Tuesday, 24 November 2020

Questions (824)

Gino Kenny

Question:

824. Deputy Gino Kenny asked the Minister for Health the timeframe for the commencement of the medical cannabis access programme; the details of same; and if he will make a statement on the matter. [38151/20]

View answer

Written answers (Question to Health)

In June 2019, the Minister for Health signed legislation to underpin the operation of the Medical Cannabis Access Programme (MCAP). This is a 5-year pilot programme, restricted to prescribing of cannabis-based products by medical consultants, for patients with certain medical conditions who have exhausted all other available medical treatment options. Those conditions are:

- Spasticity associated with multiple sclerosis

- Intractable nausea and vomiting associated with chemotherapy

- Severe, refractory (treatment-resistant) epilepsy.

For more information relating to the MCAP, including FAQs, please see the Department of Health’s website at the following link.

https://www.gov.ie/en/publication/90ece9-medical-cannabis-access-programme/

Commercial suppliers whose cannabis products have been reviewed and are considered to have met the specified requirements set out in the legislation and are in line with the clinical guidance for the MCAP, will have their products added to Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Once the products are listed in Schedule 1 of these Regulations the suppliers will be permitted to supply these products to the Irish market, in line with legal and regulatory requirements. Cannabis products will only be listed in Schedule 1 of the Regulations once they have been assessed as suitable for medical use under the MCAP.

To date four products have been added to Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. The four products are:

1. Aurora High CBD Oil Drops

2. CannEpil ™

3. Tilray Oral Solution THC10:CBD10 25ml

4. Aurora Sedamen Softgels.

The HSE has engaged in discussions with the suppliers of these products, regarding pricing and supply information. The HSE will consider such information, in line with the Health (Pricing and Supply of Medical Goods) Act 2013. The programme will not become fully operational until pricing and supply matters are agreed.

Once the Medical Cannabis Access Programme commences the HSE will establish and maintain a Register to facilitate the enrolment and recording of certain data including patient identifiers (in anonymised format), prescribers enrolled in the Programme, as well as prescribed / supplied medical cannabis products. The Department can advise that while the MCAP register is not currently operational, engagement is ongoing with the HSE in regard to progressing same.

Ministerial Licence under Section 14 of the Misuse of Drugs Acts 1977-2016

Pending full operation of the MCAP and for medical indications not included in the MCAP, doctors may continue to utilise the Ministerial licencing route to prescribe medical cannabis for their patients, should they wish to do so. In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes must 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. This information can be found at the following links:

https://www.gov.ie/en/publication/1a5c4e-applying-to-the-minister-for-health-for-a-medical-cannabis-licence/

https://www.gov.ie/en/publication/e35cb4-ministerial-licence-application-process/

It is important to note that the medical decision to prescribe or not prescribe any treatment, including cannabis treatment, for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process.