EUROPEAN HEALTHCARE DISTRIBUTION ASSOCIATION

ANNUAL REPORT 2018-2019 TABLE OF CONTENTS

P. 4 The Evolving Role of Healthcare Distributors P. 6 Healthcare Distribution in Data P. 10 Healthcare Distribution – A Highly Regulated Sector P. 11 An Ever–Evolving Environment P. 12 GIRP Introduction P. 13 GIRP in Action P. 14 GIRP Key Priorities and Upcoming Events P. 15 Year in Review P. 16 GIRP 2018 Annual Meeting and Conference, Dublin P. 17 GIRP 2018 Regional Meeting, Sofia P. 18 GIRP 2018 Autumn Meetings, Brussels P. 19 2019 European Healthcare Value Chain Forum, Brussels P. 20 GIRP 2019 Supply Chain Conference, Cannes P. 21 European Healthcare Value Chain Network P. 22 GIRP and the Falsified Directive P. 24 About Us P. 25 GIRP Board P. 26 GIRP Members we have manoeuvred a number It was also then and there that we of adaptations to our governance oversaw the name change from the structure to closely fit with the European Association of Full-Line sector’s environment and priorities. Wholesalers to the European Healthcare As the market was quickly integrating, Distribution Association with the aim we saw it beneficial to open direct to better reflect the range of products company membership and welcomed that healthcare distributors handle and the main European healthcare the expansion of our range of services. distribution companies and groups as We aimed to truly represent the role we full members of GIRP. They created play in providing innovative and efficient great value within the GIRP managing healthcare products and services to structure and shared valuable input improve the health and wellbeing of and recommendations in the way European citizens and by doing so, we operate and liaise with European to support the sustainability of the institutions and other stakeholders. healthcare systems.

More recently, GIRP along with its “I am truly honoured for the members strived for years to reach a goal which was set for February 9th, Dear colleagues, dear friends, trust you put in me over the 2019. I was equally proud and impressed last 14 years and thankful for to witness the level of preparedness After 14 years at your service as your collaboration.” achieved and the commitment GIRP President, time has come for healthcare distributors and GIRP put in me to hand the baton over to the being ready to comply with the Falsified next generation. I have tremendously Indeed, as our technologies kept Medicines Directive, together working enjoyed collaborating with you all advancing, our supply chain operation towards enhanced patient safety. during my time at GIRP’s helm and I am practices became increasingly extremely proud of the work we have interconnected. We saw a growing need It has been an educational, challenging accomplished together. for healthcare distributors, industry and invigorating experience to represent and other supply chain stakeholders to healthcare distributors. I am truly Over the years, the sector has greatly deepen ever-more our understanding honoured for the trust you put in me evolved, and our profession has of how the other operates and develop over the last 14 years and thankful for embraced change and innovative closer relationships to meet the your collaboration. I will keep being disruptions to keep offering to demands of patients and create value active as part of GIRP and look forward our customers and to patients the from new, promising technologies. In to seeing the great developments to best service and to facilitate safe response to this need, GIRP established come by in the future. We are paving and efficient access to medicines in 2015 the European Healthcare the way for a better future for European throughout . Value Chain Network, built as a true patients and citizens, together with our multidisciplinary network of partners partners. Healthcare distributors, more We, at GIRP, also took these major and providing a forum for connecting than ever, will play their part in building evolutions onboard and adapted our peers from leading pharmaceutical and tomorrow’s society! services to members and our activities healthcare companies / organisations to better reflect the profession. Over with a shared vision for the future of the All the best to GIRP and to you all. the last 14 years, we have endeavoured healthcare value chain. I am very proud to represent healthcare distributors to have seen this network grow over the René Jenny to promote the vital work we operate years and lead to new and innovative President, GIRP within the supply chain. To do so, projects among participants.

GIRP • Annual Report 2018 - 2019 3 THE EVOLVING ROLE OF HEALTHCARE DISTRIBUTORS

Healthcare distributors provide customised solutions to meet a diverse range of supply chain needs. Ensuring the availability and continuity of supply of all healthcare products and services to their customers stands at the forefront of their activities. As they are in a unique position connecting crucial supply chain stakeholders, healthcare distributors have an in-depth view of the flow of medicines in the supply chain. Thus, they are able to provide a full range of important services to all partners in the supply chain that ultimately benefit the patient.

ADDING VALUE INVISIBLE, BUT CRUCIAL Many other services have been added in TO THE SUPPLY CHAIN IN THE SUPPLY CHAIN the recent years that are driven by new societal needs. These services include Healthcare distributors increasingly Many services that healthcare customised care to meet the unique add value to the supply chain. Because distributors provide to the needs of individual patients. Examples pharmaceutical full-line wholesaling lies manufacturing industry and pharmacists include the provision of self-diagnostics at their core, healthcare distributors are invisible to the patient, but and customised delivery, have both the scope and the scale, complement the distribution of monitoring and nursing services. When in terms of product assortment and medicines, such as documentation and operating in their core role, healthcare volume, to develop and deliver products scientific information, reverse logistics, distributors and pharmacists also and services for combination therapies systems for stock management, work together in steering volume involving pharmaceuticals and medical marketing support, pharmaceutical and assortment in an optimised devices. Clients include pharmacists databases or IT management and way. Downstream activities include and manufacturers, but also patients monitoring. Healthcare distributors repackaging medicines into weekly (e.g. homecare delivery in accordance therefore add value by undertaking doses to meet patients’ needs in terms with national legal frameworks). services that are non-core to supply of controlled and timely intake and cost Moreover, healthcare distributors have chain partners, but that are of effectiveness. Logistics innovations the scale and the knowledge base to tremendous benefit, enabling all actors can support compliance and therefore support pharmacists in safeguarding involved to focus on the patient. better health. patient compliance. In the event of any harmful interactions, they can support pharmacies in quickly shifting to an of countries in Europe of countries in Europe %* %* alternative medicine. This makes GIRP 93 provide reverse logistics, 90 provide training on members true full-service healthcare including recalls and returns services medicines and medical devices to distributors. of countries in Europe pharmacists while %* provide educational 72 provide computer systems %* for stock management to pharmacies 62 leaflets for pharmacists’ countries in Europe provide %* use. emergency services to of countries in Europe 97 %* pharmacies 72 provide collection services of medical waste from pharmacies

(*GIRP member countries in Europe, excluding Malta, Cyprus, Latvia) CORE SERVICES 1

For all products: Rx, Gx, OTC, medical devices, in-vitro diagnostics, food supplements, para-pharmaceuticals, pharmacosmetics: LOGISTICS SERVICES: • Storage, pick, pack & ship according to GDP Ladies and Gentlemen, dear GIRP members, • Cold chain, specialty, orphan products and Our societies increasing request for wellbeing narcotics distribution and a bit of a focus on “work-life balance” as • Reverse logistics well as the “work smart not hard” attitude INVENTORY AND STOCK MANAGEMENT: are certainly contradictions to our industry’s • Unaltered product • Quantity-based buffer function requirements which are – almost instantaneous

MANUFACTURERS quality and falsified and accurate deliveries to clients whenever and FINANCING: medicines prevention wherever – i.e. provide healthcare almost for • Pre-financing of medicines supplies • Permanent medicines availability convenience. The increasing use of the IoT – the internet of • One stop shop for all products sold things – and the increasing digitalization does • Stock management and just-in-time delivery not only generate this contradictive situation according to GDP but luckily, also, helps to resolve the situation. • Automated order processing New challenges as well as opportunities are • Permanent medicines availability coming up, the e-prescription being just only

POINTS POINTS • Micro-logistics one of the news on the horizon. • Recalls and reverse logistics PATIENTS AND SOCIETY OF DISPENSE * DISPENSE OF • (Pre) financing Clever use of available data by means of predictive analytics helped to develop new * PHARMACIES, HOSPITALS, NURSING HOMES, DOCTORS products like KNAPP’s Smart Services or redPILOT, the MHE award winning software to optimize logistics operations. The ability to manipulate data on large scale, like as VALUE-ADDED SERVICES 1 within picture recognition applications or in machine learning applications, allows us to • Logistics services/Pre-wholesaling bring the Pick-it-Easy Robot systems to the market. KNAPP combines high-end, leading- • Product Track & Trace edge technology with industry knowledge in a • Market Intelligence sensible way so that best fit system solutions • Market access services can be designed. Designed to serve almost • Quality and professional services • Individual patient instantaneous, accurate deliveries to customers • Waste management services packaging services in a “work smart not hard” environment to the • Clinical trial logistics • Patient communication services benefit of all of our “work – life balance” MANUFACTURERS • Monitoring services Clearly, the combination of well-established • Holding national • Marketing & Sales support security emergency business partnerships, you, dear GIRP members • Education and training on the one hand and KNAPP on the other • Patient Services support hand as well as a highly active and professional • Logistics platform of health services association, namely GIRP, will help to master

POINTS POINTS • Individual patient packaging future challenges. On behalf of KNAPP, thank • Product specific training you all for your partnership.

OF DISPENSE * DISPENSE OF PATIENTS AND SOCIETY * PHARMACIES, HOSPITALS, NURSING HOMES, DOCTORS Horst Matzer, Dipl.-Ing. 1 List of services non-exhaustive KNAPP AG 2 While services related to patients are normally performed by qualified pharmacists, some health- Vice President Healthcare Solutions care distributors support pharmacies in carrying out their services 5 HEALTHCARE DISTRIBUTION IN DATA THE 5 CORE FUNCTIONS OF HEALTHCARE DISTRIBUTORS

1. FULL SUPPLY AND 2. IMMEDIATE MEDICINES STOCK-KEEPING FUNCTION AVAILABILITY AND DELIVERY FUNCTION FULL SUPPLY AND STOCK-KEEPING FUNCTION Ensures that the needs of the pharmacists and of the IMMEDIATE DELIVERY OF MEDICINES patients are met, by guaranteeing the continuous availability • Healthcare distributors guarantee efficacious patient of a complete assortment of products, in range and depth as treatments by delivering the needed medicinal set by the authorities and the market. products in the required quantity and just-in-time. • Healthcare distributors protect the healthcare sector FACTS AND FIGURES from high additional costs that would be caused by Items on stock held by healthcare distributors: 18,650 – delays in delivering urgently needed medicine. 100,000 (depending on the size of the market and the number of products authorised to be marketed). WHY IS THE IMMEDIATE AVAILABILITY Healthcare distributors deliver the required amount of VITAL? medicinal products by: • In Europe, non-adherence to medicines and • Having established close-knit distribution networks and medication plans costs governments an estimated high delivery frequencies of their warehouses ¤ 125 billion and contributes to the premature deaths • Holding safety stock to meet unexpected peaks in normal of nearly 200,000 Europeans a year 1. If medicines demand patterns are not available when and where needed, patients are unable to start or continue their treatment. INVENTORY TURNOVER DIFFERS FROM 1 Source: EFPIA PRODUCT TO PRODUCT, RANGING FROM A MONTH TO ONLY A FEW DAYS DELIVERY TIME & FREQUENCY • Countries’ average: 27 days, which means stock turnover takes place on average 13 times a year Pharmaceutical Short-line Direct sales from full-wholesalers wholesalers manufactureres 36

30 30 Average 25,2 26,99 delivery 2.5 hrs 20.5 hrs 57.86 hrs 21 21 frequency (hours)

Average deliveries 15.9 4.34 3.66 per week

DE IT ES FR UK NL Inventory turnover Average Weighted average in DE, ES, FR, IT, NL, UK 3. BUNDLING FUNCTION: POOLING OF PRODUCTS AND TRANSACTIONS

SAVING COSTS FOR CUSTOMERS Direct orders from the manufacturers • Pharmaceutical full-line wholesalers are pooling on average products of 18.8 manufacturers per delivery. • The cost difference between a delivery from a single manufacturer compared to a delivery from a Manufacturer Manufacturer Manufacturer Manufacturer pharmaceutical full-line wholesaler is ¤ 3.87. • The bundling of products from 18.8 manufacturers in one delivery through a wholesaler saves ¤ 234.84 in order management cost for a pharmacy.

Order from a full-line wholesaler Pharmacy Pharmacy Pharmacy Pharmacy Pharmacy Pharmacy

TOTAL COSTS: ¤ 243.84 ¤ 250,00 Manufacturer Manufacturer Manufacturer Manufacturer

¤ 36,28 Full-line wholesaler ¤ 10,34 ¤ 200,00

Pharmacy Pharmacy Pharmacy Pharmacy Pharmacy Pharmacy

¤ 150,00

TOTAL COSTS: ¤ 9.10 ¤ 10,00 Determination ¤ 9,00 of order demand ¤ 166,00 ¤ 8,00 ¤ 100,00 ¤ 2,48 ¤ 7,00 Transmission of order ¤ 6,00 ¤ 0,83 ¤ 5,00

¤ 4,00 ¤ 50,00 ¤ 4,69 Receiving and storaging ¤ 3,00 of delivery ¤ 2,00 ¤ 1,00 ¤ 31,21 ¤ 1,10 ¤ 0,00 Checking the delivery note ¤ 0,00 and bill Order from pharmaceutical Order direct from full-line wholesaler manufacturers (x18.8)

GIRP • Annual Report 2018 - 2019 7 4. QUALITY ASSURANCE FUNCTION

Healthcare distributors’ quality assurance systems 5. FINANCING FUNCTION ensure that: • Medicinal products are procured, held, supplied or • Healthcare distributors are the only ones to assume a exported in a way that is compliant with the requirements financing function towards manufacturers and pharmacies. of GDP (2013/C 343/01) • Healthcare distributors guarantee the continuous supply • Management responsibilities are clearly specified of all medicinal products and also secure the cash flow of the social insurers. • Products are delivered to the right recipients within a satisfactory time period • The financing function can be expressed in terms of working capital. • Records are made and kept contemporaneously • Healthcare distributors finance on average ¤ 11.8 bn • All personnel involved in wholesale distribution activities over a period of 47 days. In total, this sum is financed is continuously trained and deviations from established approximately 7.8 times per year, and represents a total procedures are documented and investigated annual volume of ¤ 92 bn. • Appropriate corrective and preventive actions (commonly known as CAPA) are taken to correct deviations and prevent them in line with the principles of quality risk management. • Since February 9th, 2019 and the implementation of the Falsified Medicines Directive and its Delegated Regulation, MANUFAC- WHOLE- PHARMACIES healthcare distributors also have complied to further TURERS SALERS protect the supply chain from entry of falsified medicines. Wholesaler Payment by Actual receipt purchase from wholesaler of payment manufacturer

Expected receipt Order- of payment delivery to from social pharmacies insurance Receipt and billing funds

WORKING CAPITAL = ¤11.8 BN FOR 47 DAYS

PRE-FINANCING BY PRE-FINANCING BY MANUFACTURER WHOLESALER IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new THE HEALTHCARE DISTRIBUTOR: approaches to clinical development and A CRITICAL PARTNER IN THE SUPPLY CHAIN commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, CHANNELS IQVIA delivers unique and actionable OF DISTRIBUTION insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With more than 58,000 employees, IQVIA conducts operations in more than 100 countries. MANUFACTURERS IQVIA is a global leader in protecting individual patient privacy. The company 61% uses a wide variety of privacy-enhancing 9% 30% technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise HEALTHCARE DISTRIBUTORS treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, 55% 6% medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.

RETAIL PHARMACIES HOSPITALS To learn more, visit www.IQVIA.com

* IQVIA estimates 2018 GIRP • Annual Report 2018 - 2019 9 HEALTHCARE DISTRIBUTION A HIGHLY REGULATED SECTOR

As the vital link in healthcare, healthcare distributors ensure that the right medicine is delivered to the right patient at the right time in a safe and reliable manner. In order to do so, distributors adhere to the Good Distribution Practice (GDP) and many other INSIGHT HEALTH ENABLES DIGITAL legislative measures, which obligate them to ensure and maintain the quality and PLATFORM SOLUTIONS integrity of medicinal products from the warehouse to the patient. Complexity in the pharmaceutical supply chain is ever-increasing. While business HEALTHCARE DISTRIBUTORS ARE FACING AN needs for new individualised therapies INCREASINGLY COMPLEX AND HEAVY REGULATORY become more and more specific, the supply chain community faces BURDEN AT EU AND NATIONAL LEVEL additional price pressure for established products and new competition through e-commerce activities. A better workflow FALSIFIED MEDICINES MEDICAL DEVICES with customers and new and improved DIRECTIVE AND ITS AND IN-VITRO DIAGNOSTIC data to push new business opportunities DELEGATED REGULATION MEDICAL DEVICES is in everyone’s interest. • Significant investments in hardware REGULATIONS With our platform solutions for and software, business processes, • Costs in relation to new business merging and analysing data, INSIGHT increased costs connected with hiring process, sampling of products, Health enables stakeholders to make additional personnel, and staff training. traceability requirements, need to business options visible and implement • Fees for medicines verification invest in additional personnel and staff digitalisation strategies. We support systems. training. our clients in the pharmaceutical supply chain to work efficiently with big data • Investments associated with applications, push in-depth market burdensome batch tracking VETERINARY MEDICINES analysis and offer clients a data-based requirements (applicable since REGULATION platform solution. 9 February 2019). • Costs for adopting new business Our digital data platform creates in- process, new specific GDPs for depth market insights for wholesalers veterinarian products, additional as well as for pharmacies and facilitates personnel, and training. real time marketing approaches to better address patients – either in the EU LEGISLATIONS community pharmacy or online. ON ENVIRONMENT INSIGHT Health looks forward to • Healthcare distributors are involved in continue supporting GIRP and its different ways in each country in the members with our custom-made management of pharmaceutical waste. solutions on this digitalisation pathway. The topic is high on the agenda at EU level as part of the discussions around Pharmaceuticals in the Environment Further information can be found at: (PIE). www.insight-health.de

And even more happening or likely to happen in the coming period … AN EVER-EVOLVING ENVIRONMENT

1. DIGITISATION Supported by authorities globally and at the European level, digitisation in healthcare is having a great impact on the delivery and dispensing of treatments as well as on the collaboration between supply chain stakeholders. A major development is the implementation of e-prescriptions which will transform pharmacies’ structure and thus impact the healthcare distribution. CHALLENGES FOR HEALTHCARE DISTRIBUTORS Healthcare distributors, with their logistic, storage, transportation and communication services within the supply chain already fulfil high standards of digitalisation and continue investing transporting and storing specificities. It Austerity in more effective digital processes and also offers a wide range of opportunities and pressure data management. to offer patients the connected on margins interfaces to manage their health and wellbeing. 2. PERSONALISATION Polarisation - OF MEDICINE Changes increase in 3. ECONOMIC PRESSURES in the high-value Advancements in genomics and distribution medicines and precision medicine as well as the Converging pressures of an ageing channels low-priced explosion of connected sensors, population and the growing burden medicines wearables and mobile devices and of chronic diseases have come to their capture of biomarker data have constitute important challenges for the rendered personalised treatment sustainability of healthcare systems. and prevention the new trend. The More specifically, healthcare distributors New pricing biologics and biosimilar markets are have seen their activity impacted models becoming very competitive with great over the years by increasing product promises for patient care. We also see polarisation which sees the traditional an important rise in specialty medicine wholesale channels losing out to and innovative therapies to treat alternative models of distribution, with complex diseases while still focusing the effect of increasing healthcare costs on personalising to the needs of the related to medicines’ distribution overall, patients. This has consequently led the putting the sustainability of healthcare supply chain to manage a great deal of system further at risk and threatening complex products each with their own medicines access to citizens.

GIRP • Annual Report 2018 - 2019 11 ABOUT GIRP 33 European The premier platform reaching across Europe and beyond with expertise and experience for our partners’ excellence countries

750+ pharmaceutical wholesalers 1,260 warehouses

Safe and sufficient supply of over 100,000 products

15 bn packs of medicines/year 62 mio packs of medicines/day

From 3,500 manufacturers to

200,000 pharmacies & healthcare professionals across Europe

GIRP represents 140,000 2.5h* 35 18.8 Average Different Different employees delivery products manufacturers time per delivery per delivery

GIRP members are trusted supply chain partners Quality, integrity, excellence the vital link in healthcare

* Average number from DE, ES, FR, IT, NL, UK GIRP IN ACTION 7 Answers to consultations BD Rowa™ stands for innovative and reliable solutions related to drug logistics. As a pioneer in automation and digitalization, the company develops and manufactures solutions for pharmacies, >65 hospitals, the pharmaceutical industry External events >20 and pouch packaging centers at its attended by headquarters in Kelberg (). presentations given GIRP staff BD Rowa has implemented more than >30 at conferences 8.000 automated solutions worldwide. Internal events held The focus is on holistic system integration within the framework of optimal business processes. When dealing with pharmaceutical distribution centers, BD Rowa focuses on automation of slow and medium movers, reintegration of returned pharmaceutical products into the distribution process, as >60 well as automated picking of narcotics >830 and cold storage goods. BD Rowa is >75 Participants Number of External at GIRP events newsletters sent specialized in identification, inventory management and dispensing of single meetings pharmaceutical products and facilitates to comply with the GDP guidelines. We are working together with strong partners, like SSI Schäfer, ensuring your competitive advantage through innovation and high performance.

Worldwide, 800 employees are committed to the competent and reliable >90 customer care. BD Rowa is part of the FMD related meetings global medical device company Becton 967 Dickinson (BD), with whom we share a Twitter followers vision for advancing the world of health.

For further information, please check: www.rowa.de/en/pharmacist

GIRP • Annual Report 2018 - 2019 13 GIRP KEY PRIORITIES AND UPCOMING EVENTS

In view of the upcoming European Parliament elections, GIRP has designed a manifesto outlining the key policy recommendations 1996-2016, 20 years of creating defined as priorities for our sector. packaging solutions. CAPPI first started out in the design and manufacturing of plastic shipping totes dedicated GIRP MANIFESTO EUROPEAN ELECTIONS 2019 to pharmaceutical wholesalers. Driven by innovation, CAPPI invests in the development and testing of customized packaging for the transport Ensure the Improving Recognise cost of safety and Improve Ensure the Incentivise of temperature-controlled products the role and regulation does reliability and medicines sustainability healthcare year-on-year. A leading company in function of not cripple removing availability and of healthcare distribution the French market, CAPPI continues its healthcare the healthcare inequity from help reduce systems digitalisation international growth in three strategic distributors distribution the supply shortages markets: pharmaceutical manufacturers, sector chain pharmaceutical wholesalers and the food industry.

CAPPI meets demands from all across the pharmaceutical supply chain, from GIRP UPCOMING EVENTS manufacturer to wholesaler and from wholesaler to pharmacy. Our range of plastic shipping totes for pharmaceutical wholesalers are designed and tested to 26 May 2019 EUROPEAN HEALTH POLICY BRIEFING & GENERAL integrate automated order preparation Stockholm, SE ASSEMBLY processes. Equipped with a qualified, 27–28 May 2019 isothermal protection inlay to respect 60TH ANNUAL MEETING AND CONFERENCE any temperature range during transport: Stockholm, SE guaranteed to satisfy all mechanical and thermal needs. 12 November 2019 EUROPEAN HEALTH POLICY BRIEFING & GENERAL Brussels, BE ASSEMBLY Learn more at: www.cappi.fr 13 November 2019 AUTUMN CONFERENCE Brussels, BE

16 January 2020 EUROPEAN HEALTHCARE VALUE CHAIN FORUM Brussels, BE

12-13 March 2020 5TH SUPPLY CHAIN CONFERENCE Vienna, AT

24 May 2020 EUROPEAN HEALTH POLICY BRIEFING & GENERAL Berlin, DE ASSEMBLY

25-26 May 2020 61ST ANNUAL MEETING AND CONFERENCE Berlin, DE YEAR IN REVIEW

1. 27-29 May 2018 3. 14 September 2018 7. 9 February 2019

GIRP REGIONAL MEETING

4. 8 November 2018

GIRP AUTUMN MEETINGS FMD IMPLEMENTATION DATE “FALSIFIED MEDICINES DIRECTIVE: GIRP 59TH ANNUAL MEETING THE FINAL COUNTDOWN” Over the years, healthcare distributors across AND CONFERENCE Europe have been committed to prepare for the implementation and have achieved a high “ENTREPRENEURSHIP IN HEALTHCARE: level of readiness for FMD compliance when POWERING INNOVATION” 5. 30 January 2019 the deadline hit on February 9th, 2019. GIRP is proud of its involvement in this first GIRP held its 59th Annual Meeting and EUROPEAN HEALTHCARE VALUE CHAIN of its kind stakeholder-driven initiative for Conference in Dublin, Ireland, where expert FORUM patient safety. On February 8th, 2019, GIRP speakers exchanged views on innovation took part in the EMVO press conference. as the key factor driving change and “CREATING VALUE BEYOND THE PILL transformation in the pharmaceutical value – A STAKEHOLDER ENDEAVOUR” chain. Across the two-day conference, 28-29 March 2019 artificial intelligence, big data analytics, sensor 8. technology were described as “valuable 1 February 2019 entrepreneurial opportunities benefitting both 6. patient care and delivery processes”.

2. 5 September 2018

4th SUPPLY CHAIN CONFERENCE, CANNES, “PHARMA DISTRIBUTION 4.0 – TOGETHER TRANSFORMING DELIVERY”

Building on the observations and exchange GIRP LAUNCHES WEBINAR PROGRAMME from the previous editions, the GIRP MEETING WITH Educational Academy Supply Chain GIRP held its very first webinar on ‘Updated conference, “Pharma Distribution 4.0 – COMMISSION VICE-PRESIDENT guideline to EU-FMD Compliance’ where JYRKI KATAINEN together transforming delivery” brought members got to clarify on the last steps forward the latest innovative solutions for of the implementation before the deadline Meeting with Mr Jyrki Katainen, European managing temperature-sensitive transportation was reached. The webinar was held in and transformative technologies for pharma Commission Vice-President for Jobs, Growth, collaboration with our partner Excellis Europe. Investment and Competitiveness, in an effort distribution. Our audience got the chance to A subsequent webinar was organised on discuss on transforming B2B Supply Chain to promote the role of healthcare distributors 25 April 2019 to offer insights to our members and share with him the challenges faced in operations using new technology models on compliance to the General Data Protection and blockchain-enabled solutions for stability having free movement of medicines across Regulation. Europe to ensure safe and equal access to budget tracking of medicinal products. treatments for all European citizens. GIRP • Annual Report 2018 - 2019 15 59TH ANNUAL MEETING AND CONFERENCE, DUBLIN, IRELAND “ENTREPRENEURSHIP IN HEALTHCARE: POWERING INNOVATION”

From 27th – 29th May 2018, the GIRP to smarter and more efficient R&D, 59th Annual Meeting and Conference improve access to personalised patient saw 14 sessions exploring innovative care, make our supply chain evolve and solutions and business models to better inform regulatory decisions. reinforce the healthcare distributors’ position as the crucial element in Under the title “Global insight in the the healthcare supply chain in the healthcare world”, a panel, composed face of current challenges and this in of top-level executives from both close partnership with stakeholders. the pharmaceutical industry and Executives across the value chain dug the healthcare distribution sector into their experience and expertise provided the audience with a to bring different perspectives on presentation of the current market how to build efficient and resilient as well as the overarching trends and healthcare systems and on the power “We, at GIRP, firmly believe in the developments in the European and of a solid cooperation to improve power of collaboration to delve international healthcare distribution outcomes. Our panellists offered case healthcare value chain levers and and services sector at present and in studies and best-in-class operating put them into motion. We believe the foreseeable future. practices to support their input. that a strong relationship through and throughout the supply chain Speakers on stage showcased how contributes to building efficient and pharmaceutical distributors have been resilient healthcare systems. A stable extending their value proposition and collaboration will at the same time how informed stakeholders and close add significantly to the knowledge- collaboration is key in today’s market. based economy. In turn, this will favour innovation and bring forth better adapted solutions to healthcare globally.” René Jenny, GIRP President

Giving a truly inspiring introduction to our two-day conference, Dr. Severin Schwan, the CEO of Roche shared his vision for a fully digital healthcare in Europe. He brought a precise vision, complemented by successive panels, of how new technologies, Artificial Intelligence and Big Data can lead us GIRP REGIONAL MEETING, SOFIA, BULGARIA TEMPERATURE-CONTROLLED SOLUTIONS TO MAINTAIN THE QUALITY AND INTEGRITY OF MEDICAL PRODUCTS DURING TRANSPORT Every second year, GIRP organises a This meeting represents a great Regional Focus Meeting, welcoming opportunity to get insights on current The design and qualification of suitable experts of the sector from different facts and trends as well as future transport equipment to ensure that countries. challenges of the pharmaceutical the required storage conditions of healthcare distribution market. medicinal products are maintained, is The meeting traditionally In 2018, GIRP held its conference in Sofia, a critical requirement of the new Good concentrates on a specific Bulgaria on 14 September. Distributions Practice (GDP) guidelines. geographic area, and this year we decided to look at the Central and The conference was a resounding Thermo King PharmaSolutions offers a Eastern European markets, focusing success, welcoming experts from wide range of GDP qualified transport equipment to fit every stage of the on Bulgaria, Croatia, , across the region, and represented a distribution process, from trailers Hungary, , Slovakia and great opportunity to get closer to our transporting goods from manufacturing Slovenia. members in a designated region and to facilities to distribution centers, to gain first-hand insights on the evolution vans in the last mile distribution. Along of the sector. with initial temperature mapping, documentation of the four stages of qualification based on Good Manufacturing Practice (GMP) Annex 15, Thermo King offers strong expertise with a wide European service network of more than 1400 CERTI-TECH trained and certified technicians.

Thermo King, as the leading manufacturer of transport temperature control systems, helps you meet additional GDP requirements, by providing GAMP5 validated real-time temperature monitoring, preventative maintenance, easy access to service and calibration activities on transport equipment and monitoring devices, 24/7 assistance as well as training.

For further information, please visit www.thermoking.com.

GIRP • Annual Report 2018 - 2019 1717 GIRP AUTUMN MEETINGS, BRUSSELS, BELGIUM “FALSIFIED MEDICINES DIRECTIVE: THE FINAL COUNTDOWN”

Every year, GIRP organises the Autumn Conference in Brussels for its members, including GIRP’s partners in the healthcare value chain from across Europe. Sensitech Inc. is focused on delivering supply chain visibility solutions that The conference aimed at: track, monitor and protect products for • updating and informing GIRP members about new developments in the pharmaceutical global leaders in the food, life sciences, distribution sector; consumer goods, and industrial markets. • offering the opportunity to participants to expand their networks, share ideas and engage in discussions with colleagues and peers; Our solutions are focused in three key • identifying opportunities for collaboration in the supply chain. areas: quality and compliance, supply chain security, and logistics performance management. Quality and compliance In 2018, GIRP held its Autumn Conference on Thursday 8 November on the topic of solutions address temperature-sensitive, “Falsified Medicines Directive – The Final Countdown”. complex supply chains focused on delivering the highest quality possible, while our supply chain security solutions In the final stretch ahead of the help to mitigate risks associated with operational phase, GIRP had convened theft, diversion and chain of custody. a strong array of panellists from Sensitech’s logistics performance stakeholders to European institutions solutions deliver origin-to-destination, representatives to cover all last real-time transparency to any in-transit segments of the matter, from the master journey. data and designated wholesalers to For more than 25 years we have helped article 23 actors and from the status of our customers to deliver higher quality the technical onboarding to vaccines products, ensure patient safety, comply decommissioning. with regulatory requirements, protect brand equity, and increase profitability. GIRP members from across the supply To find out more, please visit: chain and across Europe joined the event www.sensitech.com and seized the opportunity to share their concerns and challenges encountered in the last steps towards implementation.

Mr Andrzej Rys, Director for Health Systems and Products at the European Commission DG SANTE, joined the meeting and addressed the GIRP audience. He encouraged all stakeholders to “keep going together for the last 90 days and keep informing each other about challenges!” EUROPEAN HEALTHCARE VALUE CHAIN FORUM, BRUSSELS, BELGIUM “CREATING VALUE BEYOND THE PILL – A STAKEHOLDER ENDEAVOUR”

Movilitas is a long-term trusted partner specializing in SAP Solutions for small, medium and large companies with deep expertise in the field of digital manufacturing, traceability, warehouse logistics, custom mobility solutions, and also provides a SaaS for FMF, traceability and warehouse operations known as Movilitas.Cloud (www.movilitas.cloud). In our core areas, we are a global leader with a long record of proven success and an exceptionally close relationship to SAP for many years.

th On 30 January, members and friends of the With the patient in focus, the forum It is one of our daily paradigms to European Healthcare Value Chain Network met this year looked at technology provide constantly new innovative for their annual forum and networking reception in trends impacting the supply chain approaches and solutions in our core Brussels, Belgium. and best practice examples of and related areas. Paired with our deep The European Healthcare Value Chain Forum is strategic partnerships amongst expertise and our enthusiastic and part of the network’s recent rebranding process, supply chain actors. “With a joint dedicated employees, this motivation which aims to create an independent joint platform value approach, we can build enables us to build the foundation for exchange between supply chain stakeholders. long lasting partnerships in the for Industry 4.0 and the Internet of The forum serves as a dedicated yearly event to supply chain. This will create Things to help you outperform your bring high-level representatives from healthcare triple-win situations: for suppliers, competitors. We deliver you the digital distributors, the pharmaceutical industry and distributors, and, of course, our enterprise of the future by providing pioneering innovation. pharmacists together to exchange ideas and patients”, Stefan Jung, Head of share views on how to “create value beyond the Corporate Pharma Services & For more information, please visit: pill”, discussing new business models and ways to Sourcing at PHOENIX Group told www.movilitas.com achieve better connectivity in the supply chain. the audience.

Wolfgang Mähr, Head of Supervisory Board, Alliance Healthcare Deutschland shared his insights on technology trends and big data as opportunities for supply chain cooperation in healthcare logistics. “With patient value at the centre of our collaboration, big data has the ability to remove silos between all actors in the supply chain - by supporting and adding value to product flow, cash flow and information flow processes. We need to build partnerships and ask the right questions to turn Big Data into value”, he emphasised.

GIRP • Annual Report 2018 - 2019 19 4TH SUPPLY CHAIN CONFERENCE, CANNES, FRANCE “PHARMA DISTRIBUTION 4.0 – TOGETHER TRANSFORMING DELIVERY”

SSI FLEXI SHUTTLE – Under the umbrella of the GIRP Educational Academy, GIRP’s Supply Chain Conference took NOMINATED FOR BEST INDUSTRIAL place on 28 and 29 March 2019, where for the fourth consecutive time a record number of 120 PRODUCT delegates and speakers gathered to exchange and network at the seaside in Cannes, France, on topics such as the latest innovations for temperature control during last mile distribution, High-value products require logistics latest technologies in supply chain automation and the status of FMD implementation. solutions that guarantee safe handling and adapt to new types of packaging. Titled “Pharma distribution 4.0 – Drugs from various temperature areas together transforming delivery” the or fragile cosmetics in high-quality conference’s overarching theme this packaging – SSI Schaefer achieves a significant increase in performance year was how actors in the supply chain with maximum process security. The can harness opportunities from latest single-level shuttle SSI Flexi convinces supply chain innovations and data driven with intelligent functional variety and technologies. Building stronger networks maximum modularity – also within and connecting supply chain operators deep-freeze environments. is one of the key demands in creating more efficient and effective supply chain The rack concept with dynamically operations. adaptable storage location sizes, no assigned x-storage positions and tailored scalability of lifts and shuttles provide a maximum storage density and highest throughput. SSI Flexi combines sustainable technical components with aesthetic aspects, since the product design won the German Design Award 2019 in the category industry. Thus, the innovation driver complies with one of the basic criteria for the Best of Industry Award for which SSI Schaefer is nominated in the category “Material Flow”. The nomination for the award as best of the best industrial Presenting as part of a high-level Another highlight of the conference was once products is a high appreciation for the panel on blockchain technology for the again the discussion with our European GMDP intralogistics expert’s sustainable system healthcare supply chain, Mr. Brian inspectors, who joined the event this year from development. Thornley, VP Supply Chain at MSD Austria, Belgium, Ireland, the , , Europe, called for “a culture of and the . While the conference collaboration with wholesalers, participants were able to share ideas and ask distributors and suppliers beyond their most pressing questions, inspectors and compliance and operational efficiencies” regulators welcomed the practical insights from that would “enable new business models, stakeholders. “It was […] a good opportunity to greater automation and connectivity learn what is actually happening on the ground, across networks for a more safe and which is invaluable at this stage of implementation sustainable supply chain with a focus on of the safety features”, Isabel Holmquist from the patients”. European Commission explained. EUROPEAN HEALTHCARE VALUE CHAIN NETWORK THE EUROPEAN HEALTHCARE VALUE CHAIN NETWORK

The European Healthcare complex and dynamic chainAreas that has of collaborationFOCUS OF JOINT MEETINGS so far Value Chain Network dedicates patients’ wellbeing at their very core. AND EVENTS IN 2018 itself to a new way of thinking about healthcare: the patient- Members of the Healthcare Value centred approach. It considers Chain Network understand that GUIDANCE ON HANDLING ROOM TEMPERATURE ON that all medical care should collaboration in the healthcare MEDICAL PRODUCTS respect individual patient needs, sector has never been as important preferences and values and focuses as today. Increased collaboration PHARMACEUTICAL on outcomes of treatments rather brings new opportunities, WASTE MANAGEMENT than inputs. sustainability and new business DEVELOPMENT models and can help deliver OF A COMMONLY AGREED The provision of medicines is a meaningful solutions catering a SERVICE LEVEL crucial component in providing patient-focused approach and DEFINITION efficient patient-centric care. better outcomes in care. Ensuring that patients receive the SHARING BEST right treatment at the right time, As a platform for exchange, the PRACTICE requires a complex and carefully Healthcare Value Chain Network EXAMPLES ON THEorganised EUROPEAN chain of products and HEALTHCAREaims to facilitate the sharing of VALUE CHAIN NETWORKSHORTAGES MITIGATION services. As such, stakeholders in information, expertise and solutions SITE VISITS the pharmaceutical supply chain in the pharmaceutical supply chain TO WHOLESALING Trends,(pharmaceutical specialty,challenges branded and provides and the right environmentopportunities FACILITIES of the future and generic industries, healthcare for trust building and creating DEVELOPING STANDARDS distributors and healthcare lasting relationships amongst value FOR MORE EFFECTIVE EDI providers) are bound into a chain stakeholders.

FUTURE AREAS OF COLLABORATION and the European Healthcare Value Chain Network COLLABORATING 3 BIOSIMILAR & SPECIALTY 1 IN OTC DISTRIBUTION DISTRIBUTION 5

VALUE-ADDED LEVERAGING NEW OPTIMISTIC SERVICES 2 TECHNOLOGIES 4 REQUIREMENTS FOR TENDERS • Blockchain • eHealth • AI • eCommerce • Big Data • eLabelling GIRP • Annual Report 2018 - 2019 21

and the European Healthcare Value Chain Network GIRP AND THE FALSIFIED MEDICINES DIRECTIVE

On Saturday 9 February 2019, the major deadline set by the EU Delegated Regulation (DR) on Safety Features to Excellis is a global leader in strategy and the Falsified Medicines Directive (FMD), implementation consulting services with was reached. A Europe-wide process to a focus on value creation throughout the verify medicines, based on the European Life Sciences and Healthcare industries Medicines Verifications System (EMVS) supply chain. and the Point-of-Dispense (PoD) process We are proud to have helped hundreds of went live across Europe. manufacturers, CMOs, 3PLs, wholesalers, retail pharmacies and hospitals to establish EMVS KEY NUMBERS strategies and deliver their readiness to 1. 9 February 2019 – implementation achieve their business goals, from strategy deadline and start of the Operational to sustainability. Phase. With more than 130 employees within a 2. 28 European countries are In the course of last year, GIRP has been world wide structure and a Pan- European participating in the EMVS. These working closely with its members for a team, Excellis can rely on its experts, a 28 countries are all in the European smooth and timely implementation of proven methodology and wide range of Economic Area (EEA) (Italy and the Falsified Medicines Directive and best-in-class use cases to deliver value and Greece will make use of a longer its Delegated Regulation. We are glad success for our customers. implementation period, to confirm that healthcare distributors has a special status). We specialise in supply chain solutions across Europe achieved a high level for serialization, track & trace and 3. More than 6,000 wholesale of readiness for compliance with the brand protection (anti-counterfeiting/ distribution authorisation holders will Falsified Medicines Directive and its diversion); we are also providing ERP, be connected to the EMVS. Delegated Regulation. QMS, WMS, master data integrity and validation services and bring the industry’s best SMEs, validation resources, project managers and technical consultants to OBLIGATIONS OF deliver excellence for our customers. HEALTHCARE DISTRIBUTORS Excellis has an established thought leadership position through working with EFPIA, EMVO, GS1 Healthcare, GIRP RETURNS and the HDA, allowing us to offer unique insights into the wider serialization and traceability landscape world-wide.

We are able to leverage a strong partner network through the European pharma Pharmaceutical Pharmacy/Person Ecosystem and beyond, while remaining Manufacturer authorised to agnostic in our approach to vendors and supply medicines their solutions. to the public

Contact us at Deliveries Required by [email protected] from other Delegated Regulation wholesalers On November 2018, GIRP and Excellis GIRP also launched a new website, impacting the wholesale distribution of Europe released a guidance document “The Supply Chain and Medicines prescription medicines. to support wholesalers, and other Verification”, dedicated to the main On 1 February, GIRP and Excellis Europe logistical service providers in the supply issues faced by distributors. The website held a webinar on ‘Updated guideline to chain to ensure a safe and efficient provides background information to EU-FMD Compliance’ where members implementation of the new regulation. wholesale distributors and other logistical had the occasion to clarify remaining service providers in the supply chain on issues during the last steps of the The document provides background for what to expect from suppliers and how implementation before the deadline was the reader to understand the basics of to meet the regulatory requirements as reached. this important regulation impacting the packaging and transactions associated with the movement of prescription medicines in this supply chain.

The 9 February 2019 marked the start “Healthcare distributors have their EMVO (European Medicines Verification of the so-called Operational Phase. essential role to play to keep falsified Despite the achievements reached Organisation) proved to be a unique medicines out of the legal supply across all EU countries so far, much collaboration between supply chain remains to be done to ensure a smooth chain by verifying all medicines stakeholders comprised of EU medicine functioning of the system. In this phase, they do not receive directly from manufacturers, parallel distributors, patient health and safety as well as manufacturers, MAHs and their healthcare distributors, pharmacists, hospitals and hospital pharmacists. GIRP the continuous supply of medicines logistics providers. They also verify remain of the utmost importance to all has been working closely with its partners all returned medicines to avoid stakeholders, who continue to closely across the supply chain to deliver an work together in these first months after infiltration by backwards logistics.” operational system in time. the implementation deadline to face the Monika Derecque-Pois, GIRP Director General remaining challenges. 8 February 2019

GIRP • Annual Report 2018 - 2019 23 ABOUT GIRP

GIRP, the European Healthcare Distribution THE GIRP TEAM Association, is the umbrella organisation for pharmaceutical full-line wholesalers and distributors of healthcare products and services in Europe. It represents the national associations of over 750 pharmaceutical wholesalers serving 33 European countries, as well as major international and pan-European healthcare distribution companies. GIRP members employ over 140,000 people and distribute around 15 billion packs of medicines as well as a wide range of healthcare products per year. As the vital link in healthcare, they Monika Derecque-Pois Martin FitzGerald are committed to developing and providing Director General Deputy innovative and efficient healthcare products Director General and services to improve health and wellbeing of patients across Europe.

GIRP offers its members individual as well as collective support services and assistance affecting on a daily basis the business of pharmaceutical full-line wholesaling. GIRP works with national association and company members through the provision of advice, information, statistics and other data. The aim is to provide tailor-made services to match members’ unique needs, priorities and challenges. Giulia Colombo Andreia Dos Santos Regulatory Affairs Communications and Manager Event Manager GIRP firmly believes that rigorous and continuous cooperation at all levels of the healthcare supply chain is key to the safe and efficient distribution of medicines from the manufacturer through to the patient.

Pauline Foucher Judith Kalina External Affairs Corporate Affairs Manager Manager Mr Robert W. Andersson Mr Kevin Kettler GIRP BOARD President and CEO, Chairman of the ORIOLA Managing Board, McKesson Europe

Mr Olivier Brochain Ms Mari Krass Mr René Jenny General Director, Member of the Board, GIRP President SECOF Magnum

Mr David Cole Mr Rui Carrington Dr. Michael Kuck GIRP Vice-President Member of the Board, CEO, European Affairs ADIFA NOWEDA Director, HDA UK

Dr. Roger Sorel Mr Wolfgang Mähr Mr Emmanuel Déchin GIRP Vice-President Head of Supervisory Secretary General, Member of the Board, Board, CSRP BG Pharma Alliance Healthcare DE

Mr Carlos Varela Sanchez Caballero Mr Mauro Giombini Mr Miguel Valdés GIRP Vice-President President, Director General, Member of Governing ADF FEDIFAR Council, COFARES

Mr Oliver Windholz Mr Bernd Grabner Mr Eric Van Nueten GIRP Vice-President Vice-President, Member of the Board, CEO, PHOENIX Group PHAGO NVGV-ANGR

Mr Lothar Jenne Dr. Thomas Trümper Managing Director, GIRP Treasurer Max Jenne Arzneimittel President, PHAGRO Grosshandlung KG (Pharma Privat)

GIRP • Annual Report 2018 - 2019 25 GIRP MEMBERS

PHAGO Verband der Österreichischen AUSTRIA LAPW Lithuanian Association of Pharmaceutical Wholesalers Arzneimittelvollgroßhändler

NVGV – ANGR Association Nationale des Grossistes- Répartiteurs BELGIUM LUXEMBOURG HANFF - Global Health Solutions en Spécialités Pharmaceutiques

BULGARIA BATEL Bulgarian Association of Pharmaceutical Wholesalers NETHERLANDS BG Pharma

CROATIA PHOENIX Farmacija, Medika, Oktal Pharma, Medical Intertrade NAPW Norwegian Association of Pharmaceutical Wholesalers

CZECH AVEL Asociace velkodistributorû léčiv / Czech Association of POLAND Pelion REPUBLIC Full-line Wholesalers

MEGROS Foreningen af medecingrossister / Danish Association DENMARK ADIFA Associação de Distribuidores Farmacêuticos of Pharmaceutical Wholesalers PORTUGAL GROQUIFAR Associação de Grossistas de Produtos Químicos e Farmacêuticos ESTONIA ERHL Estonian Association of Pharmaceutical Wholesalers ADRFR Asociatia Distribuitorilor si Retailerilor Farmaceutici din ROMANIA Romania FINLAND Tamro Finland Serbian Chamber of Commerce - Group of Pharmaceutical SERBIA Wholesalers FRANCE CSRP Chambre Syndicale de la Répartition Pharmaceutique TZS Slovenian Chamber of Commerce, Pharmaceutical Full–line SLOVENIA Wholesalers GERMANY PHAGRO Bundesverband des pharmazeutischen Grosshandels AVEL Asociácia veľkodistribútorov liekov/ Association of SLOVAKIA PAPW Panhellenic Association of Pharmaceutical Wholesalers Medicines Distributors GREECE and Qualified Pharmacists FEDIFAR Federación Nacional de Asociaciones de Mayoristas SPAIN Distribuidores de Especialidades Farmacéuticas y Productos HUNGARY HAPW Hungarian Association of Pharmaceutical Wholesalers Parafarmacéuticas

LDF Läkemedelsdistributörsföreningen / Swedish Association of ICELAND Distica SWEDEN Pharmaceutical Wholesalers

IRELAND PDF Pharmaceutical Distributors Federation SWITZERLAND Pharmalog.ch Swiss pharma logistics association

UNITED HDA UK Healthcare Distribution Association ITALY ADF Associazione Distributori Farmaceutici KINGDOM

LATVIA LZLA Latvian Association of Pharmaceutical Wholesalers FULL MEMBER ASSOCIATED HEALTHCARE GIRP COMPANIES MEMBERS VALUE CHAIN NETWORK SPONSORS

OFFICE DES PHARMACIES COOPERATIVES DE BELGIQUE VERENIGING DER COÖPERATIEVE APOTHEKEN VAN BELGIE

GIRP • Annual Report 2018 - 2019 27 European Healthcare Distribution Association Groupement International de la Répartition Pharmaceutique

Rue de la Loi, 26 10th floor Box 14 1040 Brussels Belgium

Tel: +32 2 777 99 77 Fax: +32 2 770 36 01 Email: [email protected] W: www.girp.eu

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