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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
© GS1 2018
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.
© GS1 2018
Not even a year…
• Deadline is 9th February
• Today – only 115 days left
for compliance = not even
four months!
• Time is running!
© GS1 2018
Where does GS1 play a major role ?
© GS1 2018
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 »
© GS1 2018
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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© GS1 2018
Medical Devices
© GS1 2018
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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© GS1 2018
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
© GS1 2018
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
© GS1 2018
Time for change is NOW …
© GS1 2018
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.
© GS1 2018
Safer more efficient care starts with a simple scan
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© GS1 2018
Contact DetailsUlrike Kreysa
GS1 Global Office, Brussels
E ulrike.kreysa@gs1.org
W www.gs1.org/healthcare
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