DHSC reply to the original design and implementation request, 25 February 2026

JBD request: 12 January 2026 · JBD filing reference: FOI_1D · Authority case reference: FOI-1680704

JBD request date

12 January 2026; chased 16 February

JBD internal filing reference

FOI_1D

Authority case reference

FOI-1680704

Open or download the complete original

DHSC assessment requests

• DHSC reply to the original design and implementation request, 25 February 2026
• DHSC reply to the May patient-assessment request, 8 June 2026
• DHSC FOI-1712285 response 20 July 2026

Document text

The complete original retains the page layout and any redactions.

 
 
Freedom of Information Team 
Department of Health and Social Care 
39 Victoria Street 
London SW1H 0EU 
 
www.gov.uk/dhsc 
 
 
Mr Pete Lindsay 
By email to: pete.lindsay@justicebydesign.org.uk 
 
  
25 February 2026 
 
Dear Mr Lindsay, 
 
Freedom of Information Request Reference FOI-1680704 
 
Thank you for your request dated 16 February to the Department of Health and Social 
Care (DHSC), a copy of which can be found in the accompanying annex. 
 
Your request has been handled under the Freedom of Information Act 2000 (FOIA).  
  
DHSC holds information relevant to your request.  
  
However, to provide the information as it is currently framed would exceed the appropriate 
cost limit set out in the FOIA.  
  
Section 12(1) of the FOIA means public authorities are not obliged to comply with a 
request for information if they estimate the cost of complying would exceed the appropriate 
limit. The appropriate limit for DHSC is set at £600, which represents the cost of one 
person spending 24 working hours determining whether we hold the information, and 
then locating, retrieving and extracting the information.  
  
By way of background, we conducted initial searches to determine what information we 
hold. 
 
A search including ‘cannabis’ as a keyword, including additional terms such as statutory 
instrument, 2018, SI 2018/1055, development, clinical governance, and safety as 
examples bought up 3,135 emails.  
 
A cross query search of those same additional terms produced 5,496 emails.  
 
We have therefore estimated that the cost of the work required to respond to your request 
would exceed the appropriate limit. Consequently, we will not be answering your request.   
  
Although we cannot answer your request at the moment, we may be able to answer a 
refined request within the cost limit. You may wish to consider refining your request by 
narrowing the time period, limiting it to a single topic or area of focus, or specifying a type 
of correspondence — for example, only letters sent to or from a minister or the Secretary 
of State for Health and Social Care.  

 
 
 
 
Please be aware that we cannot guarantee at this stage that a refined request would fall 
within the FOIA cost limit, or that other exemptions will not apply.  
 
If you are not satisfied with the handling of your request, you can request we undertake an 
internal review. If doing so, it would be helpful for you to be explicit which areas of the 
Freedom of Information response you consider dissatisfactory. Complaints to us should 
be sent to freedomofinformation@dhsc.gov.uk or to the address at the top of this 
letter and be submitted within 40 working days of the date of this letter.  
  
Please remember to quote the reference number above in any future communication.  
  
If you are not content with the outcome of your internal review, you may complain directly 
to the Information Commissioner’s Office (ICO). Generally, the ICO cannot make a 
decision unless you have already complained to us about our original response and 
received our response to your complaint and, if applicable, our internal review decision. 
You should raise your concerns with the ICO within six weeks of your last 
substantive contact with us.  
  
Guidance on contacting the ICO can be found at https://ico.org.uk/global/contact-us and 
information about making a complaint can be found at https://ico.org.uk/make-a-
complaint.  
  
Yours sincerely,  
  
Freedom of Information Team  
freedomofinformation@dhsc.gov.uk  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Annex 
 
Dear DHSC FOI and Ministerial Correspondence Teams, 
  
I am writing further to my Freedom of Information request sent on 12 January 2026 
concerning SI 2018/1055 and Regulation 16A(3). 
  
The statutory 20-working-day deadline has now passed. I have not received confirmation 
of receipt, a case reference number, or a substantive response. 
  
Could you please confirm:that the request has been received and logged,the allocated 
case reference number, andwhen a response can now be expected. 
  
For ease of reference, I attach the original request and covering correspondence. 
I would be grateful for clarification at your earliest convenience. 
  
Yours sincerely, 
 
Pete Lindsay 
Justicebydesign.org.uk  
 
12 January 2026 
By Email 
Dear DHSC FoI Team 
 
This request is made under the Freedom of Information Act 2000. 
 
It forms part of an ongoing, transparent research programme examining the regulatory, 
criminal law, equality, and real-world impacts of the framework governing cannabis-based 
products for medicinal use (CBPMs).  
 
The programme builds on material previously submitted to the Advisory  
Council on the Misuse of Drugs (ACMD) Call for Evidence on CBPMs, which closed on 17  
October 2025, and on subsequent analytical updates and correspondence provided to the  
ACMD as the evidence base has continued to develop. 
 
This request relies on Annex A (Publicly Available Documentary Chronology, A1–A15) as 
the complete publicly available factual record evidencing the sequence of advice, 
ministerial responses, parliamentary statements, guidance, and statutory instruments 
relevant to the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) Regulations 
2018 (SI 2018/1055). 
 
It also draws on Annex B (Legal Comparators) and Annex C (Comparative Legislative  
Framework) as contextual analysis. Annex B sets out orthodox comparators for controlled  
medicines and prescribed-patient safeguards, and Annex C provides cross-framework  
comparison of exemption-withdrawal versus primary-offence models, patient-facing 
criminal signalling, proportionality norms, and equality / Public Sector Equality Duty 
(PSED) comparators. 

 
 
 
This is a new request. It is not a continuation, refinement, or narrowing of any previous 
request. 
 
Where any part of this request may engage section 12 of the Freedom of Information Act, 
please provide a breakdown of search parameters sufficient to enable refinement, and 
state explicitly where no information is held, in accordance with section 16. 
 
Yours sincerely 
Pete Lindsay 
Pete.lindsay@justicebydesign.org.uk 
JusticebyDesign.org.uk 
 
FOI 1D — DEPARTMENT OF HEALTH AND SOCIAL CARE 
 
Timeframe 
Unless otherwise specified, please provide recorded information created or held between 
1 January 2018 and 31 December 2020. 
 
This timeframe is intended to capture both the design and initial implementation phase of 
SI 2018/1055, including any contemporaneous consideration or absence of post-
implementation review, monitoring, or evaluation. If no recorded information is held in 
relation to any question, please state this explicitly. 
 
DHSC-1 — DHSC role in development and implementation 
(Annex A: A2, A4, A6, A7; Annex C – cross-government roles and accountability 
comparator) 
Please provide recorded information evidencing DHSC’s role in the development, drafting, 
or implementation of SI 2018/1055, including advice or submissions provided to the Home 
Office and any recorded constraints, limitations, or boundaries on DHSC involvement. 
 
DHSC-2 — Observer status and access 
(Annex A: A2, A10; Annex C – governance and oversight comparator) 
Please provide recorded information explaining DHSC’s observer status in relation to 
ACMD commissions on CBPMs, what information DHSC accessed or was permitted to 
access via that status, and any recorded concerns or limitations arising from observer-only 
participation. 
 
DHSC-3 — Clinical governance and Regulation 16A(3) 
(Annex A: A3, A6, A7, A9; Annex B – orthodox separation between clinical governance 
and  
criminal liability; Annex C – clinical-governance vs criminal-exposure comparator) 
Please provide recorded information evidencing how DHSC expected clinical governance  
relating to route of administration for CBPMs to interact with the legal mechanism in 
Regulation 16A(3) (withdrawal of a Misuse of Drugs Regulations exemption), including any 
DHSC consideration of resulting criminal-law exposure for prescribed CBPM patients. 
 
DHSC-4 — Patient safety implications 
(Annex A: A7, A14, A15; Annex B – orthodox patient-safety and safeguard frameworks in  
comparable regimes; Annex C – safeguards for prescribed patients comparator) 

 
 
Please provide recorded information evidencing any consideration given by DHSC, at the 
design or drafting stage of SI 2018/1055, to foreseeable patient-safety impacts arising 
from the CBPM regulatory model adopted in SI 2018/1055, including any recorded 
assessment of risks associated with exemption withdrawal under Regulation 16A(3). 
 
DHSC-5 — Emergency and self-administration contexts 
(Annex A: A3, A7, A8; Annex B – treatment of emergency or necessity contexts in 
orthodox  
regulatory frameworks; Annex C – emergency self-administration vs criminal exposure  
comparator) 
Please provide recorded information evidencing whether any consideration was given by 
DHSC, at the design or drafting stage of Regulation 16A, to foreseeable circumstances in 
which patients prescribed CBPMs might self-administer medication outside routine clinical 
settings (including urgent or acute situations), and how Regulation 16A(3) was considered 
(or not) in such circumstances. 
 
DHSC-6 — Equality Act 2010 / Public Sector Equality Duty 
(Annex A: A7, A8, A9; Annex B – foreseeability of equality and disability impacts in 
comparable  
criminal-law frameworks; Annex C – equality / PSED comparator) 
Please provide recorded information evidencing any DHSC consideration of Equality Act 
2010 duties or PSED compliance in relation to SI 2018/1055, including whether impacts on 
disabled patients prescribed CBPMs arising from Regulation 16A(3) were considered, and 
whether any mitigation or reasonable-adjustment considerations were recorded. 
 
DHSC-7 — Engagement with Explanatory Memorandum and Impact Assessment 
(Annex A: A14, A15; Annex B – orthodox transparency and disclosure of criminal-law  
consequences in comparable regimes; Annex C – transparency and presentation 
comparator) 
Please provide recorded information evidencing any DHSC input to, review of, or comment 
on the Explanatory Memorandum and/or Impact Assessment accompanying SI 2018/1055,  
including whether DHSC raised issues relating to presentation of criminal-law 
consequences or patient impacts, or recorded any views on the adequacy or clarity of 
such presentation. 
 
DHSC-8 — Post-implementation review 
(Annex A: A10–A13; Annex B – orthodox post-implementation review and monitoring 
frameworks  
in comparable regimes; Annex C – post-implementation safeguards comparator) 
Please provide recorded information relating to any DHSC involvement in the design,  
anticipation, or envisaging of post-implementation review, monitoring, or evaluation  
mechanisms in relation to SI 2018/1055, including whether criminal-law or patient-safety  
impacts affecting prescribed CBPM patients were anticipated or intended to be monitored. 
Discrimination By Design FOI_1D 
 
DHSC-9 — Section 12 safeguards 
(Annex A: A1–A15) 
If any part of this request engages section 12 of the Freedom of Information Act, please 
provide a breakdown of search parameters sufficient to allow refinement and confirm 
explicitly which elements of information are not held