Kate O'Connell (Dublin Bay South, Fine Gael) | Oireachtas source

I welcome the witnesses. I am a member of the Pharmaceutical Society of Ireland and I have two retail pharmacy businesses registered with the Pharmaceutical Society of Ireland. I am obviously a pharmacist.

I will refer to the access programme before I look at the Bill, and perhaps somebody from the Department could outline this matter very clearly to us. My understanding is - perhaps I have misinterpreted it - that before any of this conversation started in recent times, with the advent of the Bill, the mechanism has always been there for an Irish-registered medical consultant to apply to the Minister for Health for access to a schedule 1 controlled drug under specific circumstances for a named patient under the consultant's care if the consultant is to dispense and monitor those. There is and always has been a facility for an Irish-registered medical consultant to apply to the Minister before any access programme starts. I would like that to be clarified for the committee.

Senator Colm Burke brought up the issue of the access programme. I would like to know where we are and where we are going with that. Three conditions are specified and my understanding is that it is not just three. There are three now and there would be a view to including other conditions or indications as more data emerge.

Will the witnesses clarify the position? The provision is not necessary in light of the fact that people can access this product if they have a proper prescription from the registered consultant.

I have an issue with the Minister for Justice and Equality being listed in the first section as opposed to the Minister for Health. Is it not the latter who has the overriding power?

I have concerns about referring to the cohort of patients who might require this as "consumers". They are patients. Regardless of anything else, this is still a Schedule 1 controlled substance. That is done to guarantee public safety, which Mr. Byrne mentioned was one of our roles.

Deputy O'Reilly referred to research. It is my understanding that there is no barrier to research in that universities can get special exemptions for it. We would never get anywhere if we did not have exemptions, particularly as we could not trial a drug. Will the witnesses clarify the position in that regard?

Offences are listed in section 8, the final line of which reads, "is guilty of an offence." Perhaps I have missed it and someone from the Department will guide me, but is there a penalty - the word "penalty" is sensitive for some of us - for these offences?

As a pharmacist and a Member of Dáil Éireann, I have concerns about the functions of the institute listed under section 12(1)(a)(i), which refers to "medicinal and/or recreational use". It is strange that a Bill with "Medicinal" in its Title swings into a recreational format. The so-called benefits of recreational use are a different conversation to the medicinal framework.

We have a very robust system of assessing the safety risks of medicines. In my academic days, it used to be referred to - perhaps this is no longer the case - as the Swiss cheese theory. We do not want the holes to line up and something to slip through that would damage patient health. This subsection circumvents the rule that all of us in the field have worked hard to get right in order to protect patient safety. Any shifting of those regulations could leave us with the Swiss cheese effect even though our first job is to do no harm.

The systems regulating the sale and supply of controlled drugs are robust and pharmacists must comply with the regulatory framework. The public may not know it, but we take controlled drugs seriously. We cannot have baskets of them lying on the counter. Every tablet must be accounted for. If one goes missing, the Garda needs to be called. The destruction of controlled drugs must be monitored. Let us say that cannabis is moved from being a Schedule 1 to a Schedule 2 drug. Speaking in a professional capacity and assuming we can get concentrations and dosages right, the current framework is suitable and this substance could be slapped down on top of it.

I am not being sarcastic, but I do not understand the reference to drug-free workplace policies. I hope that the consultant performing my operation or the pilot flying my plane is not using cannabis. There must be a distinction between something that is okay and something that, as a psychoactive substance, will impair judgment. We must be careful.

As I mentioned last week, it is currently the case that subscription medicines cannot be promoted to the public. I cannot understand why there would be different rules for any Schedule 1 drug even if it is moving to another Schedule. Perhaps someone can enlighten me on the situation.

I wish to address the dosing of medicines. Perhaps Ms Egan will explain something. Just because something has been around for a long time does not mean that it is all right. Aspirin comes from the willow - I hope I am correct in that - and people gave children baby aspirin until recently. That moved to age six and then 16 in my time. Just because something is a naturally occurring product does not mean that it is okay. For example, one will find out what happens if one eats enough foxglove. Codeine used to be given to breastfeeding mothers but that changed in the period between my second and third children being born. We are constantly building on evidence. Once a drug is authorised, the yellow card reporting system keeps updating our data with what we learn. All of this is done in the interest of public safety.

Perhaps one of the pharmacists will outline to the committee that, from a pharmacokinetics point of view, children are not small adults. Their metabolic processes and how they process drugs are different. If a child is one quarter my size, I cannot just quarter the dose. Perhaps someone will articulate the distinct pharmacokinetic difference between a child's metabolism and that of an adult.

Someone might enlighten me as to why there are references to the imperial system of measurement, for example, ounces. I do not understand why we would measure anything in ounces. I am very concerned about the lack of detail on dosing and concentration. As a pharmacist, I would find it difficult to dispense something if I did not know what it contained.

I will add something before I drive everyone completely mad.

My understanding is that if this Bill goes to the Dáil and is voted through, any doctor would be able to prescribe cannabis for any patient, for any condition, anywhere in this country. That includes children and pregnant women, breast-feeding women and people on multiple medications. When we dispense we look at dosage, indications, side effects, contra-indications and interactions with other medicines, as well as people with reduced kidney and liver function, whether over time, because of age or because of other diseases. This is of great concern to me. When the HPRA authorises something, it rubber-stamps it as being okay. It is not okay to be ingesting cannabis, either by eating it, smoking it or taking it transdermally while also breast-feeding a neonate, as it is deposited in breast milk. The role of the HPRA is to protect public safety and help health care professionals to make decisions in the interests of the public.

The other issues include different registering and I do not see why the framework is any different. As a pharmacist, I have serious concerns about this Bill. I have other views on the decriminalisation and rescheduling of drugs but my main issue is with the use of the word "medicinal". I am concerned that we would weaken our regulatory framework in any way and expose the public to adverse effects.