15 December 2020 - NW2896
Tito, Ms LF to ask the Minister of Health
(1)Whether he has been informed that transgender women in Kimberly in the Northern Cape are given a hormonal therapy drug called Premarin; if not, what is the position in this regard; if so, (2) whether the specified drug has been sanctioned by his department; if not, what is the position in this regard; if so, what quality-control mechanisms have been undertaken to ensure that it is safe for human consumption?
1. Hormonal medicines used in transgender patients include testosterone for masculinising, and oestrogen for feminising. Access to these agents for use in transgender patients is currently off-label (i.e. not registered for this indication) and is only available at a tertiary level of care requiring specialist approval. The overall management of transgender patients requires specialised clinical skills and access to complex psychosocial assessment and interventions. The Robert Mangaliso Sobukwe Hospital in Kimberley is a Tertiary Hospital in the Northern Cape and is currently in the process of putting systems in place to offer this service. Currently, patients are managed with the support of the clinical expertise from the Universitas Hospital in the Free State.
2. Yes, the medicine has been approved by the National Essential Medicines List Committee for inclusion on the Essential Medicines List at the tertiary level of care. Inclusion of any medicine on the Essential Medicine List is based on evidence of efficacy, quality, safety. Registration by the national regulatory authority, the South African Health Products Regulatory Authority, is therefore required for human consumption.