March 1, 2024

Should countries compete to have the most permissive stem cell regulations?

A bioethical Gresham’s Law

Gresham’s Law is more familiar to economists than bioethicists. It states that “bad money drives out good”, that people will hoard valuable coins if debased coins are circulating at the same face value.

A kind of bioethical Gresham’s Law is operating in regenerative (or stem cell) medicine, claim two scientists in an article in Science. They warn that if just one country decides to relax regulations in the field, a heightened sense of competition can spur others to do the same.

Regenerative medicine focuses on developing therapies to regenerate or replace injured, diseased or defective cells, tissues or organs. Due to the use of living cells, it can be hard to set regulations in the same way as for other drugs so differences in the rules can occur.

Co-author Margaret Sleeboom-Faulkner, of the University of Sussex, says:

“Regenerative medicine contains a lot of economic promise, and there's already been enormous investments into it.

“While this is good in terms of focusing on new and innovative treatments to improve healthcare, it also leaves the field particularly vulnerable to regulatory brokerage. When one country relaxes their regulations, others are tempted to do the same in order to 'keep up'.

“Competition is the last way we want medicine to be progressing.”

South Korea, for instance, was the first country to give preferential regulatory treatment to stem cell medicine. Its decision to issue a flurry of three stem cell-based medical products between 2011-12, and a fourth in 2014, attracted international scepticism for sacrificing clinical data standards in exchange for speed to market.

Japan, who had launched a multi-billion dollar initiative to lead the world in regenerative medicine, began to see South Korea as a competitor. This resulted in a change of the law in 2013, to allow regenerative medicine products a faster entry to the market.

Professor Sleeboom-Faulkner is cautioning countries to be vigilant when it comes to developing treatments particularly in the face of deviant ventures such as the recent case of gene-edited foetuses in China, and the current trend of increasing flexibilities in regulations internationally.

Michael Cook is editor of BioEdge

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