Written answers

Tuesday, 10 November 2020

Department of Health

Medicinal Products

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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674. To ask the Minister for Health the reason access to the compassionate use programme for the new spinal muscular atrophy drug, risdiplam or Evrysdi, is not currently available to adults; and if he will make a statement on the matter. [34663/20]

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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675. To ask the Minister for Health if he will intervene in the granting of access to the compassionate use programme for the new spinal muscular atrophy drug, risdiplam or Evrysdi, by hospitals to adults; and if he will make a statement on the matter. [34664/20]

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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676. To ask the Minister for Health if there is a specific reason adults cannot currently avail of the new spinal muscular atrophy drug, risdiplam or Evrysdi, under the compassionate use programme; and if he will make a statement on the matter. [34665/20]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 674 to 676, inclusive, together.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health, I do not have any statutory power in relation to the reimbursement of medicines.

In addition, Section 6 of the HSE Governance Act 2013 precludes me from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the community drugs schemes, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

On 26 February 2019, the European Commission granted orphan designation (EU/3/19/2145)to Roche Registration GmBH for Risdiplam for the treatment of spinal muscular atrophy (SMA).

The application for marketing authorisation (MA) for Risdiplam is being reviewed under the EMA’s accelerated assessment programme since September 2020 and this process is ongoing.

Under European and Irish legislation, medicinal products (medicines) must be authorised before being marketed. In Ireland, there are two exemptions from authorisation that are relevant to patients for the treatment of conditions where there are medical needs that cannot be met by authorised medicines. These are:

- Supply through participation in an approved clinical trial; or

- In accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfill the special needs of those patients.

In Ireland, compassionate access schemes are entirely at the discretion of the manufacturer. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need. The Minister for Health has no role or powers in this regard.

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