The WHO Clarifies Its Plans To Issue Guidelines on ‘Trans and Gender Diverse People’—Significant Concerns Remain

The WHO states that there’s no evidence supporting ‘gender-affirmative care’ in minors, but will recommend increasing hormone access and legal self-identified gender recognition for everyone else.

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This article was originally published on the Society for Evidence-Based Gender Medicine’s website on February 1, 2024.

Executive Summary

On January 15, 2024, the World Health Organization (WHO) issued an updated announcement regarding its plan to develop healthcare guidelines for “trans and gender diverse [TGD] people.” The earlier announcement, issued at the end of December 2023, generated much public concern. Various stakeholders—clinician groups, LGBT groups, parent groups, and women's rights champions—expressed alarm that the WHO seemed to be proceeding on the basis of an unproven assumption that expanded access to gender-affirming hormones is universally beneficial. In addition, these groups also objected to the WHO’s assumption that legal recognition of self-declared gender is a key human right and must be adopted by legal systems worldwide.

The earlier announcement suggested that the WHO Guideline Steering Committee was focused on how to translate these two positions into authoritative guidelines for healthcare and legal systems worldwide, rather than considering whether to do so. Considering the full range of benefits and risks of such recommendations is critical given the sharp rise in the number of individuals—especially young people—declaring a TGD identity in recent years and the shift in patient demographics. There is significant uncertainty regarding this phenomenon and the implications of potential medical and legal “gender-affirmative” recommendations, especially for the vulnerable populations of youth with recent TGD histories, as well as for the safety of women and girls more generally.

Another signal that the guideline steering committee viewed these two positions as established, rather than up for discussion, is evident in the composition of the Guideline Development Group (GDG) chosen to issue the recommendations. A significant number of GDG members are in leadership positions in organizations whose core mission is to promote wide access to hormones and/or legal recognition of self-determined gender (also known as “self-id laws”). All but four GDG members appear to have significant conflicts of interest. The WHO conflict of interest (COI) policies guard against interests that may interfere with the GDG members’ ability to impartially assess the evidence and issue evidence-based recommendations. The fact that these affiliations were not viewed as problematic and passed the COI review sent a strong signal regarding the direction of the guideline.

Concerned stakeholders worldwide noted that not only did GDG members have strong intellectual and financial conflicts regarding the contemplated recommendations, but that important points of view were missing from the GDG. The GDG did not contain anyone concerned about the risks of the wide availability of hormones to youth with recent-onset TGD identity (including gay youth, youth on the autism spectrum, and youth with mental illness) or potential harms to reproductive, maternal, and fetal health. They also noted an absence of women’s rights representatives, who should be mandatory stakeholders in discussions of laws that would allow natal males to be legally recognized as female and have access to female-only spaces regardless of medical transition status.

In response to this public expression of concern, the WHO issued an updated announcement, along with FAQs providing clarifications about its planned TGD guidelines. The WHO also extended the public consultation period by an additional three weeks. The new deadline to comment is February 2, 2024.

Over the last two weeks, the Society for Evidence-Based Gender Medicine (SEGM) has been analyzing the WHO’s updated announcement, the FAQs that accompanied it, and the documents referenced by the FAQs. While some concerns have been alleviated (e.g., the WHO clarified that it does not plan to include children and adolescents in its upcoming recommendations for expanded access to hormones), other concerns remain (e.g., the vulnerable group of young adults <25 years is still in scope). The overarching concern that the WHO may be inadvertently involved in the production of a biased guideline has only intensified based on the additional information provided.

The concern that the WHO may be proceeding based on non-evidence based assumptions became especially significant once we reviewed the two prior guidelines that the WHO mentioned will serve as precedents for the upcoming recommendations: the self-care and HIV guidelines issued in 2022. In reviewing these guidelines, it became apparent that, in the process of creating these guidelines, highly consequential statements regarding the need to assure a wide availability of hormones and recognize gender self-identification in legal systems took root without appropriate justification. 

These two contested notions gained strength not through evidence reviews of the benefits and harms of the effects of hormones, or an analysis of the complex interplay of human rights involved in recommendations for legal recognition of self-declared gender, but through a process of poorly-evidenced statements and circular references among three key WHO documents: a systematic review, the self-care guidelines, and the HIV guidelines, all published between March and July 2022. By the time WHO officially acknowledged its plans for developing the TGD guideline in October 2022, the intention to promote a wide availability of hormones and self-ID laws appeared established.

Given the rapid rise in the numbers of individuals—especially youth—who declared a TGD identity in recent years worldwide, an evidence-based guideline addressing the administration of gender-affirming hormones is urgently needed. However, to restore confidence in the trustworthiness of the planned WHO TGD guidelines, the current process must undergo a substantive change. This includes re-examining the validity of the underlying assumptions, revisiting the guideline scope, and a re-composition of the GDG to ensure proper management of conflicts of interest and an adequate representation of the diversity of opinions in this challenging area. Continuing the process as-is with only minimal changes is unlikely to lead to a trustworthy guideline.

We present our detailed analysis below. We look forward to the WHO’s reassessment of the situation after the final round of community responses is received. The comments are due February 2, 2024 and should be directed to hiv-aids@who.int.

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DISCLAIMER: While we have done our best to analyze the information made available by WHO, we do not have access to key documents relating to this guideline development process. Such documents include the guideline proposal, the guideline recommendation questions, and the specific evidence reviews WHO commissioned. Further, the additional information made public by WHO in early January contains hundreds of pages of referenced material, which necessitated analyses within a short period of time. As such, our evaluation of the problems in the WHO process is necessarily limited and may contain some inaccuracies. We welcome dialogue with WHO about our conclusions. We also urge WHO to consider how to ensure more transparency in this process, in view of the paramount importance of these upcoming TGD guidelines to stakeholders worldwide.

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Detailed Analysis

Below, we elaborate on our key conclusions that (1) the WHO’s starting point on “gender-affirming” interventions is not evidence-based and is self-contradictory from the human rights perspective; (2) the WHO’s decision not to recommend gender-affirming care for adolescents is appropriate but concerns about young adults remain; and (3) significant changes to the current process are needed in order to restore confidence into the planned guideline’s validity.

We conclude with our recommendations.

1. The WHO’s presumed starting point for the current recommendation on “gender-affirming care” is not evidence-based and is self-contradictory from the “right to health” perspective.

While the language in the earlier WHO announcement suggested that in addition to recommending legal recognition of self-determined gender, the WHO planned to promote expanded access to gender-affirming hormones (e.g., the announcement stated that “the new guidelines will provide evidence and implementation guidance… aimed at increasing access and utilization” and listed “gender-affirming care, including hormones” as a key goal), the updated announcement and its accompanying FAQs furthered this interpretation. 

The FAQs state that the “proposed guideline builds on” two specific WHO guidelines: the June 2022 “self-care” guideline and the July 2022 HIV guideline. In reviewing both guidelines regarding their statements on gender-affirming care, the key passage below appears in both:

The principles of gender equality and human rights in the delivery of quality gender-affirming hormones are critical to expanding access to this important intervention and reducing discrimination based on gender identity.

Given the likely centrality of this statement to the upcoming “gender-affirming care” recommendations, we attempted to track the origin of this statement and its evolution over time. We found that this statement lacked an adequate evidence base, and became an authoritative “existing guidance statement” through circular referencing.

We also analyzed this statement from a human-rights perspective to better understand how these assertions fit within the complex framework of human rights. We found the statement to be self-contradictory from a human-rights perspective, and contradictory to the right to health, defined as “the right to the highest attainable standard of physical and mental health.” Promotion of non-evidence-based medical interventions as universally beneficial does not advance the right to health, and it can be said to threaten it by undermining true informed consent.

We present our analysis below.

History and Evolution of the WHO’s Statement Promoting Expanded Access to Hormones

The WHO’s statement, “Principles of gender equality and human rights in the delivery of quality gender-affirming hormones are critical to expand access to this important intervention and reduce discrimination based on gender identity,” first appeared in a WHO systematic review in March 2022. This statement was then repeated in the WHO self-care guideline in June 2022, and published again in the WHO HIV guideline in July 2022. Below, we detail the evolution of the statement and how it became upgraded to its current authoritative designation of the WHO “prior guidance statement” without trustworthy evidence to substantiate it.

WHO Systematic Review of Evidence, March 2022 

It appears that the statement in question may have first appeared in print in March 2022 in a systematic review of evidence (WHO SR) commissioned by WHO to support its “Self-Care” guideline.

The appearance of this statement in the conclusions of the SR suggests that the conclusion was derived from the SR analysis. However, in reading the SR, the authors credit the statement to the guideline development group (GDG) charged with developing the WHO self-care guideline, for which this SR was commissioned.

The only basis for this statement appears to be the five studies the SR found reporting on preferences and values of TGD people regarding self-administration of hormones—with no consideration of benefits, harms, or their balance. The SR authors acknowledge this “limited data” but confusingly, center the conclusion on the statement that did not originate from their analysis. Not only is republishing a conclusion by a different group as the conclusion of one’s own SR misleading, but it also sets the stage for circular referencing, making it challenging to assess this statement for credibility.

Of note, there are several instances where the SR presented evidence in a biased or misleading way that seemed to favor promoting the view that gender-affirming hormones are universally beneficial. For example, the authors referred to the findings in a WPATH-commissioned systematic review of evidence in a way that might lead a reader to assume that the review found a credible association between taking hormones and improved mental health, but to limitations in study designs, could not confirm that hormones caused the improvements:

a recent systematic review of the literature found that hormone therapy was associated with increased quality of life, decreased depression, and decreased anxiety, although confidence in the causal nature of these associations was limited as existing studies have relatively high potential for bias in study design, have small sample sizes, and may be unable to separate the effects of multiple interventions. [emphasis added]

This is inaccurate. The WPATH SR clearly states:

This systematic review of 20 studies found evidence that gender-affirming hormone therapy may be associated with improvements in QOL scores and decreases in depression and anxiety symptoms among transgender people. Associations were similar across gender identity and age. The strength of evidence for these conclusions is low due to methodological limitations (Table 6). It was impossible to draw conclusions about the effects of hormone therapy on death by suicide. [emphasis added]

Thus, the “high risk of bias” and the “low quality” of evidence designation in the review in question applied not to only to the causal nature of the associations but to the associations themselves. Further, the authors of the SR failed to note that the WPATH systematic review only evaluated the potential mental health effects of hormones and failed to evaluate physical health effects (benefits or harms), despite setting out to do so in its registered protocol.

In another instance, the authors of the WHO SR referenced WPATH as an authoritative source of information about gender-affirming hormones. The authors failed to note that the WPATH’s Standards of Care 7 guidelines, which promoted the idea that hormones should be widely available to those who want them (the so-called “informed consent model of care) failed to meet the basic standard for evidence-based guidelines (The updated Standards of Care 8 suffer from similar limitations, and are widely recognized as not evidence-based).

Returning to the key statement in question, even though this statement appears in the conclusion of the commissioned SR, in this particular case it represents a circular reference, as the SR cannot be treated as providing credible evidence to support this particular statement.

WHO Self-Care Guideline, June 2022.

The statement in question is repeated in June 2022, in the WHO Self-Care Guideline under the section “Promoting sexual health,” with the designation of “Key consideration”:

Annex 7 on page 152 of the WHO Self-Care Guideline references the source for “Key consideration 3.” However, the reference takes the readers to the WHO systematic review discussed above. This reinforces the already-established pattern of circular referencing: the WHO systematic review references the Self-Care guideline, while the Self-Care Guideline references the systematic review.

The designation of this statement as a “Key consideration,” rather than an authoritative “Recommendation,” deserves scrutiny. The “Key consideration” itself appears to be a novel category of statement in a guideline with an unclear meaning. Previously, evidence-based guidelines at WHO (and other organizations) operated with two types of statements: “evidence-based recommendations” and “good practice statements.” Each category has strict definitions and well-understood meanings. Evidence-based recommendations are based on the review of the best available evidence and are rated for strength using the standard GRADE methodology. Good practice statements express universally accepted notions that do not require systematically synthesizing evidence but are nonetheless important to state in order to promote health.

The Self-Care Guideline may be the first time the WHO introduced “Key considerations” as a third type of statement. While it lacks a formal definition, according to WHO’s description, “Key considerations” are used in situations where there is “insufficient evidence to make a recommendation and for which best practice remained uncertain” (p. 30).

While the history of the introduction of “Key considerations” and the role they will play in evidence-based recommendations remains unclear (the WHO handbook for guideline development does not describe this type of statement), it is self-evident that statements that are not supported by evidence and represent uncertain practices should not be used as the basis for changing healthcare or legal systems.

WHO HIV Guideline, July 2022. The statement next appears in the WHO HIV Guideline, published one month later. However, in the space of just one month, the statement underwent significant evolution in terms of how it was described by WHO. It is no longer described as a “Key consideration,” and instead carries the much more authoritative designation of “existing guidance statement.”

The reference for this statement (reference number 182) directs readers to the Self-Care Guideline described above, with no new information presented. It is not clear why a statement that was initially described as referring to an uncertain practice lacking evidence in the 2022 Self-Care guideline attained a much more authoritative status of “existing guidance statement” in the 2022 HIV guideline.

Further, footnote 21 references the “WHO guidelines on health services for trans and gender diverse people,” which are described as “under development at the time of writing” in 2022. Since no other WHO guidance on the topic of TGD was underway at the time, it is reasonable to assume footnote 21 is referring to the current TGD guideline effort. This further suggests that the statement in question may play a key role in the upcoming TGD guidelines.

Right to Health analysis

As noted above, the first WHO guideline to use the statement in question is the 2022 WHO Self-Care Guideline, where it appears as “Key consideration 3” in the table of recommendations section Promoting Sexual Health (see below).

From a human-rights perspective, “Key consideration 3” conflates three distinct rights: the right to self-determination, the right to nondiscrimination, and the right to health. Given that the consideration foremost relates to health and the use of medicine, we focus our analysis on the right to health, which includes the right to quality care that is medically and scientifically appropriate. 

Key consideration 3 acknowledges that the use of hormones is not supported by evidence, yet states that “expanding access” to “gender-affirming hormones” is critical. Further, the right to health and the right to self-determination include the right to informed consent. Informed consent requires a diagnosis, a plan of treatment and the presentation of potential alternatives, and an explanation of risks and benefits as well as an evaluation of the person’s capacity to understand and consent to treatment. Thus, expanded access to hormones should not be recommended until the evidence elucidates the risks and benefits of hormones for the diverse sub-populations of TGD individuals.

In summary, we are concerned that the key premise behind the planned TGD recommendations to promote the wide availability of hormones may have been shaped via a process of non-evidence-based, cross-referenced assertions. It would be inappropriate for the WHO to base its upcoming recommendations on such a problematic, non-evidence-based statement.

2. The apparent decision not to recommend expanded access to hormones for children and teens is appropriate, but concerns about young adults remain.

Previously, SEGM and other groups expressed concern that the guideline’s apparent intention to recommend “gender-affirming care,” including expanded access to hormones, may harm the health of vulnerable youth. In its FAQs, WHO acknowledged that “on review, the evidence base for children and adolescents [defined by WHO as those under 20] is limited and variable regarding the longer-term outcomes of gender affirming care for children and adolescents.” Consequently, the WHO decided not to include this group in the upcoming “gender-affirming” guidelines.

While the decision not to recommend expanded access to hormones for children and adolescents is appropriate given the current evidence, the concern that youth may be harmed by such a recommendation has not been eliminated, since young adults ages 20-24, recognized by the WHO as a distinct population of youth, are still in scope for the planned TGD guideline.

If the WHO arrived at two different sets of conclusions about the state of evidence for adolescents (10- to 19-year-olds) and young adults (20- to 24-year-olds), it is unclear what evidence supported this distinction. The well-documented phenomenon of sharply rising rates of TGD identification in recent years affects both adolescents and young adults and these groups share a common epidemiologic profile (i.e., overrepresentation of females with a high burden of pre-existing mental health conditions and neurocognitive difficulties). Existing systematic reviews of evidence have thus far focused on adolescents and have found the evidence of benefits to be of very low to low certainty. We are not aware of any evidence that would suggest any more certainty about the outcomes for young adults, and in fact the WPATH SR’s conclusions of “low quality” evidence for benefits of gender-affirming hormones applied to both adolescents and adults.

Of note, countries that have expanded access to hormones for vulnerable youth, especially those aged 18-25, based on an “informed consent model,” which facilitates wide access to hormones without mental health assessments, are now starting to see the negative effects of such recommendations. For example, there is already a documented up to 30% rate of discontinuing hormones a few years after starting gender-affirming care—an intervention that is intended to be lifelong. Currently, there is very little guidance about how to medically and psychologically support patients who detransition.

3. The process for the TGD guideline recommendations appears near completion. Significant changes are in order to restore confidence in the trustworthiness of the planned recommendations.

The original announcement stated that the upcoming February 2024 meeting of the GDG would “formulate recommendations” and “suggest implementation considerations”—steps that signal the end, rather than the beginning, of a guideline development process. This description concurs with the process as described in the WHO handbook for guideline development. By the time the Guideline Steering committee convenes the GDG meeting, all the key decisions that shape the final recommendation—from the specific recommendation questions the guideline will answer to the relevant evidence review synthesis—have already been made (see Table 1.1. below).

However, in its updated announcement, WHO seems to suggest that the process is still in its early stages:

Following the completion of the extended public feedback period, the final list of GDG members is expected to be announced and the group will begin its work. The overall process for development of the guideline could take up to 2 years, with further opportunities for external expert review and comments. [emphasis added]

It is unclear whether the WHO is now stating that the process may take up to 2 additional years, or if it is merely restating the standard timeframe for developing a WHO guideline of this kind. The latter interpretation appears more likely, as the FAQs indicate that the process began in 2021, and lists the key steps that have already taken place, including initiating evidence synthesis, which is typically completed before the GDG meets. The process should not be described by WHO as “about to begin” if it is demonstrably approaching its end.

We also note a seeming deviation from the standard WHO process as outlined in the WHO handbook for guideline development. According to the standard process, the GDG should have been formed before the scope and the guideline questions were finalized, and before the evidence synthesis were completed. Further, the GDG should have played a key role in those decisions (see below). Yet, the FAQs suggest that these steps have already occurred, while the GDG is yet to “begin its work.”

It is critical that the WHO either acknowledge that the GDG composition, shared in June 2023, has already shaped all the key parts of the process and the process is near completion—or it must recognize that significant changes are needed in light of the concerns raised, which will necessitate a reconsideration of the decisions already made.

In SEGM’s assessment, for the process to regain credibility, the GDG composition must undergo significant changes. Once the GDG issues (conflicts of interest, lack of diverse perspectives) have been addressed, the new GDG must shape the key decisions, from the guideline scope to the recommendation questions. This, in turn, will likely necessitate new evidence reviews: the evidence synthesis team cannot produce syntheses of evidence until the recommendation questions have been finalized by the GDG.

Changes to the GDG Composition

Following the public expression of concern, the WHO announced that the most controversial GDG member was removed from the group “due to scheduling conflicts.” While the balance of the GDG composition remains unchanged, the announcement invites further feedback and suggests that the composition of the guideline development group may undergo additional changes (“Following the completion of the extended public feedback period, the final list of GDG members is expected to be announced...”).

While the WHO’s willingness to address conflicts of interest in the current GDG is a step in the right direction, major changes to the composition of the GDG would be needed for this effort to regain credibility. In the updated GDG of 20 members, all but four appear to have significant intellectual and/or financial conflicts of interest, including strong ties to organizations that would benefit from a WHO recommendation to expand access to hormones (e.g., WPATH) and promote legal recognition of self-determined gender (e.g., GATE). While the WHO states that these individuals represent themselves, their leadership roles within prominent organizations with singular missions to promote medicalization and legal gender self-identification cannot be ignored.

Of note, the GDG involved in the WHO Self-Care guidelines determined that 60% majority vote was sufficient for adopting guideline recommendations (p.131). This suggests that it is possible that guidelines for trans and gender-diverse populations may be adopted with the support of as few as 12 of 20 the current guideline development group members. Once the GDG meets and makes its recommendations, there is no mechanism for changing the recommendations.

It is critical that the WHO commit to assembling a GDG comprised of stakeholders who are free from conflicts of interest and who represent a diversity of viewpoints about the risks and benefits of expanded access to hormones. In addition to expertise in the provision of gender-affirming care, the GDG should include experts in youth development, mental health (including experts in autism, neurocognitive conditions, and gender-exploratory therapy), reproductive health, and maternal and fetal health. It should also represent detransitioners, as this is a growing population of significant stakeholders impacted by WHO recommendations.

Further, the question of legal recognition of self-ID should be decoupled from the current scope. Determining the societal risk-benefit analysis of legal recognition of self-determined gender has implications not only for TGD individuals but also for the rights of women. Before making such an important societal recommendation, all affected stakeholders should be consulted. The current guideline development group includes no voices representing the rights of women.

Expanded Timeline

Allowing sufficient time to enable evidence-based decision-making in this complex and contentious arena is critical. It must also be clearly recognized that additional time alone is insufficient. As discussed above, by the time the GDG meeting is publicly announced, many of the critical decisions—from setting the guideline scope to articulating the specific questions the guideline will answer and commissioning and synthesizing the evidence—have already been made.

A guideline scope based on a biased set of assumptions (e.g., the assumption that access to “gender-affirming” hormones should be expanded for all individuals who identify as TGD) would lead to skewed recommendation questions, which in turn may lead to an inadequate assessment of the evidence. It is important to question whether expanded access to hormones and/or legal recognition of self-determined gender should be the recommended interventions, for which subgroups of TGD individuals, and under what circumstances—before embarking on writing a recommendation about how to expand these interventions. Addressing these issues will require a significant change, including reconsidering the guideline scope and questions.

SEGM Take-aways

Given the sharp rise in the numbers of young people identifying as transgender and gender-diverse worldwide, evidence-based healthcare recommendations are urgently needed. However, rather than starting from the assumption that expanded access to hormones and legal recognition of self-determined gender are universally beneficial actions, the effects of each intervention must be considered separately for all affected subpopulations (e.g., young adults, natal males, natal females, individuals with psychiatric comorbidities) and compared to alternatives.

In the wake of the WHO’s December announcement, our initial set of concerns focused on the biased composition of the GDG, which is tasked with articulating the final recommendations. However, our additional analysis of the WHO guideline development process suggests that the process may have been inadvertently biased much earlier.

Bias does not necessarily reflect a conscious decision to unduly influence the recommendations. Bias frequently arises based on one’s intellectual position and prior experiences. The WHO departments involved in the proposed guideline also led the development of the two prior guidelines mentioned in the FAQ. While proposals for expanded availability of hormones and the notion that legal systems need to accommodate access to care for TGD individuals at risk for HIV may have been justified through the lens of HIV prevention, these same positions need to be reexamined if the population under consideration now includes all persons who identify as TGD. This is particularly important since the largest and fastest-growing group of TGD-identified individuals worldwide represent a vulnerable population of youth (adolescents and young adults) with relatively recent emergence of TGD identification.

SEGM recommends that the WHO address the upstream issues that have led to the problems described above. Other aspects besides the GDG composition likely need to be addressed, including revisiting the guideline scope, the recommendation questions, and ensuring that proper evidence reviews have been commissioned to address key questions. It is possible that the steering committee itself needs to expand to introduce more diversity in perspectives, since the steering committee is ultimately responsible for key decisions, from setting the guideline scope, to formulating the recommendation questions and commissioning evidence reviews, to recruiting the GDG.

We recognize that a number of key steps have already likely occurred and that revisiting them may further delay the final recommendations. However, if the WHO continues on the current track with only minor changes, there is a serious risk that it will create a treatment guideline that may harm, rather than help, vulnerable populations, undermine the rights of women and girls, and lead to a loss of trust in the WHO guideline credibility more generally. More time—and a more open, transparent process that takes a wider range of perspectives into account—can only further the WHO’s mission to promote the right to health worldwide.

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