Dáil Éireann Debate, Tuesday - 22 March 2022
823. Deputy Duncan Smith asked the Minister for Health his views on the ongoing issues in relation to the availability of HRT patches; the plans he has to address the issue; and if he will make a statement on the matter. [13966/22]
View answer964. Deputy Emer Higgins asked the Minister for Health if his attention has been drawn to current shortages in supply of hormone replacement therapy patches and gel for the treatment of severe menopause symptoms; if he is undertaking measures to improve access to these menopause supports; and if he will make a statement on the matter. [14457/22]
View answerI propose to take Questions Nos. 823 and 964 together.
The HPRA is aware of the current challenges regarding the intermittent supply of some hormone replacement therapies (HRT). The HPRA has had regular and ongoing engagement with suppliers in this regard. The companies that place the products on the market have indicated that the current supply difficulties are due to a significantly increased demand for these medicines in Ireland in recent years. To illustrate, the supply of one range of HRT patches has increased by between 77% and 117%, for the three most-used strengths, compared to 2020. In addition, based on demand in recent months, the company expects a similar increase in the demand for all strengths during 2022. This would mean that the usage of this patch in Ireland would be approximately 4.5-7.5 times higher in 2022 (depending on the strength) compared to 2019.
Regarding the HRT patches, the suppliers have confirmed that they have increased the planned supply of HRT patches to Ireland during 2022 in response to this increased demand. In the case of one brand (Evorel/Evorel Conti), the supply of HRT patches has resumed. For another brand (Estradot), some strengths are available currently and, based on manufacturing availability, the re-supply of the full range is expected to be in July. With respect to the gels, the supplier of Divigel has indicated that it expects supply to resume next week (week beginning 21st March). Supply of an alternative gel product (Oestrogel) has recently run out and is expected to resume in April. In the interim, the companies have indicated that they are working to find solutions to the immediate supply issues.
The current supply situation has arisen due to significant increases in demand for HRT medicines and is not linked to regulatory matters. However, the HPRA continues to review available options within their regulatory remit to facilitate increased supply where at all possible. In particular, the HPRA has advised companies that they are open to providing accelerated regulatory approval to supply a product originally intended for other markets if available. HPRA are awaiting further information from the companies in this regard.
The HPRA publishes a medicinal product shortages list on its website, with the reason for the shortage, the expected dates for the return of supply and in some cases, such as HRT shortages, the HSE’s clinical guidance on the management of patient treatment in response to medicine shortages. The information is made available to assist healthcare professionals in managing medicine shortages when they do arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information the HPRA has to hand, including removal from the list when a shortage has been resolved.
The HPRA will continue to liaise with suppliers of HRT medicines over the coming weeks with a view to securing updates and commitments regarding the restoration of normal supplies for patients as soon as possible.
