Marian Harkin (Sligo-Leitrim, Independent)
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1083. To ask the Minister for Health if certain drugs can be paid for at source, either under the compassionate access programme or under an individual licensing system; if medicinal cannabis products of a company (details supplied) can be funded at source under the compassionate access programme; and if not, if the products can be funded at source using an individual licensing system, if the product is manufactured under EU law and licencing systems. [17213/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I am very sympathetic to such cases. I have asked my officials to see whether we can fund this at source. I do not yet know whether this is possible.

I would refer the Deputy to Section 10B of the Health Act 2004 (as inserted by section 6 of the Health Service Executive (Governance) Act 2013), under which the Minister for Health may not give a direction to the Executive in the manner as sought by the Deputy.

David Cullinane (Waterford, Sinn Fein)
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1085. To ask the Minister for Health if medical information and utilisation data is kept on a central register in the context of the medical cannabis access programme; if clinical patient research is facilitated and recorded; if further amendments to primary legislation are required to further enable this process; if such legislation, if required, is being prepared; and if he will make a statement on the matter. [17218/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

David Cullinane (Waterford, Sinn Fein)
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1086. To ask the Minister for Health if the HSE maintains a register to facilitate the enrolment and recording of certain data, including patient identifiers prescribers enrolled in the programme and prescribed and supplied medicinal cannabis; and if he will make a statement on the matter. [17219/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

David Cullinane (Waterford, Sinn Fein)
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1087. To ask the Minister for Health the extent to which the medical cannabis access programme and other medical cannabis, including international studies data, is analysed currently and since the 2017 Health Products Regulatory Authority report; the findings made by the analysis to date; and if he will make a statement on the matter. [17220/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regulatory Authority’s “Cannabis for Medical Review Use – A Scientific Review” advised that treatment with cannabis is only permitted under a controlled access programme for the treatment of patients with;

a. Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;

b. Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;

c. Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.

The programme, included in the HSE Service Plan for 2021, will operate on a five year pilot basis and is expected to commence mid-year.

A programme for appropriate data collection will be developed by the HSE who will manage the MCAP. The MCAP being a five year pilot programme will also be subject to review and that will probably include consideration of relevant national and international data.

David Cullinane (Waterford, Sinn Fein)
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1088. To ask the Minister for Health if his Department is actively seeking data for assessment by itself, the Health Products Regulatory Authority or any other body, from prospective suppliers of medical cannabis products; and if he will make a statement on the matter. [17221/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Prospective suppliers of products to the medical cannabis access programme (MCAP) can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Applicants must provide evidence to demonstrate that the proposed cannabis product meets the requirements of a ‘specified controlled drug’ as defined in the MCAP legislation. The onus is on prospective suppliers to submit applications to the HPRA and it has received a number since the introduction of the MCAP.

David Cullinane (Waterford, Sinn Fein)
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1089. To ask the Minister for Health if the Health Products Regulatory Authority is actively seeking data for assessment from prospective suppliers of medical cannabis products; and if he will make a statement on the matter. [17222/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Prospective suppliers of products to the medical cannabis access programme (MCAP) can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Applicants must provide evidence to demonstrate that the proposed cannabis product meets the requirements of a ‘specified controlled drug’ as defined in the MCAP legislation. The onus is on prospective suppliers to submit applications to the HPRA and it has received a number since the introduction of the MCAP.

David Cullinane (Waterford, Sinn Fein)
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1090. To ask the Minister for Health if the HSE is actively seeking data for assessment from prospective suppliers of medical cannabis products; and if he will make a statement on the matter. [17223/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Prospective suppliers of products to the medical cannabis access programme (MCAP) can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Applicants must provide evidence to demonstrate that the proposed cannabis product meets the requirements of a ‘specified controlled drug’ as defined in the MCAP legislation. The onus is on prospective suppliers to submit applications to the HPRA and it has received a number since the introduction of the MCAP.

David Cullinane (Waterford, Sinn Fein)
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1091. To ask the Minister for Health the number of applications to positions in the HSE relating to the medical cannabis access programme due by the end of February 2021; the breakdown by position; and if he will make a statement on the matter. [17224/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

David Cullinane (Waterford, Sinn Fein)
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1092. To ask the Minister for Health if he is considering the addition of conditions to schedule 2 of the Misuse of Drugs Regulations 2017, SI No. 173 of 2017; and if he will make a statement on the matter. [17225/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regulatory Authority’s “Cannabis for Medical Review Use – A Scientific Review” advised that treatment with cannabis is only permitted under a controlled access programme for the treatment of patients with;

a. Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;

b. Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;

c. Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.

The programme, included in the HSE Service Plan for 2021, will operate on a five year pilot basis.

The Minister will also continue to consider Ministerial Licence applications for cannabis-based products for medical use for conditions outside the scope of the Access Programme, where the treatment has been endorsed by a medical consultant.

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.

David Cullinane (Waterford, Sinn Fein)
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1093. To ask the Minister for Health the number of controlled drug licences currently issued for products specified in schedule 2 of SI No. 173 of 2017; if he is considering the addition of licences or the licensing of further products; the number of licences issued for import, supply and possession of each; and if he will make a statement on the matter. [17226/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Prospective suppliers of products to the medical cannabis access programme (MCAP) can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Applicants must provide evidence to demonstrate that the proposed cannabis product meets the requirements of a ‘specified controlled drug’ as defined in the MCAP legislation. The onus is on prospective suppliers to submit applications to the HPRA and it has received a number since the introduction of the MCAP. A small number of applications remain under review and, to date, four cannabis products have been accepted for use in the MCAP.

Once a cannabis product has been accepted for use in the MCAP, it will also be included under Schedule 2 to the Misuse of Drugs Regulations 2017 (S.I. No 173 of 2017). The importer of the cannabis product into Ireland is required to apply for a controlled drug licence in respect of each consignment that it proposes to import. These applications are also processed by the HPRA on behalf of the Minister. A controlled drug import licence is required to accompany each import consignment. As with all Schedule 2 controlled substances, the Irish importer is also required to have a controlled drug annual licence to possess and supply the cannabis product(s). Three wholesalers in Ireland have been issued with a controlled drug annual licence to possess and supply any cannabis product accepted for use in the MCAP.

To date, twelve controlled drug import licences have been issued for the import of consignments of cannabis products by the licensed importers; however, only two of these imports licences have been used.