I propose to take Questions Nos. 255, 331, 336 to 338, inclusive, 343, 344 and 387 together.
My Department is working towards the introduction shortly of a Cannabis for Medical Use Access Programme.
While the arrangements that will enable this programme to begin are being finalised, it is open to a registered medical practitioner to apply for a Ministerial Licence under the Misuse of Drugs Act 1977. Such a licence, if granted, enables them to legally prescribe medical cannabis for a named patient. It is important to note that the decision to prescribe such treatment is a clinical decision for the prescribing doctor.
Until acceptable medical cannabis products are available for use in Ireland, patients who are the subject of a Licence are obtaining their cannabis products from a pharmacy in the Netherlands.
Under Netherlands government policy, cannabis oil products are not permitted to be commercially exported.
Notwithstanding the fact that such cannabis products might eventually be listed as products that could be accessed under the Programme, unless the Dutch export barrier is removed, anyone who is prescribed these products will have to travel to the Netherlands to obtain them.
We are aware that a UK company may provide a service which involves it collecting cannabis products from the Netherlands for persons authorised to use it under the UK medical cannabis regime.
While this company can import medical cannabis products into the UK from the Netherlands, the UK authorities do not currently allow re-export from the UK to other countries, which includes Ireland.
I have been informed that this UK company may be acting as the patient’s “nominated representative” in the collection of their personally prescribed medical cannabis products. No similar Irish entity is known to provide this service, but it is certainly open to any patient to engage a representative on their behalf in this regard.
1. What is the Cannabis Access Programme?
(i) The purpose of the Cannabis for Medical Use 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, for three specified medical conditions:
- Spasticity associated with multiple sclerosis;
- Intractable nausea and vomiting associated with chemotherapy;
- Severe, refractory (treatment-resistant) epilepsy.
(ii) The Cannabis Access Programme was initiated after the publication of:
(a) The Health Products Regulatory Authority scientific review.
(b) Detailed clinical guidelines produced by an Expert Reference Group on medical cannabis.
Both reports may be found on the Department of Health’s web site.
2. When will the Cannabis Access Programme be introduced?
(a) Good progress has been made on the introduction of the Cannabis Access Programme. This work is well advanced. It is hoped to introduce the programme in the coming months.
3. What is a Ministerial Licence for the prescribing of cannabis?
(a) Pending full operation of the Cannabis Access Programme, clinicians may utilise the Ministerial licensing route to prescribe medical cannabis for their patients.
(b) This is provided by Section 14 of the Misuse of Drugs Act.
(c) Ministerial licences are time limited. The initial licence is valid for a period of 3 months and subsequent licenses in respect of the same patient are valid for 6 months.
4. Why do patients have to travel to the Netherlands for their medical cannabis products once a ministerial licence has been granted?
(a) Until suitable medical cannabis products are made available in Ireland under the medical cannabis access programme, prescribers and their patients are sourcing the prescribed products from a pharmacy in The Netherlands, on foot of their medical prescription.
(b) The Netherland medical cannabis product is sold under the trade name Bedrocan.
(c) Due to current Netherlands government policy, Bedrocan products, sold as cannabis oil formulations, are not currently permitted to be commercially exported from the Netherlands, but are only supplied in the Netherlands on foot of a valid medical prescription when presented to the appropriate pharmacy.
(d) This Netherlands pharmacy has confirmed to the Department of Health recently that there are no issues with the supply of THC and CBD products to Irish patients, who are in possession of a valid prescription, and that a three-month supply can be obtained.
(e) Notwithstanding the fact that Bedrocan products might ultimately be listed as products that could be accessed under the CAP, until the export barrier is removed by the Netherlands government, anyone who is prescribed Bedrocan oils under the Cannabis Access Programme, or a Ministerial Licence will have to travel to the Hague to access it.
5. Further information
(a) 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, or the Cannabis Access programme is not suitable for a patient.
6. Where can information on Cannabis Access Programme and the Ministerial Licence be found?
(a) The Department of Health website contains detailed information on medical cannabis, including clinical guidance on the use of medical cannabis and details on how a medical practitioner may apply for a Ministerial licence. This information can be found at: health.gov.ie/blog/publications/cannabis-for-medical-use.