POLICY ON JOINT WORKING WITH THE PHARMACEUTICAL INDUSTRY Issued by: Director of Quality, Governance and Patient Safety Policy Classification: Corporate Issue No: 001 Page No: 1 of 19 Policy No. POLCP007 Date Issued: 23/01/2014 Review Date: 22/01/2017
DOCUMENT CONTROL Document Name: Joint Policy Location: Consultation: Q/CCG POLICIES & TEMPLATES/BCCG POLICIES/CORPORATE Ratified by: CCG Governing Body Date: 23/01/2014 Supersedes: Description: Audience: Contact details: Code of conduct for CCG individuals and groups for receiving support, sponsorship and for joint working with the pharmaceutical industry. Governing Body, All Committees, All staff, All individuals working for the CCG keith.fowler@bromleyccg.nhs.uk Change History Version Date Author Approver Reason V0.1 02/01/2014 K Fowler Governing Body Draft for CCG Authorisation purposes Policy Ratified 23/01/2014 2
CONTENTS Page Definitions 4 1. Policy Statement 5 2. Scope of Policy 5 3. Responsibilities 6 3.1. Core Values 3.2. Principles 4. Organisational Arrangements 7 4.1. Personal declarations of interest 4.2. Sponsorship 4.3. Commercial partnerships 5. References 8 6. Appendices 10 Appendix 1: Declaration of Personal and Financial Interests Appendix 2: Commercial Sponsorship declaration form Appendix 3: Framework Checklist for Assessment of Joint Projects and Collaborative Working Policy Ratified 23/01/2014 3
DEFINITIONS Joint Working: Sponsorship: Commercial Partnership GMC: PMMG: GDC GPhC: NMC: Pharmaceutical Industry: ABPI: Joint working is different from sponsorship; in joint working goals are agreed jointly by the NHS organisation and the company/ies. The goals will be in the interests of patients and are shared throughout the project. A joint working agreement is drawn up and management arrangements are conducted with participation from all parties in an open and transparent manner For purposes of this policy, sponsorship includes any funding or support offered from the pharmaceutical industry, including all, or part of, the costs of a member of staff, training, pharmaceuticals, equipment, meeting rooms, costs associated with meetings, meals, gifts, hospitality, hotel and transport costs, and provision of services, buildings or premises. A commercial partnership is one where materials or support is supplied by a third party in addition to, and capable of being integrated with, services routinely provided in public sector health care. General Medical Committee Prescribing and Medicines Management Group General Dental Council General Pharmaceutical Council Nursing and Midwifery Council For purposes of this policy, any company that manufactures pharmaceuticals including dressings, appliances and medical devices. Association of British Pharmaceutical Industry Policy Ratified 23/01/2014 4
1. POLICY STATEMENT The Department of Health guidance Best practice Guidance on Joint working between the NHS and Pharmaceutical Industry and other relevant Commercial Organisations encourages NHS organisations and staff to consider opportunities for joint working with the pharmaceutical industry where the benefits to patients care and the differences it can make to patients health and well being are clearly advantageous. The pharmaceutical industry is involved with the NHS at all levels of the organisation and collaborative working is one of a range of options which are available to help meet the needs of patients and achieve clinical excellence. This Policy addresses the need for NHS Bromley CCG staff and representatives to manage pharmaceutical industry approaches appropriately and recognises the potential benefits to the CCG and the population of Bromley. Staff should be aware of both the NHS guidance (see Reference 1 below) and their own professional code of conduct for working with the pharmaceutical industry where available e.g. GMC, NMC, GDC, GPhC, and codes. 2. SCOPE OF POLICY This policy applies to: 2.1 All staff employed by, and individuals working for Bromley CCG (BCC) including Governing Body members 2.2 All individual items of hospitality, gifts, services, equipment, payments received, valued at above approximately 25 OR several items of lesser value from a single source adding up to a value of more than 100 in one year. 2.3 All forms of funding or sponsorship provided by the pharmaceutical industry including costs of staff, research, training, pharmaceuticals, equipment, meeting rooms, costs associated with meetings, meals, gifts, hospitality, hotel and transport costs, provision of free services (e.g. speakers), buildings or premises. 2.4 It is recommended that independent practitioners are aware of and apply the principles of this policy to their own practice. 2.5 This Policy should be read in conjunction with Bromley CCG s Anti-Fraud, Bribery and Corruption Policy (see Reference 6 below) and the Conflicts of Interest Policy (see Reference 5 below) Policy Ratified 23/01/2014 5
3. RESPONSIBILITIES In addition to professional codes of conduct, the following values and principles must underpin all joint working with Bromley CCG: 3.1. Core Values a. Accountability - Everything done by those in the NHS must be able to stand up to scrutiny by others b. Probity - Staff who deal with assets of the NHS should be honest and have integrity in everything they do c. Openness - There should be sufficient transparency about NHS activities to promote confidence between the organisation, its staff, patients and the public. CCG staff conduct must also adhere to the following values: Transparency and trust. Appropriateness of projects Patient focussed Value for Money Reasonable Contact Responsibility Impartiality and honesty Truthfulness and fairness 3.2. Principles a. Working in partnership should not conflict with professional ethics b. Openness and transparency of all parties making benefits explicit to both parties c. Clinical and prescribing protocols/guidelines are based on evidence based medicine and cost effectiveness, consistent with national guidelines, where available d. All joint working between the pharmaceutical industry and Bromley CCG must benefit the population of Bromley e. Pharmaceutical industry representatives must comply with the ABPI code at all times f. Bromley CCG staff must comply with the relevant NHS and professional ethics and code of conduct at all times g. Where joint working involves research, best practice should be applied in consultation with the Quality Assurance Subcommittee of Bromley CCG. Policy Ratified 23/01/2014 6
h. Data confidentiality must be maintained in line with the Data Protection Act and access to patient identifiable information in line with the Health & Social Care Act 2012. 4. ORGANISATIONAL ARRANGEMENTS 4.1. Personal Declarations of Interest 4.1.1. Declarations of personal interests, or finance should be made to the Head of Corporate Affairs (Appendix 1) who will keep a Register of Interests for the Governing Body and staff and individuals working for the CCG in line with the CCG s Conflicts of Interest Policy (see Reference 5 below). 4.1.2. All individual items of support, gifts, hospitality, services and equipment, and payments received, valued at above approximately 25 OR several items of lesser value from a single source adding up to a value of more than 100 in one year, should be declared in this register. This register is reviewed and updated regularly by the Head of Corporate Affairs, reported to the Governing Body and made available to the public. 4.1.3. When any part-time/sessional individuals working for the CCG, including Governing Body members, are involved in dialogue with pharmaceutical industry personnel, they should first ascertain in what capacity the industry is approaching them and make it clear at the start of such dialogue whether they are responding in their capacity as a member of the CCG in their commissioning role, OR as an independent practitioner e.g. GP or nurse in their providing role. Responses should be adapted accordingly. 4.1.4. Staff and individuals working for the CCG are obliged to report immediately to the Head of Corporate Affairs any relevant new interests as and when they arise during the financial year within 28 days of them arising. Quarterly reminders will be sent with regard to this duty. CCG staff or representatives who fail to declare their interests may be subject to investigation and where appropriate disciplinary proceedings. 4.2. Sponsorship 4.2.1. Any funding or sponsorship provided by the Pharmaceutical Industry for training or educational purposes, for an individual or group, within the organisation including hospitality should be declared to CCG s Head of Corporate Affairs. 4.2.2. Funding for organisational activities will be recorded in the CCG s Commercial Organisations Support Register held by the Head of Corporate Affairs. The register must be available for all CCG Governing Body meetings and for public scrutiny if required. 4.2.3. Any form of sponsorship should be transparent and not lead to conflict of interest between the parties involved. 4.3. Commercial Partnerships 4.3.1. Where support for a joint initiative such as practice audits, diagnostic services or research and development is to be provided, a written agreement must be Policy Ratified 23/01/2014 7
drawn up between the CCG and the pharmaceutical company(ies) involved, in line with the Department of Health Toolkit (see Reference 2 below). Such a written agreement should explicitly state the benefits and obligations for both parties (Appendix 3). 4.3.2. The completed form should then be considered by the CCG s Quality Assurance Subcommittee who will recommend to the Integrated Governance Committee and/or Governing Body whether the joint initiative should be approved. 4.3.3. The CCG may consider proactively approaching specific companies for support in implementing previously agreed and documented local prescribing decisions. In any such approaches, particular attention will be paid to ensure that a clear record of decisions made, dates and details of approaches made to companies recorded, thus enabling a transparent decision making process. 4.3.4. Where appropriate, CCG staff should seek advice from NHS England and/or neighbouring CCGs, regarding the envisaged impact of the proposed arrangements on any wider aspects of healthcare across South East London. 4.3.5. Before entering a partnership with the pharmaceutical industry, arrangements must comply with Annex B of the DH guidance on Commercial Sponsorship- Inducements and Hospitality (see Reference 3 below). 4.3.6. The declaration of interests which arise from the partnership will be documented in the CCG s Commercial Organisations Support Register held by the Head of Corporate Affairs. This Register will be reviewed annually. 5. REFERENCES 1. Best Practice Guidance for Joint Working between the NHS and Pharmaceutical Industry and other relevant organisations February 2008 (accessed 14.11.11) http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/publ icationsandstatistics/publications/publicationspolicyandguidance/dh_082370 2. Moving beyond sponsorship: Interactive toolkit for joint working between the NHS and the Pharmaceutical Industry August 2010 http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/pub licationsandstatistics/publications/publicationspolicyandguidance/dh_082840 3. Commercial sponsorship Ethical Standards for the NHS. DH November 2000 (accessed 14.11.11) http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/publicationsandstatistics/p ublications/publicationspolicyandguidance/dh_4005135 4. The Code of Practice for the Pharmaceutical Industry 2012 Policy Ratified 23/01/2014 8
http://www.abpi.org.uk/our-work/library/guidelines/pages/code-2012.aspx 5. NHS Bromley CCG Conflicts of Interest Policy (ratified 12/09/2013) http://www.bromleyccg.nhs.uk/newspublications/policies/pages/default.aspx Policy Ratified 23/01/2014 9
Appendix 1 NHS BROMLEY CCG DECLARATION OF INTEREST FORM Members, employees and individuals working for the CCG declaration form: Financial and other interests This form is required to be completed in accordance with the CCG s Constitution and Policy on Conflict of Interests. Notes: Within 28 days of a relevant event, members (including lay member) and employees need to register their financial and other interests. If any assistance is required in order to complete this form, then the member or employee should contact (the Head of Corporate Affairs) The completed form should be sent by both email and signed hard copy to keith.fowler@bromleyccg.nhs.uk Any changes to interests declared must also be registered within 28 days of the relevant event by completing and submitting a new declaration form. The register will be published on the CCG website: www.bromleyccg.nhs.uk Information assessed not to be in the public interest or to breach privacy may be redacted and should be discussed with the Head of Corporate Affairs. Members, employees and individuals completing this declaration form must provide sufficient detail of each interest so that a member of the public would be able to understand clearly the sort of financial or other interest the member or employee has and the circumstances in which a conflict of interest with the business or running of the CCG might arise. If in doubt as to whether a conflict of interest could arise, a declaration of the interest should be made. Interests that must be declared: 1. Roles and responsibilities held within member practices; Policy Ratified 23/01/2014 10
2. Directorships, including non-executive directorships, held in private companies or PLCs (who do, will or could conduct their business in the field of health and social care); 3. Ownership or part-ownership of private companies, businesses or consultancies likely or possibly seeking to do business within the CCG 4. Shareholdings (more than 5%) of companies in the field of health and social care; 5. Positions of authority in an organisation (e.g., charity or voluntary organisation) in the field of health and social care; 6. Any connection with a voluntary of other organisation contracting for NHS services; 7. Research funding/grants that may be received by the individual or any organisation they have an interest or role in; 8. Other specific interests; and 9. Any other role or relationship which the public could perceive would impair or otherwise influence the individual s judgement or actions in their role within the CCHG. 10. Whether such interests are those of the individual themselves or of a family member, close friend or a personal business contact of the individual. Policy Ratified 23/01/2014 11
DECLARATION: Name: Position within the CCG Interests Type of Interest Details Personal interests or that of a family member, close friend or a personal business contact? Roles and responsibilities held within member practices Details Materiality 1 Value Directorships, including nonexecutive directorships, held in private companies or PLCs Details Materiality Value Ownership or partownership of private companies, businesses or consultancies likely or possibly seeking to do business with the CCG Shareholdings (more than 5%) of Details Details Materiality Value Materiality 1 Related party disclosures must be in accordance with IAS 24 Related Party Disclosures. HM Treasury considers Government Departments and their agencies, and Department of Health Ministers, their close families and entities controlled or influenced by them, as being parties related to NHS bodies. A disclosure is required if a transaction (or series of transactions) is material on either side, i.e. if a transaction is immaterial from the CCG perspective but material from a related party viewpoint then the CCG must disclose it. Policy Ratified 23/01/2014 12
companies in the field of health and social care Value Positions of authority in an organisation (e.g. charity or voluntary organisation) in the field of health and social care Any connection with a voluntary or other organisation contracting for NHS services Research funding/grants that may be received by the individual or any organisation they have an interest or role in [Other specific interests?] For example are you a patient or service user for a service over which you have some decision making responsibility 2 Any other role or relationship which the public could perceive would Details Details Details Details Details Materiality Value Materiality Value Materiality Value Materiality Value Materiality 2 Such a declaration would usually be expected to become a consideration when, and if, considering issues related to service configuration. Policy Ratified 23/01/2014 13
impair or otherwise influence the individual s judgement or actions in their role within the CCG Value To the best of my knowledge and belief, the above information is complete and correct. I undertake to update as necessary the information provided and to review the accuracy of the information provided regularly and no longer than annually. I give my consent for the information to be used for the purposes described in the CCG Constitution and Conflict of Interests Policy. Signed: Dated: Policy Ratified 23/01/2014 14
Appendix 2 DECLARATION OF SPONSORSHIP I wish to declare that I have received sponsorship for the following purpose;....... Company(ies) providing sponsorship.... Sponsorship amount.. Payment to be used for.. o Sponsorship is accepted on the understanding that the company will abide by the ABPI code of practice o Bromley CCG will be accountable for ensuring that the values and principles of the working with industry policy are upheld Signed.. Line Manager..Signed Name Print Name. Designation.. Designation. Department. Date.. Submit form to the CCG Head of Corporate Affairs Policy Ratified 23/01/2014 15
Appendix 3: FRAMEWORK FOR PARTNERSHIP WORKING TITLE OF PROJECT: Name of Joint working Organisation(s): including address, phone and fax nos. Industry Contact Name(s): including phone, fax and e- mail contacts Name of NHS organisation entering partnership CCG contact Name(s) Summary of aims and objectives of the project Summary of expected outcomes Exact Nature of Partnership proposal Start Date Finish Date Exit Strategy FINANCIAL/RESOURCE IMPLICATION Overall budget for the project Direct and Indirect resource/cost commitments from each partner How will resources/costs be monitored List valid and relevant information on cost effectiveness Has value for money been shown? If so please indicate Bromley Clinical Commissioning Group Policy Ratified 23/01/2014 16
Are there any ongoing cost implications when the project ends? GOVERNANCE ARRANGEMENTS Who has been consulted prior to the partnership project How will patients be informed of the project? Is there an open and transparent decision making process OPERATIONAL AND MANAGEMENT ARRANGEMENTS How does the project relate to and integrate with existing systems of care in primary and secondary care sectors Has the project been piloted? if not are there plans and how will this be done Has the proposal been compared with other partnership proposals currently on offer MONITORING AND EVALUATION Who has designated responsibility at each stage of the project On completion how will it be evaluated in terms of patient benefits What will be/have been the learning outcomes/opportunities What audit arrangements are available? Policy Ratified 23/01/2014 17
DATA AND PATIENT PROTECTION What interests do the company and NHS have in relation to the proposal? What are the potential conflicts of interest? Who owns the data generated by the audit and monitoring of the partnership? Who has access to the data and in what form. i.e. aggregation and anonymisation criteria (bearing in mind the Data Protection Act and the requirement of the patients confidentiality of healthcare records) How will data be used? Project progress will be reviewed regularly and this agreement will be reviewed during the 200. financial year (or insert a specific review date). Principles governing our agreement: ( (Insert company name) may only be involved in the project to the extent defined by the framework and in a manner that is consistent with the set of principles for working with commercial organisations listed below. Clinical aspects will always remain under local control. The company cannot promote its products or services associated with this project beyond the work it is supporting, unless specifically agreed in advance by the CCG. Acknowledgement of the support of the company will be made in any reports resulting from the work. The identity of any patient, CCG or practice records, or information on prescribing may not be taken from the practice, nor made available to the company except, where previously specifically agreed by the CCG in the form of anonymous audit data. Report(s) or information from this work cannot be used elsewhere without explicit permission from Bromley Clinical Commissioning Group. Policy Ratified 23/01/2014 18
Company: Name: Date: Bromley CCG Chief Officer Name: Date: Bromley CCG Director of Quality, Governance and Patient Safety: Name: Date: Submit form to the CCG Head of Corporate Affairs Policy Ratified 23/01/2014 19