The Social Welfare and Environmental Hygiene Committee of the Legislative Yuan passed the preliminary review of the draft Regenerative Medicine Act on the 29th March. The Committee decided to bring all controversial provisions to legislative negotiation, such as the role of the Regenerative Medicine Review Board and the exemption from phase II clinical trials granted to non-commercial preparations.
The Committee scheduled the review of the draft Regenerative Medicine Act on the 29th and the draft Regulations of Regenerative Medicinal Products on the 30th.
There are 33 articles in the draft Regenerative Medicine Act proposed by the Executive Yuan. The Committee was not able to reach consensuses on 14 controversial articles and decided to leave them to legislative negotiation. They include Article 9 Paragraph 2, which stipulates that the products needed by hospitals for performing regenerative medicine techniques can be exempted from the requirements of drug licenses or conditional licenses if their safety and preliminary effectiveness have been proved by clinical trial results. The authority stressed that this article is in place for small-scaled tailor-made products and not for commercial products.
Legislator Lin Ui-Tsiu (KMT) expressed reservations about exempting certain regenerative medicinal products from phase II clinical trials. Legislative Chen Shu-Hua (New Power Party) said that safety and preliminary effectiveness should be more clearly defined so as to avoid disputes and lawsuits. It would be inappropriate to shirk the responsibility of judgement to the Regenerative Medicine Review Board, said Chen.
Legislator Lin Ching-Yi (DPP) expressed that this provision provides a solution for the regenerative medicinal products which, at least for the time being, cannot be commercialized. At present, conducting clinical trials is the only way for accessing such products. This provision aims to fill an urgent need, said Lin.
The roles and duties of the Regenerative Medicine Review Board also provoke disputes. As regenerative medicine is a multidisciplinary science, there are arguments about the composition of the board members. The medical community believes that the Regenerative Medicine Review Board should be given the authority to license regenerative medicinal products on the ground that regenerative medicinal products are completely different from conventional pharmaceutical products. However, the pharmaceutical community suggests that licensing power should remain within the TFDA. Further negotiation is definitely required.
【2023-03-29/ RTI News】
