Tuesday, 12 March 2019

Questions (255, 331, 336, 337, 338, 343, 344, 387)

Joan Collins


255. Deputy Joan Collins asked the Minister for Health when products of a company (details supplied) will be dispensed through general practitioners or pharmacies here in order to avoid persons having to travel abroad every three months and in some instances monthly to collect the medication. [11985/19]

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Michael Healy-Rae


331. Deputy Michael Healy-Rae asked the Minister for Health his views on a matter regarding medical distribution (details supplied); and if he will make a statement on the matter. [11697/19]

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Willie O'Dea


336. Deputy Willie O'Dea asked the Minister for Health his plans to have the medication CBD produced by a company (details supplied) dispensed to pharmacies here rather than persons having to travel abroad to collect this medication; and if he will make a statement on the matter. [11707/19]

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Thomas P. Broughan


337. Deputy Thomas P. Broughan asked the Minister for Health if he will report on accessibility for medicinal cannabis; if patients prescribed medicinal cannabis through the compassionate access programme will have their medication delivered to, and dispensed from their local chemists; the measures he will take in this regard; and if he will make a statement on the matter. [11711/19]

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Thomas P. Broughan


338. Deputy Thomas P. Broughan asked the Minister for Health if all forms of medicinal cannabis will be available to patients from their local chemists; the way in which the dispensing of medicinal cannabis will be undertaken here; and if he will make a statement on the matter. [11712/19]

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Louise O'Reilly


343. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to cases in the Northern Ireland and Britain in which a distribution company is facilitating the direct importation of distribution to pharmacies of medication by a company (details supplied); the reason the same process has not been afforded to the 16 patients who have been granted licences here for the medication; if these patients will be facilitated delivery of their mediation to pharmacies here in view of rolling out the compassionate access programme; and if not, the reason therefor. [11718/19]

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Louise O'Reilly


344. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Questions Nos. 341 and 342 of 19 February 2019, the reason patients who have been prescribed medicinal cannabis for their health needs still need to leave the State and travel to another state to acquire the medication; the reason a process has not been put in place to import the medication to chemists and pharmacies here under the supervision of the health service to be provided to patients; and his plans to put processes in place to ensure that such medication will be imported and distributed through chemists and pharmacies here. [11719/19]

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Clare Daly


387. Deputy Clare Daly asked the Minister for Health the progress made on the granting of importation licences for medicinal cannabis and the sourcing of an adequate distribution company to ensure supply of medication to pharmacies here; and if he will make a statement on the matter. [11950/19]

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Written answers (Question to Health)

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.

Background information

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.