May 5, 2021

Sweden’s Karolinska Ends All Use of Puberty Blockers and Cross-Sex Hormones for Minors Outside of Clinical Studies

Concerns over medical harm and uncertain benefits result in a major policy shift

Update May 08, 2021: Following a new policy statement from the Karolinska Hospital that went into effect May 2021, this article has been updated to reflect the changes.

Update February, 2022: Sweden's National Board of Health and Welfare has followed the Karolinska's lead and issued a national policy update closely mirroring the policy adopted by the Karolinska. You can read more about Sweden's new policy regarding hormonal interventions for gender-dysphoric minors here.

The Karolinska Hospital in Sweden recently issued a new policy statement regarding treatment of gender-dysphoric minors. This policy, affecting Karolinska's pediatric gender services at Astrid Lindgren Children's Hospital (ALB), has ended the practice of prescribing puberty blockers and cross-sex hormones to gender-dysphoric patients under the age of 18.

This is a watershed moment, with one of world's most renowned hospitals calling the "Dutch Protocol" experimental and discontinuing its routine use outside of research settings. According to the ”Dutch Protocol,” which has gained popularity in recent years, gender-dysphoric minors are treated with puberty blockers at age 12 (and in some interpretations, upon reaching Tanner stage 2 of puberty, which in girls can occur at age 8), and cross-sex hormones at the age of 16. This approach, also known as medical "affirmation," has been endorsed by the WPATH ”Standards of Care 7” guideline.

According to Karolinska’s newest policy, which went into effect in May 2021, going forward, hormonal (puberty blocking and cross-sex hormone) interventions for gender-dysphoric minors may only be provided in a research setting approved by Sweden’s ethics review board. The policy states that careful assessment of the patient’s maturity level must be conducted to determine if the patient is capable of providing meaningful informed consent. There is also a requirement that patients and guardians are provided with adequate disclosures of the risks and uncertainties of this treatment pathway. It is not clear whether minors under the age of 16 would be eligible for such trials.

The Karolinska Hospital’s new policies echo a growing international concern over the proliferation of medical interventions that have a low certainty of benefits, while carrying a significant potential for medical harm. The latest policy issued by the Karolinska cites the UK NICE evidence review, which found the risk / benefit ratio of hormonal interventions for minors highly uncertain; the 2020 UK judicial review, which highlighted the overarching ethical problems with the practice of medical "affirmation" of minors; as well as Sweden's own Health and Technology Assessment (SBU) evidence review conducted in 2019, which found a lack of evidence for medical treatments, and a lack of explanation for the sharp increase in the numbers of adolescents presenting with gender dysphoria in recent years.

In recent months, several countries’ health authorities found that the evidence base is insufficient to justify routine early medical interventions for gender-dysphoric minors. Finland revised its treatment guidelines in June 2020, prioritizing psychological interventions and support over medical interventions, particularly for youth with post-pubertal onset of gender dysphoria (currently the most common presentation). Significant changes are also underway in the UK. Following the 2020 High Court judgement, the NHS (National Health Service) suspended the initiation of hormonal interventions to minors under 16. The ruling is currently under appeal, with a hearing scheduled for June 2021.

In North America, the debate about treatments for gender-dysphoric minors has become highly politicized. A number of US states have recently introduced laws banning the use of hormonal interventions in gender-dysphoric minors. In contrast, other states have introduced laws mandating public and private insurance coverage for a wide range of gender-"affirming" medical and surgical interventions for "gender incongruence," regardless of a patient's age or mental health status. In Canada, Bill C-6 goes even further, seeking to criminalize psychological treatment modalities, which represent the primary non-invasive alternative to medical and surgical "affirmation." 

As the global awareness of the low quality of evidence of the benefits, and the potential harm of the "affirmative" medical interventions in gender-dysphoric minors grows, non-invasive alternatives for ameliorating the minors' distress, such as the provision of ethical psychological treatments and support, are expected to come into focus.

The March (going into effect April 1) and the April (going into effect May 1) policy documents, as obtained by SEGM from the Karolinska Hospital, along with our unofficial translations, are available below.