Mr. Niall Byrne:

I thank the committee for inviting the Pharmaceutical Society of Ireland here today to assist in the ongoing scrutiny of the Cannabis for Medicinal Use Regulation Bill 2016. I am the registrar and chief officer of the Pharmaceutical Society of Ireland, PSI. I am joined today by Dr. Cora Nestor, head of pharmacy practice development with the PSI.

I will begin by explaining the role of the PSI as the pharmacy regulator. I will then make some general points on the Minister’s recently announced scheme to provide access to cannabis for medical reasons, followed by some specific points on proposed provisions in the Bill. I will keep my remarks relatively brief and we will, of course, be happy to take questions from the committee.

The Pharmaceutical Society of Ireland is the statutory regulator of pharmacists and pharmacies in Ireland and is established as a public body under the provisions of the Pharmacy Act 2007. The PSI’s core mission is to work to protect and promote the health, safety and well-being of patients and the public. The PSI has a range of functions, established under legislation, which together create a regulatory framework intended to ensure the safety of patients and the public as users of pharmacy services. Our functions include maintaining the registers of pharmacists, pharmaceutical assistants and pharmacies or retail pharmacy businesses, which is the terminology used in the Act. We also set the requirements for pharmacists’ education, their continuing professional development and for their standards of professional conduct.

As part of our regulatory remit, we inspect retail pharmacy businesses to assess compliance with pharmacy, medicines, including veterinary medicines, and controlled drugs legislation. We have powers to initiate investigations where we have reason to believe there may be serious non-compliance. These inspections and investigations may involve co-operation with other relevant public bodies and may also lead to prosecution of persons and businesses who have committed offences under relevant provisions. In the case of individual pharmacists about whom there is a serious concern, or a complaint made as to their fitness to practice, the PSI can initiate statutory conduct proceedings which, after due process, can lead to sanctions being imposed on individual pharmacists and-or restrictions being placed on their practice. The PSI is, by law, independent in the exercise of its statutory functions. For public accountability purposes, the PSI operates under the aegis of the Department of Health. The PSI is governed by a 21 member council appointed by the Minister for Health.

As the committee is aware, on 10 February the Minister published the report, Cannabis for Medical Use – A Scientific Review, which had been produced at his request by the Health Products Regulatory Authority, HPRA. I know that the committee has previously heard from the HPRA in respect of the report and its specific recommendations. As the pharmacy regulator, the PSI does not have any direct role in the scientific review and approvals process for medicines. However, given the role of the PSI as the regulator of the profession responsible for medicines supply, it is relevant to state that the PSI agrees with the HPRA statement to this committee on 7 March that, "The best outcome for patients is the development of authorised ... cannabis-based medicines where the safety, effectiveness and quality can be assured, and understood by the patient and health care professionals."

In circumstances where cannabis products may be made available to meet specific patient need outside of the normal medicines authorisation process, the PSI agrees with the careful and prudent recommendation of the HPRA report, and the subsequent decision of the Minister, that a controlled access programme be established. The PSI also agrees that the operation of the programme should involve careful monitoring, including the registration of patients, doctors and pharmacists who are participating in the programme.

On the use of cannabis for medical reasons, the PSI also notes the advice provided to the Minister for Health by the Chief Medical Officer, as published by the Department of Health on 6 March 2017. In that advice, the CMO refers to the central role played by doctors and pharmacists in ensuring the safe and effective use of any drug that is prescribed. He goes on to say:

In establishing an access programme for medical cannabis, it is therefore critical that the views of these professionals, through their professional bodies, are considered. Efforts are underway to ensure that the planned access programme reflects those views and that the roles and responsibilities of doctors and pharmacists in prescribing and dispensing cannabis for medical purposes are clarified prior to its establishment.

The Pharmaceutical Society of Ireland, PSI, as the pharmacy regulator, welcomes and support this engagement process and we are actively involved in the deliberations of the expert reference group which has been established. The objectives of PSI’s involvement are primarily focused on ensuring that the access scheme works for patients who are accessing cannabis for medical use under the scheme and that those patients can have their prescriptions dispensed by pharmacists in a timely, effective and safe way.

There are two specific points that PSI wishes to make on the Bill. The role of the PSI is primarily to implement pharmacy and medicines law as enacted. Hence I will leave it to my colleagues from the Department of Health to address in detail the provisions in Deputy Gino Kenny’s Bill and what amendments the Department believes may be required, which Mr. Eugene Lennon addressed earlier. I will make two points which are intended to be helpful to the committee in its consideration of the Bill.

As I mentioned earlier, the PSI operates the regulatory framework for pharmacists and pharmacies as prescribed in the Pharmacy Act 2007 and regulations made thereunder. The PSI has been operating these provisions for ten years and our experience is that the regulatory framework is robust and works to protect the public. The PSI believes that the current system of regulation is capable, subject to the views of the expert reference group, of regulating the supply of cannabis for medical use under the controlled access programme. In so far as the Bill proposes that a parallel retail licensing scheme, including additional statutory inspections, would apply to registered retail pharmacy businesses, the PSI would regard this as an unnecessary duplication of existing provisions which are already well-proven in practice.

A central concern for the PSI is to ensure the public can rely on the professionalism of pharmacists and the quality of regulated pharmacy businesses when seeking to have medicines dispensed on foot of prescriptions from authorised prescribers. In so far as the Bill proposes a system of medical certificates as being the basis on which supply would be made by a retail pharmacy business, the PSI is strongly of the view that moving away from the current requirements whereby medicine and controlled drugs can only be supplied on foot of an original and valid prescription, signed and dated by the prescriber, would represent a weakening of the overall regulatory control framework and an unnecessary deviation from well-established practice.

I assure the committee that the PSI, as the statutory and independent pharmacy regulator, takes its responsibilities towards public safety seriously and is committed to ensuring pharmacists and pharmacies can be trusted by patients and the public to provide safe and reliable pharmacy services. The PSI is also committed to the well-being of the public and, in this regard, is playing an appropriate and assistive role in the design and implementation of the Minister’s access programme for cannabis for medical use. Once the access scheme is established, the PSI will ensure pharmacies and pharmacists comply with the provisions of the programme and we will also ensure pharmacists are fully aware of their duties and responsibilities to patients under the terms of the programme. The PSI believes that the access programme can operate effectively within the current regulatory framework under the Pharmacy Act 2007 and related medicines and controlled drugs legislation.

I hope my opening statement has been helpful. I thank the committee for its invitation here today and both I and Dr. Cora Nestor are happy to assist further by taking any questions which members of the committee may have.