Violet-Anne Wynne (Clare, Independent)
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I am delighted that this Topical Issue was selected and thank the Office of the Ceann Comhairle for facilitating this important discussion. It is an issue I am very passionate about and I hope to shed a bit of light on what the medical cannabis access programme, MCAP, and the ministerial licence mean.

As we all know, the MCAP was established in 2019 as a five-year pilot scheme. However, the programme has shown limited reach. Data released to me shows that in the first quarter this year, a mere 53 patients have managed to secure access. Alarmingly, there were zero enrollees for the first three months of this year. I believe since March, a further two, or possibly four, have managed to enrol, but for a programme that was intended to ensure accessibility for patients, I am sure the Minister of State will agree the numbers are stark.

In contrast, the ministerial licence, also established in 2019 as an alternative means of obtaining medical cannabis, has witnessed a markedly higher uptake of 319 accepted applications, with one accepted in the first quarter of this year. This shows that there is a much greater need and demand for what the MCAP currently allows and the programme must be expanded immediately. The ministerial licence has its complexities. The HSE stated it commits to reimburse patients for cannabis products obtained via this route, but that is only if prescribed for one of the three qualifying medical conditions recognised by the programme. That is a bit of a contradiction in itself that I will refer to later in my contribution. It is imperative that I outline the three conditions. They are spasticity associated with multiple sclerosis, MS, intractable nausea and vomiting associated with chemotherapy and severe refractory epilepsy. I will focus on these three conditions.

Access for patients with spasticity, but not patients with MS more generally, seems very specific. I know of patients with MS who have relayed huge frustrations to me about this. Intractable nausea and vomiting associated with chemotherapy, but not cancer patients, is covered by the scheme. Again, that is very specific and restrictive. That the definition of the final condition includes the word "severe" seems unnecessary, as refractory epilepsy already implies that medicines have not worked or do not work at all to control seizures.

Whether the Government intended to do so, it ensured access for only those three specific conditions. We were all optimistic when the programme was first announced. However, five years on it is disappointing that the numbers show just how restrictive it is. It is concerning as all of those patients who access the ministerial licence are doing so because they are not eligible for the MCAP pathway and are excluded from applying.

The absence of an eligibility criteria for the ministerial licence reflects a broader demand and necessity that exceeds the MCAP provisions. There is a pressing need for the expansion of the scheme, underscored by the higher patient numbers utilising the ministerial licence. That indicates that the current MCAP is overly restrictive.

Patients accessing the ministerial licence worked tirelessly with their medical professionals to complete what is called the ministerial licence. There are issues with the scheme, however, and the main one I want to point to is the fact that patients get no financial assistance. Medical cannabis is by no means cheap for patients who are trying to obtain treatment. The numbers speak for themselves. In light of these findings, these numbers are not just statistics but rather a testament to the urgent need for reform and the voices of patients calling for change.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy for her question. She raised two distinct issues, which I shall address in order. The MCAP is operated by the primary care reimbursement service of the HSE and is a statutory programme to enable clinicians and patients to access prescribed cannabis-based products for the treatment of three conditions as specified in the HPRA 2017 report Cannabis for Medical Use-A Scientific Review, commissioned by the Minister for Health. As the Deputy stated, the three conditions are: spasticity associated with multiple sclerosis resistant to all standard therapies and interventions while under expert medical supervision; intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes while under expert medical supervision; and severe refractory treatment-resistant epilepsy that has failed to respond to standard anticonvulsant medications while under expert medical supervision.

The Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 set out the legal provisions for the operation of the MCAP and the legal obligations for healthcare professionals and commercial operators. The MCAP commenced in late 2021 and, as the Deputy said, to date 55 patients have been treated under it. The MCAP was scheduled to be a five-year pilot programme. However, the Minister for Health brought the review forward, given the passage of time, and the Health Research Board was engaged to carry out the initial evidence gathering and subsequent synthesis for presentation to a clinical review group that will make recommendations to the Minister as to whether evidence exists to expand the range of products covered by the programme. Officials in the Department of Health are working on setting up the clinical review group.

On ministerial licence patients, the ministerial licence programme enables clinicians with a licence issued pursuant to section 14 of the Misuse of Drugs Act to treat patients with cannabis products. The programme predates the MCAP, the first licence being issued in late 2016. To date, 362 ministerial licences have been issued for the treatment of 77 separate patients.

Currently 27 patients are availing of the programme. All patients currently avail of cannabis-based products manufactured by a pharmacy in the Netherlands. Having initially been set up by the Department of Health during the pandemic, the primary care reimbursement service, PCRS, of the HSE operates a monthly service whereby the products are collected from the Netherlands, transported to Ireland and delivered to patients' homes directly. This applies to all patients. For those patients treated under the licence programme for one of the three stated conditions covered by the MCAP, the PCRS directly pays the dispensing pharmacy in the Netherlands on receipt of an invoice. Patients treated for other conditions must meet the costs of the products themselves.

Violet-Anne Wynne (Clare, Independent)
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I thank the Minister of State for the new statistics showing that 362 licences have been issued, which is very positive. Recently a patient reached out to me who had applied for a ministerial licence. The Minister for Health will be very familiar with this case because I submitted a number of parliamentary questions on the matter. What has come to light is that because the consultant is the one who completes a ministerial licence application, he or she is then deemed to be the applicant, which means that the Department will only engage with the consultant. In this particular case, the application was submitted on 7 December 2023, more than five months ago. In response to a parliamentary question, I was told that the Department would expect the consultant to hear back within a matter of days so something has gone seriously wrong here. The consultant has had to submit a complaint to try to ascertain what is going on. The patient is seen as a third party and cannot access any information whatsoever. I just wanted to highlight that again on the floor of the Dáil. Hopefully, I will get an answer for that patient.

I also want to point to recent HRB research where the board reviewed existing medical cannabis research and found evidence to support the prescribing of cannabis for the conditions that are approved, which is fantastic. The research also found evidence to support its use for nerve pain, especially in those with multiple sclerosis, diabetes and spinal cord injuries. That is very positive news and I applaud the HRB for bringing this to light. However, this report is at odds with a study by the board in 2016, which also found evidence that medicinal cannabis in some forms has at least moderate efficacy in treating sleep disorders and stimulating appetite, chemotherapy as a whole, fibromyalgia, PTSD and some Parkinson's diseases. There is also evidence for its usefulness in the treatment of dementia and a list of other conditions that I do not have time to go into now. I hope the review under way will take account of the number of different conditions that have been approved under ministerial licence and the recent research that has been conducted in the area.

Mary Butler (Waterford, Fianna Fail)
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As I stated earlier, the Department is currently establishing a clinical review group to review the publication to make recommendations to the Minister for Health. In response to an oral parliamentary question last week, he stated that he would be open to any expansion, if recommended, but that he would be entirely led by the clinicians in the group.

The Deputy spoke about a specific case in the context of the ministerial licence. To ascertain which patients are eligible to have their products funded, the PCRS would review whether the person met the clinical criteria and if so, advise that the patient could be supported for reimbursement. In situations where the HSE considered reimbursement support appropriate for patients accessing cannabis product from the Netherlands, a number of steps were taken. First, the patient’s consultant was satisfied that all therapeutic options were exhausted and was prepared to accept the responsibility of monitoring the patient’s response to the cannabis product. A prescriber, namely the person authorising the supply for a patient to a person entitled to dispense, applied to the Minister for a ministerial licence and a copy of the licence was enclosed with the application. The consultant completed an individual reimbursement form such that the therapeutic benefit for the patient is described. Only applications that were in line with the clinical guidance on cannabis for medical use that is published on the Department of Health website were considered. The three indications set out in the guidelines are: spasticity associated with multiple sclerosis; intractable nausea and vomiting associated with chemotherapy; and severe, refractory epilepsy. Anything outside of these indications is not supported for reimbursement.

If the Wynne sends on the details of the particular case she mentioned to the Minister's office, I am sure his officials will look at it for her.