The Blueprint approach

Transcription

1 the way to comply with FMD and its Delegated Regulation: The Blueprint approach Johan Verhaeghe (FMD Project Manager) Frankfurt, 16 February 2016

2 EGA Vision 2020 To provide sustainable access to high quality medicines for all European patients 2

3 At the heart of Europe s medicines industries and essential to EU public health 3

4 Facts and numbers Every year generic medicines bring in savings over 40 BN to the EU One of the Most Competitive More than Sectors in 350 Europe manufacturing sites employing over Generic medicines account for 55% 21% of dispensed medicines of pharmaceutical expenditure 7% of turnover to R&D exporting to more than 160,000 European citizens 100 countries outside the EU 4

5 EGA Membership COMPANIES NATIONAL ASSOCIATIONS GE (Hungary) HeGA (Greece) SPMA (Slovenia) 5

6 Glossary EMVO European Medicines Verification Organisation EMVS European Medicines Verification System NMVO National Medicines Verification Organisation NMVS National Medicines Verification System NBPS National Blueprint system EFPIA European Federation of Pharmaceutical Industries and Associations EAEPC - representing Europe s licensed parallel distribution industry GIRP European Association of Pharmaceutical Full-Line Wholesalers PGEU - Pharmaceutical Group of the European Union representing community pharmacists 6

7 Agenda FMD and its Delegated Regulation Intro: EMVO core concepts and principles EMVO business plan National roll-out strategy 7

8 Agenda FMD and its Delegated Regulation Intro: EMVO core concepts and principles EMVO business plan National roll-out strategy 8

9 FMD and its Delegated Regulation Falsified Medicines Directive EU directives set out results that all EU Member States must achieve (>< Regulation) 2011/62/EU FMD: the prevention of the entry into the legal supply chain of falsified medicinal products 9

10 FMD and its Delegated Regulation Delegated Regulation A DR allows Parliament and the Council to delegate to the Commission the power to adopt "non-legislative acts of general application to supplement or amend certain nonessential elements of a legislative act Enacting terms: Technical characteristics of the Unique Identifier A Tamper Verification feature Verification of the Safety Features Repository for the Unique Identifier Procedure for notification of exceptions by Member States 10

11 FMD Article 54 (12) the following Article is inserted: Article 54a - Medicinal products subject to prescription shall bear the safety features - Medicinal products not subject to prescription shall not bear the safety features Exceptions: White list: medicinal products subject to prescription that shall not bear the safety features Black list: medicinal products not subject to prescription that shall bear the safety features There is only 1 white list and 1 black list! 11

12 Some exceptions Member States can overrule the 'black' and 'white' lists and extend the scope of the safety features for medicinal products placed on the market on their territory MS can require the placing of: the unique identifier on any medicinal product subject to prescription or to reimbursement, and; the anti-tampering device on any medicinal product Some MS are considering to extend the scope of the safety features 12

13 Timelines 2 October 2015: Adoption DR by European Commission 9 February 2016: Publication DR in Official Journal Transitional measures 3 year transition phase (deadline: 9 February 2019) fade-out phase till expiry date of products 6 additional years for countries with a system to verify authenticity (Belgium, Italy, Greece) 13

14 Agenda FMD and its Delegated Regulation Intro: EMVO core concepts and principles EMVO business plan National roll-out strategy 14

15 Stakeholders take action to protect patients from falsified medicines VISION Protect legal medicines supply chain throughout EU Comply with FMD in an effective and cost-efficient way STATUS Design for Pan-European system and governance in place: National systems connected by EU Hub Start up implementation in place PLAN Work with EU and national authorities as well as EU and national stakeholder associations towards effective rollout 15

16 Common basic concept: unique identifier Data-Matrix code, developed to ISO-standards Key data elements: Product code (GTIN/NTIN or PPN) Randomised unique serial number Expiry date Batch number National health number (where necessary) Product #: Batch: A1C2E3G4I5 Expiry: S/N: 12345AZRQF Expected to be required by Delegated Acts 16

17 Common basic concept: Point of dispense verification European Hub Upload Data National Blueprint System Verification upon Dispense to Patient Product # Batch Expiry S/N risk-based verification by Wholesale distributors Product Flow Pharmaceutical Manufacturer and Parallel Distributor Wholesaler Wholesaler Pharmacist Patient 17

18 The National Blueprint System National Blueprint System National System National Blueprint System National Blueprint System Pharmaceutical Manufacturer European Hub Parallel Distributor National Blueprint System National System Pharmacy Wholesaler 18

19 Governance structure allows effective management of verification system GENERAL PRINCIPLE System management and governance by not-for-profit organisation under supervision of relevant competent authority EU LEVEL European Medicines Verification Organisation (EMVO, founded 02/2015) NATIONAL LEVEL National Medicines Verification Organisations (NMVOs), to be founded EU level and national level organisations cooperate on the basis of service level agreements 19

20 EMVO-members are allocated to a constituency Membership open to other stakeholder associations 20

21 A closer look at responsibilities around Governance and System Management EMVO Board Governance EMVO European Hub EMVO EU contracted IT firm Cooperation Agreement System management System operation Remit Establish, manage and operate European Hub Ensure interoperability of connected systems Conclude agreements with NMVOs Set standards for the EMVS Manage national Blueprint systems at request of national stakeholders NMVO Board Governance NMVO National System NMVO Nat. contracted IT firm System management System operation Remit Establish and manage national system Ensure interoperability with European Hub Conclude agreement with EMVO Analyse exceptional events at national level Expected to be required by Delegated Acts in combination with supervision by competent authorities 21

22 The Blueprint approach provides substantial benefits National Blueprint System Complexity reduction for NMVOs: Allows national stakeholders to build national system without starting from scratch Based on a standard national verification system providing all necessary functionality Strong support by EMVO during deployment & operation (system management) Cost reduction for payers through economy of scale Fewer, but bigger (aggregate) systems are less costly than many (individual) smaller systems 22

23 The National Blueprint System: Governance & management European Hub EMVO Board EMVO IT provider to EMVO NMVO Board NMVO / EMVO Cooperation Agreement IT provider (short list) National Blueprint System Governance System management System operation Governance System management System operation National Blueprint System Governance by national stakeholders Managementby EMVO on behalf of the respective national stakeholders Operation by IT provider as preselected by EMVO 23

24 Timeline Q1/2015 Completion of European Hub 09/02/2016 Publication of Delegated Regulation 04/2013 Start development European Hub 13/02/2015 EMVO Foundation Until 2013 System design System build and start up Ramp up NATIONAL ROLL OUT 24

25 We encourage stakeholders at national level to engage NOW Build on existing knowledge and experience Develop principles for cooperation (MoU, NMVO statutes) Determine scope of functionality Evaluate options to realise technical system (e.g. Blueprint) Develop milestone plan Governance organisation Implementation of technical system Plan for budgets 25

26 Agenda FMD and its Delegated Regulation Intro: EMVO core concepts and principles EMVO business plan National roll-out strategy 26

27 3 phases Start-up phase: COMPLETED Period of running and proving technical viability connecting up to two national systems and up to 40 manufacturers Establish EMVO upon agreement of the stakeholders (EFPIA, EGA, EAEPC, PGEU, GIRP) Expected to last until mid-2015 Ramp-up phase: Period of connecting companies and national repository systems with the EU-hub up to an almost complete level of participants Expected to last until mid-2018 (assuming provisions of the FMD come into effect by Q1 2019) Full operations phase: Expected after mid

28 EMVO business plan EMVO: non-profit organisation Tasks and responsibilities: cooperation with relevant stakeholders in the implementation and execution of the FMD Ensuring operational activities pertaining to the European Hub and supporting operations for the national repository systems Start-up: 13 February 2015 Self-funding as of 3 years after publication of the Delegated Act (Q1 2019) 28

29 Blueprint strategy cost containment Complexity reduction for NMVOs: Allows national stakeholders to build national system without starting from scratch Based on a standard national verification system providing all necessary functionality Strong support by EMVO during deployment & operation (system management) Cost reduction for payers through economy of scale Fewer, but bigger (aggregate) systems are less costly than many (individual) smaller systems 29

30 Full operations phase National System Pharmaceutical Manufacturer National Blueprint System European Hub National Blueprint System National Blueprint System Parallel Distributor National Blueprint System National Blueprint System Pharmacy Wholesaler 30

31 Cost allocation model: Conclusion on a flat fee model Practicality Easy way of calculating: equal division amongst MAHs and PD Fairness Takes into account market activity: companies with multiple MAHs pay more Transparency Simple accountancy / audit Predictability Calculations based on number of active participants in the market the year before the fee adjustment Balanced A company can be more active in country A, compared to country B and will therefore pay more in country A Upfront payment In order to prevent free-riders, easy calculation gives opportunity to pay upfront 31

32 Cost allocation / flat fee acceptance Fees payable by party responsible for having products on the market (MAH, Parallel distributor, ) For the avoidance of doubt, in the event that the Manufacturing Authorisation Holder and the Marketing Authorisation Holder are not one and the same legal entity, whichever entity uploads data to the System shall be liable for the service fees payable. 32

33 Total cost of an NMVO Hub cost (charged by EMVO) NMVO cost (governance and administration) System cost (charged by service provider) Estimate based on EMVO business plan and proposed allocation scheme Estimate by EMVO, to be reviewed country by country Estimate based on IT service providers standard offers, best and final offer to be negotiated country by country 33

34 Annual Cost Hub cost x k NMVO cost x k Share: x % As per system size x System cost x k Average of IT service providers offers Total: x k Flat fee model Annual fee per MAH: x k 34

35 Agenda FMD and its Delegated Regulation Intro: EMVO core concepts and principles EMVO business plan National roll-out strategy 35

36 How to implement NMVOs? 1 st 2 nd Start discussions and created a stakeholder group non-profit organization Common goals and rules for collaboration MoU & statutes 3 rd Check national prerequisites User requirements specifications 4 th Select IT service providers Pre-negotiated framework contracts 36

37 National implementation Implementation pack for NBPS: Templates of EMVO foundation documents for NMVO Framework contracts IT service providers à The more Blueprint countries, the lower the price (economies of scale) 37

38 EMVO offers support for national stakeholders: Implementation Package Administrative Template for a Memorandum of Understanding (MoU) Template for statutes of an NMVO Proposed cost allocation scheme between MAHs Technical Support for project set-up Project organisation and project plan High level budget estimate User requirement specification for national system Support for selection of system provider (Blueprint) List of Blueprint providers Frame contracts with Blueprint providers Proposal for EMVO to act as system manager for NMVO 38

39 Support by EMVO for national stakeholders: national system (NMVS) deployment project organisation M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24 Steering Group Budget provision (planning phase) Budget provision (implementation phase) Governance WS Agreements between stakeholders (MoU, NMVO statutes) Preparation of NMVO foundation (including its organisation) Cost allocation between MAHs Additional requirements from authorities (technical / non-technical)? Technical WS High level system requirements (additional to URS reqs., if any) Collect information on IT infrastructure and potential constraints Estimate of technical cost IT provider selection (potentially Blueprint) NMVS implementation Operational model for NMVS (who does what?) 39

40 Questions? 40

41 NBPS 41