Ireland’s reliance on Exempt Medical Products (EMPs) has reached concerning levels
Ireland’s reliance on Exempt Medical Products (EMPs) has reached concerning levels, with an estimated 7 million packs of unlicensed medicines dispensed last year, serving around 250,000 patients each month. While EMPs play a crucial role in addressing medicine shortages, they are subject to less rigorous regulatory controls and oversight of safety and efficacy standards.
The majority of EMPs are being used to compensate for the lack of licensed medicinal products thereby masking the seriousness of the medicine shortages situation. The overreliance on EMPs undermines the regulatory framework set by the Health Products Regulatory Authority (HPRA) and the European Medicines Agency (EMA) and is ultimately unsustainable.
In 2022, Ireland spent approximately €25 million on EMPs – €7 million more than the entire 2023 budget allocation for innovative high-priced medicines. To address the ongoing challenges, the state has entered into a two-year agreement to stabilize EMP pricing, however this overdependence on unlicensed products continues to strain the healthcare system.