Falsified Medicines Directive (FMD)IT System Solution Provider Workshops

Thursday 28-Sep-17Jerome Bertin

Objectives

• What is FMD all about and when does it need to happen?

• Who are SecurMed and what is our role in FMD?

• What is the scope of FMD and who is obliged to comply?

• What do you need do to prepare for FMD?

• Implementation Approach and Next Steps

Falsified Medicines - What is the problem?

• “There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source. These products usually contain sub-standard or falsified ingredients, or no ingredients, or ingredients (including active substances) in the wrong dosage thus posing an important threat to public health.”

Directive 2011/62/EU, Para 2

• Involving nearly 2500 cases , EU Customs seized 27.4 million doses of falsified medicines at EU borders in 2011- an almost seven-fold increase from 2007

• MHRA seized £8.6m and discovered fraudsters are infiltrating the NHS drugs supply chain and diverting medicines to street drug dealers and illegal websites – May 2014

• MHRA seized 6.2m medicine doses/ medical devices worth £15.8m as part of Operation Pangea – June 2015

• Herceptin, Spiriva Turbohaler and Kaletra

• WHO estimated in 2014 that 1% of sales in developed countries could be counterfeit. With approx. 2 billion items dispensed per year in the UK, this would equate to 20 million medicine packs if correct.

FMD history and when does it need to happen?

Objective: Protection of patients from falsified medicines in the legal distribution chain

Content: Pan-European system to verify the authenticity of medicinal products

2011

2018 (2015+3)CompleteImplementation

9 February 2016 Publication of

Delegated Regulation

July 2011Publication of

FMD

36 Mon.

20192016

Non-compliance puts supply and sales at risk

2013

Jan 2013FMD except

Safety Features implemented

FMD Go-Live - 09 February 2019

2015

Oct 2015Delegated Regulation

approved by UK Ministers

FMD requirements for safety features on medicine packs

Unique identifier

Data-Matrix Code

Randomised serial number

Product #: 09876543210982Batch: A1C2E3G4I5Expiry: 140531S/N: 12345AZRQF1

Anti-tamper Device

• Marketing Authorisation Holders (MAHs) obliged to add Safety Features on all

Prescription Only Medicines (POMs), except excluded POM medicines and included

General Supply List (GSL) medicines

• Introduced to enable wholesale distributors (all WDA holders) and those who supply

to patients:

• to verify the authenticity of the medicinal product,

• to identify individual packs,

• to verify whether the outer packaging has been tampered with (Anti-Tamper Device check)

Some labelled packs are already out there…

• FMD requires Prescription Only Medicines (POMs) to be verified/decommissioned

• Key labelling feature’s shown• Product Code (GTIN)• Batch Number• Expiry Date• Unique serial number• 2D encoded matrix (for scanner)

• No anti-tamper proofing on these packs

• Picture taken at Minal Pharmacy, Twickenham, 15-Sep-17

Point of Dispense Verification and Authentication

Required by Delegated Regulation

Commissioning Verification Decommissioning

Costs are incurred by all stakeholders

Each stakeholder pays for costs of own installations.

Manufacturers pay for cost of the verification system.

SecurMed is funded only for UK system set-up, no-one else.

Manufacturers and Marketing Authorisation

Holders

Manufacturers and Marketing Authorisation

Holders

Dispensing & Verification Entities

e.g. Pharmacies, Hospitals and Wholesalers

Installation for pack codingVerification system (Hub & national systems)

Installations for pack verification

Pharmacy Wholesaler

Pharmaceutical

ManufacturerParallel

Distributor

EuropeanHub

FMD and Brexit

• FMD legislation passed into UK law in 2013 (part of Human Medicines Act).

• Delegated Regulation approved by UK government in 2015.

• DH MHRA position April 2017 - “Until exit negotiations are concluded the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. During this period, the government will continue to negotiate, implement and apply EU legislation, including the ‘Safety Features’ policy under the Falsified Medicines Directive. The outcome of the exit negotiations will help determine what arrangements will apply once the UK has left the EU, however the government

remains committed to providing a regulatory environment which protects health and improves lives.”

• SecurMed UK has been instructed to continue as full member of Europe-wide FMD implementation.

• SecurMed has sought guidance from Dept of Health/MHRA since the General Election and the direction remains the same.

• Arvato Systems appointed on 18-Jul-2017 as UK Blueprint Service Provider.

SecurMed UK - NMVO Service

• A not for profit legal entity to establish and manage the verification system.

• A joint venture funded by pharmaceutical industry via industry associations

• Scope governed by Delegated Regulation of Falsified Medicines Directive

• UK Blueprint Service Provider is Arvato Systems GmbH

• Supervised by National Competent Authority (DH/MHRA)

EuropeanMedicines Verification

System (EMVS) Inte

rfac

e

Inte

rfac

e

Man

ufa

ctu

rer

Paralell

ManufacturerSystem

Parallel Distributor

System

Interface

NMVO Scope of Responsibility

UK MVS

UK Medicines Verification System

(UK MVS)

Interface

Pharmacy

Inte

rfac

e

Wh

ole

sale

r

Wholesaler/ Distributor

System

Interface

Hospital

Interface

Other

Community Pharmacy

System

Hospital Pharmacy

System

Other Dispensing

System

Article 23Locations

• Build UK MVS and perform pilot / validation testing

• Provide SDK for IT providers to create connections to UK MVS

• On-board wholesale/ pharmacy/ dispensing users

• Develop UK NMVO Service• MAH contracting and fee collection• Reporting exceptions & compliance to

NCAs.• Maintain data integrity and security for

all users

11

End UsersCommunity Pharmacy

Users

Wholesaler Users/

Article 23

Hospital Pharmacy

Users

GP Practice /Health Centre Users

End users verify/ decommission/

dispense medicines in supply chain

through to dispense to patients

UK FMD Implementation Overview

12

System to System

Connections

End User to IT Provider System

Registration Body e.g GPhC, CQC, GMC, PSNI

End User Registration/

Legitimacy Check

Community Pharmacy

System

IT System Solution Providers

Wholesaler/Distributor

System

Hospital Pharmacy

System

GP Practice /Health Centre System

IT System Solution Providers develop end user solutions encompassing IT system changes,

interface to UK MVS, scanners, upgraded IT infrastructure and

working practices changes

UK Medicines Verification System (UK MVS)

NMVO

SecurMed/Arvato provide IT Provider Solution Developers

Kit and User Onboarding

FMD Implementation Scope

In FMD Implementation Scope

England, Scotland, Wales, Northern Ireland, Channel Islands, Isle of Man

All persons authorized to dispense medicines to the public

All pharmacies and healthcare institutions supplying medicines to the public

All wholesalers holding Wholesaler Dealer Authorisations

Article 3 – ‘healthcare institution’ means a hospital, in- or out-patient clinic or a health

centre.

Dept of Health have confirmed all GP practices and surgeries are considered healthcare

institutions.

Article 23 – persons authorized to supply medicines to the public who do not operate

within a healthcare institution or a pharmacy (managed by wholesaler)

Dentists, vets, opticians, paramedics, universities/ higher education, prisons, hospices,

nursing/ care homes (subject to confirmation by DH/MHRA)

Out of FMD implementation scope

British Overseas Territories e.g. Gibraltar and Crown Dependencies e.g Bermuda,

Falkland Islands, St Helena (subject to MHRA confirmation)

All other healthcare organisations e.g Phone/Advice Lines

Scale of User Community

Channel Islands

Isle of Man

• England, Scotland, Wales, Northern Ireland, Channel Islands, Isle of Man

• 15,000 Community Pharmacies

• 260 Acute NHS Hospitals

• 190 Private Hospitals

• 1,200 Dispensing Doctors

• 9,800 GP Practices & Surgeries

• 2,160 Wholesaler/ Dealer Authorisations

• 200,000+ End Users to be trained

• 17,000+ Article 23 locations

• 18,000 Other Locations (Care Homes, etc)

• 750-1000 Market Authorisation Holders (MHRA & EMA)

• Ministry of Defence

• 60+ IT System Solution Providers

©

Pharmaceutical Packaging, Labelling and Artwork Origination10-11 October 2017

Phase 1

Initialisation

Phase 2Ramp-up stage A

Verify

EMVS-NMVS

connection

Phase 3Ramp-up stage B

Early Adopter dispensers &

wholesaler

testing

Phase 4Ramp-up stage C

Ramp oup of dispensers,

wholesalers and MAHs

Phase 5

Operations

Feb 9, 2019July 2017

MAH

ParallelDistributor

Data upload

(products,

packs)

Data upload

(products, packs)

Wholesaler Dispenser

Web app Web appDispenser

SystemWholesaler

system

Requests and pack

status changes

Verification,

dispense

EU Hub(EMVS)

National Blueprint System(UK MVS)

Implementation Approach

Initialisation Phase

• Implementation Planning

• Engage IT System Solution Providers

• IT Providers can commence preparation work for the FMD

implementation.

• Agree the Communications Strategy with main stakeholder

groups

• Develop the Phase 2/3 Strategy, Plan and Approach for Q1

next year.

Bertelsmann at a Glance

€17.0 billionGroup revenues

€2.6 billionOperating EBITDA

€1.1 billionGroup profit

116,434Employees

9/29/2017 | Darius Kubarth | Arvato Systems | SecurMed UK

Arvato –A leading international service provider

• Service portfolio: CRM services, supply chain management, financial services, IT services

• more than 1,1 billion parcels delivered a year

• 600 million customers serviced in customer loyalty systems

• 170 million online credit checks performed per year

• Runs more than 70 online shops for numerous international fashion brands

€3,838mRevenues

€359mOperating EBITDA

68,463Employees

GüterslohHeadquarters

9/29/2017 | Darius Kubarth | Arvato Systems | SecurMed UK

Arvato Systems -Systems integration and infrastructure services

New York

GüterslohToronto

Birmingham

San Francisco

Kuala Lumpur

Shanghai

Amsterdam

Zürich

Beijing

Nanjing

GuangszhouGreenville

Los Angeles

Further locations in Germany:e.g. Baden-Baden, Berlin, Bielefeld, Bremen, Dortmund, Düsseldorf, Hamburg, Köln, Leipzig, München, Ratingen, Rostock, Walldorf

€425mRevenues

25Locations Wordwide

>3000Employees

GüterslohHeadquarters

9/29/2017 | Darius Kubarth | Arvato Systems | SecurMed UK

▪ Comprehensive IT solutions for the trade, logistics and shipping and media industries as well as for utility companies and public administrations

▪ Competence in the key areas of BPM, Cloud Computing, CRM and E-Commerce

▪ Know-how in robust technologies, including Microsoft and SAP

▪ A broad spectrum of infrastructure Services, including Managed Services, and an according Application Management

Questions?