Liberal regulatory environments for regenerative medicine.

Liberal regulatory environments for regenerative medicine.

"First they ignore you, then they laugh at you, then they fight you, then you win” 

"And, my friends, in this story you have a history of this entire movement. First they ignore you. Then they ridicule you. And then they attack you and want to burn you. And then they build monuments to you. And that, is what is going to happen to the Amalgamated Clothing Workers of America."

the same thing will happen to my proposal for  embryonic myometrial stem cell transplantation.

India should try and follow JAPAN!

Liberalize Stem cell therapies !

The government of Prime Minister Shinzo Abe decided to establish one of the world’s more liberal regulatory environments for regenerative medicine.

But it isn’t only Japanese companies that are in a rush to commercialize stem-cell treatments. The country is becoming a magnet for scientists and entrepreneurs from around the world who are seeking a rapid route to commercializing products and therapies .

Japan’s attractiveness to regenerative-medicine entrepreneurs is prompting other countries to look closely at its regulatory changes. There is undoubtedly a competition under way, and unless something is done, it risks becoming a race to the bottom.

Supporters of Japan’s laws justify the fast-track approvals system by arguing that more conventional regulations would drive clinics underground, and regulators would constantly have to work to catch up — as is the case for the US Food and Drug Administration. Japan’s solution, they argue, means that companies are compelled to operate in the public eye, which is itself a form of transparency, because clinics are visible and not hidden.

Moreover, the law requires stem cells to be processed in high-quality, certified cell-processing centres, and treatments to pass through an independent ethical-review board — there are 100 of these. An official in Japan’s Ministry of Health, Labour and Welfare told Nature that double-blind clinical trials are expensive, and that there are ethical issues involved in giving placebos to people with illnesses.

It is possible that some of these justifications have a degree of merit, but there’s still no denying that the majority of commercially available stem-cell therapies have not been tested in more rigorous phased clinical trials.

Japan should put the brakes on stem-cell sales

That leads to a second concern. As with all medical therapies, people regard government approval for stem-cell clinics as reassurance that treatments they offer are both safe and viable. Unless people have read the text of the law, they will not know that stem-cell products and therapies have a low barrier to regulatory approval. One doctor told Nature that, from a patient’s perspective, an approval is an approval, and “everything else is just details”.

Japan’s dilemma is a global one. Every government can see a pot of gold at the end of the stem-cell rainbow, but countries know that these riches cannot come at the expense of increased risks to patient safety.

Regulators in the United States, who have also struggled with these issues, are adhering to the international regulatory consensus for medical therapies, and seem to be getting the upper hand in their battles against treatments that have not been rigorously tested.