Where Joint Working involves explicit references to a pharmaceutical company’s medicine(s), then such arrangements areonly likely to be acceptable if they are framed in the context of patient care, the relevant medicine(s) is used appropriately inaccordance with nationally accepted treatment guidelines and there is no inducement to prescribe the product(s)concerned.Activities which are designed to increase the appropriate use of medicines generally in a particular therapeutic area, such asdesigning and implementing a disease protocol, are acceptable notwithstanding that the pharmaceutical company maybenefit from a share of the general increase. This could be articulated in a Joint Working agreement as follows:“This Joint Working project is intended to create more opportunities for the appropriate use of medicines, including[company x’s] medicines in suitable patients in line with [insert treatment guidelines, e.g. NICE/SIGN/AWMSG guidelines,National Service Framework targets, locally agreed protocol]. If this improvement occurs, we are likely to see an increase inprescriptions of [product y] roughly equal to our current proportion of prescriptions in this therapeutic area.”Joint Working projects that increase the use of a pharmaceutical company’s particular medicine(s), (as opposed to increasingthe use of a class of medicines generally), whilst possible, are more open to challenge and so these arrangements need to bechecked particularly carefully to ensure that there is no actual or perceived inducement to prescribe that company’s product(s).Acceptable projects are likely to be those which implement national or local guidelines.If a Joint Working project is linked to an “agreed objective” then defined patient outcomes must be agreed by the parties.Where no “defined” patient outcomes can be agreed (e.g. because there are no recognised patient outcomes for a particularcondition), clear arrangements for measuring the objectives of the Joint Working project should be agreed. Templates forsuch agreements are contained in the Joint Working Toolkit.
Only the guidance in England was accompanied by a joint working toolkit which is accessible on the DH website and suitable for use in all parts of the UK
1. Impact to day job of NHS staff if there is to be a change in the treatment pathway. Some may benefit – use to drive positive change mood2. Signatories, line managers, 3. Money and skills – specialist skills/capabilities e.g. Health outcomesInternal stakeholders may be more obvious. Tip: sit down with main NHS contact and run through an organisational chart of each organisation asking the 3 questions of each stakeholder
ABPI joint working workshop
Joint WorkingWorkshopKevin Blakemore, National NHS Partnership Manager |ABPI
Our common goalWin:Win:Win:Win:WinPublicNHSAcademiaVoluntarySectorIndustrySocialCare
Customer Quotes on Joint Working“The NHS isstrapped forcash, the medicinesare too expensiveand nationaltherapeutic tenderingis the only answer.” –FinanceDirector, primarycare“JW withgovernance –fantastic! This isexactly what isneeded.” – LeadPharmacist, primary careWe want industry to getinvolved in the projects atthe embryonic stage. Wewant a long-termsustainable relationship.”- Consultant secondarycare“I wish this JW criteriaexisted before. It makesthe NHS feel saferworking withindustry, especially asthe ABPI is endorsingit.” – GovernanceManager secondarycare“Why doesn’tpharma just providesponsorship and letthe NHS do therest?” – PrimaryCare lead“I’m interested inJW, but what doesindustry have tooffer?” –Innovation Leadsecondary care“It’s disappointingwhen pharmaprovides financialresources but noother resource.” –Governance Managersecondary care“The CCGs aregagging for JW withindustry, but it has tobe open &transparent.” – LeadPharmacist, primarycare“NHS is wary towork withpharma, so youhave to sell theconcept of JW.” –PharmaceuticalAdvisor primarycare
DH definition of Joint Working“A situation where, for the benefit of patients, one or more pharmaceuticalcompanies and the NHS pool skills, experience and/or resources for thejoint development and implementation of patient-centred projects and sharea commitment to successful delivery”
Joint Working is n0t…….• Clinical trials• Standard product promotion• MEGS• Patient support programmes• Meetings/symposia and the like• Discounting/trading deals• Package deals• Tenders• Patient Access Schemes• Risk sharing/ Outcome agreements• Donations/grants/sponsorship• Commissioned work
Joint Working must…….• benefit patients (expected to also mutually benefit theparties).• be conducted in an ethical, open and transparent manner –overall arrangements made public.• take place at a corporate organisational level and not withindividual health professionals or reps• be in accordance with the ABPI Code, governmentguidance, NHS rules and relevant professional codes, etc.• have all materials certified in advance, including a formalsigned agreement
Agreements must include…..• Name, parties, start date and term of the project.• Expected benefits for patients, the NHS and pharmaceutical company.• Outline of the financial (and other resource) arrangements.• Roles each of the parties will undertake, how success will be measured.• Contingency arrangements.• Exit criteria.• Summary of Joint Working agreements to be made public by thepharmaceutical company.• 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.
The project may include……..• staff training• staff and/or patient education• facilitation of pathway redesign• support for guideline implementation• funding of project staff requirements (e.g. provision ofadministrative, clinical, analytical health economicand/or management resources by either party)• secondments• audit• economic analysis• nurse services
JW using your brand•Disease management (e.g. design and implement a diseaseprotocol) that may increase usage of medicines in atherapeutic area can be acceptable•Use national or local guidelines•There must be no inducement to prescribe your product•Beware perception of inducement if JW likely to increase useonly of your medicines (rather than class/group of medicines)
Make the basis clearFor example:“On the basis that the Primary Care Trust / Health Boardhas previously placed [company x’s] medicine appropriately inthe treatment guidelines for the treatment of [the condition] inline with local / national guidelines, the NHS Organisation and[company x] have agreed to work together and provide fundingand other support for this project.”
Be transparent about benefit“This Joint Working project is intended to create moreopportunities for the appropriate use of medicines, including[company x’s] medicines in suitable patients in line with [inserttreatment guidelines, e.g. NICE/SIGN/AWMSGguidelines, National Service Framework targets, locally agreedprotocol]. If this improvement occurs, we are likely to see anincrease in prescriptions of [product y] roughly equal to ourcurrent proportion of prescriptions in this therapeutic area.”
Measurement is mandatory•Patients•NHS•CompanyThe outcome of every project should be measured and thetaking of baseline measurements at the start of a projectare helpful to track success, particularly patient outcomes.
Targeting•It is acceptable to target Joint Working geographicallyaccording to:–Identified patient need–Availability, experience and commitment of relevantpersonnel to deliver the project–Areas where the NHS has expressed a need or desire toimprove benefits to patients by working together with thepharmaceutical company/ies•Pharma ROI must not be the sole or primary criterion
Communication within Your Company•Communication should be clear and unambiguous to ensurethat the Joint Working agreement is not infringed and that theproject is not used inappropriately by sales representatives togain access to customers or to influence prescribing.
ABPI/DH Joint Working Toolkithttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_082840Or just google ABPI Joint Working toolkit
What do you think?A Pharma company gets involved ina jointly resourced venture witha GP practiceto supply spirometry kitsA Pharma company gets involved in ajointly resourced venture with aPCO to carry out diabetes diagnosticsA Pharma company gets involved in ajointly resourced venture with ahospital department toredesign renal pathwaysA Pharma company gets involved in a70/30 resourced project with a PCO tocarry out angina population metricsRef: Wellards module NHS-Industry Joint working
Case study reviewIn your groups:• Review the 3 case studies using the checklist• For each discuss and agree: (Baxter/Pfizer COPD/BMS HIV)– Background/Overview/Outcomes/Services offered/Behaviours demonstrated– Is it Joint working? – yes/no/cannot say– If not, what are the reasons?– If can’t say -what extra information do you need to decide?– Prepare to share your feedback to the group
Ways of WorkingPHARMASponsorshipMedicalEducationalGoods andServices(MEGS)Joint Working Promotion
Pharma activitiesJoint Working• Secondments• Audit• Nurse services• Facilitation of pathway redesign• Economic analysis• Support for guidelineimplementation• Staff and/or patient education• Staff trainingNot Joint Working• Clinical trials• Commercial payments forconsultancy advice• NHS tenders• Package deals (medicines &other benefits)• Meetings and hospitality• Gifts and benefits in kind• Commercial arrangements e.grisk share, outcomesguarantee, pricing, margins, discountsRef: Wellards module NHS-Industry Joint working
Promotion JointWorkingMEGS SponsorshipFor patient benefitYes Yes Yes YesNHS/Pharma company pool resourcesX Yes X XPharma company investmentYes Yes Yes YesNHS investmentX Yes X ODetailed agreement in placeX Yes X XShared commitment to successfuldeliveryX Yes Yes YesDetails of the agreement are madepublicX Yes O XProspective ROI Yes Yes X XOutcomes must be measuredX Yes O X
4. Manage and Engagement3. Understand2. Analyse and Prioritise1.IdentificationStakeholder Management: 4 Stages
IdentificationDoes the person:1) Get directly/indirectly affected by the project?2) Hold any influence over the project?3) Have an impact on the project’s resources?
Analyse and PrioritiseINFORM MANAGEMONITOR ENGAGELowOutcomeInterestHighOutcomeInterestHigh Process InfluenceLow Process Influence
Understand, Manage & Engage• Develop a clear understanding of what the customer wants to achieve, make sure thatyou spend enough time doing this to ensure that all the details are covered, make surethere are no surprises.• Manage expectations. Do not promise what you cannot deliver.• Engage all customers who will have a stake in the project. Identify those who will havethe following roles:– The individual(s) who will be responsible for delivering the project– The individual who will be accountable for the project delivery– The individual(s) who need to be consulted on the project– The individual(s) who need to be kept informed of the project
What is a TOR?Terms of reference (TOR) describe the:“purpose and structure of aproject, committee, meeting, negotiation,or any similar collection of people whohave agreed to work together toaccomplish a shared goal.”
What are we going to cover…•What is a TOR?•What should be included in the TOR?•What are the benefits of agreeing a TOR in JointWorking?•What might be the challenges for developing theTOR?
Getting it right…..•Levels the playing field•All pharma partners understandhow they will work together•NHS partner understands whatis expected of them- a “two way”relationship•Reinforces the “code ofconduct” (ABPI & NHS)•Sets out roles of the JWcommittee e.g revolvingChair, minute taker etc.
Challenges….• Legal and compliance re-drafts by each party• A misunderstanding of theobjectives of a TOR• Lack of agreement• e.g. who will chair, howthe voting system shouldwork
What should be included in the TOR? – (minimum)•Name of group•Membership and appointment•Chairing•Frequency of meetings and quorum•Record of meetings•Reporting mechanism•Functions & delegated authority
Project Initiation Document (PID)•What is the PID?•What are the primary use of the PID?•When would you complete a PID?•Understanding the jargon of the PID?
What is the Project Initiation Document (PID)?“The purpose of the PID is to define the project, inorder to form the basis for its management and anassessment of its overall success.”PRINCE 2
What are the primary uses of the PID?1. Ensure the project has a sound basis before asking the JW committeeto make any major commitment to the project2. Act as a base document against which the JW committee and projectmanager can assess progress, issues and ongoing viability questions3. Provide a single source of reference about the project so that peoplejoining the “temporary organization” can quickly and easily find outwhat the project is about, and how its being managed
ExampleBackgroundBrief statement on the explaining the context of the project, and stepstaken to arrive at the current position of requiring a projectThe East of England Pharmaceutical Alliance (EPA) was created to supportthe implementation of the National Strategy for COPD and Asthma acrossthe East of England SHA. The EPA members consist of a number ofpharmaceutical companies working jointly together with the NHS.Before the EPA can start to implement a project to support the training andeducation of health care professionals in line with the national strategy, itwishes to fully understand the training requirements across the locality.The EPA has identified the need to develop a project to implement a fulltraining needs analysis (TNA) of healthcare professionals for COPD &Asthma.