the blueprint approach - optel pharmaceutical blueprint approach provides substantial benefits ......
TRANSCRIPT
the way to comply with FMD and its Delegated Regulation:
The Blueprint approach
Johan Verhaeghe (FMD Project Manager)Frankfurt, 16 February 2016
EGA Vision 2020
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To provide sustainable access to high quality medicines for all European patients
At the heart of Europe’s medicines industries and essential to EU public health
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Facts and numbers
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Every year generic medicines bring in savings over
€40 BN to the EU
More than
350 manufacturing sites
employing over
160,000 European citizens
Generic medicines account for
55% 21%of dispensed of pharmaceutical medicines expenditure
7% of turnover to R&D
exporting to more than
100 countries outside the EU
One of the Most
Competitive Sectors in
Europe
EGA Membership
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HeGA(Greece)
SPMA (Slovenia)
CO
MPA
NIE
S
NA
TIO
NA
L A
SS
OC
IAT
ION
S
GE (Hungary)
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
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Agenda
FMD and its Delegated Regulation
Intro: EMVO core concepts and principles
EMVO business plan
National roll-out strategy
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Agenda
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FMD and its Delegated Regulation
Intro: EMVO core concepts and principles
EMVO business plan
National roll-out strategy
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
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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 non-essential 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
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FMD and its Delegated Regulation
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 shallbear the safety features
• There is only 1 white list and 1 black list!
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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
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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)
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FMD and its Delegated Regulation
Intro: EMVO core concepts and principles
EMVO business plan
National roll-out strategy
Agenda
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
Stakeholders take action to protect patients from falsified medicines
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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#: 09876543210982Batch: A1C2E3G4I5Expiry: 140531S/N: 12345AZRQF1234567890
Expected to be required by Delegated Acts
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Common basic concept:“Point of dispense verification”
17Patient
Pharmaceutical Manufacturer and Parallel Distributor
PharmacistWholesaler
ProductFlow
Wholesaler
risk-based verification by
Wholesaledistributors
Product # BatchExpiryS/N
Upload DataVerification
upon Dispense to Patient
EuropeanHub
National BlueprintSystem
PharmaceuticalManufacturer
ParallelDistributor
NationalSystem
EuropeanHub
National BlueprintSystem
National BlueprintSystem
National BlueprintSystem
National BlueprintSystem
NationalSystem
18WholesalerPharmacy
The National Blueprint System
GENERAL PRINCIPLE System management and governance by not-for-profit organisation under supervision of relevant competent authority
EUleveland nationallevel organisationscooperateonthebasisofservice levelagreements
NATIONALLEVELNationalMedicinesVerificationOrganisations (NMVOs), tobefounded
EULEVELEuropeanMedicinesVerificationOrganisation(EMVO,founded02/2015)
Governance structure allowseffective management of verification system
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EMVO-members are allocated to a constituency
Membership open to other stakeholder
associations20
A closer look at responsibilities around Governance and System Management
NMVO
Remit
• Establishandmanagenationalsystem• EnsureinteroperabilitywithEuropeanHub• ConcludeagreementwithEMVO• Analyseexceptionaleventsatnationallevel
EMVO
Remit
• Establish,manageandoperateEuropeanHub• Ensureinteroperabilityofconnectedsystems• ConcludeagreementswithNMVOs• SetstandardsfortheEMVS• Manage‘nationalBlueprint’systemsat
requestofnationalstakeholdersCooperationAgreement
EMVO
EUcontracted ITfirm
EMVOBoard
Systemmanagement
Nat.contractedITfirm
NMVOBoard
Systemoperation
Governance
Governance
Systemmanagement
Systemoperation
EuropeanHub
NationalSystem
Expected to be required by Delegated Acts in combination with supervision by competent authorities
NMVO
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The Blueprint approach provides substantial benefits
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
NationalBlueprint System
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The National Blueprint System: Governance & management
Cooperation Agreement
NMVO / EMVO
IT provider (short list)
NMVO Board
NationalBlueprintSystem
Governance
IT provider to EMVO
System operation
EMVO
System management
EMVO Board
EuropeanHub
GovernanceSystem management
System operation
• Governancebynationalstakeholders
• ManagementbyEMVOonbehalfoftherespectivenationalstakeholders
• OperationbyITprovideraspreselectedbyEMVO
NationalBlueprintSystem
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Timeline
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2016 - 2019Ramp up
13/02/2015EMVOFoundation
04/2013StartdevelopmentEuropeanHub
09/02/2016PublicationofDelegatedRegulation
Until 2013System design
2014 – 2015 System build and start up
NATIONAL ROLL OUT
Q1/2015CompletionofEuropeanHub
We encourage stakeholders at national level to engage NOW
Buildonexistingknowledgeandexperience
Developprinciplesforcooperation(MoU,NMVOstatutes)
Determinescopeoffunctionality
Evaluateoptionstorealise technicalsystem(e.g.Blueprint)
Developmilestoneplan• Governanceorganisation• Implementationoftechnicalsystem
Planforbudgets
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FMD and its Delegated Regulation
Intro: EMVO core concepts and principles
EMVO business plan
National roll-out strategy
Agenda
• 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-2018
3 phases
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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)
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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
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Full operations phase
National BlueprintSystem
PharmaceuticalManufacturer
ParallelDistributor
National BlueprintSystem
NationalSystem
EuropeanHub
€
€€
€
€ €
€ €
€
30WholesalerPharmacy
€€
€
National BlueprintSystem
National BlueprintSystem
National BlueprintSystem
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
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.
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Total cost of an NMVO
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System cost (charged by service
provider)
Estimate based on IT service providers’ “standard” offers, best and final offer to be negotiated country by country
NMVO cost (governance and administration)
Estimate by EMVO, to be reviewed country by country
Hub cost (charged by EMVO)
Estimate based on EMVO business plan and proposed allocation scheme
Annual Cost
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System cost x k€
Average of IT service providers’ offers
NMVO cost x k€
As per system size x
Hub cost x k€
Share: x %
Total: x k€
Annual fee per MAH: x k€
Flat fee model
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FMD and its Delegated Regulation
Intro: EMVO core concepts and principles
EMVO business plan
National roll-out strategy
Agenda
How to implement NMVOs?
• Start discussions and created a stakeholder group• non-profit organization
1st
• Common goals and rules for collaboration• MoU & statutes2nd
• Check national prerequisites• User requirements specifications3rd
• Select IT service providers• Pre-negotiated framework contracts4th
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National implementation
Implementation pack for NBPS:• Templates of EMVO foundation documents
for NMVO • Framework contracts IT service providersà The more Blueprint countries, the lower the price (economies of scale)
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EMVO offers support for national stakeholders: “Implementation Package“
• 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
Technical
• Template for a Memorandum of Understanding (MoU)• Template for statutes of an NMVO• Proposed cost allocation scheme between MAHs
Administrative
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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 ?)
Support by EMVO for national stakeholders: national system (NMVS) deployment – project organisation
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Questions?
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NBPS
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