Ireland introduces a medical cannabis program following Denmark’s success

Ireland is the second European nation to launch a pilot medical cannabis program, following Denmark’s proven success. The Minister if Health, Simon Harris, signed a new legislation on the 26th of June 2019 allowing people access to medical cannabis on a controlled basis through the Medical Cannabis Access Program.

Further information on the ‘Medical Cannabis Access Programme’: https://t.co/b7s5RLAsFb@SimonHarrisTD @TheHPRA @HSELive #MedicinalCannabis #cannabis pic.twitter.com/oYnqIe5QtY

— Department of Health (@roinnslainte) June 26, 2019

The signing of the legislation has initiated the first stage of the programme which is for potential suppliers to apply to have their medical cannabis products assessed for suitability of medical use. The first company to successfully deliver the first medical cannabis oil shipment to Ireland is Tilray – a Canadian pharmaceutical and cannabis company that is a global leader in cannabis research, cultivation, processing and distribution. It is highlighted that a listed cannabis-based product is not authorised medicine in that it has not undergone the rigorous testing, both in laboratory and clinical trials, and authorisation process is required before such medicines can be placed on the open market. The prescribing and use of a cannabis product under the programme, is a matter for the patient  and their medical consultant.

The purpose of Ireland ‘s 5-year Medical Cannabis Access Program (MCAP) is to facilitate access to acceptable cannabis-based products for medical use that are of a standarised quality and which meet the requirements outlined in the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Us) Regulations 2019. The programme is to provide access for patients with the following medical conditions which have failed to respond to standard treatments:

• spasticity associated with multiple sclerosis;
• intractable nausea and vomiting associated with chemotherapy;
• severe, refractory (treatment-resistant) epilepsy.

Work on the establishment of the programme began in March 2017, adopting the conclusions from the Health Products Regulatory Authority’s (HPRA) expert report Cannabis for Medical Use – A Scientific Review, which was prepared at the request of the Minister for Health.This report, along with the new pilot programme, is also embraced from Epilepsy Ireland.

Epilepsy Ireland

Their position is declared on their website:

Given the devastating impact of rare epilepsies like Dravet Syndrome and the limited success of existing drugs in treating these conditions, it is understandable that many affected families are reaching out for the potential benefits provided by medical cannabis.

Epilepsy Ireland has long held an evidence-based position on medical cannabis and we agree with the path recommended by the HPRA in 2017. We also fully support the position of the NECCP and with the need for further research on all aspects of medicinal cannabis.

Our current position (which may evolve as more evidence becomes available) can be summarised as follows:

• As an organisation that funds epilepsy research, Epilepsy Ireland welcomes all research that seeks to develop safe and effective treatments for epilepsy including trials on cannabis-based products that may lead to approved medical treatments.
• We welcome the approval of Epidiolex in the US for certain rare childhood epilepsies following a series of robust clinical trials (link 1; link 2; link 3). We hope that it will shortly be approved for use in Europe in the near future and we will advocate for access to the drug in Ireland once approved.
• A clear distinction needs to be drawn between approved medications such as Epidiolex that have undergone rigorous efficacy and safety testing and non-pharmaceutical products (whether CBD or CBD+THC) that are not licenced for medicinal use. While there have been positive anecdotal accounts of some of these products, no robust evidence from high quality scientific studies exists to support the use of non-pharmaceutical cannabis-based products for the treatment of epilepsy. In the absence of robust evidence, these products cannot currently be considered as safe or effective treatments to the same degree as regular approved medications.
• In particular, there are serious concerns about the safety and risks associated with unregulated, un-standardised non-pharmaceutical products containing cannabis extracts, especially those that contain THC. While GMP-certification offers assurances around manufacturing, quality and consistency, it does not elevate cannabis products to the status of approved medications.
• Given the largely unregulated marketplace that currently exists, the June 2019 legislation establishing the Medicinal Cannabis Access Programme is to be welcomed. We support the Programme as a safer, more regulated pathway to enabling access to last-line alternative treatment options for people who could potentially benefit from them. We welcome the role that the HPRA will have in determining and regulating manufacturing and labelling criteria. The MCAP will also enable valuable data collection to inform patients and medical professionals about the role that cannabis products may play in epilepsy treatment in the years to come. We also hope that the programme will enable full and open communication between patients and doctors, an important consideration in light of the potential interactions that can exist between cannabis products and epilepsy medications.
• As with any potential treatment, further research, in the form of well-regulated clinical trials represent the only safe and objective way to assess the potential of cannabis based products in the mainstream treatment of epilepsy. Epilepsy Ireland has invited applications under our Research Funding Scheme from researchers who want to pursue this area of research.
• We do not have a position on the legal status of cannabis for recreational or non-medical purposes.
  Important Note: Please talk to your doctor/ epilepsy nurse about any concerns relating to your medications, or if you are using/ considering using cannabis-based products.

Despite the potential benefits for a wide number of patients of Ireland ‘s Cannabis Program though there have been delays in delivering it as the Irish parliament faced problems finding an appropriate supplier. Having recently passed this barrier the minister declared that

I expect patients to be in a position to access the scheme in autumn.

Critics however, state that there are serious limitations to the programme concerning the number of illnesses it includes. Neuropathic pain, i.e. pain due to a disease of the brain, spinal cord or nerves is clearly missing from the Irish list whereas it has been included in Denmark’s medical cannabis pilot programme. Neverthelss, Ireland along with Denmark set a bright example for European countries to follow and signifies the urge that a comprehensive legal framework is needed from the European Union to harmonise its laws across the bloc regarding medical cannabis research and development.