Liability · Smeehuijzen in the NJB · 2026-05-26

Smeehuijzen: the Dutch Protocol does not hold up as a legal yardstick

Lodewijk Smeehuijzen, professor of private law at VU Amsterdam, set out in the Dutch Lawyers' Journal (Nederlands Juristenblad) why a court cannot simply treat the Dutch Protocol as the prevailing medical-professional standard. His reasoning is structural: a protocol that fails every one of the three conditions that would make it a yardstick cannot serve as one.

What a protocol does in a liability case

Every liability case turns on the norm against which a physician's conduct is measured. To decide whether a clinician acted as a good clinician, courts ordinarily fall back on the medical-professional standard — and that standard is filled in, to a large degree, by the protocols and guidelines in force. Act in line with the protocol, the conventional logic runs, and you have acted with due care.

Smeehuijzen, together with Smids and Hoekstra, turns that logic around. In NJB 2023/25 they argue that a protocol can play that norm-setting role only if it itself satisfies three conditions. A court may adopt the protocol as a yardstick only once all three are met. The Dutch Protocol, the authors contend, meets none of them.

Three conditions for a norm-setting protocol

Evidence-based. The protocol rests on sound scientific evidence of efficacy and safety.
Limited medical-ethical charge. The intervention does not engage weighty ethical interests on which reasonable people may differ.
Adequate development process. The protocol came about through a careful, controlled procedure.

Condition 1 — the evidence base is weak

The Dutch Protocol rests on a narrow empirical base: in essence a handful of observational studies from Amsterdam, with small numbers, considerable attrition, and no control group. Systematic reviews abroad have since rated that base as low-quality. A protocol that prescribes an irreversible intervention in children cannot lean on an evidentiary position that has been judged inadequate elsewhere.

With that, the first pillar gives way. What is meant to serve as scientific underpinning is, in the authors' view, too thin to carry the gravity of the treatment. See also evidence base weakness and the methodological criticism of the Amsterdam studies.

Condition 2 — the ethical charge is in fact heavy

A protocol may serve as a technical-medical yardstick only where its ethical charge is limited. With puberty blockers and cross-sex hormones administered to minors, the opposite holds. The intervention bears on fertility, sexual function, and physical development in ways that cannot, or can barely, be undone — and it is deployed in patients who by their very nature cannot yet give the kind of consent such a decision demands.

Precisely because deeply contested value judgements are at stake, the medical profession cannot settle the matter as an internal, technical standard. The weighing belongs in a broader social and legal debate, not in a protocol a court adopts uncritically. See ethical criticism — informed consent in minors.

Condition 3 — the development process was deficient

The third condition concerns procedure. A norm-setting protocol must arise through a controlled, transparent, and validated process, with independent review and room for dissent. The Dutch Protocol took shape within a small circle of participants at a single centre, without the external scrutiny one would expect for a treatment of this severity.

The third pillar is therefore missing too. A protocol that has not been tempered by a sound process cannot bear the legal authority it would need in a liability case.

Other countries are pulling back

The authors point out that countries which adopted the Dutch Protocol are now retreating from it. In the United Kingdom the Cass Review led to the closure of the Tavistock clinic and to restraint over puberty blockers; in Sweden, Karolinska halted the treatment outside of research settings. When leading health systems wind down the treatment because the underpinning falls short, the claim that the protocol is the governing standard in the Netherlands weakens further still.

The legal consequence

Because the Dutch Protocol satisfies none of the three conditions, a court may not simply adopt it as the standard for good clinical practice. A physician who invokes the protocol in a liability case cannot hide behind it: the protocol offers no safe harbour. The duty of care must then be assessed independently — and in that assessment the weak evidence base counts against the physician. See how this plays out across the three legal tracks and the informed-consent route.

A follow-up: the Health Council and the regulatory climate

In a later piece Smeehuijzen shifts his focus to regulation. In NJB 2025/2811 he examines whether the Dutch Health Council's advice on puberty suppression in minors meets the demands of due care: he analyses the composition of the advisory committee, the risk of conflicts of interest, and the wider regulatory climate in which the treatment is kept in place. The thread running through both pieces is the same — the institutional safeguards that ought to support this intervention turn out, under scrutiny, not to hold.