Fate of 28-day embryo research proposal remains unclear following Dutch election 

On 22 November 2023, the Dutch Freedom Party won 37 seats in the 150-seat house of representatives, becoming the first Dutch party associated with the far right that has ever won more than 20 percent of the vote in a national election. Although innovation and more collaboration with industry were the key scientific topics during this round's election manifesto, the Dutch Embryo Act and the so-called 14-day limit have also become a significant election issue in the Netherlands.

Since 2002, the Dutch Embryo Act prohibits human embryos to develop outside the uterus for longer than 14 days. So far, this '14-day rule' has allowed research on unused embryos remaining after IVF procedures that are donated to science. However, given the recent technical advances in culturing embryos for 14 days, the Health Council of the Netherlands re-evaluated the Act and recommended doubling the limit to 28 days with the hope that more research will help prevent developmental diseases and treat infertility (BioNews 1214).

In addition to extending the 14-day rule in human embryos, this amendment to the Dutch Embryo Act also considers new scientific approaches creating embryo-like structures (ELS), which is an alternative term for stem-cell-based embryo models (SCBEMs) (see BioNews 1195, 1196 and 1206). ELS are derived from stem cells and can mimic important aspects of a human embryo.

According to the Dutch Embryo Act, an 'embryo' is defined as 'a cell or connected system of cells that has the capacity to develop into a human being'. Recent evaluations conducted by the Health Council's committee have concluded that the current legal definition may be inadequate and does not provide enough scope for determining what should and should not be regarded as an embryo in new areas of research, particularly considering ELS that closely mimic conventional embryos. As a result, the committee are of the opinion that the definition of the term embryo should be amended to one that is based on the embryo's origin, rather than on its potential to become a human being.

The Health Council launched a public consultation until Monday 4 December questioning whether the proposed amendments to the 14-day rule would guarantee sufficient research with embryos and ELS without hindering scientific progress. In addition, the public can react on whether the legal definition of an embryo should be adapted in order to protect some types of ELS in the same way as human embryos.

Among the six reactions published publicly in response to the consultation, the Dutch pro-life legal association Pro Vita and researchers at the Erasmus MC in Rotterdam have shared their concerns regarding the proposed amendments.

Pro Vita highlighted that the 28-day limit would go against the recognised Dutch legislator's principle of increasing protection of unborn life according to the duration of its development, the research group warned that long-term embryo research projects would be cut short as the new Act introduces statutory regulations, opening the way for different government compositions to rule embryo research by bypassing the States General of the Netherlands.

Additionally, both opinion letters note that some ELS types do not develop linearly as proposed in the newly proposed embryo definition, which could result in entities falling outside of the proposed definition regardless of their developmental potential. Furthermore, given that it remains unclear when to actually start counting the 14 days in relation to ELS, researchers at Erasmus MC propose to define a limit based on the formation of critical organ systems with clearly defined functionality.

Among the 26 political parties that participated in last week's Dutch general election, the Democrats 66 and the People's Party for Freedom and Democracy have proposed more freedom for human embryo research and are willing to adapt the Dutch Embryo Act such that human embryos can be created for research purposes, which is currently prohibited in the Netherlands.

The Farmer-Citizen Movement suggested to maintain the status quo but is of the opinion that two members of parliament should be assigned to debate these medical-ethical issues. In contrast, the New Social Contract and Christian Democratic Appeal would like to implement more restraint on the use of new techniques such as embryo selection, but have so far not verbally rejected human embryo research. Most parties, including the GreenLeft-Labour (GroenLinks/PvdA) party, who came second in the election, did not mention anything regarding human embryo research in their manifesto.

Multiple organisations in the Netherlands that align with the objectives of PET (the charity that publishes BioNews), such as NEMO Kennislink and the Rathenau Institute, have prompted more public dialogue in the Netherlands concerning embryo research and have published reports proving that citizens are not necessarily for or against. Interestingly, one recent DNA dialogue regarding germline modification found this technique – and the research into it – to be acceptable among the public while showing that participants without fundamental objections to embryo research or germline modification were not automatically in favour and often imposed strict conditions.

'[We] make no explicit recommendations in [our] reports. It's up to the politicians to make these choices, but they will need time and arguments to do so' said Sophie van Baalen, senior researcher at the Rathenau Institute, who is organising a collaborative session in the new year together with various political parties to find new approaches for assessing and implementing the output from these public dialogues.

Similarly, in the UK, the Governance of Stem-Cell-Based Embryo Models project – coordinated by Cambridge Reproduction, with input from PET – is currently addressing this very issue, developing a recommended governance framework for UK research involving SCBEMs (see BioNews 1194). As stated in a consultation response from the project earlier this year, such a framework will help to meet the need for greater clarity.

If the 28-day limit recommendation is to be implemented, the Netherlands would become the first country in the world to decide to extend the 14-day rule. It is important to note, however, that any amendment to the Dutch Embryo Act will require voting from both houses, which will in turn depend on the upcoming government composition.

One of the authors of the Dutch proposals to double the limit on human embryo research, from 14 days to 28 days, will give a presentation about these proposals at the 2023 PET Annual Conference – How Much Change Do We Want? Updating Fertility, Embryo and Surrogacy Law – taking place this coming Wednesday (6 December 2023).

Note that due to recently announced UK rail strikes, this conference is now taking place entirely online.

Find out more and register here.