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Cabinet Secretary for Health and Social Care submission of 28 January 2022

PE1884/C - Make whole plant cannabis oil available on the NHS or alternative funding put in place

Thank you for your letter of 23 September 2021 relating to the above petition about access to Cannabis Based Products for Medicinal Use (CBPMs) on the NHS. I apologise for the length of time it has taken to respond.

In your letter, you seek information about the progress of clinical trials connected to CBPMs. The National Institute for Health Research (NIHR) and NHS England are developing a programme of two randomised controlled trials into early-onset epilepsy, and these trials will be open to patients in Scotland. The trials will compare medicines that contain cannabidiol (CBD) only and that contain CBD plus delta-9-tetrahydrocannabinol (THC) with placebos. Commercial discussions about the supply of products to the trial are underway, and it is only after they concluded that it will be possible to confirm details of the trials, including when recruitment will commence and other timetable details.

The trials will examine the quality, safety and efficacy of the use of CBPMs in epilepsy, and crucially will help answer the question of whether adding THC to CBD improves anti-epileptic properties. Building this evidence will enable the manufacturers of these products to apply for marketing authorisation (also known as a license) for their products from the Medicines and Healthcare products Regulatory Agency (MHRA), depending on the outcome of the trials, and products could potentially be made more widely available.

My officials have engaged with NHS England and NHIR about trial delivery matters, including contacts with Scottish clinicians and discussions about Scottish patient recruitment.

Your letter also seeks information about the progress of discussions with the UK Government on this matter. I have written to the Secretary of State for Health and Social Care, Sajid Javid MP, to discuss the need to build the evidence base connected to CBPMs and the ways in which Governments might cooperate on this matter. In response to my letter, the Secretary of State invited me to meet with the Minister for Patient Safety and Primary Care, Maria Caulfield MP, in early February. We will discuss this matter and in particular will consider together ways in which the clinical trials can be expedited in order to benefit as many patients as possible.

I acknowledge this is not an immediate solution to patients seeking to access these products on the NHS. However, it is I think the lack of evidence on the quality, safety and efficacy of CBPMs that remains the main barrier to these products being prescribed by NHS clinicians. Therefore, the Government continues to support the development of clinical trials to enable clinicians to have the assurances they need to consider prescribing these products on the NHS.