The only country that has stood out in creating companies to offer stem-cell therapies has been Japan, while the other countries across the globe have been struggling to achieve the same. It has been five years since Japan has been legally allowed to extract stem cells from different skin biopsies, using them in the injections for chronic and complex diseases such as heart diseases. More than 3,700 treatments have received green light as a result of the regulatory laws being passed. However, a majority of the treatments and therapies have not passed the randomised, controlled, double blind clinical trial — a global standard to prove its safety and effectiveness. Not having passed the trial proves its unreliability on the outcome of the treatment altogether.
Although, in fast need of getting therapies and products commercialised, many entrepreneurs and scientists across the world are looking to enter Japan for a more rapid route of getting their business started. Therefore, looking at the rush that various companies are in, in order to commercialise their products, the government is looking to introduce a stringent policy framework for better regulatory changes. This also forces other countries to keep an eye on the regulations to ensure ethical work is being conducted.
The law requires high quality processed stem-cells in certified cell-processing centres and treatments that need to be passed through an independent ethical-review board. While the double-blind clinical trials are expensive in Japan, as claimed by Japan’s Ministry of Health, Labour and Welfare, there are many ethical issues that are involved by giving placebos to people who are suffering from illnesses. This is the reason behind the need for stringent ethical laws that do not hamper the lives of people in any way and risking their health.