Impressions Kaiseraugst A global view from the Pharmaceutical Industry Mathieu Aman F. Hoffmann-La Roche Ltd, Basel (Switzerland) SETRM2016 Rastreabilidade de Medicamento Sao Paulo, Jun 2016
Agenda Worldwide, the Pharma Industry is taking action What matters when implementing a Drug Traceability system Suggested path forward in Brazil 10 10 10 2
Agenda Worldwide, the Pharma Industry is taking action What matters when implementing a Drug Traceability system Suggested path forward in Brazil 10 10 10 3
Supply chain complexity and lack of control facilitate criminal activities, lead to medication error and ultimately harm patients and healthcare systems Criminal activities Re-imbursement fraud Inefficiencies Dispensing errors Lack of accountability / supply chain visibility Drug shortages / stock-outs Manufacturer Distribution Center Wholesaler Point of dispensing Patient Under MAH control Inefficient recall/return procedures Product Diversion Counterfeiting Outside MAH control 4
5 A sustainable regulatory trend, as supply chain integrity and patient safety are key concerns for the Healthcare community AND NOW With the courtesy of
Barcoding, Serialization and Traceability technologies can help to improve Healthcare to the benefit of Patients Healthcare Professionals Healthcare Systems Relying more on a system organized around modern principles of patient safety than on individual performance Fighting criminal activities Removing inefficiencies between trading partners Digitization of transactions 6
Today, Mass Serialization & Traceability is a reality across the globe And is continuing to mature Russia 2017 Ukraine Turkey 2010 EU 2019 Jordan 2018 USA 2017 Korea 2016 Algeria India China 2015 Taiwan 2018 Colombia Nigeria 2015 UAE Pakistan Philippines 2016 Brazil 2016 Egypt Saudi Arabia 2015 Draft or In preparation Published Argentina 2013 Singapore Market Response: There has been a rigorous international response to counterfeiting and supply chain integrity threats (in general) from governments, law enforcement agencies, healthcare organizations and pharmaceutical companies. 7
Early Adopter Experiences Very positive feedback and strong interest Turkey Combatted successfully re-imbursement fraud Supply Chain Visibility, including identification of re-export Argentina Roche reduced counterfeit related recall to 0 (4-7/year in previous years) Korea US Germany Successful collaboration with health authorities by shaping regulations and timelines Increased collaboration Industry Distributors to the benefit of the Healthcare Supply Chain Ongoing dialog with key Healthcare actors on product security, supply chain integrity and patient safety 8
Agenda Worldwide, the Pharma Industry is taking action What matters when implementing a Drug Traceability system Suggested path forward in Brazil 10 10 10 9
Scalability Strategic thinking & a long-term vision is required What are the trends/ commonalities? What do we think the future will bring us? Where do we want to be in 10 years from now? Vision + backward planning 2016 Maximize Biz. Value Vision ideal state Item level drug traceability is a standard by 2020 Assume 2D Barcoding enabling/accelerating e/m-health 3 2013 2 Ramp-Up 2010 1 Proof-of-concept EU VPD Korea SER TE Brazil T&T E-pedigree 2009 French Coding What we didn t want: «Classical» Incremental approach 10
Strategic thinking & a long-term vision What Roche s approach is from beginning A cross functional effort Ensure standardization, interoperability and integration Based on global standards Develop and implement an adaptable/scalable technical standard solution Co-develop and mature A constant mix of prototyping, conceptual design and operational implementation Work together with all stakeholders & Accept a Win-Win situation Associations, peers, trading partners, vendors Regulators, standard bodies, Health Authorities Patients Think BIG Start SMALL Scale FAST 11
Lessons learned Sticking to international standards is crucial, to ensure maximum interoperability GTIN + S/N + required variable data 2D DataMatrix ECC200 even the design of the product/shipping labels has to be adapted GTIN + S/N + required variable data Linear GS1 128 2D DataMatrix ECC200 SSCC Linear GS1 128 GS1: the Global standard in Healthcare now 12
Agenda Worldwide, the Pharma Industry is taking action What matters when implementing a Drug Traceability system Suggested path forward in Brazil 10 10 10 13
There is something in it for everybody Allowing for opportunities (for everybody) will ease implementation 1. PharmaCo 2. Payer/Insurer 3. Physician/hospital pharmacists 4. Patient 5. Authority More real world data / livestudies Easier personalized expiry date, recalls) (counterfeits, Less To reimbursement the fraud More benefit safety (counterfeits, Higher product safety of expiry date, Less counterfeits and fakes reimbursement Better (vendor-) managed recalls) Easier recalls and root-cause Less administrative work (e.g. inventory Safer application (e.g. analysis paperless reimbursement) Easier patient history adherence programs, online Higher supply chain integrity Less patient compliance monitoring coaching to support patient behavior) Reduce the inventories using entire issues (i.e. not taking Healthcare but Driving better diagnostics & system advanced analytics S&OP reimbursing drug) outcomes with transactional Better information (e.g. link WIP Better diagnostics & data with prescription, e-leaflet) Better understand usage treatment link improve Guidance for complex Faster reimbursement (e.g. pattern outcomes administration & automated) Innovative contracting (e.g. and e-leaflet/customer ultimately services claw backs) Less administrative work (e.g. Value based pricing paperless reimbursement) the Patient More effective adverse event reporting Higher safety (better recalls, less fakes) Better control over prescription/usage patterns Faster access to emerging markets improved safety improved time/response improved costs/earnings
What the Industry s approach should be What we should NOT do Not sure if, as an Industry, we can be successful in fighting against such a strong need for more Supply Chain integrity Instead, We should welcome Health Authorities efforts to secure drug supply chains Why? It is in the ultimate interest of our Patients We can contribute to make our Healthcare systems more secure and efficient A nice opportunity for Healthcare Innovation Digitization 15
Why the Industry wants to be part of the definition Top 30 companies invest 2 Billion USD in Mass Serialization* We have gained a lot of experience worldwide We want to leverage the investments & adhere to internationally recognized GS1 standards Because we have to comply without endangering our ability to supply while keeping a level of complexity which is still manageable We should jointly exploit opportunities beyond anticounterfeiting or traceability only e.g. Patient information, bedside scanning, e-leaflet, link to e- prescription More operational efficiency in drug dispensing process A win/win situation for all Healthcare actors * According to a Serialization benchmark 2015 performed by 4XScience 16
How we believe Brazilian Health Authorities can drive implementation of a traceability regulation to the next step Invite national stakeholders to open dialogue Clearly articulate the long-term expectations Provide clear positions as a reliable basis for planning Establish common principles as a basis for cooperation What needs to be DEFINED Standard Data Carrier * Standard Data Construct * Access to Data Reporting needs National database Implementation Timelines * Stick to the data carrier/construct standards you have defined so far 17
A joint work and shared effort between all stakeholders to increase patient safety r Installation for pack coding Repository system (National database) Installations for pack verification Manufacturers Stakeholder coalition Pharmacies / Wholesalers, respectively 18
The example of Turkey nicely illustrates the transformational effect mass serialization can trigger on Healthcare systems 2015+? What s next? E-leaflet? Adverse Event Reporting???? Figures & Facts today Number of drug types in İTS: 18 900 Number of drug unıts in İTS: 7 000 000 000 Number of daily operations in İTS: 45 000 000 Number of operations per second in İTS: 520 Response time of system: < 1 sec 2014 App for patient verification Patients Reach out to public 2013 E-prescription / e-invoicing All Health providers Onboard & Connect 2012 2011 2010 Tracking & Tracing / Chain of Custody Verification at dispensing + scanning based Re-imbursement Barcoding & Item Serialization Wholesalers Pharmacists Pharma Industry Onboard & Connect MoH builds infrastructure & Database Apply 2D Barcode / Technical features In scope 40 000 Stakeholders (Hospitals, Health Centers, Family Physician Centers, Pharmacies and Pharmacy Warehouses, Manufacturers, Importers, Reimbursement Institutions) Equivalent developments can be observed whenever a country decides to implement mass serialization 19
Healthcare engaged now in increased digitization A strong focus in hospitals, aiming for a higher process efficiency and patient safety Enabled by use of 2D-barcoding technology Development cannot be stopped Greatest risk is to be unprepared, hesitant and too timid to act advance shipping notification tracking & tracing Patient information B2B B2C e-prescription e-invoicing HCP interaction serial-nr. based adverse event reporting bed-side scanning e-leaflet
Ultimately it is our all s shared goal to ensure 5 Patient s Rights are secured RIGHT RIGHT RIGHT RIGHT RIGHT Patient Product Dose Time Channel And tomorrow 7 Patients s Rights With Barcoding, Mass serialization and Traceability Techniques. At sales unit level. RIGHT RELIABLE (e-) Information Supply Chain 21
Doing now what patients need next