Results

In order to implement the mandate of APEC Leaders and Trade Ministers, the Committee on Trade and Investment approved a project which will provide hands-on technical assistance to a suite of pilot projects using Global Data Standards in APEC supply chains. Following an open tender GS1 Hong Kong was awarded the official APEC contract which will cover implementation of pilots that will be measuring the efficiency gains by using GS1 standards and EPCIS data sharing platforms in international supply chains and cross-border government procedures.

The outcome of the pilot projects will assist APEC member economies to consider whether and how Global Data Standards can improve their supply chain performance in terms of reduction of time, cost and uncertainty as well as improvement in risk management. They will also assist APEC member economies to implement their commitments under the WTO Trade Facilitation Agreement (TFA) e.g. by providing advance and detailed information which can help government agencies focus risk assessments on high risk consignments and expedite the release of low risk consignments. Pilot shipments are scheduled to be completed by August-September 2016.

Situation

Optimizing and further enhancing the logistical elements of the global supply chains that enterprises need to engage in production and distribution on a global footing, including supply and production logistics, international transportation, and sales distribution, is growing in importance.

APEC member economies are working toward achieving the Bogor Goals for free and open trade and investment in the Asia-Pacific. Enhancing supply chains to reduce the time, cost, and uncertainty involved in movement of goods and services in the Asia-Pacific is tremendously important to advancing liberalization of trade and investment and furthering economic growth in the region. This importance is reflected in developments such as the Supply Chain Connectivity Initiative and the Supply Chain Chokepoints. The issue has remained high on the agenda since 2009.

Given their importance, active steps need to be taken to develop and enhance reliable supply chains by, among other things, capacity building to develop single windows, Authorized Economic Operators and lowering barriers to small and medium enterprises(SMEs) joining global value chains.

Approach

In any international transaction of goods, a range of information needs to be exchanged between various parties as the goods move along the supply chains. This was recognized by the APEC Business Advisory Council (ABAC), which recommended that APEC should explore the potential of leveraging Global Data Standards in APEC supply chains, for efficiency, security and visibility purposes. Global Data Standards is used to ensure that relevant information is provided in a common format which is easily understood and sharable by all parties. APEC Leaders and Trade Ministers have recognized the contribution that Global Data Standards can make to enhancing supply chains in the APEC region.

In 2013, APEC Ministers “recognized the contribution that global data standards can make to enhancing supply chain efficiency, and encouraged officials to explore what more can be done to facilitate mutual compatibility amongst data standards frameworks, and the compatibility of economies’ frameworks with the use of GDS”. In 2014, they instructed officials “to further advance work on global data standards by developing pilot projects with the participation of the private sector”. And, in their 2014 Declaration, Leaders encouraged APEC member economies to work with the private sector to promote further cooperation on GDS and their wider use by developing pilot projects.

In the GCC Region, Saudi Arabia is the first country to establish a national system of drug traceability.

Alignment on global standards to ensure harmonisation across the region is critical.

Results

The SFDA published a circular stating the dates of implementation in two phases:

• Use of 2D bar codes with Batch or Lot Number, Expiration
• Date and SFDA code will be due on the 21 February 2015
• All of the above plus a Serial Number due on the 21 March 2017

The SFDA is working with GS1 KSA on similar requirements for medical devices identification (UDI) and for cosmetics.

Situation

SFDA believes in a standardised identification system for drugs from the manufacturer to the patient to comply with increasing need for product integrity and traceability.

SFDA released requirements on barcoding of drugs imposing that all Saudi and international drug manufacturers exporting to Saudi Arabia adopt GS1 supply chain standards.

Approach

All drugs’ markings must be upgraded from linear bar codes to GS1 DataMatrix bar codes.

The GS1 DataMatrix bar code must, at minimum, carry the GTIN (Global Trade Item Number), Expiration Date, Batch or Lot Number.

The new requirements must be applied by drug manufacturers on all type of pharmaceutical products (both human and veterinary drugs).

Rick and Rosemary Drury are third-generation growers.

Their family has been supplying Woolworths ever since the supermarket introduced fresh fruit and vegetables into its stores in the 1960s.

Results

Decreased business and consumer risk, reduced costs, and helped improve food safety, protecting its business relationships and the brands of its customer.

Reduced time spent on semi-annual recall tests for HACCP audits from hours to 30 minutes.

Demonstrated fast and effective recall notification processes to its customers.

Reduced time required to issue a recall or withdrawal notification, minimized the risk of miscommunication to trading partners and consumers, and automatically notified relevant government agencies.

Situation

Fruit and vegetable producers sell to major supermarkets, market agents, processors and distributors. Increasingly, these customers are insisting that their suppliers have quality systems based on Hazard Analysis Critical Control Point (HACCP).

At the same time, Drury Orchards is always looking for ways to improve business processes in order to foster long-term relationships with its customers, which include the major Australian retailer Woolworths. Therefore, this South Australian grower was eager to improve its manual paper-based product recall and withdrawal process.

Approach

Drury Orchards had a formal process for recall and withdrawal notifications. It was based on the the Food Standards Australia and New Zealand Product Recall Protocol and followed a flowchart format. The format relied on filling out separate paper forms for each individual customer. Twice a year, the company tested the process to ensure it fulfilled HACCP’s exacting requirements, but the manual process was time consuming and created the potential for errors.

Drury Orchards transitioned its process to a web-based portal designed around global GS1 standards and best practices. The portal simplified and automated recall and withdrawal notifications, employing a template that could be reused with multiple business partners. The system’s “mock recall” functionality also allows the company to efficiently test its recall readiness.

On 17 December 2013, GS1 was accredited by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).

The basic underlying issue is the lack of a consistent, standardized way to identify devices. When it comes to doing things like adverse event reporting or aggregating adverse events or other post market surveillance, we don't currently have a way to unambiguously identify devices, which creates all sorts of problems for everyone. UDI provides a standardized, unambiguous identification which supports all these sorts of activities for devices as well.

Jay Crowley

Vice President of UDI Services and Solutions, USDM Life Sciences

Results

On 17 December 2013, GS1 was accredited by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).

Global GS1 standards meet the U.S. government’s criteria for issuing UDIs and is helping manufacturers comply with the requirements of the FDA UDI regulation, to support patient safety and supply chain security.

Situation

Following the case of the breast implants manufactured by the PIP Company in Europe and other recent scandals, the United States Food and Drug Administration (FDA) and other regulators in the IMDRF (International Medical Device Regulator Forum), have made patient safety a strategic priority by developing legislation for Unique Device Identification (UDI).

UDI is expected to improve patient safety and Healthcare business processes. A single, global system of standards is fundamental to enable an efficient and effective implementation of UDI by all Healthcare stakeholders worldwide.

More information https://www.gs1.org/healthcare/udi

Approach

The U.S. FDA released, in September 2013 a rule which establishes that a common, worldwide system for product identification should be applied to all medical devices placed on the U.S. market. The rule establishes that:

a unique device identifier number should be assigned by the device manufacturer to each version or model of a device

the unique device identifier should be both in human readable format and in AutoID format. By default, this information will be applied on the label of each device uniquely identified.

UDI should be applied to all medical devices made available on the US market.

Results

In order to allow a scaled implementation scheme, the system takes into account the different categories of drug products and the means and technological systems available, whilst reducing any obstacles that the patient may face. Implementation started with a wide list of costly critical drugs and have then been extended to all new drugs registered and launched in the market. From December 2011 until end 2014, this includes more than 111 million logistic events, which correspond to more than 25 million individual units of medicine (GTIN + Serial Number).

Situation

In 2011, the National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT) introduced a catalogue of drugs covered by its national drug traceability scheme, listing more than 3.000 medicines that require the placing of unique serial numbers and tamper-evident features on the secondary packaging.

This programme is based on the use of the GS1 system for traceability and its purpose is to actively limit the use of illegal drugs.

Today, ANMAT has shown that the implementation of the system has delivered more than favourable results.

Approach

The National Traceability System imposes that all drugs be serialised through the application of an unambiguous code, according to the recommendations of the GS1 Standards. Each drug should contain the Commercial Product Code, the Global Trade Item Number (GTIN) and a unique Serial Number placed on the secondary packaging. This information can be integrated into any type of data carrier, provided that it complies with the GS1 standards mentioned above, allowing each owner to choose the most appropriate data carrier for their products (whether it is a linear barcode, GS1 DataMatrix, EPC/RFID tag or any other). Notwithstanding the data carrier of choice, the information must always be placed in human readable format so the patient may read it.

Global Location Numbers (GLNs) are used to identify the various actors in the supply chain.