Dutch Embryo Act under revision

The Dutch Embryo Act (2002) requires an evaluation to be sent to Parliament every five years. These reports, drawn up by teams of independent researchers, contain recommendations ranging from measures to improve compliance to adapting specific regulations. After previous reports in 2006 and 2012, the third was issued in early 2021. Its main focus was on whether the act was still adequate in the light of current scientific developments.

The report's recommendations include: a) revising the legal definition of 'embryo' in order to keep pace with the development of human embryo-like structures (ELS), b) lifting the ban on creating embryos for research, c) considering the need for and acceptability of increasing the 14-day limit to possibly 28 days, d) revising current provisions with regard to creating hybrids and chimaeras, and e) reconsidering the categorical ban on clinical germline genome editing. Here we summarise the report's discussion of the first issue and briefly indicate how it connects to the second.

Current definition

With predecessor bills from the early 1990s still containing a definition of an embryo as the result of fertilisation, the birth of cloned sheep Dolly in 1996 (see BioNews 1131) showed that this no longer sufficed as embryos could be created by somatic cell nuclear transfer (SCNT).

Some countries chose to expand their definition of an embryo, with fertilisation not being the only method of an embryo's creation. However, other countries, including the Netherlands, decided to switch to a developmental approach. This led to the current legal definition of an embryo: 'a cell or cluster of cells with the potential to grow into a human being'.

Too narrow and too wide

Before the act was passed, the definition was criticised for entailing a non-intended restriction: embryos with a known chromosomal or genetic defect that would render them non-viable are not embryos for legal purposes under the Dutch Embryo Act. As an illustration of why this was problematic, the 2006 first evaluation report referred to the 'altered nuclear transfer' (ANT) debate in the USA, where researchers had proposed to use a genetic modification step in order to create non-viable human SCNT products as a morally painless approach to what at the time was known as 'therapeutic cloning'. According to the report, whether human embryos that are non-viable still have (some degree of) moral status is an important ethical question that should not be pre-empted on the level of the definition.

Interestingly, the ANT precedent has recently been followed by the Dutch Government. Part of the funding for a large research programme on different forms of human ELS was explicitly reserved for the development of 'non-viable in vitro gametogenesis (IVG)-embryos', ie, human embryos created with the use of stem cell-derived gametes that have been genetically modified to ensure non-viability. The funding call refers to these as further 'embryo models' with the specific advantage of allowing research on fertilisation and post-fertilisation processes, stages too early to model with present-day ELS. As they would not be embryos in terms of the act, this would allow investing in research on early human development while keeping the ban on creating embryos for research in place.

In addition to being too narrow, the definition has also been criticised for being too wide. If the notion of 'potential' refers to what something can be changed into, then Dolly would seem to prove that any somatic cell should be regarded as an embryo in the sense of the Dutch legal definition. The state secretary has rejected this criticism by claiming that the term needed to be understood as referring to an 'intrinsic potential' that as such would not depend on the interference of advanced technology.

A structural problem

Even if a potentially-based definition can thus be maintained (which is not obvious), it is difficult to see how, in the ELS-era, it would allow us to differentiate between what is and is not an embryo in the sense of the act. According to the recent evaluation report, this reveals a structural problem with the present definition. How do we know which IVF products are embryos? A large proportion will fail to implant or will undergo developmental arrest at some stage during (early) pregnancy. Perhaps with some rephrasing, the definition may be read as referring to a category of cells or clusters of cells of which most instances are known to have the (intrinsic) potential to grow into a human being. The tacit acceptance of this interpretation may explain why the legal definition has not until now led to any problems for the practice of regulating embryo research.

Or perhaps the rephrasing might read: ...a category of which some instances are known to have this potential. This reasoning was followed by the national review committee for embryo research (CCMO) with regard to an informally submitted protocol involving the removal of one of the pronuclei from tripronuclear (3PN) embryos. Here the question was: do 3PN-embryos fall under the legal definition? If so, then using these was no different from research with other left-over IVF embryos, which is (under conditions) allowed under the act. If not, then the proposed intervention aimed at obtaining a normal 2PN configuration might amount to creating human embryos for research, something that the act forbids. The ruling was that as a 3PN-embryo may incidentally lead to the (premature) birth of a child, and notwithstanding the fact that in most cases these children die within a few days, 3PN-embryos were to be considered embryos in the sense of the act.

Whereas, in this ruling, the CCMO could refer to case reports on 3PN-embryos leading to live births, no such data are available, or expected to become available, on the developmental potential of (specific) human ELS. Interestingly, the same applies to human SCNT products. Still, since Dolly, these have always been considered human embryos in Dutch policy documents, even at the time when the possibility of creating them was still hypothetical. Here, of course, it was known that sheep and other animals had been born as a result of SCNT. But if that is taken as sufficient grounds for human SCNT-products to fall under the legal definition, this seems to presuppose yet a further rephrasing, allowing the relevant evidence for the meant potential to be obtained in other mammals at least. This would probably mean that as soon as offspring is generated from an animal ELS, relevantly similar human ELS would have to be considered embryos under the Dutch act (unless made non-viable by building in suicide genes).

Recommendations

As the evaluation report points out, the need for these tacit rephrasings only reveals the inadequacy of the definition. In fact, they rely on categorisations (IVF-products, 3PN IVF-products, SCNT-products, tetraploid complementation-products, integrated stem cell-based ELS, etc) that refer to how these constructs came into being or what type of cells they are composed of, rather than to what they may grow into. So far, the current definition parasitises on the origin-type definition that it was meant to replace.

The evaluation report recommends moving back to the latter type of definition and comes with a tentative proposal for this. This would then serve as a basis for specifying that ELS research aimed at modelling the organised development of an intact human embryo would need CCMO review and be subject to the corresponding application of the requirements of the Dutch Embryo Act. As the report insists, this presupposes that its recommendation to lift the current ban (actually a moratorium) on creating human embryos for research will also be followed, as the meant type of ELS research may otherwise fall under this ban.

As the Netherlands chose not to ratify the Oviedo Convention, it is not bound by that treaty's similar prohibition. However, the issue remains politically contested with a coalition of two liberal (VVD, D66) and two Christian parties (CDA, ChristenUnie). A recent report from the CDA's Scientific Institute suggests that allowing the creation of research embryos to avoid human suffering may become conceivable for this party, but it is doubtful whether the stricter ChristenUnie will also follow this path.

Reception

The Government's reaction to the report was in the coalition agreement of the new cabinet that took office last January. This announced a revision of the act in the present parliamentary period, including 'the adaptation of the definition of 'embryo' also in the light of the developments in the field of embryo-like structures'. However, a decision on lifting the ban on research embryos is again postponed. Whereas VVD and D66 will draft a revision bill on that issue, the coalition agreement makes clear that this will not be voted on during the present period. How this will play out and what this will mean for the future scope for human embryo and ELS research in the Netherlands, will have to be awaited.