The legislature yesterday passed an amendment to the Medical Treatment Act (醫療法), extending the measures used for human clinical trials to cover generic medicine tests that currently are not subject to any regulations.
Democratic Progressive Party (DPP) Legislator Huang Sue-ying (黃淑英), who initiated the amendment, said she hoped that by including generic medicine tests in the Act, the risks for patients in such tests would be reduced.
“There have been reports of cases where physicians asked patients to go into clinical tests for generic medicines without getting permission [from the authorities]. Although entering human clinical tests for generic medicine poses a lower risk than entering one for a new medicine, we can’t pretend that no risk exists,” Huang said.
The current Act stipulates that “physically capable people” or “physically limited capable people” can be included in human clinical trials as long as hospitals first obtain consent from the subjects’ legal representatives.
The new amendment will include only “mentally capable adults,” meaning individuals who are capable of expressing themselves. Exceptions can be made when the test may be of apparent benefit to specific patients, the amendment said.
Huang said the revision would prevent researchers from attempting to profit from arbitrarily recruiting people for tests, including the mentally challenged.
The amendment also stipulates that medical institutions may not refuse treatment to patients who withdraw from tests or decline to take part in them.
The amendment also requires the Institutional Review Board, the authority that reviews applications for human clinical trials, to adjust its composition.
Members of the committee now must include medical technology personnel, legal experts, members of the community and representatives of civil groups, and with neither sex having more than a two-thirds majority.
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