Helen McEntee (Meath East, Fine Gael) | Oireachtas source

I thank the Senator for raising this issue. I am taking this matter on behalf of the Minister for Health, Deputy Simon Harris, who sends his apologies for not being able to attend. I understand the type of issue the Senator is dealing with, as I have dealt with a similar one in my constituency. I know how difficult it is for the individual affected and their family. The Senator will appreciate, however, that I am not in a position to comment on the case of any individual patient, even when some personal details are already in the public domain.

The HSE, as the principal provider and budget holder in respect of public health services, is obliged to use the resources available in the most beneficial, effective and efficient manner to improve, promote and protect the health and welfare of the public. This requires it to make difficult decisions to ensure the finite resources at its disposal are used to best effect. Soliris is an ultra-orphan medicine manufactured by Alexion Pharma and licensed for the treatment of two rare blood disorders. The drug is not licensed for the treatment of Degos disease by either the European Medicines Agency or the US Food and Drug Administration. The licensing of pharmaceutical medicines is a matter for the Health Products Regulatory Authority in Ireland and the European Medicines Agency in the European Union. It is not in the power of the Minister for Health to licence any pharmaceutical product, regardless of whether it has already been approved for use within the European Union. It is appropriate that such matters are dealt with by expert and impartial authorities established for this purpose.

In early 2015 the HSE decided to fund the provision of Soliris for sufferers of two specific conditions for which it had been licensed. At an individual cost of over €400,000 per patient per year, the drug is expected to cost the HSE approximately €8 million in 2016. Given these substantial costs, the director general of the HSE has put in place formal procedures to ensure each case in which Soliris is used is the subject of clear advance authorisation. These arrangements would not permit the drug to be used for the treatment of a condition beyond the terms of the marketing authorisation and where evidence of clinical benefit has not been demonstrated.

It is open to a drug’s manufacturer at any time to submit an application to the European Medicines Agency to have a product licensed for use for a specific indication. Once the drug is approved by the European Medicines Agency, the manufacturer can, if it wishes, submit an application for pricing and reimbursement to the HSE.

It should be noted that there is no provision in legislation for the approval of compassionate access programmes for specific groups of patients with an unmet medical need. I trust the Senator will appreciate the position in this matter. Perhaps such a programme might be looked at further down the line.

I will raise with the Minister the fact that the Connolly family has written to him twice and ask him to respond.