Written answers

Wednesday, 3 February 2021

Department of Health

Cannabis for Medicinal Use

Photo of Thomas GouldThomas Gould (Cork North Central, Sinn Fein)
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779. To ask the Minister for Health if an application has been made for the participation of a company (details supplied) in the cannabis access programme, CAP, scheme; if so, the status of the application; and if not, if an indication has been given that an application will be made in future. [5576/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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A prospective supplier of cannabis-based products can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a product considered for inclusion in the Medicinal Cannabis Access Programme.

Cannabis products that can be used in the Medicinal Cannabis Access Programme are defined as ‘specified controlled drugs’ in legislation (SI 262/2019) and the definition outlines the specific requirements for those products.

The criteria that cannabis-based 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.

The manufacturers of the prescribed cannabis-based products availed of by patients (whose clinicians are licenced under the Misuse of Drugs Acts 1977-2016) from a pharmacy in the Netherlands have not sought to have their products included in the Medicinal Cannabis Access Programme.

Due to current Netherlands government policy, the prescribed cannabis-based oil formulations are not  permitted to be commercially exported from the Netherlands but are only supplied in the Netherlands to Irish patients on an individual basis on foot of a valid medical prescription when presented to the appropriate pharmacy.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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780. To ask the Minister for Health the action that will be taken to ensure patients who are currently being prescribed products produced by a company (details supplied) will be able to continue to receive same and not incur further additional expenses, for example, couriering or personal collection of prescribed products; and if he will make a statement on the matter. [5581/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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On the 14th December 2020, the Minister for Health announced that patients who are prescribed  cannabis-based products from a pharmacy in the Netherlands will no longer need to travel there to collect their prescriptions. The temporary delivery service that was announced in April 2020, as a result of the COVID-19 pandemic, has now been made permanent.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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781. To ask the Minister for Health if all patients who were receiving reimbursement for their cannabis product prescription costs prior to 21 January 2021 will continue to be reimbursed; and if he will make a statement on the matter. [5582/21]

Photo of Stephen DonnellyStephen 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.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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782. To ask the Minister for Health if consideration will be given to expanding the permissible products list of the Medical Cannabis Access Programme to include cannabis flower (details supplied); and if he will make a statement on the matter. [5583/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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A prospective supplier of cannabis-based products can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a product considered for inclusion in the Medicinal Cannabis Access Programme.

Cannabis products that can be used in the Medical Cannabis Access Programme are defined as ‘specified controlled drugs’ in legislation (SI 262/2019) and the definition outlines the specific requirements for those products.

The criteria that 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.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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783. To ask the Minister for Health if the qualifying list of conditions of the medical cannabis access programme will be expanded to include chronic pain, migraines, arthritis, endometriosis, anxiety, dementia and depression; and if he will make a statement on the matter. [5584/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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In the Health Products Regulatory Authority (HPRA)  report “Cannabis for Medical Use – A Scientific Review”, the HPRA advised that if access to cannabis is to be permitted for medical purposes that it should only be made available for the treatment of patients with specified medical conditions which have failed to respond to all other previous treatments, and where there is at least modest evidence that cannabis may be effective.

The specified medical conditions (medical indications) are:

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

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

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

The HPRA did not consider that the available evidence supported the use of cannabis in other medical conditions.

The MCAP has been included in the HSE Service Plan 2021 and is a five year pilot programme for the treatment of the three specified conditions.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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784. To ask the Minister for Health if consideration will be given to the implementation of an online cannabis education programme for clinicians; and if he will make a statement on the matter. [5585/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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On foot of the conclusions from the Health Products Regulatory Authority’s report ‘Cannabis for Medical Use – A Scientific Review’, the Minister for Health established an Expert Reference Group to advise on the development of a Medical Cannabis Access Programme (MCAP).

The Expert Reference Group also developed detailed clinical guidelines for the MCAP which are available on the Department's website.

Photo of Colm BurkeColm Burke (Cork North Central, Fine Gael)
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785. To ask the Minister for Health the steps being taken in order to ensure that cannabis patients who have had to emigrate (details supplied) can return to Ireland and legally and affordably access their medicine here; and if he will make a statement on the matter. [5586/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The Department does not comment on individual cases.

There are two separate pathways for accessing cannabis for medical use in Ireland.

Medical Cannabis Access Programme (MCAP) 

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.

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

The MCAP is not currently operational and is in the HSE Service Plan 2021. The HSE will be responsible for the operation of the programme.

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:

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.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The Minister for Health has no role in this clinical decision-making process and Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

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