GS1 standards for unique identification of medicinal products Lisbon, Portugal 3 July 2013 Silverio Paixão, Chief Innovation & Standards Officier, GS1 Portugal
Who is GS1? GS1 a neutral, not-for-profit, international organisation dedicated to the design and implementation of global standards to improve the efficiency and visibility of supply chains globally and across sectors GS1 Global Office (Brussels) and local offices in 111 countries around the globe Close to two million members Over 6 billion transactions a day
GS1 in Healthcare: A global system of standards 3
GS1 Healthcare a voluntary, global Healthcare User Group To lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies.
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: http://www.mckinsey.com Available at: http://www.gs1.org/healthcare/mckinsey or http://www.gs1.org/docs/healthcare/mckinsey_healthcare_r eport_strength_in_unity.pdf 5
Huge cost savings and patient safety benefits 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 millions 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 2012 6
Pharma World (including Europe) coding & serialisation requirements It s a complex context in development that can become more and more complex, if not handle in a combined and global way In Europe since 2011 we are undergoing a major development which will come to a significant milestone in the beginning of 2014 with the finalization of the Delegated Acts and his subsequent application Regulated requirement Tender requirement Important development Emerging regulatory requirements
Serialisation of pharmaceuticals = country requires serial number = country developing requirement for serial number
DataMatrix on pharmaceuticals Canada: Vaccines Switzerland: SmartLog Pilot Spain: Pilot US: Pilot on Vaccines France: AFSSAPS regulation (2011) Belgium: Pilot project unit dose marking Austria: Cytostatics Serbia: Pilot Turkey: Regulatory requirement (2010) Korea: pharma regulatory requirement (2012) Colombia: Pilot of INVIMA on traceability Brazil: Traceability pilot successfully completed ANVISA regulation Argentina: Traceability regulation India: Tender requirement for October 2011 = country requires DataMatrix = country using DataMatrix in pilots and/or developing requirement for DataMatrix 10
The move towards harmonisation and GS1 standards in Europe
Options for countries with national numbering systems - adopting GTIN 4 options have been identified to allow those countries with national numbers use a GTIN Option Description 1 Replace the national number with a GTIN If the GTIN can replace the national number, it should be considered. Only one code has to be maintained and it will simplify packs, systems and processes. It is recognised that this migration path is not always possible or necessary. 2 3 4 Put the GTIN on pack and look-up the national number in a database Put both the GTIN & national number (in NHRN format) on the pack Allocate national numbers from the GTIN pool Place a GTIN on the pack in a data carrier such as a 2D GS1 DataMatrix and use enabled IT systems to look up the NHRN/ national number. This will not be possible without system migration in many instances but should be explored as a good option with many advantages. In doing so it needs to be ensured that national integrity is assured and that there is a one to one relationship of both numbers at the secondary packaging level. Put both the GTIN and National Number (in an NHRN format) into the data carrier on the pack. This will allow either to be accessed and is a good solution. Over time as IT systems are updated the NHRN could be removed from the pack and looked up as an attribute of GTIN. There are technical considerations for manufacturers as this increases the amount of data held in the barcode. This is a more complex path and creates a type of code called an NTIN (National Trade Item Number). The European Commission will decide the specifications for product identification in delegated acts to be released by 2014 12
ERP Entries Scanning & AIs in action... 01108576740020171714112010NYFUL0121192837? 0110857674002017 17141120 10NYFUL01 21192837 10857674002017 20 Nov 2014 NYFUL01 192837 GTIN: 09012345670016 EXPIRATION: 21.Mai 2012 SERIAL: 123456 BATCH/LOT: 123456
The need for global standards Healthcare is local Healthcare providers are local Regulations are local Healthcare is global Healthcare supply chains often cross borders Country-by-country solutions are not sufficient nor effective A global harmonised approach and implementation is needed
Contact Details Silverio Paixão Chief Innovation & Standards Officier GS1 Portugal E s.paixao@gs1pt.org W www.gs1.org/healthcare
GS1 Healthcare User Group Supply-side organisations engaging further
Leading healthcare organisations pave the way Buyer/Provider-side organisations going global France Germany Netherlands Macedonia Hong Kong Switzerland Austria Saudi Arabia Germany USA Austria USA Ireland Netherlands France USA USA
32 Local Healthcare user groups driving adoption of GS1 standards worldwide 18
GS1 Standards for Healthcare Standards development continues, but global standards are ALREADY available to build on: AIDC Application Standards for 90% of medical products AIDC Application Standards for small instruments Healthcare extension in next GDSN release Global Traceability Standard for Healthcare GTIN Allocation Rules for Healthcare Guideline for plasma derivatives Patient and Caregiver Identification AI for National Healthcare Reimbursement Number (NHRN)
A GTIN for every packaging level Pallet Tertiary package: Case / Shipper Secondary package Primary Package: Single or Multiple Unit Single Unit 20
The coding situation in Europe today 17 countries have a full GS1 GTIN (1) code structure (UK, Ireland, Czech Republic, Slovakia, Latvia, Lithuania, Estonia, Malta, Netherlands, Turkey, Romania, Bulgaria, Serbia, Albania, Bosnia and Herzegovina, Macedonia) 5 countries use an NTIN (2) (EAN 13 compatible code structure) with product identification number allocated by a number bank or an external agency for the coding of pharmaceuticals (Austria, France, Greece, Slovenia, Spain) 7 countries allow NTIN AND GTIN (DK, Finland, Iceland, Norway, Poland, Sweden, Switzerland) 4 countries have their own non- GS1 compatible solution (Belgium, Germany, Italy, Portugal) - Germany in combination with NTIN (1) GTIN: Global Trade Item Number 2) NTIN: National Trade Item Number