Dr. John Devlin:

The Chief Medical Officer. With regard to an application, it would mean the normal routine clinical information should be provided including, for example, an outline of treatment to date, the justification from the doctor as to why it is appropriate in the patient's circumstances to require a schedule one drug, the consultant supervision details, the details of the source of the cannabis-based product and how it will be administered and, more important, the arrangements for the ongoing monitoring and care of the patient once the treatment has commenced. Given the nature of their condition, these patients have underlying medical conditions and are possibly on other drugs and from a safety point of view and a drug interaction point of view, it is important that those interactions are measured and monitored.

I refer to what is intended going forward. We have the current licensing arrangement and we are talking about legislation. This week, we are establishing a medical cannabis reference group, which will provide answers to many of the operational questions that have been identified to date. The group will have an independent chairperson and it will take into account HPRA and other relevant evidence. Its membership will be broad-based with all the relevant medical specialties, including oncology, palliative care, neurology, psychiatry, anaesthesia, which includes pain management, general practice, pharmacy, the HPRA, patient representatives and ourselves. The focus of the group is to provide an operational framework as to how a scheme will work into the future. It needs to answer clear questions, for example, the clinical criteria for patient access for medicinal purposes, the forms of cannabis that can be used, the roles and responsibilities of doctors, nurses, pharmacists and other health care professionals who may be involved in the dispensing of cannabis for medical purposes, the requirements for a registry through which the scheme can be monitored and the mechanisms through which further scientific developments in the area can be monitored over time. This work has started and we anticipate that the first meeting of the group will take place in the coming weeks while we expect a report to be made available within four months. It will take that time to generate the answers to these fundamental operational issues that need to be addressed.