Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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212. To ask the Minister for Health when the necessary legislative amendments will be made in order to facilitate the implementation of the cannabis access programme; if he will expedite this process; if he will consider granting a licence to an Irish registered doctor to authorise access to medicinal cannabis for named patients with conditions such as Dravet syndrome, rare forms of epilepsy and other such conditions in the meantime; and if he will make a statement on the matter. [12508/17]

Róisín Shortall (Dublin North West, Social Democrats)
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243. To ask the Minister for Health the precise criteria which must be met in order for cannabis-based medicine to be prescribed under the present regulatory framework. [12641/17]

Róisín Shortall (Dublin North West, Social Democrats)
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244. To ask the Minister for Health his plans to give effect to the report of the Health Products Regulatory Authority in respect of establishing a compassionate access programme for cannabis-based treatments; and the timeframe proposed. [12642/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 212, 243 and 244 together.

On 3 November 2016 I asked the Health Products Regulatory Authority to examine the issue of medicinal cannabis and provide me with a report on the matter. I received the Authority's report ‘Cannabis for Medical Use – A Scientific Review’ on 31 January last.

On 10 February, I published the report and announced that I would establish an access programme for cannabis-based treatments for the following conditions;

- Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions;

- Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes;

- Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications.

- Patients accessing cannabis through the programme are required to be under the care of a medical consultant.

The report has been referred to the Joint Oireachtas Committee on Health for consideration. Meanwhile officials from my Department and the Health Products Regulatory Authority will consult with stakeholders on how the access programme will operate. It will be particularly important to engage with the clinical community in the development of a framework. Officials are also examining legislative changes that will be required to underpin the access programme.

I intend to progress the establishment of this access programme as a priority. However, to be clear, patients accessing cannabis through the cannabis access programme will need to be recommended for cannabis treatment by a medical consultant involved in the patient's care. This recognises the relevance of such treatment for overall case planning and management of the underlying medical condition.

For the period during which this access programme is being established, it remains open to me as the Minister for Health to grant a licence under the Misuse of Drugs Act for access to cannabis for medical purposes in individual cases. Such applications will be considered on a case by case basis. The granting of a licence must, however, be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.

The main elements of a licence application are expected to include:

- An outline of the treatment the patient has received to date and justification from the doctor as to why it is appropriate in their patient’s specific circumstances to prescribe a Schedule 1 drug.

- If the patient’s consultant is not the applicant, the views, if any, of the consultant in relation to the application.

- Details of the cannabis-based product which it is proposed to prescribe and administer to the patient.

- The source of the cannabis-based product.

The appropriateness of any particular treatment is a matter between the patient and their doctor, I have no role in this process.

This information has been provided to the Oireachtas and is also contained in a recent Department of Health Press Release which outlines the advice provided by the Chief Medical Officer to me in relation to the use of cannabis for medical reasons.