EMVO FMD Workshop Brussels 13. December 2016

Transcription

1 EMVO FMD Workshop Brussels 13. December 2016 State of Play EMVS and connected Systems Markus Gerigk, Andreas Walter dd/mm/yyyy

2 Content Introduction Trust and Team Building Systems Implementation Conclusion 2

3 Two Phases for Progress Monitoring Step Year 01 Year 02 Year 03 Year 04 Year 05 Budget Provision Governance WS Initiative to seek Alignment Agreement between Stakeholders (MoU) Preparation of NMVO foundation Technical WS Requirement Specification Refinement of cost estimation Trust and Team Building Start of Stakeholder Group and Shared Document Stakeholder Group Complete URS NMVO Incorporated Sound Basis for Budget provision 3 IT provider selection Provider Contract Signed Steering Group within Board of Directors Systems Implementation A lot of IT Projects, running in parallel 4 NMVS implementation Implemented System 5 Testing and Qualification System Live 6 Hypercare and Ramp up Phase Plus /Minus half a Year All Users Connected 3

4 Systems Implementation Projects* NMVS Implementations (32) On Boarding Projects European HUB NMVS On Boarding (32) Manufacturer On Boarding (2500) On Boarding Projects NMVS Pharmacies Wholesalers Hospitals Other Dispensing Organizations (Healthcare Institutions, Self Dispensing Doctors etc.) *Without internal projects from Manufacturers, Pharmacies, Wholesalers, Hospitals and Others 4

5 Content Introduction Trust and Team Building Systems Implementation Conclusion 5

6 Reference Schedule Country Readiness Year Governance WS 1 Alignment 2 Memorandum of Understanding 3 NMVO Statutes 4 NMVO Incorporated Technical WS 1 Project Manager 2 Provider Contact Trust and Team Building Systems Implementation A lot of IT Projects, running in parallel Minimum Time for Project Execution Testing and Connect all Users 3 IT provider selected 4 Provider Contract signed 6

7 Elements of Blueprint Approach Main elements Full Stakeholder participation in NMVO Governance Technical operation by a limited number of IT providers Cost allocation based on Flat Fee model Implementation of national systems based on a common standard, i.e. compliance with URS Support for national stakeholders by EMVO during deployment process (to be paid for by national stakeholders) Management by EMVO on behalf of the respective national stakeholders 7

8 Executive Summary Blueprint Tendency Blueprint candidate Small Country Blueprint Blueprint open Standalone system No Information Non EU Countries

9 Executive Summary Country Readiness Early Adopter Main Stream Late Follower No Information 16 3 Non EU Countries

10 Program Progress 10 NMVOs founded, 2 Contracts Signed EMVO Observations Majority of Countries progress and aim for Provider Contract in 2016 or Q To be improved 2/3 of Countries are late followers Still 5 Countries to start Technical Work Stream Stakeholder alignment in MOU and Statutes still to be completed in several Countries (e.g. Pharmacies and Wholesalers not integrated in NMVO set up) 10

11 Content Introduction Trust and Team Building Systems Implementation Conclusion 11

12 Interface Man. Interf. Paral. Distr. Interf. System Landscape Manufacturer System European Hub Interface Parallel Distributor System System owner = Manufacturer System owner = NMVO Nat Syst. Interf. Interface System owner = EMVO Nat. Blue Pr. Interf. Nat. Blueprint. Interf. System owner = Parallel Distributor System owner = NMVO National Standalone System National System based on blueprint standard Pharmacy Wholesaler Pharm. Interf. Wholes. Interf. Interface Interface Interface Interface Pharmacy System Wholesaler System Pharmacy System Wholesaler System System owner = System owner = Pharmacist Wholesaler System owner = Pharmacist

13 NMVS Implementation and On Boarding One system running and connected to HUB (securpharm, Germany) Next systems expected to follow Q Challenges: Contractual Relationship EMVO-NMVOs Potential Non Blueprint countries Potentially non compliant countries

14 Manufacturer Onboarding 40 Companies technically connected 80 Companies started Onboarding process Challenges: Awareness of small and companies without association membership Management of peak loads and bottle necks National Data Up Load vs. EU HUB 14

15 Timelines for End User Onboarding by NMVO First High Level Estimation on Time Schedules Year 2017 Q 2 Q 3 Q Q 2 Q 3 Q National Pilot Kick Off with End User IT Service Suppliers Pilot Participation Group defined Pilot Tests Started Pilot Participants go Live National Ramp Up Kick Off - Lessons Learned Connect all Users to Test System Connect all Users to Quality System All Participants Go Live NMVS Implementation, End User projects and Onboarding projects are highly integrated! Coordination effort must not be underestimated! 15

16 Onboarding Pharmacies and Wholesalers Verification and validation of end users is critical. Technical on-boarding will involve pharmacy/wholesaler software provider. Each solution provider will need technical support and access to test systems. Onboarding of end user locations should not be abdicated to the pharmacy/wholesaler software provider. Control must be retained by the NMVO. Overall system security is only ever as good as the weakest link (robust end user legitimacy check). The design ideals of the on-boarding portal used by EMVO can be shared as can some of the processes. Make use of existing systems to simplify, e.g. France, Norway 16

17 Support from Blueprint Service Providers Communication with and education of pharmacy/wholesaler software providers Support connection to the Test System in the Pilot Support Pilot and analyse test results Support go live of Pilot participants Provide statistics on National Ramp Up 17

18 Challenges for Hospitals Support and funding for the necessary upgrade of IT systems in hospitals and changes in work practices have to come from hospital management/owners Physical infrastructure in hospital pharmacies departments to be adapted Awareness within hospital sector to be improved

19 Activities on National Level Involvement of hospital pharmacists in governance set up via PGEU membership (e.g. Austria, Bulgaria, France, Germany, Ireland) Application of relevant use cases as laid down in the EMVS URS Discussions with hospital owners (public and private) about workflow and funding Invitation to Ministries of Health/Agencies to cooperate in order to cover state owned segment (compliance and readiness) 19

20 Activities on European Level Engagement with the hospital sector since 2011: EAHP (Hospital Pharmacists) HOPE (Hospital Managers) Purpose of this engagement: To introduce EMVO and motivate engagement early and throughout the process To highlight new requirements and the need to plan for implementation by Feb 2019 To better understand how medicines are distributed in the hospital sector & potential users of national repository system To float idea of HOPE (managers) and EAHP (employees) to join EMVO in partnership

21 Next Steps Proposal for a EMVO Stakeholder meeting with HOPE/EAHP in Q Invitation to HOPE/EAHP to participate in: Technical Advisory Committee EMVO Stakeholder Meeting EMVO Board Meeting Integration of hospital segment into EMVOs governance structure (membership duties and rights) Commitment of HOPE/EAHP to EMVOs 10 Core Principles, MoU and EMVS architecture 21

22 Content Introduction Trust and Team Building Systems Implementation Conclusion 22

23 Conclusion The FMD implementation remains a huge challenge All players need to continue their efforts, a few have to intensify Communication between all players has to remain constructive and has to continue Cross country knowledge exchange to be further developed National Health Ministries to raise awareness among hospitals via NCAs 23

24 Thank you very much! Markus Gerigk Andreas Walter Contact for On Boarding and general topics: