Bernard Durkan (Kildare North, Fine Gael)
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1453. To ask the Minister for Health the number of orphan or new drugs currently awaiting approval to qualify for reimbursement; and if he will make a statement on the matter. [33798/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

I am advised by the HSE that there are currently 81 applications for reimbursement (including new medicines and new uses of existing medicines) undergoing assessment.

The Committee for Orphan Medicinal Products (COMP) is the European Medicines Agency's (EMA) committee responsible for recommending orphan designation of medicines for rare diseases. This designation is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. The European Commission decides whether to grant an orphan designation for the medicine based on the COMP's opinion.

The HSE has advised that the appropriate repository of the information relating to designated orphan drugs is the EMA website. The status for any medicine could change in the event that a medicine is removed from the Community Register of designated Orphan Medicinal Products and therefore it will be appreciated that these figures are not readily available as the status of a medicine can change at any stage.

As of 30 October 2020, 25 of the medicines under consideration for reimbursement in Ireland had orphan designation.