Galderisi et al¹ provide an excellent overview of the complex ethical challenges in psychiatry. We subscribe to the authors’ criticism of mental health laws employing a “disorder + risk” schema for involuntary intervention, and their conclusion that these laws discriminate against people with a mental health condition. The authors put forward instead a “single law” proposal in which “involuntary treatment would only be permitted when the objecting person has an impairment of decision-making ability – from any cause – and if treatment is in the person's best interests”¹. We strongly endorse the core of this proposal, but would like to suggest three refinements to it.

First, we propose combining capacity assessment with supported decision-making, to ensure that no one is found to lack decision-making capacity before all reasonably available resources of supported decision-making have been exhausted. Second, we propose replacing the best interests standard by the substituted judgment standard, to achieve a closer alignment of substitute decisions with the will and preferences of the person concerned. Third, we suggest to explicitly define additional criteria for involuntary intervention, to avoid what we will call “the fallacious inference from substitute decision-making to coercion”. The proposed refinements are based on what we call the “combined supported decision-making model”, a model for the informed consent process that provides a non-discriminatory basis for decision-making about involuntary intervention^2-5. In this commentary, we focus on the last two refinements.

Galderisi et al refer to a terminological distinction used in a judgment of the German Federal Constitutional Court to show that the “single law” proposal is consistent with the general principles of the United Nations (UN) Convention on the Rights of People with Disabilities (CRPD) and the wording of Article 12, particularly its insistence that “measures relating to the exercise of legal capacity respect the rights, will and preferences of the person”. The terminological distinction is between “free will” (freier Wille) and “natural will” (natürlicher Wille), which, according to the authors, maps on to the CRPD's distinction between “will” and “preferences”.

This terminological distinction plays an important role in the legal discourse around the German guardianship law (Betreuungsrecht), which is part of the German Civil Code and applies to all people who need support in managing their own affairs, regardless of whether they have a mental health condition⁶. The term “free will” (freier Wille) refers to the contemporaneous preferences of a person who possesses decision-making capacity regarding the decision at hand. Expressions of a person's free will must be respected by clinicians and have the status of consent or withdrawal of consent; that is, they can make interventions permissible which would otherwise be not permissible and vice versa. The term “natural will” (natürlicher Wille), on the other hand, refers to the contemporaneous preferences of a person who lacks decision-making capacity regarding the decision at hand. Expressions of a person's natural will must be carefully considered in medical decision-making but can, in some instances, be overridden based on other considerations, to be specified below. They amount to what is commonly described as “assent” and “dissent” in the research ethics literature. Any medical intervention against a person's natural will (i.e., any medical intervention to which the person dissents) counts as “coercive medical treatment” (ärztliche Zwangsmaßnahme) under German guardianship law and is hence subject to strict conditions.

Galderisi et al propose that expressions of a person's natural will can only be overridden if doing so is in the person's best interests. Although the authors make clear that the standard of best interests should be interpreted subjectively in terms of the person's beliefs and values, we are concerned that it will nonetheless be understood objectively in clinical practice. The best interests standard originally derives from a paternalistic “doctor knows best” approach and – despite the authors’ careful qualifications – may be understood by clinicians in the light of what Hawkins⁷ calls “welfare medicalism”, the persistent idea among clinicians that what is in a person's best interests is what is medically indicated in the person's situation. To avoid this potential misunderstanding, we propose replacing the best interests standard by the substituted judgment standard. This latter standard gives center stage to the person's will and preferences: it assigns to the substitute decision-maker the task of making the treatment decision that the person would have made if he/she had had decision-making capacity⁸.

German guardianship law employs a substituted judgment standard and requires that substitute decisions be justified by reference to concrete evidence about the person's will and preferences⁶. The law introduces two additional concepts in this context. The first is that of the person's “previously declared will” (vorausverfügter Wille), denoting the preferences that a person has documented in an advance directive at a time at which he/she had decision-making capacity. Advance directives are legally binding under the German Civil Code and apply to both physical and mental health conditions. The second concept is that of the person's “presumed will” (mutmaßlicher Wille), denoting the preferences of a person which can be reconstructed based on the preferences and personal values and convictions that he/she expressed when he/she had decision-making capacity. In accord with the substituted judgment approach, the person's previously declared or presumed will serves as a proxy for the person's free will.

Consistency with the person's previously declared or presumed will is a necessary condition for the permissibility of involuntary treatment under German guardianship law. This means that, if this consistency is not ascertained, involuntary treatment may not be carried out – even if withholding treatment is not in the objective best interests of the person. All references to the term “well-being” (Wohl) were omitted from the guardianship law during the latest reform to underline this, even though the term was understood subjectively before the reform⁶.

We now turn to the fallacious inference from substituted decision-making to coercion. It is often assumed that, if a medical intervention is consistent with the person's previously declared or presumed will, that intervention may be carried out involuntarily against the person's natural will. This inference is invalid. The reason is that consistency with the person's previously declared or presumed will is a necessary but not sufficient condition for the permissibility of involuntary intervention.

While Galderisi et al in no way make the fallacious inference from substituted decision-making to coercion, we believe that it is important to make explicit and emphasize that additional criteria must be fulfilled for an involuntary intervention to be justified. Besides being consistent with the person's previously declared or presumed will, an involuntary intervention must also be suitable, necessary and proportionate in order to be permissible⁹. An involuntary intervention is suitable if it is effective in preventing the person from behaving in ways that are inconsistent with his/her previously declared or presumed will. It is necessary if there are no less restrictive alternatives to prevent the person from behaving in these ways. It is proportionate if its risk-benefit profile is more favorable than that of the option of not carrying out the intervention. Only if these three criteria are met may the person's previously declared or presumed will be prioritized over his/her natural will, and the involuntary intervention be carried out. If any of these three conditions is not met, involuntary intervention is not permissible and the person's natural will or contemporaneous preferences must be followed.

Implementation of the “single law” proposal would be a major step forward for psychiatry. We believe that the proposal can be brought into closer alignment with the CRPD's standard of “will and preferences” if capacity assessment is combined with supported decision-making; the best interests standard is replaced by the substituted judgment standard; and the proposed additional criteria for involuntary intervention are explicitly added.

Galderisi 等人¹很好地概述了精神病学中复杂的伦理挑战。我们同意作者对采用“障碍+风险”模式进行非自愿干预的心理健康法律的批评，以及他们的结论，即这些法律歧视患有心理健康问题的人。相反，作者提出了一项“单一法律”提案，其中“只有当反对者因任何原因而导致决策能力受损，并且治疗符合该人的最大利益时，才允许非自愿治疗” ¹ 。我们强烈支持该提案的核心内容，但想对其提出三点改进建议。

首先，我们建议将能力评估与辅助决策相结合，以确保在所有合理可用的辅助决策资源耗尽之前，不发现任何人缺乏决策能力。其次，我们建议用替代判断标准取代最大利益标准，以实现替代决策更符合当事人的意愿和偏好。第三，我们建议明确界定非自愿干预的附加标准，以避免我们所谓的“从替代决策到强制的错误推论”。拟议的改进基于我们所说的“联合支持决策模型”，这是一种知情同意过程模型，为非自愿干预决策提供非歧视性基础^2-5 。在这篇评论中，我们重点关注最后两项改进。

Galderisi等人引用了德国联邦宪法法院判决中使用的术语区别，以表明“单一法”提案符合联合国（UN）《残疾人权利公约》（CRPD）的一般原则）以及第12条的措辞，特别是其坚持“与行使法律行为能力有关的措施尊重个人的权利、意愿和偏好”。术语上的区别在于“自由意志”（ freier Wille ）和“自然意志”（ natürlicher Wille ）之间的区别，根据作者的说法，这映射到了 CRPD 对“意志”和“偏好”之间的区别。

这种术语区别在围绕德国监护法 ( Betreuungsrecht ) 的法律论述中发挥着重要作用，该法是《德国民法典》的一部分，适用于所有在管理自己的事务时需要支持的人，无论他们是否有心理健康问题条件⁶ . “自由意志”（ freier Wille ）一词是指具有决策能力的人对当前决策的同时偏好。个人自由意志的表达必须得到临床医生的尊重，并具有同意或撤回同意的状态；也就是说，它们可以允许原本不允许的干预，反之亦然。另一方面，“自然意志”（ natürlicher Wille ）一词是指缺乏决策能力的人对当前决策的同时偏好。在医疗决策中必须仔细考虑一个人的自然意愿的表达，但在某些情况下，可以根据其他考虑因素来推翻，如下所述。它们相当于研究伦理文献中通常所说的“同意”和“反对”。根据德国监护法，任何违背个人自然意愿的医疗干预（即个人不同意的任何医疗干预）都被视为“强制医疗”（ ärztliche Zwangsmaßnahme ），因此受到严格的条件限制。

Galderisi 等人提出，只有在符合个人最大利益的情况下，个人自然意愿的表达才能被推翻。尽管作者明确表示，最佳利益标准应根据个人的信仰和价值观进行主观解释，但我们担心它在临床实践中仍然会被客观地理解。最佳利益标准最初源自一种家长式的“医生最了解”的方法，尽管作者有仔细的限定条件，但临床医生可能会根据霍金斯⁷所说的“福利医疗主义”来理解，即临床医生中坚持认为什么是“福利医疗主义”。符合一个人的最大利益是根据该人的情况进行医学上的指示。为了避免这种潜在的误解，我们建议用替代判断标准取代最佳利益标准。后一个标准以个人的意愿和偏好为中心：它将做出治疗决定的任务分配给替代决策者，如果他/她有决策能力，他/她就会做出治疗决定⁸ 。

德国监护法采用替代判断标准，并要求替代决定必须参考有关当事人意愿和偏好的具体证据来证明其合理性⁶ 。该法律在此背景下引入了两个附加概念。第一个是该人的“先前宣布的意愿”（ vorausverfügter Wille ），表示一个人在他/她有决策能力时在预先指示中记录的偏好。根据《德国民法典》，预先指示具有法律约束力，并适用于身体和精神健康状况。第二个概念是人的“假定意志”（ mutmaßlicher Wille ），表示一个人的偏好，可以根据他/她在有决策能力时表达的偏好以及个人价值观和信念来重建。 。根据替代判断法，一个人先前声明或推定的意志可以作为该人自由意志的代表。

根据德国监护法，符合该人先前声明或推定的意愿是允许非自愿治疗的必要条件。这意味着，如果不能确定这种一致性，则可能不会进行非自愿治疗——即使停止治疗不符合患者的客观最佳利益。在最近一次改革期间，监护法中删除了所有对“福祉”（ Wohl ）一词的提及，以强调这一点，尽管该术语在改革之前是主观理解的⁶ 。

现在我们转向从替代决策到强制的错误推论。人们通常认为，如果医疗干预与个人先前声明或推定的意愿一致，则该干预可能是违背个人自然意愿非自愿地进行的。这个推论是无效的。原因在于，与当事人事先声明或推定的意愿一致是允许非自愿干预的必要条件，但不是充分条件。

虽然 Galderisi 等人绝没有从替代决策到强制做出错误的推论，但我们认为，重要的是明确并强调非自愿干预必须满足额外的标准才能证明其合理性。除了符合当事人先前声明或推定的意愿外，非自愿干预还必须是适当的、必要的和相称的，才能被允许⁹ 。如果非自愿干预能够有效防止该人的行为与其先前声明或假定的意愿不一致，则该干预是合适的。如果没有限制性较小的替代方案来防止此人以这些方式行事，则这是必要的。如果其风险收益状况比不进行干预的选择更有利，则该风险收益状况是相称的。只有满足这三个标准，才能优先考虑当事人先前宣称或推定的自然意志，进行非自愿干预。如果不满足这三个条件中的任何一个，则不允许非自愿干预，并且必须遵循人的自然意志或当时的偏好。

“单一法律”提案的实施将是精神病学向前迈出的重要一步。我们认为，如果将能力评估与支持性决策相结合，该提案可以更加符合CRPD的“意愿和偏好”标准；最佳利益标准被替代判断标准替代；并明确增加了拟议的非自愿干预附加标准。