THE UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last week released new detailed guidelines for medical cannabis companies operating in the UK. This new guidance from the MHRA and the Home Office sought, for the first time, to provide a step-by-step plan for companies ‘that do not already hold the necessary authorisations’ to begin producing cannabis-based medicinal products and APIs in the UK. Some have called this release ‘the most significant development since 2018’, suggesting it points to a step change in the Government’s attitudes towards the industry. Others have argued that the fact it is considered significant shows just how little progress the UK’s industry has made over the past four years. Regardless of its overall impact, the release suggests the Government intends to pursue a ‘truly pharmaceutical path’, and may look to relinquish its reliance on expensive ‘specials’ imports in favour of domestic production. Key Points The main purpose of the newly published guidelines is to provide a clear framework for companies, to overcome a ‘chicken and egg’ conundrum when undergoing the licensing process. Specifically, it addresses the needs of ‘an increasing number of companies’ entering the industry with a lack of previous pharmaceutical experience and licences. In order for the MHRA to grant a company authorisation, the latter must be able to demonstrate its ability to consistently and correctly manufacture its product. However, in order to be licensed to handle controlled substances, which are needed to manufacture said products ‘consistently and correctly’, companies need a licence from the Home Office. But the Home Office will not issue a licence without assurances that the company can meet the requirements of the MHRA licence, leading to companies being bounced back and forth between the two authorities. UK cannabis pharmaceutical group Celadon’s CEO James Short, one of the first to navigate this conundrum, told BusinessCann: “The ‘catch 22’ that this latest clarification solves is something we went through ourselves – we famously described it as a ‘chicken and egg’ situation in an email exchange with the MHRA back in 2019–20; it’s a metaphor that seems to have caught on. “Both the Home Office and the MHRA helped us navigate the problem and now we have a formal clarification that will help others.” Last week, the MHRA issued an illuminating update providing clarification on the UK medical cannabis licensing process. Here are my observations on what this means for the sector...MHRA Update: https://t.co/80uhUkyLgx#medicalcannabis #mhra #cannabis #licensing #UK — Rob Jappie (@RobJappie) November 25, 2022 Aside from providing a clear route past this problem, the release made a number of other important clarifications. Firstly, companies must have their facilities fully built and ready for inspection, including having all ‘necessary systems, equipment and procedures in place’ before applying for their licence. According to Mr Short, this ‘framework creates significant barriers to entry for cultivation and Active Pharmaceutical Ingredient (API) manufacturing in the sector, requiring a huge amount of capital, pharmaceutical talent and time to go through the process’. However, he argued that this was ‘absolutely what needs to happen’ in order to put the industry on a path that the ‘Government is most likely to get behind’. The MHRA also makes numerous references to increased visibility and scrutiny throughout the supply chain, making it clear they ‘need to know what is happening where’. In an analysis published by life sciences regulation expert Robert Jappie, he said this suggested ‘supply chain visibility is now the MHRA’s priority’, and ‘scrutiny will be applied to the entirety of the supply chain, and not just your part in it’. He suggested that this could signal the end to ‘GACP to GMP washing’ here in the UK, which could potentially significantly impact a number of licensed producers currently importing to the UK. ‘Truly Pharmaceutical’ Path and Domestic Supply For Patients UK medical cannabis cultivator Ananda’s CEO Melissa Sturges told BusinessCann that her key takeaway from the release was the Government’s clear intention to pursue the pharmaceutical path:“If I read anything from this guidance, it's that this is not an industry about growing medical cannabis, it’s an industry about creating a pharmaceutical product.” Instead of encouraging new companies into the industry by clearly simplifying the process, she said this focus on a pharmaceutical framework may ‘actually put a few people off’, leaving only companies that are ‘really determined and really serious’, for which she said there was ‘plenty of room in the UK’. https://twitter.com/MHRAgovuk/status/1594962048852574208 Mr Short mirrored this, stating this signalled ‘a clear intention by the UK to pursue a truly pharmaceutical path and avoid some of the mistakes other countries have made in cultivation and production’. He added that, over time, regulation such as this will ‘give UK companies the confidence to invest’, enabling the UK to build a ‘domestic industry that doesn’t rely on imported product’. “Currently under the ‘specials’ framework, patients who rely on such medicines have them imported from abroad on a named-patient basis – this is hugely expensive, and can lead to unacceptable health-impacting delays to patients with debilitating conditions such as epilepsy… By establishing UK domestic production, UK companies can resolve all of these problems.” Aside from signalling the Government’s intentions for the industry, Ms Sturgess argues that it shows the Government is directly acknowledging the industry for the first time. “Many people in the industry have felt that there was no support, no understanding for a UK medical cannabis industry, and that the regulatory authorities were actively against the industry. I think this shows that that's not the case. “The blog actually talks about the industry, not just about medical cannabis for research. I think that's really significant. The fact that the two organisations have clearly sat down and created a plan together that they felt could be communicated to all of us, I think, is also really significant.”
