Pharmacogenetics Governance for Youth Mental Health: A Scoping Review of Policy Across 13 Countries.

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Pharmacogenetics (PGx) testing could improve psychotropic prescribing for children and young people, yet youth‐specific policy guidance remains scarce. This review characterizes the international PGx policy landscape for youth mental health across 13 countries. From 940 records, 20 policy documents met inclusion criteria, yielding 190 passages for thematic analysis using the GE3LS framework.

We found that 75% of policies primarily focused on guiding medication prescribing in adult populations, with limited consideration of youth populations; only one (5%) was designed specifically for youth. Three‐quarters of documents originated from professional organizations rather than governments, indicating a structural governance vacuum. An “inverted pyramid” of policy priorities was identified, with scientific (Genomics, 29.5%) and implementation (Social, 24.7%) considerations dominating over weak economic (7.9%) and legal (14.2%) foundations.

Policy coverage primarily focused on medications used in adult populations (antidepressants 80%; cardiovascular 85%), with limited consideration of youth populations; anxiolytics, relevant in pediatric practice, were covered in only 5% of documents. Policymakers must prioritize enforceable, youth‐centered legislation to address these governance failures.

Mental disorders affect approximately one in seven individuals aged 10–19 globally,1 and the prevalence of diagnosed conditions among young people in OECD countries has risen sharply.2 This trend underscores the need for effective, personalized treatment strategies. The development of mental health conditions reflects a complex interplay of genetic and environmental factors,3, 4 and since genetics can significantly influence both susceptibility to developing a disorder and treatment response,5, 6 pharmacogenetics (PGx), the study of how genes affect a person's response to drugs, has emerged as a promising tool to enhance efficacy and minimize adverse reactions for psychotropic medications.7, 8, 9 The importance of PGx in child and adolescent psychiatry is increasingly recognized, with studies highlighting its potential to guide dosing for commonly prescribed medications.10, 11

Globally, there is growing interest in integrating PGx into routine clinical practice.12, 13, 14 However, this integration varies considerably, influenced by diverse policy approaches and governance frameworks. Recent reviews have documented PGx guidelines for specific medications and adverse reactions,15 yet less attention has been paid to the governance infrastructure required to translate guidelines into equitable clinical implementation, particularly for children and young people. While implementation challenges at the practice level have been explored,16, 17 no study has mapped the international policy environment governing PGx for youth mental health.

Policy for young people with mental health is important for these reasons. First, children and adolescents have developmental shifts in enzyme activity (phenoconversion)18 meaning adult PGx guidelines require pediatric contextualization. Second, 46% of children and adolescents receiving psychotropic medications experience phenoconversion,19 creating clinically significant deviations from expected drug metabolism that standard dosing does not anticipate.20, 21, 22 Third, the commercial expansion of PGx testing, often marketed directly to families of treatment‐resistant youth, highlights the need for regulatory stewardship to protect young people from exaggerated claims,23, 24 while reimbursement gaps create inequitable access for lower‐income families.22 Finally, most pediatric clinicians also report insufficient training to interpret PGx results and identify a need for clinical guidelines, legal frameworks, and policies safeguarding genetic privacy.25

To analyze these policies, we applied the GE3LS framework, which examines genomics research and policy through Genomics, Ethical, Environmental, Economic, Legal, and Social dimensions.26 The framework facilitates interdisciplinary analysis of genomic innovation to ensure that technological progress is equitable and maintains public confidence.27, 28

This scoping review aimed to: (1) identify and map existing policies related to pharmacogenetics for youth mental health internationally; and (2) apply the GE3LS framework to analyze the ethical, environmental, economic, legal, and social dimensions of these policies, identifying governance gaps and promising models for future policy development.

METHODS AND MATERIALS

Operational definitions

For the purposes of this review, mental health describes psychiatric and neurodevelopmental disorders with indications for psychotropic medication,29 excluding neurological conditions unless a policy makes specific reference to mental health applications.7, 10, 30, 31 Policy refers to official and semi‐official documents from a recognized authority providing direction on PGx use, implementation, or governance,32 including laws, clinical practice guidelines, and frameworks, but excluding protocols applicable only within a single institution or local health authority rather than across the broader jurisdiction in which they operate.

Study design and registration

This review was conducted in accordance with the frameworks of Arksey and O'Malley33 as refined by the Joanna Briggs Institute34 to map existing policies, guidelines, and regulatory frameworks related to PGx for youth mental health. The reporting of this scoping review adheres to PRISMA‐ScR reporting guidance.35 The protocol for this review was registered with the Open Science Framework (OSF; https://osf.io/e6by4/).

Search strategy and selection criteria

A comprehensive search of six bibliographic databases MEDLINE (Ovid), Scopus (Elsevier), Embase (Ovid), APA PsycINFO (Ovid), CINAHL (EBSCO), and Web of Science (Clarivate) and four gray literature repositories (Policy Commons, Canada Commons, Overton, and Dimensions) was conducted for documents published between January 1, 2005, and December 31, 2025. The 2005 start date was chosen to capture the modern pharmacogenomics policy era following the completion of the Human Genome Project in 200336 and the subsequent emergence of clinical PGx implementation frameworks. The search strategy, developed with a health sciences librarian (D.L.), combined keywords for four core concepts: (1) pharmacogenomics, (2) mental health, (3) youth population, and (4) policy (full strategy in TableS1).

We also conducted direct outreach to PGx experts and policy stakeholders in countries not well represented in Anglophone databases, including China, Taiwan, Chile, Brazil, and additional European countries. These experts confirmed the absence of formal PGx policies for youth mental health in their respective countries, while some did not reply.

Documents were selected using a Population, Concept, Context (PCC) framework with two reviewers independently screening titles, abstracts, and full‐text articles using Covidence systematic review software; disagreements at each stage were resolved through discussion and consensus, with a third reviewer (C.B.) consulted when agreement could not be reached. We included policies addressing PGx for children, adolescents, and young people (aged 0–25 years), comprising pediatric and transitional‐age youth populations,37 consistent with integrated mental health service models increasingly adopted in the United Kingdom, Australia, and Canada that recognize the developmental continuum from childhood through emerging adulthood. This included broader population documents with sections or implications relevant to youth mental health (full inclusion and exclusion criteria are provided in TableS2).

Eligible documents addressed the policy, regulation, implementation, funding, or ethical considerations of PGx testing in mental health care. Documents from governmental bodies, health authorities, regulatory agencies, professional organizations, or academic institutions were eligible for inclusion. The search included countries with genomic readiness, national mental health strategies, publicly funded healthcare systems, or CPIC membership; eligible documents were ultimately identified in 13 countries (Australia, Belgium, Canada, Hong Kong, Italy, Japan, the Netherlands, Singapore, South Korea, Spain, the United Arab Emirates, the United Kingdom, and the United States) and were selected on the basis of genomic readiness, national mental health strategies, publicly funded healthcare systems, and CPIC membership.38 We excluded primary research studies, non‐policy review articles, editorials without substantive policy content, conference abstracts and proceedings, international guideline consortia (CPIC, DPWG) that provide gene–drug interpretation but do not address implementation decisions, and broad genomic medicine strategies lacking specific PGx guidance for mental health.

When multiple versions of a policy existed, we included the currently implemented version. Documents were published in English. Non‐English documents were translated using DeepL Pro31 and verified by bilingual speakers when the relevance of the policy content was ambiguous.

Detailed selection criteria, exclusion rationale, and version selection logic are provided in the Supplementary MethodsS1. The review intentionally included all PGx‐relevant documents to capture the full policy landscape, with mental health as the primary focus.

Quality assessment

Included documents were appraised by two reviewers using the JBI Critical Appraisal Checklist for Textual Evidence,39 a seven‐item instrument assessing source identity, expertise, stakeholder involvement, competing interests, evidence synthesis, literature alignment, and recommendation development methods. Initial inter‐rater reliability for full‐text screening was slight (Cohen's κ = 0.20), a finding we attribute to the inherent ambiguity of classifying documents in a policy landscape where boundaries between clinical guidelines, position statements, and formal policy are poorly defined. Following deliberation sessions that refined operational definitions of “policy,” subsequent screening achieved full consensus, and all disagreements were resolved through discussion or third‐party adjudication.

Documents scoring five or more of seven criteria were included. Quality assessment results are in TableS3, and documents excluded at full‐text review with reasons for exclusion are in Supplementary AppendixS1.

Data extraction and analysis

Data from included documents were extracted into a standardized form. We employed hybrid deductive–inductive thematic analysis40, 41 using NVivo 15 to code and synthesize the data. Deductive analysis applied the GE3LS framework to categorize policy passages into six predefined domains.35 Inductive reflexive thematic analysis involved open coding, iterative codebook refinement, and consolidation into themes.

This yielded “youth‐specific considerations” as a cross‐cutting theme capturing content explicitly addressing the unique needs of children and young people. Twenty percent of passages (n = 38 of 190) were independently coded by both reviewers, achieving substantial agreement (Cohen's κ = 0.82, 87.4% agreement). Disagreements were resolved through consensus meetings, with all decisions documented.

The complete coding framework is provided in Supplementary MethodsS1.

Patient and public involvement

Patients and the public were not involved in the design, conduct, reporting, or dissemination plans of this scoping review.

SEARCH RESULTS AND DOCUMENT CHARACTERISTICS

Our search identified 940 records. After removing 94 duplicates, 846 records were screened, and 236 full‐text articles were assessed for eligibility. Twenty unique policy documents spanning 13 countries met inclusion criteria, yielding 190 distinct policy passages for analysis (Figure 1).

All 20 included documents met minimum quality standards (≥ 5 of 7 criteria; TableS4).

Documents comprised clinical practice guidelines (45%, n = 9), health technology assessments (20%, n = 4), national strategic frameworks (15%, n = 3), and regulatory frameworks (20%, n = 4). Geographic distribution included Europe (n = 5 countries), Asia‐Pacific (n = 5), North America (n = 2), and the Middle East (n = 1). Three‐quarters (75%, n = 15) of documents were issued by professional organizations, while 25% (n = 5) originated from national or provincial governments (TableS4).

Only one policy (5.0%) (the Canadian Pediatric Society's 2024 practice point) was written specifically for children and young people. Four others (20.0%) included youth‐specific sections within broader guidance. The remaining 15 documents (75.0%) primarily focused on guiding medication prescribing in adult populations, with limited consideration or discussion of youth populations.

Direct outreach to international experts confirmed that no additional formal PGx policies for youth mental health exist in other countries surveyed.

Mental health vs. non‐mental health applications

Analysis of medication coverage across the 20 documents is summarized in Figure2. Among mental health medications, antidepressants had the broadest coverage (80.0%, n = 16), reflecting their lifespan use, followed by antipsychotics (65.0%, n = 13). However, ADHD medications (among the most prescribed psychotropics for children and young people) appeared in only 30.0% (n = 6) of policies, and anxiolytics in only 5.0% (n = 1).

By contrast, non‐mental‐health medications dominated policy coverage. Cardiovascular and oncology medications appeared in 85.0% (n = 17) of policies, while pain medications were mentioned in 70.0% (n = 14). Overall, 70.0% (n = 14) of documents were non‐mental‐health‐dominant, prioritizing use of PGx for cardiovascular, oncology, and pain medications.

An 80‐percentage‐point gap between broad medication coverage (antidepressants 80%; cardiovascular 85%) and anxiolytic coverage (5%) demonstrates that current policy primarily focuses on the use of PGx to guide medication prescribing in adult populations, with limited consideration or discussion of youth populations (TableS5).

GE3LS framework analysis: The inverted pyramid

The GE3LS framework revealed a structurally unbalanced “inverted pyramid” in which scientific and implementation concerns received priority while foundational governance domains remain weak (Figure3panel A). Representative policy passages supporting each domain are provided in TableS6.

The Genomics domain was the largest (29.5%, n = 56/190), with clinical validity and utility as the dominant sub‐theme (44.6% of Genomics passages) followed by interpretation and reporting (26.8%). A fundamental divide emerged across some jurisdictions, notably South Korea, which endorsed preemptive PGx testing as cost‐effective,42 whereas the American Psychiatric Association Council on Research Workgroup on Biomarkers and Novel Treatments concluded that evidence does not support combinatorial PGx tools for depression treatment selection.43 This professional disagreement adds a new dimension to the governance problem; not only do policies inadequately address youth needs, but also professional bodies disagree on whether PGx should be recommended in mental health at all. Importantly, policies rarely addressed whether clinical interpretation frameworks should differ for children and young people, where developmental factors may require age‐specific guidance.

The Social domain (24.7%, n = 47/190) was dominated by implementation barriers (48.9% of Social passages), identifying systemic obstacles including limited test availability, high costs, and workforce knowledge gaps. Education and training needs were prominent (21.3%), with policies articulating specific competency requirements for clinicians. However, policies rarely specified how training should address the unique developmental considerations of prescribing for children and young people, perpetuating adult‐centric implementation models.

The Ethical domain (23.7%, n = 45/190) was shaped by consent and assent concerns (42.2%) and privacy and confidentiality (24.4%). Policies highlighted the profound, lifelong stakes of pediatric testing; for instance, the UK Royal College of Psychiatrists warned that data governance must establish clear control over genetic information to protect young people from future discrimination by employers and insurance companies as they enter adulthood. Equity and access concerns (20.0% of Ethical passages) were also prominent.

Documents from the UK and Australia explicitly stressed that because PGx research is heavily based on European‐ancestry populations, rolling out testing without tailored safeguards risks worsening health inequalities, particularly for minority and Indigenous youth whose PGx variant frequencies can differ.44, 45, 46 Despite these concerns, few policies addressed the practical consent complexities when the patient is a minor, including parental consent, youth assent, and the evolving decision‐making capacity of transitional‐age youth.

The Legal domain was weak (14.2%, n = 27/190), dominated by regulatory frameworks (88.9% of legal passages) with minimal discrimination protections (7.4%, just two passages), a gap particularly concerning for children and young people whose genetic information could affect educational, employment, and insurance opportunities for decades. Although Canada's Genetic Non‐Discrimination Act and the United States' Genetic Information Non‐Disclosure Act provide some protection, most jurisdictions lack equivalent safeguards. The Economic domain was the weakest foundational pillar (7.9%, n = 15/190), revealing a fragmented funding landscape.

No country offers universal public coverage for PGx testing, reimbursement varies between insurance‐covered and non‐covered tests across jurisdictions, and economic arguments about avoidable adverse drug reaction costs have not translated into sustainable public funding models. The Environmental domain (operationalized broadly to encompass both gene–environment interactions during development and the ecological sustainability of PGx implementation) received zero coverage (0.0%) across all 13 countries.

Analysis at the national level revealed substantial heterogeneity in policy priorities (Figure 3, panel B). The United Kingdom showed the most balanced profile with policy content divided almost equally between Ethical and Social domains (37.0% each). Whereas Hong Kong's landscape was dominated by the Ethical domain (58.3%), South Korea, Spain and Netherlands emphasized Genomics (66.7% and 60.8%, respectively), and Japan uniquely emphasized Economic considerations (26.7%) reflecting its insurance‐based reimbursement system.

The Netherlands and South Korea had absent Ethical coverage (0.0%), indicating technically comprehensive but ethically disengaged policy. Belgium and Italy were distinguished by their comparatively high Legal domain emphasis (30.0% and 28.6%, respectively), suggesting a regulatory‐first orientation to PGx implementation. The complete absence of the Environmental domain was a universal finding across all 13 countries.

Youth‐specific considerations: An emergent but underdeveloped theme

Youth‐specific considerations accounted for only 11.1% (n = 21/190) of passages. Analysis revealed five sub‐themes: Developmental Pharmacology (n = 8, 38.1%), Consent and Assent (n = 5, 23.8%), Pediatric Evidence Gaps (n = 4, 19.0%), Family‐Centered Care (n = 2, 9.5%), and Youth‐Specific Implementation (n = 2, 9.5%) (Table 1).

The evidence gap was the dominant concern. The Canadian Pediatric Society acknowledged that pediatric data underlying PGx guidelines are generally limited. The American Academy of Child and Adolescent Psychiatry recommended that clinicians avoid using PGx testing to select psychotropic medications in children and young people, citing insufficient evidence.

Youth‐specific medication guidance centered on ADHD pharmacogenomics (11.1%), particularly atomoxetine–CYP2D6 interactions.

DISCUSSION

This international scoping review is, to our knowledge, the first to map the PGx policy landscape for youth mental health. Our analysis of 20 policy documents within 13 countries reveals two interconnected governance failures. First, the GE3LS framework exposes an “inverted pyramid” where scientific and social considerations eclipse weak economic, legal, and absent environmental foundations.

Second, despite all policies addressing PGx, only one provides explicit guidance for children and young people, with youth‐specific considerations representing just 11.1% of policy content. Significantly, 75% of documents were from professional organizations, while only 25% came from governments, revealing a governance vacuum in which clinical guidance exists but the state‐led regulatory, funding, and implementation frameworks required for equitable practice are largely absent. This imbalance has direct consequences in that professional societies can recommend best practices but cannot mandate reimbursement, enforce data governance standards, or ensure equitable access.

These findings advance understanding beyond previous studies that identified implementation barriers at the practice level,16, 17, 47, 48 and beyond reviews documenting guidelines for specific drug–adverse reaction pairs,15 by showing that the well‐documented challenges of clinician knowledge gaps, inconsistent reimbursement, and unresolved ethical concerns are symptoms of fundamental governance failures rather than an absence of guidelines (Table 2).

This governance vacuum creates a “postcode lottery” for PGx funding,49 where access depends on local health authorities, private insurers, or families' ability to pay, rather than unified national standards. Consequently, access to PGx testing becomes concentrated in academic medical centers or regions with favorable policies, while rural, remote, and socioeconomically disadvantaged populations are left behind. The Economic domain's weakness (7.9%) reflects this reality; few countries have established sustainable public coverage, Japan being a notable exception whose reviewed policy document explicitly addressed insurance‐based reimbursement.

The Netherlands policy document reviewed contained no reimbursement component. External literature reports conflicting evidence on Netherlands PGx reimbursement, with some sources indicating partial coverage for adverse drug reaction investigation50 while more recent studies report that PGx testing is not covered by basic Dutch health insurance.51, 52 This lack of established sustainable public coverage disproportionately burdens families of children and young people.20, 53 The underdeveloped Legal domain (14.2%) means no jurisdiction has enacted comprehensive statutory protections for PGx data governance, practice standards, or genetic non‐discrimination conditions encouraging clinicians to rely on clinical intuition rather than evidence‐guided prescribing,54 precisely the approach PGx was designed to eliminate. This legislative delay is especially unsafe for “transitional‐age youth” (ages 16–25).

Because mental health conditions often peak during this period, these young people are frequently caught moving between pediatric and adult care systems. Without strong, interoperable data frameworks, their genetic information risks being misinterpreted or lost during the transition to adult care, or worse, weaponized against them later in life by third parties in the absence of legally enforceable anti‐discrimination protections. This represents a crucial “last mile” problem in which nations build ambitious genomic research infrastructure but neglect the specific policies (for funding, clinical integration, and workforce education) needed to bring PGx benefits to everyday practice.

The fundamental disagreement on testing philosophy between jurisdictions (preemptive, reactive, and pragmatic approaches coexisting without shared frameworks), and the US Food and Drug Administration's warnings about tests with inadequately supported claims,43 further underscores the need for a coherent multinational strategy. The complete absence of environmental considerations across all 13 countries represents an additional blind spot deserving future attention, given the environmental footprint of genomic data infrastructure and medication waste from altered prescriptions.55

Antidepressant PGx coverage (80%) approaches cardiovascular (85%) and oncology (85%) applications, a promising sign that mental health PGx is gaining policy traction, but existing CPIC guidelines for SSRIs were developed largely on adult evidence and explicitly caution their use in children due to developmental differences in CYP2C19 and CYP2D6 activity that can alter drug exposure by 30–300% relative to adult levels.45, 48 This disparity reveals policies that primarily focus on guiding medication prescribing in adult populations, with limited consideration of pediatric mental health prescribing needs. While the evidence base for PGx applications with established relevance for youth, such as atomoxetine–CYP2D6 interactions, exists, it remains largely unaddressed in policy.

An important evidence paradox compounds this problem. The American Academy of Child and Adolescent Psychiatry recommends against PGx testing in youth, citing limited pediatric evidence,56 yet the policy vacuum itself prevents generation of this evidence. Without governance frameworks mandating pediatric‐focused research, implementation standards, and data collection requirements, the field will struggle to produce the data that cautious professional societies await.

This evidence gap is both cause and consequence of the policy vacuum, a self‐reinforcing cycle that leaves clinicians caught between the promise of PGx and the reality of a policy landscape not designed for their young patients. The paradox is perhaps best illustrated by the disconnect between substantial publicly funded PGx research programs in countries such as Canada, the United Kingdom, and Spain57, 58 and the near‐total absence of corresponding policy frameworks to translate findings into practice. Multi‐million‐dollar research investments operate without the governance infrastructure to move discoveries into clinical care, the most likely evidence of governance failure.

The absence of youth‐specific PGx policy has created a vacuum that industry has filled through direct marketing to primary care providers in pediatric psychiatry, potentially leading to deviations from evidence‐based care.59, 60

Real‐world evidence confirms that the clinical expectations of this policy vacuum are high. Among 82% of children and adolescents with mental health conditions, undergoing PGx testing carry CYP2C19 or CYP2D6 variants associated with adverse drug reaction risk or treatment inefficacy outcomes that youth‐specific policy frameworks could help prevent through standardized testing protocols and prescribing guidance.24, 61

Furthermore, although psychotropic medications are often initiated using a “start low and go slow” approach in children and adolescents, this does not diminish the clinical utility of PGx testing. Rather, PGx complements cautious prescribing by identifying patients who are most likely to benefit from slower dose titration (e.g., poor and intermediate metabolizers) while also identifying those for whom this strategy may be less appropriate, such as normal or ultrarapid metabolizers who may require more rapid dose escalation, higher maintenance doses, or an alternative medication to achieve therapeutic benefit. Importantly, the value of PGx extends beyond dose selection to informing medication choice, adverse effect risk, and polypharmacy management.22, 58, 59, 62 This is relevant in pediatric practice, where developmental changes in CYP enzyme activity influence drug disposition20, 21 and off‐label psychotropic prescribing is common, often requiring individualized treatment decisions in the absence of strong pediatric evidence.60, 61, 63, 64

Meanwhile, the ethical dimensions of PGx for young people remain inadequately addressed. Few policies guide clinicians on consent and assent when the patient is a minor, including issues of evolving capacity, parental authority, and the rights of mature minors. The challenge of extrapolating adult data to children is compounded by extrapolation from European‐ancestry populations to genetically diverse youth; UK policymakers have warned that this risks exacerbating “health and race inequalities.”65 This risk is particularly acute for Indigenous populations, who remain severely underrepresented in pharmacogenomic reference databases and whose genomic data has historically been subjected to extractive research practices.66, 67 In alignment with the Truth and Reconciliation Commission (TRC) of Canada's Calls to Action regarding Indigenous health equity, we advocate for a parallel process to be created that is led by and for Indigenous people.

This process must determine what types of frameworks and governance structures grounded in Indigenous data sovereignty principles such as OCAP (Ownership, Control, Access, and Possession) and CARE (Collective Benefit, Authority to Control, Responsibility, Ethics) are required for PGx research and implementation to be undertaken safely and respectfully with Indigenous populations, both in Canada and globally.68 Without policies that mandate and fund research in diverse pediatric cohorts and respect Indigenous data sovereignty, PGx risks becoming a precision medicine that helps only a privileged minority of children with mental health conditions.

Despite these systemic gaps, several jurisdictions have developed promising approaches that collectively offer a blueprint for youth‐centered PGx governance. Singapore's Ministry of Health established a regulatory framework that pioneers a principles‐based approach to decision‐making capacity; rather than relying on rigid age cutoffs, it mandates context‐specific capacity assessments for minors, providing flexible autonomy for older adolescents.69 Spain's Spanish Society for Forensic Psychiatry guidelines prove that clinical translation of youth data is achievable, providing explicit pediatric dosing recommendations for ADHD medications like atomoxetine based on CYP2D6 interactions.70 The Canadian Pediatric Society's 2024 framework squarely addresses the unique triad of pediatric PGx: developmental pharmacology, complex triadic consent processes involving families, and the realities of off‐label prescribing amidst evidence gaps.23 Furthermore, Belgium's KCE Health Technology Assessment demonstrates how rigorous cost‐effectiveness analysis can build the economic case for sustainable public funding,71 while Japan's JSCPT statement offers a pragmatic model balancing mental health medication testing with strict data protection. Together, these models demonstrate that comprehensive, youth‐centered governance is achievable when clinical specificity, dynamic ethical frameworks, and regulatory oversight are integrated from inception.

We call on policymakers, clinicians, and researchers to collaborate on three main priorities: (1) enacting statutory PGx legislation with enforceable legal protections, secure data governance, and sustainable public funding; (2) centering these frameworks on the unique needs of children and young people, mandating developmentally appropriate guidance for consent, family‐centered care, and diverse populations; and (3) integrating environmental sustainability considerations into future PGx policy development. The science, the promising governance models, and the research investments exist. What is needed now is the political commitment to translate these into statutory frameworks that protect children and young people.

This review has several strengths. It is the first scoping review mapping the international PGx policy landscape for youth mental health. Our comprehensive search strategy, incorporating six databases, four gray literature repositories, and direct expert outreach, ensured broad capture of policy documents.

Non‐English document inclusion through machine translation broadened coverage beyond Anglophone jurisdictions. The hybrid deductive–inductive thematic analysis provided a methodologically rigorous, multi‐layered understanding of policy content.

Several limitations need consideration. First, some relevant policies from non‐Anglophone countries may have been missed despite mitigation strategies. Second, our review was limited to publicly available documents; internal institutional protocols may contain additional youth‐specific guidance, a limitation that applies across all 13 countries regardless of language or setting, not only to non‐Anglophone jurisdictions.

Third, none of the 20 included documents constitute formal legislation (all are professional guidelines or health technology assessments), which is itself a key finding but limits evaluation of statutory PGx frameworks. Fourth, the field evolves rapidly and our findings represent a snapshot in time. Finally, our focus on high‐income countries limits generalizability to low‐ and middle‐income settings, where almost 90% of child and adolescent live, yet implementation challenges and governance structures differ substantially.

Future research should establish a living review for youth PGx policy, examine policy development barriers in low‐ and middle‐income countries, and investigate the environmental lifecycle of PGx testing in pediatric populations. Additionally, a parallel review of adult PGx policy would be a valuable future direction to compare the evolution of governance across age groups and to determine whether the governance deficits identified here are unique to youth or reflect broader systemic failures.

FUNDING

This work was supported by a Genome Canada, Canadian Precision Health Initiative (CPHI) Pillar 1 grant. The funder had no role in study design, data collection, data analysis, data interpretation, or writing of the report. P.A. also receives support from the Cuthbertson and Fischer Chair in Pediatric Mental Health.

CONFLICT OF INTEREST

C.B. is the founder and an equity holder of Sequence2Script Inc. All other authors declared no competing interests for this work.

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