Written answers

Tuesday, 18 September 2018

Department of Health

Medicinal Products Licensing

Photo of Micheál MartinMicheál Martin (Cork South Central, Fianna Fail)
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433. To ask the Minister for Health the status of implementing the recently announced changes to medicinal cannabis; the progress to date; and if he will make a statement on the matter. [37184/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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Under existing access arrangements, Irish-based medical practitioners who wish to prescribe cannabis products containing Tetrahydrocannabinol (THC) may apply to me, as Minister for Health, for a licence under the Misuse of Drugs Act. Guidance on who may apply for a licence under the Misuse of Drugs Act, as well as instructions on how to apply, can be found on the Department’s website at: health.gov.ie.

Considerable progress is being made in relation to 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 also available on the Department’s website at the aforementioned web address. 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.

It should be noted that, while these guidelines will primarily underpin the functioning of the Access Programme, the Department invites all clinicians with an interest in considering use of medical cannabis, and in applying for a licence under the Misuse of Drugs Act 1977 to prescribe cannabis for their patient, to review this information repository.

Officials in my Department are working on secondary legislation in the form of three Statutory Instruments, which will underpin the Access Programme. This work will be finalised once appropriate cannabis-based products, to be included in the legislation, can be sourced.

Whilst medical cannabis products are not medicines, ensuring that such products meet appropriate quality standards when they are made available to the Irish market is a critical aspect of facilitating safe access to medical cannabis for patients. My officials are working intensively on this issue to ensure a supply of appropriate medical cannabis products from other EU Member States and further afield to meet the needs of patients. However, my Department 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 the Irish market.

Until these products are made available in Ireland, it will be a matter for the prescriber and their patient to source the prescribed medical cannabis-based product.

It is understood that patients who have been prescribed such products under Ministerial Licence have sourced them from a pharmacy in the Netherlands. Contact details for this pharmacy are available on the relevant section of the Department's website.

To date, Ministerial licences have been issued for the treatment of nine individual patients, upon receipt of valid licence applications from their clinicians.

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