1993 EFPIA - Executive for Administration and Finance. 2011 … › sites › default › files › docs › healthcare... · 2019-11-05 · check analysis has been performed on the

© GS1 2019 1

Andreas M. WALTER

EMVOGeneral Manager

1993 EFPIA - Executive for Administration and Finance. 2011 EFPIA – FMD Project Director2015 EMVO General Manager a.i.2016 EMVO General Manager (appointed)

[email protected]

THE IMPLEMENTATION OF THE EU FALSIFIED MEDICINES

DIRECTIVE36th GS1 Global Healthcare Conference

5th November 2019, New Delhi, India

Andreas M. WalterGeneral Manager

INTRODUCTION

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European Medicines Verification System (EMVS)/European Medicines Verification Organization (EMVO) & Falsisfied Medicines Directive (FMD)

GLOBAL GS1 HEALTHCARE CONFERENCE

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FMD – What is it about? 1/2

FMD – What is it about? 2/2

• A 2D data matrix on the side of packages carrying the Unique Identifier (UI)

• It allows all those involved across the supply chain to verify the medicine using specifically designed software to scan the data matrix to check its authenticity

• The tamper verification feature also provides a physical barrier against falsified medicines

• Before dispensing the medicines to a patient, the UI will be verified and thendecommissioned from the EMVS

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Who we are: EMVO

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Who we are: European Medicines Verification System (EMVS)

• The system carries the baton on from the Falsified Medicines Directive (FMD) and the Delegated Regulation

• The EMVS Operational Phase is the culmination of several years’ work• The main purpose of the European Hub is to serve as the principle place

for storage of master data and as a gateway for the transmission of manufacturer data to the national systems

EMVO is responsible for the EU Hub, which stores and

transmits product data to the relevant national systems

National Medicines Verification Organisations

(NMVOs) run national repositories (covering the

EU and EEA)

Together these are the EMVS

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How the system works

Medicine supply chain

Safety data

National Medicines Verification System

(country 1)

European Hub

Manufacturer/ parallel distributor

National Medicines Verification System

(country 2)

Wholesaler(country 1)

Pharmacist/ hospital

pharmacist(country 1)

Wholesaler(country 2)

Pharmacist/ hospital

pharmacist(country 2)

Patient(country 1)

Patient(country 2)

What EMVO and the NMVOs have achieved

Established a PoD system which enables supply chain actors to comply with the FMD and Delegated Regulation

The EMVS (Hub + NMVSs) is functioning and detects falsified medicines

30* EEA countries connected*Greece and Italy have a longer transition period04-06/11/2019


AGENDA

10

Readiness of the EU supply chain stakeholders

Development of alerts and root causes

Stabilisation periods in the EU

Call for a stepwise/phased approach to enforcement


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STATUS OBP/MAH ON-BOARDING(*)

11

980 1025 1025 1053 1029 1056 1075 1080 1088 1098

499614

791 823 848 881 917 930 970 994

1339

1501

21382288 2304 2355 2341 2354 2380

2479

178335

559 584 674722

808 823 883 911

0

500

1000

1500

2000

2500

3000

Dec-18 Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19

Signed Participation AgreementsOBPs Connected to the Hub (Production)Marketing Authorisation HoldersOBPs Connected to the Hub which uploaded Product Master Data

(*)The information figuring hereunder was collected in Calendar Week 40 and will be updated on a monthly basis

Estimatednumberof OBPs

1.600

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(**)

(**) The figure reflecting the number of MAHs listed in the OBP Portal has decreased between May and June as a quality check analysis has been performed on the reporting tools and the duplicate MAHs have been deleted. GLOBAL GS1 HEALTHCARE CONFERENCE

UPLOADED PRODUCT CODES(*)

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22697

4706666427

128989

182679 186311199425 205703 213619 218274 224989 229399

0

50000

100000

150000

200000

250000

300000

350000

400000

Oct-18 Nov-18 Dec-18 Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19

Number of Product Codes uploaded in the system

(**) Please note that the reported base value is only a rough estimation and is subject to continuous change. EMVO does not warrant that this information is error-free, accurate, complete and up-to-date.

(*)Product code is equal to Stock Keeping Units (SKUs)

Estimated number of Product codes (**)

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END-USERS CONNECTION OVERVIEW(*)

13GLOBAL GS1 HEALTHCARE CONFERENCE

04-06/11/2019(*)The information figuring hereunder was collected in Calendar Week 40and will be updated on a monthly basis

WHOLESALERS CONNECTION BY COUNTRY(*)

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Country AT BE/LU

BG CY CZ DE DK EE ES FI FR HR HU IE IS LT LV MT NL NO PL PT RO SE SI SK UK

(1) 392 312 230 105 736 1944 206 62 705 95 708 102 150 405 16 113 84 108 410 180 534 411 222 259 85 160 2126

(2) 3672 432(1) Number of Wholesale distribution authorisations (EudraGMDP)(2) GIRP estimate (*)The information figuring hereunder was collected in Calendar Week 40

and will be updated on a monthly basis

AT BE/LU BG CY CZ DE DK EE ES FI FR HR HU IE IS LI LT LV MT NL NO PL PT RO SE SI SK UKNot connected 0 100 0 0 15 109 0 0 55 0 5 10 15 5 0 4 0 3 37 97 0 197 185 37 0 0 0 1744Connected 139 109 120 35 388 891 13 19 295 6 215 21 93 102 3 9 33 57 51 103 12 290 112 274 13 21 60 1256Percentage remaining 0% 48% 0% 0% 4% 11% 0% 0% 16% 0% 2% 32% 14% 5% 0% 31% 0% 5% 42% 49% 0% 40% 62% 12% 0% 0% 0% 58%

0

500

1000

1500

2000

2500

3000

15

PHARMACIES CONNECTION BY COUNTRY CAP 20000(*)

(*)The information figuring hereunder was collected in Calendar Week 40 and will be updated on a monthly basis.

AT BE/LU BG CY CZ DE DK EE ES FI FR HR HU IE IS LI LT LV MT NL NO PL PT RO SE SI SK UKNot connected 1 50 986 0 19 0 0 0 0 0 22000 0 25 6 0 0 0 0 13 98 0 594 65 2281 0 0 23 2777Connected 1374 4892 2474 533 2687 19463 210 495 22091 821 0 1165 2350 1883 98 5 1250 822 217 2352 960 13396 2857 7270 1500 341 1994 11523Percentage remaining 0.07% 1.01% 28.50% 0.00% 0.70% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00 0.00% 1.05% 0.32% 0.00% 0.00% 0.00% 0.00% 5.65% 4.00% 0.00% 4.25% 2.22% 23.88% 0.00% 0.00% 1.14% 19.42%

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

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AGENDA

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OVERVIEW OF ALERTS AND SCANS IN ALL COUNTRIES

1,385,436 1,795,185 2,514,249 1,508,496 20,858,735

67,150,767

112,689,139 114,540,500

Week 11 Week 26 Week 41 Week 42

Number of Alerts Number of Total ScansRemarks: - This graph does not reflect the data for the

Netherlands in week 26 as no data werecommunicated at the time.

17Calendar Week 43 2019 EMVO MONITORING REPORT

TOTAL NUMBER OF ALERTS IN RELATION TO THE TOTAL NUMBER OF SCANS IN ALL COUNTRIES

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6.64%

2.67%

2.23%1.32%

Week 11 Week 26 Week 41 Week 42

Target rate:Less than 0,05%

Remarks: - This graph does not reflect the data for the

Netherlands in week 26 as no data werecommunicated at the time.Calendar Week 43 2019

EMVO MONITORING REPORT

AGENDA

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STABILISATION PERIODS OVERVIEW

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20 Countries

1 Country

Stabilisation period confirmed

N/A3 Countries

Phased approach to end stabilization periodNL SE

2 Countries

Note : stabilisation period only applies to packs released before 9th February 2019 for DK, FI, DE, and PL

4 Countries

AT BG CY CZ DE DK EE ES FI FR HU HR IE MT* NO LT LU PT SI SK

LI

LV PL RO UK

No stabilisation period has been decided

BE IS MT*

Stabilisation period has ended

* In Malta the stabilisation period has ended for wholesalers (9th August 2019) but has been extended for pharmacies (until the 8th February 2020)


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(NO DEAL) BREXIT PLANNING

21GLOBAL GS1 HEALTHCARE CONFERENCE

o EMVO has discussed with SecurMed the scenario of EMVOtaking a copy of the necessary data from the UK NMVS whenSecurMed can no longer finance it in order to use them in anew “proxy” system.

o There is a working understanding about the data that wouldneed to be transferred & about how this might be achievedwithout any contractual contravention.

o EMVO are working with Arvato to set up this proxy system.

o Regardless of the “progress” in UK parliament, unless Brexit isrevoked and/or the UK continues to be subject to the FMD, theissues at hand need to be addressed either now or at the endof 2020.

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AGENDA

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CONCLUSION (1/2)

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o The Hub and the National Systems need to bestabilised

o The system can only work if all actors are connectedto it

o Some manufacturers are connected but notuploading the corresponding data

o End-User issues are still present- improper scanninguse, not scanning serialised packs, uncompliant End-User software etc.

GLOBAL GS1 HEALTHCARE CONFERENCE04-06/11/2019

CONCLUSION (2/2)

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o Until the end of ‘stabilisation periods’, products triggering ‘false’alerts should still be dispensed.

o Without a connection of all supply chain actors using the system,there is a significant risk that alert levels remain high.

o EMVO/NMVOs can provide data to establish a risk map of the supply chain and focus enforcement efforts. EMVO stakeholders continue to believe in the power of ‘traditional’ on-site inspections to enforce compliance on supply chain actors.

o In consequence, EMVO would like to encourage NCAs to start enforcing the primary requirements of the FMD and DR.

GLOBAL GS1 HEALTHCARE CONFERENCE04-06/11/2019

Q&A

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Documents

1993 EFPIA - Executive for Administration and Finance. 2011 … › sites › default › files › docs › healthcare... · 2019-11-05 · check analysis has been performed on the