Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I understand why the people in the Gallery applauded Deputy Kenny. He highlights a very important issue. Having engaged with him over the past week, I fully accept and understand his sincerity and desire to try to do the right thing by Irish patients and those suffering. I thank him for the Bill and the opportunity his tabling it provides us to try to debate and progress the very important issue of medicinal cannabis. I do not propose to move the reasoned amendment to the Bill on the Order Paper after the engagement I have had with Deputies Kenny and Boyd Barrett during the week because I think we have found much common ground on the issue.

I believe the Bill is very well intentioned. Deputies from across the House have met patients and their carers who believe that medicinal cannabis should be available as a treatment option for various health conditions. Some of these conditions are extremely distressing for both the sufferers and their carers, and I recognise the urgency and constant worry they feel as they watch their loved ones in pain which they believe could be alleviated.

I, too, have met personally a number of patients and carers of patients who are seeking a change in legislation to permit use of medicinal cannabis in Ireland. While I am slow to name individuals, I, too, have had a number of meetings with Vera Twomey, and her passion and determination to do right by her young daughter, Ava, is a story that has touched all our hearts and made very clear to us in a very real and tangible sense the importance of this issue to families throughout the country. I thank Vera for her leadership in this regard. There is a strength of feeling among the public that the use of cannabis-based products should be allowed for the alleviation of symptoms associated with certain conditions. That is my view too, and I acknowledge the numerous representations from members of the public and public representatives to my Department on this issue.

I share Deputy Kenny's concern for patients who believe that medicinal cannabis should be a treatment option and I expressed this to him and his colleague, Deputy Boyd Barrett, when we met earlier this week to discuss the Bill. I share the view that medicinal cannabis could play an important role in alleviating pain and suffering, subject to medical advice. It will not come as a surprise to the Deputy that I also have significant and serious issues with parts of the Bill which I do not take lightly and to which I will return in my speech for the record of the House later. Before I do so, I would like to set out some of the facts we must consider in addressing this important issue.

The issue of the use of cannabis as a medical treatment is quite complex, and there is a range of views among the public and the medical and scientific community. Medicinal cannabis is a broad term referring to the use of part of the dried cannabis plant material or products which have been manufactured from chemicals known as cannabinoids, extracted from the cannabis plant, for medical treatment. It is important to clarify that the cannabis plant contains a range of cannabinoids, some of which are psychoactive, meaning they affect the mind, and some of which are not. The element commonly known as THC, for example, is a psychoactive cannabinoid, whereas cannabidiol, commonly known as CBD, is not psychoactive.

Under Irish law, cannabis is considered to be a drug of abuse and is controlled under the Misuse of Drugs Acts. Cannabis is the most widely used illegal drug, and I think that most people in the House would acknowledge that there are significant concerns about the recreational use of cannabis, especially among young people. Apart from being illegal, there is a body of research linking cannabis to certain mental health problems.

Under current legislation, cannabis and products which contain THC or its related derivatives are subject to strict controls, as Members will know. Cannabis is prohibited other than in specified circumstances where all activities relating to cultivation, manufacture and supply of cannabis, and products containing THC, are subject to licence. CBD is not controlled under the Misuse of Drugs Acts.

While cannabis is not viewed under Irish legislation as a product having medicinal use, it is currently open for an Irish registered doctor to apply for a licence for cannabis-based preparations for an individually named patient. Such applications can be considered case by case. A number of families campaigning on the issue of medicinal cannabis would be aware of this provision, but I feel the need to highlight and reiterate that this option is available.

While many countries have the same approach as Ireland, a number of countries have introduced changes to their drugs legislation to remove some prohibitions to permit the medicinal use of cannabis in certain circumstances.

In Europe, countries where such changes have been introduced include the Netherlands, Croatia, Malta and the Czech Republic. Denmark and Germany have also recently announced their intention to progress similar changes. Beyond Europe, schemes for medicinal access have been introduced in Australia, Canada, Israel and a number of US states. Internationally, the schemes in place are focused primarily on controlling the quality and supply, principally of dried cannabis for medicinal use, as prescribed by a doctor. Other than synthetic cannabinoids and Sativex, countries have not authorised medicinal cannabis as a medicine due to the limitations of currently available clinical data on safety and effectiveness.

I believe Ireland should now consider how we might make medicinal cannabis available as a treatment option for certain conditions. As Minister for Health, as Deputies and patients will appreciate, I have a duty to carefully consider the evidence and follow the view of the medical expertise available to me. For that reason, I have taken action. On 3 November, a few weeks ago, I commenced an official review of policy on medicinal cannabis and requested the Health Products Regulatory Authority, HPRA, to provide me with expert advice. The HPRA's statutory role is to protect and enhance human health by regulating medicines and other health products. It has clinical and scientific expertise, which will contribute significantly to this review.

Specifically I have asked the HPRA for an overview of products that have been authorised in other countries; the wider ongoing and emerging clinical research in new indications; the different regulatory regimes in place in countries that allow cannabis to be used for medicinal purposes; and the legislative changes that would be required to allow use of cannabis for medicinal purposes in Ireland. This review is being progressed as speedily as possible and I have asked the HPRA to conclude it by the end of January. Deputies should be aware that this review is of the highest priority for the HPRA, as it has reflected to me, and it has convened a working group to include input from clinicians actively practising in the therapeutic areas in which cannabis is believed to be of benefit. It is a priority issue for me and the HPRA. I hope and expect to receive its advice by the end of January.

It is a difficult task as this is a complex issue that needs to be appropriately dealt with so that all the needs of patients in Ireland who may benefit from medicinal use of cannabis can be considered. This review also needs to take account of any concerns that have been expressed on potential harm from exposure. I remind Deputies that in other countries where medicinal cannabis has been authorised, it is made available only on the basis of a prescription from a doctor. The appropriateness of any particular treatment is a matter between the patient and a doctor, and that is a very important relationship in this country. My understanding is that currently many Irish doctors would be quite cautious about recommending a cannabis-based treatment for a patient in the absence of robust clinical evidence that underpins authorised medicines. It is therefore very important that we listen to the voice of medics, as I know Deputies wish to in this debate, and that is why I particularly welcome the role of clinicians in the HPRA's review.

The Oireachtas Joint Committee on Health, under the chairmanship of Deputy Harty, who is present, is also examining the issue of medicinal cannabis. The committee recently held hearings on that and heard from a wide range of views, which would have been very informative. I look forward to receiving the output of its work alongside the HPRA's report by the end of January. If we get to the end of that month with the reports from the HPRA and the Oireachtas health committee, as well as being informed by this evening's debate, we will then be in a position to consider future policy and progress any legislative changes that may be recommended.

I have already acknowledged that Deputy Gino Kenny and his colleagues have brought forward this legislation with the intention of helping patients who may benefit from medicinal cannabis. I share the concerns of patients and their carers who believe that cannabis should be a treatment option. Although I am anxious to proceed as quickly as possible - I have outlined to the House my timeline - my preference is to have the expert advice before deciding on possible changes to legislation. That makes sense and by the end of January we will have that advice. I have no wish to pre-empt the HPRA report but it is worth remembering too that the possibility exists it may not recommend new primary legislation and could inform me I can make the necessary changes through statutory instrument under the Misuse of Drugs Acts. This could well be the quickest way to make medicinal cannabis available to Irish patients. We have a common aim in trying to make medicinal cannabis products available to Irish patients on the basis of a doctor's clinical view. When we get to the end of January we will have that advice. I assure the House I will act quickly on it as I know this is an important issue for many families.

At the outset I indicated there are some elements of the Bill with which I have serious concerns and I have discussed them with Deputy Gino Kenny and Richard Boyd Barrett. In particular, I reference the amendments proposed in section 42, which remove cannabis and its derivatives from the Schedule and various sections of the Misuse of Drugs Acts. This would, in effect, mean that cannabis would no longer be a controlled drug and possession for recreational use would not be an offence. I accept this is an unintended consequence of the legislation, as I heard Deputy Gino Kenny mention this morning on the radio. Nevertheless, we should rectify the matter if the Bill is to progress this evening, as I hope and expect it will.

I have always made it clear that medicinal cannabis is a completely different debate to the issue of recreational cannabis and we are here tonight speaking about how we can help patients and families who are suffering. A debate about the recreational use of cannabis is entirely different and I would have a different view in that compared to my view of the use of medicinal cannabis. Most Members in this House would be concerned if we inadvertently legalised cannabis for non-medical purposes. That is not what tonight's debate is about but I need to highlight the unintended consequence within this legislation. I understand there is a willingness on behalf of the Deputy to amend the draft legislation to ensure we are just dealing with the issue of medicinal cannabis.

Another issue of concern is that the Bill as proposed would provide for two new agencies, the cannabis regulation authority and the cannabis research institute. In my view there is genuinely no need to create new quangos. If a decision is taken to change the regulatory regime for medicinal cannabis, the appropriate agency to oversee this would be the HPRA, as it has the statutory role and experience in the protection of human health in respect of medicines and other health products. The HPRA is already the statutory regulator for controlled drugs and it regulates our medicine. If this is to become another medicinal product, it is appropriate for it to sit under the umbrella of the HPRA. There is openness from Deputies to engage in that regard, as the roles set out in the Bill for the proposed new agencies could be appropriate to the HPRA. It would negate the need for us to establish any more agencies for regulation of medicinal cannabis that would come at an additional cost to the State. We need to do this in as simple a manner as possible and by using existing authorities. I am putting those concerns about the Bill on the record of the House.

There are many people here this evening and following this debate so closely because people have a desire to access medicinal cannabis products. As I have said, I truly accept that and thank the Deputy for putting forward this Bill. I also accept his bona fides on this and share the desire to make progress on this matter. Clearly there is much common ground on all sides of the House and with people in all parties and none. That is why, despite having significant objections to some elements of the Bill, as I outlined, it would send the wrong message to so many people who have contacted us all with their personal stories to divide the Dáil. They want to see action and the Dáil moving on this issue. I do not intend to oppose the Bill on Second Stage; in passing that Stage, it would send a strong message to the people and patients of Ireland and their families and carers that we want and intend to see progress in this area. My caveat, as Minister for Health, is that I need to receive the HPRA and clinical medical advice before I would be in a position to act. I expect to receive that at the end of January. I must have due regard to my duties and obligations as Minister for Health and I want to stress the importance of receiving the recommendations of the HPRA before we could perhaps move the Bill to the legislative scrutiny stage at committee. I am hopeful these recommendations will coincide with the output of the committee’s own deliberations.

I believe we are all united in wanting to do the best for patients here but we will achieve the best for patients by acting on the best advice. That is why I have, for the first time in this country, initiated an expert medical review of medicinal cannabis. I look forward to receiving it as quickly as possible and having it very early in the new year. I will act on its recommendations with a view to trying to make medicinal cannabis available to patients in this country. I also look forward to sharing the information with Oireachtas colleagues so we can all proceed to the right solutions in the best interests of patients. I am thankful for this debate and the opportunity provided by the Deputy in tabling this Bill to inform the people and patients of Ireland of my intentions in this regard. I look forward to working with people on all sides of the House in trying to make progress on the issue.

See this speech in context