In the 1970s, medical specialists made advances in in-vitro fertilization that leapfrogged laws and regulations. The same is true today for bioprinting human organs for transplant.
In an article, “3D Printing of Body Parts is Coming Fast—But Regulations are not Ready,” on The Conversation web site, Dinusha Mendis, professor of intellectual property and innovation law at Bournemouth University, Bournemouth, U.K., and Ana Santos Rutschman, assistant professor of law at Saint Louis University School of Law in St. Louis, called for clarity from regulators—including government agencies and lawmakers—on issues such as intellectual property, patentability, governing law, and classification by human health regulators.
If a bioprinted organ comes to market, “we’re not sure [what will] happen,” said Santos Rutschman in an interview. Mendis, who led a European Commission (EC) project on the intellectual property aspects of 3D printing, said in the interview, “What’s clear [with the EC] is that if something’s not leading to immediate failure or is not an immediate threat to the health sector, the question is, ‘Should they do something’?”
Mendis’ report is due for publication. While the United Kingdom recently left the European Union, it will be under the European Medicines Agency, the EU’s equivalent of the U.S. Food and Drug Administration (FDA), until Dec. 31.
With regulations, vaping is a useful parallel, said Santos Rutschman. FDA has regulated tobacco since 2009 but did nothing about vaping. “As a result, we have an epidemic [of vaping-related illness] in the U.S. and the FDA intervening by removing some flavors [of vaping liquid] from the market. We don’t want this happening.”
While the FDA may have miscalculated on vaping, it appears to have bioprinting covered. A spokeswoman for the FDA emailed a statement that, “If they (patient-matched devices) include biologics or living cells (combination products) or consist entirely of biological (cellular and tissue-based), they would be reviewed within the FDA’s Center for Biologics Evaluation and Research.” Also, the FDA’s 2017 “Technical Guidance for Additive Manufactured Devices” addresses patient confidentiality, process validation and other issues relative to bioprinting.
According to Jordan Miller, assistant professor of bioengineering at Rice University’s Brown School of Engineering, 3D biologics is new but the FDA has guidelines for it. Miller, whose pre-clinical research focuses on implantable vital organs such as the heart, liver, kidneys and pancreas, co-led development of a breakthrough technique for bioprinting vasculature for implantable organs. “You say to the FDA, ‘I want to do this study with these kinds of implants, we’re going to get this kind of data out, we’re going to certify it this way, would that be enough to get us to our next conversation about the design of clinical trials?’”
After his success with bioprinting a network of vessels to carry blood, air and other substances vital for life, Miller and his team are focused on implementing good manufacturing practices (GMP), enforced by the FDA, in their lab. “The level of complexity to get to good manufacturing practices is quite high,” and quite costly, Miller said. “Most people will start thinking about GMP production as they’re doing their pre-clinical studies, but generally won’t enact GMP practices because of the labor, cost and complexity involved until right before human studies.”