ABPI briefing on the Falsified Medicines Directive (FMD) OCT 2016

ABPI BriefingFalsified Medicines DirectiveOctober 2016

1

Today’s Agenda

• 11.00am Welcome• 11.05am FMD – UK Update• 11.30am FMD – View from the MHRA• 12.30pm FMD – EU Update• 1.00pm Close

2

What are falsified medicines?

• Growing threat to public health and safety in Europe • 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

• Falsified medicines may:• Contain low quality ingredients or the wrong doses• Have their identity or source deliberately mislabelled• Have fake packaging or the wrong ingredients

3

Falsified Medicines Directive (FMD) 20011/62/EU

4

• Directive published 1 July 2011

• Entered into force 1 January 2013

• Contains measures to increase security of the medicinal supply chain in Europe

1. Strengthen Good Manufacturing and Good Distribution Practices including the sourcing of active ingredients

2. Improve supervision of actors in the distribution chain (e.g. wholesalers, parallel distributors and internet sales)

3. Ensure product integrity and authentication of medicines (safety features and product serialisation)

Delegated Regulation to the FMD

5

• Adopted on 2nd October 2015

• Published on 9th February 2016

• Enacting terms: Safety Features

1. Characteristics and technical specifications of the unique identifier

2. Modalities for the verification of the safety features

3. Establishment, management and accessibility of the repository systems

4. List of RX medicines exempted from carrying the safety features

5. Notification procedure for exceptions by Member States

6. Procedure for rapid assessment of notifications

Requirements for safety features

Code (‘safety feature’)

+

Tamper evidence

Unique identifier Data-Matrix Code Randomised serial number

Product #: 09876543210982Batch: A1C2E3G4I5Expiry: 140531S/N: 12345AZRQF1234567890

Implementation Required in Member States 3 years after publication

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 *Italy, Belgium,

Greece have 6 years longer for implementation

Costs are incurred by all stakeholders

• Each stakeholder pays for costs of own installations• Manufacturers pay for cost of verification system

Manufacturers and Marketing Authorisation

Holders

Manufacturers and Marketing Authorisation

Holders – contact EMVO to sign up for European Hub testing

Dispensing & Verification Entities

e.g. Pharmacies and Wholesalers

Installation for pack codingVerification system (Hub & national systems)

Installations for pack verification

Pharmacy Wholesaler

Pharmaceutical Manufacturer

ParallelDistributor

EuropeanHub

9

European Principle Stakeholders developed a European Stakeholder Model

Common Basic Concept:Point of Dispense Verification

Required by Delegated

Acts

10

Pan-European architecture: The “National Blueprint System“ approach

NationalSystem

PharmacyWholesaler

PharmaceuticalManufacturer

ParallelDistributor

NationalSystem

NationalSystem

EuropeanHub

NationalSystem

NationalSystem

NationalSystem

National BlueprintSystem




11

The UK Stakeholders 2012-2015

• Meeting regularly since 2012, with ABPI, BAEPD, BAPW, NPA, PSNI, RPS,

• Co-operation and consensus vital– Supporting European Stakeholder Model

• Keeping stakeholders informed:– Associations’ own members– The Competent Authorities– Reaching out to other parts of the medicines supply chain– Joint seminars– EMVO documentation was important

• BGMA joins UK ESM – 2015• RPS/PSNI drop off

UK Principle Stakeholders

System set up and governed by stakeholders under supervision of national competent authorities

Development of UK Partners

• Adoption of Interim UK Memorandum of Understanding (MOU) and then more formal Framework MoU

• ‘Observer group’ formed including: – DH/MHRA– RPS, DDA, – Guild Hospital Pharmacists

• Full engagement with Competent Authorities– MHRA letters to all MAHs and WDA holders – Nov 2015

and June 2016– Membership of DH/MHRA FMD Implementation Board &

associated workstreams– MHRA Impact Assessment work - manufacturers site visits

Where Are We Now?

• BREXIT• Formal Consultation with wider stakeholders - Summer

– MoU and URS lite • Incorporation of UKMVO – SecurMed UK - Summer

– Articles/Statutes – 5 Directors (1 Director per Constituency) – voting and

Annual Constituency Fee agreed– Officials rotate every 6 months – secretariat in place– 6 Full members – MHRA/DH in attendance at Board meetings

Where Are We Now?

• Selection of BSP – Autumn – ‘Request for Proposal’ issued to 3 BSP’s– Proposals and Pitches to every Constituency – August– Additional clarification – BSP’s advised of next steps – end of September

• Open formal negotiations with 2 ‘preferred providers’• Recruit General Manager - Autumn

– Job Description – end of September• ABPI Briefing

– MHRA and EMVO input – 19th October

17

Who will have to pay ?

Pharmacists, wholesalers, …

Installations for pack verification

Marketing Authorisation Holders

Installations for pack coding

Marketing Authorisation Holders

Repository system (Hub & national systems)

Pharmacy Wholesaler

Pharmaceutical Manufacturer

ParallelDistributor

EuropeanHub

MAHs selling products in a Member State pay for respective national system and a share of the European Hub

Mechanisms for system funding in different phases

2014 2015 2016 2017 2018

Design and Development Phase (funding:

EFPIA/ABPI)

Ramp Up Phase (funding: loans from

member companies at National and EU)

Full Operation Phase (funding:

all MAHs via NMVO’s)

2019 2020

Phased-in: 3 phases

• Start-up phase: – Financed by EFPIA/ABPI

• Ramp-up phase: Total Europe wide Costs - €90Million– Period of connecting companies and national / regional repository

systems with the EU-hub up to almost complete level of participants– Expected to start early-2016 and last until end-2018 (based on

provisions of the FMD coming into effect February 2019)– Monies collected at both EU and National level – Loans not Levies!

• Full operations phase: Total Europe wide Costs - €90Million/Annum– Period after the ramp-up phase is finished.– Post February 2019– Monies collected via NMVO’s – Flat rate per Marketing

Authorisation Holder

19

National system cost estimate 20

National Ramp-Up Costings

Sep 2015

System cost x k€

IT service providers’ proposals

NMVO cost x k€

Set-Up, Pilot and Admin/Governance Costs

Total: x k€

Loan per Company: x k€

Loan Model

National system cost estimate 21

National Full Operation Costings

Sep 2015

System cost x k€

Average of IT service providers’ offersPre-negotiated offers vary between average +/- 50%

NMVO cost x k€

As per system size

Hub cost x k€

Share: x % (Approx double during first 3 years to pay off loans)

Total: x k€

Annual fee per MAH: x k€

Flat fee model

Cost allocation: The Flat fee model

• The flat fee is transparent, non-discriminatory and proportionate in relation to the services received.

• 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 larger company often hold multiple MAH’s so will pay multiple ‘flat fees’• Upfront payment

• In order to prevent free-riders, easy calculation gives opportunity to pay upfront

SecurMed UK Organisational Structure

• General Manager– Leads and manages the project at SecurMed UK– SecurMed UK Finance and resource provision

• System Manager– Technical understanding of national processes and systems, including PMR, hospital

and wholesaler IT systems and others when Article 23 flexibilities agreed.• Stakeholder Manager

– Organise communication including marketing activities– Coordinate rollout validation, registration and certification (on-boarding) of system

users, including CRM (database) management• Quality Manager

– Develop KPI’s, reports and audits– Investigation of Exceptional Events/Alerts– Lead for engagement with MHRA/GPhC and others re system user identification and

pre on-boarding validation• Board Secretariat/Administration

– Secretarial support for Board and Management Meetings

Progress across Europe • 6 NMVO’s Founded• 3 Selections announced (Finland, Norway and Sweden)• 2/3 Countries behind schedule• 9 Countries not yet engaged with BPS’s• Several countries without stakeholder alignment (pharmacy

and wholesalers)

• 37 companies started on-boarding to EU Hub• 8 fully connected to EU Hub

26

Falsified Medicines Directive -‘Safety Features’ ABPI presentation – 19 October 2016

Jan MacDonald

27

Overview of progress• Implementation Advisory Board (IAB) and Working Groups:

– IAB meets on a quarterly basis with representatives from across the UK supply chain. It’s role is to provide recommendations.

– Working groups: Seven working groups have met (including Community Pharmacy & Wholesales). We are now seeking to join meetings to continue to capture the views of stakeholders.

• European Commission: – Continuing our engagement with the Commission through attendance at

expert group meetings.– Commission aim to create working groups on four areas: (1) supervision, (2)

access to information/data in the repository, (3) data traceability and (4) best practice. UK plan to participate.

• SecurMed: – Continuing to work with the SecurMed in our supervisory role.

28

Impact AssessmentAs a part transposition we assess the impact of the directive on the UK. This “impact assessment” will consider both the costs and benefits of the Safety Features policy.

The impact assessment will be published in two parts: • Consultation impact assessment: This will be published with evidence gaps

showing our initial analysis on the impact of the proposal on the UK, and our decisions on any flexibilities we have under the act. At this point the public has the opportunity to write in and formally provide evidence and opinions on our assessment of the impact and the policy decisions we are proposing.

• Final impact assessment: This will take account of the evidence provided during the consultation, and assess the impact of the final policy decision.

We are currently in the process of visiting businesses impacted by Safety Features.

Enter the presentation's title using the menu option View > Header and Footer

29

Timelines – key dates:

• Developing initial UK position on flexibilities + legal changes on enforcement: February-December 2016

• Developing initial impact assessment : February-December 2016

• Public consultation (12 weeks): Proposed early 2017

• Review of consultation – amendments: Proposed Q2 and Q3 2017

30

Safety Features

Introduced to enable manufacturers, wholesale distributors and those who supply to patients:• to verify the authenticity of the medicinal

product,• to identify individual packs, • to verify, by means of a device, whether

the outer packaging has been tampered with

• Published February 2016• UK has 3 years to implement

Delegated Regulation – Safety Features

Medicinal Product Manufacturer

Wholesale Distributor

Pharmacy

Patient

VERIFICATION

31

• 2D bar code with a unique identifier• Tamper evident packaging• Affects all prescription medicines (unless

exempted) POM

• No P or GSL products impacted (unless an issue of falsification has been notified)

P & GSL XDelegated Regulation – Safety Features

32 Delegated Regulation – Safety Features

33

Tamper Evidence

• Medicines required to include the safety features need to include anti-tampering devices

• CEN standard already approved“Tamper verification features for medicinal product packaging – EN 16679:2014”

• Choice will be for the MAH/manufacturer to determine



35

Chapter 2 – Unique Identifier

• Technical specifications of the UI– Sequence of alpha-numeric or numeric characters given to

individual pack– Code allowing identification of the name, common name,

pharmaceutical form and strength as a minimum– Reimbursement information if required by MS– Batch number– Expiry date

• 2D data matrix carrier• Human readable format in addition• No other codes may be displayed



37

EU-wide implementation plan

• Anti-Tampering Device• Does not impact the PI templates• If placed on immediate packaging may impact the

dossier1. New MAs

– may need to include information ins section 3.2.P.2.4 and/or 3.2.P.7 of NTA Vol. 2B

– Information required by day 180

2. Existing MAs– Will need to update dossier– Section B.II.e. of the Variation Guidelines applies

• Compliance by February 2019

38

EU-wide implementation plan

• Unique Identifier:• Must be included in the product information annexes and

associated artwork• QRD template – new sections 17 and 18 in Annex IIIA

1. New MAs must comply at the time of authorisation2. Existing MAs

– Utilise the next regulatory intervention impacting the packaging

– If no suitable intervention notify NCA under article 61(3) of Council Directive 2001/83/EC

Compliance by February 2019

39

Chapter 3 – Verification

• General provisions on the verification of the safety features

– Check the UI against the numbers held in the repository– Ensure the tamper-evident feature is intact

• At the point of supply UI will be “checked-out” of the repository

• UI can be checked back into the repository in certain circumstances


40

Chapter 4 – Manufacturers

• Impact on manufacturers– Must verify the UI– Keep records– If repacking must verify and replace UI and safety

features– Safety features are deemed equivalent if they

comply with the delegated acts– Must take action if concerns are raised and inform

the NCA– If also a wholesaler dealer the obligation following

apply


41

Chapter 5 – Wholesaler Dealers

• Impact on Wholesalers– Risk based verification– Decommission the UI in specific circumstances– Take action if issues arise and inform the NCA– Can decommission the UI on behalf of others if

flexibilities have been used by MS


42

Chapter 8 – General obligations

• Companies to upload certain information to the repositories

• Products recalled, withdrawn or stolen– UI must be decommissioned – Repository updated

• Free samples to have UI decommissioned before supply to HCPs

• Remove redundant information


43

Flexibilities within the Regulation

• Member states may – Extend the products to which the unique

identifier/safety feature applies – Require a national reimbursement or other national

number to be within the data elements of the unique identifier

• Member states may allow– Manufacturer to put additional information in the bar

code

Question for discussion: your view on use of these flexibilites


44

Information to support the impact assessment –

We are interested in looking at the areas of the business that will require a process change or new equipment, and we are interested in the views of manufacturers of any costs and benefits associated with these changes.


45

Other concerns:


dd/mm/yyyy

On-boarding and Data Management

Paul Mills

Paul Mills, 19th Oct 2016, securMed

Onboarding - Introduction

EMVO is tasked with the on-boarding activities for manufacturers and MAH’s.

EMVO refers to these clients as OBP’s. On-Boarding Partners.

OBP’s have contracts with EMVO. OBP’s are entirely responsible for the data upload

process. OBP’s cannot request a direct connection to the Hub

for use by others.

47


Relationship between OBP and EMVO

48

Marketing Authorization Holders (MAH)

EMVO

EU Hub

OBP

Client

Production 1 Production 2

Marketing Authorisation Holder A

Marketing Authorisation Holder B

Production 3 (CMO)

Marketing Authorisation Holder C

Collects data from

Paul Mills, 19th Oct 2016, securMed 49

1) Participation Request

• Initial Contact• Portal registration• Non-Disclosure Agreement

2) Legitimacy Check

• Level 1 checks• Person checks• (more detailed checks

if necessary)

3) Contractual/ Commercial On-

boarding

• Registration fee payment• Connection Request• Participation Agreement

4) Technical On-boarding

• System Connection• System Testing• System Operation

Managed and administered

by the EMVO’s

Commercial and

Partnership Management

Team

Managed by the EMVO’s Operations

Team & Solidsoft

Reply

Managed by EMVO

and supported by

IMS*

NDA

CAR

PA

CRF

Ticket


Purpose and ContextThe European Hub is the central element of the European Medicines Verification System infrastructure required by the EU-FMD.

It is to the European Hub that the data that forms the critical element of the point-of-dispense verification concept is uploaded, namely:

For every Medicinal Product: Product master data

For each individual sales pack of medicines: Unique Identifier

Any incorrect or fraudulent data uploaded will severely affect the medicines verification process and seriously undermine the trust in the system and Europe-wide process.

It is therefore critical that:

the access to the European Hub for the upload of these critical data is tightly controlled and that

the Legitimacy of any party requesting access to the European Hub is established through a rigorously administered process.

50


Checks for legitimacy

1. Is the organisation requesting access an established and legitimate business?

2. Is the organisation requesting access a pharmaceutical “manufacturer” as defined for EMVO purposes that is entitled to access the European Hub?

3. Is the person making the access request entitled to make this request on behalf of the organisation?

4. Is the request a duplicate (i.e. an organisation already covered or registered for example duplicate request? Erroneous request by subsidiary of a registered parent/group organisation)?

5. Are there any other causes for concern about giving this organisation access?

51


Legitimacy Check Process steps

Information received

through Portal (CAR form)

Level 1 checks by 3rd

party

Level 2 checks by 3rd party

Proceed with next steps of onboarding

process

STOP Onboard

ing process

52


Overall timeline

Ad-hoc process •Current on-boarding of early adopters•Will need to be run through the new process

Pilot phase•Operating the new process manually•Piloting to ensure that the process is fully workable and deal with any unknowns/unanticipated areas•EMVO Portal > email to IMS > Ticket captured manually

Semi-automatic •Refined Process automated (where this makes sense)•EMVO Portal > EMOV Ticketing System > IMS Ticketing System

BAU •Business – as – Usual process•Focus shifts from on-boarding many new organisations to change and issues management

to Q3 2016

Q4 2016

Q2 2017

Q1 2019

53


Summary / Conclusions

EMVO is in the final stages of establishing a thorough and robust legitimacy check process

The process will be controlled by EMVO but will leverage what a specialised IMS can provide

Checks for a corporation requesting to become an OBP (On-boarding Partner) will take a risk-based approach

There will be an Audit Trail for each decision: Why it was taken, by whom, when, based on what information

Phased roll-out will commence in October 2016

NMVO’s are expected to undertake similar processes to verify the clients connecting with them e.g. Pharmacies and Wholesalers.

54


EMVS Master Data

55

Product Master DataProduct codeCoding schemeNameCommon namePharmaceutical formStrengthPack typePack size (Dose Count)Product Code StatusProduct Code Version

Product per Market DataMember state ISO IDNational codeArticle 57 code/PCID (TBC)MAH IDMAH NameMAH AddressSerialisation FlagList of Wholesalers with ID, name and address

Batch DataBatch numberExpiry dateManufacturer IDManufacturer NameManufacturer AddressBatch Number Status

Pack DataSerial NumberSerial Number Status

1

N

1

1

N

N


Master Data by Market

All the relationships reduce tothis when the data is sent fromthe European Hub to eachNational System

56

Product Master DataProduct codeCoding schemeNameCommon namePharmaceutical formStrengthPack typePack size (Dose Count)Member state ISO ID

National code

Article 57 code/PCID (TBC)

MAH IDMAH NameMAH AddressSerialisation FlagList of Wholesalers with ID, name and address

Batch DataBatch numberExpiry dateManufacturer IDManufacturer NameManufacturer AddressBatch Number Status

Pack DataSerial NumberSerial Number Status


Master Data Guidance

57

Common Master Data (sample sheet only shown)


Questions?

Thank you.

58

Health & Medicine

ABPI briefing on the Falsified Medicines Directive (FMD) OCT 2016