Regulations for 3D Bioprinting


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Printing an organ for transplant seems like something from a futuristic movie but the reality of this is a lot closer than expected. The concept of 3D printers has been around for decades, particularly in engineering fields, however, the extent of their potential in the medical field, is now being realised and the opportunities they can provide are vast. The manufacture of orthopaedic devices matched specifically to an individual patient, 3D printed bones for reconstructive surgery planning, and custom 3D printing for hearing aid and dental industries are just a few applications of 3D printing which have been used to improve the lives of patients. The next step is not only to improve the standard of life of patients but to save lives. Printing cells in a bioink scaffold which will ultimately lead to production of an organ which can be transplanted into a human body without having to wait for a donor could save precious time which some may not have.

The theory, and the goal that many 3D bioprinting researchers are working towards, is that from a simple cell biopsy (e.g. from the patients themselves), these cells can be proliferated and printed into the appropriate shape within a bioink, and allowing this bioprinted tissue to grow will produce a perfectly matched organ. Whilst researchers continue to develop bioprinting technology and address the challenges of how to print complicated and intricate architecture required to ensure appropriate blood supply and oxygen levels through printed tissues, it is important to consider but what are the regulatory implications, when this theory becomes in reality?

The U.S Food and Drug Administration (FDA) would appear to be the right agency to regulate 3D printed organs as its mission “to promote and protect the public health.” explicitly applies to regulation of “cellular and tissue-based products. However, it is yet to decide on appropriate regulations which cover a manufactured organ rather than a human organ. There are many complex points to be considered as a printed organ used for transplant is not entirely comparable to one single procedure or device currently regulated such as drugs, biological products, and medical devices. A human organ according to US Dictionary Act is “born alive at any stage of development”, this does not accurately describe a manufactured organ which would be grown from manipulated human cells to produce a completely new organ. Furthermore, the printed organ transplant process would also be much less invasive with no significant detrimental effect on the donor (indeed the cell donor could be the patient themselves). This difference would also suggest human and 3D printed organs are treated differently.  Taking a different perspective, a 3D printed organ could be regulated in comparison to a drug. Whilst it does seem strange to parallel an organ with a drug, the printed organ’s intended use matches that of a drug; a drug is taken to allow a person with an illness to live a better standard of life or cure the illness completely, this would be the purpose of a 3D printed organ to potentially cure a critical illness. It has also been proposed that 3D printed organs should be regulated as a “biological product,” with these products being defined as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein or analogous product, . . . applicable to the prevention, treatment, or cure of a disease or condition of human beings.” From this list, it is the term protein that must be considered, In order to print human cells and enable these to develop into a transplantable printed organ, matrices, culture media, and bioinks will be involved which will contain proteins. Thus it seems logical that such printed organs would fall within the scope of biological products. On the other hand, 3D printed organs could not be regulated as a medical device since the organ would have a chemical action within the human body with the intention of replacing a malfunctioning organ. Medical devices are generally not made of biological material, they could be metal or plastic implants or devices that aid in the recovery or standard of life of a person.

It seems that 3D printed organs could be covered by multiple regulations due to the complexity of the applications it could be used for. And whilst the existing regulatory framework could not predict such a disruptive technology, it seems that the basis for a framework to support 3D bioprinting does exist. Like organ printing technology itself in which very little is instinctive, its regulation will be equally complex. Could the FDA compile a new regulation to cover the use of printed organs for transplant if it became a widely routine procedure, or will it be covered by one or more of the regulations already in place? As the industry looks to address to the scientific challenges associated with progressing organ printing in the lab, it must also start to address these regulatory questions for when the theory becomes a reality.

 

Source: Kelly E (2018) FDA regulation of 3D-printed organs and associated ethical challenges. Univ PA Law Rev 166:515–545

 

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