In June 2019, then Minister for Health, Deputy Simon Harris signed legislation (Statutory Instruments 262, 281 and 282) to allow for the operation of the Medical Cannabis Access Programme (MCAP). The MCAP stems from the 2017 HPRA scientific report on cannabis for medical use and the subsequent work of an Expert Reference Group (of doctors, pharmacists, patient representatives and scientific experts) which established clinical guidelines to support the MCAP. It will operate initially on a five-year pilot basis.
Qualifying medical conditions
The MCAP enables a medical consultant to prescribe a cannabis-based product for a patient under his or her care for the following medical conditions, where the patient has failed to respond to standard treatments:
- Spasticity associated with multiple sclerosis.
- Intractable nausea and vomiting associated with chemotherapy.
- Severe, refractory (treatment-resistant) epilepsy, including Dravet syndrome and Lennox-Gastaut syndrome.
The legislation means that commercial operators whose cannabis-based products meet the specified requirements set out in the legislation can now apply to supply these products to the Irish market. The Health Product Regulatory Authority (HPRA) will assess these products for suitability for medical use, as defined in the legislation. Only products approved by the HPRA and included on “the schedule of specified controlled drugs” can be prescribed by consultants under the programme.
To date, four products have been accepted by the HPRA for inclusion on the list:
- Aurora High CBD Oil Drops (CBD:THC ratio of 20:1).
- CannEpil (CBD:THC ratio of 20:1).
- Tilray Oral Solution (CBD:THC ratio of 1:1).
- Aurora Sedamen Softgels (THC-only product).
It is important to note that the cannabis-based products which will be supplied under the MCAP are not authorised medicines. Authorised medicines are those that have a positive benefit/risk profile (established from clinical trials) and are subject to ongoing monitoring by regulatory authorities such as the HPRA or the European Medicines Agency. However, some manufacturers of cannabis-based products make their products in accordance with good manufacturing practice (GMP) certification. GMP is a codified set of rules that covers all aspects of the production process and is audited and certified by regulatory agencies.
It should also be noted that the Department of Health Clinical Guidelines (page 12) states that cannabis-based products may be considered in “severe epilepsy where the severity and frequency of seizures are significantly impacting on quality of life and that has failed to respond to five or more standard anti-epileptic treatments”. It states that cannabis-based products permitted under the MCAP should be at least 98% purity Purified oral solution (high CBD with trace THC).
Currently, none of the four products included in the MCAP (see above) meet the specification required by the Department's clinical guidelines for use in epilepsy. All four have significantly higher THC content than permitted in the guidelines, meaning that specialists may be hesitant to prescribe any of these products for severe epilepsy, even when the MCAP is fully operational.
Status of the MCAP
The MCAP is not currently (March 2021) operational. Epilepsy Ireland understands that there are two main outstanding tasks that need to be completed before the MCAP can fully begin:
- The HSE must make agreements with suppliers regarding the pricing of accepted cannabis-based products.
- The HSE must establish a register to enrol patients, prescribers and products in the programme.
In January 2021, Minister for Health, Deputy Stephen Donnelly announced provision for the delivery and funding of the MCAP and it has been included in the HSE's Service Plan for 2021. On page 105, the Service Plan includes the following: “Commence the Medicinal Cannabis Access Programme, subject to the availability of suitable products and the establishment of arrangements to approve their use in individual cases, and record relevant information on a register as provided for in the regulations”.
The HSE have already confirmed that approved cannabis-based products will be available under the Long-Term Illness Scheme, GMS (Medical Card) Scheme and the Drugs Payment Scheme on a named-patient basis. Authorisation is subject to the patient having a qualifying medical condition, standard approved treatments have been exhausted and the prescription has been issued by a consultant. Enrolment on the register will not automatically mean approval for reimbursement.
When the MCAP is finally operational, patients with epilepsy will be able to access the Programme in the following circumstances:
- A suitable cannabis-based product for the treatment of epilepsy (meeting the criteria in the Department of Health's clinical guidelines) has been included on the list of accepted products. This is not currently the case.
- A prescription has been issued by a specialist (i.e. a consultant neurologist/ epileptologist) following consideration of the contraindications, warnings and precautions advised in the clinical guidelines.
- The patient has severe, treatment-resistant epilepsy (including Dravet syndrome or Lennox-Gastaut syndrome) which significantly impacts on their quality of life and which has failed to respond to five standard treatments.
- The patient and the prescriber are listed on the MCAP register.
- Reimbursement under the LTI or GMS scheme has been authorised.
Pharmacists will be able to dispense products as normal.
The MCAP will not limit or interfere with doctors and patients who wish to access a cannabis-based product via a Ministerial Licence.
For further details of the MCAP, see the FAQ document available from the Department of Health website.