Special-approval medicines join the relief system: what the Drug Injury Relief Act amendment means for the physician-patient relationship

By Patty Feng, Director of the PatientsForce Compliance Center

In modern medicine, drug therapy is a double-edged sword: efficacy and risk coexist. On 30 January 2026, Taiwan's Legislative Yuan passed amendments to Articles 3 and 28 of the Drug Injury Relief Act, formally bringing 'medicines manufactured or imported under special approval' into the relief system. This progress not only fills a gap in the social safety net, it rebuilds a bridge of trust and security between physicians and patients on the clinical front line.

Removing the moral shackles from clinical decisions

For years, when domestic shortages occurred, or when special-case medicines without a domestic license were brought in for rare diseases or urgent needs, physicians, patients and pharmacists operated in a regulatory vacuum.

• Freeing physicians' professional judgment: previously, a physician recommending a special-case medicine weighed not only the clinical evidence but also the psychological and legal burden that 'if a serious adverse event occurs, the patient will have nowhere to turn'. With the amendment, the system now stands behind medical decisions, letting physicians return purely to their profession instead of practicing defensive medicine out of fear of an institutional gap.
• Realizing patients' equal right to life: to a patient, life carries the same weight whether the treatment is a routine product or a life-saving special-approval medicine. The amendment removes relief discrimination based on a drug's 'status', ensuring that anyone who suffers an unforeseeable drug injury can receive state compensation and medical support.

From litigation to a community of shared risk

Ruptured physician-patient relationships usually stem from unclear responsibility and heavy financial pressure after harm occurs. Drug injury relief is in essence a no-fault social insurance concept, and the amendment's buffering effect is crucial:

• Lowering the incentive for conflict: timely relief payments ease a family's immediate hardship and reduce the motivation to turn misfortune into medical litigation.
• Transforming roles: the physician shifts from potential 'defendant' to 'professional partner helping the patient apply for relief'. By assisting with clinical data collection and adverse-event reporting, clinicians and patients stand on the same side against the uncertainty of medicines.

Strengthening the national drug-safety surveillance network

From a pharmacovigilance perspective, including special-import medicines in the relief system creates a positive data cycle:

• More active reporting: without a relief incentive, adverse events from special-case medicines were easily under-reported. With relief rights in place, clinical reporting will become more precise.
• A local evidence base: these data become key indicators for evaluating the safety of special medicines in Taiwan, forming a defense system of early warning, timely relief and optimized medication use.

The amendment is more than a cold change of legal text — it is a deep respect for the nature of medicine. When the legal system can safely catch the uncertainty inherent in care, physicians dare to expand the frontier of treatment and patients dare to entrust their lives. Completing this safety net marks a key step for Taiwan's healthcare environment toward greater civility and resilience.