Medicinal Products Availability

Dáil Éireann Debate, Tuesday - 17 January 2017

Tuesday, 17 January 2017

Ceisteanna (1144, 1159)

Louise O'Reilly

Ceist:

1144. Deputy Louise O'Reilly asked the Minister for Health the status of a drug awaiting approval by the NCPE (details supplied); and if he will make a statement on the matter. [1167/17]

Ruth Coppinger

Ceist:

1159. Deputy Ruth Coppinger asked the Minister for Health if a drug (details supplied) for those persons with spinal muscular atrophy type 1 will be made available through the public health service; and if he will make a statement on the matter. [1211/17]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 1144 and 1159 together.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE.

Prior to a medicine being marketed, made available to patients and/or submitted for assessment under the 2013 Act, it must have a market authorisation from the European Medicine Agency (EMA).

The European Medicines Agency provides independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.

The EMA’s evaluations of marketing-authorisation applications provide the basis for the authorisation of medicines in Europe. This is separate to the Statutory Assessment process conducted by the HSE.

I understand from the HSE that Biogen have applied to the European Medicines Agency (EMA) for market authorisation in the EU for the drug Nusinersen (Spinraza). The application to the EMA was submitted in Autumn 2016. The EMA assessment process generally takes around one year.

Should Nusinersen receive European marketing authorisation, the manufacturer would then be open to make an application to the HSE to have the product reimbursed under the community drug schemes.