The Health Council of the Netherlands has recommended that the 14-day rule for embryo research should be extended to a 28-day rule, as this could yield knowledge that helps to prevent developmental diseases and treat infertility.
The Dutch Embryo Act prohibits allowing human embryos to develop outside the uterus for longer than 14 days. This so-called '14-day rule' allows research on spare embryos remaining after IVF procedures that are donated to science. During the most recent evaluation of the Dutch Embryo Act, the question was raised of whether there are reasons to extend the 14-day rule and determine a new acceptable limit for research. The Health Council established a committee of experts to consider this question.
Writing in the report, the committee states: 'The committee believes that a limit of 28 days would meet the requirements of proportionality and subsidiarity, in view of the embryo's worthiness of being protected, the current legal ban on research between day 14 and day 28, the valuable information to be obtained from embryo research and the societal perspective.'
When the Dutch Embryo Act was originally introduced in 2002, it was not technically possible to culture human embryos for longer than seven days in the laboratory. However, advances in recent years have made it possible to culture embryos for 14 days (and potentially longer), therefore extending the possibilities for embryo research (see BioNews 850).
The committee concluded that it is difficult to identify a specific moment when embryo culture for research purposes ceases to be morally acceptable. Nonetheless, they recommended doubling the current limit to 28 days, because of knowledge that can only be acquired from studying human embryos up to this point. There is a knowledge gap between day 14 and day 28, when crucial processes such as organ formation are taking place, that cannot be investigated adequately using animal models or human cells. Congenital cardiac abnormalities and neural tube defects, which are common disorders among newborns, are thought to originate in this period of development.
The committee recommended applying the 28-day rule to 'embryo-like structures', which is an alternative term for stem-cell-based embryo models (SCBEMs) (see BioNews 1195, 1196 and 1206). In contrast to an actual human embryo, which results from the fusion of egg and sperm cells, SCBEMs are derived from stem cells.
To date, SCBEMs have not been regulated in the same way as actual human embryos in the Netherlands. According to the Dutch committee, however, 'integrated' SCBEMs – which contain, or can develop, extra-embryonic cell types – should be regarded as 'non-conventional embryos' under the Dutch Embryo Act, on the grounds that they have the potential to become a person (see BioNews 1150) or that at least this possibility cannot be ruled out. In the UK, by contrast, SCBEMs have so far been considered quite distinct from actual human embryos in law, and a project is currently underway that seeks to clarify any ambiguity on this point (see BioNews 1194).
The Dutch committee's report highlighted that scientific research after 14 days should serve a clear, evident, and justifiable interest, so as to maintain public trust and acceptance of embryo research. Additionally, human embryo research should only be allowed when no alternative method of fulfilling a research aim is available, and following a thorough review by the Dutch Central Committee on Research Involving Human Subjects.
Whether the committee's recommendation of a 28-day rule is accepted will depend in part on the composition of the government, following the Dutch general election on 22 November. Meanwhile, a public dialogue that showed openness to an extension of the 14-day rule (see BioNews 1213) and upcoming law reform proposals from the Human Fertilisation and Embryology Authority may inform future political discussion in the UK.
The 14-day rule, and the science and ethics of SCBEMs, will be the focus of presentations at the 2023 PET Annual Conference – How Much Change Do We Want? Updating Fertility, Embryo and Surrogacy Law – in central London on Wednesday 6 December 2023.
Find out more and register here.
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