Blockchain and General Data Protection Regulation (GDPR) compliance issues (2019)
Blockchain and General Data Protection Regulation (GDPR) compliance issues (2019)
I. Brief
Blockchain technology can solve the problem of trust between data demanders and data providers. In other words, in a centralized mode, data demanders can only choose to believe that the centralized platform will not contain the false information. However, in the decentralized mode, data isn’t controlled by one individual group or organization[1], data demanders can directly verify information such as data source, time, and authorization on the blockchain without worrying about the correctness and authenticity of the data.
Take the “immutable” for example, it is conflict with the right to erase (also known as the right to be forgotten) in the GDPR.With encryption and one-time pad (OTP) technology, data subjects can make data off-chain storaged or modified at any time in a decentralized platform, so the problem that data on blockchain not meet the GDPR regulation has gradually faded away.
II. What is GDPR?
The purpose of the EU GDPR is to protect user’s data and to prevent large-scale online platforms or large enterprises from collecting or using user’s data without their permission. Violators will be punished by the EU with up to 20 million Euros (equal to 700 million NT dollars) or 4% of the worldwide annual revenue of the prior financial year.
The aim is to promote free movement of personal data within the European Union, while maintaining adequate level of data protection. It is a technology-neutral law, any type of technology which is for processing personal data is applicable.
So problem about whether the data on blockchain fits GDPR regulation has raise. Since the blockchain is decentralized, one of the original design goals is to avoid a large amount of centralized data being abused.
Blockchain can be divided into permissioned blockchains and permissionless blockchains. The former can also be called “private chains” or “alliance chains” or “enterprise chains”, that means no one can join the blockchain without consent. The latter can also be called “public chains”, which means that anyone can participate on chain without obtaining consent.
Sometimes, private chain is not completely decentralized. The demand for the use of blockchain has developed a hybrid of two types of blockchain, called “alliance chain”, which not only maintains the privacy of the private chain, but also maintains the characteristics of public chains. The information on the alliance chain will be open and transparent, and it is in conflict with the application of GDPR.
III. How to GDPR apply to blockchain ?
First, it should be determined whether the data on the blockchain is personal data protected by GDPR. Second, what is the relationship and respective responsibilities of the data subject, data controller, and data processor? Finally, we discuss the common technical characteristics of blockchain and how it is applicable to GDPR.
1. Data on the blockchain is personal data protected by GDPR?
First of all, starting from the technical characteristics of the blockchain, blockchain technology is commonly decentralized, anonymous, immutable, trackable and encrypted. The other five major characteristics are immutability, authenticity, transparency, uniqueness, and collective consensus.
Further, the blockchain is an open, decentralized ledger technology that can effectively verify and permanently store transactions between two parties, and can be proved.
It is a distributed database, all users on the chain can access to the database and the history record, also can directly verify transaction records. Each nodes use peer-to-peer transmission for upload or transfer information without third-party intermediation, which is the unique “decentralization” feature of the blockchain.
In addition, the node or any user on the chain has a unique and identifiable set of more than 30 alphanumeric addresses, but the user may choose to be anonymous or provide identification, which is also a feature of transparency with pseudonymity[2]; Data on blockchain is irreversibility of records. Once the transaction is recorded and updated on the chain, it is difficult to change and is permanently stored in the database, that is to say, it has the characteristics of “tamper-resistance”[3].
According to Article 4 (1) of the GDPR, “personal data” means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.
Therefore, if data subject cannot be identified by the personal data on the blockchain, that is an anonymous data, excluding the application of GDPR.
(1) What is Anonymization?
According to Opinion 05/2014 on Anonymization Techniques by Article 29 Data Protection Working Party of the European Union, “anonymization” is a technique applied to personal data in order to achieve irreversible de-identification[4].
And it also said the “Hash function” of blockchain is a pseudonymization technology, the personal data is possible to be re-identified. Therefore it’s not an “anonymization”, the data on the blockchain may still be the personal data stipulated by the GDPR.
As the blockchain evolves, it will be possible to develop technologies that are not regulated by GDPR, such as part of the encryption process, which will be able to pass the court or European data protection authorities requirement of anonymization. There are also many compliance solutions which use technical in the industry, such as avoiding transaction data stored directly on the chain.
2. International data transmission
Furthermore, in accordance with Article 3 of the GDPR, “This Regulation applies to the processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union, regardless of whether the processing takes place in the Union or not. This Regulation applies to the processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union, where the processing activities are related to: (a) the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union; or (b) the monitoring of their behaviour as far as their behaviour takes place within the Union”.[5]
In other words, GDPR applies only when the data on the blockchain is not anonymized, and involves the processing of personal data of EU citizens.
3. Identification of data controllers and data processors
Therefore, if the encryption technology involves the public storage of EU citizens' personal data and passes it to a third-party controller, it may be identified as the “data controller” under Article 4 of GDPR, and all nodes and miners of the platform may be deemed as the “co-controller” of the data, and be assumed joint responsibility with the data controller by GDPR. For example, the parties can claim the right to delete data from the data controller.
In addition, a blockchain operator may be identified as a “processor”, for example, Backend as a Service (BaaS) products, the third parties provide network infrastructure for users, and let users manage and store personal data. Such Cloud Services Companies provide online services on behalf of customers, do not act as “data controllers”. Some commentators believe that in the case of private chains or alliance chains, such as land records transmission, inter-bank customer information sharing, etc., compared to public chain applications: such as cryptocurrencies (Bitcoin for example), is not completely decentralized, and more likely to meet GDPR requirements[6]. For example, in the case of a private chain or alliance chain, it is a closed platform, which contains only a small number of trusted nodes, is more effective in complying with the GDPR rules.
4. Data subject claims
In accordance with Article 17 of the GDPR, The data subject shall have the right to obtain from the controller the erasure of personal data concerning him or her without undue delay and the controller shall have the obligation to erase personal data without undue delay under some grounds.
Off-chain storage technology can help the blockchain industry comply with GDPR rules, allowing offline storage of personal data, or allow trusted nodes to delete the private key of encrypted information, which leaving data that cannot be read and identified on the chain. If the data is in accordance with the definition of anonymization by GDPR, there is no room for GDPR to be applied.
IV. Conclusion
In summary, it’s seem that the application of blockchain to GDPR may include: (a) being difficulty to identified the data controllers and data processors after the data subject upload their data. (b) the nature of decentralized storage is transnational storage, and Whether the country where the node is located, is meets the “adequacy decision” of Article 45 of the GDPR.
If it cannot be met, then it needs to consider whether it conforms to the transfers subject to appropriate safeguards of Article 46, or the derogations for specific situations of Article 49 of the GDPR.
Reference:
[1] How to Trade Cryptocurrency: A Guide for (Future) Millionaires, https://wikijob.com/trading/cryptocurrency/how-to-trade-cryptocurrency
[2] DONNA K. HAMMAKER, HEALTH RECORDS AND THE LAW 392 (5TH ED. 2018).
[3] Iansiti, Marco, and Karim R. Lakhani, The Truth about Blockchain, Harvard Business Review 95, no. 1 (January-February 2017): 118-125, available at https://hbr.org/2017/01/the-truth-about-blockchain
[4] Article 29 Data Protection Working Party, Opinion 05/2014 on Anonymisation Techniques (2014), https://www.pdpjournals.com/docs/88197.pdf
[5] Directive 95/46/EC (General Data Protection Regulation), https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016R0679&from=EN
[6] Queen Mary University of London, Are blockchains compatible with data privacy law? https://www.qmul.ac.uk/media/news/2018/hss/are-blockchains-compatible-with-data-privacy-law.html
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.
The Tax Benefit of “Act for Establishment and Administration of Science Parks” and the Relational Norms for InnovationThe Tax Benefit of “Act for Establishment and Administration of Science Parks” and the Relational Norms for Innovation “Act for Establishment and Administration of Science Parks” was promulgated in 1979, and was amended entirely in May 15, 2018, announced in June 6. The title was revised from “Act for Establishment and Administration of Science ‘Industrial’ Parks” to “Act for Establishment and Administration of Science Parks” (it would be called “the Act” in this article). It was a significant transition from traditional manufacture into technological innovation. For encouraging different innovative technology enter into the science park, there is tax benefit in the Act. When the park enterprises import machines, equipment, material and so on from foreign country, the import duties, commodity tax, and business tax shall be exempted; moreover, when the park enterprises export products and services, it will have given favorable business and commodity tax free.[1] Furthermore, the park bureaus also exempt collection of land rent.[2] If they have approval for importing or exporting products, they do not need to apply for permission.[3] In the sub-law, there is also regulations of bonding operation.[4] To sum up, for applying the benefit of the act, enterprises approved for establishment in science parks still require to manufacture products. Such regulations are confined to industrial industry. Innovative companies dedicate in software, big data, or customer service, rarely gain benefits from taxation. In other norms,[5] there are also tax deduction or exemption for developing innovative industries. Based on promoting innovation, the enterprises following the laws of environmental protection, laborers’ safety, food safety and sanitation,[6] or investing in brand-new smart machines for their own utilize,[7] or licensing their intellectual property rights,[8] can deduct from its taxable income. In addition, the research creators from academic or research institutions,[9] or employee,[10] can declare deferral of the income tax payable for the shares distributed. In order to assist new invested innovative enterprises,[11] there are also relational benefit of tax. For upgrading the biotech and new pharmaceuticals enterprises, when they invest in human resource training, research and development, they can have deductible corporate income tax payable.[12] There is also tax favored benefits for small and medium enterprises in using of land, experiment of research, technology stocks, retaining of surplus, and additional employees hiring.[13] The present norms of tax are not only limiting in space or products but also encouraging in “research”. In other word, in each steps of the research of innovation, the enterprises still need to manufacture products from their own technology, fund and human resources. If the government could encourage open innovation with favored taxation, it would strengthen the capability of research and development for innovative enterprises. Supporting the innovation by taxation, the government can achieve the goal of scientific development more quickly and encourage them accepting guidance. “New York State Business Incubator and Innovation Hot Spot Support Act” can be an example, [14]the innovative enterprises accepting the guidance from incubators will have the benefit of tax on “personal income”, “sales and use” and “corporation franchise”. Moreover, focusing on key industries and exemplary cases, there are also the norms of tax exemption and tax abatement in China for promoting the development of technology.[15]The benefit of tax is not only in research but also in “the process of research”. To sum up, the government of Taiwan provides the benefit of tax for advancing the competition of outcomes in market, and for propelling the development of innovation. In order to accelerate the efficiency of scientific research, the government could draw lessons from America and China for enacting the norms about the benefit of tax and the constitution of guidance. [1] The Act §23. [2] Id. §24. [3] Id. §25. [4] Regulations Governing the Bonding Operations in Science Parks. [5] Such as Act for Development of Small and Medium Enterprises, Statute for Industrial Innovation, Act for the Development of Biotech and New Pharmaceuticals Industry. [6] Statute for Industrial Innovation §10. [7] Id. §10-1. [8] Id. §12-1. [9] Id. §12-2. [10] Id. §19-1. [11] Id. §23-1, §23-2, §23-3. [12] Act for the Development of Biotech and New Pharmaceuticals Industry §5, §6, §7. [13] Act for Development of Small and Medium Enterprises Chapter 4: §33 to §36-3. [14] New York State Department of Taxation and Finance Taxpayer Guidance Division, New York State Business Incubator and Innovation Hot Spot Support Act, Technical Memorandum TSB-M-14(1)C, (1)I, (2)S, at 1-6 (March 7, 2014), URL：http://www.wnyincubators.com/content/Innovation%20Hot%20Spot%20Technical%20Memorandum.pdf (last visited：December 18, 2019). [15] Enterprise Income Tax Law of the People’s Republic of China Chapter 4 “Preferential Tax Treatments”: §25 to §36 (2008 revised).
Executive Yuan Yuan Promoted “Productivity 4.0” to Boost Global CompetitivenessExecutive Yuan Yuan Promoted “Productivity 4.0” to Boost Global Competitiveness 1.Executive Yuan held the “Productivity 4.0: Strategy Review Board Meeting” to boost industrial transformation The Executive Yuan held the “Productivity 4.0: Strategy Review Board Meeting” on June 4-5th , 2015. The GDP per capita of manufacturing and service industries, including machinery, metal processing, transportation vehicles, 3C, food, textile, logistics, health care, and agriculture, are expected to be over 10 million NT dollars by 2024. This meeting focuses on three topics: Productivity 4.0 industry and technology development strategy, advanced development strategy on advanced manufacturing and innovation application, and strategy on engineering smart tech talents cultivation and Industry-academic Cooperation. The three main themes to be used to put the advanced manufacturing into force are smart automation and robots, sensing and control technologies from Internet of Things (IoT), and technologies used in analyzing the big data. As a result, the digitalization of small- and medium-sized business and smart operation of big business are as the cornerstones to build service-oriented systems and develop advanced manufacturing in R.O.C.. Facing challenges of labor shortages and aging labor forces, the Executive Yuan is planning to implement “Productivity 4.0” to stimulate the process of industry transformation of value-added innovation and provide new products and services in global market. In implementing the above-mentioned policy goals, the Executive Yuan is planning three directions to be followed. First, global competitiveness is depended upon key technologies. As OEMs, manufacturing industry in R.O.C. is unable to provide products of self-owned brand and is vulnerable while facing challenges from other transnational companies. Second, the Premier, Dr. Mao Chi-kuo, made reference of the bicycle industry’s successful development model as an example for the Productivity 4.0 “A-Team” model. Through combining technologies and organizations, the aim is to build competitive supply chains across all the small- and medium-sized business. Finally, the new skills training and the cultivation of talents are more urgent than ever before. While technical and vocational schools, universities and postgraduate studies are needed to be equipped with sufficient fundamental knowledge, those already in the job market have to learn the skills and knowledge necessary for industrial transformation so that they could contribute their capabilities and wisdom for Ourfuture. 2.Executive Yuan Approved “Productivity 4.0 Initiative” to Promote Industry Innovation and Transformation The Executive Yuan has approved the Productivity 4.0 Initiative on September 17, 2015. Before its approval, the Office of Science and Technology (OST) gave a presentation on the Draft of the Productivity 4.0 Initiative on July 23, 2015 detailing the underlying motives behind the program. Confronted with the challenges our traditional industries and OEMs meet, including labor shortages (the national laboring population ranging from age 15 to 65 has seen a substantial decrease of 0.18 to 0.2 million annually) and a aging labor force, the the Productivity 4.0 Initiative sets the directions for industrial development tackling these issues through six main strategies: enhancing and fine-tuning flagship industries’ smart-supply-chain ecosystems, encouraging the establishing of startups, localizing production and services, securing autonomy in key technologies, cultivating practical and technical talents and injection of industrial policy tools. After hearing the presentation on the Initiative, the Premier, Mao Chi-kuo, made reference to the core ideas of the Productivity 4.0 Initiative in his concluding remarks. “The core concept of the Productivity 4.0 Initiative is to propel R.O.C. to a pivotal position in the global manufacturing supply chain by capitalizing on the nation’s core strength in industrial technology, while fostering an outstanding work environment stimulating synergy between employees and automotive systems in order to cope with R.O.C.’s imminent labor shortage,” Mao said Also focusing on the Productivity 4.0 Initiative, the Premier gave a keynote speech titled ‘Views on the current economic and social issues’ at the Third Wednesday Club. He takes the view that the GDP downslide is of a structural nature and the government is going to guide the economy towards an upward path by assisting industries to innovate and transform. In an effort to remove the three major obstacles to innovation and entrepreneurship— discouraging laws and regulations, difficulty in raising capital and gathering financing as well as lack of international partnerships, the government has been diligently promoting the Third Party Payment Act as well as setting-up R.O.C. Rapid Innovation Prototyping League for Enterprises. Among these measures, Industry 4.0 has been at the core of the Initiative, in which cyber-physical production system (CPS) would be introduced by integrating Cloud-computing and Internet of Things technology to spur industrial transformations, specifically industrial manufacturing, added-value services and agricultural production. The Productivity 4.0 Initiative is an imperative measure in dealing with R.O.C.’s imminent issues of labor shortage, and the aging society, its promising effects are waiting to unfold. 3.Executive Yuan’s Further Addendum to “Productivity 4.0 Plan”: Attainment of Core Technologies and the Cultivation of Domestic Technical Talents In an continual effort to put in place the most integrated infrastructural setting for the flourishing of its “Productivity 4.0 Plan”, Executive Yuan Premier Mao Chi-Kuo announced on the 22nd October that the overhaul infrastructural set-up will be focused on the development of core technologies and the cultivation of skilled technical labor. To this end, the Executive Yuan is gathering participation and resources from the Ministry of Economic Affairs (hereafter MOEA), Ministry of Education, Ministry of Science and Technology, Ministry of Labor, the Council of Agriculture, among other governmental bodies, collecting experiences and knowledge from academia and researchers, in order to improve the development of pivotal technologies, the training of skilled technical labor and consequently to improve and reform the present education system so as to meet the aforementioned goals. Premier Mao Chi-Kuo pointed out that Productivity 4.0 is a production concept in which the industry is evolved from mere automation- to intelligent-based manufacturing, shifting towards a “small-volume, large-variety” production paradigm, closing the gaps between production and consumption sides through direct communication, hence allowing industry to push itself further on changing its old efficiency-based production model to an innovation-driven one. Apart from the Research and Development efforts geared towards key technologies, Premier Mao stressed that the people element, involved in this transformative process, is what dictates Productivity 4.0 Plan’s success. The cross-over or multi-disciplinary capability of the labor force is especially significant. In order to bring up the necessary work force needed for Productivity 4.0, besides raising support for the needed Research and Development, an extensive effort should be placed in reforming and upgrading the current educational system, as well as the technical labor and internal corporate educational structure. Moreover, an efficient platform should be implemented so that opinions and experiences could be pooled out, thus fostering closer ties between industry, academia and research. The MOEA stated that the fundamental premise behind the Productivity 4.0 strategy is that by way of systematic, brand-orientated formation of technical support groups, constituted by members of industry, academia and research, will we able to develop key sensor, internet and core technologies for our manufacturing, business and agriculture sector. It is estimated that by the end of year 2016, the Executive Yuan will have completed 6 major Productivity 4.0 production lines; supported the development of technical personnel in smart manufacturing, smart business and smart agriculture, amounting to 2,500 persons; established 4 inter-university, inter-disciplinary strategic partnerships in order to prepare much needed labor force for the realization of the Productivity 4.0 Plan. It is estimated that by the year 2020, industry has already developed the key technologies through the Productivity 4.0 platform, aiding to decrease by 50% the time currently needed to for Research and Development, increasing the technological sovereignty by 50% and accrue production efficiency by 15% and above. Furthermore, through the educational reforms, the nation will be able to lay solid foundations for its future labor talents, as well as connecting them to the world at large, effectively making them fit to face the global markets and to upgrade their production model.
Recommendation of the Regulations on the Legal and Effective Access to Taiwan’s Biological ResourcesPreface Considering that, many countries and regional international organizations already set up ABS system, such as Andean Community, African Union, Association of Southeast Asia Nations (ASEAN), Australia, South Africa, and India, all are enthusiastic with the establishment of the regulations regarding the access management of biological resources and genetic resources. On the other hand, there are still many countries only use traditional and existing conservation-related regulations to manage the access of biological resources. Can Taiwan's regulations comply with the purposes and objects of CBD? Is there a need for Taiwan to set up specific regulations for the management of these access activities? This article plans to present Taiwan's regulations and review the effectiveness of the existing regulations from the aspect of enabling the legal and effective access to biological resources. A recommendation will be made on whether Taiwan should reinforce the management of the bio-resources access activities. Review and Recommendation of the Regulations on the Legal and Effective Access to Taiwan's Biological Rersearch Resources （1）Evaluate the Needs and Benefits before Establishing the Regulation of Access Rights When taking a look at the current development of the regulations on the access of biological resources internationally, we discover that some countries aggressively develop designated law for access, while some countries still adopt existing regulations to explain the access rights. Whether to choose a designated law or to adopt the existing law should depend on the needs of establishing access and benefit sharing system. Can the access and benefit sharing system benefit the functioning of bio-technological research and development activities that link closely to the biological resources? Can the system protect the interests of Taiwan's bio-research results? In Taiwan, in the bio-technology industry, Agri-biotech, Medical, or Chinese Herb Research & Development are the key fields of development. However, the biological resources they use for the researches are mainly supplied from abroad. Hence, the likelihood of violating international bio-piracy is higher. On the contrary, the incidence of international research houses searching for the biological resources from Taiwan is comparatively lower, so the possibility for them to violate Taiwan's bio-piracy is very low. To look at this issue from a different angle, if Taiwan establishes a separate management system for the access of biological resources, it is likely to add more restrictions to Taiwan's bio-tech R&D activities and impact the development of bio-industry. Also, under the new management system, international R&D teams will also be confined, if they wish to explore the biological resources, or conduct R&D and seek for co-operation activities in Taiwan. Not to mention that it is not a usual practice for international R&D teams to look for Taiwan's biological resources. A new management system will further reduce their level of interest in doing so. In the end, the international teams will then shift their focus of obtaining resources from other countries where the regulation on access is relatively less strict. Before Taiwan establishes the regulations on the legal and effective access to bio-research resources, the government should consider not only the practical elements of the principal on the fair and impartial sharing of the derived interests from bio-research resources, but also take account of its positive and negative impacts on the development of related bio-technological industries. Even if a country's regulation on the access and benefit sharing is thorough and comprehensive enough to protect the interests of bio-resource provider, it will, on the contrary, reduce the industry's interest in accessing the bio-resources. As a result, the development of bio-tech industry will be impacted and the resource provider will then be unable to receive any benefits. By then, the goal of establishing the regulation to benefit both the industry and resource provider will not be realized. To sum up, it is suggested to evaluate the suitability of establishing the management system for the access to biological resources through the cost-effect analysis first. And, further consider the necessity of setting up regulations by the access the economic benefits derived from the regulation for both resource provider and bio-tech industry. （2）The Feasibility of Managing the access to Bio-research Resources from existing Regulations As analysed in the previous paragraphs, the original intention of setting up the Wildlife Conservation Act, National Park Law, Forestry Act, Cultural Heritage Preservation Act, and Aboriginal Basic Act is to protect the environment and to conserve the ecology. However, if we utilize these traditional regulations properly, it can also partially help to manage the access to biological resources. When Taiwan's citizens wish to enter specific area, or to collect the biological resources within the area, they need to receive the permit from management authority, according to current regulations. Since these national parks, protection areas, preserved areas, or other controlled areas usually have the most comprehensive collections of valuable biological resources in a wide range of varieties, it is suggested to include the agreements of access and benefit sharing as the mandatory conditions when applying for the entrance permit. Therefore, the principal of benefit sharing from the access to biological resources can be assured. Furthermore, the current regulations already favour activities of accessing biological resources for academic research purpose. This practice also ties in with the international trend of separating the access application into two categories - academic and business. Australia's practice of access management can be a very good example of utilizing the existing regulations to control the access of resources. The management authority defines the guidelines of managing the entrance of control areas, research of resources, and the collection and access of resources. The authority also adds related agreements, such as PIC (Prior Informed Consent), MTA (Material Transfer Agreement), and benefit sharing into the existing guidelines of research permission. In terms of scope of management, the existing regulation does not cover all of Taiwan's bio-research resources. Luckily, the current environmental protection law regulates areas with the most resourceful resources or with the most distinctive and rare species. These are often the areas where the access management system is required. Therefore, to add new regulation for access management on top of the existing regulation is efficient method that utilizes the least administrative resources. This could be a feasible way for Taiwan to manage the access to biological resources. （3）Establish Specific Regulations to Cover the Details of the Scope of Derived Interests and the Items and Percentage of Funding Allocation In addition to the utilization of current regulations to control the access to biological resources, many countries establish specific regulations to manage the biological resources. If, after the robust economic analysis had been done, the country has come to an conclusion that it is only by establishing new regulations of access management the resources and derived interests of biological resources can be impartially shared, the CBD (Convention of Bio Diversity), the Bonn Guidelines, or the real implementation experiences of many countries can be an important guidance when establishing regulations. Taiwan has come up with the preliminary draft of Genetic Resources Act that covers the important aspects of international access guidelines. The draft indicates the definition and the scope of access activities, the process of access applications (for both business and academic purpose), the establishment of standardized or model MTA, the obligation of disclosing the sources of property rights (patents), and the establishment of bio-diversity fund. However, if we observe the regulation or drafts to the access management of the international agreements or each specific country, we can find that the degree of strictness varies and depends on the needs and situations. Generally speaking, these regulations usually do not cover some detailed but important aspects such as the scope of derived interests from biological resources, or the items and percentage of the allocation of bio-diversity fund. Under the regulation to the access to biological resources, in addition to the access fee charge, the impartial sharing of the derived interests is also an important issue. Therefore, to define the scope of interests is extremely important. Any interest that is out of the defined scope cannot be shared. The interest stated in the existing regulation generally refers to the biological resources or the derived business interests from genetic resources. Apart from describing the forms of interest such as money, non-money, or intellectual property rights, the description of actual contents or scope of the interests is minimal in the regulations. However, after realizing the importance of bio-diversity and the huge business potential, many countries have started to investigate the national and international bio-resources and develop a database system to systematically collect related bio-research information. The database comprised of bio-resources is extremely useful to the activities related to bio-tech developments. If the international bio-tech companies can access Taiwan's bio-resource database, it will save their travelling time to Taiwan. Also, the database might as well become a product that generates revenues. The only issue that needs further clarification is whether the revenue generated from the access of database should be classified as business interests, as defined in the regulations. As far as the bio-diversity fund is concerned, many countries only describe the need of setting up bio-diversity funds in a general manner in the regulations. But the definition of which kind of interests should be put into funds, the percentage of the funds, and the related details are not described. As a result, the applicants to the access of bio-resources or the owner of bio-resources cannot predict the amount of interests to be put into bio-diversity fund before they actually use the resources. This issue will definitely affect the development of access activities. To sum up, if Taiwan's government wishes to develop the specific regulations for the access of biological resources, it is advised to take the above mentioned issues into considerations for a more thoroughly described, and more effective regulations and related framework. Conclusion In recent years, it has been a global trend to establish the regulations of the access to and benefit sharing of bio-resources. The concept of benefit sharing is especially treated as a useful weapon for the developing countries to protect the interests of their abundant bio-research resources. However, as we are in the transition period of changing from free access to biological resources to controlled access, we are facing different regulations within one country as well as internationally. It will be a little bit disappointing for the academic research institution and the industry who relies on the biological resources to conduct bio-tech development if they do not see a clear principal direction to follow. The worse case is the violation of the regulation of the country who owns the bio-resources when the research institutions try to access, exchange, or prospect the biological resources without thorough understanding of related regulations. For some of Taiwan's leading fields in the bio-tech industry, such as Chinese and herbal medicine related products, agricultural products, horticultural products, and bio-tech products, since many resources are obtained from abroad, the incidence of violation of international regulation will increase, and the costs from complying the regulations will also increase. Therefore, not only the researcher but also the government have the responsibility to understand and educate the related people in Taiwan's bio-tech fields the status of international access management regulations and the methods of legally access the international bio-research resources. Currently in Taiwan, we did not establish specific law to manage the access to and benefit sharing of bio-resources. Comparing with the international standard, there is still room of improvement for Taiwan's regulatory protection to the provider of biological resources. However, we have to consider the necessity of doing so, and how to do the improvement. And Taiwan's government should resolve this issue. When we consider whether we should follow international trend to establish a specific law for access management, we should always go back to check the potential state interests we will receive and take this point into consideration. To define the interests, we should always cover the protection of biological resources, the development of bio-tech industry, and the administrative costs of government. Also the conservation of biological resources and the encouragement of bio-tech development should be also taken into consideration when the government is making decisions. In terms of establishing regulations for the access to biological resources and the benefit sharing, there are two possible solutions. The first solution is to utilize the existing regulations and add the key elements of access management into the scope of administrative management. The work is planned through the revision of related current procedures such as entrance control of controlled areas and the access of specific resources. The second solution is to establish new regulations for the access to biological resources. The first solution is relatively easier and quicker; while the second solution is considered to have a more comprehensive control of the issue. The government has the final judgement on which solution to take to generate a more effective management of Taiwan's biological resources.
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