a look into the ethical, social, legal, and
economic framework behind bioprinting
1.
Deciding if the use and research of embryonic stem cells is murdering potential humans is a widely debated topic. Many believe that because embryos do not have sentient thought they can not be considered as human and therefore can ethically be experimented on. Organizations such as the National Stem Cell Foundation work to unite both sides of the argument and pave the future with ethical stem cell use.
2.
Whether or not we should use 3D printing for human enhancement is a pending issue in the bioprinting world. If the technology can be used to develop replacement organs and bones, couldn't it also be used to develop human capacities beyond what is normal for human beings? For example, should we consider replacing our existing bones with artificial ones that are stronger and more flexible, less likely to break; or improving muscle tissue so that it is more resilient and less likely to become fatigued, or implanting new lungs that oxygenate blood more efficiently, even in a more polluted environment?
The debate about human enhancement is familiar to the context of elite sport where athletes have sought to use medical technology to extend their speed, strength or endurance beyond what is 'natural', or what they are able to achieve without drugs or supplements. In that context use of performance enhancing drugs is considered to cheat other athletes, unbalancing the level playing field.
In the case of 3D bioprinting, enhancement of human capacities could be associated with the military use of the technology and the idea that it would be an advantage if our soldiers were less susceptible to being wounded, fatigued or harmed in battle. While it is clear that it would be preferable for military personnel to be less vulnerable to physical harm, the history of military technology suggests that 3D printing could lead to a new kind of battlefield. Increasing the defences that soldiers have in the face of battle would lead to increasing the destructive power of weapons to overcome those defences. And in so doing, increasing the harm to which civilians are exposed. In this way 3D printing may open up a new gap in the vulnerabilities of "enhanced" combatants and civilians, at a time when the traditional moral rules concerning warfare and legitimate targets is muddied by terrorism and insurgency.
1.
The scope of legal regulation of 3D bioprinting action also includes a wide range of intellectual property rights, including patents, copyrights, design rights, and trademarks. Government intervention in research and new technologies development is essential because it will determine the future of technology. The political resolutions must be determined and corresponded normative issues must be addressed at the earliest stages of technological development. 3D bioprinting technology can save lives and revolutionize the medical sphere. Therefore, it deserves special attention and development of an appropriate legal framework. The U.S. Food and Drug Administration (FDA) is the appropriate agency that regulates 3D-printed organs because a manufactured organ must be treated differently than a human organ, which can be transplanted as “simply” part of the practice of medicine. The FDA gathers sufficient data to satisfy premarket approval requirements, determine who gets access and when, and how to govern the marketing of 3D-printed organs because the output is individualized.
2.
The legal issues become even more exacerbated as numerous participants are involved in the production chain of bioprinting. Thus, a question of responsibility for the development and evaluation of the 3D models arises: who and to which extent shall be responsible for the translation of the anatomical image into digital - the designers, scientists, physicians, donors, or programmers? Who will have the legal rights for the model? Will it be possible to use the model without a patient’s consent? Is it possible to apply the models commercially?
1.
One major concern about the development of personalised medicine is the cost of treatments. Until recently it has been thought that advances in personalised medicine go hand-in-hand with increasing disparities in health between rich and poor. Should these treatments only be available to those who can pay the additional cost? If so, then those patients who lack financial resources may not receive effective treatments that others can access for a range of serious conditions.
The capacity to use 3D printing technology to substantially reduce the cost of prosthetics, or orthopaedic surgery to restore lost bone structures, means that this area of personalised medicine can avoid the criticism that personalised medicine inevitably increases the cost of healthcare and puts effective personalised treatments out of the reach of many patients.
2.
Prices for conventional transplants are extremely expensive, with costs frequently surpassing $800,000 for livers and single lungs, while heart transplants carry a price of over $1,000,000. Although still very expensive, on the cheaper side of organs is the pancreas, which typically costs around $400,000 to transplant. In contrast, bioprinted pancreases are expected to go for around $100,000.
3.
A negative stigmatism surrounds the personalized medicine industry. This is rooted in the fact that conventional methods rely on lengthy and expensive processes, traditionally only available for the wealthy upper classes. With the introduction of bioprinting, the costs of transplant organs and prosthetic limbs have dropped significantly, minimizing the gap in healthcare based on socioeconomic position. This price reduction also describes the economic effect of the bioprinting industry. Due to the severe risks of immune rejection of foreign tissue, many people are currently advocating for the establishment of a safe process for the patient before further research funds are spent on bioprinted organs or their printers.
Until recently, the cost and time required to provide a series of customised prostheses of different sizes for a child who has lost a leg to cancer, for example, has been prohibitive for many patients. 3D printing will bring down the time and cost of customising and producing prosthetic legs. In cases like that of Ben Chandler, printers can also be used for implants, which might avoid the need to amputate the original limb, even where significant bone loss has occurred.
