Mr. Shaun Flanagan:

I thank the Chairman and members for the invitation to meet the committee to discuss the medical cannabis access programme. I am joined by Professor Bryan Lynch, a consultant paediatric neurologist based in Temple Street Children's University Hospital, who will have a clinical perspective on the issues to be discussed. Members will be aware the primary care reimbursement service, PCRS, is responsible for ensuring that eligibility is in place for qualifying persons for most of the primary care schemes and other arrangements within the health service, while PCRS is also generally responsible for making payments of the order of €3.269 billion to primary care healthcare practitioners and HSE acute hospitals.

As Mr. O'Connor stated, under the HSE national service plan in 2021, PCRS was given responsibility, on behalf of the HSE, to manage the medicinal cannabis access programme, subject to the availability of suitable products, and, as part of that, to establish arrangements to approve their use in relevant cases and record relevant information on the register, as provided for in the legislation. PCRS also has the responsibility to consider, pursuant to the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013, applications for pricing and requests for reimbursement of MCAP products for individual patients. Currently, three specific therapeutic indications are set out in a Schedule to the misuse of drugs regulations 2019. I will not go through them because the committee will be aware of them.

On the operation of the register, a practitioner, who has to be a medical consultant, can issue a prescription for an MCAP product only where an individual's name has been entered into the register and what is called a cannabis for medical use register, CMUR, number will have been provided by the HSE in respect of that individual. Medical consultants are required, therefore, to provide the HSE with the following information before they issue a first prescription: the name, address, date of birth and specified therapeutic indication for the person being treated, that is, which of the three currently approved uses under the MCAP the person will be treated for; the name, registration number and medical specialty of the notifying consultant; and such additional information as the HSE may require.

A person supplying a specified control drug, such as pharmacist or a pharmacy, is required to provide his or her name and address to the HSE; the name and address of the person who supplied him or her; and the following details from the prescription: the date on which supply was made; the name, quantity and, where appropriate, the dosage form and strength of the product; the dose supplied; the name and registration number of the consultant prescriber; the CMUR number, name and address of the person who received the prescription; and the date of the prescription. Finally, within the legislation, there is a requirement to provide any further information required by the HSE. The HSE is then required to record all this information on the MCAP register and assign CMUR numbers as required. The HSE is required to preserve all the information on the register for at least five years from receipt.

Turning to supply, Schedule 1 to the misuse of drugs (prescription and control of supply for medical use regulations) 2019, as amended, sets out the products that can, subject to availability, be supplied under the MCAP. As Mr. O'Connor stated, four products are currently listed in Schedule 1. The HSE does not decide which products are included in Schedule 1; it is a ministerial function. At this point, the suppliers of two products, namely, Cannepil and Tilray oral solution, have submitted final pricing positions to the HSE and the HSE confirmed acceptance of those prices in writing to the suppliers in June 2021. The HSE expects that one product, Cannepil, will become available during October 2021. The suppliers of the second product, Tilray oral solution, have indicated their intention to supply the Irish market but, to date, have not confirmed when the product will be available. The HSE understands that the supplier of the other two products does not currently have plans to supply the Irish market.

In making general decisions on reimbursement, the HSE is required, under the Health (Pricing and Supply of Medical Goods) Act 2013, to consider nine criteria set out in the legislation. It is required to consider the health needs of the public; cost effectiveness; the availability and supply of items for supply and reimbursement; the proposed costs, benefits and risks of an item, relative to therapeutically similar items, and the level of certainty in respect of those costs, benefits and risks; the budget impact; the clinical need for the item; the appropriate level of clinical supervision required to ensure patient safety; the efficacy, which means the product's performance in clinical trials, and effectiveness, which means performance in real circumstances and added therapeutic benefit against existing standards of treatment; and the resources available to the HSE.

The Department has previously advised the HSE that it considers that section 23 of the health Act 2013 appeared to be the most suitable legislative option for reimbursement on a managed access basis of community supply of the MCAP products. That section allows the HSE discretion, subject to such conditions it considers appropriate, to make arrangements to supply an item to a patient notwithstanding that the item is not normally reimbursed, provided that the HSE is satisfied the patient requires the item for clinical reasons and that no reimbursed item is a suitable alternative for the patient. The intent of the HSE, therefore, is to utilise section 23 to enable the reimbursement of MCAP products where appropriate.

In practical terms, the HSE has designed an application form for prescribers to register a person to be treated. This form will include all the information required to register an individual on the MCAP. The HSE will then assign a CMUR number and provide the applicant prescriber with a specific, pro formaprescription form for the MCAP that will contain all the information legally required, including the relevant CMUR number for the operation of the MCAP.

We welcome any questions the committee may have.