Wednesday, 8 May 2019

Questions (946, 947, 948)

Stephen Donnelly

Question:

946. Deputy Stephen Donnelly asked the Minister for Health when medical cannabis will go on sale here at licensed pharmacists; the way in which it will be distributed to pharmacists once approved; and the location from which it will be sourced. [19631/19]

View answer

Stephen Donnelly

Question:

947. Deputy Stephen Donnelly asked the Minister for Health if companies other than pharmacists will be allowed to apply for licences to distribute medical cannabis. [19632/19]

View answer

Stephen Donnelly

Question:

948. Deputy Stephen Donnelly asked the Minister for Health the number of persons here entitled to avail of medical cannabis. [19633/19]

View answer

Written answers (Question to Health)

I propose to take Questions Nos. 946 to 948, inclusive, together.

The Medical Cannabis Access Programme

As the deputy is aware, 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 Medical Cannabis 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.

The Medical Cannabis Access Programme has not yet been established but good progress is being made:

1. clinical guidelines have been drawn up and published,

2. secondary legislation is being drafted to underpin the Programme,

3. cannabis products for use under the Programme, once reviewed for suitability for medical use, will be published on an ‘approved list’.

Department officials are working intensively on finding solutions to the supply of appropriate products for Irish patients.

Ministerial Licence

In the meantime it is open to a medical practitioner wishing to prescribe cannabis for medical purposes for an individual patient under their care, to apply to the Minister for Health for a licence, under Section 14 of The Misuse of Drugs Acts 1977 to 2016 and the Regulations made thereunder.

It should be noted that it is the decision of the clinician, in consultation with their patient, to prescribe or not prescribe a particular treatment for a patient under their care. As such, medical cannabis products will not be distributed without a prescription at licensed pharmacists, and it is not envisaged that companies other than licensed pharmacists will engage in retail sales of medical cannabis.

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.

To date licences have been issued in respect of twenty individual patients under this provision of the Act.

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.