Gino Kenny criticises Medical Cannabis Access Programme limits
Gino Kenny questioned the Minister about the Medical Cannabis Access Programme (MCAP), saying the scheme is extremely restrictive and omits many patients who could benefit. He urged a wider clinical review and raised concerns about the Ministerial Licence route and joined-up research.
Programme criticisms
The Deputy argued the MCAP is too limited and excludes many people who might benefit from medical cannabis. He criticised the Ministerial Licence process as bureaucratic and arduous for parents, saying many had to "fight tooth and nail" for access and that there has been no joined-up research on licence holders.
Current access and approval figures
The Minister reiterated the programme began after a commissioned expert report and is operated by the HSC. To date 20 patients out of 22 applications have been accepted onto the programme, while about 40 patients continue to access cannabis via the Ministerial Licence Scheme.
Evidence review and potential expansion
The Department of Health has commissioned an evidence review to examine efficacy and safety of cannabis-based treatments for a wider range of conditions. A clinical group will assess that evidence and advise the government on possible amendments to the list of authorised conditions - a step the Deputy said could broaden access.
Product availability and cost developments
Two products are currently available under the programme and a third product from Tilray is expected shortly; initial supply issues have largely been resolved. The Minister noted about 85% of expected programme costs were linked to refractory epilepsy patients and that in December the HSE agreed to reimburse a licensed cannabis-based medicine, Epidiolex, providing clinicians with an authorised treatment option.
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Minister, my question surrounds a report that was commissioned five years ago, and that report was Cannabis for Medical Use, and that was commissioned by the HPRA, and obviously one of the main recommendations was an access programme, and that was five years ago, I think the programme is extremely restrictive, and has omitted many, many people that could benefit from mental cannabis, so I want to kind of get your views in relation to the programme itself. Thank you Deputy, Minister, please. Thanks very much Deputy, and can I acknowledge your ongoing advocacy work on this area, and indeed on this programme, the Medical Cannabis Access Programme. The MCAP programme was initiated, as the Deputy has said, following a ministerially commissioned expert report some time back on cannabis for medicinal, or for medical use, and access to cannabis for medical purposes is for the treatment of three specified conditions, or at least that was the recommendation, for three specified conditions, when all other treatments had failed. Now the programme commenced in July of last year, and I was very happy to initiate that. It's operated by the HSC. There have been some initial issues with availability of products, and I'm happy to come back to that. Most issues have now been resolved, and one additional product will be available in the coming weeks. Now, we must recognise that there are, of course, limitations to the programme. Products are not authorised medicines, and assurances regarding safety, quality, effectiveness, are not the same as they would be for an authorised medicine. The required structures have been put in place to function as expected. However, it is a clinical decision whether to prescribe these products. So currently, 20 patients out of 22 applications have been accepted onto the programme, and in parallel, there are 40 patients accessing cannabis for medicinal use through the Ministerial Licence Scheme. Deputy Kenny. Sir, I mean, I think we would both agree on this, that the current, the policy of a Ministerial Licence was completely, it was all bureaucratic, and very arduous for parents, and many, many parents had to fight tooth and nail to get access for their children. And I've always found it kind of strange that over 40 people that have Ministerial Licence, there's no kind of joined-up thinking for all them individuals that have a licence. There's no kind of research done, there's no kind of, you know, joined-up thinking. I just find that very, very strange. Obviously, the Access Programme gives that kind of joined-up thinking. 20 people, I mean, it's a very, very small amount of people that could be, you know, really benefiting from medical cannabis. If you look at the Danish medical cannabis access program, and I'll kind of allude to that in the next part, they have broadened out some of the, more conditions in relation to their Access Programme. So, I think the clinical review is very, very important. Thank you, Deputy. Minister, please. I think the question you're posing is, can we expand the programme to different conditions? So, as we were discussing, the original report recommended it's used for three conditions once other treatments were no longer deemed viable. And so, the question is, can we broaden that? So, the Department of Health has now commissioned an evidence review. This is examining the efficacy and the safety of the cannabis-based treatments for a wider range of conditions. And when that's completed, the clinical group is going to be convened to assess the evidence and to provide guidance to government on any potential amendments to that list. So, that's something that potentially would widen access. As I was saying to the Deputy, two products are currently available. And there's a third product at Tilray, which will be available shortly. And I know there are some clinicians, for example, who've been waiting for that specific product for their patients. Deputy? Yeah. I mean, if the programme doesn't broaden, you know, the state, the conditions, I think, you know, I don't see the programme kind of going anywhere. For, obviously, medical reasons and commercial reasons. I mean, the Danish medical cannabis access programme was open since 2018, and two and a half thousand patients have got a medical cannabis product via prescription. And some of the conditions where it's been prescribed for, which is not in the medical access programme here, and particularly, particularly, Minister, is neuropathic pain. I mean, the evidence is really, really good around neuropathic pain and cannabis. Look at throughout all the access programmes throughout the world. I mean, it's really good about cannabis and chronic pain, or neuropathic pain, whatever you want to say, because, obviously, chronic pain is a very broad term. But the omission of chronic pain in the initial report was very, very controversial. So, there's a whole host of people that could really benefit from medical cannabis. Thank you, Deputy Minister, please. Thank you, Deputy Minister. Thanks, Deputy. So, let's see what the research comes back with. I acknowledge the position you're making, and I know there are others here and around the world who would share a similar view. So, I want to see what the evidence view comes back with, and then we can look at clinical recommendations in terms of expanding the conditions. Now, part of why it might be more limited than would have been expected, potentially, is for some good news. So, about 85% of the expected cost for the programme was specifically being attributed to refractory epilepsy patients. Now, just in the last seven months, so in December of last year, the HSE has agreed to reimburse a product called Epidiolex. Now, Epidiolex is a licensed cannabis-based medicine, and it's one that the clinicians have been going for, I would imagine, in part, again, because it is licensed versus the unlicensed.
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