3D Bioprinting Ethics and Regulation – Part II, The Bad

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This is part two of a three-part series: 

  1. The Good: Ethical benefits of bioprinting
  2. The Bad: Ethical challenges of bioprinting
  3. The Unknown: Evolving regulatory landscape and policies relevant to bioprinting

 

Assumption:

One primary assumption making bioethical discussions relevant is that bioprinting (or broader concept of regenerative medicine) will work and will work soon (next five years). While it is hard to precisely predict when and what the first bioprinting product shows both technical and market success, the increasing research activities and investment inflow are good indicators that accelerated advancements in the field are in progress. [1] 

Why should Bioethics be seriously discussed?

 

From a practical perspective, bioethical issues will directly impact the functions and policies of existing regulatory bodies and future policies. The Healthcare industry is highly regulated, resulting from the intrinsic complexity of life, high potential for abuses, and grave consequences if not managed carefully. The possibility to fabricate living tissues for research and therapeutic endpoints, including tissue repair, replacement, and augmentation, brings up many new ethical questions and challenges with no clear established regulatory pathways.

Of course, even if there are existing regulatory processes, bad things will still happen. A few people will always break the law and regulations using emerging technologies. Some salient recent examples include 3D Printing firearms [3] and gene editing unborn children without proper consent [2]. Therefore, another good reason to discuss bioethics is to answer the question: 

How can we pick the right problems to solve to avoid future abuses of new technologies that could lead to humanity’s downfall?

I also don’t believe these discussions will cover all aspects of the discussion and welcome others to engage in online or offline conversations. 

A. Increase healthcare cost:

While there are a lot of cost-saving potentials discussed in the previous article, there is also a chance of increasing overall cost in healthcare. Like many new medical technologies, one potential outcome of newly available bio-printing treatment options, such as transplant organ, is being the victim of its own success. That is, increased demand as a result of the technical success can raise total healthcare cost. And when such demand outmatches supply, there is also a potential price increase, further exacerbating the potential cost crisis.

B. Worsen social stratification:

Since bio-printing is a complicated and thus expensive process, the initial offering in treatments will likely be expensive to the patients as well. Government and insurance reimbursement pathway is unclear for such technology since it usually takes a long period of time before clinical evidence demonstrates clear advantages over existing option. Although the reimbursement approval process for a certain procedure like transplantation can potentially be accelerated given the fatal outcome of not having an organ donation on time, the initial offering of the technology will likely benefit the “haves” rather than the “have nots”, once again increasing the gap of access between social and economic strata [4,5].

C.Ownership:

  • Ownership to bio-printed products

Since bio-printing utilized human stem cells, and thus genetic materials, the ownership of the final bio-printed product will likely be part of increasingly heated debate about the ownership of patient data, and in this case, patient’s cells. Potentially interested parties will include healthcare providers, researchers, biotechnology companies, and finally the patients. To avoid the potential pitfall of a “black market” for bio-fabricated organs, legal and medical professionals will likely have to work together to clarify the ethical standards in managing such assets to be fair to both the patients and other interested parties[4,6].

  • Ownership to intellectual property

Vermeulen, et al [4] has an in-depth discussion on the challenges surrounding establishing intellectual property framework around bio-printing. For one, it is still unclear if bioprinting should be considered a machine for medical purpose, and thus a patentable entity, or a non-patentable medical technique. That is, should the technology be treated as a profitable technology, or a skill for the future of medicine, or more likely, both. It is also a constant debate if granting patents stimulate or stifling innovation, and in this case, the result can potentially affect millions of lives more directly than in other industry.  Vermeulen, et al [4] suggests that a possible solution to such a dilemma includes involving both private and public sectors in creating and sharing research benefits.

  • Scope of bio-printing: Can anyone bio-print anything?

Although the starting point of bio-printing is to improve and save lives, bio-printing, like 3D-printing, is an enabling tool to create new biological entities. The “dual” nature of bio-printing was discussed in Gilbert, et al [6]. That is, with its obvious human benefits, applications aiming for human enhancement and even aiming at harming humans will also surface. Therefore, discussing what are acceptable bio-printing applications in addition to how to apply the technology will be important. That is, can anyone bio-printing anything? This concern is not without basis. With the conventional 3D printing becoming popular in the public domain, manufacturing firearm without regulation has been in the spotlight of media as well as heated debates. Similarly, with the large digital footprint, internet, current speed of information exchange, and more available desktop/garage compatible printing system, it is not inconceivable that one can not only manufacture firearm but also bio-fabricate organs for a black market, or even other unforeseeable but morbid bio-terrorism related products.

D. Unrealistic expectation: The hype

There is a mismatch between where bioprinting technology is scientifically and where the public is perceiving it to be. While bioprinting flat structures like skin and cartilage, and hollow tubular structures like blood vessels are more mature in technique, achieving whole organ printing, especially solid organ printing is facing many challenges. Scientists and companies alike typically cannot give a concrete timeframe on when there will be a commercially available transplantable tissue, not to mention a transplantable solid organ such as a kidney. More importantly, there has been no known bioprinted tissue that is implanted in humans to date to the authors’ knowledge. There are many technical hurdles that need to be addressed before full organ bioprinting can be achieved including vascularization, cell density, tissue maturation, tissue morphology, and stability over time. [4,6,7]

References:

  1. 3D Bioprinting Industry Worth $1.95 Billion by 2025 – Increasing Investments in Healthcare Applications, such as Model and Organ Prototyping & Production
  2. Chinese scientist who produced genetically altered babies sentenced to 3 years in jail
  3. A Loaded Issue 3D Printed Guns – The Current Situation 
  4. Vermeulen N, Haddow G, Seymour T, et al 3D bioprint me: a socioethical view of bioprinting human organs and tissues Journal of Medical Ethics 2017;43:618-624. http://jme.bmj.com/content/43/9/618
  5. Richard Adhikari   Bioprinting, Part 2 – The Ethical Conundrum  https://www.technewsworld.com/story/80205.html
  6. Gilbert, F., O’Connell, C.D., Mladenovska, T. et al. Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine Sci Eng Ethics (2017). https://doi-org.ucsf.idm.oclc.org/10.1007/s11948-017-9874-6   pp 1–19
  7. Hourd P1Medcalf N1Segal J2Williams DJ1. A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.https://dspace.lboro.ac.uk/dspace-jspui/bitstream/2134/18928/4/rme.15.52.pdf

Related Articles:

  1. Bio-printing Ethics and Regulation – Part I, The Good
  2. Relevant Recordings from 3DHEALS2020 including Legal and Regulatory Landscape for Healthcare 3D Printing, Bioprinting for Organogenesis, and Biofabrication Ecosystem. Recordings are on sale until September 2020.
  3. The Yellow Brick Road of 3D Bioprinting (Part 2): Soft Is Hard
  4. BIOPRINTING – An Introduction
  5. 3D Bioprinting in Space?
  6. Other articles on tissue engineering, bioprinting

 

 

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