What Is, or Should Be, the Legal Status of Brain Organoids?

Taupitz, Jochen

doi:10.1007/978-3-030-97641-5_5

Jochen Taupitz⁷

Part of the book series: Advances in Neuroethics ((AIN))

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Abstract

(Human) Brain organoids (cerebral organoids, brain models) are three-dimensional cell cultures that mimic the tissue organization and certain functional aspects of the brain. They promise substantial progress in research and therapy, not least because neurological and psychiatric diseases cannot usually be studied in animal models. Even if they are only cell clusters so far, further developments in tissue engineering will lead to them becoming more and more complex—perhaps even to the development of (pain) sensation or even beyond. Internationally, there is a controversial discussion whether potentially sentient or even (self-)conscious cerebral organoids should also be granted the same rights as human or at least animal research subjects. This question will be examined from the perspective of German law.

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Notes

1.
See Taupitz (2020a), 806 ff.
2.
See Taupitz (2020a), 810 ff.
3.
On the ethical and legal issues surrounding transplantation of human brain cells or brain organoids into animals, see Chen et al. (2019), 462 ff.; Hyun et al. (2020, p. 4); Schicktanz (2020), 203 ff.; Ethikrat (2011), in particular 110 ff.; National Academies (2021, p. 67 ff.); Taupitz and Weschka (2009).
4.
On this discussion, see, inter alia, Ethikrat (2010).
5.
Specifically on brain organoids Farahany et al. (2018) 431 f.; Boers et al. (2016), 939 f.; Cepelevicz (2020); Hyun et al. (2020), 2 f.; Jácomo (2020, p. 7); Schicktanz (2020, p. 198); Taupitz (2020a, p. 807); Taupitz (2020b, p. 212, 217).
6.
In contrast, the TPG is generally not applicable to the handling of those cells and their possible subsequent transfer to other people, see Taupitz (2020a) 810 f.
7.
Taupitz (2020a) 811 f.
8.
Viciano (2020); Parsch (2019b); see also Lavazza and Massimini (2018, p. 606): “brain in a vat”; Lavazza (2021, p. 6).
9.
Bitar (2020). On philosophical zombies, see Kirk (2009).
10.
Critical Schicktanz (2020) 194 f.—Lavazza and Massimini 2018, p. 606) on the other hand, speak openly of a thought experiment that is now becoming a laboratory experiment.
11.
Kuroczik (2018)
12.
Kurlemann (2013) and Goodall (2020).
13.
Müller-Jung (2013).
14.
Hufen (2001, p. 442).
15.
For this and the following Taupitz (2002) 23 f.
16.
BVerfGE 141, 143 (169); 128, 1 (41); 122 89 (107).
17.
Goodall (2020).
18.
Lavazza and Pizzetti (2020, p. 10). For the argumentative reference to brain death, see infra at footnote 28.
19.
Bayne et al. (2020, p. 14).
20.
On the controversial question of the relevance of (more or less) developed consciousness for the attribution of a special moral status, see Lavazza (2021, p. 6). Moreover, a problem results from the fact that there is so far no unanimous understanding of consciousness shared between neuroscience and philosophy/jurisprudence and even within sciences different concepts exist, see Schicktanz (2020) 200 f.; Bartfeld et al. (2020), 25 f.; Bayne et al. (2020, p. 13); Sharma et al. (2020) 49 f.; Singer (2019); Baars and Franklin (2007).
21.
Koplin and Savulescu (2019, p. 764).
22.
Sass (1989, pp. 160–191); Bartfeld et al. (2020p. 19); for further references, see Müller-Terpitz (2008, pp. 182–186); see further on different approaches Koplin and Savulescu (2019, p. 762).
23.
After all, researchers claim that they have already succeeded in keeping brain organoids alive for 10 months and measuring EEG signals. These are said to have reached a complexity similar to that of premature babies in the 28th week of gestationTrujillo et al. (2019). However, the comparison with brain activities of premature infants is rejected by other researchers as too broad, cf. Parsch (2019a); Cepelevicz (2020).
24.
On this argument, Lavazza and Pizzetti (2020) 8 ff.
25.
On the dissemination of the 14-day rule, see Matthews and Moralí (2020).
26.
However, according to recent findings, not functional neural connections or sensory system exist in the embryo at least until day 28, see Hurlbut et al (2017); Appleby and Bredenoord (2018, p. 2).
27.
Hostiuc et al. (2019, p. 119); Cepelevicz (2020); Matthews et al. (2021, p. 47, 49); McCully (2021, p.1); Lavazza (2021, p. 3) with further references. However, other authors deny that the 14-day rule was intended to be a line denoting the onset of moral status in human embryos. Rather, it is a public-policy tool designed to carve out a space for scientific inquiry and simultaneously show respect for the diverse views on human-embryo research: Huyn et al. (2021, p. 998); Hyun et al. (2016, p. 170); Cavaliere (2017, p. 3 f.); Chan (2018, p. 229); for further references, see Matthews et al. (2021, p. 48).
28.
The (German) Federal Constitutional Court, for example, also considers the caesura on the 14th day of development to be relevant, see BVerfGE 39, 1 ff. para 133: “Life in the sense of the historical existence of a human individual exists, according to established biological-physiological knowledge, at any rate from the 14th day after conception (nidation, individuation).”
29.
The ability to feel pain is generally considered to be a feature of consciousness, see Bitar (2020).
30.
Of this opinion is, in fact, Hostiuc et al. (2019, pp. 119–121); Bitar (2020); further references in Jácomo (2020, p. 7); see also Greely, cited by Cepelevicz (2020): “… the more human … [the brain organoid] gets, the more you’re backing into the same sorts of ethics questions that are the reasons why you can’t just use living humans”. At the same time, not least in view of research with brain organoids, there is a call to extend the 14-day rule, e.g., to 28 days, see Appleby and Bredenoord (2018).
31.
Sec. 2 (1) ESchG prohibits the use of an embryo “for a purpose not serving its preservation”.
32.
On the dispute as to whether entities not created by fertilization fall within the definition of “embryo,” see Taupitz (2014a) paras. 48 ff.; Dederer (2020b), 55 ff.; Gassner and Opper (2020, p 260 f., 272 f.).
33.
Since the brain organoids are not created by fertilization, the provisions of the ESchG, which prohibit the use of oocytes for purposes other than the establishment of a pregnancy (§ 1 (1) (2), (2) ESchG), are not relevant.
34.
It is very controversial to what extent it depends on the way of production of the corresponding entity for the applicability of the cloning prohibition, see Günther (2014) paras. 3 ff.; Taupitz (2014a) paras. 48 ff.; Gassner and Opper (2020, p 260 f., 272 f.).
35.
Faltus (2021, p. 133).
36.
Schicktanz (2020, p. 200); Koplin and Savulescu (2019, p. 762). Since the potentiality argument, together with the species argument, the continuity argument, and the identity argument (“SCIP”), is widely believed to justify the special moral and legal status of the embryo (see the references in Müller-Terpitz (2008, pp. 49–65), the converse must also apply: entities that do not have this potential cannot enjoy comparable protection. Hostiuc et al. (2019, p. 120) consider the lack of potential for wholeness irrelevant.
37.
In this sense also Dederer (2020a, p. 43): “What is clear at this point ... is that brain organoids are not to be classified as human beings”; see also National Academies (2021, p. 96); Huyn, cited by Gogol (2018): “An organoid is not a human subject, according to federal regulations.”
38.
Taupitz (2014b) B. I. para. 5 with many references; see also BVerfGE 39, 1 (45): “The legislature is in principle not obliged to take the same measures of a penal nature for the protection of unborn life as it considers expedient and necessary for the protection of born life.” The legislature therefore has a wide scope of action with regard to the protection of embryos, cf. Dreier (2013) para 114; Dederer (2020b, p. 61).
39.
Lavazza and Pizzetti (2020, p. 7); see also Koplin and Savulescu (2019, p. 764).
40.
Cf. on such aspects for the assessment of artificially created entities Taupitz (2001, p. 3440); similar later Ethikrat (2011, p. 100); Gassner and Opper (2020, p 260 f., 272 f.); further references to corresponding considerations in the Anglo-Saxon literature with regard to the moral status of early embryos in Hostiuc et al. (2019, p. 119).
41.
On the significance of likeness for the recognition of an entity as a “human being” in the sense of the human dignity guarantee Dederer (2020b, p. 66, 74).
42.
Koplin and Savulescu (2019, p. 761); Hyun et al. (2020, p. 5). But see Lavazza (2020, p. 117): “In fact, they are neither physically autonomous nor able to give rise to an adult human being.Yet the brain is the key organ of the person, the one from which one can deduce the presence of life in a person and which, if conscious, even though in a dish, should be considered a person, with increasing moral value the greater its consciousness.” Slightly different however ibid. (123): “This characteristic of cerebral organoids makes them morally special, even though they cannot be considered persons in the full sense.”
43.
For attempts to generate modularly assembled organoid systems, see Marton and Pasca (2019); Bagley et al. (2017).
44.
For attempts to generate vascularized organoids, see Shou et al. (2020).
45.
Chen et al. (2019) 463 f. This is one of the reasons why the transfer to animals is so interesting for researchers.
46.
See above at footnote 24.
47.
Cf. Koplin and Savulescu (2019, p. 762, 764); therefore, the brain-life criterion is not convincing as a normative starting point for the beginning of the (embryonic) protection of life, cf. Müller-Terpitz (2008, pp. 184–186).
48.
Ethikrat (2015, p. 73).
49.
Ethikrat (2015, p. 73).
50.
Ethikrat (2015p. 68).
51.
In this direction also Lavazza and Pizzetti (2020 10 ff.; Koplin and Savulescu (2019, p. 762).
52.
Faltus (2021, p. 133).
53.
But see Lavazza (2020, p. 116): brain organoids “are human by definition, as they come from human cells, and this biological affiliation could grant them a moral status.” Against a “species-centric” argumentation Schicktanz (2020, p. 199).
54.
Roidis-Schnorrenberg (2016, p. 56); Roth (2009, p. 65).
55.
In other jurisdictions, this is partly seen differently, cf. Boers et al. (2016, p. 938): “human tissue is neither a person nor a thing.”
56.
Detailed description by Schreiber (2019) 25 ff.; see also CJEU, C-377/98, Netherlands v Parliament and Council, ECLI:EU:C:2001:523, para. 73: “Thus … an element of the human body may be part of a product which is patentable but it may not, in its natural environment, be appropriated” (emphasis by author).
57.
The controversial question of how the emergence of ownership at the time of separation from the body can be substantiated does not need to be addressed here, cf. Schreiber (2019) 41 ff.; for the international discussion, see for example the references in Boers et al. (2016).
58.
“A person who, by processing or transformation of one or more substances, creates a new movable thing acquires the ownership of the new thing, except where the value of the processing or the transformation is substantially less than the value of the substance. Processing also includes writing, drawing, painting, printing, engraving or a similar processing of the surface.”
59.
Who acquires ownership of the bodily substances at the time of separation from the body is disputed, see Schreiber (2019) 42 ff.
60.
Cf. Schreiber (2019, p. 322); Ehrlich (2000) 57 ff.; Zech (2007) 99 ff.
61.
Schröder and Taupitz (1991) 42 ff.; for a detailed overview of the nuanced differences of opinion, see Schreiber (2019) 41 ff.
62.
See Taupitz (1991) 209 f.
63.
On the following, with references, Taupitz (1991, pp. 210–211); Schröder and Taupitz (1991, pp. 43–44).
64.
Taupitz (2020a, p. 808); Taupitz (2020b, pp. 216–217) with further references.
65.
Taupitz (2020a, p. 808); Taupitz (2020b, p. 217). The possibility of a veto (which exists anyway according to general principles) is demanded by Farahany and et al. (2018) 431 f.; Schicktanz (2020, p. 198). The particularities of the use of cells by minors cannot be discussed in this article.
66.
Version of 2018, https://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/pdf-Ordner/MBO/MBO-AE.pdf
67.
Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin, https://search.coe.int/cm/Pages/result_details.aspx?ObjectID=090000168064e8ff
68.
Taupitz (2020a, p. 813); Taupitz (2020b), 229 f., 233.
69.
Dickert (1991, p. 373).
70.
Cf. Häberle (2020) para. 2.
71.
Baumann and Kügele (2020) para. 1
72.
More detailed Gerke (2020, p. 295); Taupitz (2020a) 810 f.
73.
Taupitz (2020a) 811 f.
74.
More detailed Scholz and Middel (2018) paras. 13 et seq.; on the inapplicability of the prohibition of trafficking to substantially engineered tissues such as induced pluripotent stem cells and products derived therefrom also Harder (2020, p. 170).
75.
The same applies to the prohibition of financial gain in Art. 21 of the Human Rights Convention on Biomedicine of the Council of Europe, which will be presented below, cf. Harder (2020, p. 164).
76.
“In the fields of medicine and biology, the following must be respected in particular: […] - the prohibition on making the human body and its parts as such a source of financial gain, ….”
77.
“Prohibition of financial gain: The human body and its parts shall not, as such, give rise to financial gain.” Art. 21 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, http://www.coe.int/de/web/conventions/search-on-treaties/-/conventions/rms/090000168007cf98
78.
“Prohibition of financial gain: Biological materials of human origin should not, as such, give rise to financial gain.” Art. 6 of the Recommendation CM/Rec(2016)6 of the Committee of Ministers to Member States on research on biological materials of human origin, https://search.coe.int/cm/Pages/result_details.aspx?ObjectID=090000168064e8ff
79.
See for example CJEU, C-377/98, Netherlands v Parliament and Council, ECLI:EU:C:2001:523, para. 77; Deutscher Bundestag (1996, p. 29); further references at Roidis-Schnorrenberg (2016) 80 ff., and Fröhlich (2012) 139 ff.
80.
See Zech (2007, p. 118); Schnorrenberg (2010, p. 236); Roidis-Schnorrenberg (2016) 113 f.; Taupitz (2000, p. 157); Fröhlich (2012, p. 161 and 208), with the indication that a violation of human dignity can be considered if the body substance is used with humiliating intent. However, this is not specific to the use of human body substances, but can also occur with other material (image, sound recording, etc.).
81.
Roidis-Schnorrenberg (2016) 113 f.; see also Halasz (2004) 122 f.
82.
See for example Borowski (2019) para. 46; Heselhaus (2017) para. 24; Breithaupt (2012) 40 ff., 59.
83.
Borowski (2019) para. 46; see also Kranz (2008) 183, according to which the prohibitions on commercialization are to be interpreted restrictively.
84.
On these bodily substances, see explicitly the Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, May 1997, para. 133, https://rm.coe.int/16800ccde5; concerning hair see also the Commentary of the Charter of fundamental rights of the European Union, June 2006, 40, https://sites.uclouvain.be/cridho/documents/Download.Rep/NetworkCommentaryFinal.pdf; see also Breithaupt (2012) 43 ff., 57, 59; Heselhaus (2017) para. 24.
85.
Taupitz (2017p. 357). For an extension of the exceptions listed in the official explanations (see previous footnote) to other bodily substances, see for instance Schwarzburg (2012) 184 f.
86.
Taupitz (1996), 7 f.
87.
Tag (2017) para. 3.
88.
Art. 51 (1) of the Charter; see also Jarass (2021a) para. 9.
89.
Jarass (2021b) para. 3; Augsberg (2015) para. 7; Roidis-Schnorrenberg (2016) 120 ff.; Fröhlich (2012) 176 with further references; different view: Heselhaus (2017) para. 20.
90.
About the convention in detail Taupitz (2002).
91.
Borowski (2019) para. 46; Heselhaus (2017) para. 24; Jarass (2021b) para. 16.
92.
Those who classify human bodily substances as data do not thereby at the same time deny their character as corporeal things in which ownership may exist.
93.
Büchner (2010) 123 f.
94.
Hoeren (2019); Determann (2018).
95.
Vossenkuhl (2013, p. 6), provided that the biological cell material is obtained from the outset for the purpose of obtaining information.
96.
See also Deutscher Bundestag (2008) 22 f.
97.
Accordingly, genetic data are personal data relating to the inherited or acquired genetic characteristics of a natural person which provide unique information about the physiology or health of that natural person and which have been obtained, in particular, from the analysis of a biological sample from the natural person concerned.
98.
Ziebarth (2018) para 8.
99.
Deutscher Bundestag (2008) 22 f.; Schreiber (2019) 102 f.
100.
Breyer (2004, p. 660).
101.
Schreiber (2019) 104 f.; Breithaupt (2012) 240 f.; Fink (2005, p. 60); Halasz (2004) 263 f.; Koch (2013, p. 117).
102.
Schreiber (2019) 106 f.
103.
For example, in order to be able to contact genetic relatives, e.g. in the case of dementia research with the source cells used, cf. Ooi et al. (2020, p. 450).
104.
According to some opinions, however, human genetic material is never anonymous, see (rejecting) Taupitz (2020c) 608 f.
105.
The European Parliament’s resolution of February 16, 2017, with recommendations to the Commission on Civil Law Rules on Robotics (2015/2103(INL)) called on the Commission to study the implications of “creating a specific legal status for robots” and “applying electronic personality to cases where robots make autonomous decisions or otherwise interact with third parties independently”, https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52017IP0051&from=DE
106.
Teubner (2018) 160 ff.; Zech (2020) A 95.
107.
Mühlböck and Taupitz (2021, p. 183).
108.
Koplin and Savulescu (2019) 763 f.; Lavazza (2021, p. 3, 6); Lavazza and Massimini (2018, p. 609).
109.
Mühlböck and Taupitz (2021, p. 214).
110.
Lavazza (2020, p. 107); regarding AI systems Mühlböck and Taupitz (2021, p. 215).
111.
See Faltus (2021, p. 133).
112.
Doerig et al. (2019); Lavazza (2021) 5 f.; Birch and Browning (2021, p. 5).
113.
Bayne et al. (2020) 11 ff; Lavazza (2020, p. 112, 114); Koplin and Savulescu (2019, p. 762); Singer (2019); Farahany and et al. (2018, p. 431); Lavazza and Massimini (2018, p. 608).
114.
Lavazza and Pizzetti (2020, p. 22): “… based on Italian law and European law as a superordinate system …, it must in fact be concluded that HCOs [human cerebral organoids] have no right to any special legal protection, as they do not fall into any category other than that of biological material …”.
115.
But see Kaulen (2018).
116.
Indeed, the international debate often calls for protection of brain organoids similar to that of animals, cf. Birch and Browning (2021, p. 6); Bitar (2020); Koplin and Savulescu (2019, p. 763; Sawai et al. (2019, p. 440) with further references.
117.
On this view Iltis et al. (2019, p. 11)
118.
DeGrazia (2008) 181 ff.; Lavazza (2020, p. 116); Lavazza (2021, p. 6); Koplin and Savulescu (2019, p. 764). Shepherd (2018, p. 15) describes the attribution of a moral status as “a kind of placeholder for attribution of reasons to regard and treat an entity in certain ways”. Similar Iltis et al. (2019, p. 9 with further references).
119.
Lavazza (2020, p. 123): “This characteristic of cerebral organoids makes them morally special, even though they cannot be considered persons in the full sense.” Cf. also Schicktanz (2020, p. 198).
120.
Koplin and Savulescu (2019, p. 760); Lavazza and Pizzetti (2020, p. 14, 22)S.
121.
Weiler (2020), Koplin and Savulescu (2019, p. 761, 765), Cepelevicz (2020) and Lange (2019).
122.
See above Footnote 8.
123.
Lunshof and Greely, cited by Cepelevicz (2020).
124.
Lavazza and Pizzetti (2020, p. 20).
125.
Jácomo (2020, p. 7); Bitar (2020).
126.
Bitar (2020); Lavazza (2021, p. 7); National Academies (2021, p. 97).
127.
Reardon (2020, p. 661) and Goodall (2020).
128.
See above 5.2.
129.
The application of the precautionary principle is required with respect to brain organoids by Birch and Browning (2021), 2 ff.
130.
Taupitz (2014b), B. III. para. 23.
131.
But differently Birch and Browning (2021, p. 3): “regulation is urgently needed”.
132.
Lavazza and Pizzetti (2020, p. 20); Koplin and Savulescu (2019, p. 763); National Academies (2021, p. 97).
133.
Lavazza and Massimini (2018, p. 607).
134.
Sidhaye and Knoblich (2021, p. 53); differentiating Schicktanz (2020) 196 f.
135.
Koplin and Savulescu (2019, p. 761); Farahany et al. (2018, p. 432). However, this warning would also have to cover guidelines of research self-control/self-restraint, as they are often demanded (as an alternative to legal regulations): Reardon (2020) 661; Koplin and Savulescu (2019, p. 761); Cepelevicz (2020); Chen et al. (2019, p. 463).
136.
If the researcher only has to obtain the advice of an ethics committee, he is not bound by the advice as a matter of law. This is different if—e.g. according to the Medicinal Products Act (AMG)—he must obtain approval before carrying out the research project.
137.
Munsie et al. (2017, p. 944); National Academies (2021, p. 99 ff.); on the constitutional requirements for the need to involve an ethics committee see Hufen (2017, p.1266 ff.).
138.
Skepticism as to whether existing local research ethics committees are competent enough to assist with Farahany et al. (2018, p. 432).

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Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim, Mannheim, Germany
Jochen Taupitz

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Taupitz, J. (2022). What Is, or Should Be, the Legal Status of Brain Organoids?. In: Dederer, HG., Hamburger, D. (eds) Brain Organoids in Research and Therapy. Advances in Neuroethics. Springer, Cham. https://doi.org/10.1007/978-3-030-97641-5_5

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