UNDER  CARE
1982
AGED
ACT
RELEASED AND
BEEN  HEALTH
HAS INFORMATION
OF
OF
DOCUMENT
FREEDOM
DEPARTMENT
THIS
THE  THE
BY

FOI 5124 - Document 1A
OFFICIAL
ATTACHMENT A
Collaboration Arrangement between:
National Institute for Health and Care Excellence
UNDER  CARE
Canadian Agency for Drugs and Technologies in Health
1982
AGED
ACT
RELEASED AND
Australian Government Department of Health
BEEN  HEALTH
HAS INFORMATION
OF
Healthcare Improvement Scotland
OF
DOCUMENT
DEPARTMENT
Health Technology Wal
FREEDOM  es (Velindre University NHS Trust)
THIS
THE  THE
BY
All Wales Therapeutics & Toxicology Centre
Version dated: February 2022
OFFICIAL
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Context and Shared Purpose
Purpose and scope
1. This Collaboration Arrangement sets out the nature of the Collaboration between
the National Institute for Health and Care Excellence (NICE), the Canadian
Agency for Drugs and Technologies in Health (CADTH), the Australian
Government Department of Health (together with the Pharmaceutical Benefits
Advisory Committee (PBAC) and the Medical Services Advisory Committee
(MSAC)), Health Improvement Scotland (including the Scottish Medicines
Consortium (SMC) and the Scottish Health Technologies Group (SHTG)), Health
Technology Wales (HTW) (hosted by Velindre University NHS Trust) and the All
Wales Therapeutics and Toxicology Centre (AWTTC) (hereafter referred to as
“the Partner Organisations”) over the term of this Arrangement.
UNDER  CARE
2. This Arrangement provides an opportunity for the Partner Organisations to work
1982
AGED
together to draw on the strengths of their organisations and enhance the
ACT AND
contribution that they each make for the benefit of th
RELEASED  e audiences and users we
serve.
BEEN  HEALTH
3. This Collaboration Arrangement se
HAS  ts out a
OF  framework for close and collaborative
INFORMATION
ways of working between the Partner Organisations that will support strategic
OF
objectives and shared commitments to the identified priority areas, set out in
Appendix 1.
DOCUMENT
FREEDOM
DEPARTMENT
THIS
4. This Collaboration Arrang
THE ement is not intended to imply a legal commitment and
THE
is not intended to crea
BY  te or result in any legally binding rights or obligations; its
purpose is to define the joint arrangement between the Partner Organisations
and to indicate a common line of action. The Partner Organisations recognise
that any information and proposed activities shared under this Collaboration
Arrangement is on a confidential basis. The Partner Organisations will take
appropriate steps to safeguard such information and proposed activities and seek
permissions to share with others either internally or externally (unless there is
written confirmation from the Partner Organisation introducing the confidential
information that particular circumstances merit specific information or proposed
activities being shared more widely).
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5.  Other arrangements (such as information sharing arrangements and service level
arrangements) may be entered into separately to support the activities
undertaken as part of this arrangement.
6.  This Collaboration Arrangement does not create any financial arrangement
between the Partner Organisations and each Partner Organisation will bear its
own costs and expenses associated with its participation in the Arrangement.
Nothing in this Arrangement authorises or is intended to obligate the Partner
Organisations to enter into any contract, agreement, interagency agreement, or
other financial obligation.
7.  This Collaboration Arrangement will come into effect from the date of the final
Partner Organisation signature and will be reviewed every two years.
UNDER  CARE
Roles
1982
AGED
NICE
ACT
RELEASED AND
8.  NICE was established as a non-departmental public body in the Health and
Social Care Act 2012. Our statutory role and responsibilities are set out in 2013
BEEN  HEALTH
Regulations.
HAS INFORMATION
OF
9.  Since 1999, NICE has established
OF   itself as an international leader in technology
evaluation, guideline development and evidence synthesis. Our work today spans
three ecosystems (life science
DOCUMENT  s, guidelines, and information) that involve close
FREEDOM
DEPARTMENT
working with partners to ensure patients have access to the latest technologies,
THIS
THE  THE
advice and guidance.
BY
10. In 2021, NICE published a new strategy that sets out our strategic priorities for
the next five years with respect to:
•  Rapid, robust, and responsive technology evaluation: providing independent,
world-leading assessments of new treatments at pace, quickening access for
patients, and increasing uptake.
•  Dynamic, living guideline recommendations: creating and maintaining up-to-
date guidance that integrates the latest evidence, practice, and technologies
in a useful and useable format.

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• Effective guidance uptake to maximise our impact: working with our strategic
partners to increase the use of our guidance, monitor adoption and measure
impact on health outcomes and health inequalities.
• Leadership in data, research, and science: becoming scientific leaders by
driving the research agenda, using real world data to resolve gaps in
knowledge and drive forward access to innovations for patients.
Australian Government Department of Health
11. The Office of Health Technology Assessment within the Australian Government
Department of Health is the entity which supports the two independent advisory
committees by which Australian HTA is best known internationally.
12. The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent
CARE
statutory committee comprising experts appointed by the A
UNDER ustralian Minister for
Health. Members include doctors, health professionals, he
1982   alth economists and
AGED
consumer representatives.
ACT
RELEASED AND
13. Its primary role is to recommend new medicines for listing on the Pharmaceutical
BEEN
Benefits Schedule (PBS) or new vaccines for listing
HEALTH   on the National Immunisation
HAS
OF
Program (NIP). No new medicine or new vaccine can be listed in these programs
INFORMATION
unless the committee makes a po
OF sitive recommendation. The PBAC also
considers amendments to and reviews of listed medicines and vaccines.
DOCUMENT
DEPARTMENT
14. The Medical Services Advisory Co
FREEDOM
mmittee (MSAC) is an independent non-
THIS
statutory committee also co
THE  mprising experts appointed by the Australian Minister
THE
BY
for Health. Members include doctors, health professionals, health economists and
consumer representatives.
15. MSAC appraises new medical services proposed for public funding and provides
advice to Government on whether a new medical service should be publicly
funded (and if so, its circumstances) on an assessment of its comparative safety,
clinical effectiveness, cost-effectiveness, and total cost, using the best available
evidence. MSAC considers a range of types of services funded on the Medical
Benefits Schedule (MBS) including medical attendances, procedures, imaging,
pathology, allied health and services funded via other programmes (for example,
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blood products, high-cost therapies such as gene therapy and screening
programmes). MSAC also considers amendments to and reviews of listed
medical services.
Canadian Agency for Drugs and Technologies in Health
16. CADTH is an independent, not-for-profit agency that provides credible, impartial
advice and evidence-based information about the effectiveness of drugs and
other health technologies to Canadian federal, provincial and territorial
governments.
Healthcare Improvement Scotland
17. Healthcare Improvement Scotland has specified functions, under the Public
Services Reform (Scotland) Act, 2010, for the evaluation and provision of advice
UNDER  CARE
to the health service on the clinical and cost effectiveness of new and existing
1982
AGED
health technologies.
ACT
RELEASED AND
18. The Scottish Medicines Consortium (SMC) provides the specified function for
medicines / pharmaceuticals.   The purpose of SMC is to provide advice to NHS
BEEN  HEALTH
Scotland about the clinical and cost-effectiveness status of newly licensed
HAS INFORMATION
OF
medicines and new indications for established products. The advice is advisory
OF
not mandatory.

DOCUMENT
19. SHTG provides the specified fu
FREEDOM  nction fo
DEPARTMENT  r health technologies that are not
THIS
medicines / pharmaceutica
THE  ls. SHTG’s advice to NHS Scotland on the use of
THE
BY
health technologies takes into account clinical effectiveness, safety and cost
effectiveness, as well as expert stakeholder views.  SHTG’s work programme is
determined via an open topic referral process, and SHTG’s advice is provided
across a variety of formats – from early research support to in-depth health
technology assessments.  SHTG advice is advisory not mandatory.
Health Technology Wales
20. Health Technology Wales (HTW) was established in 2017 and brings together
NHS clinicians, healthcare professionals, academics, health economists, industry
representatives and public partners to provide advice on strategic management

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relating to the identification, appraisal and adoption of non-medicine technologies
to the Welsh Government’s Minister for Health and Social Care Services and
Welsh health boards. All seven Welsh health boards are represented on the HTW
Appraisal Panel. Health Technology Wales is hosted by Velindre University NHS
Trust.
All Wales Therapeutics and Toxicology Centre (AWTTC)
21. The All Wales Therapeutics and Toxicology Centre (AWTTC) is an NHS Wales
organisation, which provides a portfolio of services to NHS Wales. Each of the
sections within AWTTC has a unique function and a different focus; medicines
access and pathways, commercial arrangements for medicines, medicines
optimisation and development of best practice guidance, pharmacovigilance and
reporting of adverse drug reactions, analysis and monitoring of prescribing data
UNDER  CARE
and clinical toxicology services.
1982
AGED
22. AWTTC provides expert clinical, scientific, technical,
ACT  analytical, health economic
RELEASED AND
and administrative support to Welsh Government’s advisory committee on
medicines and prescribing, the All Wales Me
BEEN
dicines Strategy Group (AWMSG),
HEALTH
for the purpose of assisting in creating a healthier, better informed Wales.
HAS INFORMATION
OF
Principles
OF

23. In implementing this Collaborati
DOCUMENT  on Arrangement, the Partner Organisations are
FREEDOM
DEPARTMENT
aware of and mutually decide to uphold the following principles for the working
THIS  THE
relationship, subject
THE  to any laws, policies or other legal obligations of the Partner
BY
Organisations, including confidentiality obligations to third parties:
• Mutually supportive, respecting the status and the independence of all Partner
Organisations from each other.
• Valued at the highest level of each Partner Organisation, with visible
leadership, clear lines of accountability, and a coherent corporate approach.
• Open and transparent, with all Partner Organisations sharing information to
inform good decision-making and to minimise risk.
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•  Efficient, with business processes designed to deliver outputs quickly,
facilitate rapid communication between the Partner Organisations and to
enable the Collaboration to change and develop.
•  Based on mutual recognition and acknowledgement of each Partner
Organisation’s contributions, joint working and collaboration, for example,
through shared and mutually decided communications, conferences,
workshops.
•  Based on full adherence to any relevant legislation or governance standards
of each Partner Organisation.
Joint priorities and areas of work
Joint work and objectives
CARE
24. Through major developments in the international healthcare la
UNDER  ndscape over the
past decade, current HTA paradigms are increasingly cha
1982   llenged, and new
AGED
solutions needed. Many of these challenges are common to HTA organisations
ACT
RELEASED AND
internationally. This Collaboration Arrangement provides the basis for the Partner
Organisations to work together to identify and characterise issues of common
BEEN  HEALTH
interest and to share and develop solutions. The Collaboration is expected to
HAS INFORMATION
OF
deliver incremental improvements to Partner Organisations’ work through sharing
OF
best practice and “step change” solutions by collaborating on major challenges.
25.  The specific areas expected t
DOCUMENT o be of most importance for joint working over the
FREEDOM
DEPARTMENT
term of this Arrangement are outlined in Appendix 1.
THIS
THE  THE
Communication  BY
26.  Where appropriate, the Partner Organisations will determine a joint
communication approach to support this Collaboration Arrangement that will
recognise the collaborative nature of the mutually determined joint priorities and
areas of work.
Governance framework for publication of joint pieces of work
27. Where the Partner Organisations produce and intend to publish joint documents
and outputs, the relevant documents should set out:
•  The intended audience

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•  The aims and purpose
•  The scope of the document and what it is trying to achieve
•  Any other relevant partners involved in producing the document
•  Where the documents will be published and stored (online)
•  The need and approach to updating the document, where appropriate, and
who holds responsibility for doing so
•  Clear joint labelling indicating joint ownership.
28. The documents should receive legal clearance from each participating Partner
Organisation, where appropriate.
29. The documents should be formally approved and signed off by a relevant senior
representative of each Partner Organisation.
UNDER  CARE
30. The Partner Organisations intend to manage any intellectual property rights
1982
AGED
resulting from their joint efforts under this Arrangement through separate
ACT
agreements, factoring in relevant and applicable legislati
AND  on, if required.
RELEASED
Monitoring and arrangements f
BEEN  or engagement
HEALTH
HAS
OF
31.  At a working level, the Partner Organisations wi
INFORMATION  ll meet in working groups aligned
to the priority areas in appendix
OF 1. These groups will meet on a 3-monthly basis
to review operational progress and discuss activities in their priority area. There
DOCUMENT
will be an annual meeting of all Partner Organisations to review all activities and
FREEDOM
DEPARTMENT
to realign where a
THIS ppropriate the developing areas of collaboration. The frequency
THE  THE
of meetings may be re-evaluated once the work activities are established.
BY
Arrangements
32. The Partner Organisations may amend any part of this Arrangement by mutual
written consent. Any such amendment will be an integral part of this Arrangement
and take effect on such date as may be decided by the Partner Organisations in
writing.
33. Any amendment will not prejudice any specific understanding between the
Partner Organisations arising from, or based on, this Arrangement (including, but

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not limited to, any specific streams of work mutually determined between the
Partner Organisations) before, or up to, the date of such amendment.
34. New organisations may be added as a Partner Organisation during the period of
the Collaboration Arrangement, subject to the acceptance of all existing Partner
Organisations. They will accept the principles and arrangements of this
Collaboration and will become a Partner Organisation as of the date of their
signature upon the updated Collaboration Arrangement.
35. Organisations may also stand down as a Partner Organisation with reasonable
notice to all of the remaining Partner Organisations. When leaving, any shared
information access accrued up to the date of termination and the commitments to
grant access to information shared under and subject to clause 4 will continue in
full effect. For the avoidance of doubt, if under clause 4 separate information
UNDER  CARE
sharing arrangements have been put in place, nothing in this arrangement will
1982
AGED
affect the rights and obligations of those separate arrangements.
ACT
RELEASED AND
36. If a Partner Organisation defaults and is required to leave the Collaboration due
to the default then it will be required to co
BEEN  ntinue to allow the Partner
HEALTH
Organisations to hold and use its shared information under and subject to clause
HAS INFORMATION
OF
4 but it must delete any and all copies of such information shared with it and not
OF
be permitted to use such shared information. This will occur immediately upon
exit of the Collaboration.
DOCUMENT
FREEDOM
DEPARTMENT
37. If only one Partner Org
THIS
anisation remains, the Collaboration will cease to exist.
THE  THE
BY
Signatures
Signed by, for and on behalf of the National Institute for Health and Care Excellence,
Level 1 City Tower, Piccadilly Gardens, Manchester, M1 4BD, United Kingdom

Name:

Dr Sam Roberts
Chief Executive
Position:
SIGNATURE
Signature:
DD MONTH YYYY
Date:

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Signed by, for and on behalf of the Canadian Agency for Drugs and Technologies in
Health, 865 Carling Ave., Suite 600 Ottowa, ON Canada K1S 5S8

Name:

Suzanne McGurn
President and Chief Executive
Position:
Officer
SIGNATURE
Signature:
DD MONTH YYYY
Date:

UNDER  CARE
Signed by, for and on behalf of the Australian Government Department of Health,
1982
AGED
PO Box 9848, Canberra ACT 2601, Australia
ACT

RELEASED AND
Name:

Dr Brendan Murphy
BEEN  HEALTH
Secretary
Position:
HAS INFORMATION
OF
SIGNATURE
Signature:
OF
DD MONTH YYYY
Date:
DOCUMENT

FREEDOM
DEPARTMENT
THIS
Signed by, for and on behalf of Healthcare Improvement Scotland (including the
THE  THE
Scottish Medicines Conso
BY  rtium and the Scottish Health Technologies Group), Delta
House, 50 West Nile Street, Glasgow, G1 2NP, Scotland

Name:

Dr Safia Qureshi
Director of Evidence
Position:
SIGNATURE
Signature:
DD MONTH YYYY
Date:

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Signed by, for and behalf of Health Technology Wales (hosted by Velindre University
NHS Trust), The Life Science Hub, 3 Assembly Square, Cardiff, CF10 4PL, United
Kingdom

Name:

Steve Ham
Chief Executive, Velindre University
Position:
NHS Trust
SIGNATURE
Signature:
DD MONTH YYYY
Date:
CARE

UNDER
Signed by, for and behalf of the All Wales Therapeutics and To
1982   xicology Centre,
AGED
Cardiff & Vale University Health Board, University Hospital, Llandough, Penlan
ACT AND
Road, Llandough, CF64 2XXUnited Kingdom
RELEASED

BEEN  HEALTH
Name:

Dr James Coulson MD FRCP
HAS INFORMATION
OF
Interim Clinical Director
Position:
OF
SIGNATURE
Signature:
DOCUMENT
DD MONTH YYYY
Date:
FREEDOM
DEPARTMENT
THIS
THE  THE
BY

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Appendix 1:  Priority areas for collaboration
1.  The Partner Organisations have identified the following areas of substantive work
for  joint  collaboration  over  the  course  of  this  Arrangement,  which  reflect  the
strategic priorities for our organisations.

The working level contacts (set out in Appendix 2) will have overall ownership for
progress of the priority areas. Progress against the joint areas will be reviewed at
frequent intervals.

Priority 1: COVID 19-related intelligence sharing
Partner Organisations to share experiences on
UNDER  CARE
-  working with regulators
1982
AGED
-  prioritisation of topics
ACT
-  management of medicines with good evidence but n
AND  o plans for obtaining
RELEASED
marketing approval
BEEN
-  planning for HTAs
HEALTH
-  approaches to modelling  HAS INFORMATION
OF
OF
to optimise approaches to the management of COVID 19 topics across
agencies.
DOCUMENT
FREEDOM
DEPARTMENT
Priority 2: future-proofing of HTA systems
THIS
THE  THE
Partner  Organisations  to  exchange  ideas  on  processes  to  better  anticipate
BY
technological and methodological challenges for HTA and to work in scientific and
methodological  areas  to  address  challenges  before  they  become  issues.  This
could include exploring areas such as environmental sustainability and real-world
evidence.

Priority 3: collaborating with regulators
Joint approach to engaging with the regulatory agencies in the UK, Canada and
Australia to identify and progress opportunities to improve HTA and regulatory
collaboration.

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Priority 4: work-sharing and efficiency gains
Partner Organisations to capitalise on individual strengths, explore the feasibility
of a mutual recognition system for already published information by a Partner
Organisation, and explore running a pilot for a joint clinical assessment.
Priority 5: Digital and AI
Partner Organisations to share intelligence around developments in the
evaluation of digital health technologies including technologies that involve AI.
Explore areas such as approaches to evaluating adaptive algorithms, aligning
with regulators, allowing for regular algorithmic updates, HTA evidence
requirements and on-going data monitoring.
UNDER  CARE
2.
Work on the joint priority areas will be taken forward through  dedicated working
1982
groups aligned to the priority areas. Further separate groups
AGED  and sub-groups will
ACT
be established as and when required. RELEASED AND
BEEN  HEALTH
HAS INFORMATION
OF
OF
DOCUMENT
FREEDOM
DEPARTMENT
THIS
THE  THE
BY
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Appendix 2:  Working-level key contacts
For National Institute for Health and Care Excellence
Name
s47F
Office Address
Level 1 City Tower, Piccadilly Gardens, Manchester, M1
4BD
Telephone
s47F

number
E mail address
CARE
s47F
x@xxxx.xxx.xx
UNDER
1982

AGED
ACT
For Canadian Agency for Drugs and Technologies in H
AND ealth
RELEASED
Name
s47F
  BEEN  HEALTH
Office Address
154 University A
HAS  venue,
OF  Suite 300, Toronto ON M5H 3Y9
INFORMATION
OF
Telephone
s47F

number
DOCUMENT
FREEDOM
DEPARTMENT
E mail address THIS  s47F @cadth.ca
THE  THE
BY

For the Australian Government Department of Health
Name
s22
Office of Health Technology Assessment
Office Address
Australian Government Department of Health, PO Box 9848,
Canberra ACT 2601, Australia

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Telephone
T: +612 6289 s22
| M: s22

number
E mail address
s22
@health.gov.au
MSAC: s47E(d)
@health.gov.au
PBAC:
@
s47E
health.gov.au
(d)

For Scottish Medicines Consortium
Name
s47F

Office Address
Delta House, 50 West Nile Street, Glasgow, G1 2NP
Telephone
s47F

UNDER  CARE
number
1982
AGED
E mail address
s47F
@nhs.scot
ACT
RELEASED AND

BEEN  HEALTH
For Scottish Health Technologies Group
HAS INFORMATION
OF
Name
s47F
  OF
Office Address
Delta House, 50 West Nile Street, Glasgow, G1 2NP
DOCUMENT
FREEDOM
DEPARTMENT
Telephone
s47F

THIS  THE
number
THE
BY
E mail address
s47F
@nhs.scot

For Health Technology Wales
Name
s47F

Director of Health Technology Wales (part of Velindre
University NHS Trust)

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Office Address
The Life Sciences Hub Wales, 3 Assembly Square, Cardiff
Bay, Cardiff, CF10 4PL
Telephone
s47F
number
E mail address
s47F
@wales.nhs.uk
For All Wales Therapeutics & Toxicology Centre
Name
s47F

Office Address
All Wales Therapeutic & Toxicology Centre
The Routledge Academic Centre
UNDER  CARE
University Hospital Llandough  1982
Penlan Road
AGED
ACT
PENARTH
RELEASED AND
CF64 2XX
BEEN  HEALTH
Telephone
s47F
HAS INFORMATION
OF
number
OF
E mail address
s47F
@wales.nhs.uk
DOCUMENT
FREEDOM
DEPARTMENT
THIS
THE  THE
BY
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Document Outline