The Medicines (Gonadotrophin-Releasing Hormone Analogues) (Restrictions on Private Sales and Supplies) Order 2024: impact assessment – RPC opinion (green-rated)
Regulatory Policy Committee (RPC) opinion relating to DHSC’s impact assessment (IA) relating to an indefinite ban on the sale and supply of puberty blockers.
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This legislation implements an indefinite ban on the sale and supply of puberty blockers to under-18s by private UK providers and prescribers in the EEA and Switzerland.
The assessment outlines a sufficient rationale, focussed on preventing unsafe prescribing to protect patient health, however, this could be improved with more evidence to indicate the scale of the issue. The IA considers a suitable shortlist of three options, based on recommendations from independent reviews. The SaMBA provided is sufficient. The assessment includes a reasonable qualitative justification for the preferred way forward, drawing on evidence from the Commission on Human Medicines (CHM) and the Cass Review.
The IA sets out the need for government intervention with the claim that as the current temporary ban was set to expire, further action was required to address the potential risks with inappropriate prescribing. The Government decided that an indefinite ban was necessary to address the concerns raised by CHM on a long-term basis. The IA supports this argument by discussing some of the potential harms that could be caused by a failure to intervene, such as the return of prescribing through routes that do not have adequate evidence confirming their safety and efficacy.