Asked by
To ask Her Majesty’s Government what steps they are taking to
ensure that cannabis oil continues to be legally available to
patients when prescribed by their physician.
The Parliamentary Under-Secretary of State, Department of Health
and Social Care () (Con)
My Lords, we are on the case. I completely recognise the problems
faced by Alfie Dingley and all the individuals reliant on the
previous arrangements with the Dutch Government for the supply of
Bedrocan oils. The department is working urgently with Dutch
Minister Tamara van Ark to find a solution that will enable these
patients adequately to access the medications they need, and we
are committed to setting up clinical trials to inform future NHS
commissioning of cannabis-related medicines.
(LD) [V]
My Lords, I thank the Minister for that very encouraging
response. He will know that time is of the essence because these
medicines prevent children having severe fits, some of which are
life-threatening. Can he go back to his department and educate
some of his officials? Unfortunately, a lot of the families are
very upset at being told that they can safely be switched to an
alternative formulation. That is both ignorant and dangerous. All
the expert clinicians who know about these issues say that that
cannot be done safely. Even if it could, eventually putting these
children back on to the original formulation sometimes does not
work. Will he make sure that his officials listen to the
clinicians who are expert in prescribing and in following the
progress of people on these formulations?
(Con)
My Lords, I am grateful for the noble Baroness’s kind words, and
I will indeed take that patient feedback back to the department.
I reassure her that this is an area where patients have
undoubtedly led the way, and clinicians have to catch up. In
doing so, there will need to be a meeting of minds and regulation
in areas that are open to patient interpretation. In that period,
there will undoubtedly need to be compromises on all sides.
(Lab) [V]
My Lords, the law changed over two years ago. The then Home
Secretary said:
“We have now delivered on our promises … we will work with the
NHS to help support specialists in making the right prescribing
decisions.”
But they have not; it has been a hollow promise for terminal
brain cancer sufferers such as my nephew. NHS doctors will not
prescribe medical cannabis, and the BMA advises medics not to
prescribe it, yet I understand that the UK is the largest
producer of medical cannabis in the world. Just how many
prescriptions have been issued for unlicensed cannabis medicines,
other than those subject to randomised control trials, in the
last 12 months?
(Con)
My Lords, the noble Baroness is being a little unfair; Health
Education England published a medicinal cannabis education
package on 8 August 2019. But we cannot force clinicians to make
prescriptions. That is not how the health service works. We need
to work on clinical trials to put in place the correct
authorisations and to give marketing authorisations for these
important and promising drugs. That will require collaboration
between government, the regulator and industry, and I call on
industry to step up to that challenge.
(LD)
My Lords, some people in England and Wales are reliant on hormone
therapies produced in the EU 27. Who precisely in the NHS is
responsible for ensuring continuity of supply of those therapies
to patients?
(Con)
My Lords, procurement decisions in the NHS are done by the NHS. I
do not think that a specific or unique group is focused precisely
on hormone therapies, but I would be glad to go back to the
department and write to the noble Baroness to confirm that.
(Con) [V]
My Lords, I draw your Lordships’ attention to my interests as set
out in the register. If we can vaccinate 1.5 million people in a
few weeks with a drug that did not even exist a couple of months
ago, how come we cannot prescribe properly a drug that has been
legal to prescribe for over two years? Cannabis contains over 120
different cannabinoids and eight terpenes, and the way in which
these are configured makes a world of difference to their
effectiveness. What training is being given to ensure that the
right combination of cannabis oil required to treat different
medical conditions is correctly prescribed? I think it is time
that the Government stepped up to the plate on the training.
(Con)
My Lords, I would turn around my noble friend’s proposition and
ask this question. If many vaccine manufacturers can turn around
clinical trials in eight months for an extremely complicated
vaccine, how come the cannabis-producing companies cannot turn
around clinical trials over years?
(CB)
I thank the Minister for his reply. I declare that I am a
cannabis user to counter pain, and no doubt later today we will
be able to come back to that issue. I hope that his officials are
watching to witness the support there is in this place for the
role that he is trying to secure so that young sufferers who
shake their brains to pieces might get relief today rather than
tomorrow, when it is too late.
(Con)
I thank the noble Lord for sharing that personal testimony, which
is extremely touching and relevant. I share with him that there
is a large amount of ministerial support for the principle of
this exciting and interesting area. If there is any frustration
on my behalf, it is only that somehow the industry has not
matured to the point that it can sponsor the kinds of clinical
trials that can take these important medicines through the
necessary authorisation process that can put them on the NICE
list so that they are available for more patients.
(Lab)
It is not surprising that people are astonished that important
cannabis products, which can transform the lives of those
suffering from debilitating, painful conditions, are approved yet
still not available—and in some cases supply has been disrupted
as a by-product of Brexit. Would the Minister care to speculate
as to why this has not happened? It is not just that the
companies have not stepped up—why have they not done so? Would
the political will that has been brought to bear on various other
issues faced by this Government, such as Brexit, not be usefully
brought to bear on this one?
(Con)
The noble Baroness puts a very reasonable challenge to the life
sciences arrangements in the UK. We are blessed with major
pharmaceutical companies, and a lively and exciting biotech
industry, all of which are well plugged into the regulatory
authorisation process. This is a novel, exciting, patient-led and
innovative area. For those reasons, it has not had the financial
backing of either business or the financial institutions to put
in place the very simple, straightforward requirements of
clinical trials, which are there for patient safety in the first
place, not for government box-ticking. We are working extremely
hard to try to resolve this Catch-22 situation and I hope very
much indeed that we will be able to announce news on that
shortly.
(LD)
My Lords, it is nice to hear that the Government are taking this
problem seriously. If these drugs are effective, would it not be
a good idea to encourage the demand side of this equation, where
doctors prescribe them, by pointing out what the drugs allow a
child with epilepsy, for example, to do—that is, lead a normal
life, get educated, get qualified and be able to have a job—and
the cost to the state if they do not?
(Con)
The noble Lord alludes to an important, although frustrating,
point. If I may gently push back, the truth is that there is a
large amount of very persuasive anecdotal evidence, some of which
we have heard today. It is completely compelling—it is just not
scientific. Patient safety relies on extremely rigorous clinical
trial regimes; that is why we have safe medicines in the UK. It
is simply not possible to persuade front-line clinicians to make
prescriptions on the basis of anecdote rather than clinical
study.
(Non-Afl) [V]
My Lords, I am delighted that the Minister is on the case and
that we can make sure that this issue is resolved for this set of
parents. On a wider note, however, would the Minister consider
revisiting the NICE guidelines, last published in November 2019,
which had a list of recommended research, to ensure that we
potentially widen the base of research and bring more speed into
the process?
(Con)
The noble Baroness is right that research is the key. I reassure
her that we are looking at ways to try to bring research forward.
The issue is not with the NICE guidelines themselves; it is with
getting the scientifically backed data to be able to justify the
authorisations from the MHRA. We are working extremely closely
with the NIHR. We are looking at the NHS, which, as the noble
Baroness likely knows, does have manufacturing capability within
itself for these kinds of drugs. As some noble Lords here will
know, we are engaged in thoughts about how the NHS manufacturing
capability can be used to mobilise clinical trials in this
important area.
