Pádraig O'Sullivan (Cork North Central, Fianna Fail) | Oireachtas source

Following on from Deputy Troy's question, last month, data from the latest EFPIA WAIT indicator survey showed that just 14% of orphan medicines licensed by the European Medicines Agency since 2019 are available to patients in Ireland. This places us 26th out of the 36 European countries analysed. Treatments such as ravulizumab, which treats several forms of rare debilitating disease, have remained unavailable to patients in Ireland. In the case of the latter, it has been since its initial application in 2019, despite its availability in the majority of other countries in Europe. Reforms are often disregarded in Ireland as an option reserved to France and Germany. However, rare disease pathways are in place in several countries such as Lithuania, Latvia and Estonia, which operate ultra-orphan pathways for pricing and reimbursement, or Czechia, which operates a specialised assessment process for orphan drugs similar to what is proposed in my Bill. These processes take into account unique characteristics associated with medicines for smaller patient populations and recognise the reality apparent in Ireland. What further steps will be taken as a State to plan for future programmes in this regard?

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