Dr. Lorraine Nolan:

I am chief executive of the Health Products Regulatory Authority, HPRA, and I am joined by my colleague, Dr. Elaine Breslin, our clinical assessment manager. We are pleased to provide a brief background on medicinal cannabis. The HPRA is the competent authority for the authorisation of health products in Ireland, which includes medicinal products. It is our role to ensure that where products can demonstrate they are safe, effective and of an appropriate quality based on clinical and scientific data, they can be authorised and supplied as medicines in Ireland. Medicinal use of cannabis is a broad term where part of the dried cannabis plant material, or products which have been manufactured from chemicals, known as cannabinoids, extracted from the cannabis plant, are used in medical treatment.

Cannabis under Irish law is considered to be a drug of abuse and is controlled under the Misuse of Drugs Acts 1977 to 2016. Under this legislation, cannabis and products that contain the psychoactive chemical, tetrahydrocannabinol, commonly known as THC, or its related derivatives, are subject to strict controls. Cannabis is prohibited other than in specified circumstances where all activities relating to cultivation, manufacture and supply of cannabis, and products containing THC, are subject to licence. Under this legislation cannabis and products containing THC are not viewed as products having medicinal use. However, a doctor could prescribe in limited circumstances, if granted a licence to do so by the Minister for Health. While it is generally perceived that our current legislative framework prohibits medicinal use of cannabis, this is not fully correct.

It is important to clarify that the cannabis plant also contains a range of cannabinoids some of which are psychoactive, which means they affect the mind, and some not. Examples of cannabinoids that are not psychoactive include cannabidiol, commonly known as CBD. Products containing non-psychoactive chemicals, such as CBD. are distinct in that these do not fall under the Misuse of Drugs legislation and its restrictions. In considering medicinal use of cannabis and the debate on the need for new legislation, we must be clear that this does not extend to CBD, which can be prescribed by doctors, without special licence.

However, regardless of the control status, if cannabis or its products make medicinal claims, they would be considered to be a medicine. In general, medicines are required to have a marketing authorisation enabling supply on the Irish market. The existence of an authorisation provides reassurance that a rigorous scientific assessment of the medicine’s quality, safety and effectiveness has been carried out by an authority such as ours. Based on this, the benefit-risk profile for the authorised medicine is both known and considered positive.

Ireland has authorised one medicinal cannabis clinical trial under a ministerial licence, which the company sponsoring the trial did not progress. We have also authorised a cannabis-based medicine which is known as Sativex. This contains the psychoactive chemical, THC, and also CBD. It is indicated for the treatment of multiple sclerosis. The product met the required safety, effectiveness and quality standards for authorisation as a medicine, and demonstrated clear patient benefit. The misuse of drugs legislation was amended in 2014 to allow for its prescribing, dispensing and supply. With regard to medicinal cannabis, the authorisation of Sativex and the earlier approval of an application to conduct a clinical trial, demonstrate that there are provisions within the existing misuse of drugs legislation that can enable patient access. In addition, the legislation can also be adapted to enable wider access, as in the case of Sativex, where this is justified based on scientific and clinical evidence.

With regard to current research we are aware that a number of clinical trials evaluating cannabis and cannabis products are being conducted within Europe and internationally. These relate to treatment of a range of conditions including chronic pain, psychiatric disorders and neurological disorders including epilepsy. Currently, some 30 such trials are ongoing within Europe. The majority of these trials involve adults. Some involve children and are investigating the use of products containing only non-psychoactive CBD for the treatment of epilepsy, including severe forms of this condition, which have failed other treatments. A product known as Epidiolex is the most widely used medicine in such trials. While the results appear promising, they have not yet been peer reviewed or independently evaluated by a regulatory authority.

While many countries have the same approach as Ireland, a number of countries have introduced changes to their misuse of drugs legislation to remove prohibitions which can, in certain circumstances, permit medicinal use of cannabis. Examples of where such changes have been introduced in Europe include the Netherlands, Croatia, Malta and the Czech Republic. Denmark and Germany have recently announced their intention to progress similar changes. Beyond Europe, Australia, Canada and a number of US states have introduced schemes for medicinal access. Internationally, the schemes in place are focused primarily on controlling the quality and supply, principally of dried cannabis for medicinal use, as prescribed by a doctor. Other than synthetic cannabinoids and Sativex, countries have not authorised medicinal cannabis as a medicine due to the limitations of currently available clinical data on safety and effectiveness.

In recognition of a growing demand for access to cannabis for medicinal purposes, it is, at this time, appropriate to consider whether patients' best interests could be served through enabling access to medicinal cannabis in Ireland. If on balance, it is considered that a less restrictive approach is appropriate for Ireland, in the absence of clinical data to allow the authorisation of cannabis, and related products, as medicines, there are a number of elements that such a framework may potentially cover. Based on international models and experience, these might include securing the quality of the cannabis plant which is cultivated, and can vary in terms of its chemical constituents and growing conditions. The framework would also have to consider patient safety and how that is achieved through appropriate medical oversight, while recognising that the requirement for access has been driven by patient demand. As such, patients and carers must recognise the limitations of the framework in assuring the safety, quality and effectiveness, as compared with what would be expected from an authorised treatment.

The HPRA has been requested by the Minister for Health to provide an expert opinion on medicinal cannabis and required policy and legislative changes. This is a complex issue which needs to be appropriately dealt with in order that all the needs of patients in Ireland who may benefit from medicinal use of cannabis can be considered. This also needs to take account of concerns that have been expressed on the potential harm from exposure to cannabis. We are currently in the process of convening a working group of experts to assist us with this issue. The conclusion of our work will be an advice to the Minister on the use of medicinal cannabis and if warranted, possible frameworks, based on international experience, to address collective patient needs. If the Minister, following receipt of our advice, takes a policy decision to implement a new legal framework for medicinal cannabis, it will require time to develop, may require primary legislation and needs to be done in a manner that is effective and best meets both patient and societal needs. It would also require control of the supply systems for cannabis which have their own complexities. However, as I have explained, there is provision within the existing legislation for prescribing in limited circumstances. The HPRA would be happy to further explore, in conjunction with the Department of Health, how this could potentially be used to provide access to medicinal cannabis in the short term and in response to specific needs. We would be happy to keep the committee updated on our progress. I thank the Chairman, and we will be happy to address any questions.