At a time when new technologies are developing at an extremely fast pace, legal regulations do not always keep pace with them. It is no different with 3D printing – relatively recently the FDA spoke on the issue of certification of 3D printed medical devices. A year later, the Food and Drug Administration donated $2.6 million for research into biomedical 3D printing applications. At the same time ensured that wants to systematize issues related to one of the most popular recently development paths of modern medicine – bioprinting. However, has the FDA already taken steps to establish legal regulations for this field of science?

The development of 3D printing technology is so dynamic that it generates more and more questions about laws and regulations. In their article, intellectual law professor Dinusha Mendis and Ana Santos Rutschman discussed the legal regulations in the world of 3D printing.

For anyone interested in detailed information on 3D bioprint, we encourage you to read the article about basics of this amazing technology:

The potential of bioprinting technology is currently being explored mainly in scientific centers dealing with cellular engineering, but it is a matter of time when the treatment of biosamed tissue will become a practice. It is still unclear, however, what legal regulations will be necessary in the near future for the use of bioprinted cell therapy. Can it be the letters of law that make it difficult and postpone access to solutions in the field of 3D printing…?

The law is not keeping pace with technological progress in the field of biology, which can be problematic both for potential recipients and producers of materials or devices. We are currently at the stage when scientists are beginning to present openly the results of their research on the first 3D-printed organs or functional tissues. However, their use for clinical applications requires time, however, to prove the safety of this promising treatment method.

As the authors of the article emphasize, creating cellular structures is not a complete innovation, however, in combination with the 3D printing method, it requires a completely new approach from the legal point of view. And by following the history of the 3D printing method (which dates back to the beginning of the 21st century), it’s easy to notice exponential growth trends. This means that 3D-printed organs are closer than we might think.

And while technological obstacles are no longer a major obstacle, the development of bioengineering raises new ethical dilemmas. The more you know about 3D biography, the harder it is to find simple conclusions and unambiguous answers. The article reads that regulators will have a number of difficult problems to solve. Should already existing legal regulations regarding personalized cell therapies be adapted for the biofabrication method or create them from scratch? Going further how to qualify the tissue created in this way. Should the 3D printed organ be treated as a medical device (like a prosthesis), living tissue or a product that you can buy when you need it…?

The granting of patents in this field is another matter. The article cites the example of a cloned sheep Dolly, where the court concluded that this process could not be patented because its result is an identical copy of a live animal. Earlier, in the eighties, the legal position on the patenting of biology discoveries was clear – a “natural product” can only be patented if it “has clearly different characteristics from any other in nature.”

3D biodegradation is similar to cloning when it comes to creating tissue from cells, which is why patents on issues other than technological or hardware solutions can be problematic. Currently, the University of Bournemouth is conducting research, funded by the European Commission, which aims to develop a set of legal guidelines on issues related to intellectual property and regulations regarding the above issues. Their results should be available soon.

So far, legal action on such issues is not at an advanced level. The FDA (Food and Drug Administration) spoke on the issue of certification of spatially printed medical devices, but did not devote space to bioprinting. The prepared document is a preliminary analysis of the technology and available materials, which in the future is to lead to the establishment of uniform legal regulations for additive technology products. However, they are not legal regulations.

Bioprinting has a chance to become a solution to the shortage of available organs intended for transplantation, however, everything depends on standardized legislation in this field. The FDA wants to systematize issues related to one of the most popular recent development paths for modern medicine – bioprinting. According to specialists, it is necessary to review the regulations on biological, cellular and tissue products. However, this requires further expenditure of time, which distances the perspective of the availability of 3D printed tissues and organs…

Photo: Joint Base Lewis McChord on / CC BY-NC-SA

Magdalena Przychodniak
Editor-in-Chief of the 3D Printing Center. A biomedical engineer following the latest reports on bioprinting and 3D printing in modern medicine.

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