Canadian Briefing - June 2018
DAC Beachcroft's Canadian Briefing - June 2018 is a selection of legal and regulatory developments that we consider are the most interesting and relevant to our Canadian friends and clients.
Published 7 August 2018
Following the recent high-profile case of Billy Caldwell, the British Home Secretary announced recently that medical cannabis is to be made available to UK patients on prescription.
Cannabis-derived medicines that meet certain safety and quality standards will be reclassified by fall 2018, so that they can be prescribed by specialist clinicians without the need for a Home Office licence. All fees for permits to use medicinal cannabis are to be waived in the interim. There will be no change in the law on the recreational use of cannabis in the UK, which will remain illegal.
The proposed changes to UK legislation in relation to medical cannabis will of course be of particular interest to medical cannabis companies based in Canada.
Before any medicinal cannabis medicines could be sold or prescribed in the UK they would, under the current statutory framework, need to receive the relevant market authorisation. In this context, the following steps are relevant.
A marketing authorisation may be obtained from either the UK Medicines and Healthcare products Regulatory Agency (MHRA) or the EU European Medicines Agency depending in part on where the producer wishes to market their medicine: the UK only or throughout the EU.
A Canadian cannabis-based drug manufacturer may need to bring their drug into the UK for clinical trials (see step 3 below). Early engagement with the Home Office in anticipation of any clinical trials may be prudent if a licence for importation is required.
A marketing authorisation will only be issued if clinical trials have proved that the medicine: a) successfully treats the condition it was developed for; b) has acceptable side effects; and c) meets high safety and quality standards.
If granted, initial marketing authorisations are valid for five years, and then may be renewed on the basis of a re-evaluation.
Notwithstanding the changes announced last week, the marketing authorisation process is demanding. Any overseas medicinal cannabis company wanting to take advantage of the recent change in policy would be wise to start ensuring now that it can prove the efficacy of its product.