Working with the Pharmaceutical Industry Policy: P10 Policy Descriptor This document is intended to serve as a guide to Devon Partnership NHS Trust staff and the Trust as a whole with regard to interacting and working with the pharmaceutical industry. Related policies or documents: Code of Practice for the Pharmaceutical Industry 2016 The Bribery Act 2010 The Code of Conduct: Code of Accountability in the NHS Department of Health 2004 Do you need this document in a different format? Contact PALS 0800 0730741 or email dpn-tr.pals@nhs.net Document Control Policy Ref No & Title: P10 Working with the Pharmaceutical Industry Version: 1.0 (Amn. Sept17 Sec 14.3) Replaces / dated: New Policy Author(s) Names / Job Title responsible / email: Ratifying committee: Director / Sponsor: Primary Readers: Additional Readers Date ratified: 19 th January 2017 Date issued: January 2017 Date for review: January 2019 Date archived: James Lee, Senior Clinical Pharmacist, jameslee5@nhs.net Tina Campbell, Chief Pharmacist, tinacampbell@nhs.net Medicines Optimisation Governance Group Dr Helen Smith Medical Director This policy is applicable to all Trust sites and applies to all Trust staff including independent contractors, agency and Bank staff. This policy may be made available to pharmaceutical representatives on request.
Contents 1. Introduction... 3 2. Purpose... 3 3. Definitions... 3 4. Duties... 3 5. Code of Conduct... 4 6. Philosophy underpinning the relationship between the Trust and the pharmaceutical industry... 5 7. General Information... 6 8. Promotional Activity... 6 9. Samples... 6 10. Hospitality & Meetings... 6 11. Sponsorship... 7 12. Appropriate Projects... 8 13. Principles of Collaborative Working... 8 14. Promotion of Sponsors... 9 15. Register of Sponsorship, Gifts & Hospitality... 9 16. Research & Development... 9 17. Clinical Trials... 10 18. Code of Ethics... 10 19. Monitoring... 11 20. References... 11 21. Acknowledgements... 11 These are the key points for action from this policy: Pharmaceutical representatives can be a useful resource for healthcare professionals and joint working with pharmaceutical industry can help create innovative new services to benefit patients. Staff must ensure that they act honestly and professionally when dealing with the pharmaceutical industry. Requests for sponsorship or running of joint events must first be approved by the local Area Lead Pharmacist by emailing dpn-tr.pharmacyteam@nhs.net. A log of applications will be kept by the Medicines Optimisation team and reviewed as part of the Medicines Optimisation Governance Group. Sponsorship and gifts MUST also be declared according to the annual declaration process. 2
1. Introduction 1.1. The Trust understands the role which the pharmaceutical industry has to play in aiding health professionals in the provision of treatments that are safe and cost-effective for patients in their care. 1.2. Pharmaceutical representatives can be a useful resource for healthcare professionals and joint working with pharmaceutical industry can help create innovative new services to benefit patients. 1.3. This policy provides a framework to assist Trust staff in determining when commercial sponsorship from the pharmaceutical industry or a joint working agreement is appropriate whilst maintaining an impartial and honest approach to putting patients interests first. 1.4. Guidance on The ABPI Code of Practice for the Pharmaceutical Industry 2016 has been referred to in the creation of this document. 1.5. Disclaimer: It is not the intention of this policy to provide detailed considerations of all the possible circumstances or scenarios that may apply in terms of the Trust s interactions with pharmaceutical representatives. 2. Purpose 2.1. This policy aims to: set out the principles and standards which should be applied when Trust staff engage with pharmaceutical industry provide a guidance framework when developing joint working initiatives with pharmaceutical companies support corporate governance strategies within the Trust provide consistency across the Trust when dealing with the pharmaceutical industry. 3. Definitions 3.1. Commercial sponsorship is defined as including: NHS funding from an external source, e.g. funding of all or part of the costs of a member of staff, NHS research, staff training, pharmaceuticals, equipment, meeting rooms, costs associated with meetings, meals, gifts, hospitality, hotel and transport costs (including trips abroad), provision of free services (speakers), buildings or premises. 3.2. Hospitality is defined as the receipt of entertainment, gifts or cash (or equivalent) for personal use or benefit which has no direct benefit to patient care or the business of BEHMHT. 3.3. Joint working describes situations where, for the benefit of patients, NHS and industry organisations pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery. https://www.networks.nhs.uk/nhs-networks/joint-working-nhspharmaceutical/documents/joint%20working%20toolkit%20dh.abpi.pdf 4. Duties 4.1. The Chief Executive is responsible for ensuring the Trust employs a comprehensive strategy to support the management of risk, including clinical risks associated with a person s mental ill health. 3
4.2. The Executive Directors are responsible for ensuring the Trust has robust policies and procedures for the management of clinical risk. They are also responsible for the strategic and operational delivery of a high quality of service provision and ensure that learning is applied following any adverse incidents. 4.3. Service Line Directors, Assistant Directors and Services Managers: are responsible for ensuring that all staff within their service lines receive regular supervision, are properly supported and receive their mandatory training. 4.4. The Trust s Chief Pharmacist has the overall responsibility for the establishment, maintenance and monitoring of the system for medicines optimisation and management across the Trust. This is in consultation with appropriate senior medical and nursing staff, and other relevant healthcare professionals. 4.5. The Ward / Service Manager: Is ultimately accountable for ensuring adequate systems are in place to control all the medicines in his/her ward or unit and that these systems are followed at all times. They are also responsible for ensuring that staff have access to this policy and have working knowledge of its contents 4.6. All staff are responsible for ensuring they are familiar with the contents of this policy and adhere to it. Any staff involved in organising hospitality meetings, seeking sponsorship or who are involved in any other form of collaborative working with the pharmaceutical industry are responsible for ensuring they are familiar with the contents of this policy and adhere to it. 5. Code of Conduct 5.1. Trust staff 5.1.1. All staff including independent contractors, locums, agency and Bank staff are expected to: act impartially in all their work declare and record financial or personal interests (e.g. company shares, research grant/s) in any organisation with which they have to deal, and be prepared to withdraw from those dealings if required, thereby avoiding any conflict of interest not misuse their official position, or information acquired in the course of their official duties, to further their private interests beware of bias generated through sponsorship, where this might impinge on professional judgement and impartiality neither agree to practise under any conditions which may compromise professional independence or judgement, nor impose such conditions on other professionals or colleagues have a clear agenda from a pharmaceutical industry representative before agreeing to a meeting, which should be by appointment for a specified time and duration 5.1.2. If other personnel arrive for the meeting other than those agreed in advance, then staff are at liberty to decide the optimal numbers for the meeting and should use their discretion as to whether it is appropriate to see the additional personnel. 4
5.1.3. Further meetings should not be arranged if the representative was unhelpful or unethical in any respect or if the meeting did not produce expected outcomes, such as relevant information on a new drug. 5.1.4. If a member of staff feels uncomfortable with an approach or offer from a company, then they should discuss it with their line manager in the first instance. Advice should then be sought from an appropriate service manager or the medicines optimisation team. 5.1.5. A record of the visit should be made. 5.1.6. Any behaviour by pharmaceutical industry personnel felt to be inappropriate should be reported to the medicines optimisation team and, in the first instance, this will be taken up with the representative s line manager. If no satisfactory outcome is achieved, then a complaint will be made to the Association of British Pharmaceutical Industries (ABPI). 5.2. Pharmaceutical Representatives visiting Trust premises Visits to all Devon Partnership Trust sites should be made only to keep an agreed appointment, or to make such an appointment. Representatives are not allowed to tour Trust sites looking for staff, and are not to enter clinical areas without prior appointment with a senior member of staff. Only senior members of staff e.g. Consultants, SPRs (ST 4-6) and associate medical specialists, Lead nurses, ward managers, and Pharmacy Leads should see pharmaceutical representatives and this should be by a pre-arranged appointment. Junior staff are not authorised to see pharmaceutical representatives, or to provide them with information. Representatives MUST NOT visit or interview staff in clinical areas or other departments unless otherwise specifically invited to do so by the departmental manager. Representatives MUST NOT interview patients. Representatives arriving for a pre-arranged appointment MUST have photographic identification, which clearly states his/her name, company and position. 6. Philosophy underpinning the relationship between the Trust and the pharmaceutical industry 6.1. The Trust acknowledges the inter-dependent relationship between the pharmaceutical industry and the NHS. 6.2. The Trust believes there is a clear demarcation between the research and healthcare development interests and the marketing operations of the companies involved. However, promotion of products to mental health practitioners should be based on reputable peerreviewed evidence / practice. 6.3. The Trust does not support the issuing of samples, as treatment choice should be determined by rational (efficacy, safety and cost) prescribing / or treatment decisions. 6.4. The Trust has a duty to explore and develop the relationship between itself and the pharmaceutical industry for the benefit of the patients and clients of the Trust within a clear 5
ethical framework and the NHS s need to ensure evidence based decision-making, value for money and equity. 7. General Information 7.1. Pharmaceutical representatives should respect their position as visitors to the Trust, and recognise that the interests and priorities of the Trust may be different from their own. 7.2. The Trust will extend co-operation to drug companies where this is in the direct interest of patient care, and the general aims of the Trust. 7.3. It is recognised that in addition to providing information to health practitioners, the prime function of representatives is to promote and encourage the use of their company s products. It is expected that this task will be carried out in a proper manner in accordance with ABPI Code of Practice 2016, and that current NHS Policies will be observed. 7.4. The decision to agree the formulary inclusion of any product is to be made by the Trust s Drugs and Therapeutics Committee. 8. Promotional Activity 8.1. Representatives should inform the ward/service manager and Area Lead Pharmacist (by emailing dpn-tr.pharmacyteam@nhs.net) in advance of any teaching or promotional activity which is to be undertaken on a ward or department. Approval must be gained first. Any comparisons made with existing Trust policies, drugs or practices in use in the Trust should be based on the results of properly controlled published studies. 8.2. The intent of the meeting must not contravene existing Trust policies or guidelines. 8.3. Pharmaceutical representatives should be well informed about the products that they are promoting. In addition to standard technical and clinical data, including information on comparative efficacy, the staff may wish to know what is being promoted, the basis for the promotion, and the specific place that the product is expected to have in therapy. 8.4. Price comparisons should not be used unless a senior pharmacist (Lead Pharmacist or above) has approved them in advance. 8.5. Misrepresentation of Trust information e.g. policies or clinical guidelines, within or outside the Trust will be construed as a deliberate attempt to contravene the Trust policy/ guideline. 9. Samples 9.1. Ordinarily samples for use in the hospital MUST NOT be left with medical staff or on wards or in departments 9.2. However in circumstances samples of products e.g. pharmaceuticals, dressings, devices or nutritional products may only be provided in order to assess their physical properties. They should not be used to treat patients. 9.3. Note: According to the ABPI Code of Practice, samples of a product can only be provided to a health professional in response to a written request, which has been signed and dated. 10. Hospitality & Meetings 10.1. Pharmaceutical company sponsorship is permitted for academic meetings. It is not allowed for teaching sessions for junior doctors unless prior approval by the relevant consultant, senior registrar or associate specialist has been obtained. 6
10.2. Requests for running of events must first be approved by the local Area Lead Pharmacist by emailing dpn-tr.pharmacyteam@nhs.net. 10.3. Pharmaceutical companies may sponsor departmental meetings, with the agreement of the departmental head and providing a senior member of staff attends the meeting. 10.4. Any hospitality MUST be secondary and appropriate to the purpose of the meeting and not out of proportion to the occasion. 10.5. If a meeting is sponsored by a pharmaceutical company or companies, this fact must be disclosed in all of the papers relating to the meetings and in any published proceedings. The declaration of sponsorship must be sufficiently prominent to ensure that readers are aware of it at the outset. 11. Sponsorship 11.1. When developing a project that may include seeking sponsorship, staff should consider the following issues in the project planning stage: 11.2. Commercial involvement with the NHS may be of mutual advantage, but both partners should assess and understand the costs and benefits of any such agreement. 11.3. Purchasing decisions should always be taken on the basis of best clinical practice and value for money, and should take into account their impact on other parts of the health care system (e.g. products dispensed in hospital which are likely to be required by patients regularly at home). 11.4. Purchasing decisions on products that originate from NHS intellectual property must be based on best clinical practice and not on whether royalties will accrue to an NHS body. 11.5. Deals whereby sponsorship is linked to the purchase of particular product, or to supply from particular source, are not allowed, unless as a result of a transparent tender for a defined package of goods and services. 11.6. The confidentiality of patient information MUST be maintained. Where a sponsorship arrangement permitting access to patient information appears to be legally and ethically sound (e.g. where patients have explicitly consented), a contract should be drawn up which draws attention to obligations of confidentiality. This contract should specify the security standards that should be applied; limit the use of information to purposes specified in the contract; and make it clear that the contract will be terminated if the conditions are not met. 11.7. Where the major incentive to enter into a sponsorship arrangement is the generation of income the scheme must not interfere with the duties or obligations of the Trust. 11.8. Where more than one company produces products in a particular field, all (or a number) of companies must be offered the opportunity for sponsorship so as to ensure that the Trust does not favour one particular company. 11.9. As a general rule, sponsorship arrangements should be at a corporate level, rather than at a team, directorate, clinical service or individual level. 11.10. Sponsorship and the sponsoring company should never be in conflict with good health practices. 11.11. A written contract must be agreed between the Trust and the relevant company. The Trust Lead and the appropriate contact for the pharmaceutical company should sign the contract. 7
11.12. Requests for sponsorship must be approved by the local Area Lead Pharmacist by emailing dpn-tr.pharmacyteam@nhs.net. 12. Appropriate Projects 12.1. The Trust will not accept sponsorship from the pharmaceutical industry to support initiatives that are not in line with its strategic priorities. 12.2. Any guidelines or protocols will be developed jointly with all appropriate person(s) employed within the Trust. 12.3. Joint initiatives between the Trust and the pharmaceutical industry must promote evidencebased practice and support only those initiatives that have been considered by the relevant Trust committees. 12.4. Sponsorship will not be accepted for projects that have the prime objective of increasing the usage of a specific brand of pharmaceutical or other product. 12.5. Any learning or products developed through sponsored projects may be shared with other NHS organisations. The Trust will retain the right of approval of associated literature and material. 13. Principles of Collaborative Working 13.1. The following principles will also apply to collaborative working. All collaborative working projects should be conducted through an open and transparent process. Staff should be aware of NHS guidance, the legal position and appropriate and relevant professional codes of conduct as described in extant NHS guidance. 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. Collaborative working arrangements should take place at a corporate, rather than an individual, level. Clinical and financial outcomes and risks or governance issues must be formally assessed at the planning stage by the Trust before the collaborative work commences. Projects should address local priorities and preferred service balance. All collaborative projects will maintain the freedom of all clinicians to prescribe the most clinically appropriate and effective treatment for individual patients in line with locally approved guidelines and formulary. Clinical and prescribing policies or guidelines will always be based upon principles of evidence based medicine and cost effectiveness. These will be consistent with National recommendations and expert bodies specifically the National Institute for Health and Care Excellence (NICE). A whole-systems approach will be taken to developing collaborations. This will ensure that only arrangements that benefit the whole NHS are approved. Those that lead to higher costs or a reduction in quality in other areas of the NHS, or shift the balance of 8
investment in service in a manner not consistent with local priorities, are not acceptable. Collaborative projects that focus on broader areas are to be preferred to those which focus on specific drugs or products. Projects that encourage the preferential prescribing of one product may be viewed as a financial incentive to prescribe and may contravene national guidance. Where products are deemed equally clinically effective, assessment of costeffectiveness may include the package of additional resources and support for each product. 13.2. The Department of Health and the ABPI have jointly produced a toolkit to support joint working this is available at: https://www.networks.nhs.uk/nhs-networks/joint-working-nhspharmaceutical/documents/joint%20working%20toolkit%20dh.abpi.pdf/view 14. Promotion of Sponsors 14.1. The logo of the sponsoring company MUST NOT appear on the front of leaflets or similar publications. The logo may appear on the back of the publication. 14.2. The sponsoring company s logo MUST NOT be more dominant than that of the Trust. 14.3. The use of sponsorship must not interfere or affect the normal activity of the Trust or the normal duties of staff. Promotional material of any medication or pharmaceutical company must not be on display in public areas or places where they may be viewable by patients or carers. Promotional material is discouraged from being available overtly in staff areas. 15. Register of Sponsorship, Gifts & Hospitality 15.1. Members of NHS staff and independent contractors should record/ declare gifts, benefits and commercial sponsorship. A log of all requested will be kept by the Medicines Optimisation team and reviewed as part of the Medicines Optimisation Governance Group. Staff must also declare any sponsorship through the annual declaration process set out here. 15.2. The following do not need to be declared: Stationary e.g. pens and diaries and other low value promotional aids that are relevant to the recipients work. A low value promotional item is one that has cost the donor company no more than 6, excluding VAT. (This is the sum quoted in The ABPI Code of practice 2012, however for Trust purposes any hospitality above 25 must be declared). Income generation schemes, which will be logged separately at Trust level. Attendance at meetings held on Trust premises. 16. Research & Development 16.1. While any research MUST have prior Ethical Committee approval before commencement, it is prudent to consider the following. Exceptionally, in the case of non-commercial research and development originated or hosted by NHS providers, commercial sponsorship may be linked to the purchase of particular products, or to supply from particular sources. This should be in accordance 9
with the guidance at paragraph 28 of HSG (97) 32 Responsibilities for meeting Patient Care Costs Associated with Research and Development in the NHS. Where there is industry collaboration in such studies, companies may alternatively make a contribution towards the study s costs, rather than supply a product. Any funding for research purposes should be transparent. There should be no incentive to prescribe more of any particular treatment or product other than in accordance with the peer reviewed and mutually agreed protocol for the specific research intended. When considering a research proposal, whether funded in whole or part by industry, NHS bodies will wish to consider how the continuing costs of any pharmaceutical or other treatment initiated during the research will be managed once the study ended. Where research is primarily for commercial purposes, NHS providers are expected to recover the full cost from the commercial company on whose behalf it is carried out. (HSC (96) 32, paragraph 7). An industry-sponsored trial should not commence unless an indemnity agreement is in place; see guidelines in HSC (96) 48 NHS Indemnity, Arrangements for Clinical Negligence Claims in the NHS. A standard form of indemnity agreement, agreed with ABPI, can be found at Annex B of that guidance. The NHS should benefit from commercial exploitation of intellectual property derived from research and development that the NHS had funded, or for which it has been funded, even where the intellectual property itself is owned by people outside the NHS. NHS bodies should ensure that an agreement to this effect is included in any contracts concerning research and development. The guidelines in HSC 1998/106 Policy Framework for the Management of Intellectual Property within the NHS from R&D should be followed. 17. Clinical Trials 17.1. All clinical trials undertaken within the Trust MUST have prior Ethical Committee approval. Pharmaceutical companies planning to undertake clinical trials within this Trust must contact the relevant medical staff and provide such information as is required by the Ethical Committee in order for the committee to grant its approval for the trial to commence. 17.2. Contact should also be made with a senior pharmacist or the clinical trials pharmacist as early as possible before the trial commences, if appropriate. 17.3. Pharmacy will require a copy of the trial protocol and will fulfil its responsibilities to provide appropriate support to the trial, to protect patient safety and ensure compliance with all statutory requirements. 18. Code of Ethics 18.1. Suppliers must not attempt to influence business decision-making by offering hospitality to Trust staff. The frequency and the scale of any hospitality accepted will be managed openly and with care by the Trust. 18.2. Commercial sponsorship relating to conferences or courses is only acceptable if the attendance of the Trust s staff forms a part on an education/training course approved by an accountable manager of the Trust. 18.3. Product trials must be arranged through the Research and Development department to ensure that: Trials are carried out on a controlled basis. The product in question meets the appropriate safety standards. 10
Trials are not duplicated. 18.4. Points that will be considered when product trials are being carried out are as follows: How the trial is to be administered How the trial is to be financed How trial pharmaceuticals is to be provided How long the trial will last Whether technical staff need to be involved Current safety regulations and quality standards How the trial will be assessed Whether the suppliers need to be involved The implications for existing contracts or purchasing agreements How the results of the trial will be disseminated 19. Monitoring 19.1. Devon Partnership NHS Trust will ensure that regular monitoring of all policies takes place, this is overseen by the Trusts Policy Officer in partnership with relevant directorate and corporate clinical governance groups e.g. Directorate Governance Boards and Senior Management Board (Quality and Safety) to ensure compliance and maintain quality standards as in keeping with safe Clinical Practice. 20. References HR12 Standards of business conduct conflict of interest. Devon Partnership NHS Trust. 2014. The ABPI Code of Practice for the Pharmaceutical Industry 2016. http://www.pmcpa.org.uk/thecode/documents/code%20of%20practice%202016%20.pdf HSG (97)32: Responsibilities for meeting patient care costs associated with research and development in the NHS: The Department of Health - Pubs and stats: Letters and circulars http://www.dh.gov.uk/publicationsandstatistics/lettersandcirculars/healthserviceguidelines/ HealthServiceGuidelinesArticle/fs/en?CONTENT_ID=4018353&chk=ZUXc1q HSG (96)48: NHS indemnity arrangements for handling clinical negligence claims against NHS staff: The Department of Health - Pubs and stats: Letters and circulars http://www.dh.gov.uk/publicationsandstatistics/lettersandcirculars/healthserviceguidelines/ HealthServiceGuidelinesArticle/fs/en?CONTENT_ID=4018270&chk=0Hc10u HSC 1998/106: Policy framework for the management of intellectual property within the NHS arising from research & development : The Department of Health - Pubs and stats: Letters and circulars http://www.dh.gov.uk/publicationsandstatistics/lettersandcirculars/healthservicecirculars/he althservicecircularsarticle/fs/en?content_id=4004971&chk=f80 21. Acknowledgements Acknowledgement to Barnet, Enfield and Haringey Mental Health Trust for their help in writing this policy. 11