Taiwan successfully hosted the Global Cross-Border Privacy Rules (hereunder, “Global CBPR”) Forum Fall Workshop in Taipei from November 19 to 21, 2024, organized collaboratively by the National Development Council (hereunder, “NDC”) and the Institute for Information Industry (hereunder, “III”). The forum, held under the theme "Evolving," marked the largest international privacy law event ever conducted in Taiwan, highlighting its growing prominence in global privacy governance.

Since becoming a founding member of the Global CBPR Forum in 2022 alongside countries such as Canada, Japan, Mexico, the Philippines, South Korea, Singapore, and the United States, Taiwan has actively supported the forum's objectives of promoting trusted cross-border data flows. This recent workshop—recognized as the highest-level international privacy law forum ever hosted in Taiwan in recent decades—attracted around 150 participants from over 25 countries across five continents, including high-level government representatives from the United States, Japan, South Korea, Singapore, Malaysia, Thailand, Qatar, the Philippines, Bangladesh, Israel, South Africa, Nigeria, the United Kingdom, and Germany. The diverse participation also included government officials, privacy experts, academic scholars, and corporate leaders.

During the event, participants engaged in extensive discussions aimed at strengthening the CBPR framework. Key topics included reforming CBPR certification standards, comparative analyses between the CBPR system and the European Union’s General Data Protection Regulation (GDPR), the impact of CBPR on digital trade within ASEAN nations, and the interplay between privacy protection and responsible artificial intelligence (hereunder, “AI”). Privacy-Enhancing Technologies (PETs), an essential component for securing international data transfers, also featured prominently.

A crucial objective emphasized during the conference was advancing the concept of Data Free Flow with Trust (DFFT), first introduced at the 2019 G20 Osaka Summit. Through interactive sessions and panel discussions, Taiwan underscored its role as a facilitator for international regulatory dialogue, aiming to bridge differing legal frameworks to foster a more integrated and trusted digital economy.

III, as Taiwan's designated CBPR Accountability Agent, shared insights into the implementation and benefits of CBPR certifications, which enable businesses to align effectively with APEC privacy standards and international best practices. Several Taiwan-based enterprises have already achieved CBPR certification, reinforcing their competitive advantage in global markets.

The workshop also provided a platform for dialogue among representatives from the G7 countries, multinational corporations, and regulatory bodies. Participants highlighted the strategic importance of CBPR in balancing data sovereignty, economic growth, and individual privacy rights, particularly within the context of rapidly evolving technologies such as AI.

By successfully convening this landmark forum, Taiwan reaffirmed its commitment to enhancing global cooperation on privacy regulations and strengthening international data governance. The event's outcomes are expected to significantly contribute to ongoing efforts to harmonize privacy standards worldwide, bolstering Taiwan's leadership and influence in the global digital landscape.

I. Demographic Transition and Healthcare Challenges

Taiwan will become a super-aged society by 2025, with over 20 percent of the population aged 65 and above, and this figure is expected to surpass 40 percent by 2065. This demographic transition presents serious challenges to the healthcare system, including rising prevalence of chronic diseases and cancer, as well as a significant increase in the demand for long-term care services. Coupled with a declining birth rate and growing financial pressure on the National Health Insurance (NHI) system, Taiwan urgently requires more efficient resource allocation and flexible, person-centered care models to maintain healthcare quality and improve patients’ quality of life.

In response, ministries under the Executive Yuan have initiated plans to promote integrated medical and long-term care services within their respective jurisdictions. These efforts also emphasize the application of technology to healthcare delivery as a key strategy in building a healthier Taiwanese society.

II. Acute Care at Home (ACAH) Program

On July 1, 2024, the National Health Insurance Administration (NHIA) under the Ministry of Health and Welfare(MOHW) launched the Acute Care at Home (ACAH) Trial Project . This project enables patients with conditions such as pneumonia, urinary tract infections, or soft tissue infections, who would normally require hospitalization, to receive antibiotic treatment at home or in care institutions.

Interdisciplinary care teams composed of physicians, nurses, pharmacists, and respiratory therapists deliver care, supported by telemedicine, remote vital sign monitoring, and point-of-care diagnostics. This model allows patients to avoid hospitalization while receiving safe and effective treatment, reduces the risk of hospital-acquired infections, and eases the burden on patients and caregivers. The program is expected to benefit around 5,400 individuals, with 350 million New Taiwan dollars in NHI funding.

As of now, 169 care teams have applied for participation, and 148 teams have been approved across Taiwan to ensure widespread access for those in need.

III. Expansion of Regulations of Medical Diagnosis and Treatment by Telecommunications

To enhance healthcare accessibility, the MOHW amended the Regulations of Medical Diagnosis and Treatment by Telecommunications on July 1, 2024. These revisions expand the scope of eligible patients under special circumstances, relax prescription rules, increase the range of services that can be delivered remotely, and strengthen information security standards. Combined with the ACAH Trial Project, these changes are projected to benefit up to 2.47 million people . Key amendments include:

1. Addition of five special categories of eligible patients: patients enrolled in chronic disease care plans, end-of-life care patients, individuals in correctional institutions, persons with impaired mobility, patients affected by disasters, infectious diseases, or other major event care.

2. Conditional approval for physicians to issue prescriptions via telemedicine.

3. Expansion of remote medical services to include consultations, referrals, psychiatric therapy, examination, diagnosis, and medical orders and issuing orders for tests and examinations.

4. Provisions allowing physicians to opt out of providing telemedicine services if deemed inappropriate for the patient's condition, with recommendations for alternative care pathways.

5. Strengthening of cybersecurity and information safety standards for communication technologies and equipment used in telemedicine.

IV. ACAH Outcomes and Future Development

As of May 31, 2025, NHIA data shows that 174 care teams and 789 medical institutions have joined the ACAH projects. Among nearly 3,000 enrolled cases, 70 percent involved patients aged 75 or older, and 78 percent had Barthel Index scores below 20, indicating complete dependency. These findings confirm that the program serves predominantly frail and immobile individuals.

Based on positive outcomes, NHIA plans to introduce additional projects such as “early-discharge care” and “outpatient parenteral antimicrobial therapy (OPAT),” and to expand the range of eligible conditions, including non-infectious home-based palliative care, as well as infections, heart failure, and respiratory failure.

V. Launch of the OPAT Program

To relieve emergency department overcrowding and enhance healthcare efficiency, NHIA launched the Outpatient Parenteral Antimicrobial Therapy (OPAT) program on August 1, 2025. This initiative allows stable and mobile patients, who previously required hospitalization for intravenous antibiotic treatment, to receive such treatment in outpatient settings.

Eligible infections include pneumonia, urinary tract infections, soft tissue infections, osteomyelitis, endocarditis, and postoperative infections. NHIA estimates that about 200,000 patients are hospitalized annually due to infections. If 10 percent of these cases (approximately 20,000 patients) transition to outpatient treatment, it would significantly reduce inpatient demand and provide patients with greater flexibility and quality of life.

VI. Home-Based Medical Technology Initiative

On June 12, 2025, the National Science and Technology Council (NSTC) announced the "Home Medical Care Technology" program. This program aims to leverage smart technologies to support frontline healthcare workers, meet diverse medical care needs, and drive innovation in the biomedical industry, thereby contributing to the realization of a “Healthy Taiwan.”

In its first year, the program received 1 billion New Taiwan dollars in funding and designated rural areas as pilot sites. Artificial intelligence will be used to establish connected healthcare networks and reduce the burden on frontline staff. The initiative also includes the development of care robots to eliminate the need for long-distance travel in remote areas. Physicians will be able to prescribe medication remotely using video consultations and physiological monitoring tools.

Additional goals include optimizing existing home healthcare products and integrated systems, accelerating the adoption of effective technologies, enhancing data interoperability, and building application networks for primary healthcare providers to improve cross-professional and cross-institutional collaboration.

VII. Cross-Ministerial Implementation and Vision

Starting in 2026, the NSTC will collaborate with the Ministry of Economic Affairs(MOEA), MOHW, and the Ministry of Digital Affairs(MODA) to jointly implement the "Home Medical Care Technology" program. To promote cross-sector involvement in home-based healthcare, the MOHW will subsidize medical equipment and personnel. The MOEA will fund the development of related medical devices, care tools, and selected robotics solutions. Biotech, pharmaceutical, and cloud service providers are also expected to receive support to drive innovation and industry growth.

This cross-ministerial initiative aims to establish a sustainable home healthcare technology ecosystem and realize the long-term vision of a people-centered and healthy Taiwan.

In the wake of global pandemics and persistent geopolitical instability, the fragility of international supply chains has been starkly exposed. For nations heavily reliant on imports, this vulnerability is nowhere more critical than in the pharmaceutical sector. A shortage of a single, inexpensive, yet vital drug can have cascading consequences for a nation's public health. Recognizing this, the Republic of Korea, through its Ministry of Food and Drug Safety (MFDS), has embarked on a systematic campaign to achieve self-sufficiency in "national essential medicines."

A Phased Approach to Domestic Production

South Korea's strategy is built on a multi-phase plan to support the domestic development of active pharmaceutical ingredient (API) and finished drug products . The primary targets are medicines that, critical for public health, have been abandoned by local manufacturers due to high import dependency, low profitability, or complex production challenges.

A 1st-phase project, which began in 2022, already marked a great success, supporting the domestic technology development for five essential items. These included amiodarone (injections and tablets), ketoconazole (API), amiodarone hydrochloride (API), and benserazide (API). The stabilization of these items laid the groundwork for the second stage.

The MFDS is now accelerating its "2nd-phase support project," which aims to domesticate a total of ten additional essential medicines by the following year. According to the team leader at the MFDS's Pharmaceutical Management Support Team, the government is fully committed to this goal. As of late, nine of these projects are already underway, with the final item pending consultation with a domestic firm.

Targeting the Most Critical Vulnerabilities

The selection process for these drugs is stringent and strategic. To be eligible for support, a medicine must meet three key criteria: it must be on the official national essential medicines list, its API or finished product must not be manufactured domestically, and it must face documented supply instability.

The 10-item list for the second phase includes drugs that are cornerstones of modern medicine: acetaminophen (antipyretic/analgesic), furosemide (diuretic), hydralazine (hypertension treatment), ipratropium (respiratory disease treatment), midodrine hydrochloride (blood pressure treatment), and verapamil hydrochloride (arrhythmia treatment).

These items highlight a core market failure. An official from the Pharmaceutical Management Support Team explained the paradox: "In many cases, domestic companies gave up manufacturing essential drugs not because they lacked the technology, but because the marketability was too low due to the high costs of API development and securing production facilities." The government's support is designed to remove this financial barrier, enabling companies to establish a tangible supply system that can function independently during a crisis.

Building a Public-Private "Made-to-Order" Ecosystem

Beyond R&D funding, the MFDS is fostering a comprehensive public-private partnership to manage the entire supply chain . On September 26, the ministry announced the establishment of the "Essential Medicines Public Production and Distribution Network." This collaborative body, operated with the Korea Orphan & Essential Drug Center (KOEDC), aims to systematically support the supply chain from initial manufacturing to final distribution.

A key component of this network is the "made-to-order" production project. Unlike normal market competition, this model is not activated based on market demand forecasts. Instead, it is triggered under the following conditions:

1. An essential medicine's stable supply cannot be spontaneously maintained by the market (e.g., the original manufacturer withdraws, or generic manufacturers cease production).

2. The government, hospitals, or associations confirm a genuine clinical need.

3. The government issues a public tender; a manufacturer produces a specific quantity "per the order," which is then fully purchased by the government for distribution to hospitals.

This model guarantees that critical medicines can maintain production even in the absence of commercial incentives. It also allows the government to act as a "buyer of last resort" to ensure public health security if a supply chain is temporarily disrupted. However, the made-to-order model requires the government to proactively identify drugs at risk of shortage and partner with pharmaceutical companies that possess sufficient manufacturing technology.

This initiative utilizes the production capabilities of private pharmaceutical companies to ensure a stable domestic supply of items that have been discontinued or are at risk of being discontinued. Currently, six pharmaceutical companies are participating in the project, producing seven essential medicines under this government-supported framework.

National Strategy: Research on API Self-Sufficiency

The core of South Korea's support for pharmaceutical resilience is the "National Advanced Strategic Industry" policy. Its main measures include securing vaccine sovereignty, establishing a stable biomedical supply chain, expanding the national essential medicine stable supply council, and promoting research to improve the supply and self-sufficiency of API.

The API supply research project, in particular, began in 2022 and is scheduled to run until the end of 2026, with a total budget of approximately 5 billion KRW. The key tasks of this research include:

1. Screening for high-risk shortage drugs and APIs annually; establishing a support mechanism for R&D on localizing key APIs and their domestic production.

2. Assisting domestic companies in enhancing API production capabilities, backup networks, and technology transfer.

3. Developing contingency strategies for the made-to-order system and public stockpile lists, while promoting industry-academia collaboration to develop new APIs and core formulation technologies.

This plan is based on the priority development of urgently needed drugs and key APIs (with a focus on API R&D), subsequently promoting technological upgrades and standard-setting for both APIs and finished drugs concurrently.

Legal Reinforcement

The government is also moving to strengthen the legal framework . A proposed amendment to the Pharmaceutical Affairs Act seeks to expand the role of the "National Essential Medicines Stable Supply Council." The council's mandate will be broadened to discuss items facing supply instability due to temporary demand surges, not just chronic shortages. Furthermore, the council will be reorganized to include private-sector participation, ensuring that the voices of patient groups and frontline healthcare professionals are reflected in policy decisions.

The domestic production of a few drugs is not the endgame. South Korea's strategy is aimed at securing "pharmaceutical supply sovereignty" that protects public health when global systems fail. The process of developing these drugs necessitates facility expansion, improvements in raw material production, and the advancement of quality control standards. This comprehensive upgrade can enhance the entire industry's constitution and global competitiveness.

Korea's experience holds important lessons for Taiwan which is also facing similar supply chain challenges. Taiwan also relies heavily on foreign imports for its drug supply, particularly for critical API. The question of how to build a resilient and flexible supply chain system to protect public health and medication access in the face of global emergencies or supply disruptions has become an urgent priority.