FSRH Consultation Response: MHRA consultation to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies
Date: 23 Feb 2022
Type: FSRH Press Releases and Statements
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently consulted on whether to reclassify Gina (a tablet for the treatment of vaginal atrophy in postmenopausal women) as a Pharmacy (P) product. This means that Gina would be available for purchase from a pharmacist without a prescription. In our consultation response, we make the case for reclassification of Gina as a step towards improving women’s access to safe menopause medicines.
Gina is a 10mg vaginal oestradiol tablet, used to treat vaginal atrophy caused by oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least one year. Unlike systemic hormone replacement therapies (HRT), Gina works locally, thus reducing the risk of breast cancer and coagulation disorders and can be used long-term to relieve menopause symptoms.
Given the significant barriers to health management faced by women going through the menopause, reclassification provides women the opportunity to access medicines more easily and to take control of their menopause. We would like to see the UK government work closely with pharmacies to ensure that Gina is affordable for everyone, especially to those on low incomes, to avoid exacerbating existing inequalities in women’s healthcare and in access to menopause care in particular.
However, we are wary of the prevalence of out-of-date and misleading information in relation to both HRT and vaginal oestrogen treatment. We urge the UK government to ensure that product information for Gina does not simply duplicate that of HRT, given that many of the purported system HRT risks do not apply. Moreover, since Gina only addresses one of the many symptoms of menopause, women should be encouraged to continue to seek help from their GP or SRH professional to manage other symptoms.
You can read our response in full here.
You can view the original consultation here.