By Danny Sullivan – Longevity.Technology –
Healthspan Action Coalition’s Bernard Siegel says new state laws show the federal government needs to ‘get its act together’ on patient access to innovative therapies.
As a member of the Florida Bar Association for the past 50 years, and a full time advocate for regenerative medicine for more than 20 years, Siegel has some strong views on why these laws have started to appear.
“It’s important to realize that these bills are untested, and while each bill can be considered as progress, I think they also highlight the issue of the overall reforms that need to be made,” he says. “That is, to have all regulatory systems modified to keep up with the technologies that we have today. That’s the root of a lot of problems in the field.”
New regulation needed
To illustrate his point, Siegel refers to an article in Regenerative Medicine written in 2011 by UCL professor Chris Mason, which described cell therapy as a key “pillar” of healthcare.
“The other pillars of healthcare – pharmaceuticals, biologics and medical devices – already had infrastructure built-in, but cell therapies did not – no reimbursement, no special guide,” he says. “So, if you’re going to jam all cell therapies under the same rules as biologics, nothing could get through the rigorous clinical trials and massive expense. We needed laws to keep up with innovation, and we didn’t have them.”
Fast forward to today and Siegel feels the situation hasn’t changed much – certainly not at the federal level.
“The Healthspan Action Coalition has 275 member organizations cross sector, but there’s a huge frustration that our systems are broken down and have not taken advantage of the opportunities of innovation,” he says. “We are already overwhelmed with innovation, and emerging technologies like AI and data and analytics are going to explode things further. We need our regulatory systems to be able to keep up with it all.”
