High-Value Generics: Another Critical Piece of Taiwan’s Medical Resilience and Patient Accessibility

The healthcare industry has long been a vital pillar of national strategic development across the globe. Its significance lies not only in treating diseases but also in its direct impact on population health, labor productivity, family care burdens, social welfare expenditures, and the overall long-term stability of the economy and society.

Only when a country's healthcare system enables citizens to obtain safe, effective, and affordable medicines in times of need can a truly resilient universal health security framework be established. Therefore, healthcare policies, healthcare delivery systems, and pharmaceutical supply chains are never isolated issues; rather, they form the collective foundation for maintaining public health and social security.

In the biotechnology and pharmaceutical industry, the capacity to research and develop innovative drugs is typically viewed as a major demonstration of a country's scientific prowess, clinical research capabilities, and capital market maturity. From new targets and novel mechanisms of action to cell and gene therapies, innovative drugs represent a nation's capacity to respond to future medical needs.

On the other hand, the importance of generic drugs is equally undeniable. If innovative drugs reflect research, development, and originality, then generic drugs embody manufacturing capabilities, quality management, regulatory review, commercialization efficiency, and the overall resilience of the pharmaceutical supply chain.

Take the United States as an example, where generics already account for over 90% of dispensed prescriptions. This does not imply that innovative drugs are unimportant; rather, it demonstrates that a mature healthcare system must possess dual capabilities: continuously introducing breakthrough innovative medicines on one hand, while ensuring that more patients can receive long-term, stable, and affordable treatment through reliable-quality generics on the other. The U.S. Food and Drug Administration (FDA) has also noted that competition from generic drugs helps lower treatment costs and increases patient access to medications.¹

The situation is much the same in Taiwan. Data previously released by the Ministry of Health and Welfare (MOHW) shows that generics account for over 70% of the total volume of drugs claimed under the National Health Insurance (NHI) scheme. Although their share of the total payout amount is lower than that of brand-name drugs, it is precisely because generics support the routine treatment of a massive volume of chronic and common diseases that the limited resources of the NHI have more room to be allocated to cancer, rare diseases, and other fields with high medical needs.²

Therefore, generic drugs should not be viewed merely as "cheap substitutes." In an environment shaped by an aging population, a high prevalence of chronic diseases, and continuously escalating healthcare expenditures, generics serve as a crucial tool for sustaining medical accessibility and the sustainability of the NHI. Furthermore, high-value generics, hard-to-make generics, and special dosage forms involve complex manufacturing processes, quality control, regulatory requirements, and clinical usage demands—they cannot be viewed purely through the logic of low pricing.

Taiwan possesses a pharmaceutical industry that meets international GMP standards, with numerous local pharmaceutical companies continuously investing in the development and manufacturing of generic drugs. However, not all drugs with high technical barriers, low demand volume, or special formulations are suitable for domestic manufacturers to develop and produce independently. For certain acute and severe illnesses, rare diseases, oncology, neuropsychiatric disorders, or complex formulation products, introducing high-value generics that have accumulated regulatory and manufacturing experience in mature markets through quality-assured international collaborations will help bridge the gaps in Taiwan’s drug supply.

What truly deserves attention is not which country a drug comes from, but whether it meets several core criteria:

• First: Whether its quality and regulatory standards are reliable.

• Second: Whether the supply source is stable and traceable.

• Third: Whether it features a reasonable and sustainable pricing structure.

• Fourth: Whether a diversified supply and risk-backup mechanism can be established.

• Fifth: Whether it genuinely addresses unmet clinical patient needs.

This is also the new type of business model that has begun to emerge in Taiwan’s pharmaceutical market in recent years: it is no longer just traditional drug licensing or the introduction of a single item, but rather a systematic introduction of high-value generics with clinical value, centered around market access, regulatory strategy, medical needs assessment, supply chain planning, and commercial execution.

Take Tivoli Therapeutics as an example. In recent years, the company has focused on importing high-value generics and special formulation products. Public data indicates that it has established a product portfolio spanning over 30 molecules, covering niche generics, high-barrier drugs, and value-added dosage forms. Meanwhile, it has launched collaborations in the Taiwanese market with European pharmaceutical companies and plans to expand further into the Asian market.³

The value of this type of enterprise lies not only in bringing products into Taiwan, but also in whether it can translate global high-quality pharmaceutical resources into actual treatment options available to Taiwanese patients through precise product selection, rigorous quality reviews, professional registration, and market access strategies.

As a consultant who has long been dedicated to the biotechnology and pharmaceutical industry and international market strategy, I am honored to assist Tivoli Therapeutics with its strategic development in the Taiwan and Southeast Asian markets. What I look forward to is not just the growth of a single enterprise, but that Taiwan can gradually establish a more mature system for the introduction and supply of high-value generics.

Innovative drugs allow us to see the future of medicine; high-quality generic drugs, meanwhile, enable more patients to afford and sustain the treatments they need today. For Taiwan, a truly robust pharmaceutical policy should not force a choice between innovation and generics, but should simultaneously strengthen local R&D, local manufacturing, international introduction, and supply resilience.

Only in this way can Taiwan pursue biotech innovation and medical progress while ensuring that every patient can obtain safe, effective, accessible, and affordable treatment when they need medication.

Footnotes

¹ The U.S. FDA points out that generics account for over 90% of prescribed medication volume in the U.S., and competition from generics helps enhance accessibility and affordability.

² Data from 2019 released by the Ministry of Health and Welfare shows that generic drugs account for over 70% of the medical order volume under Taiwan's National Health Insurance, with their payment amount accounting for approximately 43%.

³ Public information from Tivoli Therapeutics indicates that its imported generics business covers over 30 molecules, and it has announced collaborations with European partners such as GENEPHARM and REMEDICA to promote the Taiwan market.