Dr. Lorraine Nolan:

I will start with the questions put by Deputy O'Connell. She asked whether a medical consultant was required in the context of the access scheme we are proposing. One of the conditions we have set out is that the patient should be under the supervision of a specialist medical consultant. The conditions for treatment would include severe epilepsy, cancer and multiple sclerosis. All patients treated in those cases would be under the care of a specialist consultant. They would also be under the control of a general practitioner – I wish to make that point straight and upfront.

The reason we have outlined the need for specialist medical consultant oversight relates to the fact that one of the requirements of the access programme is to ensure that all the conventional forms for treatment have been tried. There is a view that specialist knowledge is required to ascertain whether that is the case. We are taking about cannabis being used in addition to an established treatment programme for a patient. Specialist medical oversight is important to monitor the effects of cannabis on the patient and how the effects might interact with the current medical regime of the patient. We really believe this approach will bring about the best outcome for patients and that is what we have recommended. In other words, the patient needs to be under the supervision of a medical consultant as well. We have not necessarily said that the consultant has to prescribe. It is a question of monitoring the effects of cannabis on the patient in view of the complexity of the issues that I have outlined.

Reference was made to medical prescriptions in other countries. There are several variations in the approaches taken in other countries. It is generally the case that the medical prescriber is required to be a specialist and have specific training. That is generally the case throughout the European system and also in the international context.

Reference was made to the access programme and whether cannabis would be authorised. We need to be clear that this is not an authorisation of cannabis as a medicine that we would conventionally view as being an authorisation of a medicine, because the data is simply not available and we have no submission to work on. Cannabis would not be authorised as a medicine in the sense that we would see a medicine as being authorised in this regard.

If I recall it correctly, another question related to off-label use of medicines. It is certainly possible for a doctor to prescribe a medicine off-label. That could include an authorised cannabis medicine for treatment of another condition.

Deputy O'Brien asked about our views on the legislation that would be required to implement the access programme and the role of the International Narcotics Control Board. I wish to be clear at the outset that the role of the International Narcotics Control Board is a supervisory and monitoring role. The fundamental purpose of the board is to ensure that for whatever purpose a country permits consumption of a controlled substance, including cannabis, all the elements of consumption, including the manufacturing process and consumption by patients, are appropriately monitored and that monitoring can prevent diversion. It is usually the case that we have to declare medical needs and consumption to the International Narcotics Control Board. The board then gives us what is known as a quota or estimate system to which we must adhere in terms of the consumption requirements of the controlled substance. We need to know the medical uses in terms of adhering to the system of monitoring provided and set out.

I was asked specifically for the view of the Health Products Regulatory Authority on legislation and I am willing to answer that point. Committee members are aware that the progression of legislation is under the remit of the Department of Health. I imagine officials from the Department will give their views to the committee as well. Our report has indicated that primary legislation may be required. Again, it is for the Department to determine whether primary legislation is required to implement these measures, whether secondary legislation is a more appropriate route or whether it can be managed under existing provisions.

That is our statement on the matter.

Deputy Kelleher asked about the position in Europe, in particular the position of the European Medicines Agency, EMA, on the use of medicinal cannabis. I need to be very clear that the EMA has had no position on medicinal use of cannabis and, simply put, in terms of the current data, the EMA would not be endorsing the medicinal use of cannabis in any way. The requirements are not there to authorise this as a conventional medicine, which is the business and role of the EMA, and the medicinal use of cannabis simply would not meet the requirements. Throughout Europe nine countries currently have an access programme that is similar to what we are proposing, which is that it would be available in exceptional circumstances for the treatment of patients who are under specialist medical control and that it would be an exceptional rather than a conventional and widespread use. Three countries have a wider access programme than we are proposing. These include The Netherlands, which has a well established programme, Italy and the Czech Republic. These countries have more widespread prescribing for a range of conditions. The methodologies these countries use to secure the cannabis-based products that they are using, which are pharmaceutically controlled materials, are also different. For example, The Netherlands would grow its own cannabis. A contract is issued by the State to a company to generate the stocks of the cannabis and procure them and then these stocks are supplied to pharmacies that dispense them for patient use. Sixteen countries have a prohibitive system that would be similar to the current system in Ireland.

I will hand over to my colleague, Dr. Elaine Breslin, who will speak about the conditions that were selected and the rationale and basis to the selections.