Jack Chambers (Dublin West, Fianna Fail) | Oireachtas source

I thank Senator Martin for raising this issue which I am taking behalf Minister for Health, Deputy Stephen Donnelly. The Department of Health has informed me that Friedreich's ataxia is a rare disease affecting fewer than 200 people in Ireland. The condition involves progressive neuromuscular degeneration leading patients to have difficulty with things such as walking, speech and co-ordination. Unfortunately, the progression of the disease can shorten patients' life expectancy and severely impact on their quality of life. There is currently no approved treatment for Friedreich's ataxia in Europe. A new medicine omaveloxolone has recently been approved by the Food and Drug Administration, FDA, in the United States for this condition, as the Senator mentioned.

The European Medicines Agency, EMA, is a centralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays integral role in the authorisation of medicines in the EU. The company marketing this treatment has now applied for marketing authorisation from the EMA and its evaluation commenced on 28 December last year. In Ireland the Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.In line with the 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 formal reimbursement list. Reimbursement is for licensed indications that have been granted market authorisation by the European Medicines Agency, EMA, or the Health Products Regulatory Authority. In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria, including efficacy, the health needs of the public, cost-effectiveness, and potential or actual budget impact.

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. As Omaveloxolone has not yet been granted marketing authorisation by the EMA, an application for pricing and reimbursement cannot be made to the HSE. If marketing authorisation is granted and the company chooses to apply, the HSE will give fair consideration to the application with consideration of the criteria detailed in the 2013 Act. Omevaloxolone has been designated as an orphan drug by the EMA. This designation is given to substances for treating, preventing, or diagnosing rare and serious conditions.

The Government is committed to making new medicines available to patients in Ireland, with almost €100 million of funding dedicated to new drugs over the past three budgets. Budget 2023 allocated €18 million of dedicated funding for new drugs. As of the end of March, 15 new drugs have been approved, five of which were orphan drugs. Budget 2022 allocated €30 million for new drugs. This enabled approval for 60 drugs,16 of which were orphan drugs. Budget 2021 allocated €50 million for new drugs; 52 new medicines were approved from this funding, including 18 new orphan drugs.