Tuesday, 9 April 2019

Questions (390)

Aindrias Moynihan

Question:

390. Deputy Aindrias Moynihan asked the Minister for Health when the compassionate access programme for medicinal cannabis will be available; if it is planned to accommodate persons currently using licences; and if he will make a statement on the matter. [16421/19]

View answer

Written answers (Question to Health)

Good progress is being made in establishing the Cannabis for Medical Use Access Programme:

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 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. 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.

While both the Access Programme and the Ministerial licence route might run in parallel initially, it is possible that some of the patients currently using the Ministerial licence route might, where that is possible, be subsumed into the Access Programme, should their treating clinician decide to change their current prescribed cannabis medication to a product that will be provided under the Access Programme. It may not be possible for all the current Ministerial licence holders to transfer immediately; however this will be based on a clinical decision.

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.