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The Logistics Challenges of COVID-19 Vaccine Distribution Prove the Need for Data Integrity

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The Logistics Challenges of COVID-19 Vaccine Distribution Prove the Need for Data Integrity

Logistics companies are often described as being in the business of moving goods from points of origin to end-use destinations, and that is, of course, true — but they are also in the business of data collection, processing, and analysis. That’s because efficient transport and delivery require data from sources such as real-time navigation systems, enterprise resource planning systems, transportation management solutions, analytics solutions, and more, as well as from sensors that track internal and external environment factors: location, the temperature of shipping containers, vibration, speed, sudden stops and starts, and so on.

But just having this data isn’t enough. To successfully navigate the intricacies of the global supply chain, logistics companies must also ensure data integrity — and the challenges of COVID-19 vaccine distribution are proving just how critical that is.

What is Data Integrity, and Why Does it Matter?

Transporting mission-critical supplies around the globe is innately challenging, but successful COVID-19 vaccine distribution is proving particularly tricky for a number of reasons. A high volume of vaccines must be quickly moved from a handful of pharmaceutical manufacturing facilities to tens of thousands of global locations ranging from government facilities to private pharmacies, and deliveries must be coordinated around cold-storage availability at the receiving end. Timing is critical, because the vaccines have a limited shelf life, and the stakes are sky-high. Any vaccines that don’t make it from port to end destination on time and in compliance with certain metrics, such as appropriate temperature thresholds, represent a lost battle in the ongoing war against the pandemic.

That’s why logistics companies need to ensure data integrity, which comprises:

Quality: Vaccine shipment data must be complete, unique, valid, timely, and consistent. For example, most vaccines, that must be kept frozen, can be shipped and stored between -58°F and +5°F (-50°C and -15°C), but Pfizer’s COVID-19 vaccine must be stored at -94°F (-70°C) to remain stable. Sensors must provide real-time, accurate readings of shipping container temperatures to ensure vaccines remain at the optimal temperature throughout transport, so they can be administered to people. About 25% of shipped vaccines are compromised due to poor temperature management, according to a 2019 report from the International Air Transport Association — an untenable figure for a vaccine on which global population health and economies depend.

Location intelligence: Location data, is often used, to help identify connections between people, places, or things at specific geographic places, and what exists or occurs there. The critical need for efficient last-mile delivery of vaccines, especially to rural and remote healthcare facilities, shows why location intelligence is so important. It takes more than an accurate delivery address to complete the last mile; logistics providers also need up-to-date data on weather, road conditions, road restrictions, and traffic along the route to the destination, as well as site-specific information such as loading dock location. Location data that is outdated, inaccurate, or lacking in context can make the difference between a community that receives viable vaccines, and one that doesn’t.

Enrichment: This gives context, nuance, and meaning to the logistic firms internal data by supplementing it with data from outside sources. For example, a logistics company must supplement its own routing and scheduling data with external data on cold-storage availability at end destinations. Without this context, drivers may arrive at facilities that have no room to store the vaccine shipments, and the vaccines go to waste.

Integration: All of the systems and technologies logistics organizations use to get shipments to the right place at the right time collect and provide their own data, but none of it is much good if the systems can’t talk to each other. Seamlessly integrated data provides complete situational awareness to support decision-making at each link in a supply chain. This helps companies get time-sensitive, mission-critical supplies like the COVID-19 vaccine where they need to go, exactly when they need to be there, using the most efficient path.

Data Integrity is the Key to Logistics Success

Accurate, consistent and relevant data, integrated across all platforms and enhanced by location intelligence and enrichment, help logistics companies achieve data integrity. This elevates data’s usefulness and usability, helping companies react quickly and in real-time to any issues, and make better overall business decisions.

The need for data integrity has never been more clear — and more urgent — than it is now, and lessons learned from vaccine distribution may redefine the way the logistics industry thinks about data. By achieving data integrity, logistics organizations are better equipped to get shipments to the right destination on time — and, in scenarios such as this vaccine distribution, play an integral role in saving lives and protecting global population health.

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Clarence Hempfield is the Vice President, Product Management, Location Intelligence at Precisely. Clarence has been with Precisely through the Syncsort and Pitney Bowes days and first joined Pitney Bowes in 2006. He holds degrees from the University of Pittsburgh and the University of Maryland. Clarence is based in the Washington D.C. area.

cargo ECS charter

Air Cargo Trends in a Pandemic World

Previous predications in pharmaceutical transportation trends, highlighting declining air passenger numbers and air freight demand increasing, have been pandemic propelled. Coronavirus continues causing worldwide disruption, as it is anticipated its industry impact will continue throughout 2021 and beyond.

Pandemic Response – Preighters Take Off

Pre-pandemic passenger numbers were already on the downturn, however, the COVID-19 crisis significantly accelerated that trend.

The crisis capacity crunch came as passenger flights plummeted and the ensuing scramble to transport pandemic payloads saw the deployment of hundreds of passenger planes as freighters, known as preighters, take off.

Pioneering Portuguese charter operator Hi Fly led this trend and was the first to convert an A380 for freight, taking out the majority of seats to provide more cargo capacity.

Despite the sector seeing the grounding of hundreds of passenger planes, earlier than had been initially forecast, which led to a reduction in the availability of cargo space in the bellies of these passenger aircraft, we’ve seen more planes undergo conversions to freighters.

The preighters prevalence looks set to continue throughout 2021 and beyond. Although the air cargo industry faces continuing challenges, IATA predicts an anticipated 25% rise in freight tonne-kilometers this year.

Boeing projects growth in the global freighter fleet with the number of cargo aircraft in service forecast to increase more than 60% over the next two decades, resulting in 3,260 operational aircraft by 2039. (1)

However, the ongoing drastic downturn in travel means the loss of a lot of capacity in passenger aircraft and while freighter aircraft are still present and working hard, fleet growth takes time, so there will be a slower response to replacing some of the capacity lost from the passenger side of the industry.

Some of the 747s which have comparatively low hours on their airframes will undoubtedly become 747 converted freighters and will be flying as freighters just to try to backfill some of that loss in capacity from the passenger numbers.

Large Widebody Aircraft – Grounded or Retired

Before COVID-19, it was predicted airlines would start cutting flights from schedules, mothball larger aircraft, decline production options, and look to utilize smaller, more efficient aircraft in the future for environmental and economical reasons. All of those decisions have been massively accelerated.

The forecast to park some of the larger, widebody aircraft has been brought forward significantly, due to the COVID-19 crisis.

The ongoing impact of the pandemic has meant the majority of all 747 freighter aircraft have or are being retired. The A380, which Airbus had previously announced it would stop deliveries of in 2021, has also been retired across the board by numerous airlines, except Emirates.

Increasingly airlines are globally grounding their A380s in favor of more modern, smaller jets, which can fly more efficiently than their four-engine aviation counterparts.

With far fewer passengers flying in a pandemic world, the travel downturn has ramped up decisions to park planes, some permanently, further impacting the already dwindling resource of global air freight capacity.

What we will continue to see is a lot more interest in leaner aircraft, like the A220, the Canadian Bombardier aircraft Airbus produced in North America.

Sea Change in Modes of Transport

There will be ongoing developments in the sea freight sector, which has an estimated 17 million TEUs (Twenty-foot Equivalent Unit) serviceable globally, of which six million containers are routinely turning and carrying freight.

Put in perspective, at its lowest level of trading during the onset of coronavirus, there were 135,000 TEUs a month traveling from China to the US. However during peak months, when the US retail sector’s stocking up for Thanksgiving and Christmas, this increases to 900,000 TEUs a month. This equates to 8% of the global free flow of sea containers just crossing the Pacific from China to the States.

Any delays will see a huge build-up of sea containers, which lead to availability issues, and rate rises, as seen during the pandemic when China stopped producing. What we saw with the initial emergence of COVID-19, China stopped producing, so wasn’t pushing out those sea containers so there were availability problems in the rest of the world because all the sea containers were piling up in China.

When China returned to approximately 98% of its production output in April other countries were then in lockdown, with some like the US, holding containers for two weeks in ports to quarantine them, compounded by shorthanded workforces operating in the docks.

As sea containers started to pile up in their markets and with exports to China impacted, shipping lines cut sailings from schedules, which saw sea freight prices spike by up to 50%.

Uncertainty in sea freight and air freight availability saw pharma companies initially ship everything they could, by any mode of transport available, to get it out to the markets.

Following months of disruption passenger airlines eventually started flying passenger aircraft with cargo in the lower decks and loose load cargo on the upper decks.

We are now back in the situation where that backhaul from the US and Europe, following seasonal shipments for Christmas retail demands, China now has availability issues again with reduced sailings, so there will not be any kind of normal flows until March 2021, at the very earliest.  However as the UK is currently back in another national lockdown, with all non-essential retail effectively closed and production affected, and if this trend spreads further into Europe and possibly the US, then that will further affect the backhaul. So whereas I was hoping things might be back to some kind of normality in March, I am now inclined to add another quarter to that. So, I now think there will be exacerbated sea freight and sea container availability issues throughout the first half of 2021.

Given the sea freight situation, we will continue to see the utilization of air freight to transport pandemic payloads. When it comes to economics, without the passengers on the main deck it is a much more expensive operational option, however pharma customers are prepared to pay those premiums to move their product.

The volumetric efficiency of air craft is critical at the moment because it is such a scarce resource we need to ensure the best use is made of it.  With air freight capacity a dwindling resource, it is even more important to have the very efficient packing density of temperature-controlled products on such limited air freight resources.

Vaccines vs. Virus – Rapid Response

As the development of successful COVID-19 vaccines continues at a rapid rate, the world’s first approved vaccines are already being administered as part of ongoing mass vaccination programs worldwide.

Temperature-controlled packaging manufacturers continue to play a pivotal part in the global deployment of these approved vital vaccines, including those developed by Pfizer/BioNTech, Oxford University/AstraZeneca, and Moderna.

As COVID-19 vaccines fall into different families of technology, some have frozen and deep-frozen temperature requirements, leading to a scramble to qualify existing solutions for shipping at those specific lower temperatures.

In a rapid response to the logistical cold chain challenges involved in the deployment of these potentially life-saving vaccines, we have adapted our shippers to meet those temperature requirements, as have other providers in the market.

There has been an impetus for innovation to support these temperatures in volume. Suppliers stepped up to meet the vaccine temperature requirements by adapting existing shipping solutions and the capacity is there, so I don’t anticipate it will be an issue going forward.

The focus is reverted back to the capacities in the transport modes and given the nature of these drugs people are paying whatever it costs to ship them, with rates rising sharply from $2.5 a kilo to $23; however, that’s starting to calm down.

Beyond all of the current vaccines being approved, there will be the need to provide boosters. It is going to create a recurring step up in the volume of vaccines being shipped, alongside the flu vaccines being transported and other pharmaceutical payloads every year.

There will not be a continuous crisis, it will be a continuing trend of smaller aircraft, with reduced airfreight capacities, moving that pharma product at temperatures that sea freight cannot do. It really can only fly.

However, there’s not going to be a modal shift from air to sea because sea cannot meet the temperature requirements necessary for these shipments. You get a displacement, whereby COVID-19 shipments, whether vaccines, test kits, and reagents or some of the therapies which help with recuperation, like Remdesivir, are flying at almost any cost on a dwindling resource.

The pharmaceuticals which have more normal temperature shipping requirements, like 2 – 8C degrees or 15 – 25C degrees, get displaced and in that situation, when the air freight rates get so high, sea freight would normally be seen as a shipping solution.

However, with all of the sea freight challenges, coupled with the fact that their transportation rates have also doubled, there has been some displacement but not as much as pharma companies would have liked, which is what has kept pushing the prices up in the region of the $23 a kilo figure for air freight we had seen previously in the market.

Sea freight will improve in the first six months of 2021 so some of that displacement can take place more efficiently. But aircraft will still be full of COVID-19 related products.

2021 will see the industry learning to operate in the new norm with everyone getting used to that new norm. Next year we might start to see some improvements and efficiencies but I think this year is about adjusting our planning, our capacities, and our operations around this spike in demand and the gradually improving capacity picture. Almost like wearing in a new pair of shoes.

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Dominic Hyde is Vice President Crēdo™ On Demand at Pelican BioThermal

perishable

Cutting Waste and Best Practices in Managing Perishable Inventory

How food and beverage companies can use good inventory management and demand forecasting to reduce inventory carrying costs and sell their perishable goods before they expire..

 

The global pandemic exacerbated the need for good perishable inventory management. Afraid that they wouldn’t be able to fulfill orders during the crisis, companies stocked up on their fast-moving products and supplies. Many also switched over to making and/or selling pandemic-related necessities like hand sanitizer, face masks, and gloves.

 

With the world’s supply chains beginning to normalize, it’s time to take stock of the goods sitting in storerooms and warehouses—specifically those items whose shelf life may be coming down to the wire. Critical because these lose their value over time until rendered worthless, perishable inventory management should focus on selling those goods before they expire.

 

Typically associated with food and beverages, the word “perishable” applies to products that have to be consumed within a specific period of time before spoiling. The truth is, perishable inventory also includes flower bouquets that wither and are rendered unsaleable, event tickets that go unsold, or even the hotel room that sits empty overnight.

 

The bag of coffee that expires while sitting on the shelf in a small café, an obsolete piece of equipment that’s sitting on the shelf in a distributor’s warehouse…the list goes on. These and other perishable inventory items can be a significant expense for companies who literally get left holding the bag when the clock runs out.

 

Putting the Right Systems in Place

 

Made up of the tools, strategies, and techniques used to store, track, and replenish inventory, inventory management is critical for any product-oriented business that has money tied up in inventory. It’s especially important for companies that use and/or sell perishable goods that could wind up spoiling before they can be used.

 

To track perishable inventory, companies can use manual, automated, or hybrid inventory management systems focused on accurately matching supply with demand. And while such forecasts naturally become “hazy” in the midst of COVID-19, most times they do help provide a clear picture of what customers will need and what your company should have on the shelves (or, be able to source quickly) when the order comes in.

 

Using alerts that indicate when supply is low on certain products, for example, automated inventory software helps ensure that the goods are in stock when a customer asks for them. Unfortunately, it doesn’t always tell you when you’ve over-ordered something or when you’re in danger of losing product to spoilage.

 

“If the inventory is perishable,” Small Business Chronicle points out, “it has a defined date of usage and business owners need to pay closer attention to inventory demand cycles than non-perishable business owners.”

 

A better approach for perishable products is the single-period inventory, which focuses on ordering only enough goods for one period (e.g., a week, a month, a quarter, etc.). Only when that inventory is sold does the company reassess the potential demand and place another order. “This system will limit the amount of inventory that can spoil, go bad, or be otherwise obsolete,” the publication points out.

 

First-in-first-out or “FIFO” is another inventory management tool that can be used with perishable goods. The approach is straightforward: what arrives first gets sold first. For example, milk containers are stored according to their expiration dates in a refrigerator. The milk cartons with close expiration dates are stored in the front so that they get sold first.

 

“The main aim of this concept of inventory management ensures that the oldest stock is moved out first to guarantee cost-effectiveness and avoid waste,” Complete Controller explains. “The widespread use of this concept makes it ideal for many industries who use it along with other models of stock management.”

 

Minding the Details

 

Regardless of which approach a food and beverage company uses, its perishable inventory management should also incorporate product batch numbers, traceability, recalls, and obsolescence, all of which can be used to ensure the sale of inventory before its expiration date. When integrated with (or included as part of) a warehouse management system (WMS), inventory management systems provide high levels of visibility over stock that’s nearing the end of its useful life. This, in turn, helps food and beverage companies fine-tune their perishable inventory management processes.

 

Accurate demand forecasting is another must-have for food and beverage companies that want to reduce their inventory waste. “Demand forecasting (or sales projections) helps you understand how much of each product you need to have on hand at all times to meet customer demand,” Business News Daily points out. Established companies can base their forecasts on historical sales data, while startups can use assumptions and industry data to come up with these projections.

 

By using accurate sales numbers, putting someone in charge of the perishable inventory tracking processing, and doing regular inventory cycle counts, small businesses can save money on spoilage and unsold products. Warehouse managers who know that the 100 crates of navel oranges that arrived on Friday afternoon either have to be used or sold within the next week can either give the oranges a more prominent place on the retail floor (for a grocery) or offer a promotion for 25% off vanilla-orange smoothies (for a restaurant).

 

Stay Profitable and Keep Scaling

 

With inventory carrying costs comprising a good portion of many business budgets, effectively managing goods that could at some point expire helps keep those costs down while also avoiding excessive waste and spoilage.

 

Plus, inventory management is crucial to prevent loss of items, quickly fulfill customer orders, and know when you need to buy more of a given product. “It contributes directly to profitability,” Business News Daily points out, “and no business can successfully scale without an inventory management process in place.”

 

This article originally appeared on GenerixGroup.com. Republished with permission.

vaccine

FLU VACCINES RESULT FROM GLOBAL COLLABORATION: A COVID-19 VACCINE WILL TOO

A COVID-19 vaccine will follow flu footsteps

The global coronavirus outbreak has upended the lives of billions around the world. As anxiety levels remain high and the economy is in free-fall, it remains unclear how we will return to “normal life” in the short term.

In the long term, vaccine development is our best bet for a future free of COVID-19. Several companies around the world have already launched vaccine discovery with unprecedented speed. Some were able to begin small clinical trials as soon as mid-March, though expectations should be calibrated as the clinical trials process to test safety and immune response is a lengthy one.

The race to a coronavirus vaccine is emblematic of the balance between competition and collaboration, both routine and natural for the global health community. After all, experts around the world collaborate each year to develop, produce and deliver the influenza vaccine, also known as the flu vaccine, to billions of people. They have been working together this way for decades.

The first flu vaccine

According to an article published in the Journal of Preventive Medicine and Hygiene, the earliest confirmed flu pandemic on record first appeared in 1580 in Asia and Russia. It spread from there to Europe and northwest Africa.

Yet it wasn’t until the 1940s when the University of Michigan researchers developed the first inactivated flu vaccine using fertilized chicken eggs, still the primary method for making commercial vaccines today.

Phases in Drug Development TradeVistas

Tracking global strains for drug development

The flu virus changes annually, making it unpredictable. Developing an annual vaccine is the product of a globally-educated guess.

Members of the World Health Organization (WHO) established a surveillance system in 1952 to monitor the emergence of different strains of influenza that have the potential to become a pandemic. The Global Influenza Surveillance and Response System (GISRS) comprises an international network of national laboratories in more than 100 countries. These labs conduct surveillance and share information (including representative viruses) with five WHO centers located in the United States, UK, Australia, Japan and China.

Twice a year, in preparation for the flu season in the northern and southern hemispheres, the GISRS centers convene with representatives from public health bodies, leading research institutions and private sector experts to evaluate and recommend strains to include in the seasonal vaccine. Ultimately, each country decides for itself which viruses will be included in the flu vaccine they license that year.

A network for pandemic preparedness

The WHO also maintains a Pandemic Influenza Preparedness Framework, known as PIP, which includes member governments, vaccine manufacturers, and other stakeholders.

The PIP Framework governs the sharing of virus strains and PIP-related biological materials across organizations and borders, which is critical for determining which virus strains manufacturers should target in the seasonal vaccine. The Framework also coordinates access by the world’s most vulnerable populations to vaccines and treatments and manages agreements on intellectual property and licensing of the vaccine.

PIP’s industry partners receive access to the virus strains they need to make the vaccine. In exchange, they agree to provide benefits to the WHO and to developing countries in the form of vaccine donations, royalty-free licensing to manufacturers in low-income markets to make the vaccine, or a guarantee of a specified quantity of vaccine supply at lower prices, among other arrangements.

Flu Surveillance System

Vaccine production and distribution

Once the most dangerous virus strains for the upcoming seasonal flu have been selected, manufacturers turn to producing the vaccine. According to Sanofi Pasteur, the top global producer of the seasonal influenza shot, it takes between 6 and 36 months to manufacture, package and deliver high-quality vaccines to those who need them.

The viruses are first grown in a lab setting, after which the antigens are extracted from the viruses and purified to eliminate any raw material traces. Next, the virus goes through an in-activation process that retains the properties that will elicit an immune response in the body. Next, the active substances are combined into a single chemical component. These chemical components can be combined with others to form a single shot, like the MMR vaccine that includes compounds inoculating against measles, mumps and rubella. The vaccines are then filled into a vial or syringe, packaged and shipped all around the world.

Vaccine makers have to produce several different vaccines to meet the strain selection of each country. For example: CSL, another leading influenza vaccine maker, produced seven different influenza vaccines for the last flu season.

Moon shot against any flu virus

The laborious process of monitoring, surveilling, selecting, and then inoculating against specific flu virus strains, still leaves the possibility that an unexpected strain will emerge and result in a pandemic. Some seasonal flu vaccines are not an effective match against the strain that emerges. These lingering uncertainties have motivated the public health community to work towards making a universal flu vaccine – one that could provide long-lasting protection for multiple strains of influenza in one shot.

The potential for such a shot has captured the imagination of world leaders and influencers, including Bill Gates who committed millions in grants to this research. President Trump signed an Executive Order on September 19, 2019 that directs the U.S. Department of Health and Human Services to promote new vaccine manufacturing technologies and advance the development of vaccines that provide longer-lasting coverage against a broad range of flu viruses.

Researchers have seen some success. One example: early trials focused on proteins in the flu virus that remain stable and activate an immune response to stop and destroy the infection. While we are still years away from having access to such a vaccine, there is some momentum building behind this approach.

The here and now vaccine

We don’t know how soon we could have a vaccine against COVID-19. But we do know that COVID-19 vaccine development is benefiting from years of global collaboration on seasonal flu vaccine pandemic preparedness. This includes sharing biological resources, disseminating data and research, and coordinating manufacturing rights and distribution.

Is it a perfect system? No – but doctors, scientists, labs, drug companies and national health institutions have experience in what it takes to bring the world’s knowledge to bear in a well-coordinated framework, which could speed up the discovery of a COVID-19 vaccine.

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Ayelet Haran is a contributor to TradeVistas. She is a government affairs and policy executive in the life sciences industry. She holds a Master’s of Public Administration degree in International Economic Policy from Columbia University.

This article originally appeared on TradeVistas.org. Republished with permission.

supplies

FREE TRADE IN MEDICINES AND SUPPLIES IS THE HEALTHIEST APPROACH

What Does Trade Have to Do with the Pandemic?

pandemic is a type of epidemic, wherein an outbreak of a disease not only affects a high proportion of the population at the same time, but also spreads quickly over a wide geographic area.

As the novel coronavirus jumped continents, governments in countries yet unaffected or with low incidence rates moved to prevent “importing” the virus through individual travel. Simultaneously, governments acted to create diagnostic kits and treatments for those with the virus – all praise our frontline healthcare workers.

Unfortunately, what could worsen the situation is a policy practice that seems to be infectious. More than 20 governments are banning the export of needed supplies, a prescription for shortages and higher prices. What the crisis also lays bare is that key countries and many important healthcare products remain outside a WTO agreement that would otherwise enable duty-free trade in the medicines and supplies we need on a regular basis.

Pandemic Proportions

In the history of pandemics, there has been none more deadly than the infamous Bubonic Plague which took 200 million lives in the mid-14th century, wiping out half the population on the European Continent. The pathogen spread through infected fleas carried by rodents, frequent travelers on trading ships. The practice of quarantine began in the seaport of Venice, which required any ships arriving from infected ports to sit at anchor for 40 days — quaranta giorni — before landing. Two centuries later, Small Pox took 56 million lives. In the modern era, some 40 to 50 million succumbed to the Spanish Flu of 1918 and HIV/AIDS has claimed 25-35 million lives since 1981.

For perspective, and not to minimize its severe toll, the number of fatalities from novel coronavirus will likely exceed 10,000 by the time of this writing. COVID-19, as it is currently known, is a reminder that we live with the ongoing threat from many types of both known infectious diseases like cholera, Zika and Avian flu, as well as diseases yet unknown to us. Although we can more rapidly detect, contain and treat epidemics, diseases now travel at the speed of a person on board an international flight. Our cities are bigger and denser, further enabling rapid transmission.

Pandemic Prepping Includes Trade

Because we are interconnected, we share the health risks, but we can also problem-solve as a global community. Scientists in international labs share insights to identify viruses, swap guidance on how to conduct confirmatory tests, and quickly communicate best practices for containment.

Outside times of crisis, global trade in health-related products and services has laid the foundation for faster medical breakthroughs through international research and development projects, and by diversifying the capability to produce medical supplies, devices, diagnostics and pharmaceuticals.

Innovation thrives in the United States like nowhere else. Yet, no single country, not even the United States, can discover, produce and distribute diagnostics, vaccines and cures for everything that ails us — or invent every medical intervention that improves the productivity and quality of our lives.

One Quarter of medicines have tariffs

A Dose of Foresight

As the Uruguay Round of multilateral trade negotiations were drawing to a close in 1994, a group of countries representing (at the time) 90 percent of total pharmaceutical production came to an agreement. Each government would eliminate customs duties on pharmaceutical products and avoid trade-restrictive or trade-distorting measures that would otherwise frustrate the objective of duty-free trade in medicines.

The WTO’s Pharmaceutical Tariff Elimination Agreement, which entered into force on January 1, 1995, is known as a “zero-for-zero initiative” to eliminate duties reciprocally in a particular industrial sector. Signed onto over subsequent years by the United States, Europe’s 28 member states, Japan, Canada, Norway, Switzerland, Australia and handful of others, the agreement initially covered approximately 7,000 items that included formulated or dosed medicines, medicines traded in bulk, active pharmaceutical ingredients (APIs) and other chemical intermediaries in finished pharmaceuticals.

Signatories agreed to expand the list in 1996, 1998, 2006 and 2010 so it now covers more than 10,000 products. Tariffs were eliminated on a most-favored-nation basis, meaning it was extended to imports from all WTO members, not just parties to the agreement.

Maintenance Drugs

Though an important start, the agreement has not been updated in a decade. Trade in products covered by the WTO agreement has risen from $1.3 trillion in 2009 to $1.9 trillion in 2018. Yet, some 1,000 finished products and 700 ingredients are not covered under the agreement, leaving pharmaceutical trade subject to hundreds of millions in customs duties. With China and India increasing manufacturing over the last decade, the value of global trade included in duty-free treatment decreased from 90 percent in 1995 to 81 percent in 2009 to 78 percent in 2018.

It is challenging to chart trade statistics and tariffs on health-related products, particularly since many chemical ingredients have both medical and non-medical uses. Here we have attempted to reproduce tables developed by the WTO in 2010, but we do not include a large number of chemicals that have general use whose tariff lines were not enumerated in the WTO’s analysis.

Health Product Import Shares

In 2010, the European Union and the United States together accounted for almost half of all world imports of health-related products. Europe has become a much larger importer while U.S. imports have decreased slightly as a percentage of global imports. Imports by many big emerging markets including Brazil, Mexico, China, India and Turkey, have increased along with their purchasing power. These countries benefit from zero duties when importing from countries that signed on to the WTO Pharmaceutical Trade Agreement.

Health Product Export Shares

On the export side, Europe dramatically increased its share of global exports while the United States dropped across the board compared to 2010, particularly in medical products and supplies. China shows significant growth in exports of inputs specific to the pharmaceutical industry – including antibiotics, hormones and vitamins – as well as medical equipment including diagnostic reagents, gloves, syringes and medical devices. India also increased its exports of all types of pharmaceuticals, particularly ingredients, but did not drive up its share across all types of exported health-related products. China and India would benefit from zero duties without having to reciprocate for exports from countries that signed on to the WTO agreement.

That said, according to the trade data, China and India still only account for 5.4 percent of global exports in health-related products covered by the agreement. Therefore, simply expanding membership to include these countries is not sufficient to enlarge duty-free trade – the number of tariff lines covered by the agreement would also need to expand to capture a significant portion of traded healthcare products.

Emerging Market Pharm Trade

Tariffs as a Symptom

The final price of a pharmaceutical is determined by many factors that differ by country. Costs and markups occur along the distribution chain from port charges to warehousing, to local government taxes, distribution charges, and hospital or retailer markups. Tariffs may seem a relatively small component of the final price, but the effect is compounded as all of these “internal” costs accumulate and they are symptomatic of complex regulatory systems.

A 2017 study by the European Centre for International Political Economy determined that tariffs on final prices add an annual burden of up to $6.2 billion in China. In Brazil and India, tariffs on medicines may increase the final price by up to 80 percent of the ex-factory sales price. Imported pharmaceuticals are at a clear disadvantage and patients bear the burden in cost and diminished availability.

Side Effects

According to the U.S. International Trade Commission, the U.S. pharmaceutical industry historically shipped bulk APIs from foreign production sites to the United States before formulating into dosed products. After the WTO agreement, it became viable to import more finished products duty-free. Over the years, a failure to add more APIs to the duty-free list reinforced this trend. The U.S. Food and Drug Administration also allows firms to import formulated products prior to receiving marketing approval to prepare for a new product launch but does not allow bulk API importation before market approval.

The urgency to accrue adequate supplies and treatments for COVID-19 has reignited a debate on U.S. over-reliance on China and India for antibiotics, among other medicines. What if factories must close? What if China and India withhold supplies? If raw materials and ingredients are derived in those countries, would the United States be able to ramp up domestic production? The White House is considering incentives and Buy America government procurement requirements to stimulate demand for U.S. production and in the meanwhile has temporarily reduced tariffs on medical supplies such as disposable gloves, face masks and other common hospital items from China.

20 Countries Ban Medical Exports

A Cure Worse Than the Disease

Removing barriers to trade in essential products is a healthier approach than imposing restrictions that could exacerbate potential shortages.

Nonetheless, some 20 countries have announced a ban on the export of medical gear – masks, gloves, and protective suits worn by medical professionals. They include Germany, France, Turkey, Russia, South Korea, India, Taiwan, Thailand and Kazakhstan.

Governments generally do maintain national stocks of critical items to enable manufacturers to ramp up production in cases of health emergencies or address unexpected gaps in their supply chains. But when major producers withhold global supply, importing countries face shortages and higher prices. Dangerously, India’s trade restrictions go beyond medical gear to restrict export of 26 pharmaceutical ingredients. India, however, relies heavily on APIs imported from China for their medicines, much of it originating from factories in Hubei province where the outbreak emerged.

Bans tend to beget more bans, potentially wreaking havoc on pharmaceutical and medical product supply chains, making it more difficult for healthcare workers to stem spread of the virus. Poorer countries with already fragile and underfunded healthcare systems are left in an even more vulnerable position.

A Test for Public-Private Collaboration

Instead of export restrictions, governments can expedite purchase orders and otherwise support industry efforts to ramp up production for domestic and global use. Most global manufacturers are operating at several times their usual capacity since the initial outbreak in China. Private labs are utilizing high-throughput platforms to conduct more tests faster but require trade in the chemical reagents needed to start up and run the tests.

Biopharmaceutical firms are applying their scientific expertise to accelerate the development of a vaccine and treatments for COVID-19. They are reviewing their research portfolios, investigating previously approved medicines that have potential to treat the virus, and donating approved investigational medicines to the global research effort. Internationally, scientists are collaborating through a Norway-based nonprofit called the Coalition for Epidemic Preparedness Innovations on COVID-19 vaccine development. They know that the more options, the better – most drug candidates will not get through all three phases of clinical trials.

Recovery

Epidemic diseases evolve and they do not respect borders. Treating them, as well as the myriad chronic diseases and other ailments that affect us more routinely, requires new and adapted medical technologies arising from innovation made widely available through trade.

While there’s nothing inherently wrong with providing incentives to encourage domestic production, it should not come at the expense of free trade in health-related products. Tariffs should be eliminated on life-saving medicines and their ingredients. Governments must impose restrictions on exports temporarily and only when absolutely necessary. In this way, openness in trade will help promote the recovery of both our health and our economies.

Many thanks to economist and contributor Alice Calder for running all the trade numbers in this article. Full data tables may be accessed here.

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Andrea Durkin is the Editor-in-Chief of TradeVistas and Founder of Sparkplug, LLC. Ms. Durkin previously served as a U.S. Government trade negotiator and has proudly taught international trade policy and negotiations for the last fifteen years as an Adjunct Professor at Georgetown University’s Master of Science in Foreign Service program.

Alice Calder

Alice Calder received her MA in Applied Economics at GMU. Originally from the UK, where she received her BA in Philosophy and Political Economy from the University of Exeter, living and working internationally sparked her interest in trade issues as well as the intersection of economics and culture.

This article originally appeared on TradeVistas.org. Republished with permission.

cold Pharmaceutical

Global Air Cargo Trends Re-Shaping Pharmaceutical Transport

As we welcome the new decade and the exciting advances it is expected to unleash, many of the forces that shaped the past decade for transporting pharmaceuticals will continue. Price pressures, alternatives to air freight and increasing automation are just a few. However, there are emerging trends that make 2020 unique.

As we look forward, these are the air cargo trends expected to shape the transport of pharmaceuticals in 2020 and beyond.

The Greta Thunberg Effect — Flying Shame

We can’t ignore the effect that climate change activist Greta Thunberg is having on air travel that runs on fossil fuels. Thunberg’s reliance on trains to travel from her home country of Sweden to other countries in Europe connected by rail has triggered a material effect on passenger numbers in Sweden. According to Bloomberg, Swedish air travel diminished in 2019 — while train travel jumped to a record level.1

What could this mean for shipping pharmaceuticals by air? As “extinction rebellion” shows no sign of slowing down, air freight carriers — like their passenger transporting counterparts — will feel more pressure to seek alternative fuel sources and replace older planes with more fuel-efficient models. To further address the Thunberg effect, carriers and their logistics partners will also need to elevate their brand image by demonstrating they are adopting eco-friendly practices such as reusable or waste-stream friendly shipping containers made from recyclable materials. Especially for shipping pharmaceuticals, these shipping containers must still maintain strict temperature control to ensure valuable payloads arrive intact.

Global Trade Pressures Drive Down Air Freight Demand

After years of wrangling over the details of Brexit, the UK is departing from the European Union (EU) — and entering a transition period through the end of 2020. The effects of Brexit and the fact that Germany only narrowly avoided an official recession at the end of the last decade have been driving down European air freight demand. Furthermore, US tariffs aimed at four counties in retaliation over subsidies to Airbus has hit Germany especially hard.

Meanwhile, the US-China trade war began to thaw with the signing of an initial trade deal. But trading data showed the climate would have to improve significantly to combat the year-on-year 8.1% decline in freight tonne kilometers experienced in 2019.2 Price is the crudest and quickest tool at air freight’s disposal to address diminishing demand. However, long-term price cutting is not sustainable and in the face of continued change, air freight companies will have no choice but to cut flights from their schedules and mothball aircraft — and cease to exercise purchasing options that did not factor in declining demand.

Diminished Air Freight Demand Means Reduced Capacity

Air freight remains the predominant mode of transportation for moving life-saving pharmaceuticals around the globe, especially for the most valuable and sensitive therapies that require strict temperature control. Sea transport, accounting for approximately 20% of pharmaceutical shipments3, made gains in recent years as an alternative transport mode for non-temperature sensitive products and the return of containers after payloads have reached their destination. However, for the foreseeable future, pharmaceutical companies will remain reliant on air freight for transportation of products that could succumb to temperature excursions.

Declining air freight and passenger demand combine to produce a double whammy for the pharmaceutical industry. As air freight capacity becomes an even more precious and dwindling resource, there are things that can be done to mitigate reduced capacity. For example, temperature-controlled packaging systems will need to step more into the foreground to reduce volumetric weight, providing higher performing insulation and phase change materials that can considerably improve volumetric efficiency.

However, packaging systems currently available to reduce volumetric weight are typically more expensive unless they are re-used, and re-use can’t always be achieved efficiently for both financial and environmental reasons. The pharmaceutical packaging industry will need to look more closely at the installed capabilities of aircraft to manage temperature, which could make lower-grade packaging materials more acceptable. The capabilities of the aircraft will also need to be matched to ground conditions and reliable sourcing can be difficult in less developed regions of the world.

 Pharmaceutical Packaging: No Longer Rickshaw Vs. Tank

When it comes to pharmaceutical packaging, one size does not fit all — nor should it. The days of choosing between a rickshaw or a tank are behind us. Pharmaceutical packaging manufacturers have broadened their product portfolios to enable the most efficient solutions to be selected, qualified and deployed on a lane-by-lane basis across truly global supply chains. Making the right selections and performing the necessary qualifications can be daunting compared to the old simplicity of “I’ll have a tank everywhere.” But this is the challenge we must face to deliver value and make responsible use of dwindling resources such as global air freight capacity.

The good news is that cold chain consultants have the tools and resources to streamline this new approach. Packaging products have been engineered and tested to incorporate operational consistency and simplicity that might otherwise make it too complex to deploy. Networks and services have also been developed and deployed to enable efficient and reliable outsourcing of operations.

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Dominic Hyde is the Vice President of Crēdo on Demand at Pelican BioThermal.

References:

1. As ‘Flying Shame’ Grips Sweden, SAS Ups Stakes in Climate Battle, Bloomberg, April 14, 2019.

2. Air Cargo Demand Continues Negative 2019 Trend, International Air Transport Association (IATA), May 29, 2019.

3. Will Ocean Freight Be the Dominant Mode of Transport for Pharma Payloads?, Pharma Logistics IQ, July 12, 2018

vaccines

Report: Global Vaccines Market

The U.S. vaccine market is anticipated to experience growth of 8.9% CAGR during the forecast timeframe. The high adoption rate of vaccines to reduce the incidence of infectious diseases along with several initiatives undertaken by government by increasing immunization rates and recommendations should stimulate business growth.

Japan’s vaccine market will grow significantly over the coming years to reach over USD 6.0 billion by 2025. Introduction of the routine vaccination program in October 2016 leading to the introduction of numerous important and routine vaccines having a higher rate of administration as compared to voluntary vaccines should drive the Japan vaccine market.

Increasing demand for preventive vaccines, the rising number of people suffering from infectious as well as non-infectious diseases globally will drive the vaccine market over the forecast timeframe. Increasing government funding for vaccine development will further boost industry growth.

Widespread routine vaccination programs and numerous initiatives undertaken by governments to encourage vaccine administration especially in developing and underdeveloped countries will positively impact industry growth. Growing awareness about reduced mortality due to immunization should propel vaccines industry growth over the forecast period.

High adoption of new vaccines coupled with technological advancements should stimulate business growth. Moreover, a strong product pipeline of leading companies such as Merck, Novavax, Emergent BioSolutions will lead to industry expansion over the coming years. However, high costs associated with transportation and storage of vaccines will limit the vaccines market growth to a certain extent over the foreseeable future.

Each time a nation is hit by an epidemic wave, children are one of the groups that take the deadliest hit. According to the Centers for Disease Control and Prevention, 1 or 2 of every 1,000 children who are diagnosed with measles die. During the nation’s recently witnessed measles outbreak, around 92 percent of children received a combination vaccine that prevents measles, rubella, and mumps. Immunization programs prevent and protect toddlers and infants from dangerous complications and failing to vaccinate may certainly put them at risk for fatal diseases. This has escalated the demand for vaccines for kids, which has subsequently influenced the growth curve of the vaccines market from the pediatric populace.

As per estimates, vaccines industry size from the pediatric age group is set to witness a CAGR of 9.1% over 2019-2025, given the high vulnerability of kids to infectious diseases along with the increasing implementation of pediatric immunization programs.

Driven by the ongoing pace of urbanization and the rising awareness regarding the potential dangers a pandemic can inculcate, the global vaccines industry is gaining increased attention. According to a new research report by Global Market Insights, Inc., the overall vaccines market size is anticipated to surpass $70 billion by 2025.

Some of the major market players involved in the global vaccines market are Merck, AstraZeneca, Johnson & Johnson, Novartis, Bristol-Myers Squibb, Abbott, Sanofi Pasteur, GlaxoSmithKline, Pfizer, Emergent BioSolutions, CSL, Astellas Pharma and Novavax. Firms are focusing on product launch to fortify their product base and market reach over the coming years.

Source: Global Market Insights, Inc.

Tanzania

Partnering to Help Children in Tanzania to Survive Cancer

A donation from leading temperature control packaging company Softbox Systems has enabled the charity International Health Partners (IHP) to deliver cold-chain oncology medicines, giving children in Tanzania the chance to recover from cancer.

The recent donation of a temperature control pallet shipper enabled IHP to send cytotoxic (chemotherapy) medicines to TLM, its aid partner in Dar es Salaam. These were used to treat Kanoni, a two-year-old patient, who is now free of cancer.

Last December, Kanoni was admitted to the hospital with a huge abdominal mass and severe pain. A CT scan and tests revealed that she had a kidney tumor. “When the lab investigated, it found her cancer was high-risk, and she needed medicine that could only be transported through cold-chain packaging,” explained Colleen Harrisson-Dodds, Logistics Director for IHP.

 

Previously, IHP and Softbox Systems have collaborated to send more than 2,000 treatments to Tanzania. Softbox donated its award-winning Silverpod pallet shipper, which enables the shipment of bulk consignments of goods, and can maintain product temperature stability for up to 120 hours.

Kanoni completed her treatment last month, and scans show the cancer has gone. “We’ve seen a remarkable improvement in her condition,” said Lilian Nydyetabula, the chief operating officer of TLM, which helped establish Tanzania’s first pediatric oncology service. “She gained weight and was able to move around and play with other children. Now, Kanoni is a totally different child from the one who arrived last December.”

Softbox Systems is a market leader that has won acclaim for its emphasis on high performance, sustainable and user-friendly packaging solutions. “It’s a pleasure to support IHP and rewarding to know that our packaging systems enabled the safe transportation of Kanoni’s life-saving treatment,” said Clive Bryant, Global Product and Marketing Director at Softbox Systems. “Our award-winning Silverpod range means that temperature-sensitive medicines arrive in perfect condition and ultimately save lives. We’re always looking for ways to enhance our products to facilitate the successful delivery of life-saving medicines all around the world.”

IHP is a leading coordinator of donated essential medicines, working with healthcare companies, logistics providers and aid agencies. Adele Paterson, CEO, said: “This is a wonderful example of the way we partner proactively. We’re delighted to work with Softbox Systems to enable the delivery of high-quality medicines to vulnerable people.”

cold chain

Benefits of Cold Chain Warehousing Solutions

Not many people are familiar with cold chain warehouse solutions. However, if you are in any type of business dealing with perishable items, this is right up your alley. Cold chain warehousing is used to store items that need to be left in cool surroundings and that have a short shelf life. By using them you can prevent your items from spoiling, being attacked by insects and rotting. So, the goal is clear. Life of certain items needs to be prolonged and one of the most effective ways to accomplish this is by using cold-chain warehousing, also known as cold storage or refrigerated warehousing.

Types of products that are in need of cold chain warehousing 

First, you need to know which items are suitable to be stored in such a place. Not all items respond well to cool temperatures. The last thing you want is investing in something that you do not need, like cold storage. For example, after transporting fruits and vegetables it would be a great solution to store them in cold storage space. Hence, if your business involves some of these products you are on the right path of finding the best possible solution for your business load.

Supermarkets and other stores have a tendency to use cold storage for a lot of their goods that are not in store for sale. 

3 main groups of goods 

-Foods that are considered to be alive – fruits and vegetables

-Processed foods that are considered to be no longer alive – fish, meat and any other products that contain the fish and meat

-Items that do not necessarily need be stored in a cool or freezing atmosphere, but remain the freshest and of highest quality while in it (tobacco, beer, some oils, some types of flour, etc.)

There are two main options 

One of the great things about cold storage units is that there are many different variations. But, there are two main types of systems. First comes the vapor absorption system (VAS), followed by vapor compression system (VCS). These two systems are not cardinally different from one another. Yet, there are some important differences that need to be acknowledged. The main one being the technique in which energy input is fed to the system. To be sure you are making the right choice when making this large purchase, we strongly advise you to speak to an expert. Sooner or later you will have to learn the difference between the two systems.

Main benefits of cold chain warehouse solutions 

Still, you might not be persuaded and convinced that this type of storage will improve your business. Nonetheless, after reading these benefits, it is very likely that the next thing you do will be exploring your options in purchasing a cold storage unit. Cold chain warehousing solutions in combination with transport technologies for air cargo can be one of the best solutions for storing and moving perishable goods.

Fruits and vegetables are items that are very difficult to store because they are very sensitive to temperature and even humidity. 

The array of usage doesn’t limit you 

One great thing about cold storage is that the temperature within the unit can be easily adjusted. That isn’t all. In addition to temperature, humidity can also be controlled. Humidity, just like temperature, can be a huge factor in saving the freshness and quality of the items. These two benefits, with an airtight closing mechanism, make this a great storage option.

Customize to fit your needs 

More modern units can be customized so the temperature range and size of the unit specifically fit your storage needs. For instance, if you do not need freezing conditions, but dry and cool, your needs can be accommodated. This is a perfect option for those that import oils and fats. As a cherry on top, your unit can be fixed or portable. There is an abundance of options. All you have to do is choose the bests options for your business requirements.

Great backup and organizing option

This can be best described in an example. For argument’s sake, let’s say you are a restaurant owner. One day, out of the blue, the power shuts down and there is no electricity in your restaurant. If you are a fan of cold chain warehousing solutions, you might survive the electricity outage without any loses. If all goods are quickly moved and expedited to the cold storage space, it is very likely they will not lose their value and end up as garbage.

In the long run, you are saving money 

The initial investment is not small, but it will certainly save you money in the long run. Surely you know how much goods you’ve tossed in the past years. Imagine preserving and using or selling at least half of what you tossed. That can add up financially. Minimize waste and give yourself an option to purchase items in bigger bulks for a significantly lower price.

Investing in cold storage might initially turn out to be a financial hit, but it will pay off in the long run. Alt text: suitcase filled with dollar bills and with other bills around it.

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Danny Segno is a New York native, but currently, she lives in Boynton Beach Florida. For the past two years, she has been working for Authority Moving Group, a professional moving company. Danny enjoys her job because she likes working with people and helping them. Since she is a customer care specialist, she focuses on customer satisfaction. 

 

cold chain

Cold Chain Logistics Survey Reveals Biopharma Trends

Global temperature-controlled packaging provider Peli BioThermal shared three key insights revealed in the latest survey conducted on opinion leaders within the biopharmaceutical industry. The company’s 2019 Biopharma Cold Chain Logistics Survey took a granular look at current trends, technologies, and operations among cold chain industry players and exactly how much these trends are impacting the supply chain.

Among the most surprising trends uncovered in the survey confirmed cold-chain excursions are more common than one might assume. A total of 41 percent of survey respondents reported having multiple temperature-controlled excursions exceeding four degrees. More than half of respondents confirmed shipping internationally, adding pressure to the increasing demand for transportation optionality and flexibility within climactic zones.

Additionally, increasing quality demands made the list. As cold chain logistics increase among shippers, risk increases as well. With close to half (44.6 percent) of companies revealing multiple excursions per year, temperature and location tracking is high on the list of concerns to ensure high volumes are handled accurately.

Source: Peli BioThermal

“As strong growth continues across the global pharmaceutical industry, the sub-category of temperature-controlled products is surging ahead — growing at twice the rate of the industry overall,” said David Williams, President of Peli BioThermal. “Our survey reveals what matters most to key biopharma leaders — and what it means for the future — as the industry deals with the rapid growth and complexity of temperature-controlled logistics.” 

Source: Peli BioThermal

Among the most common modes of transportation include air and ground with the option for sea and rail due to experience an increase among shippers, according to the survey.

Reusable containers garnered 79 percent respondent approval, adding that although pricier they are worth the investment and worth it over single-use containers. A total of 37.6 percent confirmed the implementation of reusable containers, with 25 percent currently vetting options.

The final piece of the results came from nearly 70 percent of respondents focusing on total cost of ownership (TCO) optimization as important. This consideration would primarily offset market pressures such as competition  and margin, but proactive measures in defining TCO have not gathered momentum just yet. Only 10 percent of respondents confirmed exploring basic packaging costs and rates. 

To read the full 2019 Biopharma Cold Chain Logistics Survey report, visit www.pelicanbiothermal.com/survey.