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POLICY AUTHORISATION FORM

NAME OF POLICY:

Policy for the Joint Working between NHS Gloucestershire CCG and the Pharmaceutical Industry or other commercial organisations

JOB TITLE OF AUTHOR:

Deputy Director of Quality

SPONSOR:

Executive Nurse and Quality Lead

NAME OF GROUP: (if applicable)

Quality and Governance Committee (Q&GC)

EQUALITY AND DIVERSITY

An Equality & Diversity assessment has been completed (Please contact the Equality & Diversity Lead)

Date Completed:

CONSULTATION

NAME OF GROUP (S) (complete where relevant)

DATE CONSIDERED

Name of Local Committee or Specialist Group?

NHS Gloucestershire CCG Board

APPROVED BY GOVERNING BODY / AUTHORISED GROUP / DIRECTOR

NAME i.e. Governing Body NHS Gloucestershire GQC

DATE APPROVED

TO BE REVIEWED BY: (Author)

Deputy Director of Quality

DATE TO BE REVIEWED:

February 2022

TO BE COMPLETED BY CO-ORDINATOR

DATE PUT ONTO POLICY REGISTER:

POLICY NUMBER:

61

DATE PLACED ON INTRANET:

POLICY UPDATES/CHANGES (AFTER BOARD/DESIGNATED GROUP APPROVAL) Date Summary of Changes Author/Editor Approved by Version

Jan 2020

Addition of other joint working with commercial organisations and to include more informal arrangements (e.g. verbal)

Teresa Middleton

5.2

1

2

3

4

Page 2 of 17

References and hyperlinks updated

Nov 2017

Hyperlinks updated,

References checked/updated

Section on national database for disclosure altered/updated (within section 5.1.4)

Appendix 3 removed

Addition of register of joint working to be published on CCG website

Addition of references to CCG Corporate Governance Team

Teresa Middleton

5.1

Dec 2015

Hyperlinks updated,

References checked/updated

Section on national database for disclosure altered/updated (within section 5.1.4)

Teresa Middleton

2.0

The Policy Authorisation Form is part of the overall policy template and forms the front of the document and must be completed in all cases Equality and Diversity - Part 2 of the form The policy should be checked to see if it has any adverse effect on any personal group covered by Discrimination Legislation. In order to do this an ‘Impact Assessment’ must be completed. Further advice can be obtained from the Equality and Diversity Lead.

Approval & Review - Part 3 of the form Once the Policy has been approved the name of the group / individual and date of approval should be included. The policy document should be sent to the Policy Co-ordinator to log on the Policy Register. Review and amendments are the responsibility of the Author and Director of the Policy and a date for review must be set and included on the form. However, the Policy Co-ordinator will give a reminder to an author when a policy is overdue a review. The review date must be at least every two years. If, after a review, changes are made the document must be resubmitted, by the Author, for approval and therefore the ‘Policy for Policies’ must be followed again. Any changes should be included in the necessary ‘Policy updates/changes’ section at the beginning of the document. Trust Policy Spreadsheet ‘Information Register’- Part 5 of the form The Policy Co-ordinator will input the approved policy onto the Policy Register and allocate a Policy Number which will be inserted onto the authorisation form and also communicated to the Author via email. The Policy Co-ordinator will also ensure that after a review a new version number is allocated and noted on the register.

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This document may be made available to the public and persons outside of the CCG as part of

the CCG’s compliance with the Freedom of Information Act 2000.

VERSION 6

POLICY NO 61

AUTHOR Deputy Director of Quality

SPONSOR Executive Nurse and Quality Lead

APPROVED BY Information & Quality Governance Committee

APPROVAL DATE February 2020

REVIEW DATE February 2022

Policy for Joint Working between NHS Gloucestershire

CCG and Pharmaceutical Industry or other commercial

organisations

4

CONTENTS Section Section Heading Page

Number

1 Introduction 5

2 Purpose 5

3 Roles and responsibilities 5

4 Definition 5

5 Policy Details 6

6 Consultation 7

7 Target audience 8

8 Communication 8

9 Training 8

10 References 8

SUPPORTING DOCUMENTS

Appendix 1 Framework for Joint Working between

NHSG CCG & Pharmaceutical Industry or other commercial organisations

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Appendix 2 Joint Working Agreement Template 14

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1. Introduction 1.1. Department of Health (DH) Guidance1 encourages NHS organisations and their

staff to consider opportunities for joint working with the pharmaceutical industry, where the benefits that this could bring to patient care and the difference it can make to their health and well-being are clearly advantageous.

1.2. This policy is to assist NHS Gloucestershire Clinical Commissioning Group (NHSG CCG) to achieve its objectives and delivery of national and local priorities, working where appropriate by building effective and appropriate working relationships with the pharmaceutical industry or other commercial organisations.

2. Purpose 2.1 This policy will inform and advise staff of their main responsibilities when

entering into joint working arrangements with the pharmaceutical industry or other commercial organisations. Specifically, it aims to:

assist NHS employers and staff in maintaining appropriate ethical standards in the conduct of NHS business;

highlight that NHS staff are accountable for achieving the best possible health care within the resources available;

3. Roles and responsibilities

3.1 This document specifies the process for NHSG CCG and its staff to follow when undertaking a joint working arrangement with the pharmaceutical industry or other commercial organisations.

3.2 For the purposes of this guidance, the term ‘staff’ refers to:

3.2.1 All staff employed by NHSG CCG including hosted services and advisors employed on a consultancy basis

3.2.2 All NHSG CCG board members

3.2.3 Any third party organisations appointed to act on behalf of NHSG CCG to arrange pharmaceutical industry or other commercial sponsorship

3.3 Although not compulsory this guidance is also recommended to all

independent contractors including general practitioners, community pharmacies, community dentists and community optometrists and their associated staff.

3.4 Staff are reminded that at all times they have a responsibility to comply with

their own professional codes of conduct, and that representatives of the pharmaceutical industry must comply with the ABPI Code of Practice for the Pharmaceutical Industry.2

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4. Definition 4.1 Joint working is defined as situations where, for the benefit of patients,

organisations pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery. These situations are conducted in an open and transparent manner.

4.2 Joint working differs from sponsorship, where pharmaceutical companies or

other commercial organisations simply provide funds for a specific event or work programme.

5. Policy Details 5.1 Principles of Joint Working 5.1.1 Joint working must be for the benefit of patients and the NHS and to preserve

patient care. Any joint working between the NHS and the pharmaceutical industry or other commercial organisations will be conducted in an open and transparent manner. Arrangements should be of mutual benefit, the principal beneficiary being the patient. The length of the arrangement, the potential implications for patients and the NHS, together with the perceived benefits for all parties, should be clearly outlined before entering into any joint working.

5.1.2 In our commissioning, contracting and partnership working we would look to

see similar processes and assurances about working with the pharmaceutical industry or other commercial organisations in those organisations that we work with and have contact with. We would wish to make sure that our clearly stated principles of transparency and a focus on patient benefit and the adoption of best value, modern and innovative, clinically effective care and treatments are shared and supported by their procedures for relationships with the pharmaceutical industry or other commercial organisations. This will be clearly stated in contracts and agreements. A register of joint working projects between the CCG and Pharmaceutical Industry or other commercial organisations will be published on the CCG’s website.

5.1.3 The following principles will also apply to joint working:

Staff should be aware of NHS guidance, the legal position and appropriate and relevant professional codes of conduct as described in existing NHS guidance3

Contract negotiations will be negotiated in line with NHS values

Confidentiality of information received in the course of duty must be respected and never used outside the scope of the specific project

Joint working arrangements should take place at a corporate, rather than an individual, level

Clinical and financial outcomes will be assessed through a process of risk assessment.

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5.1.4 NHSG CCG has a mechanism in place for recording and monitoring, and evaluating any joint working arrangements. This mechanism consists of:

The main points of contact for the pharmaceutical industry or other commercial organisations is NHSG CCG Deputy Director of Quality and CCG Associate Director of Corporate Affairs

Review of any potential joint working arrangements will include consultation with the CCG Corporate Governance Team to establish the benefits and risks of potential joint working arrangements.

Using the Joint Working: A toolkit for industry and the NHS 5 complete appropriate documentations (Appendix 1 & 2).

Registering all activity with Deputy Director of Quality and is available to Associate Director Corporate Affairs to be quarterly declared at NHS GCCG Governance and Quality Committee.

All Joint working with the Pharmaceutical Industry will be published on the ABPI central platform4

5.1.5. A mutually agreed and effective exit strategy will be in place at the outset of

any joint working arrangement detailing the responsibilities of each party and capable of dealing with a situation where premature termination may become necessary.

Issues that may need to be addressed within a robust exit strategy include:

Mainstreaming the activities;

Intellectual property;

Residual funds;

Staff and /or staff contracts;

Availability and updating of information, tools, products etc. after the end of the project;

Impact on patients.

5.2 Confidentiality and Data Protection

5.2.1 Confidentiality of information received in the course of a joint working

agreement must be respected and must never be used outside the scope of the specific agreement.

5.2.2 Compliance with information governance policy and principles will be

maintained at all times.

5.3 Conflicts of Interest, Payments and Hospitality 5.3.1 All staff are expected to complete declaration of potential conflict of

interest/hospitality documents as and when appropriate. All staff in the CCG are expected to complete a declaration of Interests form. The Standards of Business Conduct Policy sets out the procedures and process for declaring interests.

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5.4 Approval of Joint Working Arrangements

5.4.1 Agreement of joint working arrangements (Appendix 2) by the appropriate Clinical Programme Group Chair in association with Associate Director of Strategic Planning and Deputy Director of Quality.

5.4.2 The Associate Director of Corporate Affairs will maintain a register and

report to the Governing Body of NHSG CCG quarterly

6. Consultation

6.1 This policy will be reviewed and ratified by:

The NHSG CCG Governance & Quality Committee

Deputy Director of Quality 6.2 Consideration on the development of this policy has been given by the

following individuals and groups:

Professional or service area groups within the trust who may have an interest

Senior core team including directors

NHSG CCG Board

NHSG CCG Drugs and Therapeutics Committee

7 Target audience 7.1 The target audience for this policy is for NHS Gloucestershire Clinical

Commissioning Group (NHSG CCG) and its staff who are involved in joint working with the pharmaceutical industry or other commercial organisations.

7.2 Although not compulsory this guidance is also recommended to all

independent contractors including general practitioners, community pharmacies, community dentists and community optometrists and their associated staff

7.3 Staff are reminded that at all times they have a responsibility to comply

with their own professional codes of conduct, and that representatives of the pharmaceutical industry must comply with the ABPI Code of Practice for the Pharmaceutical Industry.2

8 Communication

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8.1 This policy will be communicated to staff by making the policy available on the intranet of the organisation, and formally sending a copy to all Clinical Programme Chairs of NHSG CCG.

8.2 The most up to date policy will always be available under Policies and

Procedures on NHS Gloucestershire CCG intranet. 8.3 This document may be made available to the public and persons outside

of the Trust as part of the NHSG CCG’s compliance with the Freedom of Information Act 2000.

9 Training

9.1 There is no training element to this policy.

10 References

NHSG/GCCG Standards of Business Conduct Policy – 2020

GCCG Counter Fraud, Bribery and Corruption Policy 2017

Bribery Act 2010 http://www.legislation.gov.uk/ukpga/2010/23/contents

Innovation Health and Wealth – December 2011. Gateway 16978

(http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_134597.pdf (now archived)

Innovation Health and Wealth, One Year On – December 2012 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213204/Creating-Change-IHW-One-Year-On-FINAL.pdf

Joint working between the NHS and Pharmaceutical industry toolkit 2010. Gateway 14600.

https://www.networks.nhs.uk/nhs-networks/joint-working-nhs-pharmaceutical/documents/joint%20working%20toolkit%20dh.abpi.pdf

Preparing for joint working and the Seven Steps: A guide for NHS Organisations; Developed by PrescQIPP in collaboration with the Eastern Academic Health Science Network and the ABPI https://www.prescqipp.info/media/2319/preparing-for-joint-working 202.pdf

Joint Working A toolkit for industry and the NHS September 2019 https://www.abpi.org.uk/media/7446/joint-working-a-toolkit-for-industry- and-the-nhs_redacted.pdf

1 Department of Health 2008. Best practice guidance for joint working between the NHS and the pharmaceutical industry. https://www.networks.nhs.uk/nhs-networks/joint-working-nhs-pharmaceutical/documents/dh_082569.pdf 2 ABPI, 2019 Code of Practice for the Pharmaceutical Industry. https://www.abpi.org.uk/media/6655/abpi-code-of-practice-2019.pdf

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3 NHS England publications https://www.england.nhs.uk/publication/conflicts-of-interest-summary-guides/ E.g. Gateway reference number: 06868 Conflicts of interest summary guide for GPs in commissioning roles 4ABPI website The Central Platform (creating a central database) http://www.abpi.org.uk/our-work/disclosure/Pages/DocumentLibrary.aspx https://www.abpi.org.uk/our-ethics/disclosure-uk/ 5 Joint Working A toolkit for industry and the NHS September 2019 https://www.abpi.org.uk/media/7446/joint-working-a-toolkit-for-industry-and-the-nhs_redacted.pdf

FRAMEWORK

FOR JOINT WORKING BETWEEN

THE NHS AND PHARMACEUTICAL INDUSTRY OR OTHER COMMERCIAL ORGANISATIONS

I. JOINT WORKING PROJECT / ARRANGEMENT SUMMARY

1. TITLE OF PROJECT

2. SUMMARY OF INTENDED AIMS &

OBJECTIVES

3. SUMMARY OF EXPECTED OUTCOMES

4. NAMES OF THE PARTNER ORGANISATIONS

INVOLVED IN THE JOINT WORKING

ARRANGEMENT

5. NAMES OF LEAD REPRESENTATIVES FOR

EACH ORGANISATION

6. EXACT NATURE OF THE JOINT WORKING

PROPOSAL

7. START DATE

Appendix 1

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8. FINISH DATE

9. EXIT STRATEGY

II. RESOURCES AND COSTS

1. OVERALL COST OF THE JOINT WORKING

PROJECT

2. DIRECT AND INDIRECT RESOURCES / COST

COMMITMENTS BY EACH PARTNER

3. METHOD FOR MONITORING AND

RECORDING RESOURCE AND COSTS

4. INFORMATION ON COST EFFECTIVENESS

(Has value for money been shown?)

5. ARRANGEMENTS FOR LONGER TERM

FUNDING IMPLICATIONS OF PROJECT (To be clear and unambiguous)

III. GOVERNANCE ARRANGEMENTS

1. PARTIES CONSULTED PRIOR TO INITIATING

JOINT WORKING PROJECT / ARRANGEMENT AND HOW CONSULTATION

WAS CONDUCTED

2. METHOD FOR INFORMING PATIENTS OF

THE JOINT WORKING PROJECT

3. DECISION MAKING PROCESSES WITHIN

THE JOINT WORKING PROJECT / ARRANGEMENT (To be open and transparent)

4. OPERATIONAL AND MANAGEMENT

ACCOUNTABILITIES (Include identified conflicts of interest)

5. PILOTING ARRANGEMENTS (State if this project is a pilot)

6. RELATIONSHIP TO EXISTING SYSTEMS OF

CARE IN PRIMARY AND SECONDARY CARE

SECTORS

7. FOR CLINICAL SERVICES, PROFESSIONAL

INDEMNITY AND LIABILITY ARRANGEMENTS

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8. WRITTEN AGREEMENT STATING

OBLIGATIONS OF CONFIDENTIALITY,

SECURITY STANDARDS AND LIMITS OF USE

OF INFORMATION TO THE PURPOSES

SPECIFIED

IV. MONITORING AND EVALUATION

1. MANAGEMENT ARRANGEMENTS

2. LIST DESIGNATED RESPONSIBILITY AT

EACH STAGE OF THE PROPOSAL

3. METHOD OF EVALUATING PATIENT

BENEFITS ON COMPLETION

4. LEARNING OPPORTUNITIES FROM THIS

PROJECT

5. AUDIT ARRANGEMENTS

6. METHOD FOR HIGHLIGHTING SIGNIFICANT

PROBLEMS

V. DATA AND PATIENT PROTECTION

1. LIST INTERESTS OF PARTNERS IN

RELATION TO THE JOINT WORKING

PROPOSAL AND WHERE THESE COINCIDE

2. LIST POTENTIAL CONFLICTS OF INTEREST

3. IDENTIFY “OWNERSHIP” OF THE DATA

GENERATED BY THE PROJECT

4. DESCRIBE ACCESS ARRANGEMENTS FOR

THE DATA, AND FORMAT (Bearing in mind the requirements of theData Protection Act and patient confidentiality of healthcare records)

5. USE DATA WILL BE PUT TO

VI. DECLARATION OF INTERESTS YES NO

If Yes, qualify by inserting a tick in one box in column A and one in column B

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A B

Personal Specific

Non-Personal Non Specific

Signature Date

Personal implies that you (or your spouse / partner) receive direct payment for services or hold shares in the relevant company concerned or a competitor.

Non-Personal implies that your unit benefits by receiving funding from the company.

Specific implies that you have undertaken work or given advice on other products made by the relevant manufacturer.

This system is based on that used by the Commission on Human Medicines and other national drug regulatory bodies.

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JOINT WORKING AGREEMENT TEMPLATE

AN AGREEMENT FOR JOINT WORKING BETWEEN

NHS Gloucestershire Clinical Commissioning Group

AND

Insert second party (and any others as necessary)

FOR

Insert title of joint working initiative

This agreement is to set out the principles and values that should underpin the joint working arrangement, as well as the objectives and modus operandi for the insert title of joint working initiative.

1. Name and Members of the Joint Working Arrangement

The insert title of joint working initiative will be a joint working arrangement between:

Insert first party

Insert second party (list further parties if more than two)

The working members will be known as the insert title of joint working initiative (Joint Project Group, delete as appropriate). The number of joint working members will be decided to enable decision making to be as effective as possible whilst ensuring inclusiveness. Joint Initiative / Joint Project Group members will be designated by the parties. No more than insert number core Joint Initiative / Joint Project Group members may be assigned to the joint working arrangement by any party, except by agreement of the parties. Joint Initiative / Joint Project Group members may be replaced by an individual from their organisation at any time by a party to ensure continuity. Ad hoc membership may be agreed by the parties from time to time.

Insert relevant name/party will provide secretariat and co-ordination support for the insert title of joint working initiative, by agreement with the Joint Initiative members/ Joint Project Group.

2. Aims and Objectives

Insert a paragraph giving a summary of the aims and objectives of the joint working project / joint initiative.

3. Values

The following values should underpin joint working:

Transparency and trust

Appropriateness of projects

Patient focused

Value for money

Reasonable contact

Responsibility

Appendix 2

15

Impartiality and honesty

Truthfulness and fairness.

4. Principles of Joint Working

The following principles will apply to joint working:

All joint working must be for the benefit of patients;

Joint working will be conducted in an open and transparent manner;

Joint working will take place at a corporate, rather than an individual, level;

Arrangements will be of mutual benefit, the principal beneficiary being the patient;

Contract negotiations will be negotiated in line with NHS values, guidance and procedures;

Confidentiality of information received in the course of the arrangement will be respected and never used outside the scope of the project;

All patient identifiers will be removed from data to preserve and respect patient confidentiality in line with the Data Protection Act;

Reports and information pertaining to the agreement / projects will not be used or published without explicit permission given by all parties;

Joint working must not be used or seen as endorsement or promotion of any specific medicine or product; appropriate disclaimers will be used where necessary

Pharmaceutical companies must comply with the ABPI Code of Practice for the Pharmaceutical Industry at all times;

The company should be a member of the ABPI, or offer a statement that they comply with its requirements. The company should have had no complaints against them regarding contravening ABPI in the previous 2 years

All NHS employed staff must comply with NHS, and relevant professional body, Codes of Conduct at all times (including GCCG’s Standards of Business Conduct policy). Staff must be aware of DH Guidance relating to joint working with the pharmaceutical industry (Best Practice Guidance for Joint Working between the NHS and the Pharmaceutical Industry, February 2008).

5. Procedures at Joint Project Group Meetings

All members should make every effort to be present at Joint Project Group / Joint Initiative meetings;

The quorum for meetings will be at least insert number member from each party;

All discussions taking place in meetings will be confidential, unless stated otherwise, and not disclosed to any unauthorised person. In particular no view or opinion expressed will be attributed to any member by name;

Decisions will be made by consensus of the parties;

If any members of the joint working project are not present at a Joint Project Group / Joint Initiative meeting, their views will be requested either prior to or after the meeting;

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In the event of no consensus being achieved, a majority agreement will be accepted based on at least insert number Joint Project Group / Joint Initiative members from each party supporting the decision.

6. Powers of the Joint Project Group

The Joint Project Group / Joint Initiative members will decide by consensus what projects and plans the parties wish to undertake;

The Joint Project Group / Joint Initiative members may set up sub-committees or working groups which can include ad hoc members or non-members. The Joint Project Group / Joint Initiative members will ratify recommendations made by sub-committees or working groups;

7. Selection of Consultancies (if applicable)

Where any work requires the involvement of a selected external consultancy, this will be selected by the following process:

Drafting and sign-off of Terms of Reference for the consultancy input required;

Drafting and sign-off of quantitative and qualitative Evaluation Criteria for potential suppliers;

Agreement of a List of Suppliers to be invited to tender for the work;

Issuing of Terms of Reference and Evaluation Criteria to potential suppliers;

Receipt and evaluation of proposals from suppliers against the Evaluation Criteria;

Short-listing of potential suppliers;

Presentations by potential suppliers to the Joint Project Group / Joint Initiative members;

Final selection of successful supplier(s).

Any selection process will be open and transparent, and if undertaken by an NHS organisation, will comply with the requirements of the relevant Standing Financial Instructions and Standing Orders.

Consultancies will comply with the relevant Codes of Conduct and Practice referred to in 4 above.

8. Finances

The finance provide by each party will be limited to that agreed. Additional finance may be provided from other sources if agreed by the Parties;

All monies of the joint working arrangement will be held by insert partner and paid against approved invoices;

The Joint Project Group / Joint Initiative member(s) will monitor finances and record costs incurred.

9. Outputs, Monitoring and Evaluation

The length of the arrangement, the potential implications for patients and the NHS, together with the perceived benefits for all parties, together with a mutually agreed exit strategy, will be clearly outlined before commencement of joint working.

The parties will agree arrangements for recording, monitoring and evaluating the joint working arrangement.

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10. Data Ownership

All data generated by the project will be owned insert ownership arrangements by the parties;

No data will be disclosed to any third party except on the explicit agreement of all parties;

Patient confidentiality will be maintained at all times.

11. Communication

All external communication regarding the joint working arrangement and associated projects will be agreed by the Joint Project Group / Joint Initiative members;

All internal communication will be deemed confidential except by the agreement of the Joint Project Group /Joint Initiative members;

Minutes will be taken of all Joint Project Group /Joint Initiative meetings for subsequent agreement at the following meeting.

12. Dissolution

The joint working arrangement shall be dissolved at any time if any party wishes to withdraw; a notice period will be given of insert notice arrangements

Any outstanding matters must be wound up by all parties by agreement.

13. Change of the Joint Working Agreement

Changes may be made to the Joint Working Agreement by consensus of all parties at a meeting convened for the purpose.

14. Declaration of Interests

All declarations of interest must be declared by any working member. Declarations of interest will be recorded insert recording arrangements.

I have read the above Joint Working Agreement and commit to the Terms.

Signed: on behalf of:

Print Name: Date:

Signed: on behalf of:

Print Name: Date:

Appendix 3