Pauline Tully (Cavan-Monaghan, Sinn Fein)
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423. To ask the Minister for Health the progress that has been made to date on establishing an enquiry into the historical licensing and prescribing of sodium valproate; when an enquiry will be fully established; and if he will make a statement on the matter. [31492/21]

Pauline Tully (Cavan-Monaghan, Sinn Fein)
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426. To ask the Minister for Health if he will consider the establishment of a sodium valproate stakeholder group that would review the measures that are currently in place and make recommendations as to the way they could be strengthened; and if he will make a statement on the matter. [31495/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 423 and 426 together.

Details of the proposed inquiry into the historical licensing and use of sodium valproate in Ireland and the establishment of a stakeholder group to address ongoing concerns relating to the use of this drug are currently being considered by officials within the Department of Health.

Pauline Tully (Cavan-Monaghan, Sinn Fein)
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424. To ask the Minister for Health if it will be ensured that a product which meets his Department's own clinical guidelines on the use of medical cannabis in epilepsy is added to the medical cannabis access programme before it is launched; and if he will make a statement on the matter. [31493/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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In the Misuse of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019 (S.I. 262/2019) a "specified controlled drug" as defined can be used in the Medical Cannabis Access Programme and the definition outlines the specific requirements for those cannabis products or preparations.

A prospective supplier can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a product considered for inclusion in the Schedule of ‘specified controlled drugs’ in the Regulations. As specified controlled drugs will fall under schedule 2 to the Misuse of Drugs Regulations 2017, a controlled drugs licence, processed by the HPRA, on behalf of the Minister, is also required for possession, supply or import of such cannabis products.

Details on how to apply for a licence to possess, supply or import medical cannabis products for use under the Medical Cannabis Access Programme in accordance with the requirements for schedule 2 products in the Misuse of Drugs Regulations 2017 can be found in the operator guidance issued by the HPRA.

It is open to any supplier or producer to apply to the HPRA to have their products assessed for inclusion in the programme.