Medical Cannabis Access Programme

Image of Minister Simon Harris signing legislation for Medical Cannabis Access Programme

In June 2019, then Minister for Health, Deputy Simon Harris signed legislation 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.

MCAP products

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, seven 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)
  • Oleo Bedrobinol (THC 13.5%)
  • Oleo Bedrocan (THC 22%)
  • Althea CBD12:THC10

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 (contained within further information section below on 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 seven products included in the MCAP (see above) meet the specification required by the Department's clinical guidelines for use in epilepsy. 

All seven 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

In January 2021, Minister for Health, Deputy Stephen Donnelly announced provision for the delivery and funding of the MCAP and in July 2021, the Minister announced that the programme was open for registration and consultants can now register their patients. 

The HSE have already confirmed that approved cannabis-based products will be available under the PCRS (Long-Term Illness Scheme, GMS 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.  

As noted above, none of the seven products currently meet the Department's own clinical guidelines for use in epilepsy. Alongside Ireland's leading epilepsy clinicians, Epilepsy Ireland have called on Government to  address this matter so that the programme is more accessible to epilepsy clinicians and their patients.

Summary

When the MCAP contains a suitable product for use in epilepsy, 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. 

Please Note..

Cannabis-based products that may be supplied under the Ministerial Access Programme or the Medical Cannabis Access Programme are NOT authorised medicines approved by national or international medicine regulators. Although typically manufactured in accordance with good manufacturing practice (GMP) standards, they are not subject to the same evidence-based analysis or monitoring as authorised medications. 

Further Information