Dáil Éireann Debate, Wednesday - 3 June 2020
545. Deputy Emer Higgins asked the Minister for Health the circumstances under which a person can acquire cannabis-based products (details supplied); the details of the clinical guidance required; the Department responsible for international controlled drug export licensing requirements; and if he will make a statement on the matter. [8463/20]
Amharc ar fhreagraIn June 2019, I signed legislation to underpin the operation of the Medical Cannabis Access Programme (MCAP). This is a 5-year pilot programme, restricted to prescribing of cannabis-based products by medical consultants, for patients with certain medical conditions who have exhausted all other available medical treatment options. For more information relating to the MCAP and the clinical guidelines, please see my Department's website.
Commercial suppliers whose cannabis products have been reviewed and are considered to have met the specified requirements set out in the legislation and are in line with the clinical guidance for the MCAP, will have their products added to Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Once the products are listed in Schedule 1 of these Regulations the suppliers will be permitted to supply these products to the Irish market, in line with legal and regulatory requirements. Cannabis products will only be listed in Schedule 1 of the Regulations once they have been assessed as suitable for medical use under the MCAP.
To date three products have been added to Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. The three products are:
1. Aurora High CBD Oil Drops
2. CannEpil ™
3. Tilray Oral Solution THC10:CBD10 25ml.
The HSE has engaged in discussions with the suppliers of these products, regarding pricing and supply information. The HSE will consider such information, in line with the Health (Pricing and Supply of Medical Goods) Act 2013. The programme will not become fully operational until pricing and supply matters are agreed.
Once the Medical Cannabis Access Programme commences the HSE will establish and maintain a Register to facilitate the enrolment and recording of certain data including patient identifiers (in anonymised format), prescribers enrolled in the Programme, as well as prescribed/supplied medical cannabis products. I can advise that while the MCAP register is not currently operational, engagement is ongoing with the HSE in regard to progressing same.
Pending full operation of the MCAP and for medical indications not included in the MCAP, Doctors may continue to utilise the Ministerial licencing route to prescribe medical cannabis for their patients, should they wish to do so. In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes must be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.
This information, including the clinical guidelines, can also be found on the Department's website at the following address:
https://www.gov.ie/en/collection/fb8912-cannabis-for-medical-use/
It is important to note that the medical decision to prescribe or not prescribe any treatment, including cannabis treatment, for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. I have no role in this clinical decision-making process.
Operators require a controlled drug licence or registration processed by the Health Products Regulatory Authority (HPRA), on behalf of the Department of Health, if they wish to produce/manufacture, possess, supply, import or export any controlled drug in the schedules to the Misuse of Drugs Regulations 2017.
