Debrief: Is LEO Where Regulation Is Not A Dirty Word?

ANTALYA, Turkey—There are few topics that unite aerospace and defense industry officials—or, frankly, industry officials of any ilk—as much as a loathing for regulations, particularly when it comes to new sectors where they are frequently blasted as barriers to innovation.

In some cases, though, the only thing worse than excessive regulation may be no regulation at all.

One example may be the emerging space economy, industry officials suggest, at least as it applies to certain areas. “I think regulation, while it may be a dirty word in a lot of places, it's something that, for those of us that have been executing experiments in space to date, that lack of regulation is the impediment for some types of commercial sales,” Axiom Space CEO Jonathan Cirtain says.

In particular, he notes that there are uncertainties when it comes to pharmaceutical development. That field is seen as among the most promising for early low-Earth-orbit (LEO) research and development and potential production.

The U.S. Food and Drug Administration (FDA) regulates production of such processes in the U.S. under its Current Good Manufacturing Practice (CGMP) rules. But how that applies in space is uncertain.

“Is the FDA going to go to space and check out your current good manufacturing practices? I don't know how [they are] going to make sure that I'm following CGMP requirements, so that if I do manufacture drugs in space, that they can still meet the same standards in clinical trials here on Earth,” Cirtain said during this week's International Astronautical Congress (IAC) here.

Another uncertainty surfaces: What rules apply if Axiom hosts a foreign company’s production capability? Those of the U.S., or the country where the client is based?

“There's a lot of content around how commercialization of [LEO] economy and how regulatory bodies are going to oversee these things that I don't think is keeping up with the pace of the technology to actually build these things,” Cirtain said.

Another area where more, not fewer, rules would be helpful is when it comes to insurance, Starlab CEO Marshall Smith says. The insurance market for space is currently too small when considering the massive value of the orbital outpost that his company and rivals are talking about.

“The cost of that is just really prohibitive,” Smith said at the IAC. He suggested that if the government really wants to foster the industry, it needs to figure out how to indemnify companies or cost share. “I'll put that in the job jar for the government officials,” he said. It is a sentiment echoed by Randy Lillard, program manager for Blue Origin’s Orbital Reef outpost.

One more area where the rules of the road could use greater clarity, Cirtain said, is when it comes to what is happening in orbit, with thousands of spacecraft flying in LEO near where the outposts will be. “Throwing all those things into that orbit in an unregulated way internationally, I find to be a significant challenge,” he said.