Earlier this year, the Irish Health Service Executive (HSE) has announced that the first cannabis-based products will be available through the Medical Cannabis Access Programme from mid-October.
Despite an update from the Irish health service (HSE) and Health Products Regulatory Authority (HPRA) that CannEpil would be prescribed by the middle of October, the first prescription has been delayed.
People before Profit TD for Dublin Mid-West Gino Kenny tweeted that the first prescription should be available from next week.
Some positive news regarding the Medical Cannabis Access Programme. It has taken years of campaigning by families to get recognition that medical cannabis medicines can be a treatment option. However small the step the first person to receive it under the MCAP will be next week.
— Gino Kenny TD (@Ginosocialist) November 18, 2021
The HSE has yet to confirm that the products will be available from next week but says they would not be aware until the consultant neurologist has issued claims at the end of the month.
In a statement to Cannabis Health News, a press officer at the HSE stated: “The HSE has registered three patients under the MCAP in recent days. We would not be aware whether the consultant neurologist has proceeded with prescribing for an individual until claims were submitted from pharmacies at the end of the month.”
He also raised the issue in the Dáil earlier this month to Taoiseach, Michael Martin.
“Many families would have been very joyous during the summer when the medical cannabis access programme was to commence. But sadly, in a PQ response today, not one patient has been given access thus far. That is a huge disappointment to those families that this treatment could make life-changing benefits,” he said.
“So what do you say to families that feel let down by the program and now they have to look at other treatments and probably getting no treatment at all?” He asked.
Michael Martin replied that a lot of patients have been facilitated by the original ‘imported license’ but he was unsure as to why patients had not availed of the MCAP. He promised to follow up with the Minister for Health, Stephen Donnelly of Fianna Fáil.
Gino announced changes to the Cannabis Regulation and Control bill that he is due to submit. It will now take place next year with a focus on production and consumption for personal use.
Despite the Medical Cannabis Access Program now up and running, as of yet no one has been granted a prescription which is highly concerning.
Today I had a chance to question the Taoiseach on this matter. pic.twitter.com/CVCrMqFhHl
— Gino Kenny TD (@Ginosocialist) November 10, 2021
HSE committee meeting
In a joint committee meeting held in September, CannEpil was announced as the first drug to be made available through the program from mid-October.
Ireland’s Health minister Stephen Donnelly announced funding for the Medical Cannabis Access Programme (MCAP) in January, almost two years since the legislation was signed off in June 2019.
The programme will offer access to cannabis-based medicines to people living with one of three qualifying conditions. These include intractable nausea and vomiting associated with chemotherapy, severe treatment-resistant epilepsy and spasticity associated with multiple sclerosis (MS) where patients have failed to respond to authorised treatments.
The meeting saw officials from the Department of Health and the Health Products Regulatory Authority (HPRA) outline the current state of the MCAP programme and the Ministerial License system.
The suppliers of two products, CannEpil and Tilray are said to have confirmed their prices to the HSE, but Tilray has yet to announce its availability date. Two more cannabis-based products have been added to the schedule but suppliers are not thought to have current plans to supply the Irish market.
Morris O’Connor, the assistant national director of primary care reimbursement, announced that two additional products were expected to be added to the schedule in the coming weeks and that the programme may be extended for longer than the initial five year pilot period.
He stated: “There are currently four cannabis products on the schedule and two more to be added to schedule one of the regulations in the coming weeks. I understand that one of the products in the schedule namely CannEpil is expected to be available in October, subsequent to the introduction of the necessary legislation.”
According to Lorraine Nolan the chief executive of HPRA, since the MCAP regulations came into force in June 2019, 34 applications have been made for cannabis-based products.
Of these four cannabis oils have been placed in schedule one of the regulations, and two dry herb products have completed the final HPRA review and are awaiting a ministerial decision. Five are currently under active review.
Nolan commented: “The first cannabis-based products are expected to be made available to Irish patients through MCAP in October 2021. Once these are accessed by Irish patients, the HPRA will receive any reports of suspected adverse events and review them for any signals of concern regarding the safety of the product.
“The HPRA will also have a role in investigating any quality issues that may arise and coordinate any action that might be subsequently required.”
Doctors are asked to register patients who may benefit from this treatment to the HSE including the condition they are being prescribed for.
The HPRA will be monitoring patients for adverse effects over the coming weeks once the medication is available.
The MCAP programme has been criticised by patients who are still waiting for access to products despite the introduction of the scheme in 2019 under then Minister for Health, Simon Harris.
O’Conner also highlighted that 192 ministerial licenses have already been issued for 67 individuals who access medication from the Netherlands.
In July a direct funding scheme was announced to remove the need for patients to pay for these prescriptions up front and then apply for reimbursement from the Government.
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