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DSCSA Compliance Update with Herb Wong: What’s Happening Right Now?

Herb Wong’s a busy guy. We said that the last time we did a DSCSA compliance update with him, and it’s still true today Just last week, for instance, he participated in two Healthcare Distribution Alliance (HDA) webinars, “DSCSA 2023: How a Service Provider Can Help You Prepare” and “All About the VRS.” These were part of the HDA’s 2022 Traceability Webinar Series, which Antares Vision Group is sponsoring.

That’s why it was such a treat to get some one-on-one time with Herb for a real-time DSCSA compliance update — what’s happening right now with industry readiness.

We asked Herb to talk about what he calls “the four cornerstones” of DSCSA compliance: product identification (EPCIS and serialization), product tracing, authorized trading partners (ATPs), and verification (the Verification Router Service, or VRS). Here’s what he had to say.

DSCSA compliance update #1: product identification (EPCIS and serialization)

All solution providers’ systems are ready to send and receive serialization data in the EPCIS format, but we still need to help the industry get data flowing. To use an analogy, even though the pipes have been laid and connected, we’re just not getting enough water through to test for “leaks” in the system — errors in send/receive processing. Just as important, we need time to “flush the pipes” to ensure that we have “clean water.” By that I mean ensuring that the data is correct.

We’re trying to do everything we can. We’ve actually developed a standard process for onboarding customers and getting data exchanged with other solution partners. We’re going to be piloting this so we can refine the onboarding process. [Herb’s talking about the EPCIS Onboarding Guide Workgroup and its draft “Guide for Accelerated EPCIS Onboarding.”]

What’s the key takeaway, Herb?

The key takeaway is, “Let’s connect, let’s get the serialized data out.” Time is running out. That’s the biggest message. People who think they have time to wait until next year, you really don’t. Because what’s going to happen is similar to what happened when the lot-based laws went live: The people who waited couldn’t find help. All the solution providers were busy; everyone was busy. And everyone who waited was trying to get through the same door to meet the deadline.

So, if you’re a manufacturer, you have to start sending data early. If you’re serializing and not sending data downstream, start now. Don’t wait till the November 2023 deadline. You have to “turn on the switch.” Send your data downstream now.

At this point, we decided to ask Herb about aggregation.

DSCSA doesn’t say anything about aggregation. But wholesalers are asking for aggregation to support their business processes. When you send electronic data, wholesalers need to know what serial numbers are in the cases they just received.

Aggregation is a business requirement for operational efficiency. For example, if you get 10 cases with a hundred items in each case, you don’t want to open the cases and scan every item to see what you received and will ultimately ship. Aggregation makes things faster and more efficient. It’s similar to how VRS had both a legal and a business requirement: The legal requirement mandated a response within 24 hours for saleable returns verification. But given the potential volume of saleable returns, 24 hours was too slow for wholesalers; it would cause the receiving docs to fill up with products pending verification. For this reason, wholesalers mandated a business requirement of sub-second response times.

DSCSA compliance update #2: product tracing

A centralized solution or standard has not been defined for product tracing. A lot of different approaches have been discussed, but there’ve been no specs, no firm requirements, that solution providers can implement at this time.

Right now, we’re supporting the industry’s manual process for product tracing. The HDA, NABP, and PDG have done a really good job of outlining what’s required for tracing. [That’s the Healthcare Distribution Alliance, the National Association of Boards of Pharmacy, and the Partnership for DSCSA Governance.]

They’ve walked through a series of scenarios that can be executed manually and have helped the industry to better understand the complexity and nuances of tracing a product through the system. In parallel to this effort, the PDG is working on a data format to communicate traceability requests and responses. PDG is putting that information into a JSON format to communicate the need. [JSON is the JavaScript Object Notation data interchange format. Its advantages are that it uses human-readable text and is a more compact means of communicating data.]

What’s the key takeaway, Herb?

Pay attention to the traceability scenarios that are coming out of the HDA, NABP, and PDG. They’re doing a really good job of trying to show how tracing workflows will happen. They’ll be publishing more results and helping the industry understand. Watch for these, because it will enlighten you about what’s coming in 2023.

DSCSA compliance update #3 and #4: ATPs and VRS

From a solution provider standpoint, the ATP and VRS initiatives have become one and the same. Right now, ATPs have only been applied against the VRS, so the timing for us to get that done has become one implementation effort.

When you make a VRS request, you have to prove you’re an ATP. ATP is there to confirm two things: you are who you say you are and you are authorized to transact business. Proof that you are an ATP is especially important in the VRS network since trading partners may not have direct relationships with other VRS participants.

For VRS, there’s a new version 1.3 that will be deployed before the DSCSA 2023 deadline. The current version we have is based on the 1.2 standards interface. The 1.3 version “opens up” VRS beyond what it was intended to do, which is the verification of saleable returns.

What people should know is that VRS 1.3 is not backwards-compatible. This means VRS providers have to upgrade at once. To ensure that the upgrade occurs on time, solution providers have agreed to “decouple” the 1.3 interface from the 1.3 functionality.

What this means is that everyone on the VRS network will remain connected since we will all support the new 1.3 connections. However, solution providers (or customers) who are not ready to upgrade to the new 1.3 functionality can continue to use VRS as needed. That’s going to be important because it allows us to change the interface so we can at least keep talking to each other. We can be interoperable. But not everyone has to support the features of 1.3 at the same time.

As for timing of the update, we’re talking about doing the testing of the interoperability of 1.3 in Q1 [of 2023]. So we’ll have to push this into a production environment after Q1, but we haven’t agreed on a production date.

What’s the key takeaway, Herb?

There is going to be an upgrade required soon and the industry and solution providers are working to make sure it’s easy to implement. We realize that is not as simple as a software upgrade but we need to carefully consider the revalidation requirements of our customers.

Final thoughts

And there you have it: A DSCSA compliance update about what’s happening right now with industry readiness for product identification (EPCIS and serialization), product tracing, and ATPs and VRS. Thanks, Herb!

Contact us if you have questions about what Herb talked about or the DSCSA in general. We can explain the requirements and how our solutions will help ensure you’re ready for November 2023 and the full serialization of the U.S. pharmaceutical supply chain.

If you like, we can probably arrange a meeting with Herb. But remember, he’s busy. In the coming weeks, he’ll travel to the Antares Vision Group global HQ in Italy, visit the Group’s brand-new North America HQ in New Jersey, and join a panel discussion at the HDA Traceability Seminar in Washington, D.C. (Antares Vision Group is also a sponsor of that annual event.) So reach out today and let’s see what we can work out.

Also take a look at our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including the “four cornerstones” Herb talked about in today’s DSCSA compliance update.

Healthcare Value Chain: What It Is and Why It Is Important

In the healthcare sector, delayed, lost, and damaged products can cause grave danger, as patients might not receive the medicines they need on time and many items are susceptible to fluctuations in environmental conditions. That’s why it’s crucial to have a reliable and robust healthcare value chain.

Let’s examine the critical role that the healthcare value chain plays. Our technologies and solutions help pharmaceutical companies, hospitals, and other healthcare stakeholders streamline and manage their entire supply chain, from procurement to distribution.

Understanding the healthcare value chain

Most may believe that the value chain and supply chain are synonymous. However, they are two different terms describing different aspects of supply logistics. The supply chain refers to the movement of goods from suppliers to customers; the value chain encompasses all activities involved in creating and delivering a product or service.

In other words, the supply chain is more about the physical movement of goods and the value chain adds value to a product, including production, marketing, and customer support after the sale. So, the healthcare value chain allows medical institutions to provide patients with the best possible care by ensuring they have the supplies and treatments they need when they need them.

What happens in a healthcare value chain?

Understanding the activities involved in the healthcare value chain is the first step in managing and streamlining its processes. We’re talking about logistics, operations, marketing and sales, and service.

Inbound logistics. The value chain is not a product-driven process, so explaining inbound logistics can be challenging. Generally, inbound logistics in a value chain refers to the quality of inventory and the management of that inventory. Value-driven inbound logistics ensures that all inventory is accounted for and is of the highest quality. This includes checking that items are not expired or damaged and meet all necessary requirements (e.g., internal quality control, standard operating procedures).

Operations. The operations stage of the healthcare value chain is where the actual product or service is produced. In this value-driven scenario, product operations and/or manufacturing aim to reduce waste and create efficiencies. This might involve automating processes, changing production methods, and improving the quality of raw materials. In healthcare, the goal of operations might be to streamline the manufacturing of drugs or medical devices.

Outbound logistics. Like inbound logistics, outbound logistics in a value chain should strive to ensure that a product or service reaches the customer in the best possible condition and in a timely manner. In healthcare, this means making sure that patients receive their supplies and treatments when they need them, as well as ensuring products are safe and legitimate.

It’s also important to note that outbound logistics isn’t just about the distribution of supplies outside a warehouse. It also concerns how medical institutions distribute supplies internally. This is important to consider when managing a hospital or other medical facility.

Marketing and sales. Marketing and sales in the healthcare value chain focus on creating demand for a product or service. Traditionally, this includes advertising, promotions, and other marketing initiatives. In a value-driven context, marketing and sales are strategically designed to go beyond a one-time sale to create long-term relationships with customers. There are numerous ways to do this, ranging from creating educational materials for patients and promoting online services to partnering with insurance providers.

Service. The service stage of the healthcare value chain is where post-sales activities occur, such as continuing customer support, repairs, and maintenance. Value-driven service helps maintain customer satisfaction with the product or service and helps ensure their needs are being met. Customer loyalty programs, follow-up communications, and offering extended warranties are common examples.

The healthcare value chain in numbers

Now that we’ve summarized the different stages of the healthcare value chain, let’s look at some numbers that help illustrate why these processes are so vital to the healthcare industry.

One 2019 report found that clinicians devote about 17 percent of their time to logistics and storage management activities. This affects their productivity and the quality of care they can provide.

The report also found that more than 4,500 different medical devices and products are recalled every year — and 10 percent of these have the potential to cause harm or death. One study published by the well-known consulting outfit McKinsey & Company reported that the “costs of a single non-routine quality event, like a major recall, have been as high as $600 [million] in medical device companies.”

The long-term business benefits of an effective healthcare value chain

An effective healthcare value chain creates benefits beyond improving quality of care and securing patient safety and satisfaction. It creates business benefits, including:

Improved profitability. An effective healthcare value chain can boost a bottom line by improving supply systems, reducing waste, and creating efficiencies across healthcare systems.

Promoting innovation. Less waste and more efficient systems mean savvy companies can devote more resources to R&D that can lead to innovation in all realms, including the development of new treatments or therapies and better manufacturing and distribution schemes.

Helping meet business goals. An effective healthcare value chain contributes to business success by reducing waste, increasing efficiencies, and promoting innovation. It also helps businesses connect with customers and build brand loyalty.

Final thoughts

What’s the main takeaway from this overview of the healthcare value chain? Establishing an agile and robust value chain is essential to success in the healthcare industry — in every industry.

We’ve specialized in creating software solutions for the healthcare value chain (and the healthcare supply chain) for almost 20 years. Our No. 1 priority is to help businesses optimize their operations and improve the quality of the products they manufacture and deliver to consumers.

For the healthcare and pharmaceutical industries, this means providing a digital traceability platform that helps ensure your devices and medications are safe, are transported following proper protocols (e.g., routes and environmental parameters), are delivered on time, and meet all regulatory requirements. It means real-time data and visibility into every aspect of your operations from virtually any location in the world.

rfxcel and Antares Vision Group understand the healthcare value chain, its complexities, and how to optimize it for patient security, customer satisfaction, and business success. Contact us today to schedule a short demo of our solutions. Our experts will answer your questions and show you why major global healthcare and pharmaceutical companies rely on our technology to secure and improve their operations.

Understanding FDA DSCSA Guidance for the Pharmaceutical Industry

The Drug Supply Chain Security Act (DSCSA) was passed 10 years ago in November 2013. Congress created the legislation to secure the U.S. pharmaceutical supply chain through unit-level product identification (serialization) and electronic exchange of product information.

Over the years, the FDA has issued updates and revised DSCSA guidance for manufacturers, dispensers, wholesale distributors, and other pharma stakeholders. If your products and/or operations are regulated by the law, it is vital to remain aware of requirements, changes, and deadlines.

Let’s explore the DSCSA guidance and requirements and what the FDA has done in recent years.

What Is the DSCSA?

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

Who Must Comply with the DSCSA?

Manufacturers, wholesale distributors, repackagers, dispensers (i.e., pharmacies, healthcare systems), and third-party logistics providers (3PLs) all have requirements with which they must comply.

Recent DSCSA Guidance Updates

Recently, the most notable action from the FDA was its announcement in August 2023 that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

This DSCSA guidance primarily affects manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers (PIs) at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products.

Though this gives the industry more time to comply, the Agency has made it clear that the postponement doesn’t amount to a grace period. It said the stabilization period was “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements.”

You can read the FDA’s official document about the stabilization period here.

Other Noteworthy DSCSA Guidance Updates

July 25, 2022: The FDA published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The National Drug Code, or NDC, is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Read more about the NDC and what the FDA said here.

October 23, 2021: In a policy document, the FDA announced it was delaying enforcement of key requirements to verify saleable returns. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The timeline below provides an at-a-glance view of DSCSA guidance as the law has been rolled out over the last decade.

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

DSCSA Guidance in Context, Today

The stabilization period announced in August 2023 did not, in fact, change the original compliance deadline of November 27, 2023; it is up to individual states to decide if they’re going to enforce the requirements before November 2024.

However, the FDA said extending enforcement will give supply chain stakeholders the extra time that may be necessary “to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”

What DSCSA Requirements Are in Effect Right Now?

It follows from what we just said that there is DSCSA guidance in effect right now. Some digressions are prohibited per the FD&C Act and can be enforced — with consequences ranging from product seizure to fines to imprisonment. Both federal and state authorities may take action against DSCSA violations.

What Was Enforceable Before Nov. 27, 2023?

Here are a few regulations that can be enforced now. For a full list, see the National Association of Boards of Pharmacy’s (NABP’s) excellent article here. (And also be sure to read about how we were the first DSCSA solution provider to join NABP’s Pulse Interoperable Partner Program. Learn more here!)

  • All trading partners must be authorized trading partners (ATPs) and can only buy, sell, or trade with other ATPs.
  • ATPs must be able to identify and manage suspect and illegitimate products.
  • A product identifier (PI) must be placed on all regulated drug packages and homogenous cases — except for grandfathered products or products with an FDA waiver, exception, or exemption.
  • ATPs must provide certain information about a drug and who handled it each time it’s sold: transaction information (TI), transaction statement (TS), and transaction history (TH).

What Went into Effect on Nov. 27, 2023?

The November 2023 deadline was when enhanced security requirements went into effect. We’ve written extensively about this for years (in our recently updated DSCSA white paper, for example), but here’s a summary of what companies must do to comply:

  • Exchange TI and TS securely, electronically, and interoperably. TI must include each package’s unique identifier.
  • Verify PIs at the package level.
  • Respond to appropriate tracing requests and trace products at the package level (serialization).
  • Associate saleable returns with the TI and TS associated with its initial sale.

Final Thoughts About DSCSA Guidance

So what’s the upshot of all this information? It’s simple: Don’t stop preparing.

Use your extra time during the stabilization period to evaluate your systems, communicate and coordinate with your trading partners, and — importantly — ensure you’re working with a solution provider that knows the DSCSA guidance inside and out.

If you have questions about the DSCSA or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We are committed to meeting DSCSA compliance for all our customers in a timely manner.

Everything You Need to Know About Kazakhstan Pharma Serialization

Welcome to Part 2 of our series about Kazakhstan serialization and traceability requirements. Part 1 detailed the country context, including government efforts to achieve pharma independence. October 1, 2022, is the next deadline in the rollout of Kazakhstan pharma serialization, so today we’ll get into the specifics of the regulations, as well as regulations for other key industries. Let’s get started.

Kazakhstan pharma serialization: pilot, goals, operator, timeline, marking requirements

The transformation of Kazakhstan’s pharmaceutical supply chain began almost seven years ago, when the government in September 2015 issued guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal. In November of the same year, the Ministry of Health tapped GS1 Kazakhstan to conduct a pilot for the traceability system, which is called the Special Information System for Marking and Traceability of Goods (IS MPT).

Pilot

The pilot ran from Sept. 9, 2019, to July 31, 2021. It was led by Kazakhstan’s state-run distributor, SK Pharmacy, which labeled 100,000 packages of 30 different drugs and traced them all the way through the supply chain to hospitals and pharmacies. Four domestic manufacturers, 1 importer, 2 distributors, 5 pharmacies, and 8 medical institutions also participated.

Goals

The goals of Kazakhstan pharma serialization — and labeling of other product categories — are essentially the same as regulatory goals in other countries:

      • Communicating product information to consumers
      • Combating counterfeit and falsified products
      • Eliminating gray markets (“Shadow market” seems to be the preferred term in Kazakhstan.)
      • Protecting consumers
      • Protecting legal businesses
      • Identifying entities that violate tax laws

The Kazakh government has also said that digital labeling will help businesses increase productivity, improve logistics, increase market share, ultimately leading to increased revenue.

IS MPT Operator

Kazakhtelecom JSC, the country’s largest telecommunications company, operates the IS MPT. Sometimes referred to as “the Single Operator,” it’s the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT) and Uzbekistan’s CRPT Turon. Its main offices are in Nur-Sultan (formally Astana) and Almaty.

As operator, Kazakhtelecom JSC is responsible for the following:

      • Generating marking codes
      • Providing traceability to the state
      • Interacting with the integrated system of the Eurasian Economic Commission (EEC) and operators in other Eurasian Economic Union (EAEU) states
      • Providing a digital passport of goods for market participants
      • Developing a free mobile application (NAQTY SAUDA) ​​to accept and withdraw marked goods from circulation (primarily for participants who are unable to purchase scanners)
      • Developing a free mobile application (NAQTY ÓNIM) for the public to participate in the system
      • Creating a 24/7 IS MPT contact center

In official government reporting dated Nov. 17, 2020, Kazakhtelecom JSC’s Chair of the Board Kuanyshbek Yessekeyev talked about the benefits of the IS MT. “Among its main advantages,” he said, “one can single out a decrease in the shadow market by 50 percent until 2025, which will lead to additional budget revenues by 2025 in the amount of 58.4 billion tenge [$122.5 million], according to our calculations.”

Yessekeyev also concluded that additional legal business revenues would reach 336.5 billion tenge [$706.5 million] by 2025.

Timeline

Here are the key dates for Kazakhstan pharma serialization:

Planning and pilot

      • September 2015: The government issues guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal.
      • November 2015: The Ministry of Health taps GS1 Kazakhstan to conduct a pilot for IS MT.
      • 2018–2019: GS1 Kazakhstan conducts testing for the pilot.
      • Sept. 9, 2019: The pilot begins.
      • July 31, 2021: The pilot ends and the government issues serialization guidelines.
      • August 8, 2021: The Ministry of Health identifies 93 products — about 1% of all drugs in the country — for the first phase of serialization.

Rollout (note upcoming deadlines in October and early 2023)

      • June 5, 2022: The Ministry of Health delays the first phase of serialization from May 2022 until August 1, 2022.
      • August 2022: Mandatory serialization for the 93 products begins. This list includes drugs produced by four Kazakh manufacturers and 12 foreign manufacturers.
      • October 1, 2022: Mandatory serialization for 20% of drugs scheduled to begin.
      • January 1, 2023: Mandatory serialization for 60% of drugs and mandatory data reporting for 20% of drugs scheduled to begin.
      • April 1, 2023: Mandatory serialization of at least 80% of drugs scheduled to begin.
      • July 1, 2023: Mandatory serialization of 100% of drugs scheduled to begin

Note: At present, Kazakhstan pharma serialization regulations do not require aggregation.

Marking requirements

As in other EAEU and Commonwealth of Independent States (CIS) countries (e.g., Russia and Uzbekistan, respectively), products must be labeled with a DataMatrix code with four data points:

      1. A 14-digit product code (i.e., Global Trade Item Number, or GTIN) (GS1 Application Identifier 01)
      2. A 13-character randomized serial number (21)
      3. A four-character verification key (91)
      4. A 44-character verification code (92)

The maximum cost of one code will be 2.68 tenge ($0.0056) without VAT. Every code goes through the same five steps during its “lifetime”:

      1. The manufacturer applies a code to every package and sends them to a distributor.
      2. The distributor receives and scans the products, then sends them to the retailer (e.g., a store or supermarket).
      3. The retailer receives the new (legal) batch of goods, scans the codes, and sells the products.
      4. At checkout, the cashier scans each code (either with a scanner or using the NAQTY SAUDA app) and it’s withdrawn from circulation.
      5. Consumers can use the NAQTY ÓNIM app to learn more about the product.

Here are some images of the apps:

Kazakhstan pharma serialization Naqty Sauda

 

Other regulated products/industries

In 2019, Kazakhstan ratified an agreement for labeling of goods within the territory of the EAEU. In doing so, it agreed to the EEC’s decisions concerning labeling of fur products, shoes, perfumes, tires, and other products. Here is the latest information from IS MPT:

      • Tobacco products: Mandatory labeling of cigarettes began Oct. 1, 2020; April 1, 2021, for cigars, cigarillos, and other categories.
      • Fur products: Mandatory labeling began March 1, 2019.
      • Footwear: Production and import of unmarked shoes have been prohibited since Nov. 1, 2021; sale of unmarked shoes has been prohibited since April 1, 2022.
      • Alcohol: Mandatory labeling began April 1, 2021.
      • Light industry (primarily clothing and linens): A pilot ran from Dec. 15, 2020, to Dec. 31, 2021.
      • Dairy products: A pilot began on Oct. 1, 2020, and was extended in November 2021.
      • Soft drinks: A pilot ran from July 1, 2020, to Jan. 31, 2022
      • Jewelry: A pilot began in March 2022 and is scheduled to end on Oct. 31, 2022.

Final thoughts

That’s a lot to think about. We’ve provided the granular details of Kazakhstan pharma serialization requirements, but let’s boil them down to what you have to be ready for in just a few weeks: Mandatory serialization for 20 percent of drugs starts on October 1.

If this affects you, are you ready? The good news is that complying with Kazakhstan pharma serialization requirements doesn’t have to be difficult. The fastest way to ensure you’re ready for the October deadline — and all the 2023 deadlines — is to contact us and walk through our solutions with one of our supply chain experts.

We offer a holistic, fully validated, preconfigured, automated platform for compliance and L1-L5 connectivity. With rfxcel and Antares Vision Group, you’ll be prepared for regulations in the EAEU and everywhere else your supply chain goes.

 

Kazakhstan Serialization and Traceability Requirements, Part 1

We posted an Uzbekistan pharma serialization update the other day. This got us thinking about Kazakhstan serialization and traceability requirements, as Uzbekistan’s neighbor to the north is working to localize production, digitalize its infrastructure, and incentivize continued growth in key sectors, including pharmaceuticals.

So, welcome to the first of our two-part series about Kazakhstan serialization and traceability requirements. As we did in our series about the Africa supply chain, we’re going to start with context — information about the efforts mentioned above and a snapshot of what’s happening with the pharma industry. Part 2 will get into the specifics of Kazakhstan serialization and traceability requirements in pharma and other sectors.

Kazakhstan serialization and traceability requirements in context

To understand Kazakhstan serialization and traceability requirements, we must first understand what the country is doing to foster economic growth, including modernizing its infrastructure,  developing its business enabling environment, and improving the lives of its citizens. Here’s a rundown of what’s been happening.

The Economy of Simple Things

Launched in March 2019, the Economy of Simple Things program is designed to increase domestic production of mostly low-tech, everyday consumer goods and services. The government also hopes to simultaneously boost demand for these goods, decrease reliance on imports, and increase “Made in Kazakhstan” exports.

The program was funded with 1 trillion tenge (almost $2.4 billion in 2019), of which 400 billion tenge (approximately $953 million) was earmarked for manufacturing and services. It was originally slated to end in July 2022 but was extended until the end of 2023.

When Prime Minister Alikhan Smailov announced the continuation, he said the Economy of Simple Things had subsidized more than 1,100 projects valued at almost $2.1 billion, had helped increase production output and payment of taxes by 33 percent and 80 percent, respectively, and had retained and created 67 jobs.

Digital Kazakhstan

Digital Kazakhstan aims to utilize digital technologies to “allow the economy, business, and citizens to enter a fundamentally new development trajectory.” It began in 2018; barring an extension, it will end this year.

The “new development trajectory” means Kazakhstan will work to transition to a digital economy that will improve people’s quality of life. The initiative focuses on five areas, each with publicly stated goals for “What will change/be changed by 2022”:

      1. Digitization of the economy: reorganization of the economy using technology to increase productivity and growth; focused on businesses of all sizes. Example of “what will change by 2022”: Labor productivity will increase to the level of “TOP-30 world countries.”
      1. Transition to the digital state: transformation of infrastructure to provide services for and anticipate the demands of people and business; calls for “open, transparent, and convenient opportunities” that can be accessed online 24/7. Example of “what will be changed by 2022”: Government services available in electronic format will increase by 80 percent.
      1. Implementation of the digital Silk Way: development of a high-speed, secure infrastructure for data transfer, storage, and processing (i.e., internet access and high-quality mobile communications coverage). Example of “what will change by 2022”: ICT development will reach the level of “TOP-30 countries.”
      1. Evolution of the human capital assets: transformational changes to enable a creative society and the “transition to the new realities”; calls for a knowledge-based economy and digital literacy through innovations in education. Example of “what will be changed by 2022”: Digital literacy will increase to 83 percent.
      1. Innovative ecosystem formation: foster a supportive environment for technological entrepreneurship and industry innovation characterized by stable relations between business, academic institutions, and government. Example of “what will be changed by 2022”: The Astana Hub will become an “international park of IT start-ups.”

Promoting pharma independence

According to the United Nations Comtrade database, a repository of official international trade statistics and relevant analytical tables, Kazakhstan’s pharma imports were valued at $1.56 billion in 2020.

The country’s efforts to attain pharma independence date to at least the mid-2010s. In 2014, for example, the now-discontinued State Program of Accelerated Industrial-Innovative Development (SPAIID) aimed to increase the share of domestically produced medicines to 40-50 percent of the overall market.

How far have they come toward that goal? In October 2020, The Asana Times reported that “the share of domestic manufacturers in the procurement of medicines and medical devices has grown to 30 percent and continues to grow steadily.” It also reported the following:

      • In the first eight months of 2020, production volume increased 34.1 percent, reaching 81.5 billion tenge ($190.28 million).
      • Investments into the industry reached 5.2 percent and 4.1 billion tenge ($9.57 million).

For a little more context, consider these stats from an analysis published in early 2021:

      • In 2018, Kazakh pharma manufacturers produced products valued at 42 billion tenge (about $88 million at current exchange rates).
      • In the first 9 months of 2019, the market for finished pharmaceutical products had grown to 460 billion tenge (about $966 million today), a 22-percent year-on-year increase.

To fuel growth, the government in September 2020 adopted the “Comprehensive Plan for the Development of the Pharmaceutical Industry” through 2025. As reported in the Asana Times, the plan includes the following benchmarks:

      • Thirty new large pharmaceutical operations valued at 77.8 billion tenge ($163.4 million in 2020 dollars)
      • Double medicine production to 230 billion tenge ($537.55 million)
      • Triple exports to 75 billion tenge ($175.10 million)
      • Train more than 2,000 specialists and create permanent jobs for them
      • Increase domestic pharmaceutical production to 50 percent in physical terms

Furthermore, then-Prime Minister Askar Mamin directed the government to scale up support for the domestic pharma industry, especially by stimulating clinical and preclinical trials. He also tasked the Ministries of Industry and Infrastructure Development, Healthcare, and Foreign Affairs to incentivize blue-chip pharma companies to set up shop in Kazakhstan.

One last note for further context: Striving for pharma self-sufficiency isn’t a new idea. For example, earlier this year we wrote about Egypt’s Gypto Pharma City. The Egyptian government envisions this “medicine city” as a regional hub for the international pharmaceutical and vaccine industries, calling it “one of the most important national projects … with the aim of possessing the modern technological and industrial capacity in this vital field.”

Final thoughts

On August 8, the Kazakh Trade and Integration Ministry reported that the country boosted its exports to $34.2 billion between January and May 2022, a 37.2 percent increase over the same period last year.

It seems, then, that the Economy of Simple Things, Digital Kazakhstan, and the Comprehensive Plan for the Development of the Pharmaceutical Industry are reaping dividends. They’re promoting the economic vitality that will help propel the implementation of Kazakhstan serialization and traceability requirements across diverse industries, from pharmaceuticals to footwear.

We’ll talk about those requirements next week in in Part 2. In the meantime, take a look at our solutions for Kazakhstan and the other countries in the Eurasian Economic Union (EAEU). You can also contact us to schedule a short demo of our technologies — rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business.

Uzbekistan Pharma Serialization Update: September 1 Deadline & More

We’ve been following the Uzbekistan pharma serialization rollout as part of our ongoing survey of global pharmaceutical regulations and compliance.

As we wrote in mid-February 2022, the country’s State Tax Committee “extend[ed] the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products. That announcement, however, didn’t stipulate a new deadline.

So, what’s the latest with Uzbekistan pharma serialization? Let’s take a look.

Uzbekistan pharma serialization and Resolution No. 149

On April 2 of this year, Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149, “On the introduction of a system of mandatory digital labeling of medicines and medical devices.” This established the following labeling deadlines for medicinal products and medical devices:

      • September 1, 2022: products produced with secondary (external) packaging (except for orphan drugs)
      • November 1, 2022: products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)
      • March 1, 2023: products and medical products to treat orphan diseases as designated by the Ministry of Health
      • March 1, 2023: drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan
      • February 1, 2025: medical products on a list approved by tax authorities and the Ministry of Health

Additionally, there seems to be a grace period for the mandatory labeling in two circumstances:

      • Products that were produced domestically within 90 days of these deadlines do not have to be labeled and may be circulated.
      • Products that were imported within 180 days of these deadlines do not have to be labeled and may be circulated.

More about the labeling requirements

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

The regulations currently apply to five product categories other than medicines and medical devices: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks.

Products in every regulated industry must be labeled with DataMatrix codes that include four data points:

      • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
      • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
      • A four-character verification key generated by CRPT Turon
      • A 44-character verification code (i.e., crypto code) generated by CRPT Turon

To learn more about Uzbekistan pharma serialization, how ASL BELGISI works, and labeling requirements, read our “Uzbekistan Traceability Update” from earlier this year. Keep in mind that we wrote this before the first deadline delay and adoption of Resolution No. 149.

Final thoughts

The Uzbekistan pharma serialization deadlines are upon us — about three weeks away. Since its inception, ASL BELGISI has been a hot topic in the industry, especially in key pharma-producing countries.

India, for example, has taken a keen interest in the requirements. One recent article reported that Indian pharma companies are “looking for more clarity over regulations and technical standards … and looking for a transition period to migrate to digital labeling.” The same article noted several other interesting points:

      • India’s pharma exports to Uzbekistan more than doubled in fiscal year 2020-21.
      • India’s export of pharma products to Uzbekistan totaled $137 million in 2021.
      • Uzbekistan’s pharma market is valued at $1.5 billion.
      • There are opportunities for investment and exports in Uzbekistan’s oncology and dermatology sectors.

The good news is that we can help you navigate Uzbekistan pharma serialization requirements no matter where you’re based — India, Asia, the EU, the UK, Latin America, the United States. We have experts in all of these markets, and rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business. Contact us today and schedule a short demo of our award-winning Traceability System and our Compliance Management solution.

 

Antares Vision Group Will Be at GS1 Connect 2022 in San Diego Next Month!

We’re getting excited for GS1 Connect, June 7-9 at the Marriott Marquis San Diego Marina! Not only are we a Premier Sponsor — we’ll be speaking about supply chain traceability and smart hospital systems.

We’ll also be at Booth 115 with our award-winning Traceability System, demonstrating solutions for the food and beverage, pharmaceuticals, and cosmetics industries.

So take 20 seconds (really) to sign up to meet us. We have a limited number of discount codes for 10 percent off your registration fee. And while you’re at Booth 115, take our short survey and you could win a $500 DoorDash gift card.

More about GS1 Connect and our speakers

The theme of this year’s conference is “Adapt.” The focus is on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. There will be 40+ live sessions (including ours!), 50+ exhibitors (including us!), trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

As GS1 says, the event is a place to “network with the greatest supply chain minds and learn how to leverage GS1 Standards to optimize your business.” Indeed.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, our vice president of product and strategy, will discuss why traceability is foundational to business success in a rapidly evolving landscape of digitalization, ever-changing consumer expectations and power dynamics, tougher regulations, and supply chain uncertainty. He’ll be speaking on Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety, our Digital Healthcare Department Director Adriano Fusco and Dr. Alberto Sanna, director of the Research Center for Advanced Technologies for Health and Well-Being of the IRCCS San Raffaele Hospital in Milan, Italy, will discuss how traceability and GS1 Standards enable end-to-end visibility of medications from arrival at the hospital to dispensation and optimized resources to focus on patient safety.

Final thoughts

We’ve always valued GS1 Standards, and we’ve always ensured our customers can adhere to them and take full advantage of them to maximize efficiency and create value across their operations everywhere they do business.

And who took the time to note the 50th anniversary of the venerable Global Trade Item Number (GTIN)? We did, with a blog post devoted to GS1 barcodes.

As we said in that article, “Where would we be without standards?” We’d love to see you at GS1 Connect and talk about those standards and how they fuel traceability. We hope you’ll take those few seconds to sign up to meet us at Booth 115, get 10 percent off your registration, and enter to win a nice prize when you take our survey.

In the meantime, drop us a line if you have any questions or want to know more about our traceability solutions for pharma, food and beverage, cosmetics, and other industries. We never pass on an opportunity to talk about what makes us your best partner for end-to-end supply chain solutions, from L1 all the way to L5!

See you in San Diego June 7-9!

DSCSA EPCIS Update: 3 Questions for rfxcel SVP of Product and Strategy Herb Wong

Herb Wong’s a busy guy. As senior vice president of product and strategy at rfxcel, he’s always on the go, advising and conferring with customers, talking and brainstorming with industry leaders, dashing off to speak at conferences, and thinking of new ways to improve … everything. So we were happy that he found time to talk with us about what’s happening with DSCSA EPCIS.

Our chat comes as Herb is fresh off an appearance at the Healthcare Distribution Alliance (HDA) Distribution Management Conference in Austin, Texas, where he participated in the “EPCIS Standards and Implementation Process” panel discussion. HDA also recently published a DSCSA EPCIS Implementation Benchmarking Survey about the progress of adoption and trading partner plans for sending data.

Here’s the scoop:

Herb, what has the EPCIS Center of Excellence learned about industry readiness for the DSCSA EPCIS requirements?

Well, the EPCIS COE, which we introduced at the HDA Quarterly Update in September last year, has discovered a number of things through our studies and meetings. Here are takeaways in the key areas of education, consistency, and standards.

As we get closer to the November 2023 deadline, new participants are less knowledgeable about EPCIS and DSCSA. Their integrations take more time and they have more questions and need more education. This was a recurring theme we started hearing during our EPCIS COE interviews. Because of this, the HDA and GS1 are looking to see how they can offer/repackage training to get the industry up to speed.

In terms of consistency, we are looking into developing a common, consistent process for all solution providers to begin an EPCIS exchange. This can improve the efficiency across all supply chain partners.

And for standards, we have been discussing a process or tool to have all participants verify that their EPCIS data is formatted correctly before they begin exchanging it with others. GS1 developed an offering for this and everyone agrees that it’s a good idea; but determining who pays for this testing has been challenging.

How has the industry reacted to the EPCIS COE’s efforts?

Overall, everyone has been receptive. But this is a huge undertaking. It reminds me of the question, “How do you eat an elephant?” Answer: “One spoonful at a time.” Accelerating EPCIS data exchange is like that. It’s so big that people don’t know exactly where to start.

The answer is to just start somewhere and then learn and improve. The hardest part is getting started. Once we decide on a few areas where we can make an impact, momentum will keep us moving forward. We are in the process of agreeing on what we can do, so stay tuned!

What are your thoughts about industry readiness?

A number of supply chain partners asked me this question at the HDA Distribution Management Conference in Austin earlier this month. The industry is becoming more focused on the deadline. Everyone is realizing that the time for open-ended discussion is coming to a close and decisions must be made. We have 19 months to be ready for DSCSA 2023 and a lot of different efforts must be aligned.

Final thoughts

Herb Wong, everyone!

We hope Herb’s answers were helpful and shed light on the industry’s efforts to be ready for the DSCSA EPCIS requirements. As he said, it’s an elephant-sized undertaking with a lot of moving parts that need coordination and consensus. The EPCIS COE is “the spoon” that’s helping the pharmaceutical industry digest the requirements, address the challenges, and get everyone compliant by November 27, 2023.

If you still have questions, your first step should be to contact us. One of our supply chain experts can explain the requirements and how our solutions will get your house in order. If you like, we can probably arrange a meeting with Herb. So reach out today and let’s talk.

We also encourage you to browse our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including EPCIS requirements.

Last, we want to let you know that in June Herb will head to San Diego to speak at the GS1 Connect 2022 conference. On Thursday, June 9, he’ll present “Supply Chain Traceability: Can Your Business Survive Without It?” Herb will discuss why traceability is foundational to business success and how companies in any industry can leverage traceability in a digital supply chain to ensure they comply with regulations and much more. Check back for updates as we get closer to June!

African Pharmaceutical Regulations: The African Medicines Agency and the Push for Harmonization

Welcome to the last installment of our Africa supply chain series. Part 1 talked about geography, demographics, and the economy, and Part 2 was about challenges and opportunities. Today, we’re tackling the complex landscape of African pharmaceutical regulations.

Specifically, we’re looking at the African Medicines Agency (AMA), envisioned as a single regulatory body that would cover all 54 countries on the continent. It’s a big topic, but we’ll break it down into easy-to-understand terms. Let’s get started.

African pharmaceutical regulations: defining the key players and terminology

To understand African pharmaceutical regulations, you have to know the key players and be familiar with some core vocabulary. Today, we’re talking in broad terms to establish some baseline knowledge; if you want to know more about any of the entries below, just click on the linked text.

African Medicines Agency (AMA): According to its business plan, the AMA’s vision is “a healthy African population with access to quality, safe, and efficacious medical products and technologies.” It was established in January 2015 and officially began in November 2021 after 15 countries signed and ratified the AMA Treaty and deposited their instruments of ratification with the African Union Commission (see below). The AMA does not yet have a website; visit the African Union website for more information.

African Medicines Regulatory Harmonization (AMRH): Formalized in 2009, the AMRH is an initiative to “provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa.” It is part of the African Union Development Agency (see below) and the Pharmaceutical Manufacturing Plan for Africa (PMPA).

African Union (AU): The AU was launched in 2002, succeeding the Organization of African Unity, which was active from 1963 to 1999. It comprises five regions and has 55 members: Central Africa (9 states), Eastern Africa (14 states), Northern Africa (7 states), Southern Africa (10 states), and Western Africa (15 states).

African Union Commission (AUC): The AUC is the AU’s secretariat and runs the day-to-day activities of the Union. It is based in Addis Ababa, Ethiopia.

African Union Development Agency (AUDA-NEPAD): AUDA-NEPAD’s mandate is to “coordinate and execute regional and continental projects to promote regional integration towards the accelerated realization of Agenda 2063” and “strengthen capacity of AU member states and regional bodies.” (See Part 1 of our series for more about Agenda 2063 and read the AUDA-NEPAD 2021 Annual Report here.)

National Medicines Regulatory Authorities (NMRAs): Each country’s NMRA is responsible for regulatory functions such as marketing authorization, pharmacovigilance, market surveillance quality control, clinical trials oversight, licensing establishments, and laboratory testing.

Regional Economic Communities (RECs): RECs are regional groupings of African countries formed to facilitate regional economic integration and the wider African Economic Community. The AU recognizes eight RECs:

    1. Arab Maghreb Union (UMA)
    2. Common Market for Eastern and Southern Africa (COMESA)
    3. Community of Sahel-Saharan States (CEN-SAD)
    4. East African Community (EAC)
    5. Economic Community of Central African States (ECCAS)
    6. Economic Community of West African States (ECOWAS)
    7. Intergovernmental Authority on Development (IGAD)
    8. Southern African Development Community (SADC)

Regional Centers of Regulatory Excellence (RCORE): AUDA-NEPAD, through AMRH, designated 11 RCOREs to work in eight regulatory functions to build regulatory capacity at NMRAs:

African pharmaceutical regulations: current context

With the AMA going into force barely five months ago, and considering the vastness of the African continent and the diversity of its countries, it should be no surprise that the current context for African pharmaceutical regulations is … one of flux.

Authorities (e.g., the AU and AUDA-NEPAD), through the NMRAs and RCORES, as well as through coordination with the RECs, are working through the many challenges of harmonizing regulations. There are a lot of moving parts that need to coalesce under the AMA umbrella. For example:

Different legal and regulatory frameworks. Many countries and RECs have developed or are developing their own regulatory legislation. But right now, it appears they are not obligated to coordinate, standardize, or harmonize their laws. Therefore, regulations can vary from country to country in a REC, and any country’s laws might also diverge from their REC’s requirements. Regulations also vary from REC to REC, such as the Southern African Development Community (SADC), the East African Community (EAC), and the Economic Community of West African States (ECOWAS).

Furthermore, legal and regulatory frameworks can be unclear and incomplete, and authorities may not make public announcements about their intentions, timelines, and progress. Manufacturers and other supply chain stakeholders may have to submit paperwork to more than one NMRA, which duplicates efforts and wastes resources.

Need for capacity-building. A March 2021 article in the Journal of Pharmaceutical Policy and Practice noted that all but one country had an NMRA or “an administrative unit conducting some or all expected NMRA functions,” but only 7 percent had “moderately developed capacity” and more than 90 percent had “minimal to no capacity.” Complicating matters, some NMRAs operate as independent organizations and some operate within their country’s Ministry of Health.

Reliance on imports and the problem of counterfeits. The United Nations Economic Commission for Africa (UNECA) estimates that Africa imports about 94 percent of its pharmaceutical and medicinal needs at an annual cost of $16 billion. This is a regulatory and logistical challenge. It also means there are plenty of opportunities for illegal activity. We noted in Part 2 that 42 percent of all fake medicines reported to the WHO from 2013 to 2017 came from Africa. The WHO also estimates that one of every 10 medical products in low- and middle-income countries is substandard or fake, while another report says up to 70 percent of pharmaceuticals could be fake in developing regions.

The African Medicines Agency

These disparities, capacity needs, and logistical challenges were among the reasons why the AU wanted to establish a continental regulatory system. And like other regulatory systems, the AMA is designed to protect people, to ensure that all Africans have access to safe, efficacious, and affordable products that meet international standards.

The AMA is based on the AU Model Law on Medical Products Regulation. In broad terms, its goal is harmonization by achieving the following:

      • Registration and marketing of health technologies
      • Granting manufacturing and distribution licenses
      • Conducting quality and safety inspection of health technologies and manufacturing facilities
      • Authorizing clinical trials through an established National Ethics Committee or Institutional Review Board
      • Overseeing appeals procedures through an established Administrative Appeals Committee

International reaction to the AMA has been mostly positive. The International Federation of Pharmaceutical Manufacturers & Associations, for example, said that the “AMA has the unique opportunity to become one of the most efficient and modern regulatory systems in the world.”

And just last month before a two-day EU-AU summit, the EU (including the European Commission, the European Medicines Agency, and member states Belgium, France, and Germany) and the Bill & Melinda Gates Foundation announced they would mobilize more than 100 million euros over the next five years to support the AMA and other pharma regulatory initiatives at regional and national levels.

As of March 3, 2022, 30 African countries had backed the AMA: 19 had signed and ratified the AMA Treaty and deposited their instruments of ratification with the African Union Commission; two had signed and ratified but not deposited; and nine had signed but not ratified. Thirteen countries have said they’d want to be home to the AMA headquarters.

Still, 25 countries have not signed the AMA Treaty, including South Africa, Nigeria, Kenya, and Ethiopia, four of the most important economies on the continent.

Final thoughts

African pharmaceutical regulations and the AMA are evolving. And like all regulations, there will be stops and starts.

The important takeaway is this: The pharma industry must be prepared for the continent-wide AMA regulations and the AU’s vision of a single authority working with a harmonized set of standards. Though there are holdouts, Egypt, Africa’s third most populous country and an important economic power, has ratified and deposited the treaty. This is a significant event in the efforts to get those countries on board with the AMA.

Preparation is the key to compliance and keeping your supply chain running. And we’re experts in making sure you’re prepared for regulations — and every other aspect of supply chain management and optimization — everywhere you do business. Pharmaceutical companies rely on our solutions to comply with strict regulations and to get the most out of their supply chains, from harvesting rich, actionable data in real time to leveraging serialization technology for brand protection and consumer engagement.

Contact us today to speak with one of our experts. In just a few minutes, they can show how our Traceability System will optimize your supply chain today and, importantly, ensure you’re prepared for what’s coming tomorrow.

And if you’re like us and just can’t get enough of regulations and compliance, download our updated “Pharmaceutical Compliance: A Global Overview” white paper. We’ve added more than 25 countries, including REC member states, expanded our “rfxcel Compliance Resources” section, and a lot more. Get it today!

Last but not least, take a look at our other news from the Africa and Middle East region:

Understanding the Supply Chain in Africa: Essential Insights for the Track and Trace Industry

Welcome to Part 2 of our look at the supply chain in Africa. In Part 1, we did “Africa by the numbers,” getting into the details of the continent’s geography, demographics, economy, and goals of “Agenda 2063.” Today, we’re talking about three challenges and three opportunities. There’s a lot to cover, so let’s get started.

Three challenges for the supply chain in Africa

As we said in Part 1, Africa is big: about 11.7 million square miles (30.3 million square km). The continent has eight primary physical regions — the Sahara, the Sahel, the Ethiopian Highlands, the savanna, the Swahili Coast, the rain forest, the African Great Lakes, and Southern Africa — and traversing these diverse landscapes is not always easy.

Which brings us to the first challenge for the supply chain in Africa: physical and electronic infrastructure. Stated simply, Africa has a long way to go with infrastructure. McKinsey & Company’s “Solving Africa’s infrastructure paradox” (March 2020) provides a good overview of this challenge, the paradox being that there’s a high demand for projects and sufficient capital, but not much action. Specifically,

“… infrastructure investment in Africa has been increasing steadily over the past 15 years, and … international investors have both the appetite and the funds to spend much more across the continent. The challenge, however, is that Africa’s track record in moving projects to financial close is poor: 80 percent of infrastructure projects fail at the feasibility and business-plan stage.”

One eye-opening statistic from the McKinsey article: More than two-thirds of the world’s population that does not have access to electricity lives in sub-Saharan Africa. That’s 600 million people. The challenge is self-evident. Agenda 2063 has ambitious infrastructure components (e.g., rail, air, water) and could very well smash this paradox. But it will take time.

Here are two other key challenges for the supply chain in Africa:

The informal economy. The Center for Global Development reports that Africa’s informal sector is the largest in the world, citing International Labor Organization statistics that it accounts for almost 90 percent of the economy in sub-Saharan Africa and about two-thirds in North Africa. Research from 2019 showed that the informal sector provided 90 percent of all new jobs and 70 percent of all employment across sub-Saharan Africa.

In Africa’s urban areas — the fastest-growing in the world — World Bank data shows that almost 81 percent of jobs are in the informal sector, while the International Labor Organization reported that almost 96 percent of youth ages 15-24 and a little more than 93 percent of women work in the informal economy.

This means that a significant part of the supply chain in Africa is informal, operating through non-official channels and without government oversight, regulation, or taxation. This makes it difficult for businesses to operate in Africa and enables an environment in which other supply chain problems can arise.

Counterfeits. Illegal copying and counterfeiting is widespread in Africa, as it is in other parts of the world with unregulated informal economies and insufficient supply chain protections. Bad actors are only too happy to exploit these conditions.

For example, 42 percent of all fake medicines reported to the World Health Organization from 2013 to 2017 came from Africa. (WHO estimates one of every 10 medical products in low- and middle-income countries is substandard or fake.) Reading between the lines, the proliferation of counterfeit medicines in Africa’s supply chain might be even greater, as weak regulations and lax enforcement often results in under reporting.

To illustrate the problem, last year an Interpol-supported operation in Southern Africa targeting “trafficking of illicit health products and other goods” nabbed 179 suspects and seized products worth approximately $3.5 million. Examples of similar events include the following:

    • 2015-2018: Almost 20 tons of fake medicines seized in Mali
    • 2017: More than 420 tons of illegal pharmaceutical products seized in seven West African countries
    • 2018: 19 tons of counterfeit medicines seized in Ivory Coast, Guinea-Bissau, Liberia, and Sierra Leone
    • 2019: 12 tons of counterfeit pharmaceuticals intercepted in Ghana

But official channels are working to address the problem, including these initiatives:

    • The United Nations Office on Drugs and Crime announced a “holistic strategy” to combat crime and fake drugs in West and Central Africa.
    • The African Union announced that the African Continental Free Trade Area (AfCFTA) Secretariat had signed a letter of intent to work with other partners to combat counterfeit trade.
    • The Lomé Initiative is a binding agreement among the Republic of the Congo, Niger, Senegal, Togo, Uganda, Ghana, and the Gambia to criminalize trafficking falsified medicines.
    • The legal profession is also aware of the problem.

Three opportunities for the supply chain in Africa

The rise of manufacturing. African manufacturing made headlines last month when Afrigen Biologics and Vaccines in Cape Town, South Africa, announced it had successfully copied Moderna’s COVID-19 vaccine with no input from the U.S.-based company. At about the same time, the director of the Africa Centers for Disease Control and Prevention said 10 countries were making vaccines right now or planning to do so, with South Africa, Senegal, Rwanda, Algeria, and Morocco taking leading roles.

Led by organizations such as the African Partnership for Vaccine Manufacturing and the African Vaccine Manufacturing Initiative, a coordinated push is underway to manufacture vaccines in Africa “from scratch” (i.e., not merely “filling and finishing” imported products) and make the continent “vaccine independent.”

And this is emblematic of an African manufacturing renaissance of sorts. In the second quarter of 2021, for example, United Nations’ growth estimates indicated a 17.8 percent expansion of manufacturing output. (Output had dropped by 17.1 percent during the same period in 2020, primarily attributable to the pandemic.) Also in the second quarter of 2021, manufacturing output increased “in many African countries,” including South Africa (39.3 percent), Rwanda (30.2 percent), Senegal (22.6 percent), and Nigeria (4.6 percent).

Other examples are abundant: Carmaker Nissan is opening new facilities, and analysts see Africa emerging as an auto industry hub, including for electric vehicles. Overall, research shows that manufacturing on the continent is growing, or strongly rebounding from the pandemic, especially in key economies in sub-Saharan Africa.

A healthy manufacturing sector means a supply chain with opportunities to modernize alongside production facilities, to adopt international standards (e.g., GS1) and best practices, and to build the infrastructure to secure products from the time they leave the manufacturing floor to the time they reach consumers.

A large — and young — labor force. As we noted in Part 1 of our series, approximately 1.4 billion people live in Africa (about 17 percent of the world population) and the median age is 19.7, making it the youngest continent on the planet. According to the World Bank, half of the population in Sub-Saharan Africa will be under 25 by 2050.

This could poise African countries for an employment/ongoing manufacturing boom similar to what’s happened in Vietnam, Malaysia, Singapore, Mexico, and India. With more jobs in more sectors, including technology, and more products originating on the continent, the supply chain will need to grow and adapt. This will create opportunities for modernization and synchronization with global standards and best practices.

A consumer-centric economy. Africa is an enormous market for domestically produced and imported goods and services. As AfCFTA matures and projects under Agenda 2063 and other initiatives are completed, hundreds of millions of consumers should have more and easier access to these goods and services. They should also be willing to spend more money: As of 2021, the final household consumption expenditure in Africa was a little more than $1.9 trillion; McKinsey says this could reach 2.5 trillion by 2025.

This will have a huge impact on the supply chain in Africa — for manufacturing, logistics, distribution, warehousing, and “the last mile.” The more vigorous Africa’s economy becomes, the more businesses should anticipate development of new industries, dissipation of the informal sector, increased demand for better products, and a growing “consumer class” that will come to expect the supply chain to work everywhere on the continent.

Final thoughts

The supply chain in Africa is a work in progress. Some countries, particularly those in Sub-Saharan Africa, are farther along than others. The reasons for this are diverse, ranging from stronger institutions and more stable infrastructure to fortunate geography that facilitates better access to the flow of global trade.

It’s the wise organization that follows the progress and continuously prepares to do business in Africa. This means being able to work with the supply chain, complying with regulations as they’re rolled out and refined, optimizing your systems — and finding the right solution provider.

Contact us today to speak with one of our digital supply chain experts. In just a few minutes, they’ll demonstrate how our Traceability System will ensure your business can integrate with the supply chain in Africa. After doing that, move on to the last installment of our Africa supply chain series, which highlights the pharmaceutical regulatory environment. In the meantime, think about your supply chain and consider the words of Dr. Akinwumi Ayodeji Adesina, president of the African Development Bank Group:

The future belongs inexorably to the continent of Africa. By 2050, it will have the same population as China and India do now. There will be burgeoning consumer demand from a growing middle class, a population of nearly 2 billion people, of which around 800 million young people will be looking for meaningful and sustainable employment.

If we can harness this potential by aligning supply with demand, markets with customers, and skills with jobs, and keep most of these elements and links largely within Africa, then Africa will become an unstoppable economic force, capable of feeding itself and the rest of the world for good measure. That is the future scope for Africans to shape in their own interests and for their own economic ambitions.