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Inside-cover letter

Home Office Permanent Secretary, 27 March 2023
Mr Peter Lindsay
[Recipient address redacted]
Dear Pete,
On behalf of the Home Secretary and the Department, I would like to thank you for your contribution to the work of the Civil Service over the past 23 years.
I am aware that you began your Civil Service career in April 2000. Since then, amongst other roles, you have worked at the Department for Transport (DfT) from July 2008 until May 2011, followed by a number of roles at the UK Space Agency from May 2011 until you joined the Home Office in 2019. More recently, we have benefited from your work in UK Visas and Immigration within the Work, Study, Family and Ukraine Command, leading on the Fee Waiver project and developing the apprenticeship model for new recruits.
During your career you have led of a number of high-level policy and operational strategies, working with a number of internal and external bodies. You should be proud of this record of dedicated service. I know colleagues from across the Home Office have valued your enthusiasm, dedication, and support. You will be missed.
I would like to add my personal thanks and send you my best wishes for the future.
Yours sincerely,
[Signature]
Sir Matthew Rycroft KCMG CBE
Permanent Secretary

OFFICIAL SENSITIVE
Home Office
To: 1. Policing and Fire Minister
    2. Home Secretary
From: [redacted] Drugs and Alcohol Unit, Crime Directorate
SCS: Gwen Nightingale, Katherine Merrifield
Date: 11 September 2018

ACMD ADVICE ON CANNABIS - PROPOSALS

Summary
This submission provides advice on the letter received today from the Chair of
the Advisory Council on the Misuse of Drugs (ACMD) and provides a steer
before your meeting with him tomorrow, where he will explain the Council's
recommendations. You do not need to make a final decision on next steps
before the meeting, but you will want to balance the risk ( [redacted]
[redacted] against your desire to move quickly and ensure products you have
already licensed are rescheduled. You will want to fully consider the
explanations given at the meeting before making a final decision on next steps.
The ACMD recommends you reconsider two key issues: labelling of products
and the overall breadth of the definition. The submission sets out our
suggested proposals for you to consider before you meet with Dr Bowden-
Jones and take final decisions.
Timing: Immediate.
Your meeting with Dr Bowden-Jones is tomorrow evening. You will want to
review the proposed approach and consider before meeting him. Responding
to the ACMD advice this week will enable us to stick to our plan to lay
regulations in early October. We will provide separate briefing for the meeting
Recommendation
Anticipating the two key issues that will be raised by Dr Bowden-Jones will
raise at the meeting, we recommend you:
consider the ACMD's advice on the breadth of the definition
•
consider the proposal on labelling restrictions to specify THC and CBD
content of products to be brought into force at a later stage following the
rest of the regulations
note the other recommendations in the ACMD's advice and our work
•
with DHSC to respond to them
note the timescales for implementation;
Annex A — Letter from the ACMD responding to the Government's proposals
Annex B — Email from Gwen Nightingale to Dr Bowden-Jones setting out the Government's
proposals, including the definition of cannabis based medicinal products.
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OFFICIAL SENSITIVE
Discussion
Following your acceptance of the ACMD's advice in July and
subsequent agreement on our proposals to define cannabis based
medicinal products, the Council has now provided further advice on
that proposed definition, access routes and other the approach in
general, with a view to preventing harm. The letter from Dr Bowden-
Jones is attached at Annex A. This was in response to a request from
Drugs and Alcohol Team (see Annex B). Throughout the advice, the
ACMD refers to the products as 'cannabis derived medicinal products'
(CDMP). It is clear that in providing this advice, the ACMD has taken a
cautious approach, in view of the paucity of evidence surrounding
medicinal cannabis products. The key conclusions and concerns of the
ACMD are.
The proposed interim definition of a CDMP is currently extremely
•
broad, with no reference to safety or quality. The lack of clarity in
the definition significantly increases the risk of unintended
consequences and the Home Office, DHSC and MHRA should work
to refine the definition of a CDMP as a priority. The ACMD is
concerned that the definition could potentially encompass a wide
range of products not appropriate for medicinal use and these
would be available to be prescribed with little assurance about their
quality or safety.
All packaging CDMPs should have a clear content description. The
description should, as a minimum requirement, state the content of
CBD and THC (in mg per unit dose or volume) in a manner that
would inform the prescriber when making a clinical decision.
Consideration should be given to what additional information would
be helpful to prescribers.
The ACMD also made a number of other recommendations on
guidance for prescribers, routes of administration, monitoring and
review. The Council's rationale for these concerns centres around the
[redacted] risks osed b rogue prescribers, mainly in a private capacity ( [redacted]
We outline our broad responses to the most important
recommendations on the definition and content (labelling) issues
below. We will provide further advice on the other recommendations
later in the week.
Breadth of definition: Ensuring Quality and Safety
2. The Council is concerned that the wide breadth of the definition of a
cannabis based medicinal product means that harmful products will
effectively be available to prescribe. We believe there are sufficient
safeguards in the medicines process to provide assurances that this
risk can be mitigated. In order for a product to reach a patient
legitimately, it would need to be prescribed by a specialist doctor,
imported/produced/supplied by an MHRA licensed wholesaler and then
dispensed or supplied by a pharmacy regulated by the General
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OFFICIAL SENSITIVE
Pharmaceutical Council. This means that it is highly unlikely that products
without appropriate quality assurances, or with very high levels of THC,
would be made available to patients. Should it happen there, are
appropriate levers through regulators to take action.
3.
Additionally, we believe the breadth of the definition is needed; we
are unaware of an alternative definition which would allow those
medicines currently prescribed via the Expert Panel and previously
licensed by you to be available for legitimate use. Alternative
definitions such as those which limited the THC/CBD ratio would not be
possible, as pure THC is used in the manufacture of medicines with lower
THC/CBD ratios. All elements within the preparation of the medicinal
products must be covered by the definition of a Cannabis Based Medicinal
Product. Finally, this broader definition, gives the best chance of facilitating
a wide range of research and further medical benefits.
Ensuring content of products is clear to prescribers and patients
4.
The ACMD have raised concerns around the labelling of cannabis-
based medicinal products and have recommended that all CDMPs
should have a clear content description. They recommend the
description should, as a minimum requirement, state the content of CBD
and THC (in mg per unit dose or volume) in a manner that would inform
the prescriber when making a clinical decision. The reason for this is that
cannabis components such as THC and CBD have different effects
depending on their ratio and prescribers need to be aware of this before
prescribing. While CBD is not a controlled substance, it is thought toplay
an important role in modulating the activity of THC (which is a controlled
substance). As such, the CBD:THC ratio can have an effect on the way
that a product affects a person. Specifically, if a product is high in THC and
low in CBD the psychoactive effect is likely to be more potent.
5.
Amending the 2001 Regulations to include THC/CBD content by the
end of October is not possible. Amending the 2001 Regulations to
include these specific labelling requirements would mean that there is a
requirement for us to comply with the Technical Standards and
Regulations Directive 2015/1535/EU. The purpose of the directive is to
prevent new technical barriers to trade being created. It requires member
states to tell the European Commission, and other member states, about
their technical regulations at a draft stage. Failure to notify the
Commission will mean the labelling requirements are unenforceable.
6.
Once notified, there is a standstill period of three months, during
which the regulations cannot be laid. This is extended by a further 3
months if Member States object. We have considered alternative options
such as an urgency procedure application for the notification to be
considered expeditiously. However, the bar is set extremely high and this
is limited to circumstances such as a natural disaster. As patient access
would continue in this case through the Expert Panel, even if regulations
were delayed, this expedited route would not be available to us.
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OFFICIAL SENSITIVE
We know that you want to act at pace. Given this we recommend that
7.
you accept the ACMD advice in principle but include the labelling
requirements into legislation at a later stage (spring 2019 at the
earliest), relying on guidance in the interim. This option allows you to
continue with your intended amendments by the Autumn but also include
the ACMD's recommendation at a later date. This will allow you to proceed
at pace and accept the ACMD's recommendation 'in principle'. However, it
is unlikely to fully resolve their concerns. The ACMD may believe that the
level of risk will be increased between the implementation date and the
further changes to amend the labelling requirements. There is also going
to be a transitional period for prescribers in the first instance and
subsequent amendments to legislation will mean that guidance will need to
be adjusted to reflect these new changes so that the risk of non-
compliance is clear (i.e. not just breach of guidance but a regulatory
breach).
8.
There are other options which you may want to consider, these are:
a. To reiect the ACMD advice on labelling and rely on new guidance
which will be issued to prescribers/suppliers:
If you decided to rely on prescriber guidance you would be
technically be rejecting the ACMD's recommendation on the issue.
There are though, a number of safeguards already in place to make
sure patients and clinicians have the appropriate information about
what is contained in medicines. The current regulatory requirements
under the Human Medicines Regulations 2012 and the 2001 Regulations
already provide statutory requirements in relation to labelling for medicines
and Schedule 2 controlled drugs. This simply does not extend to the
requirements suggested by the ACMD due to the complexity of cannabis
as a substance. However, there is existing guidance from the MHRA on
the labelling requirements for unlicensed products and the MHRA will also
be issuing guidance which will specifically require the THC and CBD
content to be included in 'unlicensed products'. In addition, doctors have
an existing responsibility to 'take responsibility for the prescribing of the
medicine' and to 'make a clear, accurate and legible record of all
medicines prescribed'. Realistically it would be impossible for a doctor to
prescribe responsibly if s/he did not know the contents of a medicine. The
absence of an express labelling requirement would also be more of a
concern for 'new' products since existing known products such as
[redacted] already publish the THC/CBD content of their
products on the basis that the content or ratio of THC/CBD is what defines
the product for patients and prescribers..
b. Accept the ACMD advice and delay the implementation date to allow
the Commission to agree our proposal.
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OFFICIAL SENSITIVE
The final option is to accept the ACMD advice and postpone the
implementation date of the entire regulations (i.e. delay rescheduling
for up to 8 months). This option would mean that the labelling
requirements are added to the legislation however this could delay the
changes until spring 2019. This will be a difficult public message to provide
as there is an existing commitment to make legislative changes by the
Autumn. In addition, there will be a need for the Expert Panel to continue
for an additional 3-8 months.
9.
At present, we would recommend accepting the ACMD's advice in
principle but including the labelling requirements into legislation at a
later stage, but you may obtain a fuller picture on the labelling point
during your conversation with the ACMD chair, which will likely be
useful to help you take a final view.
Other recommendations
IO. The ACMD makes nine further recommendations, also centred
around the key aim of preventing harm caused by the products and
minimising risks of diversion. The ACMD covers guidance for
prescribers and pharmacists, a competency framework and training
pathway for the prescribing of CMDPs, that the route of administration is
stated on prescriptions (and producers should be required to state to
appropriate route of consumption), that CDMPs should not be
administered by smoking, monitoring (capturing and publishing clinical
outcomes of prescription and use), review (a programme of clinical trials
and an evidence-based review of the proposed interim approach),
communications and MHRA marketing authorisation. DHSC colleagues
have been addressing these issues in anticipation and we will provide
further detailed advice on these less contentious areas on Thursday,
following your meeting.
Overall Approach
11. It is not possible to implement the ACMD's recommendations in full
by October. As discussed above, the recommendations on the definition
and on the content description (labelling) of products are, because of their
complexity, not possible to resolve immediately. The lack of evidence
available on the harms and benefits of these products makes it difficult to
take a prescriptive approach to their quality and efficacy in legislation at
this stage. We have identified two broad approaches to responding to the
ACMD's advice in order to mitigate these concerns about safety and
quality.
12. The first option is to continue with the planned implementation date
of October 2018, conveying to the ACMD that you are conscious of
the risks of the approach, but that you will commit to monitoring
closely on an ongoing basis and then more formally reviewing after a
year. You have already committed publicly to ensuring that access to
cannabis-based medicinal products will be made available on prescription
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OFFICIAL SENSITIVE
by the Autumn. This definition will rely on the existing safeguards available
under the Human Medicines Legislation 2012, the 2001 Regulations,
MHRA guidance on unlicensed products and the NHS England guidance
issued to prescribers. However, some of the main safeguards raised by
the ACMD will not be in place at this time (e.g. labelling). The ACMD has
already advised that a wide definition of cannabis could lead to unintended
consequences (e.g. slippery slope towards the legalisation of cannabis)
and proposes further safeguards. If you decide to pursue this option,
mitigation is provided given that this proposal is subject to the ACMD's
longer-term review, World Health Organization evidence and monitoring by
DHSC. This means we will be able to review this in a year's time with a
view to agreeing a final approach by Autumn 2019 thus allowing us a year
to monitor the changes to legislation and the impact. In that interim period,
clinicians will have been supported by NHS England clinical advice, with
full NICE guidance being available by September 2019.
13. The second option is to take a cautious approach and postpone the
implementation date to September 2019 and work with DHSC, MHRA
the ACMD to work up this definition together. This would allow for the
evidence base to develop. In that timeframe, NICE would develop detailed
guidance to be issued to prescribers, the World Health Organisation would
have issued their advice on cannabis, there may also be pharmacopeial
standards available and we will have more time to develop more
safeguards in legislation. This would allow sufficient for Home Office,
DHSC and the MHRA to work closely with the ACMD to develop a more
detailed legislative approach which minimises the risks of misuse and
diversion. This would have the advantage of ensuring that a fully refined
legislative approach and full clinical guidance for prescribers would be
available. However it is by no means guaranteed that, even after this
period of time, we would be able to narrow the definition in this way. Under
this option, the expert panel will need to be in place for another year. This
would be the more cautious option but with the public commitment being
Autumn 2018 this will be a difficult public message to convey.
14. In the absence of an alternative proposal from the ACMD at this
stage, we recommend that you proceed with the definition as it
stands (subject to your meeting with Dr Bowden-Jones) but provide
assurances that it will be kept under review pending the conclusion
of the ACMD's full advice. This provides a balance between speed and
rigour. It is unlikely that there is a short-term solution giving rise to a better
definition, and we would recommend that you confirm that you want the
ACMD to advise further on an updated definition (if possible) as part of
their longer-term review. If following the meeting you agree with this, we
will draw up a proposal to set this out in more detail.
Do you agree?
Timing/Next Steps
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OFFICIAL SENSITIVE
15. In order to manage the ongoing relationship with the ACMD, we
recommend that you give Dr Bowden-Jones the opportunity to set
out the reasons for the ACMD's recommendations prior to your
coming to any decision.
16. If, following your meeting with Dr Bowden-Jones, you are content
with our proposals, we will provide a suggested response to him, to
be published on Friday. Given that a number of the issues overlap
significantly with DHSC, and indeed require a clinical rather than Home
Office solution, we recommend this response comes jointly from you and
the SoS for Health. We will also provide letters to relevant Parliamentary
(HASC, APPG on prescribed cannabis) and non-parliamentary
stakeholders to inform them of the Government's final proposals.
17.
We expect the regulations to come into force on 29 October. Subject
to PBL clearance, we now anticipate being able to lay the order on the 8
October. Allowing for the 21 -day grace period before coming into force
means that the regulations will then be in force by 29 October. This
continues to be dependent on Parliamentary Business and Legislation
Committee agreement to the laying of the SI (we expect a decision within
two weeks).
18. The Expert Panel will cease on the date of implementation for
England Scotland and Wales. We expect mirroring regulations to
come into force in tandem in Northern Ireland, but if they do not (see
Devolution Issues), the panel will continue to assess NI cases until
they do. The Expert Panel was always intended to act as an interim
measure whilst amendments come into force. Whilst the Expert Panel has
provided a route for clinicians to prescribe cannabis based products, few
clinicians have done so.
Financial and Resource Implications
19. There are no financial implications that arise for the Home Office.
There will be wider financial implications for the healthcare sector and the
NHS in particular which we will work through with the DHSC
Legal considerations
[redacted in supplied original]
Media handling advice and correspondence lines
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OFFICIAL SENSITIVE
22. Media continue to report on the medicinal cannabis debate. [redacted] Press
Office anticipate coverage of the individual application of—
to
the expert panel. Their decision to decline the license has reached the
Times. Earlier this month they published a prominent article and leader in
the Times which focused on campaigners suggesting the families are
finding it too difficult to apply for a licence (Medical cannabis panel is
failing us, families tell Sajid Javid, The Times, 4 September). The piece
also contained criticism that doctors and clinicians are unwilling to take
responsibility for prescribing this type of drugs. The issue of guidance for
doctors has also led to coverage in media outlets specialising in health
matters. For example, Dr Ellie Cannon wrote an op-ed for Pulse Magazine,
published on 21 August, in which she wrote: "It will be us GPs at the coal
face who get caught in the middle
I certainly feel unskilled and
uneducated when it comes to medicinal cannabis."
23. Whilst there has been no coverage at the time of writing of the
ACMD's response, which is now available online, we can expect
journalists to scrutinise it due course. The recommendations mirror the
Times criticism as the main concern is that there is not enough guidance
to maintain safe prescribing of these products. Media could also seize on
concerns over the wide breadth of the definition which could lean into the
debate over recreational drug use.
24. Subject to your decision regarding our response to the ACMD's
recommendations, Press Office proposes issuing a press notice on
Friday to accompany our formal response which clearly sets out our
position on the definition and guidance on prescribing decisions as
well as the issues of labelling and smoking. It is worth noting that there
are handling risks with each of the proposed options. Should you decide to
take forward the first option and continue with the planned introduction,
there is likely to be further criticism around the safety of these products
and questions as to whether the Expert Panel is qualified to make these
decisions. There is also a risk that GPs, or clinicians may speak publicly
about the lack of guidance as they will ultimately be making the prescribing
decisions. However, if you decide to take forward the second option and
postpone the implementation this is likely to receive criticism from media
and families as it has we have publicly committed to prescribed medicinal
cannabis products by the Autumn.
25. Press Office will use the press notice to respond to these potential
criticisms. This could include announcing that NHS England will work with
experts to develop interim advice for clinicians and NICE will publish full
clinical guidance for patients and health professionals next year. We will
also address the issues of labelling and smoking. Neither of these
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OFFICIAL SENSITIVE
issues have gained any significant media attention as yet. However,
should you (Home Secretary) agree to the recommendation that the new
rules should not extend to allowing patients to smoke doctor-prescribed
cannabis, we will make it clear that this is due to concerns over the health
dangers of smoking and the difficulty the police could face. It is possible
that patient groups may take exception to our stance on smoking once it is
set out publicly, [redacted]
26. We will also work with policy colleagues and partners on preparing a
factsheet to upload onto Gov.uk which we can point journalists to as well
as a comprehensive reactive Q&A to help explain the technical detail.
Proposed holding line which press office will issue for the next 24
hours:
A Home Office Spokesperson said:
"We are continuing to work with the Advisory Council on the Misuse of Drugs
(ACMD) as we make these important changes to the law - which will help patients
with an exceptional clinical need.
"We are grateful to the ACMD for their advice which the Home Secretary will
consider carefully. He will meet with Dr Owen Bowden-Jones, chair of the ACMD,
to discuss this further tomorrow and announce his decision in due course."
Are you content?
Parliamentary considerations
27. As you will be aware, both the Expert Panel and the rescheduling of
cannabis continue to generate interest from parliamentarians. Once
you have made a decision on responding to ACMD advice, we will draft
letters for interested parliamentary stakeholders (Yvette Cooper, Members
of the APPG on prescribed cannabis) for you to send on Friday once the
announcement is made. Sending out the 'interested party' letters the day
after the House rises may generate concern among parliamentarians,
however, once the regulations are laid in October, Parliament will have the
opportunity to properly scrutinise the measures. When we lay regulations
at the beginning of October we propose sending a 'Dear colleague' letter,
setting out the proposals in full.
Home Office Science agreement
28. The HO Chief Scientific Advisor has been consulted in the development of
this submission.
Devolution issues
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OFFICIAL SENSITIVE
Regulations: Northern Ireland
29. The Regulation changes will only apply to England, Scotland and
Wales. We have been liaising with the Department of Health in Northern
Ireland (DHNI) throughout the process. We expect DHNI to mirror the
regulations and have shared a draft with them. They are unable to provide
a definitive assurance that the regulations will be authorised by the
Permanent Secretary of DHNI in the absence of ministers, as in the event
that the NI administration is re-established, this decision will be taken by a
minister. They have given us assurances that, if it is not re-established, the
Permanent Secretary will authorise the regulations to be laid on public
interest grounds.
30. Should it not be possible to mirror the regulations in Northern
Ireland, the Expert Panel will continue to assess Northern Ireland
cases until legislation is amended. We have made the Expert Panel
aware of this potential development and will work with colleagues in DHNI
to ensure any practical issues with a lag in the regulations coming into
force in Northern Ireland are minimised.
Clinical matters
31. Clinical matters are devolved throughout the UK and DHSC colleagues are
working to ensure that guidance is available across England, Wales,
Scotland and Northern Ireland. Members of the Devolved Administrations
attend the NHS England Working Group.
Copy list
[redacted in supplied original]
Annex B — Email commission from Gwen Nightingale (Joint Head of Drugs
and Alcohol) to Dr Bowden-Jones, dated 17 August 2018
Owen,
Thank you very much for the constructive dialogue on Wednesday at the ACMD working
group meeting. This email sets out the issues we discussed and sought ACMD views on.
As I mentioned, following the Home Secretary's acceptance of the ACMD's advice to
reschedule a clear definition Of 'cannabis-derived medicinal products', the DHSC, the MHRA
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OFFICIAL SENSITIVE
and the Home Office have been working closely together to develop a proposal. You are
aware that this is not a straightforward matter, and we have taken a cautious approach in
ensuring access to these products is done safely, combining both existing controlled drugs
legislation and medicines legislation to develop a working definition.
We have set out our proposed interim approach, bearing in mind the ACMD'S interim advice
and the Home Secretary's drive for swift action by the autumn. We have also sought to
ensure that the approach is clinically led, ensuring safe patient access to those products
already identified to have potential therapeutic benefit in individual cases, products which
have been supplied in cases where licences were issued by the Home Secretary, as well as
similar products currently under development.
I have set out our proposal in more detail below:
Definition
The ACMD recommended that the DHSC and MHRA promptly develop a clear definition of a
Cannabis-derived medicinal product and that only products meeting this definition be
moved into Schedule 2 of the MDR pending further advice.
The DHSC, the MHRA and the Home Office have developed a definition of 'cannabis-based
medicinal products' to be included in the Misuse of Drugs Regulations 2001 ("The 2001
Regulations). We have developed a purpose approach definition which provides a three
limb requirement to constitute a 'cannabis-based medicinal product'. These are as follows:
'Cannabis-based medicinal product for medicinal use in human' means a preparation
or other product, other than Sativex that:
is or contains cannabis, cannabis resin, cannabinol or a cannabinol
1.
derivative;
is produced for medicinal use in humans;
2.
a medicinal product, or a substance or preparation for use as an ingredient
3.
of, or in the preparation or manufacture of an ingredient of, a medicinal product
Once the three requirements have been satisfied, any products which fall under this
definition would be viewed as a 'cannabis-based medicinal products' and therefore listed as
a Schedule 2 drug under the 2001 Regulations.
This means that all other legislative requirements which apply to other Schedule 2 drugs will
automatically apply to these 'cannabis-based medicinal products'. These would include:
Safe custody requirements
Prescription requirements
Marking of bottles
Mandatory Requisition forms
Record-keeping requirements
Destruction
Any product which does not satisfy the three requirements and fall outside Of this definition
will remain Schedule 1 drugs. This means that they will not be available other than with a
Home Office licence.
Access Routes
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ACMD Recommendation 3 set out that in addition to the provisions of Schedule 2 of the
MDR, the ACMD recommends that the DHSC, MHRA and Home Office should develop
additional frameworks and clinical guidance for 'checks and balances' to maintain safe
prescribing Of Cannabis-derived medicinal products.
The definition Of 'cannabis-based medicinal products' only forms part one Of the overall
proposal. We have developed three access routes which will enable these Schedule 2
'cannabis-based medicinal products' to be made available (part two). We understand the
concerns around the potential risks Of misuse and diversion and we have taken the view that
restricting access will minimise these potential risks. The controls we plan to implement
mean:
A person shall not order (whether by issuing a prescription or otherwise) a cannabis
based product for medicinal use in humans for administration to himself or herself
or to another, unless that product is—
a special medicinal product that is for use in accordance with a prescription
1.
or direction of a specialist medical practitioner;
an investigational medicinal product without a marketing authorisation that
2.
is for use in a clinical trial; or
a medicinal product with a marketing authorisation.
3.
The first access route introduces two safeguards:
As none of the products has been licensed in the UK by MHRA (other than Sativex), it
brings cannabis-based medicinal products explicitly into the scope of the existing
specials regime (established and understood by doctors) and the principle Of the
approach that is currently in place with the Expert Panel. It ensures that a product can
only be lawfully prescribed or supplied for treatment on the direction Of a practitioner
and that the supply must comply with the regime for special medicines, for the specific
unmet clinical needs Of patients.
The products would only be supplied on the direction of a specialist practitioner, i.e.
someone on the specialist register Of the General Medical Council. The specialist
practitioner would be supplying a 'special' at their own risk, which means they would
take on the responsibility for the safety, quality and efficacy of the product. This
replicates the existing medicines legislative regime for practitioners to prescribe,
administer or supply unlicensed medicinal products to patients.
The second access route is in line with Conclusion 2 from the ACMD: Clinical trials to
establish the effectiveness and safety Of Cannabis-derived medicinal products are urgently
required. It will ensure that doctors and laboratories attached to universities are able to
carry out clinical trials on these products, to ensure that the evidence base on cannabis
based medicinal products can be developed.
Finally, the third access route ensures that once 'cannabis-based medicinal products' have
done through the MHRA's market authorisation process, and are therefore of assured
safety, efficacy and quality, they are available to the public in the same manner as any other
Schedule 2 drug (i.e. available through a GP prescription, without the restrictions above).
Guidance to support practitioners
NHS England will work with relevant Royal Colleges on the production Of interim guidance to
clinicians in advance of the regulations coming into force (currently set for October 2018). As
the body with statutory responsibility for overseeing the safe management and use Of
controlled drugs in the NHS in England, NHS England will consider how it could use its
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OFFICIAL SENSITIVE
existing infrastructure of Controlled Drug Accountable Officers to support the introduction
Of cannabis-based medicinal products. We are in regular contact with the devolved
administrations to ensure that roll out will be consistent across the UK.
The legislative and non-legislative proposals above set out our interim approach. The
Department Of Health and Social Care intends to commission NICE to provide more detailed
prescribing guidance, which should be available by September 2019. Until that clinical
guidance is issued by NICE and the ACMD provide their longer-term review, the further
measures in regulations and guidance that we have outlined will ensure that products that
reach patients are Of good quality and safety and that risks Of diversion Of these products is
minimised
Licence Fees
In the course of the Home Office licensing in individual cases, it became apparent that
licensing fees presented a prohibitive economic burden for use Of Schedule 1 drugs when
the costs were transferred to patients. We therefore propose to amend the Misuse of Drugs
(Licence Fees) Regulations 2010 to provide the Secretary Of State with an express
discretionary power to waive licence fees where he thinks proper. The intention of this
amendment is to make this power plain on the face Of the legislation, and to prevent
economic hardship in individual cases concerning use of Schedule 1 drugs going forward.
However the intention is to limit this to patients seeking access, the fees for research
purposes will remain unchanged.
We are confident that the approach set out above delivers the Home Secretary's desire for
swift action with appropriate safeguards. It is based on established and embedded processes
used under controlled drugs and medicines legislation, so it is one we can rely on to be
robust and well understood. We are keen though to understand the ACMD's views on our
proposals and specifically, the Council's views on the following questions:
Whether the proposed three limb definition of 'cannabis-based
medicinal products' should be included in Schedule 2 to the 2001
Regulations and removed from the Misuse of Drugs (Designation)
Order 2015;
2.
Whether, in tandem with the definition, the three access routes for
'cannabis-based medicinal products' are sufficient to minimise the
possible risks of misuse and diversion;
3.
Whether there is anything further that should be considered to
ensure safe access for patients whilst minimising the potential risk
of misuse and diversion,
4.
Whether you agree to the amendment of the Licence Fees
regulations to clarify my (Secretary of State's) discretionary power
to waive licence fees where appropriate.
As you know, the Home Secretary is keen to progress this work as quickly as possible to
bring changes into force by the autumn. It would be very helpful if you could provide the
ACMD's feedback on these proposals by 31 August.
If you have any further queries then we stand ready to assist you or [redacted]
Very best wishes,
page 13 of 14

OFFICIAL SENSITIVE
Gwen
Gwen Nightingale and Katherine Merrifield
Joint Heads, Drugs and Alcohol Unit I Crime Directorate I Crime, Policing and Fire Group I
Home Office
Marsham Street— 5th Floor Fry, North West Quarter
Katherine works Monday to Wednesday; Gwen works Wednesday to Friday
E: [redacted]
M (Gwen): [redacted]
M (Katherine): [redacted]
page 14 of 14

OFFICIAL SENSITIVE
Home Office
To: 1. Policing and Fire Minister
    2. Home Secretary
From: [redacted] Drugs and Alcohol Unit, Crime Directorate
SCS: Gwen Nightingale, Katherine Merrifield
Date: 13 September 2018

CANNABIS: OPTIONS ON DEFINITION OF CANNABIS BASED
MEDICINAL PRODUCTS

Summary
Following on from your (Home Secretary) meeting with the chair of the
Advisory Council on the Misuse of Drugs on 12 September, this submission
provides advice on the two options you requested.
• Option I: proceed with the current definition, but agree to revisit
(with a view of strengthening) at a later date.
• Option 2: proceed with a definition which will only allow for a
set-list of known products to be prescribed by clinicians
The submission also sets out:
• the proposed approach to smoking;
• the other 8, less contentious recommendations from the ACMD
Timing
Immediate — A rapid response is needed to stick to the timetable that enables
the regulations to come into force on 29 October.
Recommendation
We recommend that you:
agree our recommendation to proceed with option I - proceed with the
current definition, but agree to revisit (with a view of strengthening) at a
later date,
reconsider the position on time-limiting the regulations, to provide
further reassurance to the ACMD,
agree the proposal to restrict smoking as a route of administration; and
•
note our proposed approach to the other recommendations from the
•
ACMD
Annex A- Draft Defintion of cannabis based medicinal products
Annex B- Summary of assurances in place under the unlicensed medicines
(specials) regime
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Discussion
Breadth of Definition. Options
You asked officials to assess two options following the ACMD's
recommendation on the definition of cannabis based medicinal
product (the ACMD and the Expert Panel refer to the products as
cannabis-derived medicinal products). As previously, you will want to
balance the speed of delivery against the risks associated with the options
before coming to a final view.
Option 1: proceed with the current definition, set out at Annex A, but
2.
agree to revisit (with a view to strengthening) at a later date.
Taking this option will mean that we continue with the original timetable
and we aim for the law change to come into force on 29 October. You will
agree the current definition (see annex), highlight the protections in the
current regime (e.g. through the unlicensed specials process) and make
the following commitments in your response to the ACMD•
Commit to ensuring that prescribers are fully informed of the content of
cannabis-based medicinal products, including to explore how labelling
of products would strengthen the system in supporting prescribers and
minimising diversion. (Any change to requirements for labelling on
products would have a potential 6-8 months lag on implementation of
these proposals whilst we consult the EU Commission under the
Technical Standards Directive (T SD)).
Consider the potential for a Good Manufacturing Practice requirement
to be added to the regulations (this would be subject to the same
requirements to be notified under the T SD so would be subject to a 6-8
month lag and whilst this was a suggestion from Dr Bowden-Jones, the
MHRA advise that this would add little practical benefit, see Annex B
for processes already in place for these unlicensed medicines)
Commit HO, DHSC and MHRA officials to working with the ACMD to
•
refine the definition iteratively following implementation, where the
ACMD is able to provide further advice on whether and how the
definition can be improved.
Set out that DHSC will monitor prescribing practices in the meantime
and that all imports will be recorded through the MHRA import
notification process and the Home Office's licensing process.
3.
This option allows you to proceed with the definition as drafted and
accept in principle the ACMD advice to refine the definition as a
priority. However, it does not immediately introduce the controls the
Council is recommending. We are confident that sufficient controls
are in place to mitigate against the risks Dr Bowden Jones expressed
in the meeting. As he outlined, this option, in using the Specials regime
places the prescriber at the heart of the process and puts the decision
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OFFICIAL SENSITIVE
about whether a product is appropriate to prescribe into their hands. As he
sets out, this will likely produce a cautious approach from clinicians, albeit
committing to a labelling requirement on THC/CBD content will mitigate
this. As we agreed with you at the meeting, rogue prescribers may well
make poor prescribing decisions, but regulatory regimes allow for action to
be taken on this. A full explanation of the assurances provided by the
specials regime is at annex B.
4.
Further mitigation can be provided under this option if you commit to
time limiting regulations. You have previously directed us not to do
so, but given the strength of the ACMD's recommendations, limiting
the regulations to 18 months would clearly set out that you are
serious about revisiting the regulations when more information is
available. The other option is to commit to reviewing without including a
sunset clause, but this will provide lower level assurance to the ACMD.
5.
Additionally, we believe the breadth of the definition is needed; we
are unaware at present of an alternative definition which would allow
those medicines currently prescribed via the Expert Panel and
previously licensed by you to be available for legitimate use.
Alternative definitions such as those which limited the THC/CBD ratio
would not be possible, as pure THC is used in the manufacture of
medicines with lower THC/CBD ratios. All elements within the preparation
of the medicinal products must be covered by the definition of a Cannabis
Based Medicinal Product. Finally, this broader definition, gives the best
chance of facilitating a wide range of research and further medical
benefits. Exploring alternative possible definitions that meet the
requirements above would take considerable time and effort, and therefore
we recommend requesting the ACMD to work with us towards refining the
definition iteratively.
Option 2: to proceed with a definition which will allow for a list of
6.
known products to be prescribed by clinicians. At this stage, the Home
Office has only licensed products for personal medicinal use from two
companies outside of the UKI [redacted] and [redacted]
[redacted] This option would allow specialist medical practitioners to
only prescribe from these two known companies and would remove any
unknown products being available on prescription. As both these
companies hold certificates of Good Manufacturing Practice, there is a
level of reassurance that these products are being developed to a quality
standard.
7.
This list could be introduced by way of a general licence or through
an amendment to the 2001 Regulations.
7.1.A general licence could be issued immediately and would allow all
determined practitioners (assumed to be specialist medical
practitioners) to prescribe [redacted]
products However,
these products have not received marketing authorisation from the
MHRA. Naming them on the licence would be a tacit endorsement of
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OFFICIAL SENSITIVE
the products, when no assessment of efficacy and patient harm has
been made. To mitigate against legal risk, a scientifically and/or
medically led assessment, based on reasonable, rational, clear and
objective criteria (such as GMP certification; labelling requirements;
clinical use), as to why these products were suitable above others
would be necessary. The Home Office lacks the expertise to
undertake this assessment; and concerns have been raised as to
whether this would amount to a hybrid 'authorisation' scheme should
the MHRA take this step. It would also need to be made clear that
other products of like determined standard can be added to the licence
as time evolves.
7.2. The other option would be to amend the 2001 Regulations to include
specified [redacted]
products by description of their
composition and not by brand name. This process would not be
unprecedented as it has been done for the case of [redacted]
another
cannabis-based medicinal product which was listed as a Schedule 4
drug in 2013. However, this amendment will not be in place by Autumn
2018 as we would need to identify the exact composition of all
[redacted] roducts and determine a mechanism for
differentiating each product (i.e. by reference to their drug content;
mode of administration etc.) without inadvertently 'opening the gates'
to like substances which seek to mimic the description before putting
this into legislation and then factor in the normal legislative processes.
This approach similarly carries the above-mentioned legal risk; i.e. a
reasonable, rational and clear reason for permitting access to these,
but not other, substances would be needed
8.
Although this may alleviate some of the ACMD concerns regarding
the manufacturing process, these products still lack the reassurance
of safety, quality and efficacy. Notwithstanding some of the issues
identified above, limiting this to [redacted]
may be perceived as
a Home Office circumnavigation of the MHRA process and tacit
endorsement of these products as safe. The Home Office is plainly not
appropriately placed to assess safety, efficacy and quality of medicines.
There is also risk that prescribers may not be as cautious as they may
have been with other unlicensed 'specials' products (which these
substances would nonetheless remain).
. In addition, there is a risk of
judicial review from other pharmaceutical companies (including British
companies such as [redacted]
who wish their own unlicensed medicinal
products to be made available (either by re-scheduling or by generic
licence) without having to go through the normal MHRA marketing
authorisation process.
9.
An alternative would be to outline the product safety requirements,
with only products meeting these criteria appearing on the list.
However, given the limited information available on these products, in
practice the only criteria that we can apply here is GMP, which is subject
to the Technical Standards Directive, so would likely incur a 6-8 month
delay.As outlined above, there is additionally a question here as to
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OFFICIAL SENSITIVE
whether the quality assessment for products supplied to patients for
medicinal use properly sits within Misuse of Drugs legislation.
10. We recommend on balance, option 1, accompanied by a commitment
to time limit the regulations as the more desirable approach, both
legally, and from a policy perspective.
Do you agree on option 1?
Do you agree to implement a 18 month review of the regulations?
Smoking
11. You have previously raised concerns about the potential for
medicinal cannabis products to be smoked. This concern is reflected
in the ACMD's advice which states 'Cannabis Derived Medicinal
Products should not be administered by smoking'. Some controls
already exist in this regard in relation to landlords/occupiers to prevent
smoking in premises, but these will be difficult to enforce and will not
prevent cannabis being smoked in public.
12. DHSC colleagues assess the likelihood that specialist clinicians
prescribing cannabis for the purposes of smoking to be extremely
low (even without further mitigating action). This likelihood is
legitimately applicable only in limited situations where the harm of smoking
is outweighed by the benefit to the patient, for example in a terminally ill
patient (eg relief of nausea in cancer sufferers). This means that the
circumstances in which cannabis could be legitimately prescribed for
smoking would be very narrow. Given the potential diversion risk that this
would represent, we recommend taking further action to mitigate against
the risk of cannabis being smoked.
13. We propose the following to mitigate the risk of smoking.
Inclusion of a specific regulation to prevent administration of cannabis
a.
by smoking: We propose introducing a requirement for a person not to
administer a cannabis based product for medicinal use in humans by
smoking
b.
Strong guidance: NHS England will issue guidance to accompany the
law change in October, providing strong messages in the clinical
guidance that prescribing cannabis for the purposes of smoking is
unlikely to be appropriate, whether prescribed privately or in the NHS
Professional regulation: Specialist clinicians are subject to professional
c.
regulation by the General Medical Council. Any prescribing contrary to
that outlined in NHS England guidance could be considered in
disciplinary proceedings. Serious or persistent failure to follow
professional guidance could result in clinicians being restricted in
practice, suspended, or struck off. Should a specialist clinician
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OFFICIAL SENSITIVE
prescribe for the purposes of recreational use (i.e. rogue prescription),
s/he will be going outside their powers as a prescriber and may
therefore be committing an offence of unlawful supply and criminal
sanctions may apply.
14. The approach of restricting smoking within the regulations has the
benefit of establishing a clear line between licit and illicit/recreational
use of cannabis. It would make clear to a police officer encountering
smoking on the street for example, that an offence has likely been
committed and serves to mitigate against the risk of decriminalisation by
the back door.
15. This restriction would not apply to vaping. We envisage that some
patients might use an appropriate medicinal devise to vape a cannabis-
based product. This could be a legitimate approach clinically.
16 [redacted]
17. [redacted]
we
recommend that you take the option to introduce the controls in
paragraph 13. Do you agree? As an alternative, it is open to you to rely on
the professional guidance and regulation to mitigate risks of irresponsible
prescribing.
Further recommendations from the ACMD
18. The ACMD makes a number of further recommendations concerning
the implementation of the measures. In brief, these recommendations
cover:
the development of interim and full clinical guidance,
o
a competency framework for training clinicians to safely
prescribe,
monitoring (capturing and publishing clinical outcomes of
o
prescription and use), clinical outcomes,
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OFFICIAL SENSITIVE
supporting a programme of clinical trials,
o
that the routes of administration is stated on prescriptions (and
o
producers should be required to state to appropriate route of
consumption),
a recommendation on communications and expectation
o
management
encouraging pharmaceutical companies to apply for MHRA
o
marketing authorisations and
undertaking an evidence based review of the approach.
o
These recommendations are not contentious and are in line with the work
currently being investigated within DHSC, NHS England and others to
allow for a safe implementation of the regulations. We will provide a draft
letter tomorrow in which these recommendations can be accepted in
principle.
Next Steps
19. If you are content with our recommendations, we will make
preparations to announce your position publicly shortly. Next week
we will provide a draft response to the ACMD, along with other
correspondence for interested parties in Parliament (the APPG on
prescribed cannabis, Home Affaris Select Committee, MPs involved in
individual Expert Panel/licensing applications.
20. You may feel that the response and other correspondence most
appropriately comes jointly from you and the Health Secretary. We
have been unable to agree this at official level, so if you are keen to take
this approach, further engagement from your office/special advisors may
assist in changing this position.
Financial and Resource Implications
21 There are no financial implications that arise for the Home Office.
There will be wider financial implications for the healthcare sector and the
NHS in particular which we will work through with the DHSC. A full impact
assessment is train and will be finalised before the regulations are laid.
Legal considerations
[redacted in supplied original]
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OFFICIAL SENSITIVE
[redacted in supplied original]
[redacted in supplied original]
[redacted in supplied original]
[redacted in supplied original]
page 8 of 12

OFFICIAL SENSITIVE
[redacted in supplied original]
[redacted in supplied original]
Media handling advice and correspondence lines
28. There has been no coverage at the time of writing of the ACMD's
response, which is available online, but we can expect journalists to
scrutinise it, as well as any Government response to their
recommendations, in due course.
29. It is worth noting that there are handling risks with each of the
proposed options. Should you decide to take forward the first option and
continue with the planned definition, while revisiting it with a view to
strengthening it later, there could be questions in the media around the
safety of these products. There is also a risk that GPs, or clinicians may
speak publicly about the lack of guidance as they will ultimately be making
the prescribing decisions. Critics could suggest that the changes are
being rushed through, without enough heed being paid to the
ACMD's advice. However, families in individual cases are likely to
welcome the swift action and broad definition.
30. If you proceed with recommended option 1 and agree to the
recommendation to introduce a regulation to stop the administration
of cannabis-based medicinal products by smoking, Press Office
recommends using a press notice to clearly set out our position on the
definition. We could also announce that NHS England will work with
experts to develop interim advice for clinicians and NICE will publish full
clinical guidance for patients and health professionals next year. The
press notice could also address the issues of labelling and smoking.
Neither of these issues have gained any significant media attention as yet.
However, the press notice could make it clear that there will be a specific
regulation to prevent administration of cannabis by smoking and explain
that this is due to concerns over the health dangers of smoking. We will
also work with policy colleagues and partners on preparing a factsheet to
upload onto Gov.uk which we can point journalists to as well as a
comprehensive reactive Q&A
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OFFICIAL SENSITIVE
31. If you decide to take forward the second option and limit this to a
small set list of known products, this is likely to prompt criticism
from families who may wish to access different products to those on the
list. There is also the risk that we could be accused of endorsing certain
companies.
32. Should you choose Option 2 to proceed with a narrower definition,
press office also recommends a press notice and Q&A to make it clear
that this is being done in response to the ACMD's advice to proceed with
caution and in the best interests of patient [redacted] safet and makin the situation
clear for doctors. We would point out that
have been
the medicines at the centre of the recent high-profile cases and work with
external communications colleagues to seek to allay criticisms from
stakeholders around the narrowness of the definition.
33. Depending on your decision, Press Office will liaise with No10 to secure a
grid slot to respond to the ACMD and send up any press materials for
clearance in the usual way.
Parliamentary considerations
34. We will provide further advice on Parliamentary Considerations in due
course
Home Office Science agreement
35 The HO Chief Scientific Advisor has been consulted in the development of
this submission.
Copy list
[redacted in supplied original]
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OFFICIAL SENSITIVE
Annex A — Current draft definition of cannabis based medicinal products
cannabis based product for medicinal use in humans" means a
preparation or other product, other than one to which paragraph 5 of part
1 of Schedule 4 applies, which—
(a) is or contains cannabis, cannabis resin, cannabinol or a cannabinol
derivative (not being dronabinol(l) or its stereoisomers);
(b) is produced for medicinal use in humans; and—
(i) a medicinal product, or
(ii) a substance or preparation for use as an ingredient of, or in the
preparation or manufacture of an ingredient of, a medicinal
product;'
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Annex B Assurances provided by the specials regime
Enforceable Statutory requirements under medicines legislation.
Unlicensed medicine may only be supplied to meet the special need of an
individual patient. The healthcare prescriber is responsible for the product
specification. The product must not be advertised to the public.
Product manufactured in UK
Manufacturing facility has to have a Manufacturer's (specials) Licence and
has to meet standards of good manufacturing practice (GMP)
Routine inspection by MHRA inspectorate and regulatory action may be taken
for non-compliance
(No vetting of individual products by MHRA at all)
Product manufactured in EU and imported from there.
Importer into UK must hold a Wholesale Dealer's Licence and must comply
with good distribution practice (GDP)
Must notify at least 28 days in advance of importation
Non-statutory MHRA requests confirmation of GMP compliance
Non-statutory - MHRA could require Certificate of Analysis
MHRA could refuse to permit the import if composition not declared
(Negative vetting of individual imported products by MHRA)
Product manufactured outside EU and imported from there:
Importer into UK must hold a Manufacturer's (specials) Licence and must
comply with good manufacturing practice (GMP) as it applies to imports
Must notify at least 28 days in advance of importation
Non-statutory MHRA requests confirmation of GMP compliance
Non-statutory - MHRA could require Certificate of Analysis
MHRA could refuse to permit the import if composition not declared
(Negative vetting of individual imported products by MHRA)
All of the above must report serious adverse drug reactions and any other
matter of which they are aware that might reasonably cause the MHRA to
believe that the product can no longer be regarded as safe or of satisfactory
quality to be administered to human beings.
page 12 of 12

To: [redacted]
Home Secretary
(Submissions [redacted] [redacted]
[redacted in supplied original]
Subject: RE: Submission: Options on Cannabis
Hi [redacted]
We had previously been working with press colleagues to aim for a 27/28
September announcement.
There are several things (no. IO announcement Thursday, DHSC announcement
Friday, conference period), which will mean it may be quite a push to announce this
week/early next, unless there is a specific push from your office/SpADS.
[redacted] will confirm if there is any update to this.
Thanks
[redacted in supplied original]
[redacted] Drugs & Alcohol Unit
Crime Directorate I Home Office 1 5th Floor Fry Building | 2 Marsham Street
London SW1P 4DF I
Tel: [redacted]
From: [redacted]
Sent: 17 September 2018 14:48
To: [redacted]
[redacted in supplied original]
9

[redacted in supplied original]
Subject: RE: Submission: Options on Cannabis
[redacted in supplied original]
Thank you for this.
The Home Secretary agrees the recommendation to proceed with Option 1 —
proceed with the current definition, but agree to revisit (with a view of
strengthening at a later date). The Home Secretary does not wish to time-limit the
regulations. He has also agreed the proposal to restrict smoking as a route of
administration / noted the proposed approach to the other recommendations from
the ACMD.
When we spoke earlier — you noted issues with securing a grid slot to respond this
week. Grateful if press colleagues could confirm when it is likely that we will be in a
position to publically respond?
Regards,
[redacted in supplied original]
From : [redacted]
Sent: 13 September 2018 17:36
To: [redacted]
Home Secretary
(Submissions) [redacted]
[redacted in supplied original]
10

[redacted in supplied original]
Subject: Submission: Options on Cannabis
Hi [redacted]
Please find attached a submission on the two options discussed yesterday with the
Home Secretary.
Do let me know if you need anything further.
Thanks
[redacted in supplied original]
[redacted] I Drugs & Alcohol Unit
Crime Directorate Home Office 1 5th Floor Fry Building | 2 Marsham Street
London SW1P 4DF I
Tel: [redacted]
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