The Association of the British Pharmaceutical Industry

Annual Review 2012

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What the ABPI does for its members

• TheABPIbringscompaniestogethertoprovideastrongvoiceonyourbehalf,ensuringyouareheardinthecorridorsofpowerandontheairwaves.

• TheABPIensuresthatthepharmaceuticalindustryisrecognisedasakeysectorfortheUKeconomy,improvingcompanies’accesstodecision-makersandplacingourissueshighontheagenda.

• TheABPIisastrongadvocateattheheartofpolicydevelopmentanddecision-makingtoimprovethecommercial,operationalandinvestmentenvironment forourmembers.

• TheABPIisthesolebodyrecognisedunderstatutetonegotiatepricingwithgovernmentonbehalfofmembersandnon-members.Aspartofthis,weworkhardtounitetheindustry,givingthebestchanceofasatisfactoryoutcome.

• TheABPIbuildstheindustry’sreputationbypromotingthevalueofmedicinesandtakingtargetedactiononissuesthataffectsociety’sandhealthcareprofessionals’perceptionsofourindustry.

• TheABPIprovideshigh-levelnetworkingopportunitieswithintheindustryandacrossgovernment,theNHSandregulators.

• TheABPIkeepsmembersinformedandup-to-datewithpolicybriefingsandupdates,supportingyourengagementatthehighestlevelsonallthekeyissues.

Werepresentresearch-basedcompaniesonawiderangeofissues,advocatingonyourbehalfwithkeystakeholdersandsecuringpolicychanges:

• Patientaccesstoinnovativemedicines

• TheoperationofHealthTechnologyAssessment(HTA)throughouttheUKincludingNICEinEngland,ScottishMedicinesConsortium(SMC)inScotlandandAllWalesMedicinesStrategyGroup(AWMSG)inWales

•Thevalueandpricingofinnovativemedicines

• PurchasingbehaviourwithintheNHS

•Marketfreedomsincludingthesupplyofmedicines

• Regulatoryaffairs

• Pharmacovigilance

• Prescribingguidancetohealthcareprofessionals

• JointworkingbetweencompaniesandtheNHS

•NHScommissioning

•Medicalaffairsandpatientoutcomes

•Taxation

•Openinnovation

• Clinicalresearchincludingrealworlddata, ehealth and clinical trials

• TheoperationofPharmaceuticalPriceRegulationScheme(PPRS)2009

•Education&skills

•Manufacturingandproductquality

• Animalresearch.

TheABPIrepresentsinnovativeresearch-basedbiopharmaceuticalcompanies,large,mediumandsmall,leadinganexcitingneweraofbiosciencesintheUK.

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Strategicprioritiesandhighlightsfor2012

Improving patient access and uptake of medicines

Building reputation and strengthening relationships

Securing a broader definition of value and preparing for negotiation

Improving the environment for research and development

Providing value for members

• Significantwinsonformularies,NICEImplementationCollaborative(NIC)andtheInnovationScorecardthroughInnovation health and wealth(IHW)implementation,supportuptakeagenda

• LaunchoftheABPIRegionalPartnershipsTeam toaddresslocalbarrierstouptake

• GeneralMedicalCouncil(GMC)agreementtoretainunchangeditsprescribingguidanceforunlicensedmedicines

• Representedindustryintheclinicaltrial transparencydebate

• Progresseddisclosureofpaymentstohealthcareprofessionals

• Shifteddebateonmedicinesupplyshortages,protectingindustryreputation

• Establishednewpatientgroupforum, facilitatingimproveddialogue

• Unitedtheindustryoncommonprioritiesinpreparationforpricingnegotiations

• SecuredagreementwithNICEandtheDepartmentofHealthfordiscussionsonindustryissueswithappraisals

• TheTranslationalResearchPartnerships,proposedbytheABPI,signedfirstthreeprojectstoadvancecollaborativeresearchinrespiratoryandinflammatoryjointdisease

• Seventy-daysetuptargettorecruitfirstpatientinclinicaltrials,supportedbytheABPI,isenshrinedinNationalInstituteforHealthResearch(NIHR)ClinicalResearchNetwork(CRN)contractsto driveNHSperformanceinclinicalresearch

• LaunchofClinicalPracticeResearchDatalink(CPRD)reflectsindustryrequirementssetoutbytheABPI

• Leddialoguewithoperatorsonthetransportationofanimalsandco-createdConcordat for openness in animal researchacrossbiosciencestakeholders

• Recruited17newmembers

• CreatednewCEOandFinanceDirectorForums

• Revisedfeestructuretosupportthegrowthofcompanieswithsalesunder£10million

1891TheABPI’sheritagestretchesbackto1891whenitwasfirstestablishedastheDrugClubinLondon,foundedforwholesaledruggists

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In this challenging environment we recognised the need for a step-change in the ABPI’s capability – across membership, advocacy and policy – to meet our members’ changing needs. Our overarching focus is in the key areas of value and partnership. The value of our medicines to patients and the healthcare system, and the value of the research and development (R&D) invested in future healthcare, are realised through the adoption and diffusion of these innovative medicines in the NHS. To deliver this value, we need to work in partnership with all stakeholders across government, the NHS and patients in England, Scotland, Wales and Northern Ireland.

TheABPIwassignificantlystrengthenedin2012.Iamdelightedtoreportwerecruitedanunprecedented17newmemberslastyear,andfeedbackfromthe2012membersurveyshowedtheABPIgoingfromstrengthtostrength,withhigherthaneverlevelsofmembersatisfaction.

Adecisivemomentin2012wasthestartofthepricingnegotiationswiththeDepartmentofHealth,encompassingboththenext PPRSandtheproposedvaluebasedpricingscheme.Thebackdropofcontinuedausteritytogetherwiththeproposedinclusionofvaluebasedpricingmakesthesenegotiationsthemostcomplex andchallengingwehaveeverfacedasanindustry.Inrecognitionofthiswemadeasignificantinvestmentlastyeartounitetheindustryaroundcommonprioritiestoputusinthebestpossiblenegotiatingposition.

IamproudofthewaytheABPIteamrosetothechallenges in2012onbehalfofourmembers,andthereweremanyachievementsduringtheyearwhicharehighlightedinthisreview.Iwouldhoweverliketomentionafewexamplesincludingourworkwiththesupplychain,establishmentofTranslationalResearchPartnershipsandthelaunchoftheClinicalPracticeResearchDatalink.

Ihavealwaysbelievedthateffectivepartnershipiscriticalinprogressingouragendaandnowherewasthismoreevident,in 2012,thaninourcollaborationwiththeDepartmentofHealth andNHSinshapingtheimplementationofIHW.InAprillastyearweannouncedournewRegionalPartnershipsTeamtodriveuptakeofinnovativemedicineslocallyandIampleasedwiththeexcellentprogresstheteamhasmadeinbuildingthefoundationsforinnovativejointworkinginitiatives.Partnershipisalsoattheheart ofourworktoprotectandbuildtheindustry’sreputation.ThisincludesourworkthroughtheEthicalStandardsinHealthandLifeSciencesGroup(ESHLSG)toprogressdisclosureofpaymentstohealthcareprofessionals,aswellasourextensiveengagementwithstakeholderstoaddressissuesaroundclinicaltrialtransparency.

Whilegoodprogresswasmadein2012,Iaminnodoubtthattherearemanychallengesaheadandwecannotaffordtobecomplacent.Wemustcontinuetodemonstrateindustry’scommitmenttotransparency.WeneedtotranslateourpartnershipworkwiththeNHSintotangiblebenefitsforpatients.Vitally,throughboththepricingnegotiationsanddialoguewithNICE,weneedtoensurethatthevalueofinnovativemedicinesisrecognisedandrewarded,andtheadoptionofnewmedicinesisacceleratedtomeetpatientneed.

Thebio-pharmaceuticalindustryintheUKisatacrucialmoment,andIamcommittedtoensuringthattheABPIisattheheartofshapingthefuturetothebenefitofourpatientsandourindustry.

Stephen WhiteheadChiefExecutiveOfficer

ForewordfromABPICEOStephenWhitehead

Asweentered2012,thebiopharmaceuticalindustryfacedhugepressureswithanenvironmentcharacterisedbyausterity,thepatentcliffbitingeverharderandfurtherjoblosses.InMarch,theHealthandSocialCareAct2012waspassed,markingthebeginningofthemostdramaticchangestotheNHSinEnglandinits65-yearhistory.

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Sweeping NHS reforms, continued austerity and a changing cast of NHS and Department of Health leadership have formed a complex backdrop for members.

Inthischallengingenvironment,theABPIsetouttodrivevalueformembers,engagewiththenewNHSandshapepoliciesaffectingourmembers.Iamparticularlyproudof ourinnovativepartnershipwiththeNHSandtheDepartmentofHealthinimplementingIHW,workwhichweneedtoseecontinueunderthestewardshipofNHSEngland(formerly theNHSCommissioningBoard).

Keytoourworkin2012waspreparingforandentering intopricingnegotiationswiththeGovernment.Itwasparticularlyimportanttoaligntheindustryand,through ourconsultation,Iwaspleasedtoseethatcompaniesofallsizesandtypessharedcommongroundonthekeyissues.

Industryreputationhasalsobeenunderscrutinylikeneverbefore.InMaylastyear,theESHLSG,whichIco-chairwith SirRichardThompsonoftheRoyalCollegeofPhysicians,launched Clinical Trials Principles and Factstohelpdrivebestpracticeinclinicalresearchreporting.ThedebateonclinicaltrialstransparencygatheredpaceattheendoflastyearandtheABPIworkedhardtorepresenttheindustryinthemedia,inParliamentandinstakeholderforums.

Thecomingyearbringswithitanumberofcatalystsforyetfurthersignificantchangeinourenvironment.Thepricingnegotiationswillbecrucial,NICE’sroleisevolvingandtherearemanymorekeyrecommendationsofIHWyettobeimplemented.

Weremaincommittedtocontinuallyimproveourservice tomembersandtospeakwithastrongandunifiedvoice onbehalfoftheresearch-basedpharmaceuticalindustry.

Deepak KhannaPresident

2012wasayearofsubstantialchangeinourenvironmentandsignificantchallengesthatwillshapeourindustryforyearstocome.Mostimportantly,in2012wesawthebeginningofcrucialpricingnegotiationswhichwillhaveanenormousbearingontheUKenvironmentforourmembersandhavebeenakeyfocusfortheABPI.

ForewordfromABPIPresidentDeepakKhanna

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2012Reviewoftheyear

January First meeting of Innovation Health and Wealth Implementation BoardABPIatthetabletorepresentindustry andgainedagreementforindustry representationonallpriorityTaskand Finishgroupstoshapethefuturedelivery ofkeyrecommendations.

March2012 BudgetIntroductionofthepatentboxand anabove-the-lineR&DtaxcreditconfirmedbytheChancellor,RtHonGeorgeOsborneMP,following industryadvocacy.

New executives appointed to the NHS Commissioning BoardABPIengagesearlytobuildrelationshipsandsecureon-goingcommitmenttothedeliveryofIHW.

Health and Social Care Act 2012 is passedABPIestablishesitsRegionalPartnershipsTeamasastrategicresponsetothestructuralchanges intheNHS.

European Commission proposes revised Transparency Directive, laying down requirements to ensure the transparency of pricing and reimbursement measures adopted by Member StatesABPIengageswithEuropeanpartnerstoensurepatients’needscontinuetobemetagainstabackdropofausterity.

AprilLaunch of the Clinical Practice Research Datalink (CPRD)ABPIengagedbeforeandafterthe launchtoconveyindustryrequirements ofthisnewresource.

JuneThen Cabinet Secretary for Health and Wellbeing, Nicola Sturgeon MSP launches Health and Wealth In Scotland: A Statement of Intent for Innovation in HealthLaunchwelcomedbyABPI Scotland.

Department of Health reveals process for establishing Academic Health and Science Networks (AHSNs)DialoguewithDepartmentof HealthensuresclearroleofAHSNsin innovation and wealth creation and an ABPI role on interview panelforAHSNapplications.

JulyNICE positioned to take over the work of the Advisory Group for National Specialised Services on assessing high cost, low volume medicines ABPIdrivesparliamentaryoutreachaheadofadebateintheHouseofCommons.

The Medicines and Healthcare products Regulatory Agency (MHRA) launches consultation on proposals for an Early Access to Medicines SchemeABPIchampionsindustryconceptofearly access to medicines with the MHRAandcoordinatesindustryresponsetoconsultation.

The European Commission publishes draft legislation on Clinical Trials ABPIworkswithacademicandcharitablestakeholdersintheUKtoagreeajointhealthcareprofessionaland industry view on the issue and withEuropeanFederationofPharmaceutical Industries and Association(EFPIA)toensure strongrepresentationinEurope.

February11th Pharmaceutical Price Regulation Scheme ReportABPIdrivesUKlowpricesmessaging,framingthepublicdebateonmedicinesprices.

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July The European Council agreed a single unitary patent valid in up to 25 European countries

ABPIrepresentsindustryconcerns totheUKGovernmentinadvanceofkeyEuropeannegotiatingmeetings.

AugustProgress report on Strategy for UK Life Sciences Strategy published by Government ABPIcallsforgreaterurgencyindeliveringactionsatalocallevelacrosstheNHS.

SeptemberRt Hon Jeremy Hunt MP becomes Secretary of State for HealthABPIactsswiftlytoengagewiththenewSecretaryofState,raisingawarenessofcriticalindustryissues.

Scottish Parliament’s Health & Sport Committee holds inquiry on availability of new medicines in NHS Scotland and the Individual Patient Treatment Request process ABPIprovidesevidenceadvocatingimprovedpatientaccessandScottishGovernmentannouncesareviewofsystemsformakingnewmedicinesavailable.

Bad Pharma published ABPIrepresentstheindustry,in ahighlychargeddebate,driving messagesaboutcommitmenttotransparencyandthecontinuing workwithallstakeholderstoaddress thecomplexissueofclinicaltrialdisclosure.

NovemberDepartment of Health publishes the Mandate for the NHS Commissioning Board ABPIengageswiththeDepartment ofHealthtoensurecommitmentssupportingresearch,innovationandeconomicgrowthareprominentin theMandate.

Health Committee inquiry on NICE ABPICEOStephenWhiteheadgivesoralevidencereinforcingtheindustry’spositiononHTAprocessesandNICE’sfutureroleinaddressingpatientaccessandvalueofmedicines.

Consultation begins on the NHS Constitution ABPIcallsforpatientcareplanstoincludespecificreferencetomedicinesandforallpatientstohaveaccessto newmedicineswithin90daysoftheirapprovalbyNICE.

IMS commentary on NHS Information Centre national metrics report Use of NICE appraised medicines in the NHS in England published, showing that patients are still struggling to access NICE recommended medicinesABPIcontinuestodrivehardhittingpatientaccessmessages.

DecemberGovernment publishes Strategy for UK Life Sciences One Year On updateABPIengageswiththePrime Minister,Chancellorandotherministers,reinforcing the need to ensure momentum is maintained.

OctoberFormal meetings begin with the Department of Health to negotiate the pricing environ-ment in the UK post-2014ABPIentersnegotiationshavingunited theindustryoncommonpriorities.

Introduction of Wales Patient Access Schemes CulminationofABPIengagement withWelshGovernmentandAll WalesMedicinesStrategyGroup.

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Implementation of IHWFollowingthepublicationofIHW1attheendof2011whichwasco-createdwithindustry,ABPICEOStephenWhiteheadwasappointedtotheIHWImplementationBoardalongsideseniorNHSrepresentatives.

The ABPI also facilitated a number of industry secondees into theDepartmentofHealthaspartofanintegratedteamsupportingtheimplementationofIHW.

Crucially,wesecuredindustryrepresentationonIHW Task&FinishGroupsestablishedtodeliverthekeyrecommendationsofthereport.SupportedbytheABPI,industryrepresentativeshavebeenabletohelpshapethedevelopmentofcriticalinitiativeslaunchedunderIHW.

While we are clear that momentum needs to continue to ensurerealchangeontheground,anumberofimportantoutcomeswereachievedin2012including:

•AclearmessagefromtheNHSChiefExecutiveandtheChiefPharmaceuticalOfficerontherequirementtoautomaticallyincludeNICErecommendedmedicines onformularies,whichmustbepublished.

•EnsuringthatthefirstInnovationScorecardincludedagoodrangeofmedicines,withagreementtofurtherdevelopasecondversionofthescorecard.

•Progressingthemedicine-focussedNICEImplementationCollaborative(NIC)pilots,whicharenowthemostadvancedofalltheNICpilots.

•SecuringaseatontheinterviewpanelforAHSNs,enablingustohelpshapehowtheywilldriveinnovationintheNHS.

DuringthefirstyearofIHW,theABPIalsosupported thecommunicationofIHW,raisingawarenessofthekeyrecommendationsthatlocalNHSorganisationswouldbeexpectedtoimplement.

ThisincludedaNICEformularygoodpracticeguidefortheNHSaswellasaseriesofworkshopsontheimplementationoflocalformulariesguidance.

Lookingahead,wewillcontinuetodriveprogressontheimplementationofIHWrecommendationsandleadtheindustry’sengagementwithNHSEngland(formerlythe NHSCommissioningBoard).

ABPI Regional Partnerships TeamAsastrategicresponsetotheNHSreformsinEngland– andtheincreasingimportanceoflocalstructures–in2012theABPIbeganinvestinginbuildinganewpartnershipsteamtoworkwithmembersandtheNHS,tohelpidentifyjointworkingopportunitiesandremovebarrierstopatientaccesstoinnovativemedicines.Withtheresourcenowfullyestablished,welookforwardtoreportingontheimpactofthisstrategicinitiativein2013.

Improvingpatientaccessto,anduptakeof,innovativemedicines

WiththeUKamongtheworstperformersinEuropeintheuptakeofnewmedicines,ensuringrealprogressingettingtherightmedicinestotherightpatientsattherighttimeremainsakeypriority.

The NHS Innovation Scorecard highlights areas of England where patients are unable to access medicines, enabling industry to work with the NHS to address barriers to patient access in those areas.

Industry participation in IHW Task & Finish Groups

• NICE Implementation Collaborative • Formularies• Innovation scorecard• Academic Health Science Networks

(AHSNs)• Aligning incentives• Never events’ regime and disinvestment• Specialised Services Commissioning

Innovation Fund• NHS Intellectual Property Strategy• Educational and training• Joint industry and NHS training• NHS Innovation Fellowship Scheme• Leadership and accountability

1DepartmentofHealth,Innovation Health and Wealth: Accelerating adoption and diffusion in the NHS,5December2011

1892 TheDrugClubholdsitsfirstmeeting

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Joint working During2012,wealsocreatedthenewABPI Quick Start Guide asatooltosupportjointworkinginthedevelopmentoflocalpathways.Wewerepleasedtoseeanincreasingnumberofsuccessfuljointworkingprojectswithimprovedpatientoutcomes.

Guidance on prescription of unlicensed medicines WhentheGeneralMedicalCouncil(GMC)announceditsconsultationonrevisedprescribingguidancetodoctors–includingaproposaltoallowtheprescriptionofunlicensedmedicinesonthegroundsofcost–theABPIHTATaskforceactedquicklytoraiseawarenessoftheimplicationsforpatientsandthemedicineslicencingsystem.

Followingadedicatedcampaignduring2012,whentheGMC’sprescribingguidancewasreleasedinearly2013itretaineda broaddefinitionofbenefittothepatientratherthanallowingtheprescriptionofunlicensedmedicinesonthegroundsofcost.Asaresult,patientchoiceandpatientsafetywerepreserved,andthemedicinesinnovationandlifecycleprocesswasprotected.

Driving public awareness of poor patient accessDrivinghardhittingaccessanduptakemessagesinthemediaremainsanimportantpartofouroverallapproach.Thenationalmediacoveragewesecuredforboththenationalmetricsreport2andthesubsequentIMScommentary,isanexampleofourplanned,proactiveengagementwiththemediaonthiscriticaltopic.

Helping the NHS plan for new medicinesHelpingtheNHStoprepareforthechallengeofintroducingnewmedicinesquicklyandefficientlyisanimportantcontributortoimprovinguptake.

Throughout2012wesupportedcompaniesinusingUKPharmascan,adatabasecoveringallnewmedicinesandindicationstobelaunchedintheUKoverthenextthreeyears.

TheABPIhassupportedtheregistrationofmorethan100companiesandmorethan500medicinesontothedatabase.PharmascanisnowtheprimarysourceofinformationfortheNHStoplanandbudgetfornewmedicines,enablingfasterpatientaccess.

Early access schemeFollowingABPIadvocacyontheearlyaccessscheme–conceivedbytheABPIandotherstakeholdersataMISGforum–theMHRAlaunchedapublicconsultationin2012onthedesignofascheme3.

TheABPIactivelyworkedwiththeMHRAtomaintainmomentumtoensuretheconsultationprogressedina timelymanner.WecontinuetoengagewiththeMHRAandotherimportantstakeholderstoensurethedesignandimplementationoftheearlyaccessschemedeliversimprovedpatientaccess.

While progress has been made there are still considerable challenges ahead on the access and uptake agenda. Ensuring better patient access to modern medicines will remain a core priority for the ABPI, working with Government, the NHS and NICE.

Innovation, health and wealth made clear that the spread and adoption of innovative practice at pace and scale in the NHS is vital if we want to deliver a better service and better outcomes for patients. The journey from co-creation to implementation of IHW has been an excellent example of joint working between the NHS, Government and the life sciences industries. We have built a partnership that has transformed the way we work together. I want to thank the ABPI and the pharmaceutical industry for the essential contribution they have made. Its leadership, technical knowledge and the commitment of experts to this work has been exceptionalSir Ian Carruthers

3MHRA,Public consultation (MLX 376), Proposal to introduce an early access to medicines scheme in the UK,July2012

2HealthandSocialCareInformationCentreUse of NICE appraised medicines in the NHS in England 2012

1929Atageneralmeetingofthe‘WholesaleDrugTradeandIndustry’,itwasagreedthatstepsshouldbetakentoformaWholesaleDrugTradeAssociation(WDTA)

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Buildingreputationandstrengtheningrelationships

Theindustryhaslongrecognisedthelinkbetweentransparencyandtrustinlinewithincreasingsocietalexpectations,andmuchhasbeenachieved,overtheyears, aswehaveadvancedonthisjourney.Thisagendagainedfurtherpacein2012withsignificantdevelopmentsandstrategicinitiativesdrivenbytheABPIonbehalfofmembers.

Reputation Disclosure of payments to healthcare professionals

Ourindustryisleadingthewayonthetransparencyofrelationshipswithhealthprofessionals.During2012,theABPIworkedwithmemberstosupporttheiraggregatedisclosureofpaymentstohealthprofessionals,which beginsin2013forpaymentsmadein2012.

Aggregatedisclosurerepresentspartofthejourneytowardstransparencyofpaymentsatanindividualhealthcareprofessionallevel.InJune2012,EFPIAannouncedapan-Europeancommitmenttomakeindividualdisclosure ofpaymentstohealthcareprofessionalsarealityby2016.

TheABPIplayedacriticalroleinthedevelopmentoftheEFPIAproposals,ensuringtheviewsofABPImemberswererepresented,and–importantly–thattherewassufficientflexibilityoverimplementationtoaccountfortheUKenvironmentandallowforapartnershipapproachwiththehealthprofessionalcommunity.

ThispartnershipapproachwasreflectedintheUKconsultationonthepublicdisclosureofindividualpaymentslaunchedbytheEthicalStandardsinHealthandLifeSciencesGroup(ESHLSG),apartnershipbetweenindustry,royalcollegesandprofessionalorganisations,formedin2011andco-chairedbyDeepakKhanna,ABPIPresident.

Developedin2012andlaunchedinJanuary2013,theconsultationwillinformanagreedapproachtothedisclosureofindividualpaymentstohealthcareprofessionalstomeettheEFPIAcommitments.

Medical education

Industrysupportformedicaleducationhaslongbeenafocusofmediascrutiny.Inthelatterpartof2012,theABPIworkedwiththeESHLSGtosurveyhealthprofessionalsandtheindustry on what they currently value and what needs to be developedorchanged.Withover1,500responseswehaveasolidplatformonwhichtoworkwithmembersandtheESHLSGtodeveloprecommendationsforevolvingourapproachin2013.

Clinical trial transparency

TheABPIhaslongadvocateditscommitmenttogreatertransparencyinthereportingofclinicaltrialsandmany stepshavealreadybeentakentowardsthisgoal.ThisisacomplexandglobalissueandtheABPIcontinuedtoworkcollaborativelythroughtheyearwithmultiplestakeholdersandinternationalcolleagues.

Tohelpensureclarityontheexistingvoluntaryandregulatorycommitmentsontrialregistryandpublicationoftrialinformation,inJune2012weworkedwiththeESHLSGtopublishClinical Trial Transparency Principles and Facts4.ThiswaslaunchedtoabroadaudienceatajointBritishMedicalJournalandABPIconferenceexaminingissuesofclinicaltrialdesign,implementationanddisclosureaspartofourongoingcommitmenttoaddresstheseissuescollaboratively.

InSeptember2012theABPI Code of Practice was amended to requirecompaniestodisclosedetailsoftheresultsofallclinicaltrialsinaccordancewiththeInternationalFederationofPharmaceuticalManufacturersandAssociation’s(IFPMA)Joint Position on Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases.

Thestrategicimportanceofprotectingtheindustry’sreputation,buildingreputationcapitalandmaintainingstrong,trustedrelationshipswithmultiplestakeholdersisparamount.

1930 TheDrugClubiswoundupandtheWDTAholdsitsfirstmeeting

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TheextensivepublicityaroundthepublicationofDrGoldacre’sbookBad Pharma5inSeptember2012resulted intheneedtorapidlyrespondonbehalfoftheindustry.Throughdedicatedmediaactivity–includinghighprofileinterviewswithABPICEOStephenWhiteheadonRadio4’sToday Programme–wesoughttohighlighttheindustry’scommitmenttogreaterclinicaltrialtransparency,thecomplexityandglobalnatureoftheissueandtheneedtocontinueworkinginpartnershipwithallstakeholders.

Insupportingourcase,weundertookresearchtoascertaintheextenttowhichcompaniespublishtheresultsofclinicaltrialsandouranalysisshowedthatthepubliclyavailableevidencebasefornewmedicineshasimprovedinrecentyears.

InDecember2012theScienceandTechnologyCommitteeannounceditsinquiryintoclinicaltrialsandwetookimmediateactiontodeveloparobustresponseforsubmissionin2013.ThisincludesourintenttointroducenewmeasurestomonitoradherencewiththeclinicaltrialtransparencyprovisionscontainedintheABPI Code of Practice.

Supply shortages

Late2011andearly2012sawtheemergenceofanincreasinglevelofmediacommentaryonshortagesinmedicinessupplies,criticisingpharmaceuticalcompanies’supply chainprocessesasthecauseofpotentialpatientharm.

TheABPIrespondedquicklytoprotecttheindustry’sreputation,buildingastrongevidence-basedargument ontheimpactonthesupplychainofexcessiveandunpredictableorderslinkedtoparalleltrading.

Throughproactivemediaactivityandextensiveparliamentaryoutreach–includingevidencetotheAllPartyPharmacyGroupinquiry–weweresuccessfulinshifting thedebatetofocusonexcessiveorderingasopposedtoaproblemwithpharmaceuticalcompanies’supplychainprocesses.

Strengthening relationships Wehavelongrecognisedthatmaintainingstrongrelationshipsacrossallourstakeholdersiscriticaltoprogressingourstrategicpriorities.

Withpartnershipsattheheartofourwork–includinginitiativessuchastheABPIRegionalPartnershipsTeam,collaborationswithESHLSGandIHWandtheTranslationalResearchPartnerships–wehavecontinuedtostrengthen ourrelationshipsin2012includingourengagementwithpatientgroups.

Developingandstrengtheningourrelationshipswithpatientgroupswasakeydriverfor2012,withanewforumdesignedtoimproveengagementandsharedunderstandingonkeytopicsofmutualconcern.Duringtheyearwesoughttobuildonthisre-energisedapproachthroughnewwaysofpartnershipworkingincludingestablishingajointsteeringgroupresponsibleforsettingtheagendafordiscussion.

Anotherimportantinitiativein2012wastheextensionofourstrategicpartnershipwiththeNHSConfederation,establishedtoencourageadoptionanddiffusionofinnovationwithintheNHSbyshowcasingbestpractice.

We are proud of the strong and sustainable relationships that we built during 2012 across the NHS, charities, patient groups and research bodies. By continuing to work in partnership, we will improve patient access to innovative medicines and build support for the industry.

4EthicalStandardsinHealthandLifeSciencesGroup,Clinical Trial Transparency and Facts,May2012 5BenGoldacre,Bad Pharma,September2012

Throughout our close working relationship with the ABPI during 2012, I witnessed at first-hand how, working as a team, the NHS and the pharmaceutical industry can deliver significant patient benefits above and beyond what can be delivered by any one party on its own. That is why I am firmly behind greater partnership working between the NHS and industry and I will be encouraging all of my colleagues across the NHS to continue to engage with this important collaboration.

Mike Farrar, Chief Executive, NHS Confederation

1940WDTApremises(GordonSquare)destroyedbyenemyaction

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Pricing negotiations Acorepriorityinpreparationforthenegotiationswastounitetheindustry.Throughawideanddetailedconsultation,weachievedconsensusacrossallcompanies–includingbothlargeandsmallcompanies–onthekeyprioritiesforindustryinthenegotiations.Thisreflectedbroadagreementthatthecurrentpricingschemeworkswell.

ThisconsensusenabledtheABPI–asthenegotiatorfor allindustry–toenterthenegotiationswiththeDepartmentofHealthinthestrongestposition.

InadditiontodetailedpreparationsupportingtheABPInegotiatingteam,weestablishedprocessestoalignwith othertradeassociationsandthegeographicalgroups.

Inadvanceofthenegotiations,theABPIteamcollectedevidenceandkeymetricsontheUKcommercialenvironmenttohelpbuildapowerfulevidencebase toleverageaspartofthenegotiations.

Asadirectresultofourtargetedadvocacy,ourkeymessagesarebeingheardatthehighestlevelsingovernment.

Reform of NICE and HTA processes During2012,wewereactivelyinvolvedindiscussionsabouthowNICEassessesthevalueofmedicines.ThisincludedengagementwithNICEandtheDepartmentofHealthbothbilaterallyandthroughtheMedicinesAccessGroup.

Underpinnedbyaprogrammeofworktodefineasetofagreedindustrypolicypositions,wesecuredagreementwithNICEandtheDepartmentofHealthtoreviewanumberofcriticalvalueassessmentandprocessissuesdirectlywithNICE.

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Securingabroaderdefinitionofvalueandpreparingfornegotiations

Weentered2012indialoguewithMinistersabouttheGovernment’sintentiontointroduceanewvaluebasedpricingscheme.This,togetherwithcontinuedausterity,makesthesenegotiationsthemostcomplexandchallengingwehaveeverseen.Alongside,NICEcontinuedtopresentachallengeintermsofsecuringpatientaccesstoinnovativemedicines,furthercontributingtoachallengingenvironmentforourmembers.

ROI

EfficiencyValue creationInnovation

Slow and low uptakeUsage restrictions

Low prices

Market accessdelays

Fast and intensevolume and price erosion

Thelife-cycleforinnovationintheUK issqueezedonallsides

Oldlifecyclecurve

Currentlifecyclecurve

1941 NewofficessecuredinBMAHouse,TavistockSquare

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6Written evidence from the Association of the British Pharmaceutical Industry (NICE29)HealthSelectCommittee,October2012

US

France

Belgium

Spain

Italy

Germany

Ireland

Austria

Denmark

Sweden

UK

2.12.1

2.01.8

1.71.5

1.4 1.4

1.4 1.5

1.41.3

0.9 1.3

1.41.2

1.41.2

1.0 1.2

1.00.9

SpendingonmedicinesasapercentageofGDP. invariouscountriesin2011

Ensuring that patients are able to access the most appropriate, clinically and cost-effective medicines relies on a constructive and transparent dialogue between industry and NICE. Our work together helps us maintain this dialogue and we look forward to continuing this productive relationship with our industry partners in 2013 Sir Andrew Dillon, Chief Executive, NICE

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2011

OurpolicypositionsalsounderpinnedourwrittenandoralevidencetotheHouseofCommonsHealthSelectCommittee onNICE.Wewerepleasedtoseethatourconcernsabouttheneedtoplacegreateremphasisontheclinicalvalueofmedicinesandtotakeintoaccountmorefullytheperspectiveofcliniciansandpatients6,werereflectedintheCommittee’sreport.

Thisworkundertakenin2012laidthefoundationsfortheengagementwithNICEin2013,whichisunderway,withacoreobjectiveofensuringthebroadervalueofmedicinestopatientsandwidersocietyisrecognisedandrewarded.

Driving awareness of the cost of medicinesTheneedtoaccuratelyframethedebateonmedicinespriceswasakeydriverin2012.Weusedthe11thPPRSReportandresearchconductedbytheOfficeofHealthEconomics(OHE)onthemedicinesbilltodrivemessagesaboutlowUKprices

andtheNHSmedicinesbillbeingundercontrolthroughmultiplechannels.Throughextensivemediacoverage–includingRadio4’sToday Programme and the Times –andstakeholderoutreach,weraisedawarenessofthesekeymessages.

Our policy work and preparation for negotiations during 2012 have put us in a strong position. With austerity in public spending expected to continue for several years, improving recognition of the value of innovative medicines will remain a key focus for the ABPI.

1948TheAssociationoftheBritishPharmaceuticalIndustry(ABPI)isformedbynamechangetomoreaccuratelyreflectthenatureofthegroup

12

ThroughafocusedprogrammeofactivitytheABPIhelpedtoensuregovernmentcommitmentsintheStrategy for UK Life Sciencestranslatedintorealaction.

Clinical trial performance FollowingtheGovernment’sacknowledgmentoftheneed fortransparentbenchmarkstodriveimprovedperformanceofclinicalresearchbytheNHS,weundertookaprogrammeofworktoinfluenceandsupporttheimplementationofmetricsforperformancemanagementwithintheNationalInstituteforHealthResearch(NIHR)ClinicalResearchNetwork(CRN).

ThesemeasuresincludeaninitialbenchmarkinNIHRCRNcontractsstipulatingthatNHSprovidersmustrecruitthefirstpatientforastudywithin70daysorlessfromthetimeitreceivesavalidresearchapplication.

Crucially,theABPIalsosupportedacommitmentforNIHRCRNfundingtobeconditionalonprovidersmeetingthe70 daytargetfrom2013.

WearepleasedtoseethattheNIHRCRNhascommittedtopublishingclinicaltrialperformancemetricsagainstagreedbenchmarksin2013,allowingindustrysponsorstoseehowmanytrialsareinprogressandhowmanypatientshaveaccesstothosetrials.

Leveraging health data LaunchedinApril2012,theClinicalPracticeResearchDatalink(CPRD)joinstogetherITsystemsacrosstheNHSandprovidesresearchers–academiaandindustry–withanalysesofhealth

recordsforarangeofpurposes,includingtoimprovetrialrecruitmentandfeasibility,tofurtherR&D(forexampleintostratifiedmedicines),foroutcomesresearchandtomonitorsafety.

Importantly,weengagedearlywiththeCPRDandthenewHealthandSocialCareInformationCentre(HSCIC)tohighlightindustry’s’requirementsfortheresource.

Oncelaunched,wehostedaworkshopwiththeHSCICandtheMedicalResearchCounciltoupdatemembersontheavailableresourcesfordatalinkagesandcapacitybuildinginkeyinformaticsskills.

For researchers: you will be able to access the bestfacilitiesandworld-leadinginstitutions,reallifedataandanintegratedsystemforbio-medicine.

For clinicians: you will have an active role ininnovationandresearchintopioneeringnew treatments and truly add value to the ecosystem,whilstimprovingpatientoutcomes.

For patients: youwillbeempoweredtohavemorechoicewithbetterandquickeraccess tonewtreatments,forbetterresults.

Strategy for UK Life Sciences

TheUKisinaglobalracetoattractR&Dinvestment.TheABPIhasrisentothischallengeanddeliveredsignificantachievementsin2012followingthelaunchoftheStrategy for UK Life Sciences.

Improvingtheenivironmentforresearchanddevelopment

1957 FirstVoluntaryPriceRegulationSchemeisintroduced12

The UK is in a global race and the Government is committed to keeping our life sciences industry at the forefront of research and development. Creating the right environment for growth and inward investment is at the very heart of this ambition.We are encouraging collaboration between the research base, industry and the NHS. We are supporting innovation through translational funding and we are boosting skills. We are determined that the pharmaceutical sector continues to be a British success story. Rt Hon David Willetts MP, Minister for Universities and Science

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Translational research During2012,weproposedTranslationalResearchPartnerships(TRPs)andco-designedtheconsortiumcontractualtemplatefortheUK.In2012,theTRPsgainedtheirfirstthreepartnershipprojectsbetweenindustryandtheacademiccentresofexcellenceinrespiratoryandinflammatoryjointdisease, withmanymoreunderconsideration.

Wealsoextendedcollaborationacrossindustry,academiaandtheNHSin2012throughleadingtheestablishmentofanewMRC-ABPIconsortiumforDiabetesStratification.

Animal research Weledinitiativesthroughout2012–inpartnershipwithotherstakeholders–toseekasustainablesolutiontothecessationofcommercialsurfaceroutesavailabletotransportanimalsbredforbio-medicalresearch.Importedanimalsaresmallinnumberbutarebothresearchandbusinesscritical,andthisobstructionalsoimpactsonimportantinternationalcollaborationinR&D.

TheABPIhelpedform,andactedasthesecretariatfor,theLifeSciencesTransportGroupwithgovernment,medicalresearchcharitiesandotherkeystakeholders.Thisgroupsoughtandobtaineddialoguewithtransportoperators,increasingsharedunderstandingoftheissuesandfocusingouron-goingdiscussionswiththem.

Followingapollofpublicattitudestowardsanimalresearch,conductedbytheDepartmentforBusiness,Innovation&Skills(BIS),theABPIworkedwithotherstakeholderstogainagreementtoaConcordat for openness on animal research,encouragingtheresearchsectorasawholetoimprovetransparencyandcommunicationstothepubliconanimalresearch.Thisworkisanhistoricopportunitytoadvancepublicconfidenceinthisimportantarea.

ABPI Guidelines for Phase 1 Clinical TrialsInamajorlandmarktosupportthecriticalroleofPhase1clinicaltrialsinmedicinesdevelopment,weproducedanupdatededitionoftheABPI Guidelines for Phase 1 Clinical Trials.Thesearewidelyusedbyindustry,academia,healthprofessionals,regulatorsandethicscommittees,notonly intheUKbutaroundtheworld.

The2012editionreflectedthechangingregulatoryenvironment,andfeedbackfromtheextensiveconsultation thattheABPIundertookwithmembersandmultiplestakeholders,resultinginathoroughandclearcompilationofupdatedinformationandguidanceonbestpractice,endorsed bytheChairoftheCommissionforHumanMedicines.

Raising awareness of incremental innovationPublishingourreportThe many faces of innovation7broughtpublicrecognitionofthevalueofmedicinesandofincrementalinnovationbythepharmaceuticalindustry.TheextensivepresscoveragehighlightedthevaluethatindustrybringstopatientsandreflectedoursoundargumentstogovernmentabouttheneedtoprotectandenhancetheUKenvironmentforinnovation.

Antimicrobial Resistance Strategy Withthetreatmentofdiseasesliketuberculosisandpneumoniacurrently under threat because of resistance to antimicrobial medicines,theABPIcoordinatedacompellingindustryresponsetotheDepartmentofHealthconsultationontheAntimicrobial Resistance Strategy.

While we are pleased with the progress in improving the R&D environment during 2012, more must be done to maintain the UK’s position as an attractive location for R&D investment. The ABPI continues to focus on addressing the challenges.

7 The many faces of innovation, a report for the ABPI by the Office of Health Economics, March 2012

TheABPIR&D ConferenceandtheScienceinParliamentlaunch

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Providingvalueformembers

Againstthebackdropofanincreasinglychallengingenvironmentfortheindustry,theABPIupgradeditscapabilityinmembership,advocacyandpolicy,in2012,todriveincreasedvalueformembersacrosscriticalissuesandagendas.

2012wasayearofsignificantexpansionfortheABPI–welcoming17newmembers–andtheresultsfromourmembershipsurveyshowedcontinuousimprovementin theengagementandsupportweprovidetomembers.

Duringtheyearwecontinuedtoevolveourmembercommunicationsandresources,buildingonourpositivesurveyscores.

Ourmembershipsurveyclearlydemonstratedthevalue ofthenetworkingopportunitiesprovidedbytheABPI. Inresponsewestepped-upourface-to-faceevents–includingaBusinessPlanningWorkshopandawiderange ofMasterClasses–andintroducednewseniorlevelforumsforChiefExecutivesandFinanceDirectors.

Followingmembers’feedbackwealsofocusedmoreattentiononoursmallercompanymembersbydeliveringregularforummeetings,providingamorecomprehensivemonitoringpackageandadjustingthemembershipfeestructureforcompanieswithsalesunder£10million.

Overtheyearwebuiltastrongerrapidresponseprocess, withanimprovedabilitytorespondtocomplexmediaissues,acrossallchannels,onbehalfofmembers.

Wealsostrengthenedourpolicyandadvocacycapability,withsignificantpolicywinsincluding:theGMC’sdecisiontoretainitsprescribingguidanceforunlicensedmedicines,avertingmorestringentsupplychainregulationandsecuringtherequirementtoautomaticallyincludeNICErecommendedmedicinesonformularies,whichmustbepublished.

In2012weextendedourgeographicalreachwithadedicatedofficeinNorthernIreland,meaningwenowhavethecapabilitytoworkinpartnershipwithstakeholdersacrossgovernment,theNHSandpatientsinEngland,Scotland,WalesandNorthernIreland.

While we are pleased that our member survey shows strong levels of satisfaction we remain committed to continuously strengthening the value of our offer and look forward to updating members on new initiatives during 2013.

More leadership and greater industry consensus on key issues. Much greater “value” of membership

ABPI member survey 2012

ABPI member survey 2012

ABPI member survey 2012

Greater visibility, more vocal and more innovative

More externally focused Leadership Team, with a willingness to more actively engage with critics

14 1958 ABPICodeofPracticeintroduced

ABPI

Scotland Office,

Edinbu

rgh

ABPI

Northern Ireland Office,

Belfast

ABPI Cymru

Wales Office,

Cardiff

ABPI Regional Partnerships

Team

North

Regio

n

ABPI Regional Partnerships

Team

Midlands

&East

Region

ABPI Regional

Partnerships Team

London

Regio

n

ABPI Regional

Partnerships Team

SouthR

egion

Key to SHA Clusters

NorthEast,NorthWest,YorkshireandtheHumber

WestMidlands,EastMidlandsandEastofEngland

SouthWest,SouthCentralandSouthCoast

London

151962 ABPIfoundstheOfficeofHealthEconomics(OHE)tocommissionandundertakeresearchontheeconomicsofhealthandhealthcare

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The ABPI in the devolved nations

TheABPIisworkingtoimprovetheenvironmentforthepharmaceuticalindustryrightacrosstheUK.In2012weachievedfirmcommitmentstojointworkingfromkeystakeholdersinbothWalesandScotlandandlookforwardtofurthersuccessinNorthernIrelandfollowingtheopeningofournew,dedicatedoffice.

DrRickGreville,DirectorofABPICymruWalesandInternationalAffairs,DeepakKhanna,ABPIPresidentandProfessorChrisMcGuiganofCardiffUniversity attheWelshAnnualLectureinCardiff ALLIANCE-ABPIworkshopseries

WalesIn2012,throughourcontinuedworkwiththeWelshGovernmentweimprovedaccesstomedicinesthroughanagreedprocessandsetofprinciplesforimplementingPatientAccessSchemesinWales.Throughthis,companiesnowhavetheopportunitytoutiliseaprocess,similartotheoneoperatinginEngland,enablingpatientstohaveaccesstomedicinesthatmaynotinitiallybeconsideredcost-effectivebytheAllWalesMedicinesStrategyGroup(AWMSG).

ABPICymruWalesalsostrengtheneditsrelationshipswithAWMSGduringtheyear,assistinginthedevelopmentof itsfirsteverpatientsummit,hostedbytheRoyalNationalInstituteforBlindPeople.Withafocusonthepatients’perspectiveofthevalueofmedicines,thesummitprovided aplatformforsharingmessagesmorewidelywithpolicy andclinicaldecisionmakersaspartofourwide-reachingadvocacyprogramme.

Ongoingengagementwithgovernment,academiaandNHSWalesontheinnovationagendaensuredthatthevalueofthepharmaceuticalindustryanditsproductswererecognisedandreflectedinTheNationalInstituteofSocialCareandHealthResearchIndustry Engagement in Walesreport8.ThisreportconfirmedtheWelshGovernment’scommitmenttohealthsciencesresearch,particularlyinthreekeydiseaseareas:cardiovasculardisease,canceranddementia,whilstalsorecognisingthemandatoryfundingdirectiveinWales forallmedicinesrecommendedbyAWMSGandNICE.

ScotlandTheABPIScotlandteamwasattheforefrontofpolicydevelopmentin2012.Increasinglyrelieduponbygovernmentasanimportantpartner,theABPIwaspart ofthecoreteamdevelopingtheScottishGovernment’sStatement of Intent on Innovation in Healthcare9,leadingtotheinclusionofcommitmentspromotingaccesstomedicinesandsupportingtheGovernment’saimtodoubletheeconomiccontributionoflifesciencestotheScottisheconomyby2020to£6billion.

Atthebeginningof2012,ABPIScotlandsecuredcommitmentsfromtheScottishGovernmenttointroduce a90daylimitonlocaldecisionmakingonSMCacceptedmedicinesandtheintroductionofgreatertransparencyinlocaldecisionmaking.WehavecontinuedtodrivetheaccessagendaresultinginABPIScotlandpresentingwrittenandoralevidencetoaScottishParliamentinquiryintoaccesstomedicinesinScotland,whichresultedintheannouncementbyScottishGovernmentofareviewofaccesstomedicinesinScotlandencompassingSMCdecisionmaking,theindividualpatienttreatmentrequest(IPTR)processandtheuptakeofnewmedicines.Theresultsofthereviewwillbepublished forconsultationinmid2013.

16 1980 ABPImovesHeadOfficetoWhitehall

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Duringtheyearwealsoplayedacriticalroleinprompting anewversionoftheChiefExecutiveforNHSScotland’sguidanceforjointworkingbetweenNHSScotlandandindustry,A Common Understanding 201210.Thisbuiltontheprevious2003guidanceandprovidedanup-to-datetemplateforjointworkingbetweenNHSScotlandandthepharmaceuticalindustry.

FinallywestrengthenedourpartnershipworkingbyjoiningforceswiththeALLIANCE(formerlyLongTermConditionsAllianceScotland).Thisincludedfacilitatingathreeyearprogrammeofseminarsandtraining,fortheir200patientgroupsandcharities,linkedtoScotland’sHealthcareQualityStrategy.

Northern Ireland In2012wemadeadecisiveinvestmentinNorthernIrelandbyestablishingadedicatedofficeinBelfast.ABPINorthernIrelandhadaproductiveyear,continuingtobuildstrongrelationshipswithpolicyandhealthcarestakeholdersacrosstheregion.Wewereimmenselyencouragedbythedegreeof

MinisterialparticipationinABPINIevents,demonstratingcross-departmentalsupportforthepharmaceuticalindustry,andweredelightedthattheChiefScientificAdvisorandluminariesfromacademicandclinicalresearchengagedwithABPImemberspersonallytodiscussthedevelopmentofastrategytoenhanceNorthernIreland’sglobalR&Dpotential.WewerealsoinvitedtositontheDepartmentofHealth&SocialCare’sSteeringGroupfortheStrategicReviewofCommunityPharmacy,providingindustryinputintotheevolvingroleofcommunitypharmacistsinaddressinglocalhealthandsocialwell-beingneeds.

Ourpatient-focusedworkcontinuedtogofromstrengthtostrength,withpolicystakeholders,patientgroupsandclinicianspraisingABPINIprojectsintheareasofoncology,immunologyandpainmanagement.

Across the devolved nations of the UK, 2012 saw notable successes in deepening our partnerships with governments, the patient community and clinical groups in order to improve the commercial environment and enhance access.

8TheNationalInstituteforSocialCareandHealthResearch,Industry Engagement in Wales,20129ScottishGovernment,Health and Wealth in Scotland: A Statement Of Intent For Innovation In Health,June2012

10ScottishGovernment,A Common Understanding 2012 - Working Together For Patients,November2012

We know that the Scottish Medicines Consortium is globally respected and has the fastest and most efficient medicine review process anywhere in the UK. Some clinicians, charities and patients have, though, raised concerns about access to medicines, so it is only right that we look at ways that we could potentially improve access arrangements. Scotland’s NHS is renowned as being at the forefront of new technologies and innovation – I want to make sure that the same is true of access to new medicines.Alex Neil MSP Cabinet Secretary for Health and Wellbeing, Scottish Government The Scottish Government, New medicines review, press release, 14 November 2012

1993 ABPIestablishesthePrescriptionMedicineCodeofPracticeAuthority(PMCPA)toadministertheABPICodeofPracticeatarm’slength

18

TheABPIisworkingtoimprovetheenvironmentforthepharmaceuticalindustryrightacrosstheUK.Ourobjectives for2013reflecttheprioritiesofourmembers:large,medium andsmall.

ABPIstrategicprioritiesfor2013

Achieve a satisfactory outcome for the pricing negotiation

Ensure the economic contribution of the industry to the UK is recognised Create a leading R&D

environment in the UK

Ensure the industry is recognised as a trusted and valued partner at a national, regional and local level

Ensure the value of the industry to the health of the UK is recognised

2000 ABPIScotlandofficeestablishedinEdinburgh

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Improve and protect market freedoms

Build the strength and credibility of the ABPI as the voice of the industry

Achieve improvement to current HTA processes

Ensure EU and international legislative reform is positive for the UK industry

Improve the environment for access and uptake of innovative medicines

Maintain effective operation of the current PPRS

2003 ABPICymruWalesofficeopensinCardiffBay

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ListofABPImembers(asat31.12.2012)

Full members

2011 ABPIrebrandsandmovesitsHeadOfficetoVictoria

A.MenariniFarmaceuticaInternazionaleS.r.l.

AbbottLaboratoriesLimited

ActelionPharmaceuticalsUKLimited

AlexionPharmaUKLimited

ALK-AbelloLimited

AlliancePharmaceuticalsLimited

AlmirallLimited

AmgenLimited

AstellasPharmaLimited

AstraZeneca Plc

Bausch&LombUKLimited

BaxterHealthcareLimited

Bayer Plc

BiogenIdecLimited

BoehringerIngelheimLimited

Bristol-MyersSquibbPharmaceuticalsLimited

CelgeneLimited

Cephalon(UK)Limited

ChiesiLimited

ChugaiPharmaEuropeLimited

DaiichiSankyoUKLimited

DainipponSumitomoPharmaEuropeLimited

DavalInternationalLimited

EisaiLimited

EliLilly&CompanyLimited

FreseniusMedicalCare(UK)Limited

GlaxoSmithKlinePlc

GrunenthalLimited

IpsenDevelopmentsLimited

Janssen

LeoPharma

LundbeckLimited

MerckSeronoLimited

MerckSharp&DohmeLimited

MerzPharmaUKLimited

NappPharmaceuticalsLimited

NovartisPharmaceuticalsUKLimited

NovexPharmaLimitedt/aQuintilesUK

OrionPharma(UK)Limited

OtsukaPharmaceuticalEuropeLimited

PfizerLimited

PierreFabreLimited

RosemontPharmaceuticalsLimited

SanofiLimited

ServierLaboratoriesLimited

ShionogiLimited

ShirePharmaceuticalsLimited

TakedaUKLimited

UCBPharmaLimited

ViforPharmaUKLimited

ViroPharmaLimited

WarnerChilcottPharmaceuticalsUKLimited

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Research affiliatesAxessLimitedCentreforMedicinesResearchInternationalLimitedCharlesRiverLaboratoriesCovanceLaboratoriesLimitedICONLimitedLifeSciencesResearchLimitedMitsubishiPharmaEuropeLimitedNDARegulatoryScienceLimitedORIONClinicalServicesLimitedParexelInternationalLimitedPharmaNetLimited

PrimeVigilanceLimitedQuintilesLimitedQuotientClinicalLimitedRandoxLaboratoriesLimitedRichmondPharmacologyLimitedSequaniLimitedSucampoPharmaEuropeLimitedTakedaGlobalResearchandDevelopmentCentre(Europe)LimitedTranScripPartnersLLP

General1HQLimitedAccenture Plc AddleshawGoddardLLPAmericanExpressEuropeLimitedAmygdalaLimitedArnold&Porter(UK)LLPAshfieldIn2FocusLimitedAtlantisHealthcareUKLimitedBaker&McKenzieLLPBanksSadlerLimitedBCDMeetingsandIncentivesLimitedBird&BirdLLPBMISystemLimitedBristowsBTGPlc(BritishTechnologyGroup)CegedimRelationshipManagementCMSCameronMcKennaLLPComplianceHubLimitedComplianceinPracticeCovington&BurlingLLPDACBeachcroftLLPDeloitteLLPDHRInternationalLifeSciencesEuropeDLAPiperUKLLPErnst&YoungLLPEvershedsLLPExcelCommunications(HRD)LimitedFiveHatsInternationalLimitedGalbraithWightLimitedHarlanLaboratoriesUKLimitedHaywardMedicalCommunicationsLimitedHealthcareatHomeLimitedHealthcareMediaEuropeLimitedHoganLovellsInternationalLLP

IDBusinessSolutionsLimitedIDISLimitedIMSHealthLimitedJigsawConferencesLimitedKPMGLLPLinklatersLLPMDEventsLimitedMedicinesManagementSolutionsLimitedMorgan,Lewis&BockiusLLPPAConsultingGroupLimitedPeach ProfessionalsPHAssociatesLimitedPharmaMixLimitedPMGroupWorldwideLimitedPolicyMattersLLPPowellGilbertLLPPresentValueLimitedPricewaterhouseCoopersLLPRedDoorCommunicationsGroupLimitedRouseLegalLLPRSAConsultingLimitedSimmons&SimmonsLLPSNRDentonUKLLPSpectrumRegulatorySolutionsLimitedStarMedicalLimitedTakedaPharmaceuticalsEuropeLimitedTaylorWessingLLPThomasEggarLLP(rejoined 8/9/11)TrinityEventsSolutionsLimitedTrioMediaLimitedVirgoHealthLimitedWragge&CoLLP

2012 ABPIappointsdedicatedNorthernIrelandDirectorbasedinBelfast

22

ABPIBoardofManagement(asat31.12.2012)

Deepak Khanna, Merck Sharp & Dohme Limited – President of the ABPI

Lisa Anson, AstraZeneca Plc

Robin Bhattacherjee, Actelion Pharmaceuticals UKLimited

Nick Burgin, EisaiLimited

Martin Dawkins, Bayer Plc

Amadou Diarra, Bristol-MyersSquibbPharmaceuticalsLimited

Jonathan Emms, PfizerLimited

John Kearney, AmgenLimited

Steve Oldfield, SanofiLimited

Cesar Rodriguez, Janssen

Ramona Sequeira, EliLilly&CompanyLimited

Camilla Soenderby, AbbottLaboratoriesLimited

Matthew Speers, UCBPharmaLimited

Erik van Snippenberg, GlaxoSmithKlinePlc

Sue Webb, Novartis PharmaceuticalsLimited

Co-opted MembersPete Butterfield, Alliance Pharmaceuticals Limited

Nicola Massey, ShirePharmaceuticalsLimited

Kate Tillett, MerckSharp& DohmeLimited

Steve Turley, LundbeckLimited

22

23

ABPISeniorLeadershipTeamABPISeniorLeadershipTeam(asat31.12.2012)

Stephen Whitehead Chief Executive of the ABPI

Jane Atkin (picture not shown) InterimDirectorof CorporateAffairs

Geoff Bailey DirectorofFinance

Carol Blount DirectorofNHSPartnership

Paul Catchpole DirectorofValueandAccess

Alison Clough DirectorofCommercial

Colette Goldrick DirectorofABPINorthernIreland

Dr Richard Greville DirectorofABPICymruWales and International Affairs

Samantha Ogden DirectorofMembershipServices

Andrew Powrie-Smith DirectorofABPIScotland

Dr Bina Rawal DirectorofResearch,MedicalandInnovation

Heather Simmonds DirectorofthePrescriptionMedicinesCodeofPracticeAuthority

Professor Adrian Towse DirectoroftheOffice ofHealthEconomics

Carol L. Wilson SecretaryandLegalDirector

23

24

KeyfactsonthevalueofindustrytotheUK

Thepharmaceuticalindustryemploysaround68,000peopledirectly(23,000ofthosein researchanddevelopment)1

InNorthernIreland,thepharmaceuticalindustryemploysapproximately 1,500inmanufacturing2

InWales,thelifesciencessector contributes £1.3billion to the country’seconomy 3

Thetradingandmanufacturingsectorwithinthepharmaceuticalindustryisestimatedtocontribute £121,000peremployeetothegrossoutputoftheScottisheconomy5

In2012,thepharmaceuticalsector’s contribution to the balance of trade was thegreatest of9major industrial sectors 4

Eachemployeeinthepharmaceuticalindustrycontributes,onaverage, £210,000totheUK’sGrossDomesticProduct(GDP)6

Thepharmaceuticalindustry generatesatradesurplusof£5bn7,whichisgreaterthananyotherindustrialsectorintheUK

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1OHEcalculationsbasedonONS,Business Enterprise Research and Development (2008, 2009, 2010, 2011),accessedMarch2013

2DepartmentofEnterprise,TradeandInvestment,CensusofEmployment3TheNationalInstituteforSocialCareandHealthResearch,Industry Engagement in Wales,20124HMRevenueandCustoms,UK Trade Info 2012,February20135EPAssociates,Contribution of Pharma-Related Businesses to the Scottish Economy,analysisfor ABPIScotland,2008

6ONS,Annual Business Survey 2011 Provisional,November2012(SectionC,Manufacturing)7HMRevenueandCustoms,UK Trade Info 2012,February20138ONS,Business Enterprise Research and Development 2010,November20119OHE,UK NHS medicines bill projection 2012 – 2015,analysisfortheABPI,June201210ONS,Business Enterprise Research and Development, 2011,November201211&12DepartmentofHealth,PPRS Report to Parliament,6th,10thand11threports,2002,2009and201213OHEcalculationsbasedonIMSHealthWorldReviewAnalyst2011

In2011,theoverallspendonmedicinesrepresentedonly9.6%oftotalUK-wideNHSexpenditure,whilebranded medicines represented7.5%of totalUKNHSspend 9

Therewasmoreresearchanddevelopmentperformedinthepharmaceuticalsectorthananyothersectorin2011,representing28%ofallexpenditureonR&DinUKbusinesses10

ThepricesofbrandedmedicinesintheUKareamong thelowestinEurope 11

Total medicine costs intheUKrepresent0.9%ofGDPcomparedtoa1.7%averagefor 6majormarkets12

Onesixthoftheworld’smostpopularprescriptionmedicines weredeveloped intheUK

13

TheUK’spharmaceuticalsector invests approximately £13.3million every day in R&D8

Association of the British Pharmaceutical Industry7thFloor,Southside,105VictoriaStreet,LondonSW1E6QTTel:+44(0)8708904333Email:abpi@abpi.org.uk

ABPI Cymru Wales Floor4,2CaspianPoint,PierheadStreet,CardiffBayCF104DQTel:+44(0)8708904333

ABPI Northern IrelandTheMount,2WoodstockLink,BelfastBT68DDTel:+44(0)8708904333

ABPI Scotland3rdFloorCrichtonHouse,4Crichton’sClose,EdinburghEH88DTTel:+44(0)8708904333

www.abpi.org.uk