Bioprinting: Ethical and societal implications

In a recent ASCB Post article in the “What’s it all about?” series, Amanda Haage explains developments in the recent field of 3D printing with biological materials (i.e., bioprinting). Although these methods are still being fine-tuned, the field holds tremendous promise in such areas as biology, pharmacology, and medicine. For example, one day scientists may be able to use bioprinting to manufacture artificial organs for patients who need life-saving organ transplants, and bioprinting may speed up the process of testing the safety of new drugs with little need for animal testing. However, as this field is still new and rapidly growing, it’s important for us as a society to have conversations now about how this technology will challenge our ethical and cultural ideals. As noted above by Haage and discussed at length in a recent review on social and ethical implication of bioprinting, the broader societal impacts of this field need to be better addressed now before the technology becomes more widespread. Although the ideas discussed below are far from comprehensive, here are three areas in the field of bioprinting where we will need to bridge the gap between science and humanity.

Reducing the demand for animal testing with “organs-on-a-chip”

This lung-on-a-chip serves as an accurate model of human lungs to test for drug safety and efficacy. Credit: Wyss Institute for Biologically Inspired Engineering, Harvard University

Although the ability to produce an entire organ by bioprinting is far off in the future, scientists are already producing smaller organoids and tissues in the lab, sometimes called “organs-on-a-chip.” These lab-produced organs-on-a-chip are already being used by several pharmaceutical and cosmetic companies (including L’Oréal, AstraZeneca, Sanofi, and Roche) to test the safety of new drugs and products on certain types of tissues (such as skin, nerves, and liver). These organs-on-a-chip allow researchers to quickly and reproducibly test many drugs or products at once, as well as reduce the need for animals to test the safety and toxicity of products. Although animal models are still necessary and invaluable for certain kinds of biomedical research, such as testing how diseases like cancer or dementia progress through the entire body, reducing the number of animals needed for earlier steps in the research process will be a win for the ethical use of animals in research. At the same time, scientists will need to carefully assess if “organs-on-a-chip” are as effective as animal models at predicting drug toxicities, since ensuring patient safety during new clinical trials should always be a top priority.

In December at the ASCB/EMBO Meeting, ASCB will release a white paper on organoids that will discuss the challenges and opportunities in this area of research.

Bioprinting organ transplants: Democratizing life-saving treatment or widening the gap of income inequality in medicine?

Although currently only a hypothetical scenario, bioprinting organs may revolutionize the field of organ transplants by significantly reducing huge costs and wait times. According to the National Foundation for Transplants, the current cost of transplanting an organ in the United States can easily surpass $500,000-$1,000,000, and certain insurance companies make patients prove they can pay 20% of the upfront costs before the transplant can occur. This total does not include post-transplant medications and medical care to prevent organ rejection, which costs tens of thousands of additional dollars per year. In addition, the average wait time for a suitable organ donor for most organ transplants ranges from six months to two years. As of now, the ability to print an entire functional organ is still many years or even decades away. However, as happens with all sectors of technology, it’s predicted that bioprinting will become cheaper, faster, and more widespread as time goes on. A printed organ that costs tens of thousands of dollars and could be produced in a few weeks would still be a huge leap for the field compared with the current costs of organ donation and would be a boon for the hundreds of thousands of patients in dire need of a transplant.

Pediatric patients, in particular, have the potential to hugely benefit from bioprinting technology. Children provide a unique challenge for transplant and biomedical device technologies because kids’ bodies are still growing and changing. For example, if a child receives an artificial heart valve, they may need multiple surgeries in the future to upgrade to a larger valve as they continue to grow. Bioprinting new tissues or organs for pediatric patients may allow for the new devices to grow with the child, reducing the need for multiple surgeries.

That being said, expensive personalized therapies such as bioprinting also pose the risk of widening the ever-growing socioeconomic gap in medical treatment. Widespread affordable accessibility has been a challenge with other cutting-edge and pricey therapies, such as gene therapy, cancer immunotherapy, and genomics-driven personalized medicine. 3D bioprinting runs the same risk of becoming accessible only to the very rich (or very well-insured) if we as a society don’t make a way for it to become widely available to anyone who needs it, not just for anyone who can afford it.

Intellectual property: Who owns and profits from a bioprinted product?

The process of producing a 3D bioprinted organ or tissue is incredibly complex and uses methods developed by many different people to turn an idea into a living, functional product. Although the field of 3D printing as a whole relies heavily on open-access data and designs, the question of who owns the results has legal and monetary implications in regards to regulation and patents even before bioprinted products are sold to patients. To strike a balance between full open-access for patients to promote accessibility and restricted use with strong legal protections for companies to promote innovation, a recent law review proposed that we allow patents on the bioprinting process but not on the actual final products. “Organ-on-a-chip” technologies alone are projected to be worth about $60 million by 2022, and the field has the potential to become a multi-billion dollar industry, so deciding how to properly patent this technology could greatly influence how the field develops and how much access patients and consumers would have.

In addition, medical devices such as printed organs don’t fit easily into our existing system of clinical trials, so scientists may need to develop a new system of preclinical and clinical trials to test the safety in humans of bioprinting and other “open-access” devices. As technology improves, it’s likely that scientists will also develop more ways to customize bioprinted organs (such as using a patient’s own induced pluripotent stem cells to grow new tissue types), leading to even more challenges to the idea of who legally “owns” and profits from something that is printed with living material. Furthermore, if cells are taken from a donor instead of directly from the patient, protections will be needed to keep identifying genetic information private and to ensure proper informed consent from donors (i.e., that donors know exactly what their donated cells will be used for). Legal and economic questions like these won’t be answered by scientists alone, so collaborations between scientists, policymakers, lawyers, and more will be needed to fully address these issues.

Science is messy and complicated, not only because life itself is so incredibly complex, but also because science is inseparable from how we interact with it as a society. Bioprinting is a prime example of technology affecting humanity and vice versa. To fully harness the benefits of bioprinting, we need to have conversations now about when it is ethical and beneficial to use the technology and who really gains from it, both medically and economically.

The views and opinions expressed in this blog are the views of the author(s) and do not represent the official policy or position of ASCB.

About the Author: