Stronger evidence needed to improve confidence in medicinal cannabis

03 July 2019

Despite the rescheduling of medicinal cannabis, very few prescriptions have been issued. One of the many reasons for this is because of the gaps in the evidence base.

Most forms of medicinal cannabis are unlicensed and do not have NICE approval, says the Health and Social Care Committee report on Drugs policy: medicinal cannabis.

Current Evidence Base

Throughout this inquiry, the Committee's attention was drawn to the major gaps in the research base for medicinal cannabis.

Without a robust research base, products remain unlicensed and may only be prescribed if the specialist doctor prescribing them is satisfied that there is sufficient evidence for the product's safety and efficacy for an individual patient.

This Report recommends that the Government and pharmaceutical industry need to make sure that the necessary clinical trials into medicinal cannabis are taken forward and that there should be a greater sense of urgency about exploring its potential in the treatment of intractable childhood epilepsy.

Clinical trials were very difficult prior to the rescheduling of medicinal cannabis but it is concerning that some pharmaceutical companies are still resistant to making their products available for research.

A robust evidence base allows patients and clinicians to weigh up any risks and benefits and establishes the place of any new treatment alongside existing therapies. Without this research, medicinal cannabis products will remain unlicensed for the many areas where patients wish to know if they could be effective.

The Committee welcomes the broad call for research proposals into medicinal cannabis products by the National Institute of Health Research (NIHR).

Industry involvement

The Department of Health and Social Care should investigate those instances where pharmaceutical companies do not provide their medicinal cannabis products for research.

The Committee encourages the Department to 'name and shame' companies which are not doing all they can to make their products available. Medicinal cannabis should not be exempt from the processes that other medicines have to go through to obtain a licence and NICE approval.

Given the challenges presented when a product cannot be patented, the Department should also set out a plan to incentivise industry to take a more active role in research itself and should present this plan in response to this report.

Intractable epilepsy

The Committee recommends that resources should become immediately available for a programme of clinical trials focusing on the treatment of intractable childhood epilepsy. These trials should be facilitated as a matter of urgency.

Families of children suffering from these distressing and life-threatening conditions should not have to travel abroad to seek treatment – the current system will fail future patients if a strong evidence base is not established for the place of medicinal cannabis in treatment. The Committee recognises that many families whose children are already receiving treatment may decline involvement in clinical trials and does not think their existing treatments should be confiscated.

The Committee heard strong evidence that where treatments are highly effective this can be established with fewer trial participants and the results can be established more quickly than is the case for marginal benefits.

The best way to help current and future generations of children living with severe epilepsy is to be clear about the place of medicinal cannabis within treatment and which forms may be most effective.

Interim Guidance

This Report concludes that the current interim guidance produced by professional bodies is there to help clinicians. If in their clinical judgement, clinicians believe prescribing medicinal cannabis will benefit their patient, they should not be dissuaded by other factors.

The Committee also recommends that patient voices should be considered during the creation of guidelines for medicinal cannabis by NICE, by allowing patient groups the opportunity to comment on the draft guidelines and receive a response to those comments from NICE.

This Committee also recommends that NHS England should encourage providers to make their prescribing structures known and transparent to ensure that clinicians are aware of the possible barriers they face and how to tackle them.

Poor communication leads to raised expectations

Dr Sarah Wollaston MP, Chair of the Health and Social Care Committee, says:

"Although the recent changes to Government policy were welcomed, there was a failure to communicate what this would mean in practice for the availability of medicinal cannabis.

Expectations were unfairly raised that these products would become widely and readily available, and there needs to be far clearer communication that this is not the case.

However, recent changes to the scheduling do make it easier to conduct robust research into medicinal cannabis, which would build a stronger evidence base so that patients can weigh up any risks and benefits of treatment. At present there are too many gaps in the evidence to allow most forms of medicinal cannabis to be licensed for use and approved by NICE. We welcome the calls for research proposals from the NIHR and we recommend that intractable childhood epilepsy should be a priority."

Further information

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