Thomas Gould (Cork North Central, Sinn Fein)
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328. To ask the Minister for Health if consideration will be given to permanently extending the temporary delivery arrangement for cannabidiol oil and tetrahydrocannabinol oil. [40826/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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On the 6^thApril, the previous Minister for Health announced an initiative to assist patients access to their medical cannabis products during the COVID-19 pandemic period. The Department of Health has so far organised a number of collections from the Netherlands for patients of clinicians in possession of a ministerial licence under the Misuse of Drugs Act owing to the COVID-19 travel restrictions and quarantine requirements and the initiative will continue while these are in place.

Thomas Gould (Cork North Central, Sinn Fein)
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329. To ask the Minister for Health the number of consultants who can currently grant a licence for cannabidiol oil and tetrahydrocannabinol oil. [40827/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Misuse of Drugs Acts 1977 – 2016, it is open to the Minister for Health to consider granting a licence for access to medical cannabis-based preparations for named patients, where this course of treatment has been endorsed by the consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.

To date, one hundred and twenty-nine licences have been issued to 32 individual clinicians for the treatment of medical cannabis via the Ministerial licence application route.

Medical practitioners and patients are encouraged to consult the Department of Health website which contains information on medical cannabis, including clinical guidance on the use of medical cannabis and details on how a medical practitioner may apply for a Ministerial licence for medical cannabis. This information can be found on the Department of Health's website.

It is important to note that the 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. The Minister for Health has no role in this clinical decision-making process.

Thomas Gould (Cork North Central, Sinn Fein)
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330. To ask the Minister for Health the timeline for the provision of cannabidiol oil and tetrahydrocannabinol oil in Ireland without patients having to source themselves. [40828/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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In June 2019, the previous Minister for Health 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. Those conditions are:

·Spasticity associated with multiple sclerosis

·Intractable nausea and vomiting associated with chemotherapy

·Severe, refractory (treatment-resistant) epilepsy.

For more information relating to the MCAP, including FAQs, please see the Department of Health’s website at the following link.

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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 four 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 four products are:

1. Aurora High CBD Oil Drops

2. CannEpil ™

3. Tilray Oral Solution THC10:CBD10 25ml

4. Aurora Sedamen Softgels.

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. The Department can advise that while the MCAP register is not currently operational, engagement is ongoing with the HSE in regard to progressing same.

Ministerial Licence under Section 14 of the Misuse of Drugs Acts 1977-2016

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, either by a consultant or by a GP 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 can be found at the following links:

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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. The Minister for Health has no role in this clinical decision-making process.