Ms Maria Egan:

I will put the reason for the cannabis access programme into a bit of context. The evidence for the effectiveness of cannabis, which is being discussed in the public domain at the moment, in treating a number of conditions, including curing some serious medical conditions, is anecdotal and such an approach ignores the fact that the scientific data supporting them do not exist. As a result of these concerns it is very important that the access programme draws on the expertise of medical specialists who are responsible for the management of the qualifying patient groups.

The HPRA's report concluded that robust scientific evidence on safety and effectiveness does not support the use of cannabis for clinical indications other than in very limited cases. Its review concluded that the cannabis access programme that is being established could include access to cannabis-based therapies for the treatment of patients with spasticity associated with MS, resistant to all standard therapies and interventions; intractable nausea and vomiting associated with chemotherapy despite the use of standard anti-emetic regimes; and severe refractory treatment-resistant epilepsy that has failed to respond to standard anti-convulsant medications. Under the access programme, patients with a diagnosis of any of these medical conditions will be under the care of a specialist consultant. We would all agree that the use of cannabis products in patients, especially children, with these very serious medical conditions should only be permitted under the direction and supervision of a specialist doctor. This is particularly important given that very few cannabis products are authorised as medicines.

As my colleague has already said, they have not gone through the normal regulatory approval process for medicines which are, of course, designed to protect patients and ensure treatments are supported by good evidence of their effectiveness and safety. Through our work in setting up the cannabis access programme, we are engaging with clinicians, patients and pharmacists who will be central to the work of drawing up guidelines on the safe use of cannabis for those patients who will be prescribed these treatments through the access programme. A reference group has been established and is being independently chaired by Dr. Máirín Ryan, the director of health technology assessment at HIQA. She is also an assistant professor in pharmacoeconomics at Trinity College Dublin.

The aim of the group is to produce operational, clinical and practice guidelines for the access programme for medicinal cannabis in Ireland and to answer many of the operational questions that have been identified to date. This process is being informed by the HPRA report. The membership of that group draws on a broad range of representation from areas including oncology, palliative care, anaesthesiology and general practice. There are two patient representatives on the group. It includes adult and paediatric neurology, multiple sclerosis, psychiatry, pharmacy practice, the pharmacy regulator, health care ethics, a health technology assessor and the health products regulator and ourselves. The reference group began its work on 30 March and it is making progress on the drafting of the guidelines.

As well as having regard to the HPRA report, the group will also be guided by other international scientific evidence in developing these operational guidelines and implementing the programme. The focus of the work is to provide an operational framework as to how the scheme will work into the future. It needs to address clear questions such as the clinical criteria for patients accessing cannabis for medicinal purposes. It will include areas such as the use of any of these particular products in specific patient populations such as expectant mothers or whether there would be contra-indications for specific patient populations.

The cannabis access programme will be established but ultimately the decision on the appropriate course of treatment for any patient will be a matter for the clinician treating that patient and the Minister for Health would not have a role at that stage. Somebody asked how long it will take to finalise the guidelines. In announcing this programme, the Minister has requested that the group complete its work by the end of June this year so the access programme can be up and running as soon as possible. This work is well under way but it will take time to generate the answers to these fundamental and very important operational issues that need to be addressed. There is also the question of legislation that will be required to underpin the programme.

Deputy O'Connell asked about other conditions that were not included in the HPRA report. Whereas the HPRA report did not conclude that certain other indications should be facilitated through the cannabis access programme, this does not mean patients cannot access such treatments if the consultant deems it appropriate. My colleague has already explained that the licence application process remains open to a consultant to apply for a named patient if assurance can be provided that the treatment will be monitored and overseen for that patient.