MHRA clarification is a step in the right direction
By James Smith, Sunil Arora, Kirsty Morrison and Elisabetta Faenza.
In recent years, it has been increasingly challenging for businesses to know what exact process they should follow to be allowed to develop a cannabis medicine.
However, the MHRA has recently published an article, which clarifies the current process, entitled: ‘Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use’.
Firstly, before getting into the detail, it was positive to see the MHRA seeking to be proactive and providing the industry an overarching process and flowchart to follow.
We reviewed the MHRA article carefully within the Cannabis Industry Council (CIC) to seek a consensus view among members. We believe that the outlined MHRA regulations are both reasonable and appropriate. We support their reminder to the industry of policy and process, and moreover that patient healthcare requires this level of stringent regulatory oversight.
Barrier to entry
However, we understand there has been an extreme volume of applications for cultivation licences made to the Home Office (1500+). Many of these applications are understood to be for home-based production, with most not professionally prepared, resulting in a backlog building. As an organisation, the CIC supports rigorous, scientific, pre-planned, well-designed applications for cultivation that fully take into account all matters of compliance, science, security and safety.
To manage and reduce this backlog, ideally there would be an increase in support staff at the Home Office to process the applications. Instead, it appears that it has been determined that no applications will be accepted where facilities are not yet fully operational – including all production, quality and compliance components. Unfortunately for businesses this results in vast upfront costs, risks for investors, and ultimately could require a prohibitive level of investment, planning and preparation.
We express concern that these cultivation requirements in relation to operational facilities are likely to make it more difficult for small/new businesses to obtain licences. As an organisation, we believe there needs to be a lower ‘barrier to entry’. This particular regulatory hurdle will negatively affect investment in CBPMs, and in-turn options available to patients in need.
With regards to what is colloquially known as ‘green-washing’ or ‘GMP washing’, regulations surrounding this are known to have been pre-existing. As an organisation, we have no oversight on the level of enforcement to date.
We note that it appears the MHRA is now going to take these issues more seriously, and will pay greater attention to each link in the supply chain, in order to ensure all processes are compliant.
It is clear that the MHRA are mandating that all drying and microbial management only be performed in GMP-approved facilities. However, many in the industry have suggested that this is not occurring, and that CBPMs not following this process may currently be on shelves. We will be seeking to engage with the MHRA to seek further clarification on the enforcement of these regulations, and how any enforcement could affect existing producers.
More generally, we support the enforcement of policy as it is prescribed, in order to create a stable business environment, and a fair and level playing field for all parties involved. Additionally, this will ensure the medication received by patients is clean, stable, and always has an accurate certificate of analysis.
Finally, the CIC believes that establishing a common set of calibrations for testing CBPMs would be a logical next regulatory step that would enforce standardisation across the industry. Doing so would also further assure clinicians and patients that what is written on any packaging/label is in fact reliable. Cannabinoid and terpene levels can be manipulated by unscrupulous businesses via calibration of testing equipment, and we support proactive and proportionate steps to prevent such occurrences.
This clarification from the MHRA is a step in the right direction, as it provides more transparent and clear route for businesses involved with manufacturing CBPMs. The CIC will seek to engage further with the MHRA and Home Office in order to ensure medication classification can be depended upon by the industry, clinicians and patients alike.
CIC Prescription Cannabis Working Group
- James Smith, Sunil Arora – Chairs
- Kirsty Morrison – Vice Chair
CIC Standards Working Group
- Elisabetta Faenza – Chair