updated joint environmental statement · 2019-04-04 · 1 company profile 5 1.1 medac stands for a...

with the environmental performance indicators of 2016for the sites in

Wedel, Germany - with the properties:Theaterstr. 6, Theaterstr. 1, Rosengarten 25, von Linné Str. 14,

Feldstr. 170 and Tinsdaler Weg 183Tornesch, Germany

Lyon, FranceRome, Italy

Brno, Czech RepublicJorvas, Finland

Warsaw, PolandAlgés, Portugal

Bratislava, SlovakiaVarberg, Sweden

Stirling, United Kingdom

Updated joint environmental statement

in accordance with Regulation (EC) No 1221/2009 (EMAS)

Initial review: 22/12/2016

2017

2 Updated environmental statement 2017

3Updated environmental statement 2017

Preface 4

1 CompanyProfile 5

1.1 medacstandsforahuman-centredperspective 5

1.1.1 Diagnostics 5

1.1.2 Therapeutics 5

1.2 Sites 6

1.2.1 Wedel 6

1.2.2 Tornesch 6

1.2.3 International 7

2 Structureoftheenviromentalmanagementsystem 9

2.1 Responsibilities 9

2.2 Documentation 9

2.3 Compliancewithlegislation 9

2.4 Emergency precautions 10

2.5 Integrationofmedacemployees 10

3 Environmentalpolicy 11

4 Environmentalaspectsandimpacts 12

4.1 Emissions,mobilityandtraffic 12

4.2 Waste 17

4.3 Resources/materialefficiency 20

4.4 Energy 23

4.5 Procurement 28

4.6 Biodiversity 28

4.7 Water 30

4.8 Generalaspects 32

5 Updateoftheenvironmentalgoals 33

StatementofValidation 38

Contact 39

Certificates 40

Table of contents


Preface

medacGmbHisactiveinthefieldofmedicinaltherapiesforautoimmuneandoncologicaldiseases.Itfollowsthatwehavetodealwiththesubjectandthepeopleinvolvedinaresponsiblemanner.Insomecases,ourmedicinalproductswillhelpinthelongtermbutinothercases,wehavetoacceptthefactthatourhelpisrestrictedtopalliativemeasures.Thistension,whichisapartofourdailyworkinglives,callsforaconscientioushandlingofresourcesofallkinds.Thisappliestoethicalandeconomicalnecessitiesinequalpart,andtheyarenotmutuallyexclusive.

Atthesametime,wearewellawarethataprofit-basedapproachandtechnologicaldealingsal-waysgohandinhandwithecologicalinterferenceandintrusionintonature.Thus,inordertouseresourcesconsiderately,appropriateenvironmentalprotectionconceptsarenecessary.

Wehaveattemptedtomeetthischallengewiththeappropriatemeasures.Inthisupdatedenviron-mentalstatementwehavedescribedthefoundationsofourcompany’senvironmentalmanagementsystemanddefinedtheareasofresponsibility,tasks,structuresandprocessesofthatsystem.Thestatementissupplementedbyadditionalapplicabledocuments.Everyemployeeofourcompanyisobligedtotaketheproceduresandresponsibilitiesdefinedinthisdocument,whicharealsopartofourCodeofConduct,intoconsiderationinhisorherdailywork,inaccordancewiththerespon-sibilitywehavetakenonforourproducts,theirtherapeuticuseandforourenvironmentingeneral.

CEOAdministration,Finance&HR

Jörg Hans

Nikolaus StolbergDr. Rainer DickhardtDr. Ulrich Kosciessa Jens Denker Heiner Will

Managing Director InternationalSales

Managing Director QualityOrganisation &SupplyChain

Managing Director ProductDevelopment

Managing Director OncologyGermany

Managing Director Therapeutic Areas & AutoimmuneGermany


1 Company profile

1.1 medac stands for a human-centred perspectiveAsaglobalpharmaceuticalcompanybasedinGermany,wehavebeenawareofthespecialrequi-rementswefaceeversinceourfoundationin1970asacompanyspecialisingintheproductionanddistributionofproductsforthetreatmentanddiagnosisofoncological,urologicalandautoimmunediseases.Weassumeresponsibilityforouractionsandharnessourcumulativeexpertisetoprovi-desafeproductsofimpeccablequalityforpatients,doctors,laboratorypersonnelandhospitals.medacsuppliestheGermanandmanyinternationalmarketswithnichetherapeuticproductsinthefieldsofoncology,urologyandautoimmunediseases.WithourownDiagnosticssectionwecom-plementthecompany’sorganisation.

1.1.1. Diagnostics

medacoffersbothdiagnosticsand therapeutics fromourowndevelopmentandproduction. Intheareaofpersonalisedmedicine,thismeansthatwehavethebestprerequisitesforthedevelop-mentandcontinuousimprovementofactivesubstances.Precise,patient-specificdiagnosticsarecrucialforoptimisingtherapeuticmeasuresandthebestpossibletreatmentoutcome.ThemedacDiagnosticsdivisioncounts44employeeswhoareresponsibleforthedevelopment,productionandmarketingofin vitro diagnostics (IVD). These are standardised methods and reagents used in specialisedlaboratoriesforthetestingofpatientsamplesandtheidentificationofdiseases.Blood,cerebrospinalfluid(CSF),urineandtissuesamplesareassayedhere.medacspecialisesinthedia-gnosisofinfectiousdiseases,tumours,andinlifescienceresearchandundertakestheseservicesforregisteredlaboratoryphysicians,hospitallaboratoriesandresearchorganisations.

1.1.2. Therapeutics

Forthepast40years,thepharmaceuticalcompanymedachasofferedinnovativeandtried-and-testedtherapeuticsinthefieldsofoncology,haematology,urology,rheumatologicalanddermato-logicalautoimmunediseases,andneurosurgery.Goodtoleranceatmaximumefficacyisthede-cisive factorhere. Inaddition,medacsuppliesproducts thatalleviatesideeffectsofanticancertreatmentssuchasdrynessofthemouthorhand-footsyndrome.medac’sportfolioalsofeaturesananticoagulantforthemedicinaldissolutionofbloodclots(fibrinolysis).Inadditiontothewiderangeofestablished therapeutics,medacattachesgreat importance to researchingand furtherdevelopingmedicinalproductsusedforthetreatmentoforphanindications.Here,thefocusisonprovidingtangiblehelpandonthewelfareofthepatient.


1.2 Sites

1.2.1Wedel

In1999wemovedfromHamburg’scitycentretoacompany-ownedbuildingatTheaterstr.6 inWedel/Schleswig-Holstein.Besidesoffices,thepackagingdepartmentandalaboratoryforqualitycontrolarelocatedatTheaterstr.6.Here,employeescanhavelunchatthecompany-ownedres-taurant Jungfernstieg.FurtherofficesarelocatedatthepropertiesatTheaterstr.1,Rosengarten25,von-Linné-Str.14,Feldstr.170,andTinsdalerWeg183inWedel.Altogether,closeto900peopleworkattheWedelsites.

1.2.2 Tornesch

Since2010,wehavebeen runningacentre for logistics,qualitycontrol,and thedevelopment,manufacturing and support of diagnostics that meets the highest process and safety standards at theTorneschsite.Inaddition,partofthemetex®PENproductionhasbeenallocatedheresince July2016.InTornesch,120employeesareinchargeofanefficientproductionprocesstoensurethegreatimportancemedacplacesonaconsistentlyhighqualitystandardismet.SinceJuly2017,atthissite,too,theemployeescaneatatacompany-ownedrestaurant,theEssbar,whichwasformerlyoperatedbythecompanyEurest.

TorneschLogistics centre atWilfried-Mohr-Str. 1-5120 employees

WedelTheaterstraße 6449 employees

WedelTheaterstraße 132 employees

WedelRosengarten 2596 employees

WedelFeldstraße 170199 employees

Wedelvon-Linné-Str. 1453 employees

WedelTinsdaler Weg 18362 employees


1.2.3International

Specialisedsalesandmarketingteamsareinchargeofintroducingmedacproductstotherelevantmarkets–inGermanyandworld-wide,withthehelpofourlocalsubsidiariesandbranches:

Subsidiaries:

• medacs.a.s,Lyon,France(12employees)• medacPharmaS.r.l.,Rome,Italy (15employees)

• medacPharmaLLP,Stirling,UnitedKing-dom(22employees)

Affiliates:

•Brno,CzechRepublic&Bratislava, Slovakia(13employees)

•Jorvas,Finland(7employees)•Warsaw,Poland(37employees)•Algés,Portugal(6employees)•Varberg,Sweden(12employees)

In addition to the international sites listed above, which are subject to the field of applicationoftheenvironmentalmanagementsystem (EMS) according to DIN EN ISO14001:2015butarenot subject toEMAS IIIregistration, medac also has representativeoffices in Kazakhstan, Russia and theUkraine,subsidiaries intheUSAandJapan,andownssharesinthecompaniesoncomedmanufacturing a.s. and ONCOTEC PharmaProduktionGmbH.There, too, the same high standards and expectationsasatourothersitesapplywhenit comes to our work. The representativeoffices, the US and Japanese subsidiaries,oncomedmanufacturinga.s.,andONCOTECPharma Produktion GmbH, however, arenotsubject to thefieldofapplicationofourenvironmentalmanagementsystem.


Developmentofstaffnumbers2015to2016

medac’sstaffnumbersonceagaingrewbyaround6%in2016.

medac staff numbers

Employees [number] 2015 2016 Trend

Theaterstr. 6 470 449

Theaterstr. 1 32 32

Rosengarten25 94 96

Feldstr.170 207 199

von-Linné-Str.14 43 53

TinsdalerWeg183 0 1 62

Tornesch 122 120

Rome (IT) 13 15

Lyon(FR) 5 12

Brno&Bratislava(CZ/SK) 13 13

Jorvas (FI) 6 7

Warsaw(PL) 30 37

Algés(PT) 7 6

Varberg (SE) 12 12

Stirling(UK) 18 22

Totalstaffnumbers 1,072 1,135 (+5.88%)

1 LeaseoftheofficespacesinTinsdalerWegonlystartedin2016.


Structure of the environmental management system

Tocomplywiththedemandingrequirementsofmedicinalproductandmedicaldeviceregulations,all processes and procedures atmedac are highly structured and reviewed internally onmorethanonce.Thanks toGood Manufacturing Practice (GMP),DINEN ISO13485, anestablishedqualitymanagementsystemandotherqualityassurancesystems fordevelopment,production, storageandsales,wearealreadyinpossessionofamanagementsystemwheretherequirementsof the twoenvironmentalmanagementstandardsDINEN ISO14001:2015andRegulation (EC)No.1221/2009(EMASIII)havealreadybeenimplemented.Thishelpsuscompileandevaluateallcompanyprocessesthatmayhaveanimpactontheenvironment.Theannualassessmentofdirectandindirectenvironmentaleffectsisbasedontheirrespectiverelevanceandinhowfartheycanbecontrolled.Withthisinmind,ourkeyenvironmentalaspectsarecurrentlyair/emissions,waste,resources,energy,procurementandmobility.

2.1 Responsibilities

InordertostrengthentheenforcementofourEMS,medacemploysafull-timeenvironmentalma-nagementrepresentative(UMB),LenaSander,whoreportsdirectlytotheCEO/ManagingDirectorAdministration,Finance&HR.ThetasksoftheUMBincludethecontrollingandcoordinationoftheEMSandthecompilationandpreparationoftheenvironmentalstatement.MsSanderhasbeenonmaternityleavesinceFebruary2017;inthemeantimeherresponsibilitiesareassumedbySwantjeThiele,PhD,asdeputyUMB.

2.2 Documentation

ThecentraldocumentationoftheEMSisdoneelectronically.Allimportantdocumentsarestoredon themedac server and can be accessed by every employee. In addition, the environmentalpolicyandprogrammecanbeaccessedviathecompany’sintranet.Theemployeesatmedac’s internationalsitesarekeptup-to-datebyregulare-mailsandcanasktheUMBforaccesstoallthedocuments. In addition, the environmental policy andenvironmental statement arepubliclyaccessibleontheinternetonmedac’swebsite.SinceuploadingtheenvironmentalstatementtothehomepageatthebeginningofMay2017,theGermanversionoftheenvironmentalmanage-mentsitewasvisited17 timesand theenvironmentalstatementwasdownloadedseven times;theinternationalsitehad137visitorsandtheEnglishversionoftheenvironmentalstatementwasdownloadedtwice(asof23/11/2017).

2.3 Compliancewithlegislation

Wecomplywith legislationrelatingtotheenvironmental impact.Neworamendedlaws,regula-tions,directivesorprovisionsareanalysedinmedac’selectronicregulationmanagerbytheSafety,HealthandEnvironmentteam(SHEteam).Theteam’sexpertsassessandinterprettheresultingchangesinregularworkshops,initiatetherequiredproceduresifnecessary,anddeterminedutiesforcomplyingwithandimplementingthoserequirements.

Allauthorisationsrelevanttoourcompanywereidentifiedandenteredinthelistofrelevantauthori-sations.Importantconditionsimposedbytheauthorisations,andcompliancewithwhichmustberegularlyinspected,wereenteredinthelistofrecurringduediligence.Duringtheinternalaudits,noinfringementsoftheregulationsrelevanttouscouldbefound.

2


2.4 Emergency precautions

Wereducethepotentialforoperationalmalfunctionsresultinginenvironmentalpollutionwiththehelpofcomprehensiveenvironmentalandhealthprotection,safetyandqualityconcepts.Emer-gencyplans,predeterminedcontainmentactionandregulartrainingcourseshelpreducepotentialeffectsincaseofemergency.Inordertoensurethatallmachinesanddevicesareinproperworkingorderandtoreduceenvironmental risks,wehavealsoestablishedanelectronicsystemfor theplanning,managementandcontrolofregularmaintenancework(CAFM1softwareKeyLogic).

Werunanactivehazardoussubstancemanagement,i.e.wehandlehazardoussubstancesinanenvironment-orientedandresponsiblemanner;thisincludescheckingwhetherhazardoussubstan-cescanbesubstituted.Wekeepanup-to-datehazardoussubstanceregisterforallhazardousma-terialsinuseatourcompanywiththehelpofadatabase(ChemSich).Thoseemployeesthathavetodealwithhazardoussubstancesintheirworkingenvironmentareregularlytrainedinthehandlingofthosematerials.Additionally,therearedesignatedcleaningteamsforthelogisticsareas.Incaseofspillageofmedicinalproducts,thedesignatedemployeesareinformedimmediatelyandtheyproceedtosealoff,cleanandthenreleaseagainthecontaminatedareas.

During the reportingperiod, therewereno instancesofsignificantenvironmental impactatanyof the sites, andwewere not informedof any complaints concerning the environment. For all possible,conceivableaccidentsorincidentswehaveavailablealarmplans,fireprotectionsystemsandspecialemergencyplans.

2.5 Integrationofmedacemployees

Theintegrationofallmedacemployeesintothecontinuousenvironmentalimprovementprocesstakesplaceviatwomeans:

•DirectcontacttotheUMBandregularinformationpublishedontheintranet

•medac’sownsuggestionscheme“Environmentalideas“:Allsubmittedideasareconsideredandimplemented,ifapplicable,bytheUMB.

Moreover,fromJuly2016totheendofFebruary2017theUMBhaspublishedtheweeklyenviron-mentnewsletter “Tips forhavingagreenweek”whichprovidesemployeeswith informationoncurrentenvironmentaltopicsandtipsforimprovingsustainabilityineverydaylife.SincetheendofFebruary2017,thedeputyUMBhasalsoprovidedinformationoncurrentenvironmentaltopics,suchastheintroductionofwasteseparationinthestaffkitchens,ontheintranet.

1 CAFMcomputer-aidedfacilitymanagement


Thebasisforourenvironmentalmanagementsystemisthevoluntarycommitmentofourcompanytoenvironmentalprotection.Thiscommitmentisreflectedinourenvironmentalpolicyandiscom-municatedtoallemployeesofthecompanyaswellastoexternalparties.

Withthis,weaimtoachievethefollowing:As a responsible, forward-looking pharmaceutical company we strive for an economical useof natural resources.Wewill take reasonable and practical steps tominimise or eliminate ne-gativeeffectson theenvironmentandtheclimate.We implementcurrent regional,nationaland internationalstandardsconsistentlyandminimisetherisksformankindandtheenvironmentbycomplyingwithandregularlyreviewingtherelevantlaws,regulationsandrules(seeindexoflegalprovisions)aswellasour internalqualitymanagementsystems.Throughtargetedmeasuresweaimforacontinuousimprovementofourperformanceconcerninglabour,healthandenvironmentalprotectionandtrytoconciliateeconomicsandecology.

Thisresultsinthefollowingenvironmentalguidelines:

1.Inordertocontinuously improveourenvironmentalperformance,activitieswhichmayhaveanegative impactontheenvironmentwillbemeasuredandevaluatedwithinanenvironmentalmanagement system.

2.Ouraimistocontinuouslyreducetheconsumptionofresourcesandenergywithinourmeansand,whereverpossible,tocutair,soil,waterorwastewateremissionsandreducewasteinsuchawaythatwecontributetoamoresustainablefuture.

3.medac promotes environmental awareness and the environmental responsibility of its staff.Eachindividualemployeeofmedaccanandshouldactinanenvironmentallyresponsibleand resource-conserving way within his area of responsibility and control. Beyond that, each employeeisencouragedtoshareanypossibleconcernsregardingenvironmentaltopics.

Ourenvironmentalpolicyisassessedatregular intervals.Thisispartoftheannualenvironmentauditandthemanagementreview.Basedontheresultsofthefirstenvironmentalauditandtheresponsibilityvis-a-vistheenviron-ment and society set out inmedac’s environmental policy, the environmental team developeda range of tangiblemeasures that have been summarised inmedac’s first environmental pro- gramme.Inthefuture,measureswillbeagreedanddocumentedonanannualbasis.Suggestionsfor improvementsbyemployeeswillbetakenintoaccountforthis.Themostimportantenvironmentaltargetsaresummarisedintheenvironmentalstatementaccor-dingtotherespectiveenvironmentalaspects.

Environmental policy3


Environmental aspects and impacts4

Weidentifytheenvironmentalimpactresultingfromouractivities,productsandservicesanddeter-minethoseenvironmentalaspectsthatdoorcouldhaveasignificantimpactontheenvironment.Oncealldirectandindirectenvironmentalaspectshavebeenrecorded,weevaluatetheirrelevancetotheenvironmentandourpotentialtocontrolthemwiththehelpofdefinedcriteria.Air/emissions,waste,energy,procurement,andmobilitywereidentifiedasimportantenvironmentalaspectsdu-ringthefirstenvironmentalaudit.Attheinternationalsites,theenvironmentalimpactisverylowastheysolelyoperateasmarketingandsalesunits.

ForourrentedpropertiesatTheaterstr.1,von-Linné-Str.14,Feldstr.170,TinsdalerWeg183,andthesubsidiariesandinternationalaffiliates,itwasnotalwayspossibletocompiledataonenviron-mentalperformanceas,forexample,wastedisposalisorganisedbythelandlordandtheactualvolumeofwasteisnotrecorded,orbecauseutilitiesarepaidonaccountandtheactualinvoicesdonotallowadeductionofthepreciseconsumptionfigures.Inthosecases,afootnoteindicateswhichsitesorpropertiesarenotincludedinthedataprovided.If,ontheotherhand,acertainen-vironmentalaspectisonlyrelevantforafewsitesorproperties,onlythosesitesorpropertiesarelistedwherethisenvironmentalaspectapplies.

4.1Emissions,mobilityandtraffic

medac’sfleetisresponsibleforthemostsignificantdirectairemissions,CO2andparticulatemat-ter,inthecourseofprivateandbusinesstrips.2015sawtheconsumptionof586,355litresofdieseland30,179ofsuperpetrol,andthustheemissionof1,504tonsofCO2and138kgofparticulatematter. In2016,consumptioncouldbereducedto522,759litresofdieselund21,201litresofsuperpetrol,resultingindecreasedemissionsof1,328tonsofCO2and121kgofparticulatematter1. The re-ductioninfuelconsumptionwasachievedbythereplacementofaroundathirdofallfleetvehiclesin2016.Modelswithoutdatedtechnologywerereplacedwithnewer,moreeconomicalmodels.Furthermore,2016alsosawaslightlylowermileageofthefleetvehicles.WewillsucceedinreducingCO2emissionsevenfurtherbyassessingwhetherelectricbicyclesandelectriccarscouldbeusedinWedelandTornesch,withthesuccessfulintroductionofadayeventontheoccasionofthe“car-freeday”on22/09/2017;byestablishingmeasuresfordeterminingasetofdatatobecollectedregularlyconcerningtheenvironmentalaspectsofthefleetvehicles,andwithaprojecttodeterminethepotentialforsavingsonemissionscausedbyfleettraffic.Thefirstelectriccar(BMWi3)wasputintooperationasapoolcarfortheInfrastructuredepartmentinmid-April2017.

Comparedto2015,thenumberofbusinesstripstakenbytrainwasreducedby8.5%from1,783to1,631,whilethenumberofflightswasincreasedby5.3%from2,172to2,288.In2016,thetraintripstakenaspartoftheDeutscheBahnlong-distancetransportamountedto635,897passengerkilometres; in2015 incomparisontheyamountedto686,515passengerkilometres.Themedacstafftravelsunderthebahn.businessschemeinDeutscheBahntrainsusing100%greenelectrici-ty.Byusingrenewableenergies,fossilfuelsarereplacedaccordinglyanddirectemissionscanbeavoided right from the start 2.Theflightstakenwereoverwhelminglyforthepurposeofbusinesstrips to the subsidiaries and business partners in overseas.

1 Asallcompanycarsarealsousedforprivatetripsandthefuelusedonthoseoccasionsismostlynottalliedsepa-ratelyfromfuelduringbusinesstrips,thatfuelconsumptionisnotincludedinthetotalamountofemissions.

2Source:DeutscheBahncertificatesformedacfrom01/01–31/12/2015,and01/01/–31/12/2016.


OtherairemissionsarecausedbythetransportofcytostaticsandcisplatinfromtheTorneschsitetothespecialistdisposalfirmsbytwodifferentdisposalcompanies.In2017,weevaluatedwhetherwecoulduseonlyonedisposalserviceforthecollectionofthiswasteinthefuturetoevenfurtherreduceCO2 emissions but had to dismiss this idea for economic reasons.

Furthermore,thecoolantsusedinthechillersatTheaterstr.6andinTorneschcouldbeharmfultotheclimateincaseofleakage.In2015,30.9kgofR134a(tetrafluorethane)hadtobereplenished,and76.0kgin2016.Thus,441.87tonsofCO2equivalentsin2015and1,086.8tonsin2016mayhavebeenemittedbecauseofcoolantleakage.In2016,morecoolantneededtobereplenishedthanin2015becausealeakagewasdetectedduringamaintenancecheck.Afterthoroughinves-tigation,thisleakagecouldbeisolatedexlusivelytothecoolingappliancewithinonecoldstoragecell.Remedialmaintenanceconsistedinreplacingtheapplianceswithinthecoldstoragecellwithonesmadefromstainlesssteeltoguaranteetightnessinthelongterm.Throughtheuseofstain-less-steelappliancestheriskofnewleakageswasreducedcomparedtotheconventionalapplian-ces.Aspartoftherepairwork,thecoolantintheaffectedpartofthesiteneededtobedrainedandthenreplenished,whichexplainsthehighamountofcoolantusedforrefilling.Inthelongterm,acoolingalternativethatislessharmfultotheclimateisenvisaged.

medac’s location inWedel andTornesch aswell as the large commuting area explain the factthatmanyemployeestraveltoworkbycar.Weencouragetheworkcommutebypublictransport throughsubsidisingthe“HVV Profi Card”(jobticketbyHamburg’spublictransportservice).Weliketoencourageouremployee’smobilityawareness,whichiswhywehaveimplementedactivitiestosupportcarpoolingandcyclingtowork(bicyclestands).Inourtravelguideline,employeesarealreadyadvisedtochoosethetrainovertheaeroplaneforbusinesstripswithinGermany.In2017,the“car-freeday”event,whichtookplaceon22September,wasorganisedforallemployeesinWedelandTornesch.Anumberofboothsprovidingindividualmobilityandcommutingadviceandinformationonthehealthbenefitsofdoingwithoutacarweresetuptomakeemployeesmoreawareandtopromoteaclimate-consciouscommute.

Noiseemissionsarecausedbythelorriesdeliveringandcollectinggoodsaswellasthemonthlytest runs of the emergency generators at Theaterstr. 6 and in Tornesch. In addition, noise emissions arecausedbyemployeesarrivingatanddepartingfromworkatallsitesandproperties.Aninvesti-gationofacousticsforthemedaclogisticscentreinTorneschin2009bythecompanyLärmkontorGmbHfoundthatnoiseemissionwasby10dB(A)lowerthantheimissionguidevaluesdefinedbytheTALärm(GermanTechnicalGuidelinesfornoisereduction).

Theproductionprocessesdonotproducedust.Onlythelorryandpassengercartrafficmaypro-duceparticulatematteraswellasnormalamountsofroaddust.


1 Goalwasachieved.Achievementofgoalstillinprogress.

Ourgoals

Reducedemissionofairpollutantsthroughthefollowingmeasures:

• Examination of the possibility to buy coolants with less impact on the climate (Wedel & Tornesch) 30/09/2017Thecheckhastakenplace(asof28/08/2017):Thecoolantusedbymedac,R134a, isalreadytheleastharmfultotheclimateoutoftheavailablefluorisedhydrocarboncoolants.Allcoolantsthataresuperiorfromanenvironmentalperspectivedonotachievethenecessarycoolingeffect and/orarenotcompatiblewiththeequipmentinstalledcurrentlybythecompanyTrane.Further-more,Tranehasnotreleasedtheuseofalternativecoolantsintheequipmentinstalledatmedacsothatthereiscurrentlynopossibilitytochangethestatus quo. 1

• Examination of the possibility to pool the collection of cytostatic medicinal products and cisplatin waste (Tornesch) 30/09/2017Examinationhastakenplace:Unfortunately,itisnotpossibletoonlyuseoneserviceforcollec-tion,asthedisposalserviceusedforthecytostaticwastecannotrealisethecollectionofout-of-datebutstillready-for-salegoodsorofcisplatin.Thisiscarriedoutbyadifferentcompanywhichinturn,however,cannotcollectcytostaticwaste.

• Introduction of a “car-free day” (all locations) 30/09/2017Acar-freedayeventtookplacefortheemployeesinWedelandTorneschon22/09/2017.

• Check whether electric bikes could be introduced for transit between the medac site in Tornesch and the train station (Tornesch) 30/09/2017Thecheckhastakenplace(asof30/09/2017):UsingelectricbikesfortransitbetweentheTor-neschsiteandthetrainstationinTorneschiscurrentlynotpossibleduetothelocalcircumstan-ces.However,wearecurrently assessingwhetherbikescanbeused for transitbetween thedifferentWedelsites.Sofar,threeworkshopshavetakenplaceonthisin2017. 1

• Definition of a set of data to be collected regularly concerning the environmental aspects of fleet vehicles (Wedel & Tornesch) 30/09/2017On25/08/2017fleetmanagementprovidedthecurrentsummaryofthemedacfleetcontainingallreferencefiguresthatarerelevanttotheenvironment.WearecurrentlycollaboratingwiththeITdepartmentongeneratingadatabasefortheassessmentandanalysisofdatasetsconcerningtheenvironmentalaspectsofthefleetvehicles.Inthefuturewecanthenregularlydrawdatasetsconcerningenvironmentalaspectsofthefleetvehiclesdirectlyfromthedatabase.


Core indicators/key figures 2015 2016 Trend

TotalannualemissionsofgreenhousegasinCO2equivalentsperemployee[t/quantity]

5.9 6.8 (+15.25%)

Totalannualemissionsintotheair(NOx,SO2,PM)peremployee [t/quantity]

0.0054 0.0058 (+7.41%)

Core indicators

Emissions of CO2 equivalents [t] 1 2015 2016 Trend

Electricity 3,833.392 3,512.34 3

Naturalgas 1,040.06 4 983.90 5

Liquidgas/propane 1.04 1.11

Diesel(emergencygenerator) 9.81 9.10

Fueloil(emergencygenerator) 0 6 5.67

Lossofcoolant 441.87 1,087

Totalannualemissionsofgreenhousegas

5,326 5,599 (+5.13%)

Emissions by medac

1 ThecalculationwasperformedbasedonCO2emissionfactorsfromthefollowingsources: forGermany:GEMISdatabase4.93(2015) Forelectricityattheinternationalbranches:Covenantofmayorsforlocalsustainableenergy/IntergovernmentalPanelon

ClimateChange(IPCC)2 withoutvon-Linné-Str.andStirling,UK3withoutTinsdalerWegandvon-Linné-Str.4withoutvon-Linné-Straße5withoutTinsdalerWeg,von-Linné-Str.,France,Finland,Sweden,PortugalandPoland6In2015,dieselinsteadoffueloilwasusedfortheemergencygeneratoratTheaterstr.6.

• Identification of the potential to reduce emissions of air pollutants by the fleet (Wedel & Tornesch) 30/09/2017Thefirstelectriccar(BMWi3)wasputintooperationasapoolcarfortheInfrastructuredepartmentinmid-April2017.Followingatrialphase,adecisionwillbemadeonwhethermoreelectriccarswillbeintroducedatmedac.Inaddition,thefirstelectric-mobilitymeetingwithrepresentativesofthecityofWedelandtheStadtwerke Wedel(municipalutilitiesWedel)ontheintroductionofelectric vehicle charging stations tookplaceat thebeginningof 2017.Using thedataon themedacfleetprovidedbythefleetmanagement,wewillalsoanalysewhereweseepotentialforsavings.


Emissions [t] 2015 2016 Trend

SO2 1.8 2.0 1

NOX 3.5 3.7 1

PM(particulatematter) 0.3 0.3 1

Annualtotalemissionsintothe atmosphere

5.5 5.9 1 (+7.27%)

Emissions by medac

Developmentofthecoreindicatorsforemissions,mobilityandtrafficfrom2015to2016Whencompared,thecoreindicatorsforthefieldsofemissions,mobilityandtrafficshowthefollo-wingdevelopment:Bothcoreindicatorsontotalannualemissionshaveincreasedcomparedtothepreviousyear.Thisincreaseisduetothelargeamountsofcoolantthathadtobereplenisheddu-ringthe2016repairswheretheapplicanceinthecoldstorageunitwasreplacedbystainless-steelmodels.When lookingat the inidividualemissionsasCO2equivalents, it isclear that there isadecreasingtrendintheareaofelectricityandnatural-gasconsumptioninnoteworthydimensions.Thisislargelyduetoanincreaseofaround30%intheuseofrenewableenergiesintheelectricitymix.Also,lessnaturalgaswasusedin2016,leadingtoloweremissions.

1 withoutTinsdalerWegandvon-Linné-Str.


4.2 Waste

Themainwastefractionsofnon-hazardouswasteatthesitesinWedelandTorneschwereresidualwasteandusedpaper/cardboardpackaging.Hazardouswasteotherthancytotoxicandcytostaticagentsweremainlyorganicandinorganiclaboratorychemicals,wastewhosecollectionanddis-posalissubjecttospecialrequirementsinordertopreventinfection,otherhalogenatedsolventsandmixturesofsolvents,usedelectricalandelectronicappliancesaswellasabsorbentandfiltermaterials.

In order to minimise the used electrical appliances waste, old devices in working order are preppedbytheITdepartment inWedelandTorneschandareeithersoldtostaffordonatedtowelfareservices.Brokenappliancesarecollectedtogetherwiththeusedelectricalappliancewasteanddisposedofinaccordancewiththeregulations.

Additionally,reusabletransportboxesareusedinthepackagingdepartmentwheneverpossibleandwhenincompliancewithdrugsafety.Theinternationalbranches,too,areworkingproactivelytopreventwaste,forexamplebystrictwasteseparationinJorvas;inWarsaw,foldersarereusedinordertokeeptheamountofresidualwastelow.

Insomestaffkitchens,wasteseparationisnotyetimplemented.There,potentialforavoidingwasteandmoreefficientrecyclingwasrealisedthroughmoretargetedandimprovedseparatecollectionofwastetypes,whichinturnmakestherecyclingofthematerialspossible.Thus, thewaste-binconcept in thestaffkitchenswasoptimised in2017andseparationof thewasteaccordingtoresidualwaste,recyclablematerial (plastic,packaging,compositematerials,metal,etc.),cardboard/paperand,dependingonthesite(e.g.inTornesch),evenorganicwaste,was introduced successfully. Further, a concept for the implementation of the currentGermanCommercialWasteOrdinance(Gewerbeabfallverordnung)wasdrawnup.Thisincludesthesepa-rationofcommercialwasteaccordingtorecyclablefoils,plasticandpaperinthelogisticsareainTornesch.ThisconceptisaninterimsolutionuntiltherecyclingdepotinTorneschhasbeenrealisedandreconstructedaccordingly.Ifapplicable,theamountofresidualwastewillbereducedinotherareasinthefutureaswell.Inaddition,employeeswereandare regularly trained inwastepreventionandseparation throughwastetrainingsessions,theenvironmentnewsletterandarticlesontheintranet.Thisalsoservestomotivatethestafftoreducewasteamountsevenfurther.FoodwastefromthetwocompanyrestaurantsinWedelandTorneschiscollectedseparatelyandpickedupbytheBioCyclingGmbHforgenerationofenergy.Thecompanyusesthewastetopro-ducerenewableenergyinbiogasplantsforuseintheelectricityandcommunityheatinggrid.

Fortheshippingcartonsandthestyrofoambroughtintocirculationbyus,medachasjoinedthedualsystemandthusmeetsthelegalrequirements.



Totalannualgenerationofhazardouswasteperemployee[kg/quantity]

36.17 61.90 (+71.14%)

Core indicators

OurgoalsReductionoftheresidualwasteratioby2%:

• Optimisation of the waste-bin concept in the offices and staff kitchens (Wedel & Tornesch) 30/09/2017In2017,separationofthewasteaccordingtoresidualwaste,recyclablematerial(plastic,packa-ging,compositematerials,metal,etc.),cardboard/paperand,dependingonthesite(e.g.inTor-nesch),evenorganicwaste,wasintroducedsuccessfullyintheofficesandstaffkitchensinWedelandTornesch.Inhowfartheintroductionofwasteseparationinthestaffkitchenswillhaveledtoareductionintheamountofresidualwastewillonlybecomeapparentinthefollowingyear.

• Raising awareness of staff (all sites) 30/09/2017Thestaffwasmadeawareofthetopicswasteseparationandwasteavoidancethroughtheen-vironmentnewsletterandseveralintranetarticlesontheintroductionofwasteseparationatthedifferent sites.


Waste 2015 2016 TrendTheaterstr. 6

Paper,cardboard,cardboardpackaging/ departmentstorewaste[t]

54,075 36,125

Slurry/sludge[m³] 17 14

Residualwaste(mixedmunicipalwastefordisposal)[l]3

233,200 228,800

Medicinalproducts(otherthancytotoxicandcytostaticmedicinalproducts;200131)[kg]

5.0 0.0

Styrofoam[t] 63.0 55.0

Punchingwaste[t] 20.1 23.0

Plastics[t] 30.1 17.1

Hazardouswaste[t] 6.9 9.2

Theaterstr. 1

Residualwaste[l]3 29,700 28,600

Rosengarten25

Residualwaste [l]3 116,600 114,400

Feldstr.170

Residualwaste [l]3 116,600 114,400

von-Linné-Str.14

Residualwaste[l]3 58,300 57,200

Tornesch

Paper,cardboard,cardboardpackaging/ departmentstorewaste[t]

61 64.3

Waste(notspecifiedotherwise)[t] 4 2.2

Slurry/sludge[m³] 13 13.0

Mixedpackaging/residualwaste[t] 31 32.5

Hazardouswaste[t] 28.1 53.3

Differenttypesofwaste1,2

1Duetothediversityofthewasteunits,noindicatorofthetotalannualvolumeofwastecanbegiven.2Thecollectedwasteisnotmeasuredorisdisposedofdirectlybythelandlordattheothersites/properties.3Estimatebasedonthecycleofcollectionandthesizeofthecontainer.

Developmentofthecoreindicatorsforwastefrom2015to2016Generally,in2016adecreasingtrendintheamountofwastebecameapparent.Onlythecoreindi-catoroftheamountofhazardouswasteperemployeeincreasedby71%in2016asalargenum-ber of defective cytostatic batches occurred and had to be disposed of compared to the previous year.Therefore,inTorneschinparticular,alargeamountofspecialdisposalswerenecessary.In2016,staffnumbersincreasedaswell.Inhowfartheintroductionofwasteseparationinthestaffkitchenswillhaveledtoareductionintheamountofresidualwastewillonlybecomeapparentinthefollowingyear.


4.3Resources/materialefficiency

Fortheproductionandpackagingofmedicinalproducts,manyresourcesareusedbutduetostrictlegalrequirementsandlongmarketingauthorisationproceduresthereisverylittleroomtominimisetheresourcesused.Duetothevarietyandheterogeneityoftheusedmaterials,thelowpossibilityofinfluencebytheenvironmentalmanagementsystemandduetoconfidentiality,theseresourcesarenotspecifiedinthisenvironmentalstatement.

Inordertoensurethebestpossiblequalityofourproductsduringtransportationandtoprotectthemagainstexternalinfluences,thepackagingneedstobeexceptional.32,600kgofpaper,card-boardandcardboardboxes,and7,100kgofplasticmaterialswereusedforthispurposein2015.In2016,werecordedanincreaseto36,070kgofpaper,cardboardandcardboardboxes,andto10,080kgofplastic.ThisincreaseisduetoincreasedproductionattheGermansitesin2016.

In themanagementarea, thepaperconsumption (2016:5,692,302sheetsofpaper, i.e.approx.5,015sheetsperemployeeperyear,whichisanincreaseofaround5%comparedto2015)willbeexaminedinordertodeterminemeasurestoreducethepaperconsumption.DuplexprintingsetasdefaultprintingoptionisnotpossibleduetoGMPrequirements.Theemployees,however,havebeenmadeawareintheenvironmentnewsletterandanintranetarticleonsavingpaperofthead-vantagesofduplexandmulti-pagedprintingofnon-GMP-relevantdocumentsandofavoidingtheunnecessaryprintingofdocuments,inparticularofe-mails.AtthesiteinRome,thereceiptoffaxdocumentshasalreadybeendigitisedandthe“paperlessoffice”projectwillbedevelopedfurtherforWedelandTornesch.Beyondthat,wearecurrentlylookingintotheuseofmoreenvironmentallyfriendlypapercertifiedwiththeBlueAngeleco-label.Currently,medacisalreadyusingFSC-mixcertifiedpaper.

Theexternalcleaningcompanyhasbeenorderedtousecleaningagentsandparapherneliaspa-ringlyandresponsiblyand,wherepossible,toconsiderusingmoreeco-friendlyalternatives.Inthesanitaryareas,papertowelsareused.Electricityandfuelconsumptionaredescribedinthechapter„Energy“.

OurgoalsReductionofpaperconsumptionby2%bytheendofthe2017/18financialyearcomparedtotherateattheendofthe2015/16financialyearbythefollowingmeasures:

• Further development of the project “paperless office” (Wedel & Tornesch) 31/03/2018Theproject“digitalmailroom”hasbeenlaunched.Followingthereasonablycomplexdevelop-mentofaconceptandthecreationofasuperordinateprocessforthedigitalinitialprocessingofinvoices,theprojecthasnowenteredthetechnicalimplementationstage.Digitalisationofoutgo-inginvoicesisalsocurrentlybeingrealised.Inaddition,aspartoftheprojecttointroduceaMa-nufacturing Execution System(MES)whichwaslaunchedin2014,thepaper-lessdocumentationofallproductionprocesseswaspursuedsothatthesewillonlybeprocessedelectronicallyinthefuture.ThemanufacturinginstructionsarethusreleasedthroughanelectronicworkflowandthereviewofthepackagingrecordtakesplaceaccordingtotheReviewby ExceptionprincipleinthefinalexpansionstageoftheMES.Thishelpsreducemanualcheckingandenablesconcentratingonevaluatingspecialincidentsoccurringduringtheproductionofabatch.


Materialconsumption

Packaging material [kg] 2015 2016 Trend

Paper, cardboard and cardboard boxes(Wedel&Tornesch)

32,600 36,070

Plastics(Wedel&Tornesch) 7,100 10,080

Totalpackagingmaterial 39,700 46,150 (+16.25%)


Paper/employee[A4sheet/quantity] 5,061 5,015 (-0.91%)

Core indicators

• Information for employees: “Avoid unnecessary printouts of e-mails” (all sites) 31/03/2018Employeeswereprovidedwiththeinformationintheenvironmentnewsletterandaseparatein-tranetarticleonsavingpaper.Inaddition,on17/11/2017allemployeesinTorneschandWedelwereprovidedwithcliplabelswiththemotto“SavePaper.SaveEnergy”thatcanbeattachedtoe.g.computermonitorsandthatserveasvisualreminders.

• Communicate to staff: “Use duplex printing whenever possible” (all sites) 31/03/2018Hasbeencommunicatedtostaffintheenvironmentnewsletterandaseparateintranetarticleonsavingpaperon08/06/2017.


Paper consumption [A4 sheet] 2015 2016 Trend

Wedel&Tornesch(DE) 5,184,905 5,431,152

Rome (IT) 58,099 52,000

Lyon(FR) 30,000 25,000

Brno&Bratislava(CZ/SK) 12,500 12,500

Jorvas (FI) 2,250 10,000

Warsaw(PL) 70,000 106,250

Algés(PT) 24,100 32,500

Varberg (SE) 23,000 4,900

Stirling(UK) 20,000 18,000

Totalpaperconsumption 5,424,854 5,692,302 (+4.93%)

Developmentofthecoreindicatorsforresources/materialefficiencyfrom2015to2016

Paperconsumption inA4sheetsperemployeestayednearly thesameas in thepreviousyear,withaslightdecreasingtrend.However,totalpaperconsumptionrosebyabout5%becauseofrisenstaffnumbers.Theincreaseinpackagingmaterialin2016attherespectiveproductionsitesisduetoincreasedproductionandmoreextensiverequirementsregardingthesafepackagingofproducts.


4.4 Energy

medacisnotanenergy-intensivecompany,howeverhere,too,thereisstillpotentialforsaving.With the introduction of the environmentalmanagement system, the opportunitywas taken torecordandevaluatetheenergysourcesandthemost importantenergyconsumers inmorede-tail,andtoassess them in termsofoptimisationpotential.Asafirstmeasure,wehavetackledthe improvementofdatacollection:All energyandenvironmentaldata iscollectedannuallybythe respective responsible employees and evaluatedby theUMB.Some energy-efficientmea-sureshadalreadybeen implemented intheconstructionoftheadministrationbuilding,suchas movement-sensitive lighting in the rest rooms. At the site in Rome, the outdoor lighting was equippedwithdaylightsensors.

In2016,atotalof6,075,483kWhofelectricitywereusedatallsites.Thisisequaltoanannualelectricityconsumptionofapprox.5,956kWhperemployee.ThemainenergyconsumersaretheventilationandlightingatTheaterstr.6,andtheventilationandcoolinginTornesch.Wewereabletouse365MWhself-generatedelectricityfromourcombinedheatandpowerplant(CHP)inTorneschandfed1MWhintothepublicgrid.

Employeesweremadeawareofenergy-savingmeasuresintheenvironmentnewsletter.Further-more,fromOctober2017onwards,themainconsumersatthesiteswithpackagingdepartments,storageunitsandlaboratorydutieswillbecompiledwiththehelpofanenergyadvisertoreduceenergyconsumptionandtoenablethemtobeusedinamoreenergy-efficientmanner.In2017,wealsocheckedwhetheramoreprecisecontrolofthelightingispossible.Additionally,on25/03/2017,medactookpartintheEarth Hour 2017 event organised by the WWF (WorldWildlife Fund): All lightswere switched off for the duration of theEarth Hour at medac headquartersinTheaterstr.6andatmedac’slogisticscentreinTorneschasasignformoresus-tainability,formoreprotectionoftheenvironmentandtheclimate,andtoraisestaff’sawarenessoftheseissues.Allemployeeswereinformedaboutmedac’sparticipationinthisglobaleventviatheintranetandencouragedtosaveenergyandtotakepartfromhome.

TheTornesch,Rome(IT),Brno/Bratislava(CZ/SK),andStirling(UK)sitesaswellasthepropertiesatRosengarten25,Theaterstr.1andTheaterstr.6areheatedwithnaturalgas.In2016,4,881,194kWhofnaturalgaswereusedforthispurpose.

In 2016, 81,214 m³ of compressed air were generated at the Wedel site through the use of approx.34,000kWhofelectricity.AttheTorneschsite,compressedairisgenerated,too.However,thecompressedairconsumptioncannotbereadoutthroughthecompressorcontrol.InTornesch,anestimated42,924kWhperyearareusedtogeneratethecompressedair.

Additionally,374kgofpropanegaswereusedforoperatingtheforkliftsatTheaterstr.6in2016.


Ourgoals

Reduceconsumptionofelectricityby2%bytheendofthe2017/18financialyearcomparedtotheendofthe2015/16financialyearthroughthefollowingmeasures:

• Assessment of the potential for more precise control of lighting (Wedel & Tornesch) 31/03/2018

Ithasbeenassessedwhetherthelightingsystemscanbecontrolledmoreprecisely.Principally,it ispossibletoretrofitthesystemswithmoreenergy-savingcontrols.Currently,suppliersofsuchsystemsarebeingcontactedinordertodeveloprelevantconcepts.Followingcost-benefitanalysisthesecouldbeincludedinbudgetplanningasprojectswithintheenergymanagementwhichhasbeenunderdevelopment togetherwithanexternalenergyadviser sinceOctober2017.Additionally,environmentalandenergy-managementconcernsaretakenintoconsidera-tionforallrepairmeasuresaspartofdailyfacilitymanagement.Forexample,iflightswitchesstopworkingtheyarereplacedbypresenceormotiondetectorswheneverpossible.AtThea-terstr.6,presencedetectorshavealreadybeeninstalledinsomeoftherestroomsandcommonroomsinthepackagingdepartment.

• Increase of employee awareness of how to save energy (all sites) 31/03/2018Employeeswereencouragedtosaveenergyandgiveninformationonhowtodosointheen-vironmentnewsletterin2016andinaseparateintranetarticleon16/11/2017.Inaddition,allemployeesinTorneschandWedelwereprovidedwithcliplabelswiththemotto“SavePaper.SaveEnergy.”thatcanbeattachedtoe.g.computermonitorsandthatserveasvisualremin-ders.

• Identification of options for reducing energy consumption • Development of ideas in a workshop

• Introduction of a measurement concept (all sites)

31.03.2018ThefoundationsforintroducingameasurementconceptarebeingdevelopedtogetherwithanexternalenergyadvisersinceOctober2017.Atthesametime,themainconsumersaretobecompiled.Duetoalackofresources,ithasnotbeenpossibletodosountilnow.


Totalenergyconsumption [kWh/quantity]

10,934 10,824 (-1.01%)

Core indicators


Total consumption of renewable energy [MWh]

2015 2016 Trend

Wedel 1,2051 1,285 1

Tornesch 746 1,130

Shareofannualtotalconsumption(Wedel1 & Tornesch)

17% 22 % (+29.4%)

Electricity [MWh] 2015 2016 Tendenz

Theaterstr. 6 2,416 2,370

Theaterstr. 1 19 19

Rosengarten25 415 441

Feldstr.170 134 143

Tornesch 2,953 2,994

Rome (IT) 13 34

Lyon(FR) 12 12


Jorvas (FI) 10 6

Warsaw(PL) 12 15

Algés(PT) 7 8

Varberg (SE) 15 12

Stirling(UK) 0 2 8

Totalelectricityconsumption 6,018 6,075 (+0.95%)

medac’senergyconsumption

1withoutTinsdalerWegandvon-Linné-Str.2advancepayment;notrecorded


Natural gas [MWh] 2015 2016 Trend


Theaterstr. 1 49 59



Rome (IT) 25 22


Stirling(UK) 18 15

Totalheatenergyconsumption 5,185 4,881 (-5.86%)

Other energy consumption [MWh] 2015 2016 Trend

Fuelforemergencygenerators

Diesel(Theaterstr.6) 23 0

Fueloil(Theaterstr.6) 0 21

Diesel(Tornesch) 17 37

Fuelforfleet

Diesel(Wedel&Tornesch) 5,805 5,175

Petrol(Wedel&Tornesch) 270 190

Propanegasforforklifts(Theaterstr.6) 4.5 4.8

Totalotherenergyconsumption 6,119 5,428 (-11.29%)

Total direct energy consumption [MWh]

2015 2016 Trend

Allsites 11,251 11,041 (-1.87%)

Electricity generated by combined heat and power plant [MWh]

2015 2016 Trend

Tornesch 748 365 (-51.20%)


Developmentofthecoreindicatorsforenergy2015to2016

Totalenergyconsumptionwaskeptatthesamelevelasthepreviousyearwithaslightdecreasingtendency.

Thankstoanincreaseintheratioofrenewableenergiesintheelectricitymixbythesupplier,thetotalconsumptionofrenewableenergiesincreasedin2016.ThisresultedinanoverallimprovedCO2balanceforthecompany.

AsdieselwasusedinsteadoffueloilfortheemergencygeneratoratTheaterstr.6in2015,thefueloilconsumptionincreasedatthatsitein2016withacorrespondingdecreaseindieselconsump-tion.

In2016,theperformanceoftheCHPinTorneschwaslowerbyabouthalfthanin2015becausetheplantcouldnotbeoperatedthroughoutthewholeyearduetomaintenanceandreconstructionwork.Thisincludedreplacementoftheabsorberandthebuffertank,whichhadbecometoosmall,withabiggerone.Thenewbuffertankresultedinthecoldmanagementnotworkingproperlyandhavingtoberecalibrated,whichinturncausedfurtherdelaytotheCHPresumingoperations.



Landuseperemployee[m²/quantity] 32.70 33.12 (+1.28%)

Core indicators

4.5Procurement

Wecontinuouslyevaluatethequalityofoursuppliersthroughaspectssuchasdeliveryreliabilityorcomplaintsprocessingbutalsoby“grading”thequalityofthedocumentssupplied.

Ourgoals

Increaseduseofsustainablegoodsandservicesthroughthefollowingmeasures:

• Evaluationofinhowfarenvironmentalandsocialaspectscanbetakenintoconsiderationwhenselectinggoodsandservices(allsites) 31/03/2017Itwasagreed that theexternal insurancebrokerwill be remindedannually tocheck for theoptionoftakingoutsustainableinsurancepolicieswherepossible.Evaluationhasstilltotakeplaceforotherareas(e.g.purchasingdepartment,kitchens).Initialmeetingswiththesupplierqualificationunitofthequalitymanagementandthepurchasingdepartmentonthistopichavetakenplacein2017.Currently,anextendedsupplierquestionnaireisbeingdrawnupaspartofthemedacqualitymanagementsystem(plannedintroduction:beginningof2018).

4.6 Biodiversity

Weplantthegroundsandpatiosatthepropertiesthatweown.Theplantingprovidesshelter,nes-tinggroundsandfoodforbirdsaswellasforbutterflies,beesandotherinsects.


Land use [m²] 2015 2016 Trend

Theaterstr. 6 17,483 17,483



Feldstr.170 440 440

von-Linné-Str.14 718 718

TinsdalerWeg183 0 1 2,099

Tornesch 13,652 13,652

Rome (IT) 360 360

Lyon(FR) 217 230


Jorvas (FI) 91 91

Warsaw(PL) 382 727

Algés(PT) 170 170

Varberg (SE) 150 165

Stirling(UK) 100 100

Totallanduse 35,059 37,597 (+7.24%)

Developmentofthecoreindicatorsforbiodiversityfrom2015to2016DuetoanexpansionofsalesactivitiesinFrance,CzechRepublic/Slovakia,PolandandScandina-viaadditionalofficespaceneededtobeleasedresultinginanincreaseoflanduse.InWedel,too,anewofficesitewasleasedatTinsdalerWeg183.

1TheofficespacesatTinsdalerWeg183haveonlybeenrentedsince2016.



Waterconsumptionperemployee [m³/quantity]

12.72 14.9 3 (+17.32%)

Core indicators

Water consumption

Water consumption [m³] 2015 2016 Trend





Rome (IT) 87 102

Jorvas (FI) 0 9

Warsaw(PL) 0 355

Algés(PT) 0 27

Varberg (SE) 0 263

Totalwaterconsumption 11,871 13,346 (+12.43%)

4.7Water

Water is used atmedac in the sanitary facilities, laboratories, employee kitchens and the staff restaurantsand,toasmallextent,forirrigation.Whenbuildingtheadministrationbuildingandthelogisticsbuilding,water-savingdevicessuchastoiletswithawater-saverbuttonwereinstalledasstandard.Freshwaterisobtainedfromthecommunesandwastewaterispassedintothepublicsewersys-tem.In2016,12,590m³offreshwaterwereconsumedinWedelandTornesch.Thiscorrespondsto the consumption of approximately 143–217 households (average consumption in Germany: 58–88m³ofwaterper2-personhouseholdperyear1)and isthereforewithinthenormalrange.Waterisapreciouscommodity;thereforeemployeesareencouragedtousewatereconomically.

1Source:http://www.energiesparen-im-haushalt.de/energie/tipps-zum-energiesparen/hoher-wasserverbrauch/wasserverbrauch-personenhaushalt.html

2onlyforGermany(excludingFeldstr.,TinsdalerWegandvon-Linné-Str.)andIT3excludingFeldstr.170,TinsdalerWeg,von-Linné-Str.,FR,UK,andCZ/SK


Wastewater

Waste water [m³] 2015 2016 Trend





Totalwastewater 11,939 12,564 (+5.23%)

Developmentofthecoreindicatorsforenergy2015to2016Theincreaseinwaterconsumption,inparticularforTornesch,isprobablyduetoincreasedwaterconsumptionbytheevaporationcoolingplantnecessitatedbythewarmertemperaturesduringthesummerof2016ascomparedto2015.TheincreasedwaterandwastewaterconsumptionatTheaterstr.1whencomparedtothepreviousyearisduetothemeetingroombeingusedmorefrequentlybystafffromothersites,thoughstaffnumbersworkingtherehavestayedthesame.In conclusion, it can be stated that the growth in staff numbers led to an increase in the consumption of drinking water and sanitary waste water in 2016. Furthermore, in 2016 we receivedconsumptionfiguresforthesites inFinland,Poland,PortugalandSwedenforthefirsttime.In2015,theproperties’landlordsonlyprovidedanannualstatementofutilitiesusingflatrateswherewaterconsumptionwasnotlistedindetail.


4.8Generalaspects

Afterthefirstenvironmentalaudit,wedecidedtoregularlycollectandanalyseenvironmentallyre-levantdata,suchasfueluse,inordertorecordandevaluateourenvironmentalimpactevenbetterinthefuture.Moreover,westartedacompanysuggestionschemeforenvironmentalideas.SinceitsintroductioninJuly2016,72ideasonhowmedaccouldreduceenvironmentalimpacthaveal-readybeencollected.Altogether,112environment-relatedideashavebeensubmittedbystafftotheEnvironmentalManagementsinceJanuary2016(date:15/11/2017).

Furthermore, medac representatives from the Environmental Management and the technicalprojectsandconstructionsdivisionoftheFacilityManagement,amongstothers,tookpartinthe 3rd WedelClimateConference(3. Wedeler Klimaschutzkonferenz)atthebeginningofOctober2017.Infourworkshops,theparticipantsjoinedrepresentativesfrombusiness,politicsandadministration,andWedelcitizenstocomeupwithtangibleideasfortheimplementationoflocalclimateprotectionprojects1.

Ourgoals

Improvementofthedatasituationthroughthefollowingmeasure:• Definition of a set of data to be collected regularly concerning environmental aspects at medac

(all sites)

31/03/2017On25/08/2017fleetmanagementprovidedthecurrentsummaryofthemedacfleetcontainingallreferencefiguresthatarerelevanttotheenvironment.WearecurrentlycollaboratingwiththeITdepartmentongeneratingadatabasefortheassessmentandanalysisofdatasetsconcer-ningtheenvironmentalaspectsofthefleetvehicles.

Settingupa“greenletterbox”throughthefollowingmeasure:• Establishing a company suggestion scheme to collect ideas for reducing harmful effects on the

environment (Wedel & Tornesch) 30/07/2016The e-mail address “[email protected]” was set up and announced via e-mail andon the intranet toallmedacemployees inGermany.Thesubmitted ideasarecollectedand administeredbytheenvironmentalmanagementrepresentativeorherdeputy,respectively.

1Source:https://www.wedel.de/rathaus-politik/newsdetail/news/klima-konkret.html


5Updateoftheenvironmentalgoals

Basedontheresultsoftheenvironmentalaudits,theexternalauditsoftheenvironmentalmanage-mentsystemandtheresponsibilityvis-a-vistheenvironmentandsocietysetoutintheenviron-mentalpolicy,arangeoftangibleannualmeasuresweredevelopedandhavebeensummarisedinmedac’senvironmentalprogramme.Suggestionsforimprovementsbyemployeesweretakenintoaccountforthisaswell.

Thefollowingtabledepictsmedac’sfirstenvironmentalprogrammefrom2016andthecurrentsta-tusofthemeasures(date:15/11/2017):

Key area: Air/emissions and mobility Status: For details, see

Goal: Reducedemissionofairpollutants

Measures:

1. Examinationofpossibilitytobuycoolantswithlessimpactontheclimate(Wedel&Tornesch)

P. 14

2. Examinationofthepossibilitytopoolthecollectionofcytostaticmedicinalproductsandcisplatinwaste(Tornesch)

P. 14

3. Introductionofa“car-freeday”event(alllocations) P. 14

4. CheckwhetherelectricbikescouldbeintroducedfortransitbetweenthemedacsiteinTorneschandthetrainstation(Tornesch) P. 14

5. Definitionofasetofdatatobecollectedregularlyconcerningtheenvironmentalaspectsoffleetvehicles(Wedel&Tornesch) P. 14

6. Identificationofthepotentialtoreduceemissionsofairpollutantsbythefleet(Wedel&Tornesch) P. 15

Key area: Waste

Goal: Reductionoftheresidualwasteratioby2%

Measures:

1. Optimisationofthewaste-binconceptintheofficesandstaffkitchens(Wedel&Tornesch)

P. 18

2. Raisingawarenessofstaff(allsites) P. 18

Key area: Resources/material efficiency S. 14

Goal:Reductionofpaperconsumptionby2%bytheendofthe2017/18financialyearcomparedtotherateattheendofthe2015/16financialyear

Measures:

1. Furtherdevelopmentoftheproject“paperlessoffice”(Wedel&Tornesch) P. 20

2. Informationforemployees:“Avoidunnecessaryprintoutsofe-mails”(allsites)

P. 21

3. Communicatetostaff:“Useduplexprintingwheneverpossible”(allsites)

P. 21


Key area: Energy Status: For details, see

Goal: Reduceconsumptionofelectricityby2%bytheendofthe2017/18financialyearcomparedtotheendofthe2015/16financialyear

Measures:

1.Assessmentofthepotentialformoreprecisecontroloflighting(Wedel&Tornesch)

P. 24

2.Increaseofemployeeawarenessofhowtosaveenergy(allsites) P. 24

3.Identificationofoptionsforreducingenergyconsumption P. 24

Key area: Procurement

Goal: Increaseduseofsustainablegoodsandservices

Measure:

Evaluationofinhowfarenvironmentalandsocialaspectscanbetakenintoconsiderationwhenselectinggoodsandservices(allsites) P.28

General measures S. 14

1st goal: Improvement of the data situation

Measure:

Definitionofasetofdatatobecollectedregularlyconcerning environmentalaspectsatmedac(allsites) P. 32

2nd goal: Settingupa“greenletterbox”

Measure:

Establishingacompanysuggestionschemetocollectideasfor reducingharmfuleffectsontheenvironment(Wedel&Tornesch)

P. 32

Goalwasachieved.Achievementofgoalstillinprogress.


medacenvironmentalprogramme2018

Theupdatedenvironmentalprogrammefor2018includesthefollowingmeasures:

Key area: Air/emissions and mobilityResponsible for the

implementationBudget Deadline

Goal: Reducedemissionofairpollutants

Measures:

1.Checkwhethermedaccouldofferacompanybicycleleasingscheme

Compensation & Benefits

/ 10/2018

2.Annualanalysisandexaminationofthepotentialtoreduce emissionsofairpollutantsbythefleet(Wedel&Tornesch)

Fleetmanagement / 10/2018

3.ImplementationoftheFederalImmissionControlAct(Bundes- Immissionsschutzgesetz,BImSchG)(WedelandTornesch)

FMT/G €5,000 10/2018

Key area: Waste

Goal: Reductionoftheresidualwasteratioby2%incomparisontothecalendaryear2016,i.e.lessthan31.38tofresidualwasteinTornesch,andlessthan476.476LofresidualwasteinWedel(withoutvon-Linné-Str.andTins-dalerWeg)duringthecalendaryear2018

Measures:

1.IntroductionofanorganicwastebinatTheaterstr.6(Wedel) Waste managementapprox. €750

02/2018

2.ImplementationofthecurrentGermanCommercialWaste Ordinance(Gewerbeabfallverordnung)(WedelandTornesch)

Waste managementapprox.

€16,80010/2018

3.Continueraisingawarenessofstaff: Thegoalforthekeyarea“Waste”willbecommunicatedtotheemployeesandtheywillbeaskedtohelpachieveit.

Waste management / environmental management

/ 10/2018

Key area: Resources/material efficiency

Goal: Reductionofpaperconsumptionby2%incomparisontothecalendaryear2015(=103,698sheetsofA4paper),i.e.consumptionoflessthan5,081,207sheetsofA4paperduringthecalendaryear2018(Wedel/Tornesch)

Measures:

1.Furtherdevelopmentoftheproject“paperlessoffice”:1. Introductionoftheelectronicsignature(e-signature)at

medacin20182. IntroductionoftheelectronicITauthorisationapplication

form(e-authorisation)atmedacin20183. IntroductionoftheElectronicTrialMasterFile(eTMF)at

medacin2018

IT

IT

MaxHorneck(ClinicalData Management and

eClinialSystems)

/ 1

/ 1

/ 1

04/2018

12/2018

02/2018

2. Introduction of MES (Manufacturing Execution System) in2018;this is estimated to save ~300,000 sheets of paper per year

MichailHerrmann(Production Support,

projectleader)/ 1 12/2018

3.Introductionofsub-project1ofthe“digitalmailroom”project:Digitalinitialprocessingofinvoices

Sven Schneider (FacilityManagement

Infrastructure)/ 1 07/2018

4.Introductionofdigitalinvoicesforthepharmaceuticalwholesalesector.Atthesametime,theelectronicdispatchofinvoicesinPDFformatwillbepromotedtocustomersasanalternative.

Customer Service / SönkeLorenzen

(ITApplicationsand Development)

/ 1 10/2018

1Forthismeasure,therespectiveresponsiblepersonsordepartmentshavealreadyappliedforabudgetindependentoftheenvironmentalprogramme.Thus,thecostsarenotlistedhereagain.

v


Key area: EnergyResponsible for the


1st goal: Reductionofelectricenergyconsumptionby2%(=114,616kWh)incomparisontotheamountattheendofthefinancialyear2015/16,i.e.energyconsumptionoflessthan5,616,196kWhduringthe financialyear2017/18(Wedel/Tornesch,withoutvon-Linné-Str.andTinsdalerWeg)

Measures:

1.Creationofamoreenergy-efficientlightingconceptinTorneschfor the

- largelogisticshall(dispatch)- smalllogisticshall(incoming/outgoinggoodsarea)

- laboratoryareas

FMtechnicalprojectsand constructions

/ 1

approx. € 2,000 approx. € 2,000

12/201812/2018

12/2018

2.Implementationofamoreenergy-efficientlightingconceptforthelargelogisticshall(dispatch)inTornesch


/ 1 12/2018

3.Raisingawarenessofstaffconcerningthesavingofenergy: Checkwhetherthishasalreadymadeadifferenceforthefinancialyear2017/18andledtoareductionby2%attheofficesites.

Environmental management

/ 04/2018

2nd goal: Collectionofinventorydataconcerningtheenergysectoranddeterminationofinitialactions

Measure:

Compilationofthemainconsumerswiththehelpofanexternalenergy adviser


€ 30,000 10/2018

v

Key area: Procurement

1st goal: Increaseduseofsustainablegoodswhenprocuringofficesupplies,inthekitchensandforthecatering

Measure: Analysisofthestatus quoandpotentialforoptimisation...

...whenprocuringofficesuppliesAnnetGerberding

(FacilityManagementInfrastructure)

/ 10/2018

...inthekitchens UteHacke(kitchens) / 10/2018

...for the cateringManuelaDilling

(catering)/ 10/2018

2nd goal: Increaseduseofsustainableserviceswhenbookinghotels

Measure:

Analysisofthestatus quoandpotentialforoptimisationwhenbook-inghotels

Travelmanagement / 10/2018

1 Forthismeasure,therespectiveresponsiblepersonsordepartmentshavealreadyappliedforabudgetindependentoftheen-vironmentalprogramme.Thus,thecostsarenotlistedhereagain.


General measuresResponsible for the


1st goal: Improvement of the data situation

Measures:

Collectionofinventorydataintheenergysectorandcontinuousdatamaintenance


see above (€ 30,000 intotal)

10/2018

Annualanalysisofthedatasituationconcerningthemedacfleet Fleetmanagement / 10/2018

Analysisofthedatasituationconcerningtheprocurementofofficesupplies

AnnetGerberding(FacilityManagement

Infrastructure)/ 10/2018

Analysisofthedatasituationconcerningthekitchens UteHacke(Services) / 10/2018

AnalysisofthedatasituationconcerningthecateringManuelaDilling/UteHacke(Services)

/ 10/2018

Analysisofthedatasituationconcerningthebookingofhotels Travelmanagement / 10/2018

2nd goal: Assessmentoftheideasreceivedbyemployeesviatheenvironmentalsuggestionscheme

Measure:

Creationofaconceptfortheanalysis,assessmentandprocessingofthesuggestionsandideas;formationofan“environmentteam”ifapplicable.

Environmental management /

“Environmentteam”/ 10/2018


Statement of Validation


Contact

Forfurtherinformationandquestions,commentsandcriticism,pleasecontacttheEnvironmentalManagementRepresentative,LenaSander,andherdeputy,SwantjeThiele,PhD,atanytime.

Lena SanderEnvironmentalManagementRepresentativeSafetyHealthEnvironment(SHE)

E-mail:[email protected]:+4941038006-8109Fax:+4941038006-8474

Theaterstr. 622880WedelGermanywww.medac.de

Swantje Thiele, PhDDeputyEnvironmentalManagementRepresentative;Junior Manager Product SafetySafetyHealthEnvironment(SHE)

E-mail:[email protected]:+4941038006-8427Fax:+4941038006-8474

Theaterstr. 622880WedelGermanywww.medac.de


Certificates

EMASIIICertificate


Number 94023

Valid from 12.12.2016

Valid until 11.12.2019 Page 1 of 3

Kiwa International Cert GmbH Kiwa International Cert GmbH Managing Director Technical Manager

Kiwa International Cert GmbH

Grüner Deich 1

20097 Hamburg

Germany

Telefon +49 (0)40 30 39 49 60

Telefax +49 (0)40 30 39 49 79

e-mail: [email protected]

www.kiwa.de

medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6 22880 Wedel for the scope

design, manufacture and sales of therapeutic substances and diagnostics; oncology, urology and autoimmune diseases marketing and sales of pharmaceutical products has implemented and applies an environmental system, which is in compliance with the requirements of

ISO 14001:2015 This is a multi-site certification. Additional site details are listed on subsequent pages.

Kiwa International Cert GmbH certifies that the company

DINENISO14001:2015Certificate


Number 94023

Valid from 12.12.2016

Valid until 11.12.2019 Page 2 of 3


Grüner Deich 1

20097 Hamburg

Germany

Telefon +49 (0)40 30 39 49 60

Telefax +49 (0)40 30 39 49 79


www.kiwa.de

for the scope

design, manufacture and sales of therapeutic substances and diagnostics; oncology, urology and autoimmune diseases (valid for all sites on page 2) several sites: medac Gesellschaft für medac Gesellschaft für klinische Spezialpräparate mbH klinische Spezialpräparate mbH Tinsdaler Weg 183 Rosengarten 25 22880 Wedel 22880 Wedel medac Gesellschaft für medac Gesellschaft für klinische Spezialpräparate mbH klinische Spezialpräparate mbH von-Linné-Str.14 Feldstraße 170 22880 Wedel 22880 Wedel medac Gesellschaft für medac Gesellschaft für klinische Spezialpräparate mbH klinische Spezialpräparate mbH Wilfried-Mohr-Straße 1-5 Theaterstraße 1 25436 Tornesch 22880 Wedel

medac Gesellschaft für klinische Spezialpräparate mbH


Nummer 94023

Gültig vom 12.12.2016

Gültig bis 11.12.2019 Page 3 of 3


Grüner Deich 1

20097 Hamburg

Germany

Telefon +49 (0)40 30 39 49 60

Telefax +49 (0)40 30 39 49 79


www.kiwa.de

medac Gesellschaft für klinische Spezialpräparate mbH for the scope

marketing and sales of pharmaceutical products (valid for all sites on page 3) several sites: medac s.a.s medac Pharma S.r.l. 23 rue Pierre Gilles de Gennes Via Viggiano, 90 69007 Lyon, France 00178 Rome, Italy medac GmbH – organizační složka medac GmbH sivuliike Suomessa Cervený kopec 4 Jorvas Hitech Center 639 00 Brno, Tschechische Republik Hirsalantie 11 02420 Jorvas, Finnland medac GmbH Sp. z o.o. medac GmbH Oddział w Polsce Sucursal em Portugal ul. Postępu 21 B Alameda António Sérgio nº. 22 - 6º.C 02-676 Warschau, Polen 1495-132 Algés, Portugal medac Gesellschaft für klinische Spezialpräparate m.b.H. organizačná zložka Slovensko Štúrova 4 811 02 Bratislava, Slowakai medac Scandinavia (Sweden, Denmark, Norway, Iceland) Box 120 / Kungsgatan 32 432 23 Varberg, Schweden medac GmbH Scion House Stirling University Innovation Park Stirling FK9 4NF, Großbritannien

Theaterstraße622880Wedel·Germanywww.medac.de

updated joint environmental statement · 2019-04-04 · 1 company profile 5 1.1 medac stands for a...

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