Countries that relax regulations for regenerative medicines could be causing a downward spiral in international standards, according to the authors of a new research published in Science.
The authors suggest competitive pressures may lead to regulations becoming “more permissive” and say the field of regenerative medicine may be particularly susceptible to “regulatory brokerage” because of its economic promise, investment made in the field and the hope of relief for growing public health budgets.
They describe how, when South Korea became the first country to give preferential regulatory treatment to stem cell medicine, there was a subsequent "flurry" of approvals of stem cell-based medical products. The authors say that while the Korean approvals attracted international scepticism for "sacrificing clinical data standards to expedience", it had a different effect in Japan, which began to see South Korea as a competitor. This resulted in changes to the law to allow regenerative medicine products faster entry to the market. Furthermore, the authors say some regulators have responded to Japan's new regulatory regime as a "competitive challenge".
“Competition is the last way we want medicine to be progressing,” said author Professor Margaret Sleeboom-Faulkner. “Ideally, regulations should be internationally coordinated and there should be a collaborative global approach in order to maintain basic standards."