15th July 2021
By Roland Sebestyén
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Billy Caldwell, the boy from Northern Ireland who helped to change the UK law prohibiting the medical use of cannabis, along with his mother Charlotte Caldwell has secured an agreement with the Department of Health and the National Institute for Health Research (NIHR) to carry out real-world studies, through ‘I am Billy’ non-profit clinics, to collect evidence to support medical cannabis expansion in the UK.

The deal represents a potential solution to unlock the deadlock in the provision of medical cannabis on the NHS.

Following the rescheduling of cannabis in the UK, Billy went on to secure the first life-long medical cannabis prescription through the NHS. The law changed in November 2018 to allow for the medical use of cannabis, however, access to these medications remains extremely limited – particularly through the National Health Service (NHS).

Charlotte Caldwell, Billy’s mother, said: “The solution we discussed has at its heart, the need to gather data on the safety and efficacy of cannabis-based medicines so that they can be prescribed with confidence by our wonderful NHS doctors.

“The initial priority will be to gather real-world evidence to support the prescription of cannabis medicines for patients like Billy with Refractory Epilepsy – an indication already noted by MHRA as being of interest.

“The proposal includes funding by the NIHR for these historical real-world evidence studies to be managed by leading experts in the area of clinic and trial management under the governance of the I am Billy Foundation, a charitable company founded by myself and Billy to conduct research into cannabis medicines and to relieve the financial burden on vulnerable and chronically ill patients who are obliged to seek private prescriptions.”

Billy Caldwell secures historic partnership to “unlock the deadlock” on medical cannabis access on the NHS
Billy Caldwell with his mother Charlotte

Despite calls from NIHR, there is yet to be any government-funded clinical research trials into the safety and efficacy of cannabis medicines.

The proposed first-of-its-kind solution presents a collaborative opportunity to help improve lives and improve the financial wellbeing of the NHS through the innovative use of cannabis medicines.

Commenting on the developments, Conservative MP Heather Wheeler said: “I wholeheartedly welcome the historical news DHSC has agreed NIHR will work with I am Billy Foundation, non-profit organisation, investing in Real-World Evidence Studies to unlock the deadlock of our wonderful NHS prescribing cannabis-based Medicine.

“I commend Billy and Charlotte for their determination to make this happen in particular groups of patients like Billy with refractory Epilepsy who are already accessing cannabis-based Medicine in the private sector.

“This non-profit concrete proposal is deliverable and undoubtedly will not only gather much-needed data but relieve the financial burden of these chronically ill patients.”

Adding her “heartfelt thanks” to Heather Wheeler and to the Department of Health officials who facilitated the meeting, Charlotte Caldwell said: “Billy and I are beyond humbled and filled with gratitude for our meeting with Minister Jo Churchill, and DHSC officials.

“It was agreed we should work with NIHR in trying to find a way of collecting much-needed data and information that will allow our wonderful NHS to prescribe cannabis-based medicines in groups of patients like Billy with refractory Epilepsy from I am Billy non-profit Clinics.

“Everyone agrees that this is a problem to be solved and we look forward to continuing to collaborate to find an urgent solution. I am a mother of a patient with lived experience and I know it has saved Billy’s life, and I am confident that these medicines can save many more.”

“I also want to say a huge thanks to all our amazing supporters; Grow Pharma, LVL, Northern Leaf, Medisonal and Kanabo along with everyone else whose support never faltered along the way.”

For further information on the campaign and foundation, please visit the ‘I am Billy Foundation’ website.

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