David Cullinane (Waterford, Sinn Fein)
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107. To ask the Minister for Health if an application has been received to add the PCBD110 product to the medical cannabis access programme; if so, when he expects a decision to be made on the addition of the product to the programme; and if he will make a statement on the matter. [22373/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I have been informed by the Health Products Regulatory Authority that no application has been made from any prospective supplier looking to add PCBD110 to the Medical Cannabis Access Programme (MCAP).

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.

David Cullinane (Waterford, Sinn Fein)
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108. To ask the Minister for Health the criteria which prospective products for the medical cannabis access programme must meet in order to be recommended for use in the programme; if trace-THC products may be considered for inclusion; and if he will make a statement on the matter. [22374/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 outline the legal framework for the Medical Cannabis Access Programme (MCAP) in Ireland.

Products that meet the definition of ‘specified controlled drugs’ as per the Regulations can be assessed for inclusion in Schedule 1 of the Regulations by the HPRA.

Products containing THC at trace levels are still subject to control under the Misuse of Drugs Act and are eligible for inclusion in the MCAP provided they meet the definition of “specified controlled drugs” in the regulations.  

The application forms can be found on the ‘Publications and Forms’ section of www.hpra.ie or by contacting controlleddrugs@hpra.ie.

David Cullinane (Waterford, Sinn Fein)
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109. To ask the Minister for Health the reason none of the four products currently recommended for use in the medical cannabis access programme meet the criteria of less than 2% THC for use in the treatment of resistant epilepsy established in the clinical guidance on cannabis for medical use of his Department; his plans to address same; and if he will make a statement on the matter. [22375/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Cannabis products that can be used in the Medical Cannabis Access Programme are defined as ‘specified controlled drugs’ in legislation and the definition outlines the specific requirements for those products.

Only products included in the schedule of specified controlled drugs can be prescribed by medical consultants under the Medical Cannabis Access Programme.

The criteria cannabis products must meet in order to be considered by the Minister for inclusion on the schedule are set out in the legislation and can be found in the operator guidance issued by the HPRA

Details on how to apply for a licence to possess, supply or import medical cannabis products for use under the Medical Cannabis Access Programme in accordance with the requirements for schedule 2 products in the Misuse of Drugs Regulations 2017 can be found in the operator guidance issued by the HPRA.

It is open to any supplier or producer to apply to the HPRA to have their products assessed for inclusion in the programme.

David Cullinane (Waterford, Sinn Fein)
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110. To ask the Minister for Health when the medicinal cannabis access programme will be launched; and if he will make a statement on the matter. [22376/21]

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 on this matter, as soon as possible.

David Cullinane (Waterford, Sinn Fein)
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111. To ask the Minister for Health if Brexit has had or will have implications on the supply and use of products approved for use under the medical cannabis access programme considering that products approved for use on the programme must be sold or supplied for medical purposes by the relevant public or state body of a member state other than the state and must be currently supplied to patients in the member state as outlined in the legislation; and if he will make a statement on the matter. [22377/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Cannabis based products accepted for use in the medical cannabis access programme must meet the definition of a ‘specified controlled drug’ as set out in the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Conditions (d) and (e) of the definition stipulate that a cannabis based product must be permitted to be sold or supplied in another Member State and currently supplied to patients in that Member State.

(d) which is permitted to be sold or supplied for medical purposes by the relevant public or state body of a Member State other than the State,

(e) which is currently supplied to patients in the Member State referred to in sub-paragraph (d),

As the United Kingdom (UK) has left the European Union, it is no longer a Member State. Cannabis based products that are permitted to be sold or supplied in the UK only and/or are currently supplied to patients in the UK only do not meet the definition of a ‘specified controlled drug’. Accordingly,  applications to consider such cannabis based products for inclusion in the medical cannabis access programme cannot be accepted. 

Four cannabis based products have been accepted for use in the medical cannabis access programme to date, and a small number of applications are currently under review by the Health Products Regulatory Authority (HPRA).

David Cullinane (Waterford, Sinn Fein)
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112. To ask the Minister for Health further to Parliamentary Question No. 2152 of 21 April 2021, the exact matters which he has requested officials to examine; the barriers identified; the possible measures to rectify this problem; and if he will make a statement on the matter. [22378/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Officials were asked to examine the reimbursement process. I was informed that pursuant to Section 10B of the Health Act 2004 the Minister for Health shall not give a direction under section 10, or specify a priority or performance target under section 10A, as respects:-

(a) any function of the Executive relating to the provision of treatment or a health or personal social service to any particular person,

(b) any function of the Executive relating to a decision concerning—

(i) whether or not a particular person is eligible for a particular health or personal social service (including the payment of a grant or allowance),

(ii) the extent to which and the manner in which a person is eligible for any such service.