Help support Cork Safety Alerts by becoming a member – Click Here
The Minister for Health Stephen Donnelly TD has welcomed a multistakeholder meeting to discuss ongoing efforts to minimise the impact of medicines shortages currently being experienced in Ireland and across the EU.
The meeting between industry, health sector and patient representatives, officials from the Department of Health and the Health Products Regulatory Authority took place today.
Minister Donnelly said:
At my request the Department of Health today held a multistakeholder event to listen to the experiences of all parties, to update on work ongoing to manage this situation and to discuss any further potential actions deemed appropriate during this period. I look forward to hearing the outcome of this meeting and supporting my officials in ensuring all suitable actions are progressed.
I wish to acknowledge the ongoing work by all stakeholders in the management of medicines shortages at present. The Medicines Shortages Framework, operated by the Health Product Regulatory Authority (HPRA) on behalf of my Department, aims to prevent, where possible, and mitigate the impact of medicines shortages when they occur through timely communication with stakeholders. The current situation is being coordinated by the HPRA through this framework in close collaboration with my Department, the HSE, industry and healthcare professionals.
I would particularly like to commend the valuable contribution being made by our prescribers and pharmacists who are working closely together in ensuring best outcomes for patients in accessing medicines at this time.
Due to the high levels of respiratory illnesses in the community in recent weeks, a significant increase in demand for medicines used to treat seasonal conditions such as colds and flus has been observed. Demand in some cases is 2 to 3 times the typical demand seen at this time of year.
The issue is mirrored across EU countries. The European Commission along with the European Medicines Agency (EMA) are working on a suite of measures to tackle the immediate issues as well as looking to implement long-term, sustainable solutions to ensure continuity of supply to the EU market.
The Minister said:
Ireland very much welcomes this Commission-led approach to addressing this pan-European problem and is encouraged by the long-term solutions being put in place at EU level.
Whilst there are currently many products listed as being in short supply on the HPRA website, there are typically multiple alternatives available from various sources and suitable substitutes continue to be available on the market to treat respiratory illnesses. Of all products out of stock at this time the Department can confirm that there are none for which there is no suitable clinical alternative.
Furthermore, contrary to some industry claims, the Department can confirm that no company has cited pricing as a reason for current product shortages. To support this the HSE completed a comprehensive review of the published HPRA shortages list on 16 January 2023. Of all products listed in short supply, none were attributable to pricing issues.
Through close engagement with industry, the HPRA has confirmed that in several instances suppliers have increased production and sourced additional stock to respond to this recent increase in demand. The HPRA remains open to expediting regulatory procedures to enable supply of additional stock, where possible.
The HSE has established an Incident Management Team (IMT) to address shortages of antibiotics and has issued several memos to support prescribers and pharmacists at this time. Working closely with the HPRA, they have developed a webpage to include information on products currently available (www.antibioticprescribing.ie).
The pricing approach in Ireland is in line with the framework agreements with industry representative groups and is based on a ‘basket of goods’ approach, including a representative average of EU Member States. Shortages impact all EU Member States (including those that are reported to pay higher prices). These Agreements were signed just over 12 months ago after comprehensive research and negotiations by the Department and HSE with industry representatives; with security of supply being recognised by all parties as crucially important to the effective operation of the Agreements.