Once a company responsible for the commercialisation of a new medicine receives marketing authorisation from the European Medicines Agency (EMA), it can apply for reimbursement in the country (or countries) of its choice.
The timing of company applications for new medicines reimbursement in different countries can vary for several reasons, not least the available market share in each country.
Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. The reimbursement assessment process cannot begin until an application is received. The HSE cannot decide to reimburse a new medicine if no application is received from a company.
Access to medicines requires industry and the State to work together, through timely assessment, and reasonable pricing with fully completed HTAs (Health Technology Assessments).
Pharmaceutical firms are encouraged to proactively engage with the HSE, to submit application dossiers that contain the information needed by the National Centre for Pharmacoeconomics (NCPE) to undertake the required assessments as efficiently as possible on behalf of the State.
