The new European Regulations – the Importance of GS1 standards in the Healthcare sector

Safer, more efficient care starts with a simple scan

Ulrike Kreysa, Senior Vice-President Healthcare, GS1 Global Office

17 October 2018

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Why regulation? A main driver - counterfeiting

According to Interpol more than one million people die each year from

counterfeit drugs!

An estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified. They affect every region of the world.

WHO Fact Sheet on Substandard and Falsified Medical products, 31 January 2018

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Is Europe safe? Are we safe?

In 2018: Parallel import companies have discovered four falsified batches of cancer medication, Velcade, in the Dutch and Danish supply chain

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The economic impact

European study on the economic impact of counterfeit medicines in the

European Union marketplace and its wider costs to industry, government

and society shows.

• Main findings:

• 4.4 % of sales lost annually by the sector due to counterfeiting

• EUR 10.2 billion of revenue lost annually by the sector

• Additional EUR 7.1 billion of revenue lost annually in related sectors

• 37 700 direct jobs lost annually

• 90 900 direct and indirect jobs lost annually

• EUR 1.7 billion of government revenue lost annually (taxes and social

contributions).

Source: EU IPO (Intellectual Property Office), September 2016

https://euipo.europa.eu/tunnel-web/secure/webdav/guest/document_library/observatory/resources/research-and-

studies/ip_infringement/study9/pharmaceutical_sector_en.pdf

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Protecting patients - the EU Falsified Medicine Directive

EU Falsified Medicine Directive 2011/62/EU (FMD)http://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf

EU Commission Delegated Regulation 2016/161https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

Prevent the entry into the legal supply of falsified medicinal products by requiring the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging of certain medicinal products for human use for the purposes of allowing their identification and authentication.

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Not even a year…

• Deadline is 9th February

• Today – only 115 days left

for compliance = not even

four months!

• Time is running!

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Where does GS1 play a major role ?

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The Unique Identifier in the Delegated Acts

Source: EU Commission Stakeholder Meeting, February 2016

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In Europe – and the world:A serialised secondary pack of medicines…

Product Identifier (GTIN)

Serial Number

Expiry date

Lot/Batch number

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The Unique Identifier for Portugal

Expiry date

Batch number

Serial number

Product identifier

National reimbursement

number – the « 5th data

element »

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EU FMD system - Authentication

Source: EFPIA

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Will everybody be ready by 9th February 2019?

• Nearly all European national hub’s (NMVO’s) connected. Missing are only Malta,

Liechtenstein/Switzerland and UK.

• Supplier: Large ones are ready and also connected to European Hub, but many

still missing

• Pharmacies: Not all ready – system integration necessary

• Hospitals: Very few to none – some pilots underway, but still many issues to be

discussed

• What will happen on 9th February with those not compliant???

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Medical Devices

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2010: The PIP scandal

The European Commission embarked on a

full regulatory overhaul of the medical

device regulations with the goals of

providing high levels of safety and restoring

public confidence. The new regulatory

framework around the medical device

industry, called the European Medical

Devices Regulation (MDR) includes

Regulations (EU) 2018/745 and 2018/746

and establishes an UDI (Unique Device

Identification) System enabling to

capture the link between the medical device

and the patient

http://europa.eu/rapid/press-release_IP-12-96_fr.htmhttps://www.lemonde.fr/societe/article/2012/01/18/les-grandes-dates-du-scandale-des-implants-pip_1625045_3224.html

© Copyright GS1 AISBL, 2012-2018. All Rights Reserved.

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The UDI system

UDI

• DIDevice Identifier

(static data)

• PIProduction Identifier

(dynamic data)

Static Data

Elements

• DI = primary access

key

• …

•…

AIDC

Machine –

readable Data

Carrier

• Linear Bar Code

• 2D Bar Code

• RFID

•…

UDID(database)

UDI/UDID - System

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GS1 role as UDI assigning entity

• GS1 was the first accredited UDI issuing agency by

the US FDA

• GS1 is listed in the EU Regulation as “UDI

assigning entities” until the EU Commission

potentially designates others. Final designation

expected in Q2 2019.

• All GS1 MO’s are supporting their users throughout

implementation including training and education

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UDI and GS1

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UDI Example of label

Device Identifier (DI)“Static” portion

GTIN (product

identifier) Production Identifier (PI)“Dynamic” portion

Application Identifiers (e.g. serial, lot number & expiry date)18

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Identifier

AT100A

GTINs

QTY DI

1 GTIN A

50 GTIN B

250 GTIN C

Level

UoU UDI-DI

Base Pack

2nd

3rd

Package DI

Package DI

Base Package DI

UDI Unit of Use

Before or after the supply chain,

where Basic UDI-DI is needed (see next slide)

NEW : EU specificity: “Basic UDI-DI”

In the supply chain, where trade item ID (GTIN) is to order, deliver, or invoice

Basic UDI-DI

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NEW GS1 Standard : “Global Model Number” to support implementation of the Basic UDI-DI

• GS1 Company Prefix + a model reference

• Model reference number: manufacturers internal numbers, can be alphanumeric

• In healthcare:- data title: “BUDI-DI” - for medical device registration- independent of packaging- never used in a data carrier

• GS1 implementation guide to be drafted in 2018-2019, based on the EU Commission guidelines

Example of Basic UDI-DI on regulated documentation:BUDI-DI: 5149854J856M

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UDI Databases – USA and EU

Part that the U.S. FDA UDI system focuses on today...

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Manufacturers are able to provide data to all UDI databases and their customers (hospitals, distributors, wholesalers, GPOs) simultaneously, with a single connection

Mapping of GDSN data elements with EUDAMED will start when technical specifications will be released by the EU Commission

Managing data and global standards: Global Data Synchronisation Network (GDSN)

GDSN Source Data Pool

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Time for change is NOW …

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The benefits of UDI

Manufacturers:

- cost optimization

- data synchronization

- process efficiency

Hospitals:

- adequately identified medical devices

- single and integrated system of information management

Regulators:

- higher levels of market surveillance

- more efficient adverse event reports and quicker recall - also across borders

Patients:

- Improved patient safety

- Better information and documentation

REGULATOR

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Reasons to care about patient safety…

...and the highest quality of care.

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Safer more efficient care starts with a simple scan

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Contact DetailsUlrike Kreysa

GS1 Global Office, Brussels

E ulrike.kreysa@gs1.org

W www.gs1.org/healthcare