Kathleen Lynch (Cork North Central, Labour) | Oireachtas source

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. This product is indicated for the relief of symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed to provide adequate benefits.

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. 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. They are not political or ministerial decisions.

Following the granting of a marketing authorisation, it was open to the holder of that authorisation to make the product available for prescribing in Ireland. In September 2014, the HSE received an application for inclusion of Sativex under the community drugs scheme's high-tech arrangements. A health technology assessment report on Sativex has been completed by the National Centre for Pharmacoeconomics, which did not recommend reimbursement of Sativex at the submitted price. The report by the NCPE is an important input to assist the HSE in its decision-making process, and informed further engagement between the HSE and the supplier in relation to potential pricing arrangements for this product.

As the matter remains under consideration by the HSE, unfortunately, I am not in a position to make any further comment.

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