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, a new report by the Health and Social Care
Committee says.
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
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.”
