Ruth Coppinger (Dublin West, Anti-Austerity Alliance)
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38. To ask the Minister for Health if he will address the case of a person (details supplied) with a pharmaceutical company; his views on the National Plan for Rare Diseases; and if he will make a statement on the matter. [12076/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health I have no function in this statutory process.

I am informed that the manufacturer has submitted an application to the HSE for reimbursement of Procysbi. As far back as December 2015, the manufacturer was asked to submit a health technology assessment dossier to assist in decision-making. That dossier is awaited.

The NCPE recommendation in relation to the need for a full health technology assessment is published online on the NCPE website. The NCPE reviewed the medicine again in January 2017, following, some revisions by the manufacturer, and recommended that an HTA dossier would still be required to assist decision-making. The HSE informed the manufacturer of this ongoing requirement again on 31 January 2017.

I have asked the HSE to reply directly to the Deputy in relation to the individual case raised.

The National Rare Disease Plan provides a policy framework for the diagnosis and treatment of people with rare diseases, of which there are between 5000 and 8000 Ireland. The plan made 48 recommendations designed to help improve the lives of people affected by rare disease. An Oversight Group – chaired by the Department – is overseeing progress with the plan.

An Interim Report on the implementation of the National Rare Disease Plan for Ireland was published last Tuesday, 28th February. Implementation of the plan is well underway and we are already into the second half of the implementation period.

In 2016 a number of projects were funded by the State with €1.686m, matched by charity funding of €1.224m. The total funding of €2.91m is shared between 11 charities. The next round of this joint funding initiative will open in autumn 2017.

The EU commission now intends to explore the possibility to further strengthen the collaboration between Member States and the Commission in the area of research on rare diseases. In addition, rare diseases have already been tabled on the agenda for North-South meetings. Therefore, future work to deepen cooperation between both jurisdictions on rare diseases is anticipated.