Jackie Cahill (Tipperary, Fianna Fail)
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1508. To ask the Minister for Health if synarel can be prescribed by a consultant as a hormone treatment for a person who is transitioning; and if he will make a statement on the matter. [63458/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The use of a medicinal product outside of the specific terms of its marketing authorisation is often described as “off-label use”. This is a not an uncommon practice and reflects the fact that there are not enough approved products to deal with every medical need and proposed practical usage of the product to deal with all patients’ needs. 

A different indication for the use of a product other than that described in the marketing authorisation would be the responsibility of the prescriber to satisfy him/herself that the indication was supported by good quality information from the scientific literature. The 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 or her care outside of the terms of the marketing authorisation, such usage is not covered by nor prohibited by medicines legislation. No specific provision is mentioned in the legislation either at national or European level with regard to the practice of “off-label use”. 

The medical decision to prescribe, or not prescribe, any 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.