PA Consulting’s cell & gene therapy experts, Benjamin Solaski and Paolo Siciliano, are quoted in an article about the regulation of stem cell-based therapies amid rising concerns about unscrupulous cell therapy clinic operators.
The article reports that the number of stem cell clinics in the US rose from two in 2009 to about 700 by 2017, and desperate patients who are not covered by insurers or national health reimbursement schemes are spending vast sums on unproven treatments. This has highlighted the need for tighter regulation; regulators need to protect vulnerable patients whilst also continuing to encourage innovation in cell and gene therapy.
It goes on to discuss how as part of a $1bn initiative to promote regenerative medicine, in Japan, two laws passed in 2014 to allow companies to market certain stem cell-based therapies without passing through conventional clinical review processes.
While the measures were intended to bring a degree of oversight to a market that was filling up with rogue clinics, Benjamin says they may put patients at risk: “Broad claims are being made about curing cardiovascular or liver disease through intravenous cell therapy, but there’s no evidence to support these claims,”
The article goes on to cite concerns that countries may start competing to deregulate cell therapy. Japan’s 2014 reforms, for instance, were a response to earlier measures in South Korea that sought to speed up the route to market.
Paolo says a race to deregulate could create a new and dangerous medical tourism market. “We need to avoid a regulatory framework that is too different globally,” he observes.