Ireland is considered one of the more conservative countries in Europe as it relates to cannabis regulation and legality. Cannabis remains illegal, classified as a Schedule 1 drug, for both medical use and broader recreational use. While there have been very limited attempts at amending the law, the Irish government has made strides towards allowing limited compassionate medical use of cannabis. Currently, a very limited number of patients (49 in mid-2020) with a ministerial license can access medical cannabis, with the majority traveling to the Netherlands to purchase authorized cannabis from Bedrocan. In August 2020, the Irish Examiner reported that the Department of Health spent €8,975 on couriers to collect and deliver medical cannabis on behalf of dozens of Irish patients who could not travel abroad during the COVID lockdown.

In June 2019, the Minister for Health signed legislation to allow for the operation of the Medical Cannabis Access Programme on a pilot basis for five years, though it did not begin approving patients and prescribing medications in 2020, largely due to COVID-related delays. The Medical Cannabis Access Programme will allow eligible patients to access specific approved products from international suppliers, currently limited to Aurora, MGC Pharmaceuticals (CannEpil) and Tilray. While this program will make great strides in creating a regulated cannabis market in Ireland, it is still only approved under a very limited scope. Patients can access treatment under three relatively rare conditions (epilepsy, MS and chemotherapy-associated nausea). Additionally, patients must have tried all existing treatments before being granted compassionate use of medical cannabis products. It is expected the Medical Cannabis Access Program will take off in 2021 and grow as more patients gain access to these treatments and more companies receive authorization to supply the market. The Pilot Access Programme and the Ministerial License route will run in parallel initially.

Ireland has strict regulations on cannabis and has made very few changes or exceptions to regulation in the past decade. Cannabis is still classified as a Schedule 1 drug, both medically and recreationally, allowing very limited space for a regulated market to exist. The possession, use, and sale of cannabis is still illegal in Ireland, though the consequences are less severe than those seen in regions of the United States. While cannabis seeds are legal to purchase and sell, the cultivation of cannabis is illegal as well. While recreational cannabis remains illegal and there is little expectation of legislation in the coming years to change that, efforts have been made to allow further access to medical cannabis.  

Until the broader Medical Cannabis Access Program (MCAP) becomes active, it is only through ministerial licenses under section 14 of the Misuse of Drugs Act that patients in exceptional need can gain access to cannabis for medical reasons. Even in this case, patients only have access to medical cannabis sourced from the Netherlands, limiting them to Bedrocan products. This program is so limited in scope that as of June 2020, the Department of Health reported that just 49 patients across the country have attained these ministerial licenses.  

In 2019, the Minister for Health signed legislation to allow for the operation of the Medical Cannabis Access Programme on a pilot basis for five years. Only specific medical cannabis products (defined as ‘specified controlled drugs’) which meet the requirements set out in legislation can be used in the Medical Cannabis Access Programme, and must be supplied by commercial international operators. Access through the pilot scheme will be limited to patients suffering from multiple sclerosis with spasticity; severe, refractory epilepsy; and nausea/vomiting associated with chemotherapy where standard treatments have failed. Prescriptions must be issued by a registered medical consultant with specialist training in the specified medical condition, and eligible patients will be required to have their names entered on the Cannabis for Medical Use Register.

As of the end of 2020, Ireland has yet to approve patients under the MCAP. It has approved just three products (oil and oral solutions) produced by three vertically integrated producers (Aurora, MGC Pharmaceuticals, and Tilray) for circulation on Ireland’s domestic market. The MCAP will be regulated by the Health Products Regulatory Authority (HPRA), who are responsible for selecting additional suppliers, and the Health Service Executive will establish and regulate the Cannabis for Medical Use Register. This program is expected to launch in 2021 and run for five years, after which final judgements will be made regarding further regulations and licensing for the domestic market.

The MCAP program is the first trial run Ireland has made at loosening regulations on the cannabis market, and while it will be operating under a very narrow scope, it shows promise with regard to more progressive cannabis laws to come.  

Ireland has approved three products from as many vertically-integrated cannabis producers through its MCAP, though access to prescriptions is not expected to begin until 2021. The approved suppliers are all international companies, as restrictive regulations have not allowed for a domestic market. The companies approved thus far include:  

• Aurora Cannabis (Canadian licensed producer), approved to supply their oral solution extract, Aurora High CBD Oil Drops.  
• MGC Pharmaceuticals (headquartered in Australia) has been approved to supply their oral solution extract, CannEpil.  
• Tilray (Canadian licensed producer) has been approved to supply their oral solution extract, Tilray Oral Solution Balanced 10:10.  

On a highly exceptional basis, patients can continue to access Bedrocan (Netherlands) ground flower products with a ministerial license to do so.

Both medical and recreational cannabis markets did not exist in Ireland before the passage of the MCAP in 2019, which created the first regulated cannabis market in Ireland. While a very limited number of patients did have access to medical cannabis before 2019, it was solely authorization to access product picked up from the Netherlands rather than creating a domestic market. Conversely, the MCAP will allow prescriptions to be issued by specialist doctors and dispensed to patients through pharmacies in Ireland.  

On Ireland’s formal medical market, to date only three products have been permitted: one oil and two oral solutions, thus oils are expected to dominate the market in the medium term. Though historically Bedrocan dried flower product made up all cannabis sales in the country, sales were negligible as patients were required to fly to the Netherlands in search of product and very few registered. Flower is expected to fade out of the market as MCAP grows, given the tremendous logistical challenges presented when accessing cannabis via ministerial license.