Dara Calleary (Mayo, Fianna Fail)
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219. To ask the Minister for Health the criteria and application process involved for inventors/product developers in having new products added to the list of products available on the medical card scheme; and if he will make a statement on the matter. [12480/14]

Alex White (Dublin South, Labour)
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The first step for a medicine to be placed on the Irish market involves the manufacturer seeking an authorisation from the Irish Medicines Board (IMB) or in the case of certain medicinal products, the European Medicines Agency (EMA). A determination on the application for authorisation is based on a rigorous scientific assessment of the application against legal and regulatory requirements. Once authorised on the Irish market, the supplier must make an application to the HSE for the product to be included on the list of products covered under the GMS and other community drug schemes. The application is considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA) for the assessment of new medicines.

In accordance with these procedures, the HSE may ask the National Centre for Pharmacoeconomics (NCPE) to conduct a pharmacoeconomic evaluation of the new product which provides detailed information on the potential budget impact of the medicine. It also assesses whether the product is cost effective at the price quoted by the company in question. The NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the supplier. The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable.