HISTORY MAKERS

As global supply chain security goes, the worldwide distribution of coronavirus vaccines is being headlined as the ‘biggest challenge for a generation’. Given the stakes involved, it is extremely hard to disagree… the world is waiting.

Whichever statistics you choose to look at, the pressure of ensuring every dose of the vaccine reaches patients safely, securely, and with its efficacy intact is loud and clear:

 

·       218 countries have confirmed cases of coronavirus

·       >60 million of the global population have been infected by the virus

·       >1,400,000 people have lost their lives to Covid-19

·       Up to 19 billion vaccine doses are expected to be produced

·       60-70% of the global population will need to gain immunity to stop the virus from spreading

 

Measured against the risks to human life, the financial opportunity for the pharmaceutical industry presented by demand for a vaccine may seem insignificant but, obviously, it cannot be ignored either. Some reports suggest it will be worth $10 billion annually across developed countries, others predict this market size in the US alone. If the vaccine is required to be taken annually, these estimates rise to $25 billion. One media report describes the size of the market to be ‘equivalent to the annual revenue of 10 blockbuster drugs.’

 

According to the World Health Organization (WHO) on 12 November, there are currently 48 candidate vaccines in clinical evaluation and a further 164 in pre-clinical evaluation. This, coupled with news of the projected effectiveness of vaccines produced by leading global pharma companies, is only adding to public confidence and expectation that the end of this unprecedented period in history is in sight.

 

The world needs this to work, and not simply to keep us all fit and healthy. A study by the University of Sydney puts the global economic cost of the coronavirus at $3.8 trillion. It also estimates the virus has so far put some 147 million people out of work. For businesses clinging to life, a vaccine and its promise of a return to normal life – or even a ‘new normal’ – cannot come fast enough.

 

The scientists seem to have done their outstanding work in finding a viable vaccine for Covid, and in record time. The production lines are rolling, and the logistics industry is gearing up to play its part in the global recovery. All eyes are now on the supply chain.

 

Pharmaceutical supply chains are already among the most regulated, safe and secure of any industry so, even at the outset, there’s plenty of reasons to be confident in their ability to rise up to the task in hand. This doesn’t make them immune from cargo thefts, of course. A black market in which prices escalate on a simple ratio of demand vs. supply means many Organised Crime Groups may consider targeting vaccine shipments as too good an opportunity to miss – or maybe not. It’s one thing to find ‘black market’ buyers for products such as electronics goods, cosmetics, clothing and footwear, and food and drink, but would you be in the market for a vaccine from an unknown source? Presumably, not, and this fact will be clearly understood by criminal masterminds.

 

But, if losses do occur – or even if vaccine shipments are tampered with or contaminated during the delivery process - the knock-on effects for vaccine developers, their logistics providers, and patients will be extremely disruptive. The ‘domino-effect’ of the theft of pharma products is costly, far-reaching, and takes times to recover. Now, more than ever, we all need seamless and uninterrupted deliveries.   

 

“Ensuring the secure storage, transportation and delivery of every pharmaceutical shipment is of paramount importance to the healthcare industry to ensure patient safety. This explains why pharmaceutical supply chains are among the most resilient of any sector. In terms of cargo security, the true cost of loss of a pharma cargo has been estimated to be between 5-7x the value of the product because of the knock-on effect it creates, including wide-scale product recalls, to say nothing of the reputational damage to companies. Product losses are clearly the biggest threat but contamination of pharma cargoes during a cargo crime – even if they are not actually stolen – can be just as damaging. In terms of world health, the Covid vaccine represents the biggest supply chain security challenge of our generation because so much is expected from both a public health and economic perspective. It is no coincidence that on the day we saw an announcement about successful vaccine trials, European stock markets soared by 7%, so there’s so much at stake for both the pharma industry and its logistics service providers,” commented TAPA EMEA’s President & CEO, Thorsten Neumann.

 

With vaccine deliveries expected to begin as early as next month, the focus of all supply chain security stakeholders will be to avoid any disruption to the delivery process and to protect the integrity of vaccines on their way to patients. TAPA EMEA, however, says companies must leave no stone unturned in assessing the associated cargo security risks and requirements on a country-by-country basis because the threat of cargo theft is never far away.

 

“With a black market controlled by supply and demand, Organised Crime Groups (OCGs) will be very aware of the value of doses of the vaccine and are highly likely to be looking for ways to intercept supply chains to steal shipments, especially with such high volumes being distributed within a short timescale. If such losses do arise, the impact on the global community will be much more far-reaching than the theft of a single shipment of vaccines. As we have already seen this year with the high number of thefts of Personal Protective Equipment (PPE) from supply chains, cargo thieves are very active in targeting Covid-related products so, as industry, we must be ready,” Neumann adds.

 

He says the supply chain security programmes in place to protect deliveries of Covid vaccines are likely to include the use of armed escorts, additional truck security and driving in secure convoys, depending on the level of risk in each geography. Some countries may even be considering military support to ensure vaccine deliveries are not delayed in any way.

 

To get a ‘boots on the ground’ perspective, Vigilant spoke to two respected experts in this highly specialized field, Chuck Forsaith, Vice President within the Healthcare Distribution Alliance – which incorporates the Pharmaceutical Cargo Security Coalition (PCSC) - and Rogier Wils, Manager, Operations & Planning at BK Sneltransport – BK Pharma Logistics.

 

Chuck Forsaith says learning lessons from the past has given us the resilient pharma supply chains we appreciate today and he is confident in their ability to manage any new risks associated with the distribution of Covid vaccines.     

 

“Over the years there have been a number of significant advancements in pharmaceutical supply chain security - of which TAPA has been a visual participant. One of the most notable contributions that TAPA has made came as a result of a large-scale warehouse burglary in the United States several years ago. In that incident, over $70m of pharmaceutical products were stolen in a brazen night-time break-in. After that incident, the victim company made a conscious decision to improve their supply chain security (SCS) posture and adopted both TAPA’s Facility and Trucking Security Requirements globally. Disruptions decreased significantly as a result. The company then shared its positive experience with others and a renewed focus developed, pretty much industry-wide. As bad as what happened was, it was a ‘wake-up call’ to all of us and we have, as an industry, strived to improve SCS ever since.

 

“It is this sense of purpose, now mated with improved supply chain security infrastructures, that will help to carry us through this period of critical product dissemination. While I do believe there will be some enhanced SCS scrutiny in these upcoming efforts, I genuinely can’t think of any other industry that is as well prepared (from a supply chain security standpoint) than ours is right now,” he says.

While he expects existing requirements and responsibilities to once again prove more than adequate to protect the world’s most critical and expensive pharmaceutical products as they move through the global supply chains, there will be no complacency on the part of the stakeholders involved. Chuck Forsaith adds: “It would not surprise me if manufacturers, distributors and retailers may be looking to add some additional resources to assure the security of this particularly critical commodity. Things such as the use of additional tracking technology, possibly shipment escorts, and a deeper dive into route risk analysis, are just some of the actions which will be considered during these times.”

Rogier Wils agrees, saying: “Existing security precautions are already quite comprehensive but an increasing number of pharmaceutical companies are demanding the TAPA FSR Level  A and TSR Standards. We have received an increasing number of enquiries about TSR in combination with temperature controlled pharmaceutical transports. Extra drivers for non-stop transit is already common practice, and convoys and (armed) escorts in some countries are, in my opinion, highly likely. A lot is still unknown about the availability of the coming vaccines and possible shortages. Supply and demand generally make a product valuable and, therefore, more interesting to criminals. Another factor to take into account with these shipments are the anti-vaxxers and conspiracy theorists who believe Covid-19 is a hoax. They may also represent a security risk to vaccine shipments.”

 

Working with global Customs and Health agencies, detailed descriptions and depictions of what these vaccines will look like when packaged and shipped are also being developed to help better differentiate authentic from suspect products. Government regulatory agencies in many countries are also known to have made verbal enquiries - if not actual visits - to companies shipping and/or storing vaccines to add additional levels of scrutiny and assurance to the security of the supply chain process. PCSC, Chuck Forsaith says, has been asked to review a number of corporate and vendor shipment programmes as well.

Discussing the security risks, he states: “The complexity of the dissemination process is what causes the most concern at this point in time – and the majority of that concern surrounds the unique temperature requirements for this type of product. For instance, because the vaccines need to be kept cold (in some cases “super cold”), traditional cartage methods may be different. This will potentially limit the amount of vaccines that can be shipped in a single conveyance, at a single point in time. Limited space means more shipments will be required to fulfil the need. More shipments, logically, translate into the possibility of additional risk. 

“A number of these vaccines involve ‘two-shot’ courses, which means that two separate shots are required a number of days apart to successfully complete the treatment. Hence a shipment of, say, 50,000 vaccines will only be able to treat 25,000 people. Again, that equates to an increased number of shipments that will need to be made to successfully inoculate a particular population.”

Keeping with that same temperature control theme, he says not all locations the vaccines will be going to will have current configurations to maintain the vaccines within those temperature ranges. This means modifications will need to be made to existing infrastructure - and this may not align well with the existing supply chain security programs at those locations. “The dissemination of these vaccines will truly need to be global. Hence, we may be going into areas where SCS has rarely been a principal focus. Now it will have to be.”

Rogier Wils adds: “Temperature control will be essential for the quality of the vaccine. The first vaccines available will have a storage and transportation temperature of minus 70 degrees. If freezers are opened and temperatures move outside of the required specifications, complete batches will be lost. Transportation will be done in dry-ice shippers and boxes. If these are opened by criminals, the vaccines will be useless. With dry-ice shipments, transit time is very important as well because delays will potentially risk losing the product.”

Strict cybersecurity protocols will have to be enforced, too. This is not simply to ensure vaccine shipping transactions are performed under the highest levels of cybersecurity. It also means ensuring each business partner in these supply chains complies with those protocols.  

The first wave of vaccine shipments will come under the greatest scrutiny. Pharma and logistics companies recognize the vaccines will draw a considerable amount of attention, particularly in the initial stages of launch. As the amount of vaccines being disseminated increases, over time it’s reasonable to believe this degree of attention may not necessarily be as intense. “That being said,” Forsaith adds, “this particular product (similar to other temperature sensitive products - like insulin, Hepatitis C drugs and CAR-T shipments) will continue to receive the same level of supply chain security attention, no matter what period of time it is in the product’s overall life cycle.”

Previous ‘total cost of loss’ reports relating to pharma thefts have demonstrated the longer-term scale of disruption caused to pharma supply chains. Chuck Forsaith comments: “A partial loss of a product manufactured under a specific lot number could, conceivably, require that all of the remaining product that was manufactured under that same specific lot number needs be held until the stolen/diverted portion of the lot has been recovered, or a determination made if it cannot be recovered.

“At that time, the remaining product under the original lot number would need to be eliminated, to reduce the risk of confusion within the supply chain of product properly maintained for distribution, and product in which there wouldn’t be any known assurance of proper maintenance (stolen or diverted goods). Particularly when considering consumable goods, products that cannot demonstrate a thorough accountability of their travel through a supply chain directly equate to a patient safety issue – for which the pharma industry, and its regulatory bodies, have no tolerance. 

 

“These instances obviously become problematic in other ways as well, such as: causing enhanced regulatory scrutiny by government agencies; affecting customer confidence in the product; encouraging consumers to seek other product brands, causing additional cost to re-manufacture replacement product; diverting resources to conduct investigations into why the incident occurred, increasing insurance costs/liability, etc… Typically, these issues are isolated to a specific manufactured brand as opposed to an entire type of product manufactured by multiple brand companies. What will be more unique in this instance is the current amount of underlying skepticism, in certain quarters, about the validity of vaccines in general. The exposure of incidents involving the diversion or theft of vaccines within a supply chain could, conceivably, erode some of the confidence in the vaccines themselves.”

Rogier Wils is confident that the logistics sector’s preparations – including the provision of adequate warehouse and freezer space, temperature controlled vehicles, trained staff, security protocols and GDP compliance – mean the industry will be ready for the ‘enormous challenge’ it anticipates. Increased security and quality will come at a higher price for pharmaceutical companies but, as he says: “As long as there is a shortage of vaccine availability, security will be of the utmost importance.”

We don’t have to wait too long now to see how pharma supply chains perform under this unprecedented global spotlight. We’ll all be hoping they’re able to uphold their traditional exemplary standards.