Taiwan Recent Regulatory Development- Promoting Biotech and New Pharmaceuticals Industry
Over the past twenty years, the Government has sought to cultivate the biopharmaceutical industry as one of the future major industry in Taiwan. Back in 1982, the Government has begun to regard biotechnology as a key technology in Technology Development Program, demonstrated that biotechnology is a vital technology in pursuit of future economic growth. Subsequently, the Government initiated national programs that incorporated biotechnology as a blueprint for future industrial development. In order to enhance our competitiveness and building an initial framework for the industry, The Executive Yuan has passed the Biotechnology Industry Promotion Plan. As the Government seeks to create future engines of growth by building an environment conducive for enterprise development, the Plan has been amended four times, and implemented measures focused on the following six areas: related law and regulations, R&D and applications, technology transfer and commercialization, personnel training, investment promotion and coordination, marketing information and marketing service.
In 2002, the Executive Yuan approved the Challenge 2008, a six-year national development plan, pointing out biotechnology industry as one of the Two Trillion, Twin Stars industries. The Government planned for future economic growth by benefiting through the attributes of the biotechnology: high-tech, high-reward and less pollution. Thus, since 1997 the Strategic Review Board (SRB) under the Executive Yuan Science and Technology Advisory Panel has taken action in coordinating government policies with industry comments to form a sound policy for the biotechnology industry.
Additionally, a well-established legal system for sufficient protection of intellectual property rights is the perquisite for building the industry, as the Government recognized the significance through amending and executing related laws and regulations. By stipulating data exclusivity and experimental use exception in the Pharmaceutical Affair Act, tax benefits provided in Statute for Upgrading Industries , Incentives for Production and R&D of Rare Disease Medicine, Incentives for Medical Technology Research and Development, provide funding measures in the Guidance of Reviewing Programs for Promoting Biotechnology Investment.
Clearly, the government has great expectation for the industry through establishing a favorable environment by carrying out these policies and revising outdated regulations. Thus, the Legislative Yuan has passed the “Act for The Development of Biotechnology and New Pharmaceuticals Industry” in June, 2007, and immediately took effect in July. The relevant laws and regulations became effective as well, driving the industry in conducting researches on new drugs and manufacturing new products, increasing sales and expanding the industry to meet an international level.
For a biopharmaceutical industry that requires long-term investment and costly R&D, incentive measures is vital to the industry’s survival before the product launches the market. Accordingly, this article will be introducing the recent important regulation that supports the biopharmaceutical industry in Taiwan, and analyzing the government’s policies.
Biotechnology is increasingly gaining global attention for its potential in building future economic growth and generating significant profits. In an effort to support the biotechnology industry in Taiwan, the Government has made a step forward by enacting the “Act for the Development of Biotech and New Pharmaceutical Industry”.
The biopharmaceutical industry is characterized as high-risk and high-reward, strong government support and a well-developed legal system plays a vital role from its establishment throughout the long term development. Therefore, the Act was enacted tailor to the Biotech and New Pharmaceutical Industry, primarily focuses on tax benefits, R&D activities, personnel recruitment and investment funding, in support of start-up companies and attracting a strong flow of funding worldwide.
To pave the way for promoting the biopharmaceutical industry and the Biotech and New Pharmaceutical Company, here the article will be introducing the incentive measures provided in the Act, and supporting development of the industry, demonstrating the efforts made by the Government to build a “Bio-tech Island”.
Reference
“Act for Development of Biotech and New Pharmaceutical Industry”, webpage of Law and Regulations Database of the Republic of China. 4 July, 2007. Ministry of Justice, Taiwan. 5 Nov. 2008 http://law.moj.gov.tw/Eng/Fnews/FnewsContent.asp?msgid=3180&msgType=en&keyword=undefined
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).
The Key Elements for Data Intermediaries to Deliver Their PromiseThe Key Elements for Data Intermediaries to Deliver Their Promise 2022/12/13 As human history enters the era of data economy, data has become the new oil. It feeds artificial intelligence algorithms that are disrupting how advertising, healthcare, transportation, insurance, and many other industries work. The excitement of having data as a key production input lies in the fact that it is a non-rivalrous good that does not diminish by consumption.[1] However, the fact that people are reluctant in sharing data due to privacy and trade secrets considerations has been preventing countries to realize the full value of data. [2] To release more data, policymakers and researchers have been exploring ways to overcome the trust dilemma. Of all the discussions, data intermediaries have become a major solution that governments are turning to. This article gives an overview of relevant policy developments concerning data intermediaries and a preliminary analysis of the key elements that policymakers should consider for data intermediaries to function well. I. Policy and Legal developments concerning data intermediaries In order to unlock data’s full value, many countries have started to focus on data intermediaries. For example, in 2021, the UK’s Department for Digital, Culture, Media and Sport (DCMS) commissioned the Centre for Data Ethics and Innovation (CDEI) to publish a report on data intermediaries[3] , in response to the 2020 National Data Strategy.[4] In 2020, the European Commission published its draft Data Governance Act (DGA)[5] , which aims to build up trust in data intermediaries and data altruism organizations, in response to the 2020 European Strategy for Data.[6] The act was adopted and approved in mid-2022 by the Parliament and Council; and will apply from 24 September 2023.[7] The Japanese government has also promoted the establishment of data intermediaries since 2019, publishing guidance to establish regulations on data trust and data banks.[8] II. Key considerations for designing effective data intermediary policy 1.Evaluate which type of data intermediary works best in the targeted country From CDEI’s report on data intermediaries and the confusion in DGA’s various versions of data intermediary’s definition, one could tell that there are many forms of data intermediaries. In fact, there are at least eight types of data intermediaries, including personal information management systems (PIMS), data custodians, data exchanges, industrial data platforms, data collaboratives, trusted third parties, data cooperatives, and data trusts.[9] Each type of data intermediary was designed to combat data-sharing issues in specific countries, cultures, and scenarios. Hence, policymakers need to evaluate which type of data intermediary is more suitable for their society and market culture, before investing more resources to promote them. For example, data trust came from the concept of trust—a trustee managing a trustor’s property rights on behalf of his interest. This practice emerged in the middle ages in England and has since developed into case law.[10] Thus, the idea of data trust is easily understood and trusted by the British people and companies. As a result, British people are more willing to believe that data trusts will manage their data on their behalf in their best interest and share their valuable data, compared to countries without a strong legal history of trusts. With more people sharing their data, trusts would have more bargaining power to negotiate contract terms that are more beneficial to data subjects than what individual data owners could have achieved. However, this model would not necessarily work for other countries without a strong foundation of trust law. 2.Quality signals required to build trust: A government certificate system can help overcome the lemon market problem The basis of trust in data intermediaries depends largely on whether the service provider is really neutral in its actions and does not reuse or sell off other parties’ data in secret. However, without a suitable way to signal their service quality, the market would end up with less high-quality service, as consumers would be reluctant to pay for higher-priced service that is more secure and trustworthy when they have no means to verify the exact quality.[11] This lemon market problem could only be solved by a certificate system established by actors that consumers trust, which in most cases is the government. The EU government clearly grasped this issue as a major obstacle to the encouragement of trust in data intermediaries and thus tackles it with a government register and verification system. According to the Data Government Act, data intermediation services providers who intend to provide services are required to notify the competent authority with information on their legal status, form, ownership structure, relevant subsidiaries, address, public website, contact details, the type of service they intend to provide, the estimated start date of activities…etc. This information would be provided on a website for consumers to review. In addition, they can request the competent authority to confirm their legal compliance status, which would in turn verify them as reliable entities that can use the ‘data intermediation services provider recognised in the Union’ label. 3.Overcoming trust issues with technology that self-enforces privacy: privacy-enhancing technologies (PETs) Even if there are verified data intermediation services available, businesses and consumers might still be reluctant to trust human organizations. A way to boost trust is to adopt technologies that self-enforces privacy. A real-world example is OpenSAFELY, a data intermediary implementing privacy-enhancing technologies (PETs) to provide health data sharing in a secure environment. Through a federated analytics system, researchers are able to conduct research with large volumes of healthcare data, without the ability to observe any data directly. Under such protection, UK NHS is willing to share its data for research purposes. The accuracy and timeliness of such research have provided key insights to inform the UK government in decision-making during the COVID-19 pandemic. With the benefits it can bring, unsurprisingly, PETs-related policies have become quite popular around the globe. In June 2022, Singapore launched its Digital Trust Centre (DTC) for accelerating PETs development and also signed a Memorandum of Understanding with the International Centre of Expertise of Montreal for the Advancement of Artificial Intelligence (CEIMIA) to collaborate on PETs.[12] On September 7th, 2022, the UK Information Commissioners’ Office (ICO) published draft guidance on PETs.[13] Moreover, the U.K. and U.S. governments are collaborating on PETs prize challenges, announcing the first phase winners on November 10th, 2022.[14] We could reasonably predict that more PETs-related policies would emerge in the coming year. [1] Yan Carrière-Swallow and Vikram Haksar, The Economics of Data, IMFBlog (Sept. 23, 2019), https://blogs.imf.org/2019/09/23/the-economics-of-data/#:~:text=Data%20has%20become%20a%20key,including%20oil%2C%20in%20important%20ways (last visited July 22, 2022). [2] Frontier Economics, Increasing access to data across the economy: Report prepared for the Department for Digital, Culture, Media, and Sport (2021), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/974532/Frontier-access_to_data_report-26-03-2021.pdf (last visited July 22, 2022). [3] The Centre for Data Ethics and Innovation (CDEI), Unlocking the value of data: Exploring the role of data intermediaries (2021), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1004925/Data_intermediaries_-_accessible_version.pdf (last visited June 17, 2022). [4] Please refer to the guidelines for the selection of sponsors of the 2022 Social Innovation Summit: https://www.gov.uk/government/publications/uk-national-data-strategy/national-data-strategy(last visited June 17, 2022). [5] Regulation of the European Parliament and of the Council on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act), 2020/0340 (COD) final (May 4, 2022). [6] Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and The Committee of the Regions— A European strategy for data, COM/2020/66 final (Feb 19, 2020). [7] Proposal for a Regulation on European Data Governance, European Parliament Legislative Train Schedule, https://www.europarl.europa.eu/legislative-train/theme-a-europe-fit-for-the-digital-age/file-data-governance-act(last visited Aug 17, 2022). [8] 周晨蕙，〈日本資訊信託功能認定指引第二版〉，科技法律研究所，https://stli.iii.org.tw/article-detail.aspx?no=67&tp=5&d=8422（最後瀏覽日期︰2022/05/30）。 [9] CDEI, supra note 3. [10] Ada Lovelace Institute, Exploring legal mechanisms for data stewardship (2021), 30~31,https://www.adalovelaceinstitute.org/wp-content/uploads/2021/03/Legal-mechanisms-for-data-stewardship_report_Ada_AI-Council-2.pdf (last visited Aug 17, 2022). [11] George A. Akerlof, The Market for "Lemons": Quality Uncertainty and the Market Mechanism, THE QUARTERLY JOURNAL OF ECONOMICS, 84(3), 488-500 (1970). [12] IMDA, MOU Signing Between IMDA and CEIMIA is a Step Forward in Cross-border Collaboration on Privacy Enhancing Technology (PET) (2022),https://www.imda.gov.sg/-/media/Imda/Files/News-and-Events/Media-Room/Media-Releases/2022/06/MOU-bet-IMDA-and-CEIMIA---ATxSG-1-Jun-2022.pdf (last visited Nov. 28, 2022). [13] ICO publishes guidance on privacy enhancing technologies, ICO, https://ico.org.uk/about-the-ico/media-centre/news-and-blogs/2022/09/ico-publishes-guidance-on-privacy-enhancing-technologies/ (last visited Nov. 27, 2022). [14] U.K. and U.S. governments collaborate on prize challenges to accelerate development and adoption of privacy-enhancing technologies, GOV.UK, https://www.gov.uk/government/news/uk-and-us-governments-collaborate-on-prize-challenges-to-accelerate-development-and-adoption-of-privacy-enhancing-technologies (last visited Nov. 28, 2022); Winners Announced in First Phase of UK-US Privacy-Enhancing Technologies Prize Challenges, NIST, https://www.nist.gov/news-events/news/2022/11/winners-announced-first-phase-uk-us-privacy-enhancing-technologies-prize (last visited Nov. 28, 2022).
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.
Impact of Government Organizational Reform to Research Legal System and Response Thereto (2) – Observation of the Swiss Research Innovation System3.Commission of Technology and Innovation (CTI) The CTI is also an institution dedicated to boosting innovation in Switzerland. Established in 1943, it was known as the Commission for the Promotion of Scientific Research[1]. It was initially established for the purpose of boosting economy and raising the employment rate, and renamed after 1996. The CTI and SNSF are two major entities dedicated to funding scientific research in Switzerland, and the difference between both resides in that the CTI is dedicated to funding R&D of the application technology and industrial technology helpful to Switzerland’s economic development. Upon enforcement of the amended RIPA 2011, the CTI was officially independent from the Federal Office for Professional Education and Technology (OEPT) and became an independent entity entitled to making decisions and subordinated to the Federal Department of Economic Affairs (FDEA) directly[2]. The CTI is subject to the council system, consisting of 65 professional members delegated from industrial, academic and research sectors. The members assume the office as a part time job. CTI members are entitled to making decisions on funding, utilization of resources and granting of CTI Start-up Label independently[3]. The CTI primarily carries out the mission including promotion of R&D of industrial technology, enhancement of the market-orientation innovation process and delivery of R&D energy into the market to boost industrial innovation. For innovation, the CTI's core mission is categorized into[4]: (1)Funding technology R&D activities with market potential The CTI invests considerable funds and resources in boosting the R&D of application technology and industrial technology. The CTI R&D Project is intended to fund private enterprises (particularly small-sized and medium-sized enterprises) to engage in R&D of innovation technology or product. The enterprises may propose their innovative ideas freely, and the CTI will decide whether the funds should be granted after assessing whether the ideas are innovative and potentially marketable[5]. CTI’s funding is conditioned on the industrial and academic cooperation. Therefore, the enterprises must work with at least one research institution (including a university, university of science and technology, or ETH) in the R&D. Considering that small-sized and medium-sized enterprises usually do not own enough working funds, technology and human resources to commercialize creative ideas, the CTI R&D Project is intended to resolve the problem about insufficient R&D energy and funds of small- and medium-sized enterprises by delivering the research institutions’ plentiful research energy and granting the private enterprises which work with research institutions (including university, university of science and technology, or ETH) the fund. Notably, CTI’s funding is applicable to R&D expenses only, e.g., research personnel’s salary and expenditure in equipment & materials, and allocated to the research institutions directly. Meanwhile, in order to enhance private enterprises' launch into R&D projects and make them liable for the R&D success or failure, CTI’s funding will be no more than 50% of the total R&D budget and, therefore, the enterprises are entitled to a high degree of control right in the process of R&D. The industrial types which the CTI R&D Project may apply to are not limited. Any innovative ideas with commercial potential may be proposed. For the time being, the key areas funded by CTI include the life science, engineering science, Nano technology and enabling sciences, etc.[6] It intends to keep Switzerland in the lead in these areas. As of 2011, in order to mitigate the impact of drastic CHF revaluation to the industries, the CTI launched its new R&D project, the CTI Voucher[7]. Given this, the CTI is not only an entity dedicated to funding but also plays an intermediary role in the industrial and academic sectors. Enterprises may submit proposals before finding any academic research institution partner. Upon preliminary examination of the proposals, the CTI will introduce competent academic research institutions to work with the enterprises in R&D, subject to the enterprises' R&D needs. After the cooperative partner is confirmed, CTI will grant the fund amounting to no more than CHF3,500,000 per application[8], provided that the funding shall be no more than 50% of the R&D project expenditure. The CTI R&D Project not only boosts innovation but also raises private enterprises’ willingness to participate in the academic and industrial cooperation, thereby narrowing the gap between the supply & demand of innovation R&D in the industrial and academic sectors. Notably, the Project has achieved remarkable effect in driving private enterprises’ investment in technology R&D. According to statistical data, in 2011, the CTI solicited additional investment of CHF1.3 from a private enterprise by investing each CHF1[9]. This is also one of the important reasons why the Swiss innovation system always acts vigorously. Table 1 2005-2011 Passing rate of application for R&D funding Year 2011 2010 2009 2008 2007 2006 2005 Quantity of applications 590 780 637 444 493 407 522 Quantity of funded applications 293 343 319 250 277 227 251 Pass rate 56% 44% 50% 56% 56% 56% 48% Data source: Prepared by the Study (2)Guiding high-tech start-up Switzerland has learnt that high-tech start-ups are critical to the creation of high-quality employment and boosting of economic growth, and start-ups were able to commercialize the R&D results. Therefore, as of 2001, Switzerland successively launched the CTI Entrepreneurship and CTI Startup to promote entrepreneurship and cultivate high-tech start-ups. 1.CTI Entrepreneurship The CTI Entrepreneurship was primarily implemented by the Venture Lab founded by CTI investment. The Venture Lab launched a series of entrepreneurship promotion and training courses, covering day workshops, five-day entrepreneurship intensive courses, and entrepreneurship courses available in universities. Each training course was reviewed by experts, and the experts would provide positive advice to attendants about innovative ideas and business models. Data source: Venture Lab Site Fig. 3 Venture Lab Startup Program 2.CTI Startup The CTI is dedicated to driving the economy by virtue of innovation as its priority mission. In order to cultivate the domestic start-ups with high growth potential in Switzerland, the CTI Startup project was launched in 1996[10] in order to provide entrepreneurs with the relevant guidance services. The project selected young entrepreneurs who provided innovative ideas, and guided them in the process of business start to work their innovative ideas and incorporate competitive start-ups. In order to enable the funding and resources to be utilized effectively, the CTI Startup project enrolled entrepreneurs under very strict procedure, which may be categorized into four stages[11]: Data source: CTI Startup Site Fig. 4 Startup Plan Flow Chart In the first stage, the CTI would preliminarily examine whether the applicant’s idea was innovative and whether it was technologically feasible, and help the applicant register with the CTI Startup project. Upon registration, a more concrete professional examination would be conducted at the second stage. The scope of examination included the technology, market, feasibility and management team’s competence. After that, at the stage of professional guidance, each team would be assigned a professional “entrepreneurship mentor”, who would help the team develop further and optimize the enterprise’s strategy, flow and business model in the process of business start, and provide guidance and advice on the concrete business issues encountered by the start-up. The stage of professional guidance was intended to guide start-ups to acquire the CTI Startup Label, as the CTI Startup Label was granted subject to very strict examination procedure. For example, in 2012, the CTI Startup project accepted 78 applications for entrepreneurship guidance, but finally the CTI Startup Label was granted to 27 applications only[12]. Since 1996, a total of 296 start-ups have acquired the CTI Startup Label, and more than 86% thereof are still operating now[13]. Apparently, the CTI Startup Label represents the certification for innovation and on-going development competence; therefore, it is more favored by investors at the stage of fund raising. Table 2 Execution of start-up plans for the latest three years Quantity of application Quantity of accepted application Quantity of CTI Label granted 2012 177 78 27 2011 160 80 26 2010 141 61 24 Data source: CTI Annual Report, prepared by the Study Meanwhile, the “CTI Invest” platform was established to help start-up raise funds at the very beginning to help commercialize R&D results and cross the valley in the process of R&D innovation. The platform is a private non-business-making organization, a high-tech start-up fund raising platform co-established by CTI and Swiss investors[14]. It is engaged in increasing exposure of the start-ups and contact with investors by organizing activities, in order to help the start-ups acquire investment funds. (3)Facilitating transfer of knowledge and technology between the academic sector and industrial sector KTT Support (Knowledge & Technology Transfer (KTT Support) is identified as another policy instrument dedicated to boosting innovation by the CTI. It is intended to facilitate the exchange of knowledge and technology between academic research institutions and private enterprises, in order to transfer and expand the innovation energy. As of 2013, the CTI has launched a brand new KTT Support project targeting at small-sized and medium-sized enterprises. The new KTT Support project consisted of three factors, including National Thematic Networks (NTNs), Innovation Mentors, and Physical and web-based platforms. Upon the CTI’s strict evaluation and consideration, a total of 8 cooperative innovation subjects were identified in 2012, namely, carbon fiber composite materials, design idea innovation, surface innovation, food study, Swiss biotechnology, wood innovation, photonics and logistics network, etc.[15] One NTN would be established per subject. The CTI would fund these NTNs to support the establishment of liaison channels and cooperative relations between academic research institutions and industries and provide small- and medium-sized enterprises in Switzerland with more rapid and easy channel to access technologies to promote the exchange of knowledge and technology between both parties. Innovation Mentors were professionals retained by the CTI, primarily responsible for evaluating the small-sized and medium-sized enterprises’ need and chance for innovation R&D and helping the enterprises solicit competent academic research partners to engage in the transfer of technology. The third factor of KTT Support, Physical and web-based platforms, is intended to help academic research institutions and private enterprises establish physical liaison channels through organization of activities and installation of network communication platforms, to enable the information about knowledge and technology transfer to be more transparent and communicable widely. In conclusion, the CTI has been dedicated to enhancing the link between scientific research and the industries and urging the industrial sector to involve and boost the R&D projects with market potential. The CTI’s business lines are all equipped with corresponding policy instruments to achieve the industrial-academic cooperation target and mitigate the gap between the industry and academic sectors in the innovation chain. The various CTI policy instruments may be applied in the following manner as identified in the following figure. Data source: CTI Annual Report 2011 Fig. 5 Application of CTI Policy Instrument to Innovation Chain III. Swiss Technology R&D Budget Management and Allocation The Swiss Federal Government has invested considerable expenditures in technology R&D. According to statistic data provided by Swiss Federal Statistical Office (FSO) and OECD, the Swiss research expenditures accounted for 2.37% of the Federal Government’s total expenditures, following the U.S.A. and South Korea (see Fig. 6). Meanwhile, the research expenditures of the Swiss Government grew from CHF2.777 billion in 2000 to CHF4.639 billion in 2010, an average yearly growth rate of 5.9% (see Fig. 7). It is clear that Switzerland highly values its technology R&D. Data source: FSO and OECD Fig. 6 Percentage of Research Expenditures in Various Country Governments’ Total Expenditures (2008) Data source: FSO and OECD Fig. 7 Swiss Government Research Expenditures 2000-2010 1.Management of Swiss Technology R&D Budget Swiss research expenditures are primarily allocated to the education, R&D and innovation areas, and play an important role in the Swiss innovation system. Therefore, a large part of the Swiss research expenditures are allocated to institutions of higher education, including ETH, universities, and UASs. The Swiss research expenditures are utilized by three hierarchies[16] (see Fig. 8): Government R&D funding agencies: The Swiss research budget is primarily executed by three agencies, including SERI, Federal Department of Economic Affairs, Education and Research, and Swiss Agency for Development and Cooperation (SDC). Intermediary R&D funding agencies: Including SNSC and CTI. Funding of R&D performing institutions: Including private enterprises, institutions of higher education and private non-profit-making business, et al. Therefore, the Swiss Government research expenditures may be utilized by the Federal Government directly, or assigned to intermediary agencies, which will allocate the same to the R&D performing institutions. SERI will allocate the research expenditures to institutions of higher education and also hand a lot of the expenditures over to SNSF for consolidated funding to the basic science of R&D. Data source: FSO Fig. 8 Swiss Research Fund Utilization Mechanism ~to be continued~ [1] ORGANIZATION FOR ECONNOMIC CO-OPERATION AND DEVELOPMENT [OECD], OECD Reviews of Innovation Policy: Switzerland 27 (2006). [2] As of January 1, 2013, the Federal Ministry of Economic Affairs was reorganized, and renamed into Federal Department of Economic Affairs, Education and Research (EAER). [3] The Commission for Technology and Innovation CTI, THE COMMISSION FOR TECHOLOGY AND INNOVATION CTI, http://www.kti.admin.ch/org/00079/index.html?lang=en (last visited Jun. 3, 2013). [4] Id. [5] CTI INVEST, Swiss Venture Guide 2012 (2012), at 44, http://www.cti-invest.ch/getattachment/7f901c03-0fe6-43b5-be47-6d05b6b84133/Full-Version.aspx (last visited Jun. 4, 2013). [6] CTI, CTI Activity Report 2012 14 (2013), available at http://www.kti.admin.ch/dokumentation/00077/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDen16fmym162epYbg2c_JjKbNoKSn6A-- (last visited Jun. 3, 2013). [7] CTI Voucher, THE COMMISSION FOR TECHOLOGY AND INNOVATION CTI, http://www.kti.admin.ch/projektfoerderung/00025/00135/index.html?lang=en (last visited Jun. 3, 2013). [8] Id. [9] CTI, CTI Activity Report 2011 20 (2012), available at http://www.kti.admin.ch/dokumentation/00077/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDeYR,gWym162epYbg2c_JjKbNoKSn6A--(last visited Jun. 3, 2013). [10] CTI Start-up Brings Science to Market, THE COMMISSION FOR TECHOLOGY AND INNOVATION CTI, http://www.ctistartup.ch/en/about/cti-start-/cti-start-up/ (last visited Jun. 5, 2013). [11] Id. [12] Supra note 8, at 45. [13] Id. [14] CTI Invest, http://www.cti-invest.ch/About/CTI-Invest.aspx (last visited Jun. 5, 2013). [15] KTT Support, CTI, http://www.kti.admin.ch/netzwerke/index.html?lang=en (last visited Jun.5, 2013). [16] Swiss Federal Statistics Office (SFO), Public Funding of Research in Switzerland 2000–2010 (2012), available at http://www.bfs.admin.ch/bfs/portal/en/index/themen/04/22/publ.Document.163273.pdf (last visited Jun. 20, 2013).
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