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Bioethical and legal issues in 3D bioprinting
commercialization of the human body or its uteruses is not directly related to the threat of
individual parts . Bioprinted human organs life, but to perceptions of the quality of life.
[41]
have objective features that distinguish them from Gonadotoxic oncological treatment can result
human organs. Biofabricated organs are created in primary ovarian insufficiency in women of
artificially, and the creative process is purposeful reproductive age. Therefore, different methods of
and controlled. They are formed outside of the fertility preservation (such as oocytes, embryos,
human body and there are no significant risks and ovarian tissue cryopreservation) have been
to life and health of the cell donor during the developed . Unfortunately, there are currently
[50]
biofabrication of artificial organs. Moreover, the no options for fertility restoration after remission
informed consent concerns only the production for the group of patients with ovarian cancer or
of biological material, but not biofabrication of types of cancer metastasizing into the ovaries
the organ itself . These particular traits of 3D (such as leukemia, neuroblastoma, and Burkitt
[47]
bioprinted organs before their transplantation to lymphoma) . After the ovariectomy or the
[16]
the human body might allow them to relate to gonadotoxic oncological treatment, these patients
objects of civil rights. As a result, the assumption suffer from irretrievable loss of reproductive and
of limited commercialization of the creation ovarian endocrine function. The development of
and utilization of biofabricated organs might artificial ovary technology gives hope to this group
be permitted . However, after implantation of of patients for fertility preservation and the birth
[47]
organs and tissues, they should be recognized as of genetically-related children. Such technology
an integral part of a human body. Therefore, it is currently under development, and the first
is necessary to recognize the legal death of this successful animal experiments are known .
[9]
organ as an object with the termination of the Human clinical trials are still far away, however
title of ownership and with the corresponding at this stage of technology development, it is of
prohibitions and restrictions on their removal and high importance to identify and solve several
subsequent sale, which exist with regard to the important ethical and regulatory issues associated
human biomaterial today . with artificial ovary 3D bioprinting.
[46]
The scope of legal regulation of 3D bioprinting Along with the ethical and legal issues of 3D
action also includes a wide range of intellectual bioprinting technologies discussed above, the
property rights, including patents, copyrights, bioprinted ovary project addresses issues related
design rights, and trademarks. Government to human reproduction. First and foremost, the
intervention in research and new technologies major ethical issue related to the development of a
development is essential because it will determine 3D bioprinted ovary project is the question of the
the future of technology. The political resolutions risk-benefit ratio. Ovariectomy and gonadotoxic
must be determined and corresponded normative chemo- and radio-therapies, as oncological
issues must be addressed at the earliest stages treatments are necessary procedures for patient’s
of technological development. 3D bioprinting life preservation and therefore can be considered as
technology can save lives and revolutionize the the good. However, loss of reproductive function
medical sphere. Therefore, it deserves special is a harm, and if there is an opportunity to correct
attention and development of an appropriate legal it following the principle of primum non nocere
framework . and restore reproductive function, then it will be
[49]
2.3 Ethical issues of artificial ovary 3D possible to compensate for the caused harm. It is
bioprinting and introduction into clinical a strong argument in favor of developing artificial
practice ovary technology, but a number of profound
conditions should be taken into consideration.
Among organ bioprinting, biofabrication of The risks associated with transplantation of
reproductive organs stay apart as the need for 3D printed artificial ovaries should be clinically
transplantation of artificial ovaries, testes, and assessed as minimal. Therefore, all the possible

12 International Journal of Bioprinting (2020)–Volume 6, Issue 3