I propose to take Questions Nos. 673, 695, 712, 733, 744, 786 and 816 together.
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 multi-faceted, 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), notably transdermal patches. 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 products, Estradot, has increased by between 77% and 117% for, 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 Estradot in Ireland would be approximately 4.5-7.5 times higher in 2022 (depending on the strength) compared to 2019.
The suppliers have confirmed that they have increased 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. 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 our regulatory remit to facilitate increased supply where at all possible. In particular, the HPRA has advised the companies that we are open to providing accelerated regulatory approval to supply a product originally intended for other markets if available. We 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.
