IMPACCT Working Group Importation of Medicines and Medical Equipment during disease outbreak
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IMPACCT Working Group Importation of Medicines and Medical Equipment during disease outbreak © GS1 2021 1
GS1 Competition Law Caution • GS1 operates under the GS1 Competition Law Caution. Strict compliance with competition laws is and always has been the policy of GS1. • The best way to avoid problems is to remember that the purpose of the group is to enhance the ability of all industry members to compete more efficiently. • This means: - There shall be no discussion of prices, allocation of customers, or products, boycotts, refusals to deal, or market share - If any participant believes the group is drifting toward impermissible discussion, the topic shall be tabled until the opinion of counsel can be obtained. • The full caution is available via the link below, if you would like to read it in its entirety: http://www.gs1.org/gs1-anti-trust-caution • © GS1 2021
Zoom poll 1: What does GS1 stand for? 1. Global Supply Chain 1; 2. Global Services 1; 3. Global Specifications 1; 4. Global Standards 1 © GS1 2021
Zoom poll 2: What does GS1 do? 1. GS1 is a solution provider; 2. GS1 is a sectoral association; 3. GS1 is a global standard development organisation; 4. GS1 is a donor organisation; © GS1 2021
GS1 believes in the power of standards to transform the way we work and live ➢ Everything began with a barcode on 26 June 1974: a packet of chewing-gum is the first barcoded product to be scanned in a store ➢ Global, neutral, non-profit standard development organisation that brings efficiency and transparency to the supply chain;NGO to the UN ➢ Standards are proven, open and benefit from collaboration with respected global companies and local SME’s; ➢ Strong engagement with governments across multiple sector and geographies; ➢ GS1 Global works with Retail, Food, Technical industries, Transport/Logistics and of course Healthcare © GS1 2021
GS1 standards and traceability of healthcare products Tracking products across the healthcare supply chain: - helps to decrease counterfeit healthcare products; - Increase supply chain efficiency as well as patient safety; - complies with regulations Traceability in healthcare enables you to see the movement of drugs, medical devices, vaccines and PPE across the supply chain. = Visibility* = What, When, Where & Why RIGHT RIGHT RIGHT LOW PRODUCT TIME PLACE COST © GS1 2021 10
GS1 Healthcare in access and humanitarian aid in the developing world https://www.youtube.com/watch?v=CI_Ae7JXZKQ © GS1 2021 11
Comment (Géraldine) There is a need for global harmonisation in a very challenging global healthcare context © GS1 2021
The need for harmonised Pharmaceutical and UDI requirements The legal landscape for traceability of pharmaceutical products and medical devices is always moving which means long-term compliance is a two-fold challenge. © GS1 2021
Unique identification of pharmaceuticals = country accepts GS1 Standards = country requires national ID # = no input available © GS1 2021
GS1 DataMatrix on pharmaceuticals © GS1 2021
Requirements for medical device identification © GS1 2021
WHO Policy paper on traceability of medical products This policy paper outlines the features of existing traceability systems and provides guidance on developing workable traceability regulation. For this purpose, Member States are encouraged to: - establish a suitable governance process for their traceability system based on the analysis of national specificities (e.g. regulatory environment, supply chain management); - include a costing analysis as well as a sustainability mechanism in their traceability system planning to prevent costs from negatively impacting patients, government, supply chain stakeholders, and ultimately, access to medical products; In particular, this paper refers to the use GS1 global standards for product identification, production identification, automatic identification, and data capture and data exchange to reduce set-up and operating system costs and maximize national and international interoperability. https://www.who.int/publications/i/item/policy-paper-on-traceability-of-medical-products published in March 2021 © GS1 2021 17
Africa Strategy for Pharmaceutical Traceability https://www.gs1.org/events/2019/lagos/call-to-action © GS1 2021 18
Last question for Sophie/ Géraldine How can GS1 support and collaborate with the IMPACCT working group on this topic? © GS1 2021
What has been done in partnership with the WCO Border Procedure Up to 2015 – now abandoned In 2019 World Customs Organisation (WCO), has dubbed 2019 as: Warehouse management “the year of SMART Borders”, focusing on the swift and smooth cross- border movement of goods, people and means of transport. GS1 is supporting WCO to improve border operations, working with both industry and government. © GS1 2021
What is currently done in terms of humanitarian logistics Border Procedure Warehouse management © GS1 2021
Future actions to support IMPACCT working group • Raising awareness • Training and education of people • Supply chain efficiency and integrity • Fight against counterfeiting and diversion of goods • Connect with regulatory authorities and other intergovernmental organisations Proposal: Facilitation of working group with concrete list of projects (mapping of countries which are using the SSCC or not; mapping of suppliers using GS1 or not, etc…) © GS1 2021
Contact Details Géraldine Lissalde-Bonnet Sophie Molle Director Public Policy Senior Manager Healthcare GS1 Global Office, Brussels GS1 Global Office, Brussels E g.lissalde@gs1.org E sophie.molle@gs1.org W www.gs1.org/healthcare
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