Tuesday, 11 December 2018

Questions (354)

Robert Troy

Question:

354. Deputy Robert Troy asked the Minister for Health the status of legislation to legalise certain cannabis-based products for the treatment of specific medical issues. [51738/18]

View answer

Written answers (Question to Health)

The Medical Cannabis Access Programme aims to facilitate access to certain cannabis products which have not been authorised as medicines by a statutory Medicines Competent Authority. As such, they 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. 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 of these products, as advised by the HPRA. However, the barrier to full operation is the availability of suitable product.

Availability of cannabis products that are of an appropriate quality standard and are affordable to patients is clearly critical in establishing the access programme. Department of Health officials are working intensively on this issue to ensure a supply of appropriate medical cannabis products to meet the needs of Irish patients. However, the Department of Health has no control in relation to business decisions taken by commercial product manufacturers and has no powers to compel such companies to supply their products to Irish market.

An Expert Group has drawn up clinical guidance for healthcare professionals treating patients through the Access Programme. These guidelines are available on the Department’s website. The guidelines contain detailed information on medical cannabis, including clinical guidance on the use of medical cannabis and guidance on which cannabis products are appropriate for medical use.

Three Statutory Instruments (S.I.) made under the Misuse of Drugs Acts are required to underpin the establishment of the Access Programme. Department officials are working on this legislation, which will be finalised when medical cannabis products become available.

Pending full operation of the Access Programme, doctors may continue to utilise the Ministerial licensing route to prescribe medical cannabis for their patients.  Licences have now been granted in respect of thirteen individual 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.