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DRUG INJURIES RELIEF LAW


Patrick Wong

The Drug Injuries Relief Law was promulgated on 31 May 2000.

To protect consumer interests, the law provides that persons injured by the proper use of legal pharmaceutical drugs should receive timely re-lief. The right to seek relief for a drug injury lapses if not exercised within three years after a person entitled to seek relief becomes aware of a drug injury. Drug injuries sustained before the law came into force are not eligible for relief under the law.

A drug injury as referred to in the law means an adverse reaction to a drug, leading to death, disability or serious illness. Relief is provided in the form of death benefit, disability benefit or serious illness benefit. Benefit rates are to be determined by the competent authority, which is the Department of Health (DOH).

The law also requires the DOH to set up a Drug Injuries Relief Fund to provide relief under the law. The main source of the fund is a levy on manufacturers and importers of pharmaceuticals, who must pay a certain proportion of their pre-vious financial year's revenue from drug sales into the fund within time limits set by the DOH.

The levy is set at a rate of 0.1% until the fund reaches NT$300 million. Once the fund exceeds NT$300 million, the DOH may adjust the rate within a range from 0.02% to 0.2%, taking ac-count of the actual income and expenditure of the fund. However, where a pharmaceutical product has caused injury for which benefits are paid under the law, the DOH may increase the levy upon its manufacturer or importer for the sub-sequent fiscal year to 1%.

To handle matters related to drug injuries, the law also requires the DOH to set up a Drug In-juries Relief Assessment Committee to assess cases. The committee must reach a decision on cases within three months following receipt of the application; this period may be extended if necessary, but any such extension may not ex-ceed one month.
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