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Medical Cannabis Access Progresses in Ireland

Medical Cannabis Access Progresses in Ireland
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The Irish Ministry of Health has announced a new Medical Cannabis Access Programme (MCAP) is operational as of July 2021. In addition, patients obtaining medical cannabis under Ministerial approval will now have their products directly reimbursed by the government. However, access to medical cannabis in Ireland still lags far behind other European countries.

Ireland maintains one of the more restrictive systems for access to medical cannabis products compared to other high-income European countries. With the announcement of the new Medical Cannabis Access Programme, Ireland now has three routes which together offer limited access to medical cannabis products, with less than 100 patients likely having access to such products at the time of writing.

The three routes for accessing medical cannabis in Ireland are as follows:

  • Ministerial approval, whereby a patient can, in theory, access any medical cannabis product for any condition with the written approval of the Minister of Health. Applications must be made by a patient’s specialist physician or their doctor with endorsement from a specialist. Currently, 63 patients access medicines in this way.
  • Pharmaceutical cannabis  medicines such as Sativex and Epidyolex have approval for a limited set of conditions – e.g. spasticity in MS and rare childhood epilepsies – and can be prescribed by any physician. These approved products are not recommended for reimbursement by Ireland’s Health Services Executive (HSE) and so remain difficult to access.
  • The new MCAP, whereby a patient can be registered by a specialised physician, to access a set of cannabis-based products for a limited number of conditions.

New system of legal access

On Monday 15th July, the Minister of Health announced that doctors can now apply to register their patients for the MCAP. The programme has been in preparation for a number of years, since being proposed by the Health Products Regulatory Authority (HPRA) in 2016. Under the scheme, only doctors specialised in relevant fields will be able to register their patient for the purposes of obtaining medical cannabis products from a curated list of medicines.

Patients will only be eligible for the MCAP if they have not responded to conventional treatments while suffering from: spasticity associated with multiple sclerosis, intractable nausea and vomiting associated with chemotherapy or severe, treatment resistant epilepsy. A restricted set of medicines will be approved by the HPRA for the scheme. As of the time of writing, four products have been approved for use in the MCAP. These include:

  • Aurora High CBD Oil Drops
  • Aurora Sedamen Softgels (THC rich)
  • MGC Pharmaceutical’s CannEpil (CBD rich)
  • Tilray Oral Solution THC10:CBD10

Reimbursement of the costs of these medicines is not guaranteed, and will only be approved on a named patient basis and only for those patients obtaining via: a Medical Card, the Long Term Illness Scheme or Drugs Payment Scheme. Some details around pricing of medical cannabis dispensing fees with pharmacies are yet to be finalised.

Health Minister Stephen Donnelly, who announced the initiation of the programme this month. Source:Independent.ie, Prohibition Partners

Once a product has been approved for the MCAP, operators wishing to distribute the medicine need to apply for a controlled drug annual license in addition to a controlled drug import license for each consignment of the medicine. As of March 2021, three wholesalers were approved to handle imports of medical cannabis products, 12 licenses to import consignments were granted, of which just two had been used.

More recently, on 20th July, it was announced that the HSE will now pay for the medication of 17 patients who are obtaining medical cannabis products under Ministerial approval from Transvaal pharmacy in the Netherlands. Until now, patients had been paying thousands of euros out of their own pockets for medicines before subsequently being reimbursed, which hampered accessibility.

During the pandemic, the Irish government has also made arrangements for these medicines to be delivered to Ireland instead of being collected by the patients which had, until then, required considerable time and money on the part of patients and carers. These positive changes have been brought about by the sustained efforts of campaigners such as Vera Twomey, who has fought an enduring battle to gain access to cannabis medicines for her daughter, Ava, who experiences Dravet’s syndrome, a rare form of epilepsy.

Ireland lagging behind other European countries

For now, medical cannabis access in Ireland remains restrictive, compared to countries like Germany, which grants access to an estimated 128,000 patients on an ongoing basis, or Denmark, which has a comparable population size to Ireland but provides access to over 1,600 patients each month. Although patient access to medical cannabis products in Ireland now appears to be improving, this positive shift is preceded by more broadscale access in other countries across Europe. Recent surveys have shown overwhelming support from the Irish public for the legalisation of medical cannabis.

Source: Irish National Drug and Alcohol Survey, Prohibition Partners

Unfortunately, the Medical Cannabis Access Scheme is not due to be reviewed for 5 years, and currently lacks the components that would support broad scale patient access, such as physician’s full discretion over prescriptions, prescriptions for other conditions such as pain, guaranteed reimbursement of costs for patients, and a wider range of products being approved.

Support for legalisation of adult-use cannabis remains low amongst the general public. The current Minister for health has in the past stated support for legalisation, saying of personal consumption: “You’re doing something that’s not harming anybody else, it’s hard to see a legitimate role for the State in prosecuting you for it”.

To date, no adult-use cannabis legislation has made it far under the successive rule of conservative, centre-right government parties of Fianna Fáil and Fine Gael. In December 2020, cannabis possession was added to a list of crimes which will not be actively prosecuted but instead result in a caution from police, as well as a fine.

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