Written answers
Tuesday, 24 May 2022
Department of Health
Cannabis for Medicinal Use
Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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696. To ask the Minister for Health the number of persons who are registered as patients under the medical cannabis access programme; and if he will make a statement on the matter. [26558/22]
Stephen Donnelly (Wicklow, Fianna Fail)
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As this is an operational matter, the question has been referred to the Health Service Executive for their attention and direct reply to the Deputy.
Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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697. To ask the Minister for Health the number of approved medical products that are now prescribable under the medical cannabis access programme; if he will provide details of each product; and if he will make a statement on the matter. [26559/22]
Stephen Donnelly (Wicklow, Fianna Fail)
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On 16thMay 2022, the Minister for Health signed SI 237/2022 the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2022 amending Schedule 1 of the 2019 Regulations (S.I. No. 262 of 2019) and adding a new product to the Schedule of products that meet the specifications as set out in the regulation. There are now a total of 7 products in Schedule 1 as set out in the table below.
Specified Controlled Drugs
| Name of Cannabis product or preparation and brand name | Dosage form | Concentration of THC (percentage, weight/weight or weight/volume) | Name of manufacturer |
|---|---|---|---|
| Aurora High CBD Oil Drops | Oral solution | Less than 3% w/v (< 30mg/ml) This product also contains cannabidiol (CBD) 60% w/v (600mg/ml) | Aurora Cannabis Enterprises Inc., 4439 Township Road 304, Cremona, Alberta, Canada, T0M 0R0 |
| CannEpil ™ | Oral solution | 0.5% w/v (5mg/ml) This product also contains cannabidiol (CBD) 10% w/v (100mg/ml) | MGC Pharmaceuticals d.o.o., Kamniška ulica 29, 1000, Ljubljana, Slovenia |
| Tilray Oral Solution THC10:CBD10 25ml | Oral solution | 1% w/v (10mg/ml) This product also contains cannabidiol (CBD) 1% w/v (10mg/ml) | Tilray Canada Ltd., 1100 Maughan Road, Nanaimo, BC, V9X 1J2, Canada |
| Aurora Sedamen Softgels | Capsules | 5mg/capsule This product also contains cannabidiol (CBD) less than 0.2mg/capsule | Aurora Cannabis Enterprises Inc. 4250 14th Avenue, Markham, Ontario, Canada L3R 0J3 |
| Oleo Bedrobinol | Dried Flower | 13.5% w/w (135mg/g) This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g) | Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands |
| Oleo Bedrocan | Dried Flower | 22% w/w (220mg/g) This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g) | Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands |
| Althea CBD12:THC10 (50ml) | Oil | 1% w/v THC (10mg/ml) This product also contains 1.25% w/v (12.5mg/ml) cannabidiol (CBD) | Tasmanian Alkaloids pty Ltd T/A Extractas Bioscience, Westbury, Tasmania, Australia 7303 |
Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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698. To ask the Minister for Health when the clinical review of the medical cannabis access programme will take place; if he will provide details of the persons who will sit on the review panel; and if he will make a statement on the matter. [26560/22]
Stephen Donnelly (Wicklow, Fianna Fail)
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In 2016 the Minister for Health requested that the Health Products Regulatory Authority (HPRA), convene an expert working group to assist with its review of the potential medical use of cannabis. Following this review the HPRA published “Cannabis for Medical Use – A Scientific Review” in January 2017. Subsequently an expert group was convened to draw up clinical guidance to underpin the functioning of the Medical Cannabis Access Programme which was published in 2019.
In 2022, following completion of an updated evidence review, the Department plans to establish an expert group to further review the use of cannabis for medical use. Members have not yet been appointed to this review panel as work is ongoing on the research aspect of this work.
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