Michael Creed (Cork North West, Fine Gael)
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586. To ask the Minister for Health when the new drug recently approved for MS patients (details supplied) will be available on prescription for patients; and if he will make a statement on the matter. [40981/14]

Michael Creed (Cork North West, Fine Gael)
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724. To ask the Minister for Health when the new drug Sativex, recently approved for MS patients, will be available on prescription for patients; and if he will make a statement on the matter. [41648/14]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 586 and 724 together.

On 18 July 2014 the Health Products Regulatory Authority granted a marketing authorisation for cannabis based medicinal product Sativex® to be marketed in Ireland. The remaining timeframe for making the product available for prescribing in Ireland is the responsibility of the holder of the product authorisation, GW Pharmaceuticals PLC and their European partner Almirall.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the GMS and community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Applications for reimbursement are considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines.

The HSE received an application for inclusion of Sativex® under the Community Drugs Schemes High Tech Arrangements in early September 2014. The application is being considered in line with agreed procedures.

A Health Technology Assessment on Sativex® has been completed by the National Centre for Pharmaceoeconomics (NCPE) and the report is available on the NCPE's website (www.ncpe.ie). The NCPE did not recommend reimbursement of Sativex® at the submitted price. The HSE will be engaging with the pharmaceutical company (Almirral) to discuss some issues of relevance to the pricing and reimbursement of Sativex® which have been identified by the NCPE.

The NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the supplier. However it is not the only input into decision making. The HSE assessment processes are intended to arrive at decisions on the funding of Sativex® and other medicines that are clinically appropriate, fair, consistent and sustainable.

Decisions on which medicines are reimbursed by the taxpayer, are therefore not political or ministerial decisions. These are made on objective, scientific and economic grounds by the Health Service Executive (HSE) on the advice of the National Centre for Pharmacoeconomics (NCPE).

No further comment can be provided at this time as the assessment process is on-going.