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Medicinal Products Availability

Dáil Éireann Debate, Friday - 16 September 2016

Friday, 16 September 2016

Questions (1120, 1121)

Louise O'Reilly

Question:

1120. Deputy Louise O'Reilly asked the Minister for Health the reason the drug Sativex is not available to persons who suffer from multiple sclerosis despite the former Minister of State for primary care signing a statutory instrument legalising its use in July 2014; and when it will be available. [24851/16]

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Louise O'Reilly

Question:

1121. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question No. 61 of 2 February 2016, if he will provide an update on the issue of potential pricing for the Sativex drug, which was under consideration by the HSE; and if he will make a statement on the matter. [24852/16]

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Written answers

I propose to take Questions Nos. 1120 and 1121 together.

On 11 July 2014, the Misuse of Drugs Regulations 1988 were amended to allow for certain cannabis-based medicinal products to be used in Ireland. The Health Products Regulatory Authority subsequently granted a marketing authorisation for the cannabis-based medicinal product Sativex to be marketed in this State. It was then open to the holder of that authorisation to make the product available for prescribing in Ireland.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the GMS and community drug schemes, under the Health (Pricing and Supply of Medical Goods) Act 2013. Decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The HSE has received an application for the inclusion of Sativex on the High Tech Scheme. However, an NCPE health technology assessment report on Sativex did not recommend reimbursement at the submitted price. The NCPE report is an important input to assist the HSE in its decision-making process and informs engagement between the HSE and the supplier.

Sativex is not currently reimbursed; the HSE is awaiting further engagement from the supplier.

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