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

Transcription

1 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

2 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

3 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 3

4 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 direct jobs lost annually 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

5 Protecting patients - the EU Falsified Medicine Directive EU Falsified Medicine Directive 2011/62/EU (FMD) EU Commission Delegated Regulation 2016/ /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.

6 Not even a year Deadline is 9 th February Today only 115 days left for compliance = not even four months! Time is running!

7 Where does GS1 play a major role?

8 The Unique Identifier in the Delegated Acts Source: EU Commission Stakeholder Meeting, February

9 In Europe and the world: A serialised secondary pack of medicines Product Identifier (GTIN) Serial Number Expiry date Lot/Batch number 9

10 The Unique Identifier for Portugal Product identifier Expiry date Batch number Serial number National reimbursement number the «5th data element»

11 EU FMD system - Authentication Source: EFPIA 11

12 Will everybody be ready by 9 th 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 9 th February with those not compliant??? 12

13 Medical Devices

14 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 Copyright GS1 AISBL, All Rights Reserved. 14

15 The UDI system UDI/UDID - System DI UDI Device Identifier (static data) PI Production Identifier (dynamic data) UDID (database) Static Data Elements DI = primary access key AIDC Machine readable Data Carrier Linear Bar Code 2D Bar Code RFID 15

16 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 Q All GS1 MO s are supporting their users throughout implementation including training and education 16

17 UDI and GS1 17

18 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

19 NEW : EU specificity: Basic UDI-DI Identifier AT100A Before or after the supply chain, where Basic UDI-DI is needed (see next slide) Basic UDI-DI Level UoU UDI-DI Base Pack 2nd QTY DI 1 GTIN A 50 GTIN B UDI Unit of Use Base Package DI Package DI In the supply chain, where trade item ID (GTIN) is to order, deliver, or invoice 3rd 250 GTIN C Package DI GTINs 19

20 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 Example of Basic UDI-DI on regulated documentation: BUDI-DI: J856M GS1 implementation guide to be drafted in , based on the EU Commission guidelines 20

21 UDI Databases USA and EU Part that the U.S. FDA UDI system focuses on today... 21

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

23 Time for change is NOW

24 The benefits of UDI Manufacturers: - cost optimization - data synchronization - process efficiency Hospitals: - adequately identified medical devices - single and integrated system of information management REGULATOR 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 24

25 Reasons to care about patient safety...and the highest quality of care.

26 Safer more efficient care starts with a simple scan 26

27 Contact Details Ulrike Kreysa GS1 Global Office, Brussels E ulrike.kreysa@gs1.org W