The Journey

Transcription

1 The Journey Dr. Tikesh Ramtohul Interim Head of PHOENIX Corporate Serialization Implementation 6 th October th Symposium of the Medicines and Medical Devices Agency, SERBIA

2 EU FMD Go- Live:9 th Feb 2019 ONLY 125 DAYS LEFT UNTIL EU FMD GO-LIVE 2

3 Agenda PHOENIX Overview FMD Overview FMD Impact within PHOENIX The FMD Journey: Part 1 The FMD Journey: Part 2 The FMD Journey: Part 3 Lessons Learned 3

4 PHOENIX group in figures Key figures for fiscal year 2017/18 Total operating performance 31.5 in billion Revenue 24.9 in billion EBITDA in million TOP 10 family business 31.7 % More than 36, TOP 100 company Equity ratio Employees 1 Countries 1 As of 31/01/ As of 31/07/2018 following acquisition in Romania 4

5 Integrated healthcare provider: link between manufacturer and patient Pharmaceutical Industry Patient Healthcare Logistics Hospitals Wholesale Doctors Retail 5

6 PHOENIX Footprint PHOENIX Universe 27 countries ~120wholesale warehouses ~40 pre-wholesale warehouses ~2500 own pharmacies 6

7 Overview Delegated Regulation Falsified Medicines European Hub National System 1 - n Upload Data Product# Batch Expiry S/N Product Flow Pharmaceutical Manufacturer / Parallel Distributor 3PL / Designated Wholesaler risk-based verification by Wholesale distributors Verification upon Dispense to Patient Wholesaler Pharmacist Patient Safety features: unique identifier anti-tampering device The Falsified Medicines Directive (FMD) basic guidelines for medicines verification: Implementing an end-toend verification system for falsified medicines (Delegated Regulation) Implementation deadline: February

8 EU FMD: The Unique Identifier/Serial Number Data-Matrix code, developed to ISO-standards Key data elements: Product code (GTIN/NTIN/PPN) Randomised unique serial number Expiry date Batch number National health number (where necessary) Product #: Batch: A1C2E3G4I5 Expiry: S/N: 12345AZRQF Is required by Delegated Regulation 8

9 PHOENIX Group & FMD: The Challenge FMD impact on business segments GMP Activities 3PL Wholesaler Retail FMD impact on PHOENIX countries PHOENIX FMD compliance challenge FMD: 19 PHOENIX markets 9

10 PHOENIX Journey to FMD Compliance: Stakeholder Interaction/Engagement Publication of EU FMD Directive (2012) PHOENIX active in stakeholder discussions at EU level to set the basis for the Delegated Regulation Publication of Delegated Regulations (2016) PHOENIX active in stakeholder discussions at EU and national levels EFPIA/EMVO workshops in Brussels Close collaboration with GIRP NMVO discussions Engagement with the Industry (2017) F2F meetings with manufacturers Workshops/Roundtables with manufacturers Surveys/Questionnaires 10

11 PHOENIX Journey to FMD Compliance: Define FMD Roadmap & Strategy 2016 Q1-Q Q3-Q Preliminary FMD requirement gathering Impact assessment Business opportunities FinaliseFMD Roadmap & Strategy Central project team & project setup Firming up FMD requirements FinalisePHOENIX FMD Solution IT solution Scanning solution Contingency plan 11

12 PHOENIX Journey to FMD Compliance: Execute FMD Strategy Q Q2-Q Q Q Feb 2019: Go-Live Start Implementation PHOENIX Cloud Development Procurement of scanners ERP upgrades Monitor/Facilitate/Coordinate FMD Project Business FMD Playbook Quality SOP Manual Contract Addendum Template Country visits Communication material FMD solution ready and validated Staff Training Fine Tuning 12

13 Lessons Learned Engagement with other stakeholders Be proactive, reach out, share ideas. FMD is for the whole industry; work together to understand the requirements and develop a solution accordingly FMD Roadmap & Strategy: Start early, brainstorm with cross-departmental stakeholders Focus on compliance rather than looking at commercial aspects Treat it as a proper project Define a contingency plan FMD implementation: Do not underestimate the task at hand, especially for the 3PL business It is much more than an IT project Stay up-to-date, engage with national and EU organisations FMD Interpretation Be aware that the FMD EU Directive and its Delegated Regulations are subject to interpretation bias at country-level 13

14 We deliver health. PHOENIX Pharmahandel GmbH & Co KG Pfingstweidstraße Mannheim Each and every day. Across Europe. 14

15 PHOENIX Pharmahandel GmbH & Co KG Pfingstweidstraße Mannheim BACKUP SLIDES 15

16 PHOENIX 3PL/Pre-wholesale FMD IT Solution EU Hub NMVS DK NMVS CZ NMVS BG NMVS NL NMVS SK MAH1 FMD cloud PHOENIX FMD solution MAH2 FMD cloud MAHn ERP 3PL DK 3PL CZ 3PL BG 3PL NL 3PL SK 16

17 PHX WHOLESALE & 3PL FMD Solution: PHOENIX responsibility EU Hub NMVS PHX FMD solution PHX 3PL ERP FMD = PHOENIX responsibility o PHX Wholesale Solution; extended to 3PL business ophx 3PL takes over MAH s responsibility with regard to FMD: Performs physical scan of goods Verifies/decommissions/re-commissions goods in the National Medicines Verification System ono feedback to MAH envisaged opre-requisite: contractual agreement between parties & acceptance of service offer oadvantages: Ensures MAH compliance to FMD in February 2019 No additional interfacing required between the systems Lower implementation & maintenance costs 17

18 PHX 3PL FMD Alternative Solution: PHOENIX responsibility with immediate feedback to MAH NMVS PHX FMD solution PHX 3PL ERP Business channel MAHFMD cloud/repository FMD = PHOENIX responsibility with feedback o PHX 3PL takes over MAH s responsibility with regard to FMD: Performs physical scan of goods Verifies/decommissions/re-commissions goods in the National Medicines Verification System (NMVS), using PHX 3PL credentials o The decommissioning information is routed both to the MAH system and PHX 3PL. o Pre-requisite: contractual agreement between parties & acceptance of service offer; business channel setup between PHX 3PL and MAH o Advantages: Ensures MAH compliance to FMD in February 2019 Ensures PHX compliance to FMD vis-à-vis national competent authorities + ensures smooth operations 18

19 PHX 3PL FMD Alternative Solution: Shared Accountability MAH1 FMD cloud PHX FMD solution PHX 3PL ERP 1 EU Hub MAHn ERP PHX 3PL ERP n FMD = shared accountability ophx 3PL performs the physical scan on the goods ophx FMD Cloud is interfaced with MAH FMD solution MAH FMD solution verifies/decommissions/recommissions goods in the EU Hub MAH FMD solution sends NMVS response/feedback to PHX FMD Cloud (PHX pre-condition) o PHX 3PL continues normal operations opre-requisite: MAH FMD solution in place, contractual agreement between parties & acceptance of service offer oadvantages: Only one interface to PHX FMD Cloud for any number of PHX 3PL markets 19