Carol Nolan (Offaly, Independent)
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179. To ask the Minister for Health when the compassionate access programme will be in place. [15616/19]

Simon Harris (Wicklow, Fine Gael)
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Good progress is being made in establishing the Cannabis for Medical Use Access Programme:

- clinical guidelines have been drawn up and published,

- secondary legislation is being drafted to underpin the Programme,

- cannabis products for use under the programme, once reviewed for suitable for medical use, will be published on an ‘approved list’

Background

The Health Products Regulatory Authority’s (HPRA) report ‘Cannabis for Medical Use – A Scientific Review’ recommended that if access to cannabis is to be permitted for medical purposes, it's use should only be initiated as part of a structured process of formal on-going clinical evaluation, in a limited number of clearly defined 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.

All such patients should be under the direct supervision of an appropriately trained and experienced medical consultant. The specified medical conditions (medical indications) are:

- Spasticity associated with multiple sclerosis;

- Intractable nausea and vomiting associated with chemotherapy; 

- Severe, refractory (treatment-resistant) epilepsy.

The purpose of the Access Programme is to facilitate access to cannabis-based products or preparations that are of a standardised quality and which meet an acceptable level of quality assurance during the manufacturing process.

Quality Standards for medical cannabis products

The Programme aims to facilitate access to certain ‘acceptable’ cannabis products which have not been authorised as medicines by a statutory Medicines Competent Authority. Such products are not subject to the same rigorous safety, quality and efficacy standards that are in place for medicines, nor are the producers subject to the same responsibilities as the marketing authorisation holders for authorised medicines. Therefore, whilst efficacy and safety data are not available for these products, it is crucially important to be assured, as far as possible, of the quality standards of these products. 

Access to Medical Cannabis products

Availability of cannabis products that are of an appropriate quality standard and are affordable to patients is critical in establishing the access programme. The Department is aware of only two countries, Canada and the Netherlands, who currently permit commercial export of cannabis products which meet acceptable quality control standards, beyond their borders. The Netherlands permits exports of cannabis dried herb products only, it does not permit commercial export of oil-based cannabis formulations. Canada permits commercial export of all formulations of cannabis products for medical use. 

Department officials are working intensively on finding solutions to the supply of appropriate products for Irish patients and maintain regular contact with their counterparts in Denmark and Canada.

Ministerial Licence Access Route

Pending full operation of the Access Programme, doctors may continue to utilise the Ministerial licencing route to prescribe medical cannabis for their patients. Until suitable medical cannabis products are made available in Ireland, prescribers and their patients are sourcing the prescribed product from a pharmacy in The Netherlands, on foot of their medical prescription. It is intended that the Ministerial licence application scheme will continue to operate in parallel with the Cannabis for Medical Use Access Programme, after the programme becomes operational, for exceptional cases only where there is an unmet clinical need.

Department of Health Website

The Department of Health website contains detailed information on medical cannabis, including clinical guidance on the use of medical cannabis. It is updated in the event of new developments on the issue.

Carol Nolan (Offaly, Independent)
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180. To ask the Minister for Health if there will be changes to the licensing system to allow ill persons under the guidance of general practitioners to receive CBD. [15617/19]

Simon Harris (Wicklow, Fine Gael)
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Cannabis is strictly controlled under the Misuse of Drugs Acts 1977 to 2016, and the Regulations and Orders made thereunder.

The two most common active components found in cannabis oil are tetrahydrocannabinol (THC) and cannabidiol (CBD).

- THC is the principal psychoactive constituent of cannabis. Under the Misuse of Drugs legislation products containing THC are strictly controlled and possession is unlawful except under licence.

- CBD is derived from cannabis. However, since it is not psychoactive it is not controlled under the Misuse of Drugs legislation, and does not require a Ministerial Licence. CBD oil is sometimes marketed as a nutritional or dietary supplement, however it should be noted that it is not authorised as a medicinal product in Ireland.

If a doctor wishes for a patient to access medicines containing CBD the products can be prescribed by the doctor for use by their individual patients under their direct personal responsibility and supplied as unlicensed medicines. Once in receipt of a prescription, a pharmacy can than assist a patient in sourcing the CBD product through a wholesaler authorised to import unlicensed medicines.

Cannabis products for use under the Cannabis for Medical Use Access Programme, once reviewed as suitable for medical use, will be published on an ‘approved list. This will include certain CBD products as outlined in the Department of Health's Clinical Guidelines on Cannabis for Medical use, which is available on the Department's website.

Department of Health Website

The Department of Health website contains detailed 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.