The Legislative Yuan yesterday passed an amendment to the Pharmaceutical Affairs Act (藥事法), which includes increased punishments for manufacturing or importing counterfeit or banned drugs.
The Food and Drug Administration (FDA) said that the amendment aims to increase the liability of pharmaceutical companies and establish a tracing mechanism to report drug shortages, as well as improving drug use instructions to better inform the patients, while creating a mechanism for emergency manufacturing or imports of drugs and better drug source management.
Before the amendment, pharmaceutical companies or people who produced or imported counterfeit or banned drugs faced a maximum fine of NT$10 million (US$303,260) and a maximum jail term of 10 years.
The amendment increased the maximum fine to NT$100 million, but it can climb as high as NT$200 million if the drugs cause any deaths, while prison terms remain unchanged.
As for drugs that fail to meet standards imposed by authorities, the companies that manufacture or import them are to face fines ranging between NT$100,000 and NT$5 million — a significant rise from the previously enforced fines ranging between NT$60,000 and NT$300,000 — as well as the confiscation of any illegal gains from sale of the drugs.
Moreover, if pharmaceutical companies find it difficult to continue supplying necessary drugs designated by the government for any reason, they are to report to the authorities within six months, or at least 30 days if the supply interruption is caused by a natural disaster or accident.
Regarding an article of the amendment that requires the clarification of drug use instructions for easier understanding, the Taiwan Healthcare Reform Foundation urged the FDA to set a schedule for enforcing a reform of drug package labeling and instructions, saying the reform should begin with over-the-counter drugs.
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