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Kirillova, et al.
acceptable and safe for the patients. The efficiency somatic cell therapies and tissue engineered
and safety of the custom-made organs cannot be products are called advanced therapy medicinal
tested on other individuals; therefore, in this products (ATMPs) . The principles developed in
[44]
respect; each patient becomes the first examinee. the ATMPs Regulations of the EC might be applied
Consequently, the question arises of the ratio of to different stages of 3D bioprinting production.
risks to benefits, criteria of inclusion, for instance, The key aspects of bioprinting management include
the participation of terminally ill patients in the risks regulation and responsibility for product
experiments. quality . In this regard, the following issues may
[45]
Another issue concerning clinical studies of 3D be very important: Who is primarily responsible
bioprinting-assisted treatments is the question of for the quality of bioprinted products – the 3D
study termination by a participant. Unlike standard bioprinting providers or medical organizations;
clinical trials, for example, when drug dosage can who should be responsible for quality control;
be gradually adjusted, patients involved in a 3D who should be liable in case of bioprinted organ
printing trial may have difficulties with exercising quality claims from the recipient; etc.
their right to withdraw from the trial after Legal problems of creation and use of
implantation of an artificial organ. Interventions bioprinting human organs, discussion of a
in 3D bioprinting treatments might be limited in possible model of legal regulation of bioprinting
terms of procedure reversibility (removal of the technologies received special consideration in
implant and all cells that have grown out of it) Russia [41,46,47] . The absence of norms in Russian
and the attempts of reverse implantation might legislation that regulates in the area of creation
lead to further harm to patients. Most importantly, and implantation of bioprinted human organs is
a patient might lose a chance for an alternative proposed to be a deterrent factor of 3D bioprinting
treatment due to participation in a bioprinting technologies development . Current revision of
[41]
trial . the Federal law dated 23.06.2016 No. 180-FZ “On
[24]
biomedical cellular products” for the time being
2.2 Legal issues of 3D bioprinting and cannot regulate the utilization of biofabricated
introduction into clinical practice
human organ, as this law does not govern organ
Legal and government institutions around the transplantation issues. At the same time, the
world define the legal regulation of 3D bioprinting Law of the Russian Federation dated 22.12.1992
as a complex problem with no generally accepted No. 4180-1 “On human organs and (or) tissue
satisfactory solutions for addressing the potential transplantation” can neither regulate the use of
and uncertain risks of harm. The issues become 3D printed organs, as 3D bioprinted products are
even more exacerbated as numerous participants artificial [41,48] .
are involved in the production chain of At present, the relations between 3D bioprinting
bioprinting. Expertise from 3D model designers, providers, medical organizations, and patients can
medical professionals, lawyers, engineers, be settled down in the contract for works or medical
[46]
biologists, members of the ethical committee, services contract . Such types of contracts can
and insurance companies are necessary for multi- be used in case of personalized biofabrication of
stakeholder collaboration to form an acceptable organs or tissues for an individual order. However,
path for the bioprinting technology development if bioprinted organs are depersonalized, then the
and introduction into clinical practice. There sale-purchase agreement сan be applied .
[46]
is currently no sui generis regulatory regime It also seems permissible for some specialists
governing the entire bioprinting process, but there to “commercialize” the products in the field
is partial legislation concerning tissue engineering of bioprinting, as the final product of tissue
and regenerative medicine. engineering is so far from its original source
According to the European Commission (EC) (human biomaterial), that is, why the turnover
and European Medicines Agency gene therapies, of such products cannot be considered as

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