Work with embryonic stem cells – legal considerations

Constitutional law

From the outset, the revolution of the life sciences was accompanied by constitutional doubts. Some of them were well-founded, some rather erratic, some apparently lacked sufficient knowledge. In particular, the handling of human oocytes and embryos in scientific research was and still is fiercely contested, as standards of bioethics are directly connected with constitutional considerations and allude to abstract normative concepts of life or human dignity. The debates reached their peak about 20 years ago. Since then, the sometimes highly emotional struggles over the regulation of bio-medical research have abated but remain dormant under a seemingly calm surface of legal debates.

On the one hand, legal debates often suffer from over-abstraction, because arguments are made with rather lofty and vague concepts such as human dignity or potentiality of human life. The degree of abstraction then (at least, gradually) promotes moralization, which usually leads to bad legislation. On the other hand, law can also objectify debates because it reduces – often uninformed – moral disputes to questions of legality that relieve researchers of moral justification.

The main constitutional question was and is whether consumptive research on embryonic stem cells is compatible with human dignity, as enshrined in Article 1 para. 1 the German Constitution [Grundgesetz]: “Human dignity shall be inviolable. To respect and protect it shall be the duty of all state authority”. In its case law, the German Federal Constitutional Court has emphasized that human dignity is inherent to human life from its beginning to its end: “Where human life exists, it has human dignity; it is not decisive whether the bearer is aware of this dignity and knows how to preserve it himself. The potential abilities inherent in human existence from the beginning are sufficient to establish human dignity” [1]. In this context, the Court has already accorded human dignity to the fertilized oocyte, at least, after the nidation [2]. Constitutional protection is therefore not linked to current abilities, but to the potentiality to develop into a human being, a part of our species. The potentiality argument is based on human dignity and is therefore a legal-functional concept of protection, not a moralizing commitment. According to this rationale, embryos are not protected if they are not viable from the outset for reasons of developmental biology. This would be the case, for example, with a polyploid human embryo, whose protection could not fulfill any meaningful legal function. Whether human dignity also applies to oocytes that are fertilized in vitro and have, from the outset, no chance of growing into a human being has so far remained unresolved and controversial [3], [4], [5], [6]. Indirectly, the European Court of Justice seems to advocate a broad protection of human dignity, including the oocyte in vitro [7], but this is far from clear, too, because the Court did not directly address specific questions of constitutional status and fundamental rights of the Embryo, so far. If it were possible – following the example of animal experiments [8] – to grow human embryos outside the uterus, the question would take on a completely different urgency in a different context and would probably be answered in the affirmative with regard to the rationale to protect human life and its inherent dignity.

Thus, from a constitutional point of view, it is by no means clear that research with or on (embryonic) stem cells has to be prohibited under German law or whether the permissibility remains a political question, which has to be solved by parliamentary legislation. However, limits are set for research. I would like to outline a very short and very rough sketch of some basic considerations:

1. The planned creation of embryos for the purpose of using them as a resource for stem cell production turns human life into an object of extrinsic disposition and would be incompatible with human dignity. The violation of dignity does not simply lie in withholding a perspective on life that an embryo would not have in any case (notwithstanding the process of its natural or ‘artificial’ creation). Rather, dignity is violated when human embryos are produced for the benefit of others in order to use it as mere research material. You might well argue that life is a continuum: omnis cellula e cellula. From a legal point of view, it is not sufficient that any cell with human DNA is generated (this would also apply, e.g., to the haploid spermatozoon) or that human tissue is created (this is also the case, e.g., with an organoid). In each case, there is no need for protection. The decisive factor is rather that a potentially viable embryo is created. As a result, the state’s duty to protect human dignity, in principle, requires a strict prohibition of the fertilization of human oocytes to gain research or therapeutic material. It should be clarified that this is not a question of “naturalness” or romanticized “artlessness”. Whether a birth should take place vaginally or (“artificially”) in a test tube is not a question of the dignity of the embryo, but of technical feasibility. Naturalness has no inherent legal value. Nature can be cruel, human intervention can produce a humanity that we do not leave to nature. Human dignity does not preserve the course of nature, but is solely concerned with the instrumentality of appropriating human life for a specific purpose.

2. In contrast, there are no constitutionally valid reasons to prohibit the reprogramming of differentiated cells to obtain pluripotent cells. Mere biomaterial, even if gained from human cells and, thus, containing a complete set of human DNA, has not attributable dignity, which – at least – requires the potential to develop into a human living being. Even blastoids developed from reprogrammed cells are, as such, not bearers of human dignity without the potential to develop into a viable embryo. If it should be, one day, feasible to develop human embryos from blastoids in vitro, these questions might arise differently and must be addressed by the law (in one way or another). Legislators would then have to face the challenge of fundamentally revising its embryo protection legislation. However, it is perhaps one of the advantages of democratic legislation not to have to decide conflicts today that may only arise the day after tomorrow. The limits of technical feasibility in the present are also the limits of the need for regulation by law. This calls for regulatory modesty, which is particularly necessary in moralized subject areas.

3. The use of embryos, which were not created for research purposes but have no prospect of life from the outset, may be bioethically controversial. From a legal point of view, the mere utilization of tissue neither destroys human life nor makes it an object of disposal for altruistic benefit. Thus, a poor embryo tragically stranded somewhere in a culture dish doomed to die (or to be frozen forever) can be used for the benefit of scientific research, without violating its dignity. There should be, at least, no insurmountable constitutional concerns, using embryonic tissue from abortion or stillbirths to gain multipotent fetal stem cells. The general right of personality, as protected by Articles 2 para. 1 with 1 para. 1 of the German Constitution, might require parental consent of the mother, as the body of a dead fetus might be seen as still ‘belonging’ to the mother with regard to the personality dimension of the line of descent.

4. The use of existing stem cell lines for medical application to cure diseases is not only necessarily allowed, from a constitutional point of view. There may even be a state obligation to make available medical technology (e.g., for regenerative therapy), because the fundamental right to health provided by Article 2 para. 2 sentence 1 of the Constitution, also in conjunction with the prohibition against discriminating against the disabled (Article 3 para. 3 sentence 2 of the Constitution) triggers a responsibility to protect [9], [10], [11], [12], [13], [14] with regard to severe or even fatal diseases. There may be ethical considerations, as to how far medical cure should be utilized in a society. Nonetheless it would be hard to justify withholding existing therapies or bar scientific research developing cures. Whether a duty to protect exists by virtue of fundamental rights depends on many factors, in particular the severity of the disease, its treatability and its preventability. Constitutional obligations will generally not exist where diseases are typical consequences of lifestyle that can be more or less easily avoided elsewhere. It remains a political decision, however, to invest funds in appropriate research.

Administrative law

From this rough sketch of constitutional reservations, I would like to introduce the administrative frame work, regulating the research with human embryonic stem cells under German law.

Conclusions

For a law that should uphold bio-ethical principles, the Stem Cell Act established an irritatingly heavy-handed form of double standard. The inherent conflict that research freedom and embryo protection collide inevitably provokes tragic decisions that have unavoidable hardships one way or the other. Instead of coming to a reasoned decision here, legislation has just shifted the conflict abroad. Instead of deciding whether or not to accept the embryo in vitro as a bearer of human dignity and to draw consequences from this, the conflict is evaded. Domestic embryos receive the maximum protection, remaining ethically difficult conflicts must be decided for us by foreign legal systems, which we exploit by importing stem cells. Let others do the dirty work! Our scientists get a new approval procedure with the participation of an ethics committee, which further diffuses responsibility. A fundamental ethical conflict is simply bureaucratized. A solution that fits perfectly with the German way of life. What else could you expect?

Legislation is rarely consistent. And this is right in principle, because laws are not applied ethics, but political products of a compromise aiming at a practical conflict resolution. And, as a society, we do not want to have regulation of the Chinese type, thus, restrictions based on respect for human dignity and life will always be required. The regulation of the stem cell law, however, is made of such crooked wood that it is neither bioethically consistent nor reasonable from a practical point of view. Of course, a fundamental reform is not to be expected, because ultimately the whole regulation of embryo research depends on the question of the status of the embryo, which refers to human dignity. On the one hand, the close coupling of human dignity and biomedical research is, up to a certain degree, a German peculiarity. Active research nations such as the United Kingdom, the United States or Israel discuss comparable ethical issues, of course, but have not juridified them with comparable density. On the other hand, the German concept of human dignity has meanwhile found its way into the European catalog of fundamental rights (Article 1 of the European Charter of Fundamental Rights). Legalizing ethical issues in biomedicine is more likely to follow a common European trend, as the decision of the European Court of Justice in the Brüstle-case [7] vividly illustrates.

Research with embryonic cells unavoidably affects fundamental issues that are highly disputed both legally and ethically. The law is mostly a relatively inert subject, difficult to move, because political change usually occurs only when social interests are successfully politicized. That is not the case at present with regard to stem cell research. The chances that scientific progress will make the current stem cell law obsolete are higher than those that the legislator will adapt statutory legislation to the times. Not least, the reprogramming of differentiated stem cells has made rapid progress [24, 25], ultimately enabling stem cell research outside the regulatory framework of the Stem Cell Act. The fact that this renders the Stem Cell Act largely obsolete is not necessarily a shortcoming of the law. The law was never intended to prevent stem cell research, but only to protect embryos as the starting material for stem cell lines. From the outset, legislation was expected to catalyze research advances to make the restrictive regulatory framework obsolete. In order to accompany the rapid scientific research process, sometimes temporary legislation is sufficient.

Should ethical issues once again boil up as a socio-political topic, this need not be to the advantage of scientific research. “When scientific research interferes with politics, economics or culture, science is most often the loser” [26]. For the time being, we will have to live with the compromise of the Stem Cell Act. I am no bearer of glad tidings, but glad tidings are outside the purview of lawyers, anyway.