Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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707. To ask the Minister for Health when the medical cannabis access programme will commence; and if he will make a statement on the matter. [23551/20]

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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708. To ask the Minister for Health the details of the budgetary constraints stated by his Department as the reason for the delay in the roll-out of the medical cannabis access programme; and if he will make a statement on the matter. [23552/20]

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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709. To ask the Minister for Health if a date has been established for the commencement of the medicinal access programme; the concerns and obstacles to the roll-out of the programme; and if he will make a statement on the matter. [23553/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 707 to 709, inclusive, together.

Deputy Kenny has asked three questions about the Medicinal Cannabis Access Programme, I intend to answer them all collectively.

On 26th June 2019, the Minister for Health signed legislation to allow for the operation of the Medical Cannabis Access Programme on a pilot basis for five years.

The Programme will facilitate access to cannabis-based products for medical use in line with legislation and with the clinical guidance for the scheme.

Cannabis products will only be listed in Schedule 1 of the Regulations once they have been considered as suitable for use under the Medical Cannabis Access Programme.

The Medical Cannabis Access Programme will make it possible for a medical consultant to prescribe a cannabis-based treatment for a patient under his or her care for the following medical conditions, where the patient has failed to respond to standard treatments:

- Spasticity associated with multiple sclerosis

- Intractable nausea and vomiting associated with chemotherapy

- Severe, refractory (treatment-resistant) epilepsy.

The following specified controlled drug products (cannabis-based products) have been accepted as being suitable for use under the Medical Cannabis Access Programme:

- Aurora High CBD Oil Drops

- CannEpil Oral Solution

- Tilray Oral Solution THC10:CBD10 25ml

A fourth product, Aurora Sedamen Softgels from Aurora Cannabis Enterprises Inc. has also been recommended by the HPRA to be considered for inclusion in Schedule 1 of the Misuse of Drugs (Prescription and control of supply of cannabis for medical use) Regulations 2019, and legislation is currently being drafted to add this product to the regulations.

The HSE is currently engaged in pricing and supply negotiations with manufacturers and suppliers of the products listed above, for this reason the programme is not yet operational. Pending the conclusion of these negotiations I am not in a position to put a specific date on the commencement of the programme.