March 2022 - rfxcel.com
EnglishFrenchGermanItalianPortugueseRussianSpanish

DSCSA EPCIS Update: 3 Questions for rfxcel Vice President of Strategy and Innovation Herb Wong

Herb Wong’s a busy guy. As vice president of strategy and innovation 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 AMA

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, Part 2: Challenges and Opportunities

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.