Home > Cannabis for medical use- a scientific review.

Health Products Regulatory Authority. (2017) Cannabis for medical use- a scientific review. Dublin: Department of Health.

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The Health Products Regulatory Authority (HPRA) convened an expert working group to assist with its review of the potential medical use of cannabis, as requested by the Minister for Health. The key findings of the working group are:

1. To date there is an absence of scientific data demonstrating the effectiveness (efficacy) of cannabis products. The safety of cannabis as a medical treatment is not well characterised. In particular, there is insufficient information on its safety during long-term use for the treatment of chronic medical conditions, such as those for which there is a public interest. For these reasons, and because most cannabis products available under international access schemes do not meet pharmaceutical quality requirements, they are not capable of being authorised as medicinal products (medicines). There appears to be a significant gap between the public perception of effectiveness and safety, and the regulatory requirement for scientific data which is mandatory to determine the role of cannabis as a medicine. Any proposal to circumvent the medicines regulatory system, established by law, would require careful consideration, so as to avoid unintended consequences, and lower standards of patient protection.

2. The best outcome for patients is the development of authorised (or capable of being authorised) cannabis-based medicines where the safety, efficacy and quality can be assured, and understood by the patient and healthcare professionals.

3. A distinction can be drawn between cannabis products containing tetrahydrocannabinol (THC) and those, such as certain cannabidiol (CBD) oils, which contain no THC. The latter are not subject to the Misuse of Drugs legislation, and do not contain the psychotogenic (capable of causing symptoms associated with psychosis, including delusions, delirium and hallucinations) element of cannabis. As such, products containing only CBD are not considered ‘controlled drugs’, and can be provided under existing legislation. While the research is still limited, there are reports that a CBD oil is capable of being authorised as a medicinal product and an application for the first authorisation is expected in the USA and Europe in 2017.

4. The decision to permit access to cannabis for medical use is a societal and policy decision due to the paucity of scientific research, the recreational use of the product and the strong public and patient demand. If cannabis products that are not capable of being authorised as medicines, are made available through an access programme, patients and healthcare professionals must recognise the limitations of the programme in assuring the safety, quality and effectiveness, as compared with what would be expected for an authorised medicine.

5. If the policy decision is to make cannabis available for medical purposes, the HPRA advises that it should recognise patient need, but be evidence based. Therefore, it is advised, that treatment with cannabis is only permitted under a controlled access programme for the treatment of patients with;

a. Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;

b. Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;

c. Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.

Date:February 2017
Pages:84 p.
Publisher:Department of Health
Corporate Creators:Health Products Regulatory Authority
Place of Publication:Dublin
EndNote:View
Related URLs:
Subjects:B Substances > Cannabis product (synthetic cannabinoids)
E Concepts in biomedical areas > Substance by legal status
E Concepts in biomedical areas > Substance by legal status > Prescription drug (medicine / medication)
L Social psychology and related concepts > Legal availability or accessibility
VA Geographic area > Europe > Ireland

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