Strengthening Taiwan’s Pharmaceutical Resilience: Legal Reflections from the European Union’s Critical Medicines Act

Strengthening Taiwan’s Pharmaceutical Resilience: Legal Reflections from the European Union’s Critical Medicines Act

2025/11/15

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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）。