A bill to support advanced regenerative medicine and high-tech biopharmaceuticals is likely to pass the National Assembly’s legislation and judiciary committee on Thursday, after getting the nod from the health and welfare committee.
The bill will become a law if it wins final approval at the assembly session scheduled on Friday.
The government and the biotech industry is raising hope that the bill will pass, just as major advanced countries have already enacted a similar law to support the advancement of biopharmaceuticals.
The high-tech biopharmaceuticals bill puts a priority on reviewing biopharmaceutical drugs for the treatment of rare diseases, offering step-by-step preliminary evaluations for developers of biopharmaceutical products, and giving conditional approval to drugs proven sufficiently effective to expand treatment options.
The bill also aims to help biotech firms release a medicine for rare diseases, serious diseases such as cancer, and infectious diseases only with confirmed data of phase-2 clinical trials alone. Studies in stem cell-using regenerative medicine will also be boosted, observers said.
The regulations on biopharmaceutical drugs have been subject to the Pharmaceutical Affairs Act, along with synthetic medicines.
Although gene and cell therapies are different from synthetic drugs in development and manufacturing, there was no separate law to manage the former in Korea.
However, the U.S. and Europe have separate laws to handle advanced biopharmaceutical drugs, in addition to laws commonly applying to pharmaceutical goods.
The U.S. applies the Food, Drug, and Cosmetic Act to medicines universally, and Section 351 of the Public Health Service (PHS) Act to biological products that are vulnerable to contamination specifically. The U.S. additionally enacted the 21st Century Cures Act in December 2016 for advanced regenerative treatments.
The 21st Century Cures Act enables speedy approval for Regenerative Medicine Advanced Therapies to meet the medical demand for treatments of serious diseases. The act is similar to the advanced biopharmaceuticals bill in Korea.
Europe also has a separate regulation on Advanced Therapy Medicinal Products such as cell therapies, gene therapies, tissue engineering agents, and complex high-tech medical products.
Japan defines cell and gene therapies as “advanced regenerative medicinal products.” While the U.S. and Europe have separate laws to control them, Japan divides medicines and regenerative medicines in different sections within the pharmaceutical drug/medical devices law.
The domestic biopharmaceutical industry expects the passage of the bill on advanced biopharmaceuticals will significantly enhance the sector’s growth.