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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

2

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

3

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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EMVO business plan


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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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 – 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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14



EMVO business plan


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





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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EMVO business plan


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

29

Full operations phase


PharmaceuticalManufacturer

ParallelDistributor


NationalSystem

EuropeanHub

€

€€

€

€ €

€ €

€

30WholesalerPharmacy

€€

€




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

35



EMVO business plan


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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Documents

The Blueprint approach - Optel Pharmaceutical Blueprint approach provides substantial benefits ... M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 …