Japan’s venture in regulating regenerative medicines
The regulations on stem cells and regenerative medicines that Japan passed in 2013 were intended to increase patients’ access to promising new medical treatments. Economic, safety and ethical issues are raised by the creation of a legal pathway for public and private institutions to use unapproved regenerative medicine treatments.
What questions & challenges are raised?
For years researchers have discussed the potential for stem cells (SCs) and regenerative medicines (RMs) to deliver a profoundly new way to treat and potentially cure injuries and disease. The clinical trial process for testing new drugs and treatments examines both safety and efficacy, but for many this process is perceived as too slow and laborious. To meet the demands of patients, clinicians and biomedical companies, many countries are considering or have already implemented new regulations to allow RMs to be given to patients - even if treatments have not yet been proven to work. Japan passed two laws in 2013 in an effort to promote RM research and address the growing demand for access to SC treatments. Dr Tamra Lysaght from the National University of Singapore identifies several ethical and economic issues of Japan’s new RM regulation in her paper “Impacts of Japan’s Framework for Regenerative Medicine”. Dr Lysaght points out how frameworks of this kind are vulnerable to exploitation, give credibility to treatments with unproven efficacy and can potentially damage the reputation of SC research and RMs in Japan and around the globe.
What questions & challenges are raised?
For years researchers have discussed the potential for stem cells (SCs) and regenerative medicines (RMs) to deliver a profoundly new way to treat and potentially cure injuries and disease. The clinical trial process for testing new drugs and treatments examines both safety and efficacy, but for many this process is perceived as too slow and laborious. To meet the demands of patients, clinicians and biomedical companies, many countries are considering or have already implemented new regulations to allow RMs to be given to patients - even if treatments have not yet been proven to work. Japan passed two laws in 2013 in an effort to promote RM research and address the growing demand for access to SC treatments. Dr Tamra Lysaght from the National University of Singapore identifies several ethical and economic issues of Japan’s new RM regulation in her paper “Impacts of Japan’s Framework for Regenerative Medicine”. Dr Lysaght points out how frameworks of this kind are vulnerable to exploitation, give credibility to treatments with unproven efficacy and can potentially damage the reputation of SC research and RMs in Japan and around the globe.
What questions & challenges are raised?
For years researchers have discussed the potential for stem cells (SCs) and regenerative medicines (RMs) to deliver a profoundly new way to treat and potentially cure injuries and disease. The clinical trial process for testing new drugs and treatments examines both safety and efficacy, but for many this process is perceived as too slow and laborious. To meet the demands of patients, clinicians and biomedical companies, many countries are considering or have already implemented new regulations to allow RMs to be given to patients - even if treatments have not yet been proven to work. Japan passed two laws in 2013 in an effort to promote RM research and address the growing demand for access to SC treatments. Dr Tamra Lysaght from the National University of Singapore identifies several ethical and economic issues of Japan’s new RM regulation in her paper “Impacts of Japan’s Framework for Regenerative Medicine”. Dr Lysaght points out how frameworks of this kind are vulnerable to exploitation, give credibility to treatments with unproven efficacy and can potentially damage the reputation of SC research and RMs in Japan and around the globe.