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 line 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. Many of the reasons people die from medication use it 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 yourself 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 for an increase in recreational use. It is not there in the scientific literature.