CCG Policy for Working with the Pharmaceutical Industry

CCG Policy for Working with the Pharmaceutical Industry 1. Introduction Medicines are the most frequently and widely used NHS treatment and account for over 12% of NHS expenditure. The Pharmaceutical Industry has always worked closely with the NHS, clinicians and commissioning organisations. The establishment of Clinical Commissioning Groups puts clinicians at the centre of commissioning to deliver excellent healthcare by building effective and appropriate working relationships with key partners such as the pharmaceutical industry. This means that there is even greater complexity in relation to what could be deemed conflict of interest. It is essential that there are clear procedures for the CCG staff and members and supporting individuals and organisations (including private and voluntary) where there may be potential for a conflict of interest that could affect commissioning decisions related to medicines and associated services. CCG staff and members should be aware that industry representatives must follow the ABPI Code of Practice for the Pharmaceutical Industry. Link to the 2015 version http://www.pmcpa.org.uk/thecode/documents/pmcpa%20code%20of%20practice%20201 5-NOV14_WEB.pdf It is a condition of membership of the Association of the British Pharmaceutical Industry (ABPI). The Code of Practice for the pharmaceutical industry is designed to ensure a professional, responsible and ethical approach to the promotion of prescription medicines in the UK through a self-regulatory system. If CCG staff or members believe that an industry representative has broken the Code, they should contact the CCG Lead pharmacist for information and advice, they will oversee any complaints being reported. CCG staff and members and private provider staff involved in NHS business should be aware that the nature of marketing and therefore pharmaceutical marketing means that decision making can be influenced in ways where the target audience may be unaware of being subject to influence. Therefore staff should maintain awareness and accept that this is possible and even probable. This is why full declarations of interests that are open to public scrutiny are important enabling greater objectivity. 2. Aims and Objectives of the Policy The aim of this policy is: To provide the CCG Governing Body with assurance that decisions made on medicines and medicines management in relation to pharmaceutical industry sponsorship, which give mutual advantage, are made within a framework of probity. To make clear to CCG employees, independent contractors and their staff the relevant principles, process and procedures to follow regarding business conduct Page 1 of 15

and accountability in relation to commercial sponsorship and dealings with the Pharmaceutical Industry (PI). To safeguard the interests of the CCG and reassure the public. To establish ways that the CCG can work constructively with the pharmaceutical industry. This policy should be read in conjunction with local CCG Standards of Business Conduct Policy and the CCG Anti-Fraud, Bribery and Corruption policies. This policy covers CCG employees, independent contractors and their staff in the course of NHS business. The CCG requests that member practices also adhere to the principles outlined within it. 3. Declarations of interest and Hospitality Register The CCG must maintain registers of interest in relation to the CCG staff and membership. Conflicts might occur due to the possibility of individuals having: A direct financial interest An indirect financial interest Non-financial or personal interests Conflicts of loyalty. The CCG is also required to maintain a register of any hospitality provided or offered to any staff member in the course of carrying out CCG duties. Please refer to local Standards of Business Conduct policy regarding declarations of interests and hospitality register. 4. Attendance at Sponsored Clinical Training or Education Meetings CCG staff and membership should ensure there is an entry made on the CCG hospitality register regarding any clinical training or education provided by or sponsored by a pharmaceutical company. This should include details of company name, drugs discussed at meetings, and hospitality or other sponsorship provided. The CCG hospitality register will be available for CCG and public scrutiny. CCG member practices - it is recommended that each practice should maintain a register of dealings with the Pharmaceutical Industry including any clinical training or education provided or sponsored by a pharmaceutical company. This should include details of company name, drugs discussed at meetings, and hospitality or other sponsorship provided. The Practice Register of Interests should be available for CCG and public scrutiny. 5. Meetings with Pharmaceutical Company Representatives The CCG does not approve any cold calling to CCG employees, independent contractors and their staff from PI representatives. Page 2 of 15

All requests for meetings and contacts by PI representatives to staff, or the membership should be undertaken using the dedicated proforma (See Appendix 1). All contact should then be via email to a generic email address until such a decision has been made that a meeting will take place. In considering requests for meetings with representatives of the PI, consideration should be given to whether this will represent best use of CCG staff or member s time and therefore not all requests can be granted. Details should be forwarded to the CCG lead pharmacist via email following any PI meetings for maintenance of a register of meetings which will be available for public scrutiny. GP and any other clinician members of the CCG who PI representatives may contact in their capacity as prescribers or related health professionals should follow good practice and ensure representatives complete a similar form prior to meeting, for inclusion in the practice register of dealings with the pharmaceutical Industry. The register should include details of the meeting, date, representative and company name, practice members present, drugs and services discussed, hospitality received. This register should be available for CCG and public scrutiny. Members of the CCG considering meeting with PI representatives in their capacity as clinicians at practice level should also consider whether this will represent good use of their time given the arrangements in place locally through CCG and Area Prescribing Committee for recommendations on new drugs, formulary, and guidelines and on medicines safety. 6. Sponsorship of Meetings Sponsorship of meetings is not permitted for routine internal meetings of the CCG. Sponsorship may be obtained only for educational or special events. The ABPI Code states that meetings must be held in appropriate venues conducive to the main purpose of the event. Hospitality must be strictly limited to the main purpose of the event and must be secondary to the purpose of the meeting i.e. subsistence only. The level of subsistence offered must be appropriate and not out of proportion to the occasion. The costs involved must not exceed that level which the recipients would normally adopt when paying for themselves. It must not extend beyond members of the health professions or appropriate administrative staff. For sponsored meetings being organised by staff or CCG members (other than for their own GP practice), a form for proposed sponsorship of meeting must be completed and forwarded to the Lead Pharmacist so that an overview of sponsorship of meetings by the CCG can be maintained and details can be held as a register of sponsorship of meetings available for public scrutiny. This form is attached in appendix 2. When seeking sponsorship for a meeting, use of a company with products directly related to the topic under consideration should be avoided as far as possible. Please Page 3 of 15

contact the lead pharmacist for advice if you are unsure. Products that are not approved by the CCG or the Pan Mersey APC formulary should not be promoted. If meetings are sponsored by pharmaceutical companies, that 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. Details of the sponsorship should also be highlighted to attendees at the beginning of the meeting. For PI sponsored meetings, the level of access to clinicians or associated staff for the promotion of specific drugs or services by the pharmaceutical company (before the primary purpose of the meeting commences) must be agreed in advance, (as stated on sponsorship request form). For a sponsored sandwich lunch for example the representative could have a stand with promotional materials and attend the stand to engage with attendees during lunch and before the meeting starts. Representative/s of the pharmaceutical company sponsoring the meeting should be thanked for the sponsorship ahead of the commencement of the primary purpose of the meeting and then must not remain in attendance at the meeting unless it is a public meeting. For CCG members obtaining sponsorship for practice meetings details of the sponsorship must be kept in a practice register of dealings with the pharmaceutical industry, which should be available for CCG and public scrutiny. Meetings of the Governing Body The CCG holds meetings of its Governing Body in public and is required to do so both by statute and its Constitution. They are often attended by representatives of pharmaceutical companies. Those representatives attend meetings in their capacity as members of the public and have no special privileges when they do so. They should receive no greater or lesser opportunity to participate in the meeting or engage with individual members of the Governing Body than would any other member of the public. Members of the Governing Body may be approached by representatives who seek to engage with them for the purpose of promoting their particular products or canvassing support for products or projects. It is recommended that they politely but firmly decline to engage with pharmaceutical representatives in these circumstances. 7. Joint working with Pharmaceutical Companies For the purpose of this policy joint working is defined as situations where, for the benefit of patients, the CCG and one or more pharmaceutical companies pool skills, experience and/or resources for the joint development and implementation of patient centered projects and share a commitment to successful delivery. Joint working agreements and management arrangements are conducted in an open and transparent manner. Joint working differs from sponsorship, where pharmaceutical companies simply provide funds for a specific event or work programme. Page 4 of 15

Joint working between the pharmaceutical industry and the CCG must be for the benefit of patients or the NHS and preserve patient care; the main beneficiary being the patient. Joint working arrangements must be entered into at a corporate level and not with any individual member of staff or CCG member practice. Any tentative discussion about entering into joint working which staff or CCG members may have and consider worth pursuing should first be discussed with their line manager and the Lead Pharmacist and as appropriate brought to the attention of the Chief Officer. If the proposal is deemed suitable to explore further the designated lead should provide initial details on the joint working outline proposal using the quality standards checklist for considering commercial partnerships and this should be submitted to the Lead Pharmacist for consideration. (see appendix 3) If the initial outline is supported by the Quality/Standards Committee and the Medicines Management Committee a project group should be established to produce a full proposal for consideration by the CCG Board. 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. When entering into an agreement for joint working, the CCG must also consider the impact once these arrangements are concluded. An effective exit strategy must be in place at the outset of a given project detailing the responsibilities of each party. A formal written agreement must be in place and an executive summary of the joint working agreement must be made publicly available before arrangements are implemented. All aspects of confidentiality with regard to patient information must be observed and how this will be achieved clearly stated in the Joint Working Agreement. Confidentiality of information received in the course of duty should be respected and should never be used outside the scope of the specific exercise. Arrangements for monitoring the operation of the agreement and assessing clinical and financial outcomes should be agreed and clearly stated within the Joint Working Agreement. All assessments of the joint working programme should be made readily available to other NHS organisations and the public. 8. Primary Care Pharmaceutical Rebate Schemes Primary care rebate schemes (PCRS) are contractual arrangements offered by pharmaceutical companies, or third party companies, which offer financial rebates on GP prescribing expenditure for particular branded medicine(s). Such schemes are increasingly being offered to Clinical Commissioning Groups (CCGs) by the pharmaceutical industry as a means to introduce new drugs into the NHS, or more simply as a tool to increase/ establish market share of existing or new medicine(s). Page 5 of 15

This policy provides the clarity and guidance for the CCG when considering entering in a primary care rebate scheme. Rebate schemes are different from national patient access schemes, which are recognised by NHS England to manage entry of new products to the market at a reduced cost. However both approaches serve to protect the list price of the product, which is used as a reference by markets in other countries. The London Primary Care Medicines Use and Procurement (LPP) group have reviewed such schemes and following legal and stakeholder consultation, have set out principles of good practice for use by CCGs, to facilitate robust scrutiny of rebate schemes. The document acknowledges the disparity of whether these schemes are allowed within current regulations, acknowledging the concern that proliferation of primary care rebate schemes may cause an unacceptable administrative burden to the NHS. To help to manage concerns, LPP obtained legal advice and are satisfied that the schemes are not unlawful but do need to meet certain requirements to avoid falling foul not only of the Drug Tariff and the controls on pricing under the NHS Act 2006, but of a raft of other UK legislation including the Medicines Act, Human Medicines Regulations, the Bribery Act and EU laws. Any rebate scheme must be compatible with the effective, efficient and economic use of NHS resources. The CCG will adhere to the principles of good practice when deciding whether it participates in a PCRS or not these principles are set out in the LPP check list (appendix 4) The Pharmaceutical Industry Scheme Governance Review Board of PresQIPP (an organisation hosted and funded by NHS England to support quality optimized medicines management within the NHS) will assess any rebate scheme for clinical, financial and contractual issues to support CCGs in addressing the risk of perverse incentives from Rebate schemes. Previous assessments are saved on the website for CCGs to consider. Any rebates offered to the CCG will be considered in full by the Medicines Management Committee and any decisions will be ratified by the Quality committee and Finance Committee. Note This policy has been reproduced with kind permission from a document prepared by the Medicines Management Lead for Halton CCG Page 6 of 15

Appendix 1. Appointment Request Form for Representatives from the Pharmaceutical Industry Request Date All sections must be completed prior to consideration of an appointment Please email to the appropriate email address detailed on overleaf Name of Representative Name of Company Email/Mobile No. (NB we may offer teleconference appointments) Category of topic(s) you wish to discuss Please mark the relevant category/categories CCG commissioning pathways and service development Prescribing please complete additional table below for any requests relating to prescribing Proposed joint working ALL requests relating to prescribing please complete (highlight all relevant) Please mark the relevant category/categories New Medicine Formulary Sharing Resources Clinical data (efficacy, safety etc) Licence extension Medicines optimisation collaborative initiative Budget impact document New formulation of existing medicine Other collaborative initiative Pre-licence advanced planning notification Efficiency saving Outline what you wish to discuss and attach relevant pre-reading material What is the outcome you hope to achieve from the meeting? How long do you anticipate the meeting lasting? Page 7 of 15

Office Use Only Date of last appointment To be given an appointment Yes No Urgent Routine If no appointment given give a brief explanation for the reason Appointment details appointment Duration 15 mins 30 mins Other (specify).. 45 mins 60 mins Date Venue (give full address and post code) Time Please email the completed for to the following email address: CCG commissioning and service development please email- Insert CCG contact Requests to discuss prescribing please email Insert CCG contact Please note any requests to discuss prescribing not sent to the correct email address will not be responded to. Page 8 of 15

Appendix 2. Request proforma (CCG internal) for sponsorship of a meeting by a pharmaceutical company CCG Lead or member of staff organising the meeting: Title and details of Meeting: Target audience: Venue: Proposed date: Proposed Pharmaceutical Company: Representative name and contact details: Details of sponsorship requested: Approximate value of sponsorship: Details of direct marketing contact at meeting: e.g. whether representative will attend the meeting, have a marketing stand showing product information; which products and or services will be marketed. Please forward the completed form to the CCG Lead Pharmacist for recording on the Pharmaceutical company register of sponsorship Page 9 of 15

Appendix 3 Quality Standards Checklist for considering Joint Working with a commercial company or the pharmaceutical industry (Adapted from Harrogate and Rural District CCG policy) Quality Standards Checklist for considering Joint Working with a commercial company or the pharmaceutical industry Is the company or organisation legitimate that is, is it a registered company capable of being independently audited? Does the scheme have aims and objectives? Yes No Does the sponsorship offer any benefits to the following aspects of health care? a) Diagnostic and referral? b) Investigations and measurements? c) Informing and educating patients? Is the material non-promotional accurate and culturally appropriate? Will the material be checked by the CCG before it is distributed? d) Informing and educating health professionals? Is the information valid, complete, balanced and up to date? Sponsorship that is directly related to patient treatment a) Is the sponsorship related to patient treatment? b) Have alternative treatments been considered and evaluated? c) Has an assessment of the costs and benefits of the package in relation to alternative options been investigated? d) Has monitoring of the patients been considered as part of the treatment? e) Has a criteria for success of the project been established? f) Has patient perceptions been included as part of the criteria? g) Has a health care professional been designated clinically responsible for the patient at each stage of the package? h) Has an assessment been made as to how the package fits with existing systems of primary and secondary care? Information/data considerations a) Is the sponsorship related to the collection of data? Page 10 of 15

b) Who will own the data? Please state: c) Will the sponsor have access to the data? d) Have the provisions of the Data Protection Act been taken into consideration? e) Who will evaluate the data? Please state: Sponsorship related to the provision of products Is the sponsorship related to any of the following? a) Provision of clinical products? Will this encourage the use of a particular product in the future? Will the use of the product limit patient choice? b) Provision of equipment? Is the equipment linked to the use of one particular brand of consumables? Has an assessment been undertaken to establish that it is the best for purpose? c) Provision of free stationery? Does the stationery include commercial advertising? Has the CCG control over the content of the advertising? Are there any recurring costs for the scheme? Who will be responsible for recurring costs? Please state Further Information Page 11 of 15

Appendix 4 Primary Care Rebate Scheme Checklist Developed from the London Primary Care Medicines Use and Procurement (LPP) group checklist http://www.lpp.nhs.uk/page.asp?fldarea=10&fldmenu=5&fldsubmenu=0&fldkey=271 Date: Name of Drug: Company Name: Company Contact: CCG Checklist for Primary Care Rebate Schemes Issue Good practice principles Comments 1. Product-related 1.1 Before any consideration of price, the clinical need for the medicine and its place in care pathways should have been agreed by established local decision-making processes. The clinical decision should inform the financial/procurement decision and not vice versa. 1.2 Health professionals should always base their prescribing decisions primarily on assessments of their individual patients clinical circumstances. The impact of a rebate scheme is a secondary consideration. 1.3 Any medicine considered under a PCRS must be licensed in the UK. Where there is more than one licensed indication for a medicine, a scheme should not be linked to a particular indication for use. 1.4 Rebate schemes promoting unlicensed or off label uses must not be entered into. All recommendations for use of a medicine within a PCRS must be consistent with the Marketing Authorisation of the medicine in question i.e. the PCRS should only advocate the use of the drug in line with the data sheet for the drug in question. Page 12 of 15

2. Rebate schemerelated 1.5 Medicines not recommended by NICE might still be the subject of a PCRS, but specific and documented consideration must be given to how such a product can properly be recommended to prescribers notwithstanding NICE s position. CCGs will need to explain how the scheme helps it meet its duty to use its resources effectively, efficiently and economically. 2.1 Decision making processes should be clinically-led and involve all appropriate stakeholders, including patients where appropriate. 2.2 Rebate schemes should be approved through robust local governance processes that include Medicines Management Working Group and Quality Committee approval 2.3 The administrative burden to the NHS of setting up and running the scheme must be factored into assessment of likely financial benefit of the scheme. Consideration should be given to audit requirements, financial governance, data collection, any other hidden costs and practical issues such as the term of agreement. 2.4 Primary care rebate schemes should be agreed at a statutory organisational level, they should not be agreed at GP practice level. 2.5 Schemes encouraging exclusive use of a particular drug should be avoided. 2.6 Rebate schemes for medicines in Category M and some medicines in Category C of the Drug Tariff, should be especially carefully considered because of the potential wider impact on community pharmacy reimbursement. Short term local savings are likely to be offset by increased costs to the wider NHS in the longer term. Schemes which promote prescribing of branded generics or original brands in preference to generics pose the added risk that they undermine the concept of generic prescribing. 2.7 The PCRS should not be directly linked to requirements to increase market share or volume of prescribing. 2.8 Schemes which link a rebate directly to increase in volume of prescribing above a defined threshold could be judged to be an attempt to influence prescribing inappropriately and should be avoided. Page 13 of 15

2.9 Commissioners should ensure that a formal written contract is in place, signed by both parties to ensure (i) that the terms of the scheme are clear and (ii) to maximise the legal protection. All negotiations around a scheme should be expressed as being "subject to contract" i.e. not binding until the formal contract has been signed by both parties. 2.10 PCRS agreements should include a right to terminate on notice (i.e., without having to have any reason for doing so) with a sensible notice period e.g. three or six months. 3. Information and Transparency 2.11 The need for exit criteria and an exit strategy should be considered before a scheme is agreed. It is essential to allow flexibility to respond to emergence of significant new clinical evidence, or significant changes in market conditions. A shorter notice period should be agreed in these circumstances. 2.12 Is the value of the offer quantifiable and proportionate to the administrative burden? Is there an appropriate return on investment? 2.13 Schemes which link a rebate to prescribing of more than one drug should be especially carefully considered to avoid the risk that savings made on one are indirectly offset by costs incurred on another. 3.1 The CCG will make public the existence of any PCRS they have agreed to. 3.2 The CCG will not enter into any PCRS which precludes them from considering any other schemes subsequently offered by manufacturers of competitor drugs, should they wish to do so. 3.3 There should be no requirement to collect or submit to the manufacturer any data other than volume of use as derived from epact data. 3.4 PCRS agreements must meet the requirements of the Data Protection Act and patient confidentiality must never be compromised. 3.5 The CCG will not enter schemes that require them to provide information to a manufacturer about competitor products market share. Page 14 of 15

3.6 Freedom of Information provisions about FOI requests and commercially sensitive information should be contained in the contract. As a general principle, information about rebate schemes may be released under FOI requests, but commercially sensitive information is usually withheld. 3.7 Discounts and details of any PCRS offered should be allowed to be shared within the NHS. This should be agreed as part of the PCRS contract. 3.8 Is the invoicing process transparent as per NHS financial requirements? Page 15 of 15