David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

634. To ask the Minister for Health his views on the import and distribution of medicinal cannabis through community pharmacies following a referral from a general practitioner or consultant; and if he will make a statement on the matter. [28119/20]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

In June 2019, the 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.

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

Prescribers (medical consultants on the specialist register) will be able to prescribe cannabis for medical use to patients as set out in the legislation. It is important to understand that it will only be possible for specialist consultants to prescribe a specified controlled drug (medical cannabis products) under the Access Programme, once suppliers make these products available on the Irish market. Prescribers should also refer to the clinical guidelines prepared by the Expert Reference Group, available on the Department of Health Website.

Pharmacists will be able to dispense Cannabis for Medical Use to patients as set out in the legislation, on foot of a valid prescription, once suppliers make the specified controlled drugs available on the Irish market. Pharmacists should also refer to the Clinical Guidelines prepared by the Expert Reference Group, available on the Department of Health website.

The offences and penalties for unauthorised supply and possession of controlled substances remain unchanged.

It is important to note that where a cannabis product is a specified controlled drug legally permitted for medical use, in connection with the MCAP, this does not signify any endorsement whatsoever of the safety, quality or efficacy of the specified controlled drug for the indication prescribed and the Minister for Health will have no liability in respect of the use of such products by a person issued with a prescription by their clinician under this Regulation. The use of a cannabis product for the purposes of the MCAP is a matter for the patient and their medical advisor.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

635. To ask the Minister for Health the process for access to medicinal cannabis through the EMA compassionate use access programme; and if he will make a statement on the matter. [28120/20]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

There is no access to medicinal cannabis through an EMA compassionate use access programme.

However, in June 2019, the 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.

www.gov.ie/en/publication/90ece9-medical-cannabis-access-programme/.

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. 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, 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:

www.gov.ie/en/publication/1a5c4e-applying-to-the-minister-for-health-for-a-medical-cannabis-licence/.

www.gov.ie/en/publication/e35cb4-ministerial-licence-application-process/.

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.

I hope that this information is of assistance.