The Ministry of Health and Welfare yesterday announced a draft amendment to the Pharmaceutical Affairs Act (藥事法), that would require drug companies to give the ministry advance warning if stocks are running low on any of 968 “essential” medicines.
According to the WHO, essential drugs are those needed to satisfy the priority healthcare needs of a population.
They should be available for a healthcare system at all times in adequate amounts, in the appropriate dosage forms, with assured quality and at a price the individual and the community can afford, the WHO says.
Food and Drug Administration specialist Tsai Shih-chih (蔡士智) said the ministry specified the 968 types of drugs in reference to the WHO’s Model Lists of Essential Medicines and the National Health Insurance Administration’s List of Essential Medicines.
The ministry’s list includes medicine for treating Parkinson’s disease, epilepsy, the “three highs” — high blood pressure, high blood cholesterol and high blood sugar, vaccines and various common diseases.
Starting from yesterday, the ministry is to collect any opinions or suggestions from the public on the amendment, over a period of 14 days.
Once the amendment is implemented, drug companies would be required to give the ministry six months’ advance warning if stocks of any essential medicines are running low, or within one month if the situation is due to a natural disaster or unpredictable accident, so that the ministry can take ad hoc measures to avoid drug shortages.
Companies that fail to report shortages according to the terms of act would face having their names made public for a first violation, and subject to fines of NT$60,000 to NT$300,000 for repeated violations.
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