Deputy Gino Kenny: There has been much frustration about the lack of progress with the medical cannabis access programme, MCAP. The first time the access programme was mooted was in 2017 after a report by the Health Products Regulatory Authority, HPRA. In the meantime, there has been a lack of progress. Since 2016 and 2017, there has been much campaigning by families and individuals to get access. The majority of people who campaigned have got access via a licence system. That is not perfect by any means but at least they have access. The whole idea of the medical cannabis access programme was to give individuals access via prescription. To date, only 50 people have got access. That is a tiny number when you consider that the programme has been up and running for two years. From the outset, we have always said that the programme was extremely restrictive with the conditions that were stipulated. There is significant evidence, particularly regarding neuropathic pain, that medical cannabis can be very beneficial.

The programme has been reviewed by the Health Research Board. There is hope among those who have been campaigning for this for a long time that the review will support and recommend the expansion of the programme. If it does not expand to other conditions, it is redundant.

There are major issues regarding who can prescribe medical cannabis. The programme is a good concept but it is extremely onerous on the consultants who register their patients for it. Consultants say that there is significant paperwork to register patients and for access.

The main thing we are requesting for those who have been campaigning for better access is an expansion of the programme. It should be general practitioner-led rather than consultant-led because consultants, at the best of times, are hard to see in the first place. That restrictive process needs to be looked at. Another issue with lack of access is where people have to go to the black market. It is onerous when people who have an illness must rely on the black market. Some people even go abroad to get access to medical cannabis. The worst of all is when people have to go without. That is just not acceptable. This programme was set up to give people access. At the moment, however, the programme is too restrictive. Hopefully, the review will support and recommend the expansion of the programme in order that people, particularly those with neuropathic pain and chronic pain, can get access. Otherwise, the programme will stand still and will be largely redundant if it does not expand in the context of the three conditions that are stipulated.

Minister of State at the Department of Health (Deputy Hildegarde Naughton):

I thank the Deputy for raising this matter, which I am taking on behalf of the Minister, Deputy Stephen Donnelly. 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 specific conditions, as specified in the HPRA's 2017 report, Cannabis for Medical Use - A Scientific Review, which was commissioned by the Minister for Health. 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 antiemetic 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 prescribed cannabis-based products are not authorised medicines that have gone through the normal processes for medicines to get a marketing authorisation, hence the requirement for the programme to access the products. There are authorised cannabis-based medicines for the treatment of conditions such as epilepsy, multiple sclerosis and nausea. As such, these are not available for inclusion in the programme and can be prescribed like any other authorised medicine in the normal manner. The Misuse Of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019, SI 262/2019, set out the legal provisions for the operation of the medical cannabis access programme and the legal obligations for healthcare professionals and commercial operators. Schedule 1 of the regulations comprises the specified controlled drugs, specifications for which are defined in the regulations, which may be included in the programme for patient treatment. Manufacturers can apply to the HPRA to have their cannabis-based product assessed for inclusion in Schedule 1 as a product that meets the requirements for a specified controlled drug, as set out in the regulations. Any addition to the Schedule 1 products is done by way of ministerial approval, by statutory instrument. Ten cannabis-based products have been added to the regulations for prescribing by consultants for their patients.

The MCAP commenced in late 2021. To date, 49 patients have been treated under the programme. Some 34 patients have been treated for reason 1, which is spasticity associated with multiple sclerosis resistant to all standard therapies and interventions. Three patients are for reason 2, which is intractable nausea and vomiting associated with chemotherapy despite the use of standard antiemetic regimes. Twelve patients are for reason 3, which is severe refractory epilepsy that has failed to respond to standard anticonvulsant medications.

Deputy Gino Kenny: The Minister of State can understand why people are frustrated. The programme has been up and running for two years and fewer than 50 people have got it via prescription. This review is going on forever. It was first mooted a year and a half ago. My most recent correspondence with the Health Research Board indicated that this is an ongoing review and will be finished by the end of the year. The Minister of State can see the frustration and what people are feeling.

I am not sure if the Minister of State will be able to comment on the other issue, which is those who get it via licence. Not all those who have it via licence are reimbursed. In fact, there is a cohort of people in a ridiculous situation. Those who have it via licence cannot be reimbursed but the same product is on the MCAP register. Because the programme is so restrictive, however, the same people who can get it via licence cannot get onto the programme and then have to pay out of their own pockets.

It needs to be reviewed.

The concept is good but the programme needs to be expanded. If that does not happen, I cannot see a future for it. We will have the same situation whereby people who could benefit greatly from an intervention of medical cannabis will go without or have to go to the black market, and that is not acceptable. Many people have been following this, especially those who might benefit from it, and they are very frustrated by the lack of progress. Hopefully, the review will support the programme's expansion.

Deputy Hildegarde Naughton: I will pass on those comments to the Minister. The original 2017 HPRA report, Cannabis for Medical Use - A Scientific Review, recommended that an access programme for a five-year pilot that permits patients with the defined medical conditions to be treated with cannabis or cannabinoids prescribed by their doctors. Due to the drafting of the required legislation needed to commence the programme and sourcing of cannabis-based products, the programme did not commence until 2021. Given the passage of time, the Department of Health decided not to wait for five years of operation of the programme before carrying out a review. MCAP is undergoing an evidence synthesis review on whether evidence exists to expand the number of conditions covered by the programme. This work has been undertaken by the Health Research Board on behalf of the Department of Health. The evidence synthesis review will be peer reviewed after which a clinical group will review the evidence synthesis to ascertain whether evidence exists to expand the scope of conditions covered by the programme. This is expected to be completed by the end of 2023 or early in 2024.