Dr. Lorraine Nolan:

We welcome the opportunity to come before the committee again to provide it with information on the medical cannabis access programme, MCAP, the HPRA's role in this and to answer any questions members may have about the programme. In setting the context for our discussion, it is important to be clear on the status of the products that may be considered under this access programme, what they are and, importantly, what they are not.

In doing so, it may be helpful to return to some key aspects of the HPRA's 2017 review. The review considered the scientific data available at the time in respect of medical use of cannabis, which was very limited and fell well short of the standard required for a medicine to receive market access. The review concluded that, from a policy perspective, should the Minister consider it in society's interest to establish a cannabis access programme, it should be in a limited set of circumstances for three specified medical conditions where it can be considered. The committee will be familiar with these.

A key recommendation for the programme was that would need to take into account that access should be provided only where patients with the specified conditions have a clear unmet clinical need, meaning they have failed to respond to treatment with all available authorised medicines. These limited recommendations were also based on the fact the safety and efficacy data available did not support a wider form of access.

The report also advised that cannabis-based products that may be available through such a programme should not be confused with authorised medicines and are not equivalent to them. Authorised medicines undergo comprehensive clinical and quality evaluation, including clinical trials, to assess their safety and efficacy. The data generated from these studies are reviewed by scientists and companies to determine whether there is a positive benefit-risk ratio, and if so, these data are submitted as part of an application for marketing authorisation.

The application is then reviewed by medicines regulators, such as the HPRA, to establish if they agree with the conclusion of the benefit-risk assessment. Where this is the case, the medicine is authorised.

Not meaning to detract from the focus on cannabis, something perhaps the pandemic has shown in a very real way is how this process for authorisation of medicines works in practice. It has also increased the public understanding, appreciation and value of this process.

As the committee members are aware, there are two cannabis-based products that are authorised as medicines. These are Sativex oromucosal spray for the treatment of spasticity in MS and Epidyolex oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex. Both products have met the standards and level of data required to receive a marketing authorisation. As such, these are quite distinct and do not fall under the scope of the medical cannabis access programme, MCAP.

Provision for the MCAP was made under regulations developed by the Department of Health in 2019. These set out how the programme operates in terms of prescribing, supply to patients and subsequent patient monitoring. They also define the criteria a cannabis-based product must meet in order to be considered for inclusion. The regulations, importantly, are supported by clinical guidance that was generated by an expert reference group convened by the Department of Health in 2017. This publicly available guidance underpins the introduction of the access programme. It also highlights a very important point around the decision to enrol a patient in the MCAP, which is that the relationship between the patient and the doctor is paramount in terms of clinical oversight. That clinical oversight allows for consideration of critical issues, such as disease progression, whether all conventional treatment options with authorised medicines have been exhausted and the doctor’s decision as to whether these products may then be a suitable option for their patient.

The role of the HPRA in the MCAP is quite distinct and different from the role that we have with respect to the authorisation of medicines. While we receive and review applications from companies seeking to supply cannabis-based products in Ireland via the programme, the extent and nature of this is very different in terms of review. It involves initially reviewing the product applications against the criteria set out in the regulations. The key requirement for accepting a product onto the programme is that it must be approved for supply in another EU member state and is being supplied in that state. This is a way of providing access for Irish patients to cannabis-based products that are available to other EU patients and that could previously only be obtained by travelling out of the State. It acknowledges the reviews performed by other member states and does not seek to create additional barriers where these reviews have already been conducted. Other requirements are that the tetrahydrocannabinol, THC, limits are not exceeded and that the packaging and labelling is sufficient in terms of detail to support safe and effective dosing and product use. It is also our role to ensure that the products are aligned with the published clinical guidance.

When our review is complete, we make a recommendation to the Minister where an application meets all of the above criteria. The final decision as to whether or not the product is included on the MCAP rests with the Minister. It is important to note, as per the criteria in the regulations and the overarching principle of the clinical guidance, that applications can only be made under the MCAP where an equivalent authorised cannabis-based medicine is not available.

Since the regulations came into force in June 2019, we have received 34 product applications. Of these, four cannabis-based oils have been placed in Schedule 1 of the regulations and two dried herb products have concluded the HPRA final review and are with the Minister for his final decision. Five are currently under active review. In addition, 11 have been withdrawn or paused by the applicant company itself. In the case of the remaining 12 applications, the company has not met either the legislative criteria or the clinical guidelines, and these have been placed on hold by the HPRA as a result. We are continuing to work with a cohort of these companies on these issues.

The HPRA provides significant support to prospective applicants through guidance on both the legal framework and the product criteria to be met in advance of submission of an application. In all cases, we have direct meetings with these companies to advise and support their applications. The provision of this support also continues throughout the application review process. The first cannabis-based products are expected to be available to Irish patients through the MCAP from mid-October 2021, as outlined by other colleagues. Once these are accessed by Irish patients, the HPRA will receive any reports of suspected adverse events and review them for any signals of concern regarding the safety of the products. The HPRA will also have a role in investigating any quality issues that may arise and co-ordinating any action that might be subsequently required. I am very happy to take any questions.