Experiences about opening data in private sector
Experiences about opening data in private sector
Ⅰ. Introduction
Open data is the idea that data should be available freely for everyone to use and republish without restrictions from copyright, patents or other mechanisms of control. The concept of open data is not new; but a formalized definition is relatively new, and The Open Definition gives full details on the requirements for open data and content as follows:
Availability and access: the data must be available as a whole with no more than a reasonable reproduction cost, preferably by downloading over the internet. The data must also be available in a convenient and modifiable form.
Reuse and redistribution: the data must be provided under terms that permit reuse and redistribution including the intermixing with other datasets. The data shall be machine-readable.
Universal participation: everyone must be able to use, reuse and redistribute the data— which by means there should be no discrimination against fields of endeavor or against persons or groups. For example, “non-commercial” restrictions that would prevent “commercial” use, or restrictions of use for certain purposes are not allowed.
In order to be in tune with international developmental trends, Taiwan passed an executive resolution in favor of promoting Open Government Data in November 2012. Through the release of government data, open data has grown significantly in Taiwan and Taiwan has come out on top among 122 countries and areas in the 2015 and 2016 Global Open Data Index[1].
The result represented a major leap for Taiwan, however, progress is still to be made as most of the data are from the Government, and data from other territories, especially from private sector can rarely be seen. It is a pity that data from private sector has not being properly utilized and true value of such data still need to be revealed. The following research will place emphasis to enhance the value of private data and the strategies of boosting private sector to open their own data.
Ⅱ. Why open private data
With the trend of Open Government Data recent years, countries are now starting to realize that Open Government Data is improving transparency, creating opportunities for social and commercial innovation, and opening the door to better engagement with citizens. But open data is not limited to Open Government Data. In fact, the private sector not only interacts with government data, but also produces a massive amount of data, much of which in need of utilized.
According to the G20 open data policy agenda made in 2014, the potential economic value of open data for Australia is up to AUD 64 billion per annum, and the potential value of open data from private sector is around AUD 34 billion per annum.
Figure 1 Value of open data for Australia (AUD billion per annum)
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Source: McKinsey Global Institute
The purpose for opening data held by private entities and corporations is rooted in a broad recognition that private data has the potential to foster much public good. Openness of data for companies can translate into more efficient internal governance frameworks, enhanced feedback from workers and employees, improved traceability of supply chains, accountability to end consumers, and with better service and product delivery. Open Private Data is thus a true win-win for all with benefiting not only the governance but environmental and social gains.
At the same time, a variety of constraints, notably privacy and security, but also proprietary interests and data protectionism on the part of some companies—hold back this potential.
Ⅲ. The cases of Open Private Data
Syngenta AG, a global Swiss agribusiness that produces agrochemicals and seeds, has established a solid foundation for reporting on progress that relies on independent data collection and validation, assurance by 3rd party assurance providers, and endorsement from its implementing partners. Through the website, Syngenta AG has shared their datasets for agricultural with efficiency indicators for 3600 farms for selected agro-ecological zones and market segments in 42 countries in Europe, Africa, Latin America, North America and Asia. Such datasets are precious but Syngenta AG share them for free only with a Non-Commercial license which means users may copy and redistribute the material in any medium or format freely but may not use the material for commercial purposes.
Figure 2 Description and License for Open data of Syngenta AG
Source: http://www.syngenta.com
Tokyo Metro is a rapid transit system in Tokyo, Japan has released information such as train location and delay times for all lines as open data. The company held an Open Data Utilization Competition from 12 September to 17 November, 2014 to promote development of an app using this data and continues to provide the data even after the competition ended. However, many restrictions such as non-commercial use, or app can only be used for Tokyo Metro lines has weakened the efficiency of open data, it is still valued as an initial step of open private data.
Figure 3 DM of Tokyo Metro Open data Contest
Source: https://developer.tokyometroapp.jp/
Ⅳ. How to enhance Open Private Data
Open Private Data is totally different from Open Government Data since “motivation” is vital for private institutions to release their own data. Unlike the government data can be disclosed and free to use via administrative order or legislation, all of the data controlled by private institutions can only be opened under their own will. The initiative for open data therefore shall focus on how to motivate private sectors releasing their own data-by ensuring profit and minimizing risks.
Originally, open data shall be available freely for everyone to use without any restrictions, and data owners may profit indirectly as users utilizing their data creating apps, etc. but not profit from open data itself. The income is unsteady and data owners therefore lose their interest to open data. As a countermeasure, it is suggested to make data chargeable though this may contradict to the definition of open data. When data owners can charge by usage or by time, the motivation of open data would arise when open data is directly profitable.
Data owners may also worry about many legal issues when releasing their own data. They may not care about whether profitable or not but afraid of being involved into litigation disputes such as intellectual property infringement, unfair competition, etc. It is very important for data owners to have a well protected authorization agreement when releasing data, but not all of them is able to afford the cost of making agreement for each data sharing. Therefore, a standard sample of contract that can be widely adopted plays a very important role for open private data.
A data sharing platform would be a solution to help data owners sharing their own data. It can not only provide a convenient way to collect profit from data sharing but help data owners avoiding legal risks with the platform’s standard agreement. All the data owners have to do is just to transfer their own data to the platform without concern since the platform would handle other affairs.
Ⅴ. Conclusion
Actively engaging the private sector in the open data value-chain is considered an innovation imperative as it is highly related to the development of information economy. Although many works still need to be done such as identifying mechanisms for catalyzing private sector engagement, these works can be done by organizations such as the World Bank and the Centre for Open Data Enterprise. Private-public collaboration is also important when it comes to strengthening the global data infrastructure, and the benefits of open data are diverse and range from improved efficiency of public administrations to economic growth in the private sector. However, open private data is not the goal but merely a start for open data revolution. It is to add variation for other organizations and individuals to analyze to create innovations while individuals, private sectors, or government will benefit from that innovation and being encouraged to release much more data to strengthen this data circulation.
[1] Global Open Data Index, https://index.okfn.org/place/（Last visited: May 15, 2017）
On March 6, 2014, The Energy Bureau of Ministry of Economic Affairs has published a pre-announcement on a Trial Program of Voluntary Base Green Electricity Framework （hereafter the Trial Program） and consulted on public opinion. In light of the content of the Trial Program, STLI provide the following suggestions for future planning of related policy structure. The institution of green electricity as established by the Trial Program is one of the policies for promoting renewable energy. Despite its nature of a trial, it is suggested that a policy design with a more options will be beneficial to the promotion of renewable energy, in light of various measures that have been undertaken by different countries. According to the Trial Program, the planned price rate of the green electricity is set on the basis of the total sum that the electricity subsidy to be paid by the Renewable Energy Development Fund divided by the total sum of electricity generated reported by Tai Power Company. The Ministry of Economic Affairs will adjust the price rate of the green electricity on the base of both how many users subscribe to the green electricity and the price rate of international green electricity market rate and, then announce the price rate in October of each year if not otherwise designated. In addition, according to the planned Trial Program, the unit for the subscription of green electricity is 100 kW·h. It is further reported that the current planned price rate for green electricity is 1.06 NTD/ kW·h. And it shall be 3.95 NTD/ kW·h if adding up with the original price rate, with an 37% increase in price per kW·h. In terms of the existing content of the Trial Program, only single price rate will be offered during the trial period. In this regard, we take the view that it would be beneficial to take into account similar approaches that have been taken by other countries. In Germany, for instance, the furtherance of renewable energy is achieved by the obligatory charge（EEG Umlage）together with the voluntary green electricity program provided by the private electricity retail sectors. According to German Ministry of Economics and Energy （BMWi）, the electricity price that the German public pays includes three parts: （1）the cost of the purchase and distribution of the electricity, including the margin of the electricity provider（2）regulated network fees, including those for the operation as well as for the measurement works of the meters（3）charges imposed by the government, including tax and the abovementioned obligatory charge for renewable energy（EEG Umlage）, as prescribed by the Act on Renewable Energy （Gesetz für den Vorrang Erneuerbarer Energien, also known as Erneuerbare-Energien-Gesetz - EEG）. In terms of how it is implemented on the ground, an example of the green electricity price menu program from the German electricity retail company, Vattenfall, is given in the following. In all price menu programs provided by Vattenfall in Berlin, for instance, 29.4% of the electricity comes from renewable energy as a result of the implementation of the Act on Renewable Energy. Asides from the abovementioned percentage as facilitated by the existing obligatory measures, the electricity retail companies in Germany further provide the price menus that are “greener”. For example, among the options provided by Vattenfall（Chart I）, in terms of the 12-month program, one can choose the menu which consist of 39.4% of renewable energy, with the price of 0.2642 Euro/ kW·h（about 10.96 NTD/ kW·h）. One can also opt for a menu of which the energy supply comes from 100% of renewable energy, with the price of 0.281 Euro/ kW·h（about 11.66 NTD/ kW·h） Chart I : Green Electricity Price Menus provided by Vattenfall in Berlin, Germany Percentage of Renewable Energy Supply Percentage of Renewable Energy Supply Electricity Price 12-month program 39.4% 0.2642 Euro/ kW·h（about 10.96 NTD/ kW·h） All renewable energy program 100% 0.281 Euro/ kW·h（about 11.66 NTD/ kW·h） Source：Vattenfall website, translated and reorganized by STLI, April 214. In addition, Australia also has similar programs on green electricity that is voluntary-base and with the goal of promoting renewable energy, reducing carbon emission, and transforming energy economy. Since 1997, the GreenPower in Australia is in charge of audition and certification of the retail companies and power plants on green electricity. The Australian model uses the certification mechanism conducted by independent third party, to ensure the green electricity purchased by end users in compliance with specific standards. As for the options for the price menu, take the programs of green electricity offered by the Australian retail company Origin Energy for example, user can choose 6 kinds of different programs, which are composed by renewable energy supply of respectively 10%, 20%, 25%, 50%, 75%, and 100%, at various price rates （shown in Chart II）. Chart II Australian Green Electricity Programs provided by Origin Energy Percentage of renewable Energy Electricity Price per kW·h 0 0.268 AUD（About 7.52 NTD） 10% 0.274868 AUD（About 7.69 NTD） 20% 0.28006 AUD（About 7.84 NTD） 25% 0.28292 AUD（About 7.92 NTD） 50% 0.2838 AUD（About 7.95 NTD） 100% 0.2992 AUD（About 8.37 NTD） Source：Origin Energy website, translated and reorganized by STLI, April 214. Given the information above, it can thus be inferred that the international mechanism for the promotion of green electricity often include a variety of price menus, providing the user more options. Such as two difference programs offered by Vattenfall in Germany and six various rates for green electricity offered by Origin Energy in Australia. It is the suggestion of present brief that the Trial Program can reference these international examples and try to offer the users a greater flexibility in choosing the most suitable programs for themselves.
The Study of Estonian Human Genes DatabaseI. Introduction The human genes database or human genome project, the product under the policy of biotechnology no matter in a developed or developing country, has been paid more attention by a government and an ordinary people gradually. The construction of human genes database or human genome project, which is not only related to a country’s innovation on biotechnology, but also concerns the promotion of a country’s medical quality, the construction of medical care system, and the advantages brought by the usage of bio-information stored in human genes database or from human genome project. However, even though every country has a high interest in setting up human genes database or performing human genome project, the issues concerning the purposes of related biotechnology policies, the distribution of advantages and risks and the management of bio-information, since each country has different recognition upon human genes database or human genome project and has varied standards of protecting human basic rights, there would be a totally difference upon planning biotechnology policies or forming the related systems. Right now, the countries that vigorously discuss human genes database or practice human genome project include England, Iceland, Norway, Sweden, Latvia and Estonia. Estonia, which is the country around the Baltic Sea, has planned to set up its own human genes database in order to draw attention from other advanced countries, to attract intelligent international researchers or research groups, and to be in the lead in the area of biotechnology. To sum up, the purpose of constructing Estonian human genes database was to collect the genes and health information of nearly 70% Estonia’s population and to encourage bio-research and promote medical quality. II. The Origin of Estonian Human Genes Database The construction of Estonian human genes database started from Estonian Genome Project (EGP). This project was advocated by the professor of biotechnology Andres Metspalu at Tartu University in Estonia, and he proposed the idea of setting up Estonian human genes database in 1999. The purposes of EGP not only tried to make the economy of Estonia shift from low-cost manufacturing and heavy industry to an advanced technological economy, but also attempted to draw other countries’ attention and to increase the opportunity of making international bio-researches, and then promoted the development of biotechnology and assisted in building the system of medical care in Estonia. EGP started from the agreement made between Estonian government and Eesti Geenikeskus (Estonian Genome Foundation) in March, 1999. Estonian Genome Foundation was a non-profit organization formed by Estonian scientists, doctors and politicians, and its original purposes were to support genes researches, assist in proceeding any project of biotechnology and to set up EGP. The original goals of constructing EGP were “(a) reaching a new level in health care, reduction of costs, and more effective health care, (b) improving knowledge of individuals, genotype-based risk assessment and preventive medicine, and helping the next generation, (c) increasing competitiveness of Estonia – developing infrastructure, investments into high-technology, well-paid jobs, and science intensive products and services, (d) [constructing] better management of health databases (phenotype/genotype database), (e) … [supporting]… economic development through improving gene technology that opens cooperation possibilities and creates synergy between different fields (e.g., gene technology, IT, agriculture, health care)”1. III. The Way of Constructing Estonian Human Genes Database In order to ensure that Estonian human genes database could be operated properly and reasonably in the perspectives of law, ethics and society in Estonia, the Estonian parliament followed the step of Iceland to enact “Human Genes Research Act” (HGRA) via a special legislative process to regulate its human genes database in 2000. HGRA not only authorizes the chief processor to manage Estonian human genes database, but also regulates the issues with regard to the procedure of donation, the maintenance and building of human genes database, the organization of making researches, the confidential identity of donator or patient, the discrimination of genes, and so on. Since the construction of Estonian human genes database might bring the conflicts of different points of view upon the database in Estonia, in order to “avoid fragmentation of societal solidarity and ensure public acceptability and respectability”2 , HGRA adopted international standards regulating a genes research to be a norm of maintaining and building the database. Those standards include UNESCO Universal Declaration on the Human Genome and Human Rights (1997) and the Council of Europe’s Convention on Human Rights and Biomedicine (1997). The purpose of enacting HGRA is mainly to encourage and promote genes researches in Estonia via building Estonian human genes database. By means of utilizing the bio-information stored in the database, it can generate “more exact and efficient drug development, new diagnostic tests, improved individualized treatment and determination of risks of the development of a disease in the future”3 . In order to achieve the above objectives, HGRA primarily puts emphasis on several aspects. Those aspects include providing stronger protection on confidential identity of donators or patients, caring for their privacy, ensuring their autonomy to make donations, and avoiding any possibility that discrimination may happen because of the disclosure of donators’ or patients’ genes information. 1.HERBERT GOTTWEIS & ALAN PETERSEN, BIOBANKS – GOVERNANCE IN COMPARATIVE PERSPECTIVE 59 (2008). 2.Andres Rannamae, Populations and Genetics – Legal and Socio-Ethical Perspectives, in Estonian Genome Porject – Large Scale Health Status Description and DNA Collection 18, 21 (Bartha Maria Knoppers et al. eds., 2003. 3.REMIGIUS N. NWABUEZE, BIOTECHNOLOGY AND THE CHALLENGE OF PROPERTY – PROPERTY RIGHTS IN DEAD BODIES, BODY PARTS, AND GENETIC INFORMATION, 163 (2007).
Introducing and analyzing the Scope and Benefits of the Regulation「Statute for Upgrading Industries」in The Biotechnology Industry in TaiwanThe recent important regulation for supporting the biopharmaceutical industry in Taiwan has been the 「Statute for Upgrading Industries」 (hereinafter referred to as 「the Statute」).The main purpose of the Statue is for upgrading all industry for future economic development, so it applies to various industries, ranging from agriculture, industrial and service businesses. In other words, the Statute does not offer incentive measures to biopharmaceutical industry in particular, but focuses on promoting the industry development in general. Statute for Upgrading Industry and Related Regulations Generally speaking, the Statute has a widespread influence on industry development in Taiwan. The incentive measures provided in the Statute is complicated and covered other related regulations under its legal framework. Thus, the article will be taking a multi-facet perspective in discussing the how Statute relates to the biopharmaceutical industry. 1 、 Scope of Application According to Article 1 of the Statute, the term 「industries」 refers to agricultural, industrial and service businesses. Consequently, nearly all kinds of industries fall under this definition, and the Statute is applicable to all of them. Moreover, in order to promote the development and application of emerging technology as well as cultivating the recognized industry, the Statute provides much more favorable terms to these industries. These emerging and major strategic industries includes computer, communication and consumer electronics (3C), precise mechanics and automation, aerospace, biomedical and chemical production, green technology, material science, nanotechnology, security and other product or service recognized by the Executive Yuan. 2 、 Tax Benefits The Statute offers several types of tax benefits, so the industry could receive sufficient reward in every way it could, and promote a sound cycle in creating new values through these benefits. (1) Benefits for the purchase of automation equipment The said procured equipment and technology over NTD600, 000 may credit a certain percentage of the investment against the amount of profit-seeking enterprise income tax payable for the then current year. For the purchase of production technology, 5% may be credited. For the purchase of equipment, 7% may be credited. And any investment plan that includes the purchasing of equipment for automation can qualify for a low-interest preferential loan. Besides, for science-based industrial company imported overseas equipment that is not manufacture by local manufactures, from January 1, 2002, the imported equipment shall be exempted from import and business tax. And if the company is a bonded factory, the raw materials to be imported from abroad by it shall also be exempt from import duties and business tax. (2) Benefits for R&D expenditure Expenditure concurred for developing new products, improving production technology, or improving label-providing technology may credit 30%of the investment against the amount of profit-seeking enterprise income tax payable for the then current year. Research expenditures of the current year exceeding the average research expenditure for the past two years, the excess in research expenditure shall be 50% deductible. Instruments and equipments purchased by for exclusive R&D purpose, experimentation, or quality inspection may be accelerated to two years. At last, Biotech and New Pharmaceuticals Company engages in R&D activities, such as Contract research Organization (CRO), may credit 30% of the investment against the amount of profit-seeking enterprise income tax payable. (3) Personnel Training When a company trained staff and registered for business-related course, may credit 30% of the training cost against the amount of profit-seeking enterprise income tax payable for the then current year. Where training expenses for the current year exceeds the two-year average, 50% of the excess portion may be credited. (4) Benefit for Newly Emerging Strategic Industries Corporate shareholders invest in newly emerging strategic industries are entitled to select one of the following tax benefits: A profit seeking enterprise may credit up to 20% of the price paid for acquisition of such stock against the profit seeking enterprise income tax. An individual may credit up to 10%. As of January and once every year, there will be a 1% reduction of the price paid for acquisition of such stock against the consolidated income tax payable in the then current year. A company, within two years from the beginning date for payment of the stock price by its shareholders, selects, with the approval of its shareholder meeting, the application of an exemption from profit-seeking enterprise income tax and waives the shareholders investment credit against payable income tax as mentioned above. However, that once the selection is made, no changes shall be allowed. (5) Benefits for Investment in Equipment or Technology Used for Pollution Control To prevent our environment from further pollution, the Government offers tax benefits to reward companies in making improvements. Investment in equipment or technology used for pollution control may credit 7% of the equipment expenditure, and 5% of the expenditure on technology against the amount of profit-seeking enterprise income tax payable for the then current year. For any equipment that has been verified in use and specialized in air pollution control, noise pollution control, vibration control, water pollution control, environmental surveillance and waste disposal, shall be exempt from import duties and business tax. And for investment plans that planned implementation of energy saving systems can apply for a low interest loan. (6) Incentive for Operation Headquarter To encourage companies to utilize worldwide resources and set up international operation network, if they established operation headquarters within the territory of the Republic of China reaching a specific size and bringing about significant economic benefit, their following incomes shall be exempted from profit-seeking enterprise income tax: The income derived from provision of management services or R&D services. The royalty payment received under its investments to its affiliates abroad. The investment return and asset disposal received under its investment to its affiliates abroad. (7) Exchange of Technology for Stock Option The emerging-industrycompany recognized by government, upon adoption of a resolution by a majority voting of the directors present at a meeting of its board of directors attended by two-thirds of the directors of the company, may issue stock options to corporation or individual in exchange for authorization or transfer of patent and technologies. (8) Deferral of Taxes on the Exchange of Technology for Shares Taxes on income earned by investors from the acquisition of shares in emerging-industry companies in exchange for technology will be deferred for five years, on condition that the shares exchanged for technology amount to more than 20% of the company's total stock equity and that the number of persons who obtain shares in exchange for technology does not exceed five. 3 、 Technical Assistance and Capital Investment The rapid industry development has been closely tied to the infusion of funds. In addition to tax benefits, the Statute incorporates regulations especially for technical assistance and capital investment as below: (1) In order to introduce or transfer advanced technologies, technical organization formed with the contribution of government shall provide appropriate technical assistance as required. (2) In order to advance technologies, enhance R&D activities and further upgrade industries, the relevant central government authorities in charge of end enterprises may promote the implementation of industrial and technological projects by providing subsidies to such R&D projects. (3) In order to assist the start-up of domestic small-medium technological enterprises and the overall upgrading of the entire industries, guidance and assistance shall be provided for the development of venture capital enterprises.
Strengthening Taiwan’s Pharmaceutical Resilience: Legal Reflections from the European Union’s Critical Medicines ActStrengthening Taiwan’s Pharmaceutical Resilience: Legal Reflections from the European Union’s Critical Medicines Act 2025/11/15 Introduction: From Vulnerability to Vision For Taiwan, an island state positioned at the crossroads of geopolitical tension and globalized medical trade, the question of pharmaceutical resilience is no longer a technical concern but a constitutional one. A nation’s ability to secure the continuous availability of essential medicines defines not only its public health capacity but the very credibility of its governance. In this light, the European Union’s (hereunder, the “EU”) proposed Critical Medicines Act (hereunder, “EU CMA”) offers Taiwan an illuminating case of how law can move beyond crisis management toward systemic foresight[1]. Resilience in the pharmaceutical sector is not merely about supply stability; it embodies a triple constitutional function—protecting life and health as fundamental rights, safeguarding national security through stable access to critical goods, and reinforcing trust in regulatory governance. Law thus becomes the medium through which uncertainty is rendered governable. The global pandemic revealed that the absence of legal foresight can paralyze even the most advanced health systems, exposing the structural fragility behind administrative efficiency. While Taiwan’s current pharmaceutical regulatory framework remains largely event-driven, reactive, and post-facto, the EU CMA exemplifies an industry-oriented, anticipatory, and pre-emptive model. The contrast underscores a jurisprudential lesson: resilience cannot be legislated through emergency decrees alone; it must be architected through a continuous, legally structured process that anticipates vulnerabilities before they materialize. This article identifies three foundational principles embedded in the EU CMA—visibility, diversification, and agility—and explores how these principles could guide Taiwan in constructing a forward-looking pharmaceutical resilience regime. The goal is not imitation, but inspiration—extracting from the EU experience a conceptual framework for a resilient Taiwanese pharmaceutical order. The EU CMA as a Law of Foresight The EU CMA represents a paradigm shift in pharmaceutical governance. Instead of fragmented national reactions to shortages, the Act establishes a Union-wide framework “to strengthen the availability and security of supply of critical medicinal products” through coordinated information systems, joint vulnerability assessments, and strategic industrial actions[2]. Its architecture reflects a policy-cycle logic: identification of critical medicines (Union list), assessment of vulnerabilities (harmonized monitoring), and action to strengthen capacity (strategic projects, coordinated procurement). Each stage is legally codified and procedurally transparent. The EU CMA thus transforms resilience from a policy aspiration into a governance architecture mandated by law. This approach reveals a fundamental evolution in regulatory philosophy: from law as reaction to law as anticipation. The EU does not merely respond to pharmaceutical disruptions; it legislates the ability to foresee them. This transformation elevates resilience from a managerial tool to a juridical principle that guides administrative behavior and industrial coordination. In this sense, the EU CMA operates as a constitutional statute of preparedness—one that embeds strategic vigilance within the ordinary operations of the market. Moreover, the Act’s systemic design demonstrates a rare synthesis of industrial, health, and competition policies under a unified legal grammar. By integrating economic instruments (such as incentives for local production) with public health imperatives (such as the availability of essential drugs), the EU CMA transforms siloed policy domains into a coherent resilience regime. It institutionalizes coordination not as an afterthought but as a binding legal discipline. Crucially, the EU’s approach embodies what might be called the legality of anticipation: law as an instrument that compels foresight. Resilience here is treated as a public good, transcending national borders but rooted in legal coordination. For Taiwan—whose pharmaceutical imports are geographically concentrated and whose market size limits domestic leverage—the lesson is profound: foresight must be institutional, not intuitive. Visibility: Law as an Instrument of Anticipation At the heart of the EU CMA lies the principle of visibility—the legalization of information as a tool of preparedness. The Act mandates the creation of a Union list of critical medicines[3] and a continuous monitoring system for supply vulnerabilities, coordinated through the Critical Medicines Coordination Group[4]. By institutionalizing information flows, the EU transforms data into a public good and transparency into an act of resilience. Visibility performs a dual function. On one hand, it is technocratic, enabling states to detect early signals of supply risk. On the other, it is constitutional, embedding accountability within knowledge. Uncertainty, when unregulated, leads to discretion; when structured, it becomes a risk, which law can govern. The EU CMA thus converts chaos into cognition—an epistemic transformation at the heart of modern administrative law. For Taiwan, this implies a shift from episodic crisis reporting toward permanent, cross-sectoral data governance. Information duties should not be seen as bureaucratic burdens but as civic infrastructures that permit collective foresight. Visibility, therefore, is not simply about surveillance but about legally enabling knowledge—the first step toward prevention rather than post-hoc management. Diversification: Embedding Resilience into Market Rationality The second principle, diversification, redefines efficiency itself. The EU CMA promotes manufacturing capacity within Europe under the doctrine of “open strategic autonomy”[5]. It supports Strategic Projects that enhance production, encourages cooperation with like-minded countries, and authorizes procurement methods that reward resilience factors alongside price—what EU law calls “MEAT” (Most Economically Advantageous Tender)[6]. This reframes the very idea of market rationality: security and competition are not opposites but complements. Law functions here as a corrective to market myopia, ensuring that the invisible hand does not ignore visible fragility. By quantifying resilience as a measurable value, the EU transforms precaution into an economic variable. For Taiwan—whose procurement and reimbursement systems have historically emphasized price containment—this perspective opens conceptual space. Resilience should not be perceived as inefficiency, but as intertemporal justice: a society’s investment in its future continuity. A diversified system—of suppliers, regions, and regulatory instruments—creates not redundancy but adaptability. In this sense, diversification is law’s expression of prudence in an interconnected economy. Agility: From Administrative Response to Legal Readiness The third principle, agility, captures the law’s capacity to act swiftly yet lawfully. The EU CMA institutionalizes flexibility through accelerated procedures for strategic projects, coordinated procurement frameworks, and crisis response mechanisms[7]. These powers are accompanied by procedural safeguards and sunset clauses, ensuring proportionality and reversibility. Agility thus represents legality in motion: action without arbitrariness. It reconciles speed with scrutiny by embedding emergency measures within predefined legal channels. The lesson for Taiwan is both institutional and philosophical—true readiness is not improvisation, but preparation that preserves legitimacy. In Taiwan’s current system, regulatory energy peaks during emergencies and dissipates thereafter. A mature resilience framework would instead cultivate continuous readiness—administrative structures that learn, anticipate, and adapt. Agility, understood legally, means codifying responsiveness as a standing competence of governance. It is the hinge connecting foresight and execution, legality and flexibility. Taiwan’s Legal Trajectory: From Event-Driven to Industry-Oriented Regulation Comparatively, Taiwan’s Pharmaceutical Affairs Act—even with its proposed amendments—remains largely event-driven and post-crisis in design[8]. Regulatory intervention often follows episodes of shortage or disruption. While recently introduced draft revisions strengthening supply chain obligations[9], these proposed revisions still operate primarily within a reactive paradigm. By contrast, the EU CMA envisions an industry-oriented, anticipatory, and system-based model. It embeds resilience into the legal DNA of pharmaceutical policy—linking regulation, industrial strategy, and public health. For Taiwan, this means evolving from regulatory firefighting to regulatory design: from curing failures to cultivating foresight. To achieve this, Taiwan’s legal development must transcend compliance formalism and embrace a culture of legal learning—where rules are not static commands but adaptive instruments of governance. The transition from event-driven to foresight-driven lawmaking will not only strengthen national health security but also elevate Taiwan’s position in the network of like-minded economies pursuing resilient supply systems. Conclusion: Toward a Resilient Legal Modernity The EU Critical Medicines Act demonstrates that law can be an architecture of anticipation. Its three pillars—visibility, diversification, and agility—form a grammar of resilience that integrates market mechanisms, administrative capacity, and democratic legitimacy. For Taiwan, the value of this model lies not in replication but in reflection. Visibility teaches that knowledge must be institutionalized. Diversification reminds us that resilience can coexist with efficiency. Agility shows that speed and legality are not mutually exclusive. Together, they suggest a new philosophy of governance: one that replaces reaction with design, and uncertainty with structured foresight. Yet the deeper lesson of the EU CMA is that resilience is not simply a functional attribute of a regulatory system—it is a constitutional virtue of modern states. To build resilience is to affirm the social contract anew: to promise citizens not that crises will never occur, but that when they do, institutions will stand ready, transparent, and just. This transforms law from a mirror of disorder into an instrument of collective composure. For Taiwan, embracing resilience as a constitutional principle means reimagining the relationship between law, science, and sovereignty. In a world where disruption is perpetual—whether by pandemics, trade shocks, or technological change—resilience becomes the language through which legality and modernity converge. It marks the transition from governing by reaction to governing by imagination. While the EU CMA relies on the Union’s vast market power to incentivize and coordinate pharmaceutical resilience, Taiwan faces a distinct structural challenge: its market size, though dynamic, cannot generate comparable leverage on a global scale. This asymmetry compels Taiwan to craft a dual strategy—anchoring its domestic resilience through legal foresight, while simultaneously aligning with international frameworks that promote secure and diversified supply chains. How Taiwan can reconcile these two imperatives—maintaining openness and integration with global partners, yet safeguarding autonomous resilience at home—will define the next frontier of its pharmaceutical governance. It is within this strategic and normative intersection that the Institute for Information Industry’s Science and Technology Law Institute (STLI) will continue its research efforts, exploring legal architectures capable of linking Taiwan’s national resilience with the broader ecosystem of global health security. Ultimately, resilience is not merely a regulatory principle but a moral commitment to time—a covenant between generations that law will foresee, prepare, and preserve. As Taiwan refines its pharmaceutical governance, the lesson from the EU CMA is both institutional and existential: to govern resilience is to govern the future itself, and to govern the future is to affirm the dignity of foresight as the highest form of rule of law. [1] EUROPEAN COMMISSION, Proposal for a Regulation of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products as well as for improving the availability of, and access to, medicinal products of common interest (Critical Medicines Act), COM(2025) 102 final (Mar. 11, 2025), https://health.ec.europa.eu/document/download/2abe4fc8-059e-47d9-a20a-d9e3bfc5dc2c_en?filename=mp_com2025_102_act_en.pdf (last visited Nov. 2, 2025). [2] id. at Page 17. [3] id. at Page 27. [4] id. at Page 35. [5] CRITICAL MEDICINES ALLIANCE, STRATEGIC REPORT OF THE CRITICAL MEDICINES ALLIANCE (Feb. 28, 2025), https://health.ec.europa.eu/document/download/3da9dfc0-c5e0-4583-a0f1-1652c7c18c3c_en?filename=hera_cma_strat-report_en.pdf (last visited Nov. 2, 2025). [6] EUROPEAN COMMISSION, Proposal for a Regulation of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products as well as for improving the availability of, and access to, medicinal products of common interest (Critical Medicines Act), COM(2025) 102 final (Mar. 11, 2025), https://health.ec.europa.eu/document/download/2abe4fc8-059e-47d9-a20a-d9e3bfc5dc2c_en?filename=mp_com2025_102_act_en.pdf (last visited Nov. 2, 2025). [7] id. at Page 7. [8] Pharmaceutical Affairs Act (Taiwan), Ministry of Justice, https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030001 (last visited Nov. 2, 2025). [9] 〈衛生福利部公告「藥事法」部分條文修正草案〉，法源法律網，https://www.lawbank.com.tw/news/NewsContent.aspx?NID=206187.00（最後瀏覽日：2025/11/03）。
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