Joint Working with the NHS Joint Working between Pharmaceutical Companies and the NHS and Others for the Benefit of Patients An introduction to the ABPI guidance notes

Content This presentation is a brief summary of key issues in the ABPI Guidance Notes on Joint Working. Joint Working between the NHS and the pharmaceutical industry is a relatively new concept and companies are likely to have little or no historic experience. The purpose of the ABPI Guidance is to support appropriate Joint Working including how potential pitfalls might be identified and avoided.

Quick Guide to the Guidance Notes ChapterKey content Purpose of this GuidanceOutlines the need for a framework for joint working. Background to Joint WorkingDescribes how NHS and pharmaceutical company relationships are evolving. Definition and Scope of Joint WorkingPatient benefit and pooled resources are core. Describes what is not Joint Working. Principles of Joint WorkingNeed for patient benefit, mutual benefit, transparency and organisational level sign off. Examples of Joint WorkingSuggested types of activity that can be included in Joint Working projects. Joint Working GovernanceTransparency and the need to avoid inappropriate influencing of prescribers.

Quick Guide to the Guidance Notes ChapterKey content The Mutual Benefits of Joint WorkingDescribing patient, NHS and company benefits. Being clear about expected outcomes. Measuring Joint WorkingAffirms that measurement is required and suggests criteria that can be assessed. Deciding to Take Part in Joint WorkingBeing transparent, how to calculate return on investment for all and the importance of patient benefit. Joint Working AgreementsNeed for a formal agreement and specific areas that should be included. Disengagement/Exit CriteriaNeed to define a clear end point at the outset. Reasons to exit an agreement early.

Quick Guide to the Guidance Notes Chapter Key content Joint Working Projects and Clinical No inappropriate influencing of Guidelines prescribers. Supported guidelines must be independent. Communicating Joint Working Projects Consistency of message. Ensuring JW is not within the Company used as inducement by representatives. Using Data Obtained from Joint Working Outlines the various legislation that applies. Projects Competition and Commercial-In-Conference Applies when more than one company is Issues involved. Legal counsel may be required. Other Considerations Personal benefit must not come from joint working. Anti corruption rules.

Other relevant documents Moving beyond sponsorship: Interactive toolkit for joint working between the NHS and the pharmaceutical industry, Department of Health/ABPI (March 2008) Best practice guidance for joint working between the NHS and the pharmaceutical industry, Department of Health (February 2008) A Common Understanding: Guidance on Joint Working between NHS Scotland and the Pharmaceutical Industry (2003) Guidance for Partnership Working between NHS Organisations, Primary Care Contractors, the Pharmaceutical Industry and the Allied Commercial Sector in Wales (2004) ABPI Code of Practice for the Pharmaceutical Industry (2008)

ABPI Code Most relevant clauses – Clause 18. Joint working must not be an inducement to a health professional to prescribe, supply, administer, recommend, buy or sell any medicine. Only informal guidance about the Code can be provided by the PMCPA.

What’s in this presentation?  Overview of content  Definition of Joint Working  Suggested audiences  How to articulate benefits and return on investment  Summary of mutual benefits  Placing of initiatives (Targeting)  Measurement  Communication to sales forces and others  Key differences between medical and educational goods and services and joint working  Potential pitfalls

Suggested Audiences This presentation is for those most likely to have a key role in the development and implementation of joint working projects such as: –Medical signatories –NHS liaison team management –NHS liaison teams –Brand marketing teams –Compliance officers –Legal

Definition of Joint Working Joint Working is defined in the DH/ABPI Joint Working Toolkit ‘Moving Beyond Sponsorship’ as: Situations where, for the benefit of patients, one or more pharmaceutical companies and the NHS pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery.

The key requirements from this definition are that: the Joint Working project must be focused on benefits to patients; and there must be a ‘pooling’ of resources between the pharmaceutical company/ies and the NHS organisation(s) involved.

Each party must, therefore, make a significant contribution to the Joint Working project to avoid the arrangement being construed as merely a gift, benefit in kind, donation or some other non-promotional/commercial practice. Resources may come in various forms, including people, expertise, equipment, communication channels, information technology and finance. Key requirements continued

Joint Working must: benefit patients (expected to also mutually benefit the parties). be conducted in an ethical, open and transparent manner – overall arrangements made public. take place at a corporate organisational level and not with individual health professionals. be in accordance with the ABPI Code, government guidance, NHS rules and relevant professional codes, etc.

Investment Joint Working projects are likely to be of significant scope and size, involving resources in the region of £15 - £20k or more and lasting six months or longer. Lower figures may be applicable depending on circumstances. The key determinant is whether a project follows the principles of joint working.

Benefits of Joint Working  When describing the benefits of a specific joint working project one must be able to: –Clearly define patient benefits –Show how the NHS will benefit –Describe how the company will benefit –Ensure that both parties are comfortable with the arrangements  As these are ‘business to business’ arrangements it is both reasonable and appropriate for both parties to consider return on investment (ROI) before committing to any project. Commercial benefit to either party must not be the sole benefit.

Benefits of Joint Working  Pharmaceutical companies can calculate ROI provided governance arrangements are in place –ROI calculations should be set out in the context of patient care and shared with the parties –The aim of conducting ROI analysis should be made clear eg to make decisions on resource utilisation –Companies should not terminate a project solely on the basis of a negative ROI for its medicines  Both parties, the NHS and company, should be able to articulate their ROI in clear and measurable terms

Benefits of Joint Working for patients can include:  Care closer to home  Fewer hospital admissions  More equitable and consistent care and access to care  Better information about conditions and treatment options  Clearer and improved care pathways  Better experience of the healthcare system

Benefits of Joint Working for the NHS can include:  Higher quality, more consistent care achieved more rapidly  Services configured around patients’ needs  Better health outcomes  Better use of resources, more value for money, lower costs  More people treated appropriately (eg in line with national guidelines)  Lower costs of hospital admissions  Support towards achievement of performance targets  More creative approaches to problems  Better cross-sectoral working  Better skilled personnel

Benefits of Joint Working for the pharmaceutical company can include:  Market expansion and/or more appropriate use of medicines, including the company’s medicine(s)  Better understanding of customers’ and patients’ needs  Improved reputation  Faster NHS implementation of policy which may be relevant to the company’s business

Deciding to take part  It is acceptable to target Joint Working geographically according to: –Identified patient need –Availability, experience and commitment of relevant personnel to deliver the project –Areas where the NHS has expressed a need or desire to improve benefits to patients by working together with the pharmaceutical company/ies  When targeting a project to a location ROI for the company must not be the sole or primary criterion

Measurement The outcome of every project should be measured and baseline measurements might be helpful to track success, particularly patient outcomes.

Exit Criteria Must be agreed and included in the Joint Working agreement. Either party should be able to exit an agreement if patients are not benefiting and must do so if the project is detrimental to patients. A pharmaceutical company may not terminate a Joint Working project solely on the grounds that prospective ROI is not met.

Joint Working Agreements must include Name, parties, date and term. Expected benefits for patients, the NHS and pharmaceutical company. Outline of the financial arrangements. Roles of the parties, how success will be measured. Contingency arrangements. Summary of Joint Working agreements to be made public by the pharmaceutical company.

Communication within the company  Companies should consider how sales representatives and other personnel are briefed to ensure that the Joint Working agreement is not infringed and that the project is not used inappropriately by sales representatives to gain access to customers or to influence prescribing  The importance of consistent communication within a company regarding Joint Working initiatives should not be underestimated

Potential pitfalls  Joint Working is different to the provision of Medical and Educational Goods and Services (MEGS) that enhance patient care or benefit the NHS and maintain patient care.  It is very unlikely that the provision of MEGS would ever meet the definition of Joint Working as they are mainly provided by a pharmaceutical company in circumstances where there is no ‘pooling of resources’.

Key Differences between Medical and Educational Goods and Services and Joint Working MEGSJW NHS/Pharma company pool resources x  Detailed JW agreement x  Outcomes must be measured O  Shared commitment to successful delivery  Details of arrangement made public O  O = Optional

Is a proposal for Joint Working in line with ABPI guidance? ChapterFeatures of proposal Definition and ScopeAble to describe how patients, the NHS and of Joint Workingthe company are likely to benefit. There is a clear and significant pooling of resources between the company and the NHS. Certainty that this is not just a traditional MEGS activity. Principles of Joint WorkingPatients are the principal beneficiary. A written agreement will be in place. Joint Working GovernanceThe project is transparent. Have ensured that the project has been agreed at an organisational level so that inappropriate influencing of prescribers has not occurred.

Is the proposal for Joint Working in line with ABPI guidance? Chapter Features of proposal Measuring Joint Working Have a range of measures that are specific to the patient, NHS and company. Have expected outcomes for this project and an agreed schedule for measurement to ensure these take place. Deciding to Take Part in Have considered a balance of benefits for all parties and can Joint Working clearly show that decisions have been made at an appropriate level in the company. Any ROI calculations have been made to support resource allocation decisions. Joint Working Agreements Have a formal agreement in place that is very clear about what all parties have agreed. Have not started the project prior to having this agreement.

Is the proposal for Joint Working in line with ABPI guidance? ChapterFeatures of proposal Disengagement/Exit CriteriaBoth parties know exactly when and why the project will end. All know what interim steps must be achieved in order to reach the project end and can describe the circumstances that will end the project earlier than planned. Joint Working Projects andAny clinical guidelines being followed are Guidelines independently approved. If the company previously supported their development can independence from the project be demonstrated? Guidelines are not a disguised switch programme. Communicating Joint WorkingEveryone in the company who has contact with Projects within the Company any customer affected by this project understands their role. All have clarity about the expected outcomes and know that the project must not be used to influence prescribing.

Further advice  ABPI - Martin Anderson (Director, NHS Policy and Partnerships) on or  ABPI Extranet  PMCPA – Heather Simmonds, Director on or