Collaboration: GS1 and Joint Initiative Council (JIC) in Healthcare

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1 Collaboration: GS1 and Joint Initiative Council (JIC) in Healthcare International Organisation for Standardization European Committee for Standardization Health Level 7 international International Health Terminology SDO Clinical Data Interchange Standards Consortium Integrating the Healthcare Enterprise World Health Organization World Customs Organization International Society for Blood Transfusion European Association of Hospital Pharmacists European Association of Medical Device manufacturer European Association of Pharmaceutical Manufacturer 1

2 Regulations in Healthcare Unique Device Identification: GS1accredited as UDI Issuing Agency by U.S. Food & Drug Administration (FDA) And other UDI regulations under development wordlwide Importance of Asian Harmonisation Working Party Regulatory bodies mandating traceability to fight against falsified medicines 2

3 UDI Purpose A common, worldwide system for product identification should eliminate differences between jurisdictions and offer significant benefits to manufacturers, users and/or patients, and regulatory authorities. 3

4 Unique Device Identification 1. A standardized system to develop Unique Device Identification numbers (UDI) 2. UDI in human readable and bar code/rfid on the device label 3. Data to be submitted to the UDI Database 4. Users need to implement. FDA expects GS1 to play a major role. 4

5 Examples of GS1 current activities in Asia-Pacific Facilitating the Track and Trace Systems Working Group of APEC project on Global Medical Product Integrity and Supply Chain Security: Strategic Roadmap and training Tool Kits to be developed Cooperating with regulatory bodies and with key trade associations on globally harmonised implementation of UDI systems: work with IMDRF members, supporting the US FDA on UDI regulations as UDI issuing agency, participation in key events and meetings with regional regulatory authorities GS1 Global Healthcare conferences: non-for-profit conferences bringing together regulators, industry and hospitals to learn from the latest updates and experiences directly from their local and international colleagues from over 25 countries Latest conference: 1-3 April 2014, Seoul, South Korea 5

6 Asian Harmonization Working Party Goals - To study and recommend ways to harmonize MD regulations in the Asian and other regions establish harmonized requirements, procedures and standards to coordinate with the GHTF/IMDRF, APEC and other related GS1 appointed as liaison member of the AHWP in December 2013, providing technical expertise 6

7 New McKinsey & Company report quantifies supply chain issues in Healthcare New McKinsey report Strength in unity: The promise of global standards in healthcare Highlights the cost savings and patient safety benefits of adopting a single global supply chain standard in healthcare Source: Available at: 7

8 Huge patient safety benefits and cost savings when adopting a single global standard in healthcare Implementing global standards across the entire healthcare supply chain could save 22,000-43,000 lives and avert 0.7 million to 1.4 million patient disabilities Rolling out such standards-based systems globally could prevent tens of billions of dollars worth of counterfeit drugs from entering the legitimate supply chain [We] estimate that healthcare cost could be reduced by $40 billion-$100 billion globally from the implementation of global standards Adopting a single set of global standards will cost significantly less than two (between 10-25% less cost to stakeholders) SOURCE: McKinsey report, Strength in unity: The promise of global standards in healthcare, October

9 55 Healthcare Leaders endorse GS1 Standards 9

10 Imagine a world where bedside scanning confirms that the patient gets the right product in the right dosage at the right time and the patient records captures all the details. where hospitals and pharmacies know the exact location of short-supply medical devices and drugs and when they can be delivered. where regulators can recall products with accuracy and speed from every point in the supply chain and there is no possibility of receiving a counterfeit product. 10

11 THANK YOU VERY MUCH!!!! 11