A bill that supports advanced generative medicine and high-tech biopharmaceuticals has failed to pass the National Assembly’s legislation and judiciary committee, hit by Kolon Life Science’s revelation that it had mislabeled a drug ingredient of cell gene therapy Invossa-K over a decade.
Other revision bills – related to establishing an emergency center for the mentally ill and allowing non-profit groups and consumer groups to receive administrative and financial support for patient safety – have also been put on hold at the Assembly panel.
On Thursday, the legislation and judiciary committee reviewed bills related to the health and welfare committee. During the review, Rep. Oh Shin-hwan of the minor opposition Bareunmirae Party said the committee should return the high-tech pharmaceuticals bill to the subcommittee for further discussion.
“Although I generally agree with the purpose of the bill, I think advanced biopharmaceutical products should go through long-time research verification before becoming finished goods,” Oh said. “We should further discuss carefully applying experimental drugs to study subjects from the clinical trial stage.”
Oh noted that Kolon Life Science’s suspension of Invossa came amid the discussions for the high-tech biopharmaceuticals bill. “In this situation, we should make a clear definition of research subjects who can receive investigational drugs. We need to discuss the bill further,” he said.
In response, Minister of Food and Drug Safety Lee Eui-kyung emphasized that enacting the high-tech pharmaceuticals bill could prevent a similar Invossa mishap.
However, Oh strongly insisted on returning the bill to the subcommittee and the bill failed to pass the legislation and judiciary committee.
Rep. Song Ki-hun of the ruling Democratic Party of Korea put brakes on other bills that aimed to establish an emergency center for the mentally ill and to allow non-profit groups and consumer groups to receive the government’s administrative and financial support for patient safety.
Song said establishing such emergency center needs a mere insertion of the clause into the Emergency Medicine Act, not a separate law. He also noted that the definition of “non-profit civic groups and consumer groups” subject to the government support was too broad.
Other healthcare-related bills that did not pass the legislation and judiciary committee include one that sought to mandate physicians to report a serious safety accident such as patient death due to surgery different from the one explained in the consent form or general anesthesia.
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