Tuesday, 19 February 2019

Ceisteanna (340, 341, 342)

Stephen Donnelly

Ceist:

340. Deputy Stephen S. Donnelly asked the Minister for Health the progress made on the commencement of the compassionate access programme for patients that require treatment with medicinal cannabis; and if he will make a statement on the matter. [7779/19]

Amharc ar fhreagra

Stephen Donnelly

Ceist:

341. Deputy Stephen S. Donnelly asked the Minister for Health the progress made on the granting of importation licences for medicinal cannabis; and if he will make a statement on the matter. [7780/19]

Amharc ar fhreagra

Stephen Donnelly

Ceist:

342. Deputy Stephen S. Donnelly asked the Minister for Health if there are changes in circumstances envisioned for patients already granted licences for medicinal cannabis when the compassionate access programme is commenced; and if he will make a statement on the matter. [7781/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 340 to 342, inclusive, together.

Considerable progress is being made in relation to the introduction of the Cannabis for Medical Use Access Programme.

- 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 HSE has been requested to establish and maintain a Register to facilitate the programme and work is continuing in relation to the sourcing of appropriate quality-controlled, affordable cannabis-based products for Irish patients.

- Drafting of secondary legislation to underpin the access programme continues and will be finalised once appropriate cannabis product supplies have been established.

The 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.

Availability of cannabis products that are of an appropriate quality standard and are affordable to patients is clearly critical in establishing the access programme. To the Department’s knowledge only two countries, Canada and the Netherlands, currently permit export of such cannabis products, which meet acceptable quality control standards, beyond their borders. The Netherlands permits exports of cannabis dried herb, but does not permit commercial export of their oil-based cannabis formulations.

Department officials are working intensively on finding solutions to the supply of appropriate products for Irish patients, in parallel to their ongoing work on other significant projects. As a result of extensive recent discussions with Danish and UK counterparts, Department of Health officials are now in contact with a number of potential suppliers of medical cannabis. These discussions may take some time to become productive.

Pending full operation of the Access Programme, doctors continue to utilise the Ministerial licencing route to prescribe medical cannabis for their patients.  Twenty-nine licences have now been granted in respect of sixteen individual patients. Licences are valid for a period of three months initially and for six months for subsequent licences. All valid applications are processed promptly.

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.

Further information on medical cannabis is available on the Department of Health website at:

health.gov.ie/blog/publications/cannabis-for-medical-use/.

Question No. 343 answered with Question No. 329.