Oireachtas Joint and Select Committees
Tuesday, 7 March 2017
Joint Oireachtas Committee on Health
Cannabis for Medical Use: Discussion
12:00 pm
Dr. Lorraine Nolan:
This possibly overlaps with Deputy O'Connell's question on what products are under discussion. From our review, we know that a number of products could be supplied using this route. Some are effectively cannabis flowering tip itself, where the cannabis plant is grown in carefully controlled conditions that comply with the European good manufacturing practice, GMP, requirements. While a product would not necessarily meet the full standard requirement for authorisation of a medicine, we have a reassurance of the quality of the product. This relates to the content of the cannabinoids in it, namely, the CBD and THC content. Knowing the products' content will provide a basis for working out a dosing regime. This might answer the Deputies' questions.
There is also the potential for a number of processed oils that are extracted from the plant and contain cannabinoids to be sourced. Some of the companies that manufacture these products are interested in considering these and putting them through clinical trial programmes so that they may become authorised as medicines.
Regarding Deputy Boyd Barrett's question on opinions on this matter, we are a medicines regulatory authority. Our job is to ensure that the medicines that are available in our market are safe, appropriate and work for patients. Our fundamental reason for being is the protection of public health. It is difficult to have any discussion on cannabis for medicinal use without the question of it being a medicine on the table. This is about the best outcome for a patient. The medicines system and framework exist in Europe in order to protect public health. For example, Deputy O'Connell mentioned the thalidomide disaster. Everything we do is founded on that principle. Were I, as chief executive of our authority, asked to put any other substance on the market for access to a wide group of patients when I could not say whether it worked or was fully safe, committee members would ask me why I did that and why I was negligent.
Other countries that have examined this topic outside of a medicines programme ended up with two parallel systems and ran into difficulties. That has been the experience in Australia and Canada, where policy has seen an access programme set up but clinicians do not know whether the substance works and clinical societies have advised that, from a clinical perspective, it is not safe and they do not know whether it treats anything. That is confusing for patients and is not helpful to the argument.
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