market application, as well as, establishment of circulation integration platform and operational model for intellectual property. (2) Creating the ideal Ecosystem for innovation industries Strategic planning of demo site, constructing an ideal habitat for the flourishing of innovation industries, as well as the inland solution capability. Promotion of international-level testing environment, helping domestic industries to be integrated with overseas markets and urging the development of new business models through open competition. Encouraging international cooperation efforts, connecting domestic technological innovation capacities with industries abroad. (3) Integration of Cross-Branch Advisory Resources and Deregulation to further support Industrial Development Cross-administrations consultations further deregulation to support an ideal industrial development environment and overcoming traditional cross-branch developmental limitations in an effort to develop innovation industries. IV. Conclusion Taiwan is currently at a pivotal stage in upgrading its industry, the role of the government will be clearly evidenced by its efforts in promoting cross-branch/cross-fields cooperation, establishing a industrial-academic cooperation platform. Simultaneously, the implementation of land, human resources, fiscal, financial and environmental policies will be adopted to further improve the investment ambient, so that Taiwan’s businesses, research institutions and the government could all come together, endeavoring to help Taiwan breakthrough its currently economic impasse through a thorough industrial upgrading. Moreover, it can be argued that the real essence of the present action plan lies in the urge to transform Taiwan’s traditional industries into incubation centers for innovative products and services. With the rapid evolution of ICTs, accelerating development and popular use of Big Data and the Internet of Things, traditional industries can no longer afford to overlook its relation with these technologies and the emerging industries that are backed by them. It is only through the close and intimate interconnection between these two industries that Taiwan’s economy would eventually get the opportunity to discard its outdated growth model based on “quantity” and “cost”. It is believed that the aforementioned interaction is an imperative that would allow Taiwanese industries to redefine its own value amidst fierce global market competition. The principal efforts by the Taiwanese government are in nurturing such a dialogue to occur with the necessary platform, as well as financial and human resources. An illustration of the aforementioned vision can be seen from the “Industrie 4.0” project lead by Germany – the development of intelligent manufacturing, through close government, business and academic cooperation, combining the internet of things development, creating promising business opportunities of the Smart Manufacturing and Services market. This is the direction that Taiwan should be leading itself too. References 1.Executive Yuan, Republic of China http://www.ey.gov.tw/en/(last visited: 2015.02.06) 2.Industrial Development Bureau, Ministry of Economic Affairs http://www.moeaidb.gov.tw/(last visited: 2015.02.06) 3.Industrial Upgrading and Transformation Action Plan http://www.moeaidb.gov.tw/external/ctlr?PRO=filepath.DownloadFile&f=policy&t=f&id=4024(last visited: 2015.02.06)

The EU's New Legal Framework for European Research Infrastructure

Recognized 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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