Sorca Clarke (Longford-Westmeath, Sinn Fein)
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683. To ask the Minister for Health the steps that he and his Department are taking to tackle the continued shortage of hormone replacement treatments across the country; and if he will make a statement on the matter. [26470/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Unfortunately, medicine shortages have become increasingly prevalent worldwide over the past decade and are a feature of modern health systems around the world. There are many reasons for such shortages including shortages of raw materials, manufacturing difficulties, logistical/transport issues or product recalls due to potential quality defects. 

Medicines shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicines shortages require a multifaceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. Ireland has a multi-stakeholder medicines shortages framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.

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.

Based on information provided by companies involved in the recent HRT shortages, we now appear to have entered a stabilisation period in supply. During this stabilisation period, it is essential that patients do not seek supplies of medicines over and above their normal requirements as doing so will disrupt existing stock levels and hamper the supply of medicines for others. Following a meeting with key stakeholders involved in the supply of HRT products to the Irish market it was agreed to establish a multi-stakeholder group to closely monitor the supply of HRT until the issue is fully resolved.

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.