The Regenerative Medicine Dual Bills have long been regarded as one of the key pieces of legislation for the Ministry of Health and Welfare. Minister Hsueh, Jui-yuan stated that the bills underwent review by the Executive Yuan on the afternoon of the 19th and would undergo some textual revisions before being sent to the Executive Yuan's Regulatory Reform Committee for final confirmation. It is expected that they will be submitted to the Legislative Yuan before May 20th.
The Regenerative Medicine Dual Bills consist of the "Regenerative Medicine Act" and the "Regenerative Medicine Preparations Act." Hsueh, Jui-yuan, who is due to step down on May 20th, stated yesterday that this marks the final push. The dual bills had previously passed the first reading in the Legislative Yuan last year. However, due to the expiration of the session, they were not further reviewed. Therefore, the Ministry of Health and Welfare submitted a new version to the Executive Yuan last month, which underwent review on the 19th.
Hsueh, Jui-yuan stated that the review by the Executive Yuan was completed on the 19th, but there would be some textual revisions. The bills will then be subject to final confirmation by the Executive Yuan's Regulatory Reform Committee. It is uncertain when they will be approved by the Executive Yuan, but it is expected that they will be passed and submitted to the Legislative Yuan for review before May 20th. Among the dual bills, there were not many adjustments made to the "Regenerative Medicine Preparations Act," with the main focus being on the "Regenerative Medicine Act."
Comparing the versions submitted to the Executive Yuan last year and this year, Hsueh, Jui-yuan said there were mainly four differences. First, the articles regulating human trials were moved forward in the sequence. While human trials are required for the implementation of regenerative medicine, there are two exceptions: "compassionate use" and "those already approved under special measures." Additionally, the controversial "preliminary efficacy" clause was removed from the regulations.
Furthermore, in last year's draft, medical institutions could establish biotech companies to carry out regenerative medicine, which was removed in this draft. Thirdly, to curb irregularities, the penalties for non-medical institutions conducting regenerative medicine were increased from NT$2 million to NT$20 million, and their equipment and preparations will also be confiscated.
Finally, regarding regenerative medicine advertisements, Hsueh, Jui-yuan stated that the previous "filing" system was replaced with an "approval" system in the new version. Advertisements must be approved before they can be broadcast. Unapproved advertisements will be subject to penalties by local governments. Both central and local governments will have their respective responsibilities in this regard.
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