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Joint Committee on Health debate -
Wednesday, 5 Apr 2017

Cannabis for Medicinal Use Regulation Bill 2016: Discussion

The purpose of this afternoon's session is to engage with Deputy Gino Kenny on his Private Members' Bill, the Cannabis for Medicinal Use Regulation Bill 2016. On behalf of the committee, I welcome Deputy Gino Kenny, who is accompanied by his advisers, Dr. Peadar O'Grady and Professor David Finn.

By virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to this committee. If you are directed by the committee to cease giving evidence in relation to a particular matter and you continue to so do, you are entitled thereafter only to a qualified privilege in respect of your evidence. You are directed that only evidence connected with the subject matter of these proceedings is to be given and you are asked to respect the parliamentary practice to the effect that, where possible, you should not criticise or make charges against any persons or entity by name or in such a way as to make him, her or it identifiable. Any submission or opening statements you have made to the committee may be published on the committee's website after this meeting. Members are reminded of a long-standing parliamentary practice to the effect that Members should not comment on, criticise or make charges against a person outside the Houses, or any official by name or in such a way as to make him or her identifiable.

I ask Deputy Gino Kenny to make his opening statement.

I want to explain the rationale for bringing forward this Bill. First and foremost, this is about trying to alleviate unnecessary suffering. People may have had prejudged perceptions about the benefits of medicinal cannabis but the situation is constantly evolving into a more enlightened and educated debate. What has driven me as an elected representative over the course of the past nine months has been the personal testimony of the many people who have found themselves in circumstances not of their choosing. I have given a commitment, and I will honour that commitment, that in my capacity as a Deputy, I will be their voice in the Dáil.

The Bill that I published last July provides for the regulation of cannabis for medicinal use and, for that purpose, to do the following: to establish the cannabis regulation authority and the cannabis research institute; to provide for the licensing of the supply of cannabis for medicinal use; and to provide for related matters.

The Bill takes a health-led approach to enabling access to cannabis-based products based on the evidence of the health benefits of doing so. These health benefits are the effectiveness and greater safety of cannabis-based products than many available authorised medicines such as opioids and benzodiazepines which have serious effects, such as withdrawal, addiction and fatal overdoses. The Bill supports the drug policy outlined in the current programme for Government, which states: “We will support a health-led rather than criminal justice approach to drugs use...”.

The Cannabis for Medicinal Use Regulation Bill 2016 is designed to provide for the regulation of cannabis for medicinal use so that patients can obtain from a pharmacy with a doctor’s recommendation a legally protected, secure supply of a quality-controlled cannabis-based product that is effective and safer than many authorised products, especially for pain relief.

The Bill allows for legally protected access to cannabis-based products by patients with a doctor’s recommendation in the form of a certificate from their doctor that they suffer from a condition that responds to cannabis-based products. Labelled, quality-assured cannabis-based products would only be available from a licensed pharmacy. Importation, production, transport and sale could only be carried out on under a licence issued by a cannabis regulation authority. Advertising and sponsorship of cannabis-based products would be prohibited. Sale to children would be prohibited. A research institute would also be established to improve knowledge about the use of and effects of cannabis-based medicines.

There are now regulations in at least nine countries including four EU countries, Germany, Italy, the Netherlands and the Czech Republic, which specifically regulate access to cannabis-based products for medicinal use. Many other countries are examining their laws with a view to a more health-based approach in light of evidence of the effectiveness of cannabis-based products and their relatively favourable adverse effects compared with other more toxic authorised medicines as well as the failure of criminalisation to reduce drug misuse in terms of harm or level of consumption for recreational use.

The Bill is based on legislation in the US and EU which attempt to provide legal protection for patients to access a safe supply of cannabis-based products from licensed pharmacies on the recommendation of a doctor. It seeks to address concerns about the need for more research by addressing the funding of a research institute and the regulation of cannabis products by a regulation authority.

Increased numbers of patients using cannabis-based products instead of more toxic alternative authorised medicines will result in a net improvement in the health of the population as a whole. This is borne out in the US where increased use of cannabis for medicinal use has coincided with falling sales and use of more toxic drugs and with a consequent fall in drug overdoses, including fatal overdoses. No overall increase in recreational use has been associated with the legalisation of cannabis for medicinal use in the US and youth cannabis use for recreational purposes is actually falling there. Diversion of regulated products to recreational use, which happens for all authorised drugs with a misuse potential, in the absence of an increase in the overall level of recreational use, does not in itself represent a health concern. This means that the Bill should not be expected to increase recreational use and should be expected to save lives through reducing fatal overdoses from other more toxic drugs.

There is no record of any fatal overdose of cannabis and this is a very important strength of the safety profile of cannabis. Doctors and pharmacists should be trusted to advise their patients, as they do with other more toxic medicines, of the risks and benefits, and to recommend caution with populations at risk such as with children. Nothing in the Bill prejudges professional judgment or attempts to influence how doctors or pharmacists carry out their professional duties.

I welcome Deputy Gino Kenny, Dr. O'Grady and Professor Finn and thank them for attending. I have a few questions for the Deputy. Who will be on the cannabis regulation authority? What process will be put in place to establish this authority? Will it be an application process or will its members be appointed by the Minister? Section 6(1) states: "The principal function of the Authority is the development and maintenance of a regulatory framework for the sale (wholesale and retail), labelling, advertising and marketing of cannabis and cannabis-based products for medicinal use." In Part 10, section 39 states: "It shall be an offence to advertise or market cannabis or cannabis-based products...". What issues may arise from this? Will a television or radio advertising campaign need to fit in within certain parameters as set out by bodies such as the ASAI, or will it be necessary to stick to the same rules and regulations as everyone else?

Is it expected that all pharmacies will seek a licence or just some? Will someone using cannabis and cannabis-based products for medicinal purposes need to carry a licence or medical certificate at all times to distinguish him or her from a normal user?

I thank the witnesses for the presentation. As someone who has brought forward Private Member's Bills myself, I am aware that a great deal of work goes into drafting any legislation. I thank them for the time and effort they have put into this, which is very much appreciated. To clarify the current position, I understand that the legislation in force allows the Minister to issue a licence where a certificate has been provided by a doctor to certify that the use of medicinal cannabis would be of benefit in respect of a particular person's medical condition. As such, there is a current licence situation in place and the Minister is talking about placing it on a more structured footing. Would the witnesses be satisfied with a structure set up under current legislation rather than having to go through the whole process of enacting new legislation? What is the difficulty with the existing legislation? This is something new in the sense that a licence has been issued in at least one case, but I am not sure if there are other cases pending.

The public debate has been very much to the effect that if the Bill passes, there will be no difficulty with anyone getting cannabis. There is a misconception. In the opening statement, it was clearly stated that the Bill allows for legally protected access to cannabis-based products by patients with a doctor's recommendation in the form of a certificate. The legislation is providing clearly that cannabis will not be available unless a doctor signs off on it. The perception, on the other hand, is that the Bill will allow people to get access to these products without having had a doctor sign off on that. The witnesses might clarify that because it needs to be made clear in the public domain.

I should have noted that we are going to bring in three members before asking for responses.

I will try to answer as much as possible. It is a great deal of information.

Perhaps we will respond to the two members who have spoken so far.

Senator Burke asked about the current law on compassionate access. One family has got access, but it is extremely restrictive. There is another family which has applied for a licence but, thus far, they have not been successful. As such, the access scheme under the Minister's remit is completely inadequate at this time. On a long-term basis, it will not work. There is also the matter of the grey area between the Minister and the medical profession and, as such, the regime is inadequate. As to whether many other people will apply, it is possible but the last thing the Minister will want is hundreds of people applying under the compassionate scheme. It is not workable, which is why I have put the Bill forward. Its aim is relatively simple: to give people safe access to medicinal cannabis. Through circumstances which are not of their choosing, many people in the country are already using medicinal cannabis and they should not be criminalised. It is immoral to criminalise people who are using cannabis to alleviate their suffering or that of their children. It is the 21st century at this stage and our eyes should be opened as eyes have been opened in the USA and in other European countries. Enlightenment as to the health benefits of the cannabis plant can only be beneficial. That is the reason I put the Bill forward. It is not perfect by any means, but I am here to represent the legislation and the many people who could benefit from it. It is hoped it can go to the next Stage.

In his statement, Deputy Kenny said that a certificate will have to be provided by a medical practitioner.

He might just expand on that because there is a public perception that the Bill does not contain that requirement. In his statement, Deputy Kenny says it does.

If somebody is to get access to medicinal cannabis, it will have to be under a doctor's recommendation. As such, he or she will have to have a certificate to say that his or her condition could greatly benefit from medicinal cannabis. The person will obviously have that certificate on his or her person all the time.

The public perception is different. It is important to clarify it.

I cannot control perception but that is the reality and it is what our Bill says. Section 32 sets out the requirement for a recommendation by a registered medical practitioner and states:

Cannabis for medicinal use may only be sold on the certification of a registered medical practitioner, on a form approved by the Authority, that the patient has a condition for which a trial of cannabis or cannabis-based product is a reasonable course of treatment to improve the symptoms or course of the condition.

Before we move on to the next questioner, the witnesses might address Deputy Murphy O'Mahony's questions.

Dr. Peadar O'Grady

On the membership of the authority, I refer people to section 10 which provides that members of the board shall be appointed by the Minister and its constitution shall reflect the need for the efficient and effective running of the authority. The key concerns we outline in the section are that there should be an adequate gender balance and that members should have relevant experience. Those are the only strictures we set out, but if any section of the Bill could be amended to improve access to medicinal cannabis for those who need it, we are wide open to suggestions. Section 10 is the extent of the provision at the moment.

We were asked about advertisements and the number of pharmacies we envisage applying for a licence. We hope the majority of pharmacies will apply. Pharmacies will obviously be free to apply or not. It is a key stricture in the rationale of the Bill that it does not seek to prejudge or prescribe to pharmacists or doctors what they should or should not do. If there is a feature of the Bill which does so, it needs amending. It is hoped all pharmacies will apply for a licence.

Advertising medicines to the public is a dubious and otherwise illegal practice. Even advertising to the medical profession and pharmacists is a questionable practice, albeit a currently permissible one in respect of other medicines. That clash might cause a problem for the manufacturer asking to be treated on a like-for-like basis, but it will be a matter of which change we make. Do we stop the advertising of medications to professionals who should be getting their continuing professional development from proper educational sources rather than from manufacturers and marketers? As such, the issue of the restriction on advertising might be a matter to be taken up in other areas of pharmaceutical marketing.

Would a person have to carry a licence or certificate?

Dr. Peadar O'Grady

It came up on the Second Stage of the debate on this that removing cannabis from the Misuse of Drugs Act, as the Bill recommends, leaves open the notion of possession being decriminalised in general. In some ways, there needs to be an amendment, as we have acknowledged and acknowledge again today, to restore possession of cannabis for reasons other than medicinal use without a certificate as an offence. There may need to be further detail as to whether one needs to carry a certificate at all times one is in possession of one's medication, which one would not have to do in any other case.

The Bill provides for a certificate because we appreciate the past history and concerns about diversion and so on. It probably would be necessary. A key element of the Bill is that the certificate not alone gives access through a pharmacy but also gives legal protection against wrongful prosecution.

Is the certificate the same as a prescription? Is that what is envisaged, that it would be a certificate for a medical product?

Dr. Peadar O'Grady

The certificate is necessary to avoid prosecution. The prescription is something that a doctor is free to do. Nothing prescribes what a doctor can or cannot do. Doctors can issue prescriptions in keeping with their own practice. What the Bill covers is the legal side of it. The legal protection is provided by the doctor's certificate.

Does a doctor's certificate protect the doctor from any adverse affects from cannabis?

Dr. Peadar O'Grady

Unless he consumes it. I am not sure I follow the question.

If a doctor gives a recommendation that a patient would benefit from using cannabis for his or her medical condition and the patient suffers an adverse reaction from using it, does the certificate indemnify a doctor against adverse reactions?

Dr. Peadar O'Grady

It is not the purpose of the Bill, as I understand it, to interfere in any way with any of the existing rules, from the Medical Council and so on, that govern those areas. There may be some expertise that says they do conflict and therefore would require an amendment, but I am not aware of any. Doctors' responsibilities are not changed in any way. All this Bill does is protect the patient from prosecution and enable them to access medicinal cannabis safely, and as a good quality product, from a pharmacy and so on. Doctors' responsibilities are still their responsibilities.

I could spend hours discussing this today. My major problem with this is the word "medicinal" in the sense that it is a different argument to decriminalisation or rescheduling of drugs. I want to disclose at the outset that I am a community pharmacist and am registered with the Pharmaceutical Society of Ireland and, as such, have ethical responsibilities in that regard.

I will try to be brief. I see this Bill as undermining the current regulatory frameworks, those being the Health Products Regulatory Authority, HPRA, and the Pharmaceutical Society of Ireland, which are internationally recognised as very competent authorities. There is no question about their capabilities.

I have heard plenty of evidence from Members connected with this, and I understand that one of the witnesses here is a medical doctor, but there is anecdotal evidence, scientific evidence and sound scientific peer reviewed data. We do not form rules and regulations in science based on anecdotal evidence or hearsay. The HPRA is the authority on this - I am not the authority and neither is anyone else in this room - and it has been very clear. There is a complete lack of clinical and scientific evidence to show safe and effective use. I know people who have used cannabis recreationally and for pain relief for years. I am not debating that. The decriminalisation of drugs is a different argument and we can fight that fight on another day.

I clarified this with the Minister yesterday, and the current situation is that for three conditions - nausea and vomiting from chemotherapy, multiple sclerosis, MS, and intractable seizures - people can get access through a consultant neurologist writing a prescription. I was also reassured that the Minister can issue a licence for another condition if a medical consultant prescribes it for a patient under his or her care. If I had a pain in my toe and my medical consultant decided that the only treatment for it was medicinal cannabis, there is a pathway there to do that. Anyone who has a competent, qualified, Irish-registered hospital consultant, who is the person I like dealing with my health care or that of my children because he or she is the expert in the field, and if that person judges that a patient requires this product, there is a pathway to do that. I would not want anyone listening to think that we were trying to prevent the alleviation of people's pain.

Deputy Gino Kenny said this Bill was about safe access to medicinal cannabis. That is a shocking statement when the HPRA has said the data are not there. He also said that we are in the 21st century. Yes we are. Years ago, centuries ago, we used to give random bits of drugs to people and see if they died or lived. We now have in place regulations and procedures for testing and trialling. To my mind, what this Bill is trying to do is circumvent all of the regulatory arrangements we have which are not there to serve us but to serve the public and to safeguard minors as well.

There are so many issues with this. There are a huge number of inconsistencies throughout the Bill. There is inconsistency over the age of what constitutes a minor, which is 16 in one place and 18 elsewhere. On the idea of a certificate and prescription, we have very strict procedures for prescriptions in Ireland when it comes to different schedules of drugs. I am using my own words here, but it says that the books would have to be balanced on a monthly basis. It would be normal procedure that controlled substances would be balanced on a daily basis. I think it is a 24-hour period. These things have to happen.

To return to the science behind it and following on from the Chairman's comment about liability, there is evidence that in adults with epilepsy, ingesting or smoking cannabis can reduce the seizure threshold. As an example, person who has been seizure free for two years takes a particular form of cannabis prescribed by his or her doctor, who might be under pressure to do so, and has a seizure behind the wheel of a car. This is a practical scenario that could arise. If that person has a fit and has a car accident, who is responsible?

I am looking at the Bill and have notes through every bit of it. In one place it refers to the consumer. If this is medicinal cannabis, the people are patients. Even on the first page, before regulations, it refers to the Minister for Justice and Equality. The Minister for Health is the Minister with responsibility for this. I do not understand the certificate. Cannabis-infused products make an appearance along the way.

Let us say this all happened. Why would cannabis have any special status compared with any other controlled substance? We have diamorphine, which has the street name heroin, in the safe. I have it in the safe in my pharmacy. I do not understand the logic of dealing with this drug in any other way to any other medicine.

I think it was last week or the week before that I spoke here-----

I have quotes from the Deputy. I will speak to them in a second.

-----and I endured about ten days of vile abuse on social media as a result.

I will repeat what Deputy O'Connell said.

Let Deputy O'Connell finish.

The fact is, the HPRA is there to safeguard the health of the people. Someone said on social media that cannabis is a natural product and thalidomide was created in a lab.

The simple fact is that the Health Products Regulatory Authority, HPRA, applies very strict rules and regulations on drugs licensing to safeguard the population. When Members of the Oireachtas try to circumvent the regulations for whatever purpose - I am not 100% sure what the purpose of this proposal is - we open ourselves up to creating a dodgy scenario for public health. I feel very strongly about this matter.

On the offences a person must not have committed to be eligible to be a licenceholder, I note that a person may not have committed murder but the Bill does not refer to drug offences. This means a convicted drug dealer who has served time could be a licenceholder. I do not understand this strange omission as it is obvious that a person with a history of drug offences should be precluded from holding a licence.

Why would the regulations governing a retail licence be any different from those governing pharmacy licences? Pharmacies are regulated to an extreme degree by the Pharmaceutical Society of Ireland. It is beyond me that it is proposed to introduce another framework for regulating this area. The rules on the keeping of records should not be any different either. I note the definition of a child is different in the Bill.

The legislation is completely flawed and I am not sure where it will lead. An issue arises with the use of the word "medicinal" in this context. As a pharmacist, I have major concerns about the Bill about which I could not speak in any way positively. Of most concern is section 42 which provides for the amendment of the Misuse of Drugs Act by the deletion of references to cannabis. This is a major step.

I am concerned when elected Members try to circumvent the regulatory procedures that have been introduced to serve and safeguard citizens from the dangerous effects of drugs and to promote well-being. The Deputy used the word "immoral". This legislation verges on being immoral. It is inappropriate for people to snigger at an Oireachtas committee meeting.

I take a different position from Deputy O'Connell on the Bill. I congratulate Deputy Gino Kenny on the work he has done as it takes a great deal of work to get a Bill to this stage. The Deputy pointed out that the legislation may not be perfect. It can be tweaked on Committee and Report Stages.

Having listened to the points made by the previous speaker, there is clearly a misconception abroad that one shoe fits all. I and many members of the public seek clarity as to whether the Bill, if passed in its current form, would resolve the case of Vera Twomey. Notwithstanding that, improvements can be made on Committee Stage to benefit people in future. I know people who use cannabidiol, CBD, which I have also used. In the past seven years, I tried every available product for certain conditions, including CBD, and none of them worked.

I support the Bill proceeding to the next Stage for further debate. However, I seek clarity on whether, in its current form, it would benefit many people. This matter needs to be addressed because we do not want to build up expectations. This legislation is part of a process and sometimes processes take a long time.

To reply to some of the points made by Deputy O'Connell, there is a huge body of evidence on this issue. The most contemporary report is probably the Barnes report. Its author, Professor Michael Barnes, will make a presentation on the benefits of medicinal cannabis in the audio-visual room tomorrow. I hope the Deputy will attend and be enlightened.

The Health Products Regulatory Authority report on this issue is fatally flawed. One glaring omission from the report is the issue of chronic pain. As most people will know, medicinal cannabis is highly beneficial in cases of chronic pain.

Medicinal cannabis programmes are in place in 28 states in the US and 11 countries in the European Union. Other countries are way ahead of us on this issue.

If I may, the Deputy has made three points.

Please allow Deputy Kenny to respond.

There is plenty of evidence available. Deputy O'Connell clearly takes a biased view of the Bill and I am sure she will not vote for it. That is fair enough, and while the Deputy is entitled to her opinion, I would like to address the extraordinary statement she made last month.

The Deputy may not address statements made in the past. He should answer the questions asked of him.

Deputy O'Connell stated-----

The Deputy has been ruled out of order.

Deputy Kenny should discuss the Bill rather than comments other people made in the past.

I have answered the Deputy's question.

I approach the Bill from a background of being a qualified pharmacist with 12 years' experience. When the Deputy refers to a "huge body of evidence", he means his evidence.

Has Deputy O'Connell read the Barnes report?

I have read everything on this issue which I have studied for years. Deputy Kenny made a sweeping statement in referring to a huge body of evidence. He is speaking of his evidence.

Where is the Deputy's evidence?

The Health Products Regulatory Authority is an internationally respected agency which is used to regulate every cream and tablet sold, prescribed or dispensed here. I take serious offence at the Deputy's suggestion that I should go to the audio-visual room tomorrow to be enlightened. There is no darkness on this issue, on which I am fully aware of the position. It is a major issue when an elected Member believes it appropriate or responsible to describe a report by the HPRA, a State agency that is respected internationally, as fatally flawed. He also spoke about me taking a biased view of the Bill. I oppose it because it is madness.

Legalising or decriminalising drugs is a different argument. As I stated, my issue with the Bill is the use of the word "medicinal" and the circumvention of the rules and regulations on the issue.

I have to leave shortly to speak about vaccinations in the Chamber. Large amounts of taxpayers' money and European Union funding goes into research and science. There appears to be a gap between the dissemination to the public of research findings and the use of fake facts or what is described as new or independent evidence that is distinct from the evidence provided by the scientific bodies and regulatory authorities we trust. I am concerned, from a public health point of view, by the Deputy's irresponsible statement that there is a huge body of evidence in support of his position which holds the same weight as the evidence of the HPRA or the regulations of the Pharmaceutical Society of Ireland. My role in this regard is to protect public health.

I ask Professor Finn to contribute.

Professor David Finn

I speak from a position of having worked on cannabinoids, the endocannabinoid system and cannabis for 16 years as a researcher and academic.

I am a professor of pharmacology at NUI Galway and president of the Irish Pain Society. For the information of the committee, my research interests have included cannabinoids and pain and anxiety in particular.

I have a great respect for the Health Products Regulatory Authority and the HPRA report. Those involved had a limited amount of time to do the job they did. On the whole, there are many good aspects to the report. There is, however, a substantial body of evidence in support of cannabinoids and cannabis to treat chronic pain. There are at least four thorough, comprehensive and excellent systematic reviews or meta-analyses. That is the way those of us in science, research and medicine gather together all the primary original research articles that have been done on a topic. We synthesise the literature and come up with a conclusion based on it. Whiting et al, Hill et al, McCormick et al and the Barnes report are excellent peer-reviewed published articles in the Journal of the American Medical Association, JAMA, and other leading international reviews. Their conclusions are that, on the whole, the weight of evidence is that cannabinoids or medical cannabis or cannabis - whatever we want to call it - has moderate to substantial efficacy for the treatment of chronic pain. That is where we are at.

The second point is a point of information. There is precedent in Ireland for the HPRA having approved a cannabinoid product already. It is called nabiximols or Sativex. It has been approved for spasticity in multiple sclerosis. That compound or drug contains tetrahydrocannabinol, THC, and cannabadiol. It is an oromucosal spray. We also have a situation where another cannabinoid compound, nabilone, which is a synthetic form of THC, is under Schedule 2 to the relevant regulations in Ireland and can be prescribed. It is authorised for the treatment of chemotherapy-induced nausea. Dronabinol is another form of THC which is listed under Schedule 1, but I believe the HPRA report recommended that this classification be reviewed with the possibility to include it under Schedule 2.

We have had some history of the HPRA approving some cannabinoid-based medicines. The HPRA has left some room for three indications within the latest report, namely, spasticity related to multiple sclerosis, chemotherapy-induced nausea and vomiting, as well as epilepsy. The report states that chronic pain is the condition that is most researched, and that is true. Most studies have examined chronic pain.

I will refer back again to the meta-analyses and the systematic reviews. The body of evidence is substantial. The studies suggest, depending on which one is cited, moderate to substantial effect.

I am fully aware of all the evidence that Professor Finn is quoting. Will Professor Finn enlighten us on where the breakdown is between what he is speaking to and the HPRA? Professor Finn maintains the HPRA is not fit for purpose. Why does he believe, in his professional opinion, there is a barrier with respect to the HPRA? I have my own views but I am keen to hear from Professor Finn given his experience as outlined? Where has it fallen down?

Professor David Finn

To be clear, I am certainly not saying the HPRA is not fit for purpose.

Why would the evidence he is giving suggest that? What is the problem? What is the roadblock?

Professor David Finn

Cannabis, as a plant, and cannabis extracts are complex. Cannabis contains many hundreds of compounds. Most drugs that we approve for pain and other conditions are single molecules, single structures or single chemicals. Therefore, it is difficult to make a direct like-for-like comparison between cannabis in all its complexity as plant material versus individual drugs that are single molecules.

We also have cannabinoids, which are the components of the cannabis plant. These include THC and cannabidiol as well as many other cannabinoids. These are individual molecules and we can look at them. A like-for-like comparison can be done more easily with these compounds. That is one aspect that feeds into it.

Another factor is the history of misuse and abuse. That aspect colours the debate as well. It is not trivial and not to be overlooked.

These are some of the features of cannabis that set it apart from other medicines, to some degree. However, some of the drugs used in the pain field, for example, opioids are also subject to abuse and misuse. A major problem in developed countries and throughout the world is the misuse, dependency and overdose on opioids and so on. We have already approved drugs that suffer from those limitations.

Professor Finn is a pharmacologist. Is it true to say that the lack of clear pharmacological pathways for the action of cannabis could be holding it back? Normally, a standard drug interacts with a receptor and elicits an effect. Where we have something for which we cannot define the pathway, we could have potentially unintended side effects. I am putting the question to Professor Finn as a pharmacologist. We could have unintended or unforeseen interactions with other molecules because the tests have not been done. I am assuming Professor Finn would accept that as a pharmacologist.

Professor David Finn

We have learned a great deal about the pharmacology of cannabinoids and cannabis in the past 30 years.

Let us be very clear. I want that question answered as a pharmacologist. What I am getting at is the pharmacological pathway being undefined.

Professor David Finn

I do not think it is undefined. We know that cannabinoids work primarily at cannabinoid receptor type 1 and cannabinoid receptor type 2. These are G protein-coupled receptors. We know the signal transduction cascades well. There is a great deal of molecular biology and neurochemical data on the mechanism of action of the cannabinoids.

We have to be honest to the committee. The pharmacologist has to be honest here and say that-----

I am conscious that other members want to come in. I know your expertise, Deputy. Deputy O'Connell referred to a particular point relating to the safety of cannabis. Perhaps you would address that, Deputy Kenny.

Dr. Peadar O'Grady

Deputy O'Connell made four points that I wanted to address. One related to a question about the Minister for Justice and Equality. The point is well made. In fact, the concentration on the Minister for Justice and Equality reflects the existing criminal law position. However, we are open to suggestions. As Deputy O'Connell suggested, we would far prefer if the relevant Minister was the Minister for Health. We would appreciate any input with regard to an amendment on that line. We would be very interested in that.

The issue of minors is currently complicated, as probably you well know, Chairman, with regard to the age of consenting to treatment. It might be something to consider further. For most conditions, except for mental health conditions, the age is actually 16 years and not 18 years. However, Deputy O'Connell is quite right to say that 18 years is the legal age defining a child, although under 18 years provided the person is not previously married is the full definition. Strangely, that is the case since an age will not do it on its own.

We are very interested in any input that amends the Bill to facilitate safe access to good quality cannabis-based products. We realise no Bill that gets past Second Stage is perfect. We want the Bill to move to the amendment stage.

Before I address the safety point, I wish to make another point relating to consultants. Deputy O'Connell brings up a good question. Why not treat it like other drugs? As Professor Finn has suggested, there are some reasons cannabis products are not as easy to treat in the same way. Some jurisdictions have used bodies like the HPRA to regulate the use of herbal products or whole plant products. It is possible that the HPRA could do so, but it appears that the HPRA may not be in a position to or may not want to do that.

For any other drug, even restrictor drugs, GPs prescribe. GPs are registered specialists and, as specialists, we did not see any reason it should be restricted when other drugs that are considered to be risky in whatever way are available to be prescribed by GPs.

There are many concerns about safety and knowing the physiology, the effects, the pharmacokinetics and the pharmacodynamics of a drug. For many drugs that work, particularly in my field of psychiatry, the way in which a drug acts is poorly understood and much of what is put forward as the way in which a drug works is merely theory, which is not particularly well-established. There is little long-term evidence of risk or benefit for most of the drugs we use. In the US, up to 10% of boys are on an amphetamine-like drug for which there is no long-term evidence of benefit or risk.

We are appreciative if anybody wants to raise the standard of safety but I refer to Deputy Buckley's question regarding who would benefit. In the US, where cannabis is allowed for medicinal use, the sale and use of opiate painkillers reduces as does the number of people who die from overdoses every year. That amounts to tens of thousands of people. If those figures are extrapolated for Ireland - we have asked the HSE for accurate figures but it does not seem to have them - we reckon hundreds die of opiate overdoses annually, many of whom are at the top end of the dose trying to relieve their pain, in particular. Unfortunately, as they increase the dose to try to get more pain relief, they exceed the toxic level and they die. Nobody has ever died from cannabis use. One of the answers as to who would benefit is people who are near the maximum of their pain medication and who are thinking of increasing it, thereby putting themselves at risk of overdosing. Hundreds of people probably die that way every year and, therefore, making an alternative available to reduce the toxic dose will save lives.

The Barnes report outlines all the people who would benefit if they were allowed access on the recommendation of their doctor. Professor Barnes has done fantastic work and his report is well worth reading. Every condition mentioned would be made available for access. Anyone suffering from those conditions would be able to access medicinal cannabis under this Bill. The answer to the question of whether Vera Twomey's six-year old daughter, Ava, would benefit is absolutely and categorically "Yes".

With regard to safety, will Dr. O'Grady comment on the adverse effects of cannabis?

Dr. Peadar O'Grady

Rather than taking my word for it as a non-expert, I refer members to the Barnes report which goes into the adverse effects in detail. It is available online. There is also the UK all-party report.

What is Dr. O'Grady's view on the safety of cannabis in respect of its adverse effects?

Dr. Peadar O'Grady

In terms of its adverse effects, it is worth starting with the major benefit of cannabis. Unusually for a medicine, there is no fatal toxic dose. It has never killed anyone. That is true of very few medications, particularly alternative medications for one of the biggest areas of use of cannabis medicinally, which is for pain. Opioids, benzodiazepines and valium-type drugs are commonly used and these are major causes of death. Cannabis does not cause death, which is the first important aspect to understand about it. The second aspect to be understood about it is that it has side effects, which vary depending on the balance of the blend that is being used. Knowing that it does not kill people is important in that while tytrating the dose, which doctors to for pain medications anyway, one starts low, goes slow and builds up slowly. One of the concerns is that if the dose of many drugs is increased too quickly, the patient may be killed. This is not a concern with cannabis. However, all the other side effects such as dry mouth, blurred vision, sedation, somnolence and so on are generally graded low. When authorisation is applied for a drug, regulators are interested in how common are the side effects. Such side effects are common. They are also concerned about their severity but none of these is severe.

The long-term side effects and the particular concern about the development of dependency or psychosis are well described. Doctors are used to dealing with these concerns. Doctors who prescriber opioids and benzodiazepines deal with the dangers of dependency and death but also with the concern about the development of mental health problems in people who use their drugs, and they are well used to advising appropriately when there is a population at risk such as young people and so on. This is the bread and butter of doctors. Trying to make out the risks and benefits, weighing them up and advising their patients accordingly is something unusual and associated only with medicinal cannabis. Any medical practitioner will tell one this is what doctors do for a living every day. There is nothing unusual in cannabis except that it does not kill. That is quite unusual.

Dr. O'Grady said if we move on to Committee Stage and tweak the legislation that eventually, through the Barnes report and its recommendations and findings, the legislation would benefit Vera's family and other families. I do not mean to pick on anybody but if the Bill passed in its entirety today, it would not be as strong as it could be if we amended it. I do not want to extend people's expectations. There should know there is a process under way and it will take time but there has to be a consensus on both sides. It is down to debate and getting this right.

The Bill clearly sets out that a doctor must prescribe whereas Dr. O'Grady is saying that it automatically sorts out the problem for one individual. However, the Bill still requires a doctor to prescribe. Let us get that clear because that is not clear from his reply. That is different from the answer Deputy Kenny gave.

Dr. Peadar O'Grady

There is a difference between what is available under the compassionate access scheme, which because it does not provide access cannot be described as "compassionate".

A doctor is needed to prescribe.

Dr. Peadar O'Grady

All we can do is promise access to people who would benefit from a cannabis-based treatment

A doctor must still prescribe.

Dr. Peadar O'Grady

Absolutely, and in Vera's case-----

Dr. O'Grady has given the impression that this is not the position. My understanding is under the Bill the doctor must prescribe.

Dr. Peadar O'Grady

That is the case in Vera Twomey's case. A doctor has prescribed cannabis but she cannot access it because the Minister is demanding that a consultant not alone prescribes it, but follows it up in detail. That is just not available here. This is Ireland with the HSE. She just cannot get that.

Where a doctor prescribes in normal practice, is it not up to the doctor to make sure the advice he or she has given is followed through? That is what we are providing for in this legislation.

Dr. Peadar O'Grady

Absolutely. Last October, the Minister of State, Deputy Finian McGrath, confirmed that a doctor doing what the Senator outlined, which is all that is required under our Bill, would give access to Vera Twomey but that turned out not to be true. The Senator is saying-----

The doctor was not doing the supervising. That is the difference.

Dr. Peadar O'Grady

No, a doctor was supervising. They insisted on a consultant to do this and a consultant does not have a legal standing in Ireland. Only specialists have legal standing and GPs are specialists.

To be clear on the point, anyone that gets a doctor's recommendation could access a cannabis-based product. Anybody who does not get that could not access it. People who suffer from those conditions, as certified by their doctor, should all know that they will be able to access cannabis-based products when this Bill passes. If a person's doctor says that he or she thinks that person has a condition that would respond to cannabis and is going to recommend it, that person will have a way of accessing it. Doctors are saying that today. There is just nowhere to go to access the cannabis. This Bill would allow for that. The major obstacle to that is criminal law, not health law.

I thank Dr. O'Grady and call Deputy Kelleher.

I welcome the witnesses. I have a few questions, answers to some of which may have already been provided.

For a patient with co-morbidities or multiple morbidities, on multiple prescriptions, where is the evidence to support the case that medicinal cannabis is a safe product or medicine, if it is being prescribed as medicinal cannabis, and that it is safe to use with other medicines for other conditions and co-morbidities? That is one matter in which I am interested.

I am also interested in why there is no reference in the Bill to the Health Products Regulatory Authority, HPRA, since, ultimately, we have a statutory authority that oversees the licensing of health products in this country. I understand the purpose of the Bill but, at the same time, I believe there has to be some interaction with the agency that is statutorily obliged to oversee that. It also takes into account people who are on multiple prescriptions, ensuring that medicines are compatible with each other, etc.

Primum non nocere - first, do no harm - is the point from which most clinicians start from. Reference has been made to how nobody has ever died from an overdose of cannabis. It would be impossible to say that nobody has died because of use of cannabis in the sense that a person may have contracted psychiatric problems and there may be depression or anxieties which may have caused a situation where people may have died by suicide, for example. Is there research on that or is it just anecdotal that people could suffer from side-effects from using cannabis in whatever guise?

There are 750 chemicals in the plant itself and over 100 cannabinoids. When the witnesses talk about prescribing for a condition, is the whole plant being prescribed or would there be reference to parts of it, whether tetrahydrocannabinol, THCs, or cannabidiol, CBDs? What would be the prescribing format, particularly as there are so many chemicals and cannabinoids in the plant? Is it possible to break it down? Can that be done through pharmacology and, if so, what is the evidence to support that concept?

The witnesses referenced a medical practitioner. Every doctor in the country is entitled to prescribe this, like everything else. Is there any obligation on the doctor to use anything other than his or her ethical conscience when prescribing this product or is there an obligation on him or her to actually see his or her patient? Would there just be the normal ethical process on the basis of which clinicians in this country operate? Could the witnesses envisage a situation where a particular medical practitioner would be in a position to prescribe quite a lot of cannabis? Is there any obligation on medical practitioners to have interaction with patients other than the ethical obligations that are there already through their oath, etc.?

That is about it. We may come back to the matter again. There is a broader debate on where we should stand on the criminalisation or decriminalisation of drugs in general. If one considers Lisbon and other cities or areas in which decriminalisation of many drugs - not just cannabis - has been tried, one could argue that there is evidence to support us examining that particular concept. Perhaps we have been looking at drugs in the context of the criminal justice system for too long when we should be looking at them more in terms of the health system. That is a matter for another day. Is there any concern that there would be a leakage of the medicinal product out to the broader community? As we know, these drugs are often supplied through criminal markets because they are illegal substances. Are there concerns that there could be leakage into that grey, criminal area?

I thank Deputy Kelleher. Would Senator Mullen allow Senator Swanick to speak for two minutes before him? Senator Swanick has to leave.

Yes. I would be quite happy to wait for the answers to Deputy Kelleher's questions also. I am learning with each new question that is answered, so it might rule out the need for some of my questions.

I thank Senator Mullen and call Senator Swanick.

I thank Senator Mullen. I will be going to the Seanad in a few minutes and so will be very brief.

From a medical viewpoint, we know that cannabinoids bind with receptors in the brain. Some of those receptors are in the amygdala, which is involved in processing fear, stress and paranoia. My first question is to Professor David Finn. Would he agree or disagree that these products could possibly exacerbate paranoia?

I am somewhat reassured that there would be a list of specific conditions for which products could be used. Am I correct in stating that these could be circumvented in some way by consultants if they deemed it necessary? Would only consultants be allowed to prescribe or would specialist GPs be allowed to do so? Every GP on the specialist register, such as myself, is called a "specialist GP". So would I be allowed to prescribe that? If so, what safeguards are in place for rogue prescribing? Would that be covered by this legislation or would it be covered by the Medical Practitioners Act?

Finally, I am struggling to distinguish between certification and prescription. If a doctor prescribes a product, he or she issues a prescription. I am struggling to get my head around this because, if the consultant gives a prescription for this product, is this classified as a high-tech product? Does the patient bring that to the pharmacy and is the product dispensed there or is it bought like a high-tech drug for rheumatology or such? What often happens is that the consultant would give a prescription to a patient, the patient would come to the GP, and that would be transcribed on a medical card prescription or whatever else. That is something of a grey area. Those are my three points.

I thank Senator Swanick and call Deputy Gino Kenny.

I will ask Dr. O'Grady to speak.

Dr. Peadar O'Grady

I will answer Deputy Kelleher's questions first. I will start with the HPRA and cannabis regulation authority proposed under the Bill. The key issue with the cannabis regulation authority is that the Bill really does not say that anybody cannot do it. We would be delighted for the functions of the cannabis regulation authority to be carried out by any agency that says it can regulate cannabis-based products. The information we have is that the HPRA is not willing or able to regulate cannabis-based products. It is not for us to say if it is and Deputy O'Connell was quite adamant in her defence. We are not here to criticise or undermine the HPRA but its report does not explain why it cannot do what is done in other countries. Many other countries have legislation that is almost exactly the same as ours and the number is increasing by the day. I heard that Argentina has just passed very similar legislation. Germany passed very similar legislation in January, and so on. The difficulties in regulating plant-based whole-plant products, as Deputy Kelleher pointed out, are real. When there are 750 components, those issues of regulation and of distribution for pharmacies and for doctors are real.

The point is other countries are getting on with regulating that. It seems that people are so keen that we have a fantastic regulation system they are quite happy to leave it that we have no regulation system at all. The Bill allows for a regulation system and we should pay more attention to that. We could and should also pay a lot of attention to the quality and safety of drugs that pass through the Health Products Regulatory Authority, HPRA. We have no opposition in principle to any agency were it willing to carry out the necessary functions of cannabis regulation.

The Deputy is right about the principle of first do no harm. There is a tendency towards using medications first where other approaches would be better. That is very true in my profession and there is a backlash against that at the moment. The level of prescription of psychotropic drugs for mental health problems is enormous. One of the concerns is very much the one the Deputy brought up, the risk of suicide, which is already a key concern in regard to the medications sadly being used to deal with the risk of suicide and to treat depression, anxiety, psychosis and so on. I would be more concerned that people would die in falls or crashes. One of the reasons people die from medication use is that it affects their ability to function. Do not use machinery is a common warning. That really means be careful not to fall, crash, trip or injure or kill oneself in some way. No drug can be immune from that. All we can do is try to warn people what precautions they should take if they use this medication. The difficulty with a lot of pain medications if they are taken daily is that they constantly affect the patient. There has to be a higher level of concern and precaution, not a lower one.

The prescribing format is an issue for the profession to take on. Prescribing requires making a recommendation for the dosage, frequency and duration, and usually by what route. There has been very little discussion of the route issue in Ireland. It is worth saying nobody recommends smoking cannabis. It is not a healthy thing to do, no matter the reason one takes it. For medicinal use there is no recommendation to smoke cannabis. Vaporising and inhaling cannabis is probably the most useful way and much prescribing for a metered dose is from a piece of vaping equipment, then possibly a pro re nata, PRN, basis whereby the patients monitor their own. Many doctors do this. The notion that patients only do what the doctor recommends is not in keeping with reality. It is not how patients operate or necessarily how doctors operate. If patients take an antibiotic for a week they should stick strictly to what the doctor has written on the script. Often, however, doctors and patients have to alter and modify. Even on a daily basis the patient has to modify the amount of a drug, always with a tendency to modify down. How prescriptions will work is for doctors and patients to sort out. The problem in the HPRA report is that there is very little evidence taken from expert witnesses who have experience using cannabis based products. If I was to make only one criticism of the HPRA's investigation it would be that it asked nobody who had experience using cannabis-based medicines to answer many of the questions the committee is raising.

The leakage issue has been well established in the United States, so far as we know, in the early years after medicinal cannabis has been introduced. While some medicinal cannabis, the product itself, has been used by people for recreational purposes, there is no evidence that the overall level of use has gone up, which means there is no basis for a public health concern in terms of increased recreational use, which would be a concern and which we do not want to happen. We would be happy to consider any amendment to the Bill that prevents leakage because it is not the intent. We have seen from other countries that the level of usage, particularly among young people, does not go up. The notion that if the product is safe people will be more inclined to use it does not turn out to be true. Giving good information, labelling, is very important. To respond to the other Deputy's question, labelling the products will mean describing exactly what proportion of cannabidiol, CBD, and tetrahydrocannabinol, THC, in particular and up to 50 other of the components it contains. Most manufacturers are now describing the components in greater detail. Moving from where we are now to where we will be after the Bill is passed, with labelling, there will be much more information for the users of cannabis products on what they are actually taking. Therefore, safety will improve. Usage will not go up. There is no basis for a public health concern about an increase in recreational use. It is not there in the scientific literature.

Thank you. Can someone respond to Senator Swanick's question?

Professor David Finn

In response to Senator Swanick's question about the exacerbation of paranoia and the presence of cannabinoid receptors in the amygdala in the brain, that is an area we have done a lot of research on in Galway. The literature on cannabinoids, anxiety, paranoia and psychosis is somewhat complex. It depends on exactly which cannabinoid, which constituent of the plant we are talking about. There is some evidence that high THC containing cannabis may exacerbate paranoia and, of course, any doctor who would consider prescribing medical cannabis or cannabinoids to a patient would want to take into consideration the psychiatric history of the patient, particularly any history of psychosis or paranoia. It is likely that if such a history were present cannabis would not be the most appropriate course of action for that patient. There is evidence that with some of the high THC containing products, cannabidiol does not act at CB1 or CB2 receptors but is still present in significant quantities in cannabis and may reduce anxiety, paranoia and psychosis.

The balance of THC to cannabidiol, the ratio of the two, will be really critical. I would concur with Dr. O'Grady's comments on the essential need to label the products correctly and in detail so that the patient and the doctor know exactly what they are prescribing or taking in terms of THC content, cannabidiol content, but also some of the other cannabinoids that are present in significant quantities too. Many of the 700, or 114, if one likes, cannabinoids are present in very low or trace concentrations and there is a question mark over precisely what sort of effect they may be having on the body and their efficacy. The mechanisms of action for each and every one of those hundreds of compounds has not been elucidated but we do have a significant body of knowledge around the use of cannabis going back over hundreds if not thousands of years and understand quite a lot about its effects on the body, in the context of misuse, recreational use and more recently in medical use. The possibility of exacerbating paranoia could be dealt with by taking into account the history of the patient. If there is a history of paranoia or psychosis, it is possibly contraindicated.

As to whether it might precipitate paranoia or psychosis - although the question was not asked, we should maybe talk about this - the evidence is mixed. There is evidence to suggest there may be a moderate effect of cannabis inducing or precipitating psychosis in those at risk.

If one starts using it early in life, during adolescence or as a teenager, and perhaps if there is a genetic background or predisposition to psychosis, cannabis likely precipitates psychosis and, potentially, schizophrenia. However, and Dr. Barnes has written on this and will probably speak on it, with the majority of users of cannabis, either in the recreational or medical setting, schizophrenia and psychosis are not major concerns if the use is monitored carefully and if there is no prior history or genetic predisposition.

Deputy Kelleher asked about co-morbidities and adjunctive treatment. Many of the studies on cannabis and cannabinoids have been in the adjunctive treatment setting, where medical cannabis or cannabinoids have been studied alongside the patient taking additional medicine, for example, opioids for chronic pain or anti-spasticity drugs for multiple sclerosis, MS. There is good evidence from the scientific literature and basic science studies to suggest that there might be some synergistic interactions between cannabinoids and some of the other medicines, particularly the opioids, where the two drugs working together might produce a synergistic beneficial therapeutic effect more so than either drug alone. By giving lower doses of each drug, cannabinoids and opioids, one might get a greater and additive therapeutic effect which allows one to reduce some of the side effects of both classes of drugs. That is interesting in terms of drug interactions, which is probably the origin of the question.

With regard to co-morbidities, the MS patient group has been well studied. There are multiple symptoms there ranging from spasticity to neuropathic pain and other symptoms. There is good evidence that cannabinoids and medical cannabis can reduce the spasticity and the neuropathic pain that was experienced by many multiple sclerosis patients.

I agree with what Dr. O'Grady said about the risks of diversion. We should continue to monitor studies coming from the US and other countries that have made the move towards legalising medical cannabis, but so far the studies suggest that the diversion issue is not a major concern.

I hope that is helpful.

There was another question from Senator Swanick regarding the distinction between a recommendation and a prescription. My understanding is that prescription carries legal implications while a recommendation would not have those implications.

Dr. Peadar O'Grady

To make a final point, there is nothing that we are aware of in this Bill, and certainly nothing we intended, to affect the rights or duties of a doctor or a pharmacist. Whatever one is obliged to do in terms of recommendations, prescriptions and so forth is still a requirement. The Bill protects the patient from unnecessary criminalisation and protects all levels. Currently, from production to consumption has no regulation. In terms of production, it is mainly through importation. There will be little production in Ireland. That might be an issue in the future but it is not dealt with in the Bill to any great extent. The Bill seeks to ensure that all of the process is licensed to ensure good quality medical product ends up in the pharmacy, that the product can only be got by a person with a certificate and that the certificate will defend them against prosecution. Everything the doctor recommends must be based on good medical practice, and that will take a while. The fact the HPRA did not ask for experts with experience of using medicinal cannabis was largely because there is none. That is because it is illegal to use cannabis in Ireland. This Bill makes it legal to use it for medicinal purposes. If anybody thinks there is a way of amending any part of the Bill, including the certification part, to make access to medical cannabis safer, better or better facilitated, we would be interested in their suggestions. The certificate is designed to ensure that only people who will benefit will be able to get access.

With regard to how much additional information the doctor gives, of course the doctor will have to see the patient. If they need to see them for any other treatment, they will need to see them in the same way to prescribe cannabis. If they do not, they will be dealt with in the same way. It happens occasionally that people write scripts for drugs that have a street value and those people often end up being stricken from the medical register. None of those rules is in any way breached or commented on in our Bill. There is no attempt to change or alter in any way the rights or responsibilities of a doctor or pharmacist. I cannot emphasise that enough.

I thank the witnesses. I also thank my colleagues because I am approaching this from a lower knowledge base, I suspect, than other people present. I told Deputy Gino Kenny when we discussed this privately that I have no skin in this game, so I wish to give the Bill the fairest hearing and consideration. Anything that purports to bring relief to people who are suffering deserves serious consideration. However, I will ask devil's advocate questions, because it is the only way I can understand what is happening here.

It is not usual for campaigns for improvements in the provision of medicines to be as political as this campaign appears to be. Dr. O'Grady and Deputy Gino Kenny are well known for their socialist political activity and that is absolutely fine. It does not mean that anything they have said here today is untrue. However, it strikes me, as an outsider, that it invites scepticism when the push for change does not appear to be coming from the people we usually trust as the arbiters of what constitutes good medicine. I doubt that Dr. O'Grady or Deputy Gino Kelly will disagree that this is, as it were, a public relations problem for a campaign starting among, and led by, politicians. The case for the prosecution, unfair though it may be, will be that there is a group of politicians coming from a particular political wing and, critics will say, holding out false hopes for people and gathering another constituency, the better to march forward and so forth. That is not my view, but the case for the prosecution. The case for the defence appears to be that the witnesses have spotted something that other countries have noticed but which the medical establishment in Ireland has not yet noticed.

Is Professor Finn free of any political skin in this game? Is he coming to this as an academic professional? Has he, for example, received research funding in this area? I have looked at his biography and it is very impressive. Has he received research funding for his work with cannabinoids? Can he tell us about that? What do his peers say? Professor Finn is involved in the Irish Pain Society, but what do other people in pharmacology in this country and abroad tend to say? Is Professor Finn in a minority or in an emerging majority? He said a little about why things are as they are in terms of the lack of support. What is the position of the Irish Medical Organisation, IMO, the Irish College of General Practitioners and the Irish Pharmacy Union on this? The Irish Pain Society dissented respectfully from the HPRA report and I saw the three circumstances where it says that if permission is to be given, it should be along those lines. The concern of the Irish Pain Society is that chronic pain is not included.

The witnesses referred to the countries that have made changes, which included Germany.

Is that on the back of the medical establishments the witnesses have not quoted in terms of their support? Have the equivalent medical establishments in those countries changed their views or has it happened without prejudice to what they may or may not believe? In other words, are the recognised bodies in Ireland, namely, the Pharmaceutical Society of Ireland, the Irish Medical Organisation, IMO, and the others I mentioned, out of step with their equivalent organisations in the other countries where this has been legalised?

Given that the pharmaceutical industry is massive and well-funded, are we talking about legalising products people can smoke? I think I understood from what Dr. O'Grady said that it is not primarily that but that it is tablets. Are these tablets made by well-known, recognised pharmaceutical companies? Are they on sale internationally but not in Ireland or other countries that have not changed the law?

I am not comfortable with individual cases being mentioned as the lever with which to get change because whatever care and concern one might feel for those cases, one wants to arrive at a decision about the legality of certain products as medicines in a more dispassionate way. I am concerned that it appears to be a problem that a consultant is required. Whether a consultant has legal status or not, if there is controversy about whether certain products should be provided or allowed as medicines, and there is controversy, surely one should seek the reassurance that, say, a consultant holding a recognised post would be required to sign off on certain items. That would appear to be more in step with the precautionary approach one would normally take in such matters, asking as a non-medical person.

The point was made that since it is not legal in Ireland we cannot know, but does that not point to the need to establish legality for research projects which seek to establish first whether the case for such medicines is beyond doubt, one presumes on the balance of probabilities? As opposed to the "legalise and let us see" approach, should we not be talking about providing in law for the carrying out of certain research? Has that gone on in other countries and has it led to named products emerging onto the market of the kind the witnesses would like to see available across the counter in Ireland?

I believe the witnesses have no problem with there not being a cannabis regulation authority. Their case is that this should be regulated like any other drug. They used the word "certificate" so presumably they have no problem with this being a prescription drug and that it is a defence in law then to say that these drugs are being used on foot of a doctor's prescription. I presume none of that would be controversial to them.

Is Professor Finn in total agreement with everything that has been said by his colleagues here, up to and including the case for this Bill?

I will ask Deputy Kenny, as the politico here, to respond to this question. Does he believe there has been an attempt to throw mud in the eyes of the members of the public on the real import and purpose of this Bill? I believe there has, but I am interested to hear Deputy Kenny's response. I would describe Deputy O'Connell's intervention as nothing short of a hatchet job and a gross misrepresentation, but I will ask the question of Deputy Kenny. I will not ask the-----

Deputy O'Connell is not here to-----

Yes, she made these allegations and then left, which is telling in and of itself.

I do not think Deputy Boyd Barrett can make comments about a member who is not here.

In fairness, she was at the committee-----

She is not here now.

I do not think Deputy Boyd Barrett can call her bona fides into question.

Do we not want to get away from what one politician thinks about what another politician said here? If we are to get any clarity on this, it is the experts we need to hear from.

Senator Mullen just made comments about people's political background.

I asked about them.

I am just asking Deputy Kenny whether he believes the Bill has been misrepresented because I believe it has. It is entirely legitimate for me to comment on something that happened at this committee meeting. If the person who made those comments has left, that is her problem. It is entirely legitimate to respond to issues that were discussed as part of this committee meeting.

The substance of our meeting this afternoon is to examine the Bill. We should concentrate on that.

Yes, absolutely, but a suggestion was made that the Bill was immoral in its import, which is an extraordinary statement to make. What is Deputy Kenny's view of comments to the effect that the Bill is immoral and so on? As I understand the Bill, and I have read it, it explicitly states that it will be an offence for people to use cannabis-based products other than on the grounds set out in the Bill. Can Deputy Kenny confirm that? There has been an attempt to suggest that somehow this Bill is a back door for recreational use when, for example, section 14 specifically refers to the prohibition of unlicensed sale of cannabis for medicinal use and the prohibition of unlicensed transportation of cannabis and that all of those things will be offences. Is it not clear that providing for the medicinal use of cannabis, as recommended by a doctor and only when recommended by a doctor, is the purpose of this Bill? That is my first question.

Second, much of the muddying of the waters in terms of the Bill centred around the question of possible side effects and unintended consequences, the leakage effect and so on. My question is to the experts. What is their opinion of the potential of all of those to happen with existing drugs, even drugs sold over the counter? For example, Solpadeine, which is sold over the counter, has serious side effects and the potential for addiction, misuse and so on yet that product is authorised. There is also a range of other drugs like anti-depressants and so on which we know are misused on quite a wide scale and potentially have serious side effects. Is there any reason to believe that there should be a different set of criteria and a higher bar set for cannabis based medicinal products than for those drugs that are already sold either over the counter and have not been authorised or that are sold on the basis of people having a prescription? Is there any reason to believe that a higher bar should be set for cannabis-based products?

Do the witnesses know of any authorised products that a general practitioner, GP, cannot currently prescribe and that only a consultant can prescribe? They might tell me what those products are because there seems to be a suggestion here that it is somehow legitimate to say that for cannabis-based medicine we have to have a consultant but for all sorts of other medicines a GP's prescription is fine. As we know, in the case of Vera Twomey, a GP has prescribed it for her daughter but the legal position is such that that GP's prescription is not good enough, given the legal set up here. For the benefit of the public and for the committee, will the witnesses tell us whether this bar in terms of a consultant having to prescribe applies to any other medicine?

With regard to the HPRA report, does Dr. O'Grady find it surprising that there is direct conflict between what it says about cannabis-based products and what Professor Barnes says? The report says that to date, there is an absence of scientific data demonstrating the efficacy of cannabis products. Professor Barnes says the opposite, namely, that they have "found good evidence for one or more of the cannabis products or 'natural' cannabis in the management of chronic pain, including neuropathic pain; spasticity; nausea and vomiting, particularly in the context of chemotherapy; and in the management of anxiety". He goes on to say: "We have found moderate evidence in sleep disorders; appetite stimulation in the context of chemotherapy; fibromyalgia; post-traumatic stress disorder", and some evidence in dementia, Parkinson's disease, epilepsy, childhood epilepsy, bladder dysfunction, Tourette's syndrome and so on. He goes on to say that we need more research in those areas. Does Dr. O'Grady have any comment on that contradiction?

Dr. Peadar O'Grady

On the political issue, the reason legislation is required in the first place is that the medicinal and general use of cannabis has been politicised. The UN General Assembly recently commented that the prohibitionist approach to drugs generally was not helpful, to put it mildly, and has affected the way in which this plant and its products have been dealt with. Otherwise, this might have just been a plant that was discovered to have useful properties and developed in the usual way. Why is it coming through political avenues? It is because of criminalisation. That is the shortest answer I can give.

There are many types of products, from vaping to aerosols to tablets. The variety of products is the reason this requires regulation. When somebody has a product it should be properly labelled. The user should know what is in it and have the opportunity to consult with a doctor. It is worth reminding the committee of what the status quo is. People are accessing cannabis from street sources and taking it on their own, or growing it on their own. They are making decisions about how much to take and how long to take it for without any medical consultation. This Bill would improve the situation.

I fully agree with the Senator that the more research there is the better. The main reason research has not been carried out to date is illegality and lack of regulation. We need to regulate products so that they are consistent and can be consistently researched. We also need to make it legal to research them.

Is that not the first step, though, before we regulate their availability?

Dr. Peadar O'Grady

No, it is not. It has not been the first step in the development of almost any drug. The first step is to stop criminalising a thing so that it can be researched. We cannot research a life that is criminalised. We cannot do research on an area that is not allowed to happen. The two-----

Surely it is possible to legalise the production of cannabis in controlled circumstances for research purposes and to legalise research activity without changing the rules on whether cannabis itself is a prohibited drug generally.

Dr. Peadar O'Grady

We cannot do research without subjects for the research. Without a way in which cannabis can be used medically, there is not really an avenue for developing that research. The amount of research that is necessary to get a drug passed is actually not a lot. That is why there is provision for a research institute in the Bill. The two processes, research and decriminalisation, should work together. If the Senator is saying that one is the horse and the other is the cart, it is not that simple. I will let Professor Finn respond to the issues about research in more detail. The major obstacle to research at the moment is criminalisation. The major obstacle that is removed by this Bill is criminalisation. We are not telling patients, doctors, pharmacists, manufacturers or anyone else what to do in this Bill. We are just providing that it is no longer a criminal act as long as it is done in a regulated way, with licences, a regulatory authority and statutory provision to ensure it is done in a proper way.

On having doctors rather than consultants prescribe, I ask the committee to remember that both doctors and consultants are experts. A need for a specialist consultant to get involved rather than a GP would be based on the skills and knowledge necessary. However, the big problem at the moment is that people do not have the skills and knowledge. Saying that only a consultant should prescribe would make sense if consultants were the only ones who had the skills and knowledge to do so. The stark reality is that nobody has the skills and knowledge. One does not have to be a consultant to acquire the skills and knowledge necessary to make that recommendation. Every doctor still has the opportunity to refer on to a specialist should additional expertise be required.

They do not exist.

Dr. Peadar O'Grady

A big problem at the moment is that we do not have enough specialists. The colleges will have to take this on. It is like when keyhole surgery came along. The surgeons did not know how to do keyhole------

What are those specialists called, where they do exist? What is their branch of medicine?

Dr. Peadar O'Grady

If the Senator would just bear with me, the analogy I would use is keyhole surgery. When it came along first, none of the surgeons knew how to do it. They had to go and train to do it. A number of years ago I came across a new assessment for children and I had to go and learn how to do it. People will have to train and acquire the skills and knowledge. We have to trust that doctors will not make recommendations that are beyond their skills and knowledge. They are required to act responsibly. This is where the Medical Practitioners Act, the Medical Council, all of those things come in. Saying we will limit the power to prescribe to consultants so that we can all step back and feel safe is-----

Is there a specialist somewhere internationally? What is he or she called and what is his or her job title? Where are they?

Dr. Peadar O'Grady

I think the Senator is missing the point. I am saying there is no such specialist in cannabis-based medicine, nor is there any requirement to develop such a specialism. Nobody to my knowledge, including us, is making any such recommendation. What we are saying is quite the opposite. This is an ordinary feature of everyday medicine. One knows of a treatment and of an application from reading the literature as outlined by Professor Barnes. One makes a recommendation to a patient that a course of treatment would be good for him or her and one does everything to facilitate his or her access to that treatment.

At the moment, doctors and pharmacists are only prevented from doing so because it is against the law. This Bill would remove that obstacle. That is what it is for. Sticking in a constraint about consultant-only prescribing is not based on any rationale. It would not make things safer. It would only serve to restrict treatment. It would also put work on consultants in the same way that the Minister is trying to approve everything at present. We would be trying to get a small group of specialists to approve every recommendation for cannabis-based medicines. It would just be a waste of their time and it is not necessary. It is a restrictive move that has no other utility. It is not required.

Who would Dr. O'Grady put on the cannabis regulation authority, then?

Dr. Peadar O'Grady

Someone with experience. Initially, a little like our Garda Authority at the moment, we may have to go abroad and look for expertise there to find the right people.

And the person with experience is somebody who has been prescribing cannabis-based medicine and has compiled a certain amount of data about what he has experienced.

Dr. Peadar O'Grady

I think the Senator is mixing up two different things. The cannabis regulatory authority will consist of regulators. I am presuming some of them will have clinical and pharmacy experience and so on. Doctors who want to prescribe and recommend cannabis to their patients will just need to train in it and that training should be available here. This is a constant element of working in medicine. When we want to upgrade our skills we just get training. We read a book or journal or go to a lecture, course or conference.

We do whatever is necessary to acquire the level of knowledge and when we feel we have enough knowledge and we have conferred with our colleagues, we practise. That is how medicine works.

Where are the bodies of expertise, the equivalent ones that would be used in this case?

Dr. Peadar O'Grady

All over the world - everywhere except Ireland where it is a criminal act to prescribe cannabis-based products.

Everywhere except Ireland.

Dr. Peadar O'Grady

No, all over the world. There is an increasing number of countries but Ireland is not one of them because it continues to criminalise use. I am sorry, I have to leave.

I thank Dr. O'Grady.

I would like to address the contributions of Senator Mullen and Deputy Boyd Barrett. We have been misrepresented but that is for another day.

Does the Deputy mean by the committee?

No, by an individual Deputy. She completely misrepresented my view but that is for another day.

I would like to respond to Senator Mullen. I am a Deputy and I come from a certain political persuasion. In my eyes, everything is political. When I get up in the morning, it is political and when I go to sleep, it is political. That is just the reality of things. The reason I got involved and put the Bill forward is simple and objective. Families approached me before I became a Member to ask me if I would champion the idea of medicinal cannabis use if I was elected. I said I would and I was true to my word. When I met Vera Twomey in Leinster House last May with her husband, Paul, she outlined her circumstances and one would want to have a heart of stone not to say there is something dramatically wrong with a mother being unable to legally access medicine for her child. Surely that is immoral. I was driven by that and I will always be driven by that. For the many people who could benefit from medicinal cannabis, I will always be driven by their hidden suffering and how they could benefit. That is my bottom line in being in this building and in getting up in the morning.

I have no doubt the Bill could have a major benefit for countless people and this is my driving force. The Bill is not perfect by any means and I am the first to acknowledge that. There are many reservations about cannabis use and I am educating myself. This time last year, I had little knowledge about cannabis. What I knew about it was elementary but I have come to know the science to a limited extent and to know about the people who could benefit. Many people could benefit. I refer to the likes of Vera Twomey and the countless others who could benefit. What drives a woman to walk nine days between Mallow and Dublin? It is the circumstances in which she wants to get medicine for her child. The Senator should put himself in her shoes. I would do the exact same as Vera. One would do anything for one's child. I am taking the emotion out of this and putting the politics and the science in it. People should have access in the 21st century to medicinal cannabis. Many other countries are beginning to put programmes in place. There are issues with the medical profession in this country, which is cautious. The Irish Times reported in an article before Christmas that 56% of GPs favour medicinal cannabis use. I understand the profession is a broad church. Elements of the profession are probably completely against it, which is fair enough. Members of this committee are probably completely against it but the reason we are here is to stop the suffering of people who could benefit from medicinal cannabis. That is my sole purpose in putting this Bill forward.

Deputy Boyd Barrett asked which medicines GPs are not allowed to prescribe. Perhaps Dr. Finn could comment.

I stopped my contribution because I knew Dr. O'Grady was in a rush. It has been stated that there is evidence that where medicinal cannabis is made available, it has an impact on the use of other drugs and there is some evidence that use of benzodiazepines, opiates and so on has reduced where that is the case. Do the companies that manufacture those products feel threatened by medicinal cannabis being made available and potentially substituting for their products given there is evidence that such substitution is happening?

Professor David Finn

I have been taking notes and, therefore, I will try to address as many of the questions as I can in the order they were asked.

I am 100% apolitical in this. I am not a member of a political party. I have no association or relationship with any member of the People Before Profit Alliance. I have been invited in my capacity as a professor of pharmacology at NUIG, president of the Irish Pain Society and as somebody who has worked on cannabinoids and the endocannabinoid system for 16 years in the UK and Ireland. My main motivation is to inform the debate as best I can and provide evidence-based input into the debate. A question was asked about my research funding. I have had funding from Science Foundation Ireland, the Health Research Board, the International Association for the Study of Pain, other charitable organisations and peer-reviewed grant agencies. This is peer-reviewed grant funding from the Government and other agencies around the world primarily for basic science research, much of which has been around cannabinoids and pain.

There was a question about my peers and where they stand on the issue. It is a complex question and, therefore, there is no absolute consensus. It may depend on which body of peers one looks to. A paper was published in the Harm Reduction Journal, by Crowley et al, earlier this year. It was a survey of Irish GPs and the finding was that a majority are supportive of a move towards authorisation or legalisation of cannabis for medical use and the figure increases if they have additional training in dependency or addiction.

I am president of the Irish Pain Society. The society represents the health professionals who study, research, educate and manage pain. Our executive committee released a statement recently in which we came out in support of the inclusion of chronic pain as a fourth indication. The HPRA recommended three indications - spasticity in MS, chemotherapy induced nausea and vomiting, and epilepsy. The executive committee feels there is a sufficient body of evidence and a significant unmet clinical need to justify inclusion of chronic pain as a fourth indication. A paper was also published in The Journal of Pain, which is the primary journal of the American Pain Society, which also supports the use of medicinal cannabis and cannabinoids for chronic pain.

There is a really excellent review by the National Academies of Medicine in the USA, McCormick et al. It is hundreds of pages long. It is an outstanding review and was published in 2017. That review is authored by many leading experts in the world in cannabinoids and cannabis-based medicine. They conclude that there is a body of evidence in support of medical cannabis for some indications but not for others. By and large, those indications reflect and concur with the indications supported by the HPRA, but, importantly, chronic pain is one for which the National Academies of Medicine review says there is a substantial body of evidence. A number of my peers in the cannabinoid field and members of the International Cannabinoid Research Society co-authored that report.

There are at least two world bodies that meet and comprise experts in cannabinoids, cannabinoid science and cannabinoid medicine. These are the International Cannabinoid Research Society, ICRS, of which I am a member, and the International Association for Cannabis as Medicine. In terms of where could doctors go for their continuing professional development and to find information, I guess they could go to those annual conferences. Those are excellent conferences and they would be a forum to provide continual professional development for doctors and health professionals. They would not be the only source of such information but they would be good sources of that information.

There was a question around the formulations and tablets versus drops versus smoking versus vaping. All of these exist and they are possibilities. One of the complexities is that there are so many different potential formulations and routes of administration, some of which have been researched more than others. There is a formulation which has been approved by the HPRA. I referred to it earlier. It is nabiximols or Sativex, which is an oromucosal sublingual spray in an ethanolic suspension. Then there is dronabinol and nabilone, which are, I believe, capsules or tablets, as well. Certainly, I would feel that smoking is not the best way to go. There are risks of bronchitis and, potentially, lung cancer. Vaping is probably safer than smoking. Drops and oils are another option which has been studied, and probably have a more favourable side effect profile, at least in terms of bronchitis, versus smoking.

On the question of research, I am a researcher and an educator. I absolutely support the need for further research. That was a strong statement in the HPRA report. It was nice to see that the HPRA is supportive of trying to create a framework within Ireland to facilitate more research. As a researcher, I would be supportive of that. We certainly could do with more research. I would feel that there is already - the systematic reviews and meta-analysis, particularly on chronic pain, that I cited earlier - a strong body of evidence in support of medical cannabis and cannabinoids for chronic pain and that have moderate to strong efficacy, depending on the study and the type of pain.

I agree one can always have more research. Two of the limitations perhaps are that some of the studies done are relatively short term and more long-term studies would be useful, and-----

On the research point, before Professor Finn leaves it, did he understand Dr. O'Grady to suggest that research cannot happen because cannabis is criminalised? If that is what I understood Dr. O'Grady to say, does Professor Finn agree with that? Is Professor Finn limited in his capacity to do research because of the legal status of cannabis?

Professor David Finn

Hitherto we have been somewhat hindered, especially for clinical trials. I believe that a process could be put in place and a framework, perhaps to allow for some types of research in the absence of a broader legalisation for medical use. Maybe the type of research that could not take place unless it was a broader type of legalisation would be population-based research. Perhaps researchers could do focused and well-defined studies on a small number of patients, if we were granted a licence just for research. That probably could happen. I am not an expert in the law on that but I would feel that there probably would be a way to achieve that. The type of research that looks at population-based effects and the use of cannabinoids or medical cannabis in a larger group of patients across different parts of the country or across the country as a whole probably could not take place.

I was talking about two limitations of the research. At present, one would be the short-term nature of the studies. I suppose population-based research gets at that a bit better. The other limitation would be that some of the studies have used relatively low N-numbers, that is, low sample sizes. If we are to do studies that include a significant number of patients and a big enough sample size, population-based research can help to achieve that as well. It depends on the type of research that one is talking about.

Why does the illegality of cannabis affect Professor Finn doing it with a larger population? Presumably studies happen under a permitted structure. It is not merely a case of saying: "Let us know how you are getting on if you are smoking some cannabis." Why would the legal position affect Professor Finn's ability to conduct a more broad study?

Professor David Finn

I refer to population and health research once a drug is being used in the community in a real-life situation as opposed to in a laboratory. There is a need for both. Of course, in the laboratory setting we can do a well controlled placebo-controlled randomised double-blind study.

Is this work already done in countries where cannabis has been legal? Are the drugs there on the market elsewhere?

Professor David Finn

It has already been done and published in the peer review papers.

Has it led to drugs on the market in other countries?

Professor David Finn

Cannabinoid drugs?

Professor David Finn

It has. Sativex is on the market in quite a few different countries for spasticity in MS and also, in Canada, for neuropathic pain and severe cancer pain.

Is this legislation only seeking the availability in Ireland of drugs which, under other countries' legal structures, are now available under prescription in pharmacies where prescribed by responsible clinicians?

Professor David Finn

That is Sativex which is not cannabis. It only has two compounds: tetrahydrocannabinol, THC, and cannabidiol, CBD. Medical cannabis is more complex. It is the plant material. There have been clinical trials and clinical studies on cannabis also and these have been published. I suppose it is merely a case of how many do we feel we need to satisfy us. Some people are satisfied now. Others feel they want more to be satisfied. That is the bottom line. It is where, as a professional, one sits on that. Different professional bodies sit on either side at present.

I thank Professor Finn. Following Deputy Boyd Barrett, Deputy Kelleher has a question. Then I will bring in Deputy Durkan.

My question has just been answered.

For the purpose of clarity, I suppose, for anybody looking in on this debate, the herbal product is available in other jurisdictions and approved and authorised and can be made available through prescription in other jurisdictions. Maybe the speakers could confirm that. It is my understanding that it is.

Professor David Finn

Yes.

This Bill seeks to allow for that. I am not just referring to the limited number of herbal products - I believe it is one - that are available in Ireland. It has components of cannabis but is not the entire product.

I wish to ask Professor Finn about something. As someone who is involved in the pain area via an organisation named-----

Professor David Finn

The Irish Pain Society.

It is not Professor Finn's job to be political, but is he surprised that pain has been left out of the recommendation of the Health Products Regulatory Authority, HPRA, or that it suggested that there was not much evidence of this product's efficacy when Professor Michael Barnes says the opposite? Professor Barnes seems to suggest that the highest level of evidence concerns pain and that there is less evidence of its efficacy for some of the recommended conditions on the HPRA's restrictive list. I find that odd. Does Professor Finn?

I have a supplementary question on the comparison between cannabis and other products for pain and conditions for which cannabis may be, or is evidentially, beneficial and how the two are treated in law and in this debate. Has Professor Finn a comment on this matter? Would it be fair to say that almost all, or certainly the vast majority, of approved drugs for pain and almost every other condition have significant, even severe, side effects in some or a large number of cases, yet they are authorised nonetheless? Is there evidence to suggest that any of those side effects is more dangerous in cannabis than drugs that are currently available over the counter or on prescription? Would Professor Finn go so far as to say that the evidence suggests that, while cannabis has some side effects, they are generally not as severe or dangerous?

Perhaps Deputy Gino Kenny or Professor Finn would answer those questions, after which we will go to Deputy Durkan.

I thank the Chairman. I am waiting patiently, very patiently. I might need some of the product soon.

I will ask one or two questions to conclude.

Our Bill stipulates that the full plant extract will be available to patients. That is the bud form, the oil form, etc.

As has been mentioned a number of times, the HPRA stipulated three conditions in its report. As far as I know, the medications that have been stipulated for the two conditions in question are Sativex and Epidiolex. That is like fast-tracking a pharmaceutical brand, and I have many problems with that.

Deputy Boyd Barrett asked about replacing other harmful drugs. It has been found in the US that, since medicinal cannabis has become a treatment, the use of opiates has decreased, as has the number of deaths. Pharmaceutical companies have a major problem with that. According to a report in The Guardian last November, the makers of Vicodin and OxyContin were prominent financial supporters of anti-cannabis lobbies and projects because sales of drugs, which were harmful, had decreased dramatically due to being replaced by medicinal cannabis. That can only be a good thing. Some opiates are extremely addictive and can be harmful or lead to death.

Professor David Finn

The omission of pain as one of the indications in the HPRA report is controversial. I was surprised. Given the meta-analysis and systematic reviews that have been published, including the Barnes report, which we have discussed, but also papers from Whiting et al., Hill et al. and the National Academies of Sciences, Engineering and Medicine, pain is the condition that has been most studied in terms of cannabinoids. A substantial body of evidence suggests moderate efficacy or, depending on the study and the condition, better-than-moderate efficacy in some cases. It is a pity that chronic pain was omitted. The HPRA gave four reasons for doing that and the Irish Pain Society's statement examined and commented on them. I will run through the commentary quickly.

The first reason was that the causes of chronic pain are diverse and that a suitable patient population or clinical indication for treatment with cannabis cannot be defined due to the complexity and variety of chronic pain syndromes. We have learned quite a lot in the past 15 or 20 years about the mechanisms and causes of chronic pain. Central sensitisation and peripheral sensitisation are well recognised as the neurobiological bases for chronic pain. As has been shown in many studies, cannabinoids work to reduce these two mechanisms. The clinical research to which I alluded has shown that cannabinoids have moderate-to-significant efficacy in terms of chronic pain, including neuropathic and cancer pain. Sativex has been licensed in Canada for neuropathic pain in MS and for cancer pain, so there is a precedent for that type of drug, namely, a cannabinoid medicine that has passed the usual hurdles that a medicine must jump over in order to be authorised for chronic pain. In other jurisdictions that have authorised medical cannabis, its primary use is for chronic pain. In Colorado, 84% or 90% of patients reported their main reason for using medical cannabis as being chronic pain.

The second reason in the HPRA's report was "physical, emotional, social, spiritual and other subjective factors inform the individual pain experience, making it difficult for a doctor to objectively assess the effectiveness of treatment". The complexity of a disease is not a reason to avoid treatment. A pain consultant would be able to assess the effectiveness of a treatment. Otherwise, how could we justify prescribing any drug for chronic pain if doctors were not able to assess their efficacy? The efficacy of cannabis and cannabinoids could be assessed.

The third reason was that there was "a large number of authorised medicines that are of proven effectiveness, and other non-pharmacological treatments available to treat the many factors involved in chronic pain". This is true. There are many other analgesic drugs and non-pharmacological approaches to the treatment of pain, but we cannot ignore the fact that one in five people in Europe suffer from chronic pain. In Ireland, the figure is approximately the same. Depending on the study, it is between 13% and 35% of patients. This is the case despite the availability of other treatments. The largest study ever carried out on this matter in Europe involved 46,000 patients.

The study, Survey of chronic pain in Europe: Prevalence, impact on daily life, and treatment, by H. Breivik et al, showed that 40% of chronic pain patients said that their pain was inadequately managed by current treatments. This illustrates that there is a massive unmet clinical need here. Existing drugs are working well for some patients but they are not working well for all. That may be because of lack of efficacy or unacceptably high levels of side effects.

The fourth reason the HPRA gave was that chronic pain is common and the potential use of cannabis-based medicines by a large number of patients raises concerns about misuse and diversion into the wider community. I understand those concerns but when we look at countries that have introduced medical cannabis, we can see that there is no significant evidence that this has led to diversion and misuse or to an increase in the overall recreational use of cannabis. The other point is that those concerns about diversion and misuse are not unique to cannabis and cannabinoids. They certainly apply to opoids and benzodiazepines. Opoids involve a greater dependence liability and probably present a greater harm to the individual and society overall than cannabis and cannabinoids. This addresses Deputy Boyd Barrett's question. It is very difficult to objectively compare side effects of one class of drugs with those of another. It is hard for me or anyone else to say whether one is worse than the other. Certainly, the risk of overdose with opoids and benzodiazepines is significantly higher than for cannabis. There are very few, if any, documented cases of fatality due to cannabis overdose. The dependence liability relating to cannabis is generally thought to be less than that of opoids. Depending on the study, the percentage of people who use opoids for chronic pain and who become dependent on them is around 3% but it could be as high as 10%. The risk of overdose also exists. Does that answer the questions?

I thank Deputy Gino Kenny and his colleagues for appearing before the committee and giving us their views. I do not have any vested interest one way or another. Deputy Boyd Barrett mentioned pain, which is the crucial and most significant element in this debate. Having had a condition that involved a lot of pain and having been referred to pain management in the past, I can speak with some experience. One of the things I discovered was that management of the pain does not necessarily treat the cause of the pain. My question follows from that. To what extent did the witnesses's research go into the cause of the various forms of pain and the treatment of those conditions?

I am also talking about severe pain - the kind that involves contraction of the muscles, the clenching and breaking of teeth and a series of frightening degenerative effects. People have different pain thresholds so when a person with a high pain threshold reaches that stage, it is getting serious and they will do virtually anything to alleviate the pain, including beating their head off a wall. I looked at all the options and discovered a person who told me that treating the condition that caused the pain was the most important thing and that individual was right. That is only my personal experience. I am fully aware that it does not apply to everybody. I put that out there as a particular experience and would be very conscious of people with conditions that involve severe pain as a result of those conditions, be they children or adults. It is an appalling situation to be in and something we need to spend far more time dealing with in order to get to grips with it. I am not in any way dismissing the rest of the argument. I emphasise that point and I want to know as much about the research into that area as possible.

The HPRA has advised against what is proposed, with the exception of a limited number of conditions. The only exceptions are where the consultant and the GP are involved and approve, on prescription, with full authority. The reason for that is simple. If we do not do that, a serious problem exists and there is a liability. Who accepts liability? If one or other of those people is removed from the chain of command, and we say it is not going to work in every case, who will accept responsibility in the event of there being a serious liability and from where will the insurance to cover that liability come? Will the liability be so serious as to deter the provision of insurance cover and could it proceed without cover? I am talking about matters relating to the State as well.

The general idea would be to protect the patient as much as possible. Is that accepted in so far as the witnesses are concerned? Is it agreed that the patient's interests, not ancillary issues or advice, are the most important considerations? Will the lifting of the ban, for want of a better description, protect the doctor or consultant? Do the witnesses envisage changes that will protect the doctor, consultant or whichever person prescribes?

Could the patient have grounds to ignore the advice of the consultant? That is a serious question. Could evidence the witnesses might put forward be of such a nature that the patient or the patient's relatives feel it necessary, advisable or possible to ignore the advice of the conventional medical consultants and, as a result, bypass the GP and consultant and operate on the basis of a licence? To what extent will that licence protect the patient, those prescribing or providing the drug or both, as well as the State, in the event of there being a claim?

In respect of insurance cover and in the event of a conflict, we have the HPRA on one hand and the removal of the ban on a particular product on the other. Who protects the patient, society and the State in the event of a conflict? The witnesses say that this is no worse than any other drug, that the procedure is no worse than any other and that it is hugely helpful in respect of particular conditions. We know that and the HPRA has said it as well, but it has also specified instances where it should not be utilised under any circumstances. It has also drawn attention to the limited access in other countries in Europe and the rest of the world. I know the witnesses will tell me that this has been very effective in the US. I am going through a hiatus in respect of the US. I do not think it necessary to follow all the experience the US has had in recent times.

Am I correct in stating that cannabis-based products are already available and in use? I think there are two.

Professor David Finn

There are probably four but it depends on how one looks at it.

The HPRA indicated this. It also indicated that the products were beneficial. A patient who had used cannabis oil came into my clinic last week and she was not dramatically different from the way she was the week before. It is claimed by the HPRA that the four cannabis-based products are as effective for certain conditions as what are in the Deputy's proposal.

I have already raised the issue of a licence versus prescription and would like to know which option we would be better to rely on in the future. I have also covered alternative drugs, which are available and can have a similar effect. The side effects have been covered by various people and I accept that there are side effects with every drug. The fear among some people is that, given the association of cannabis with illegal drug activity, we might be attempting to legalise it by the back door. I know that is not the intention of Professor Finn or Deputy Kenny but it would not promote the product very well if other people saw it as a means of introducing a banned drug for general use. We want to see a distinct barrier between that use and its use for medicinal purposes. In the absence of meeting those criteria, the Bill needs to be looked at in considerably more detail and with much more research.

Can the Deputy define what the word "medicinal" means in the Bill? Does it mean a medicine in the conventional sense of the word? Does he define cannabis as a medicine? Cannabis is a whole-plant product and has up to 170 different components. How can one define what cannabis means in that context? Much of the Bill refers to herbal cannabis and to selling cannabis by the ounce. I presume this refers to tobacco cannabis.

It is not tobacco. It is a bud.

It is a leaf. Would it be smoked?

Section 44 refers to banning the smoking of cannabis in the workplace in the same way as tobacco is banned. This suggests that smoking cannabis outside the workplace would be acceptable. Can the Deputy comment on that?

If pure, synthetic components of the cannabis plant, CBD and THC, could be developed, would that satisfy the provision of medicinal cannabis as a product, as opposed to providing the plant extract in its own right? There are two references to recreational use in the Bill. In section 12 of Part 3 it states:

The Institute shall perform the following functions:

(a) conduct or commission and publish cannabis-related research in the areas of—

(i) safety, risks and benefits of medicinal and/or recreational use,

In section 41 of Part 11 it states: "the Minister shall have regard to legislative regimes in other jurisdictions concerning the regulation of the recreational and medicinal use of cannabis."

Can the Deputy address those four questions?

I accept what Deputy Durkan says about there being a debate between recreational and medicinal use. As for whether both are mixed up at times, the answer is "Yes", and sometimes it is very difficult to differentiate in the debate. I regard "medicinal" as meaning the extract from the full plant and that is how I define cannabis. I regard it as the organic cannabis plant and its derivatives, of which there are over 700. The two most known of these are CBD and THC and CBD oil is perfectly legal in this country, although if it has over 0.2% of THC it is deemed illegal. People who want to use cannabis to treat their condition want an element of THC. They do not, however, want to get stoned.

They do not want it for its psychoactive properties.

There is a misconception that people are out to get stoned all the time but that is not the purpose of this. The THC and the CBD work in tandem. They are complementary and many reports show that they are very effective in combination.

I am not a smoker and I do not advocate smoking tobacco at all but if somebody gets pain relief from vaping outside work they should be allowed to do that. In most cases, vaping is prohibited in the workplace. This Bill is not perfect but we are putting it forward to try to bring it to the next stage where it can be amended and, hopefully, legislated for.

I may have missed a couple of questions.

Professor Barnes did not recommend that cannabis be smoked but the Bill refers to smoking herbal cannabis.

If somebody wants to smoke cannabis in a joint, it is their prerogative. If they want to vape, take an oil or take it in any other way that gives them relief, that is their prerogative. The vast majority of people these days vape but if somebody wants to smoke a cannabis joint for medicinal purposes, it is their prerogative. If they get relief from it, so be it.

There were two references to recreational use.

As I said before, the debate-----

It is Part 3 and Part 11.

It is page 11. Section 12(1)(a)(i) states: "safety, risks and benefits of medicinal and/or recreational use". It relates to the cannabis research institute.

I have never seen that. Certain parts of the Bill can be amended. It is unintentional if that is the case.

Recreational use is also referred to in Part 11 in section 41(3)(e).

Page 23. It states "have regard to legislative regimes in other jurisdictions concerning the regulation of the recreational and medicinal use of cannabis."

Again that can be amended on the next Stage.

This relates to research and not to use. The specific sections the Chairman has mentioned state that if there is a research institute, that research institute would look into both the medicinal and recreational use and would look at research being done in both of those areas in other countries. It is important to say that. We could have a debate on Committee Stage as to whether the research institute should look into recreational use at all. Certainly, there will be debate outside. Professor Finn might have an opinion on that.

Professor David Finn

I had no hand, act or part in writing the Bill. My reading of that was that the research institute would research the possibility of diversion or recreational use around the medical use of cannabis in Ireland. It would look at whether diversion was happening. I believe it should do that. That is a really important question. If we are to take steps to legalise medical cannabis, someone should look at whether recreational use is increasing or decreasing as a consequence. I am not sure if that is what was intended.

Does medicinal cannabis, as mentioned in the Bill, refer to smoking cannabis?

It is one form of how people treat themselves with cannabis. If people have a treatment of cannabis, it is their prerogative if they want to smoke it.

If a person wants to smoke cannabis for recreational purposes in breach of the law and in the company of somebody who is using cannabis for medicinal purposes, it is very difficult to say to the other guy, "Show me your prescription". Merging the two together is a dangerous place to go.

It is very simple. Without a certificate from a doctor giving the right to use medicinal cannabis, a person will be committing an offence. That is what the Bill stipulates. Nothing has changed.

It is regardless of what form that medicinal cannabis takes. Possession of the vape form, tablet form or herbal form will be an offence without possession of a certificate provided by a doctor recommending the use of that product for that specific person.

My response to that-----

If I am with Deputy Durkan and I do not have the certificate and I am using his medicinal cannabis for which he has a certificate, I will be guilty of an offence, but he will not because he has a certificate.

I am saying it is virtually impossible to police what the Deputy is suggesting. He is suggesting that gardaí will have to walk into wherever there is a group of people and go from one to the other asking, "Do you have a doctor's certificate?" There could be a guy there who does not have one who is using it for recreational purposes. He is just having fun and is just getting a high for himself when the alleviation of pain is a serious issue for other people. I do not agree with that at all. The crossover is wrong there and we need to avoid that.

Pharmacies throughout the country dispense methadone, which is a very dangerous drug. It is highly illegal for anybody to have possession of methadone that is not prescribed and given out under controlled conditions by pharmacies. Is it enforced well? How is it enforced? We know there is leakage with methadone that gets sold on in the black market and so on. That could be just as easily applied. It would probably be a more serious proposition to say we need better enforcement of that. Nonetheless that happens now with methadone. I believe we should not create a higher bar for medicinal cannabis, which can help sufferers, than we would provide for methadone, which is being done currently. Why provide a higher bar?

I do not accept the analogy because there are issues regarding methadone which is the degree to which methadone reduces the level of indulgence, use or whatever the case may be and not for medicinal purposes. For that reason a new product, which I have mentioned to the Chairman, is now available which will in fact correct that. It breaks the habit-forming urge that is there. I presume that will be examined by the HPRA in due course, if it has not been done already. Its purpose is to limit this recreational use.

That product may be medicinal cannabis.

In fact it is not.

At some point it will be.

Deputy Boyd Barrett seems to have the notion that medicinal cannabis will cure everything, including political ills. It will not do any of those things I can assure him.

I wish something would.

It is not going to work that way.

I thank Deputy Durkan. Most unusually he has the last word in this debate. On behalf of the committee, I thank Deputy Gino Kenny.

Professor David Finn

May I have two minutes to respond to an important point by Deputy Durkan on the root causes of pain? Of course, for many chronic pain patients, the root cause may be known. It may be rheumatoid arthritis, osteoarthritis, an accident or post-operative pain. Where possible, the best approach is to try to address the root cause, modify the underlying disease and have a disease-modifying approach to the treatment of the pain. However, for a great many chronic pain patients the root cause is not known, particularly for neuropathic pain patients, for example, where there is no underlying disease, incident or accident to which that pain can be traced back. That type of pain, particularly neuropathic pain, is really difficult to treat and it is refractory to many of our current medications. There is some evidence that cannabinoids may be helpful to a subset of those patients.

Is it disease-modifying? That is debatable. We know that the root cause of that type of pain is peripheral and central sensitisation, the increase in synaptic plasticity in the pain pathway, the strengthening of synaptic connectivity in the spinal cord and the brain. There is good evidence that cannabinoids can reduce those things - they can reduce peripheral and central sensitisation. Are cannabinoids and cannabis a panacea, a cure-all for everything? Absolutely not. It will not be suitable for every patient or even every chronic pain patient.

It could be an option for those patients who are refractory to current treatments, who do not do well on current treatments or who are experiencing unacceptably high numbers of side effects, perhaps from current treatments. I would not recommend that anyone ignore the advice of his or her consultant. I attach great importance to and emphasise the consultant's expertise. I certainly recommend that all patients heed the advice of their consultant in this or any other arena.

Reference was made to one patient who did not respond well. That does not surprise me. I do not know anything about the patient in question or the type of cannabinoid product that was taken. Whether someone will respond or not depends on many factors. It depends on the type of patient, his or her medical history, the exact type of pain and the length of time for which it has been experienced, whether there are other comorbidities, and the type and exact composition of the cannabinoid being taken. One must determine whether it is THC, cannabidiol or other constituents. These factors need to be taken into account and known. Of course, as scientists we cannot come to any conclusion based on low-end numbers and individual patients. We must examine objectively the evidence in larger patient groups and studies.

Whether THC and cannabidiol themselves are enough or medical cannabis and the plant extract are needed is a big question. There is some belief that there is an entourage effect with the plant. What I mean by that is that the cannabinoids and constituents in the complex plant material may combine in some way that we do not yet fully understand to have a greater therapeutic benefit in certain indications - greater than just THC or cannabidiol on its own. That is a subject for research. More research is needed on that, for sure. There is some evidence, however, that in some cases there can be a greater therapeutic benefit by virtue of having the complexity of the plant and the entourage effect versus just one or two of the molecules on their own. I refer to the possibility that the molecules can interact so cannabidiol, which does not induce euphoria or the same types of psychoactive effects that THC induces, can attenuate and dial down some of the psychoactivity of THC. That ratio is really important.

Regulation is key. This is not for me and my expertise is not in legalities or how the Houses or Government would go about regulation, but I believe regulation is very important. It is a question of the extent. Does one opt for continual monitoring to be able to know with certainty what patients are taking what products and what doctors are prescribing so they may be regulated tightly?

I thank Professor Finn. Deputy Durkan did not have the last word at the meeting.

There is always time. The Chairman should not encourage me.

On behalf of the committee, I thank Dr. Peadar O'Grady, Deputy Gino Kenny and Professor David Finn for attending and engaging in the pre-legislative scrutiny of this Bill. As there is no other business, this meeting of the joint committee is adjourned until 9 a.m. on Thursday, 13 April 2017, when we will hear the views of departmental officials on the Cannabis for Medicinal Use Regulation Bill 2016.

The joint committee adjourned at 4.45 p.m. until 9 a.m. on Thursday, 13 April 2017.
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