Authorised Schedule 1 cannabis based products not expected to be available for some time

Cannabis-based products from two international companies have been authorised by the Minister for Health Simon Harris for importation, prescribing and supply to the Irish market.

As these two Schedule 1 products are to be subject to international export licensing requirements, outside the control of the Department of Health, they were expected to be unavailable in Ireland for a further period, the Department anticipated.

Meanwhile, a member of the Medical Cannabis Risk Alliance, GP Dr Ray Walley, confirmed their support for the formal approach adopted to evaluating plant-based cannabis for safety and efficacy in appropriate patients, in a pilot medical access programme, which must issue a report at the end of five years.

The former Irish Medical Organisation President dismissed the “clamber” for cannabis-based products to be made available through general practice. Such calls had been voiced despite the recommendations of the Expert Group that prescribing should be by consultants on the specialist register of named patients, where patients failed to respond to standard treatments – and this was a particular project where access to consultants would be restricted. It was “unbelievable” to propose accessibility to GPs when efficacy and safety were unproven. “We don’t know whether it is ‘medicinal’, cannabis has not been tested in the same manner as a drug,” Dr Walley added.

He described the members of the Alliance, who came together earlier this year amid their shared concern Ireland was being led down the path of cannabis legalisation without proper consideration of the plant’s negative effects, as “disappointed” after Health Minister Simon Harris reportedly declined their request to meet. The Alliance includes multidisciplinary specialists, several with involvement in addiction treatment, and no vested interests, said Dr Walley who revealed they were due to meet in a closed session in the New Year.

“Clinical guidelines for prescribers have been drawn up by an expert group of doctors, pharmacists, patient representatives and scientific experts, to support the Medical Cannabis Access Programme [MCAP], which contains guidance on ingredient combinations that are recommended for each of the three indications included in the scheme,” the Department of Health advised.

The specified conditions are spasticity associated with multiple sclerosis; intractable nausea and vomiting associated with chemotherapy or severe, refractory (treatment-resistant) epilepsy.

Canadian manufacturer, Aurora Cannabis Enterprises, has been approved for “Aurora High CBD Oil Drops” with less than 3 per cent weight/volume Tetrahydrocannabinol (THC) and cannabidol (CBD) 60 per cent w/v (600mg/ml). The second product is “CannEpil”, also an oral solution, from a Slovenian manufacturer, MGC Pharmaceuticals, and contains 0.5 per cent w/v (5mg/ml) THC and CBD 10 per cent w/v (100mg/ml).

The Health Service Executive is to establish and maintain a Register for the MCAP 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 Minister for Health is to have no liability for the use of cannabis-based products under the MCAP, with the prescribing of cannabis-based products for medical use to be a matter for the patient and their medical advisor.

valerie.ryan@imt.ie