Written answers

Tuesday, 22 June 2021

Department of Health

Medicinal Products

Photo of Peadar TóibínPeadar Tóibín (Meath West, Aontú)
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606. To ask the Minister for Health the persons or bodies that oversee the purchasing and administration of puberty blockers to be utilised in gender transitions. [25841/21]

Photo of Peadar TóibínPeadar Tóibín (Meath West, Aontú)
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608. To ask the Minister for Health if a review has been conducted by his Department or the HSE of the side effects of puberty blockers in view of recent reports from England questioning their utility. [25843/21]

Photo of Frank FeighanFrank Feighan (Sligo-Leitrim, Fine Gael)
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I propose to take Questions Nos. 606 and 608 together.

As these Parliamentary Questions relate to operational issues, it is a matter for the HSE.

However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is on-going, and the HSE is working hard to restore its IT capacity and resume normal services. Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.

Photo of Peadar TóibínPeadar Tóibín (Meath West, Aontú)
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607. To ask the Minister for Health the regulations pertaining to the usage or prescription of puberty blockers by medical professionals. [25842/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Puberty blockers, also called puberty inhibitors, are drugs used to postpone puberty in children. The most commonly used puberty blockers are gonadotropin-releasing hormone (GnRH) agonists, which inhibit the release of sex hormones, including testosterone and oestrogen. In addition to their various other medical uses, puberty blockers are used off-label for transgender children to delay the development of unwanted sex characteristics. 

The use of a medicinal product outside of the specific terms of its marketing authorisation (MA) is often described as “off-label use”. It is the responsibility of the prescriber to satisfy him/herself that off-label use of a medicine is supported by good quality information from the scientific literature. Such off-label use therefore falls within the professional, clinical judgement of the prescriber.   

Where a product is used by a healthcare practitioner for patients under his care outside of the terms of the MA, such usage is not covered by, nor prohibited by, medicines legislation. The medical decision to prescribe or not prescribe a specific treatment for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Department of Health has no role in this clinical decision-making process.

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