Speaker:
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Darren Scully, Medicines Shortages & Borderline Classification Manager, HPRA
Summary:
Darren Scully discusses the multi-stakeholder framework approach to tackling medicine shortages. He explains how any issue in the supply chain can lead to shortages and emphasises the need for a collaborative approach involving various stakeholders. The framework aims to prevent shortages and mitigate their impact on patients. When a shortage is verified, the marketing authorisation holder is given a chance to address it, and if they can't, alternate suppliers may be engaged. Darren also discusses the regulatory options available to address shortages, such as importing similar products or allowing the supply of exempt medicinal products. The examples of shortages and the efforts taken to resolve them are highlighted, emphasising collaboration and communication between stakeholders. Overall, the speaker stresses the importance of early notification of shortages and the need for stakeholder meetings to implement prevention measures.