The Dutch Embryo Act at a crossroads

The Dutch Embryo Act has governed the handling of oocytes, sperm cells and embryos since 2002. Its primary purpose has always been to balance competing interests and values; notably respect for early human life and the advancement of biomedical science.

For more than two decades, few changes were made to this legal framework. However, the rapid emergence of stem-cell-based embryo models (SCBEMs) and scientific interest in early human development are now driving debate around multiple provisions of the Act.

Background: The 2021 statutory evaluation

The Dutch Government is required by law to periodically evaluate the functioning of the Act. The third evaluation, completed in 2021, concluded that the Act is broadly working well but is lagging behind scientific developments.

A key challenge identified was the emergence of embryo-like structures (ELS). Also known as SCBEMs, these are entities created from stem cells that can replicate key features of early embryonic development without arising from fertilisation. The existing definition of embryo, – 'a cell or coherent group of cells with the potential to develop into a human being' – was not designed with these entities in mind. Since no ELS has ever given rise to a human being, this definition offers little regulatory clarity.

The evaluation committee made three key recommendations:

1. Clarify the legal definition of an embryo.
2. Lift the longstanding prohibition on creating embryos specifically for research.
3. Seek independent advice on whether the 14-day rule should be extended.

Each recommendation has given rise to a distinct policy and legislative debate, as set out below.

What counts as an embryo?

The government's legislative response to the 2021 evaluation has focused on the first recommendation: updating the definition. A bill was recently adopted by the House of Representatives (Tweede Kamer) and is currently under consideration by the Senate (Eerste Kamer). The proposed amendment seeks to clarify the Embryo Act, without expanding or restricting its substantive scope.

Under the proposed new definition, an embryo falls within the scope of the Act if it can 'reasonably be expected, if development were to proceed through the stage of gastrulation, to give rise to the same essential functions for continued development as a classically created embryo'. This formulation contains three deliberate elements:

1. The standard is probabilistic ('reasonably be expected'), acknowledging that scientific assessment of the potential for development is necessary based on current knowledge, rather than requiring certainty.
2. Gastrulation serves as the relevant developmental reference point. In contrast to the current definition, the new definition does not require an assessment based on the full developmental trajectory toward a fetus or human being.
3. The requirement that the 'same essential functions' are present means that non-integrated models, lacking the precursor cells for key structures (such as the brain, heart or placenta), would not meet the proposed definition.

ELS that meet the proposed threshold would be subject to the same rules as classic embryos, including mandatory review by the Central Committee on Research Involving Human Subjects (CCMO), the 14-day culture limit, and all other provisions of the Act.

There is, however, one exception. Unlike classically created embryos, ELS may be created specifically for research purposes under the government bill. ELS that fall outside the proposed new definition of an embryo would not be unregulated – rather, they would instead fall under forthcoming legislation governing human biological material more broadly.

The bill has attracted broad parliamentary interest and – on balance – political support from the House of Representatives.

The ban on creating research embryos

The second discussion is more controversial. Under current law, researchers may only use patient-donated surplus embryos that remain after IVF treatment. Creating embryos specifically for research has been prohibited since the Act came into force in 2002. That prohibition was explicitly described as temporary at the time, but it has never been lifted.

Two Members of Parliament – Jan Paternotte of the Democraten 66 party and Harry Bevers of the Volkspartij voor Vrijheid en Democratie party – introduced a private member's bill (initiatiefwetsvoorstel) to lift this ban, subject to strict conditions.

Under the proposed legislation, creating embryos for research would be permitted provided that the research serves a clear scientific purpose, there is no reasonable alternative, and the research proposal has been positively reviewed by the CCMO. Although the bill was heavily debated, it was passed by the House of Representatives and is currently under consideration by the Senate.

The 14-day rule

The third discussion remains at an early stage. In 2023, the Dutch Health Council recommended extending the 14-day culture limit to 28 days (see BioNews 1214). The Council reasoned that, from the perspective of moral status alone, no clear threshold other than a late stage of embryonic development can be identified. The Council proposed 28 days as a pragmatic, evidence-based limit.

The Health Council's recommendation has not yet been translated into legislative action. The current government coalition decided that a broader public dialogue (maatschappelijke dialoog) should first be conducted, to incorporate wider societal perspectives. That dialogue is expected to take place in 2027. Only after its conclusion will the cabinet issue a formal response to the Health Council's advice.

Three trajectories

In summary, the Dutch Embryo Act is the subject of three simultaneous processes, each at a different stage.

The government bill clarifying the definition of an embryo and the private member's bill lifting the ban on creating embryos for research were both passed by the House of Representatives and are now under consideration by the Senate. The question of the 14-day limit remains open, pending a public dialogue whose outcomes are yet to be determined.

What is clear is that, after more than two decades, the Dutch Embryo Act seems to be entering a period of substantial change.

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Research into public attitudes toward embryo research and the 14-day rule, in the Netherlands and in three other European countries, can be found in the recent PET/ESHRE report Fertility, Embryo Research and Genome Editing: Public Attitudes in Europe.