Ireland’s decision to launch a medical cannabis trial is a significant breakthrough for patients and a step forward for the sector, but experts believe the legislation is overly cautious and contains significant gaps.
On 26 June, the Irish Health Minister, Simon Harris, signed a law that will permit Irish citizens to access certain medicinal cannabis products as part of the five-year pilot programme.
Under the Medical Cannabis Access Programme (MCAP), consultants can prescribe medicinal cannabis of a regimented quality to patients who have failed to respond to standard treatments for specific conditions.
These conditions include spasticity associated with multiple sclerosis, intractable nausea and vomiting associated with chemotherapy, severe refractory (treatment-resistant) epilepsy, but it does not cover chronic pain.
Since the programme has been legislated for via secondary legislation the Oireachtas Joint Committee on Health did not have the power to scrutinise or support/reject the legislation. They can only do this for primary legislation. The committee does, however, have the right to invite the Minister to appear before the committee in future, in order to scrutinise both the policy behind the MCAP and/or its implementation.
Cautious reception for Irish cannabis
Dublin Mid-West and People Before Profit campaigner Gino Kenny TD cautiously welcomed the decision as a victory for campaigners but said it did not go far enough.
Deputy Kenny, who tabled the Cannabis for Medicinal Use Regulation Bill 2016 in the Dáil, noted the programme’s ‘serious limitations’ concerning the number of illnesses it includes, specifically chronic pain.
‘For the first time medicinal cannabis can be prescribed by a medical practitioner, which is hugely significant in terms of the Irish health system’s acknowledgement of the medicinal properties of cannabis,’ he said. ‘I would, however, say that the programme, as the government have laid out, is quite restrictive in that it does not include a number of conditions that could derive benefit from medicinal cannabis, most notably chronic pain.’
Kenny said he will be raising the matter with Irish officials and looking to work on improvements to the legislation.
Delays
The programme was initially announced two years ago but was delayed in the Irish parliament due to problems finding an appropriate supplier.
Irish delegations flew to Canada and Denmark as Minister Harris and his team sought quality-assured medical cannabis from countries with the highest standards of expertise.
Earlier in 2019, a supplier was eventually found in Denmark, ensuring the law could be signed. It is expected that patients will be in a position to access the scheme in the autumn.
‘The purpose of this programme is to facilitate compassionate access to cannabis for medical reasons, where conventional treatment has failed,’ said Harris. ‘Ultimately it will be the decision of the medical consultant, in consultation with their patient, to prescribe a particular treatment, including a cannabis-based treatment, for a patient under their care.’
Echoing experiences in many other European Union states, Irish citizens suffering from an array of debilitating symptoms have been forced to spend thousands of euros travelling to areas such as Canada and the Netherlands to access cannabis-based medicines.
Under the new law, commercial operators whose products meet the specified requirements can now supply products to the Irish market.
Next steps for Irish cannabis
The passing of the legislation is a positive step towards patients access but there are a number of hurdles to overcome before producers can get their product to market.
In the first stage of the process, potential suppliers apply to have their medical cannabis products assessed for suitability. While Tilray have had certain cannabis oils approved, the group had been building relationships with the Irish government over the last 12 months and other producers will likely experience challenges in getting their product to market.
Once a suitable medical cannabis product is assessed and approved, the Access Programme can make it available for prescription. However, the medical consultant must prove the patient has failed to respond to other treatments, as cannabis will still be defined as a ‘specified controlled drug’.
According to the Health Service Executive (HSE), authorisation will be on a named-patient arrangement and subject to the following conditions:
- Treatment is consultant-initiated
- Online reimbursement approval is required for each patient
- All standard approved treatments have been exhausted for that patient
- New patients are initiated on Irish pharmacy-supplied products
Patients can apply for reimbursement from the HSE. For further information on licensing producers, importers and distributors are instructed to contact the HPRA at controlleddrugs@hpra.ie
Sowing seeds for cannabis cultivation
The Irish government have been discussing proposals to cultivate medical cannabis with Bord na Móna, the Irish semi-State vehicle responsible for peat-based activities as part of a wider agenda to move towards more sustainable business.
The proposal is receiving cross-party support from Ireland’s two largest parties, Fianna Fail and Fine Gael.
Minister Harris explained ‘I did have a very good and interesting meeting with Bord na Mona with Minister Canney in recent weeks and it is true that Bord na Mona are looking at this area.’
‘Instinctively I think in the medium term this is something that would make sense, for Ireland to have its own supply.’ However, the Minister insisted that Ireland is a ‘little bit away from that yet.’
European market moves
‘Ireland looks to have taken a similarly cautious view to that which was adopted in the legislation recently introduced in the UK, in that it must be demonstrated that standard medical treatments have been ineffective before a patient can be prescribed medical cannabis,’ said Dylan Kennett, Corporate Senior Associate at DLA Piper.
He said it was a ‘welcome change to the law in Ireland in relation to medical cannabis’ and follows the examples set by a number of European jurisdictions in recognising the benefits of medical cannabis.
The European Union is taking steps to harmonise its laws across the bloc in relation to medicinal cannabis research and development, and while at an early stage, optimism is strong that barriers to entry such as prohibitive trial costs and legal barriers to handling cannabis compounds for testing purposes can be removed.
Research conducted for The European Cannabis Report™ 4th Edition reveals a fully mature Irish market could be worth €2.3 billion annually.
The Medical Cannabis Access Programme will operate on a pilot basis for five years before a review in 2024. The group have also published the ‘Clinical Guidance on Cannabis for Medical Use’, which is intended to support physicians and clinicians with prescribing guidance and information on available products.
This legislative update is intended to implement findings published in the 2017 report by the Health Products Regulatory Authority, entitled ‘Cannabis for Medical Use – A Scientific Review‘.
