CEIV Pharma: industry cooperation that is taking off

The pharmaceutical sector is dependent on the secure and reliable transport of valuable time and temperature-sensitive goods. Committing a single mistake along the cargo supply chain can destroy the integrity of an entire batch of medicines or vaccines, rendering them worthless and potentially harmful, or even deadly, to end recipients. Although mishandling does not occur often, it is an unfortunate fact that more than 50 percent of all temperature excursions that do occur happen while the package is in the hands of airlines and airports. As a result, there is a strong industry need for pharmaceutical trade lanes that assure the integrity of pharmaceutical products being shipped via air.

In order fill this industry gap, several air transport industry stakeholders and regulators have joined forces to create the CEIV Pharma programme.  This joint effort aims to effectively help reverse the current lack of standardisation, compliance and transparency currently afflicting the pharmaceutical air transport supply chain via mutual cooperation, honest sharing of data and a strong emphasis on accountability. 

An industry need for standardisation

According to Pharmaceutical Commerce Magazine, the pharmaceutical cold chain logistics industry will surpass the $10-billion mark in 2018. Traditionally, this industry has relied heavily on air transport due to its speed and efficiency. However, over the past decade, air cargo’s share of the overall global pharmaceutical product transport has been continuously declining. The use of air transportation is reconsidered given the current amount of annual product losses in air transport (up to US$12.5 billion) and the current trend towards improved reliability in ocean freight.

In an effort to reduce overall levels of pharmaceutical mishandling, a growing number of countries are issuing their own cold chain regulations and guidance based around the non-air-cargo-specific Good Distribution Practices (GDP). Although the focus on higher standards is a great initiative, the result has been the creation of a heavily regulated (and very difficult to manage) industry with no global standards or universal certification for the handling and transportation of pharmaceutical products.

Nevertheless, this lack of standardisation has not stopped the drive towards using cold chain air transportation for the distribution of pharmaceutical products. As Juerg Zimmermann, Executive Vice President Airline Handling for Cargologic explains, “We expect an increasing number of airfreight shipments with pharmaceutical products due to global trends like demographic and economic development in various regions. This will lead to more demanding and rigorous requirements to all parties involved in the transportation of temperature sensitive air freight shipments.”

In their quest to satisfy the growing pharmaceutical product demand, particularly in Pharmerging countries (countries with US$ 1 billion in incremental sales in the past 5 years), shippers are turning toward the air industry’s benefits of speed and global reach. As such, there is a growing business opportunity for air cargo. Therefore, air carriers, handlers and freight forwarders have responded in turn with the creation of “pharma-regulated” branded products and services to grab a share of this lucrative niche market. These are typically cold chain management solutions which follow one out of the many pharmaceutical storage (but not air transport focused) standards and regulations currently available.  However, the current challenges of considerable annual product losses and regulatory complexity remains, both being key issues to which the air industry is seeking an answer for.

The solution: CEIV Pharma

In 2014, the International Air Transport Association (IATA) launched the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) to address certain critical cool chain air industry issues:

• Decreasing levels of competency;
• Deteriorating levels of technical and operational preparedness; and
• Lack of global standardization covering both international standards and country-specific requirements.

CEIV Pharma addresses these issues by promoting and developing an industry- and regulator-backed training and validation certification programme that ensures a reliable pharmaceutical air transport cold chain worldwide.

In addition to delivering a single, internationally recognised standard, the CEIV Pharma programme harmonises and simplifies the number of audits thus generating multiple benefits at various industry levels.

• At the individual scale, CEIV Pharma helps companies properly train their personnel, develop adequately equipped facilities and attain compliance with globally recognised standards. Companies also benefit from a simplified (or reduced) number of pharmaceutical company audits given CEIV Pharma’s marketable common audit format which minimises disruption of operations and increases an entity’s probabilities to effectively meet the ever growing number of governmental regulations.
• At the global scale, the CEIV Pharma programme ensures that the industry as a whole meets all applicable standards, regulations and standards, thus protecting the end users of the various pharmaceuticals goods shipped by air, for whom swift and unaltered access to vaccines and medications could be a matter of life or death.

As a result of its global standardisation approach, CEIV Pharma encompasses, or even supersedes, many of the existing pharmaceutical standards and guidelines such as:

• IATA Temperature Control Regulations (TCR);
• European Union Good Distribution Practices (EU GDP);
• World Health Organization Annex 5; and
• United States Pharmacopeia Standards.

The general goal being to not only elevate the industry know-how but also to  identify and recognise the best pharmaceutical handlers who are ensuring vital  product quality benefits by actively reducing the number of temperature excursions which can render pharmaceutical products unusable to end recipients. In the end, all organisations that achieve CEIV certification will establish trust and confidence that their facilities, systems and qualified people are in place to handle and transport valuable time- and temperature-sensitive pharmaceutical goods appropriately.

As Mr. Navot Hirschorn, Temperature Controlled & Special Products Manager at Cal Cargo Airlines explains “Our entire corporation is [now] streamlined to the same standards, a positive development. We have thorough planning cooperation internally and with customers, with close and direct communication between all stakeholders. We are able to offer our customers full transparency and maintain the integrity of transported products across the entire chain”.

CEIV Pharma gaining momentum

The CEIV Pharma certification programme is already proving to be very successful. Participating companies are seeing the benefits of the industry wide acceptance generated by CEIV Pharma. “The certification has helped position our CAL pharma product at the forefront of the industry.  Shippers and forwarders understand that CEIV pharma certification means we are established experts in pharma transport.  When the certification doors are opened, our clients know they are in the best hands. Since our certification, we found that our audits are shorter,” Mr. Navot Hirschhorn, Temperature Controlled & Special Products Manager at Cal Cargo Airlines states. There are currently 17 companies certified, but a total of 40 locations will be undergoing the assessment stage by the first half of 2016, with approximately 15 of those expected to successfully meet certification requirements by April 2016.

Furthermore, based on the successful 11 company community approach to establish a CEIV Pharma certified gateway at Brussels Airport in December of last year, three more airport communities (Miami, Madrid and Barcelona) have recently launched their own joint effort to improve, align and standardise their pharmaceutical handling processes. These are the first gateways in an ever growing far-reaching network of independently assessed, industry compliant companies and trade lanes. In the image below, you can see where CEIV Pharma certifications are currently taking place.

CEIV Pharma: Certified Pharmaceutical Trade Lanes Development (As of December 2015)

How to get on-board?

What does an airport need to do to improve its handling of pharmaceutical products?

The CEIV certification process varies from one organisation to another. It can encompass basic upgrading of facilities (such as the refrigerated zones) or perhaps the enhancement of ground handling equipment to ensure the proper handling for both acceptance and delivery of pharmaceutical shipments. However, it can also entail the complete overhaul of processes including staff training.

As an entity, the airport itself does not get certified unless it owns and operates its own pharmaceutical facilities. Rather, an airport achieves “CEIV Pharma Gateway” designation once a minimum amount of pharmaceutical handling companies operating within its premises commit to and achieve CEIV Pharma certification. All stakeholders committed to quality handing of pharmaceuticals can participate in the rigorous CEIV Pharma training and certification programme: airlines, airports, freight forwarders, ground handlers, trucking companies, etc.

The process begins with an assessment of an entity’s cool chain/pharmaceutical processes and facilities against international standards, guidelines and regulations which are pragmatically summarised within IATA’s comprehensive CEIV Pharma Audit Checklist. The result of the assessment is a gap analysis report encompassing findings and recommendations from our independent validators. The gap analysis assists those being certified with the identification of the critical elements currently in non-compliance with national and international regulations and criteria. The assessment also supports them in the determination of an implementation plan necessary to close the gaps and meet all of the programme’s requirements.

The required training consists of two multiple-day courses which cover a variety of topics regarding temperature controlled cargo operations as well as the audit, quality and risk management of temperature controlled cargo.

The final stage of certification, the validation phase, ensures all requirements established during the assessment phase are in compliance and that all the gaps and recommendations have been implemented. During the validation, IATA’s independent validators go through the checklist one more time and at the end recommend whether all requirements have been fulfilled and an entity can be “CEIV Pharma Certified”.

But it doesn’t end there, a recertification will take place every three years and will include an assessment and one refresher training plus a validation if necessary. This will ensure the companies maintain their high-standard of transporting pharmaceutical products and that they adjust to new best practices for years to come.

As the momentum within the industry continues, CEIV Pharma will continue to evolve in order to fully address the industry’s need for more safety, security, com​pliancy and efficiency to create a globally consistent and recognised pharmaceutical product handling certification. By promoting supply chain partner collaboration on pharmaceutical handling standards, the programme will warrant seamless integration of pharmaceutical cargo movement throughout the whole process. By ensuring open communication, trust will be built regarding product integrity based on the guarantee that temperature–sensitive pharmaceuticals will be consistently managed in the same way every time. Once that trust is built, the industry as a whole will be able to move forward. As Mr. Hirschhorn asserts, “For the benefit of the market in general, as well as for the individual [stakeholder], one single standard is critical for the pharma transport market.”

Focus on Miami International Airport

A brief discussion with Joseph Napoli, Chief of Staff and Senior Policy Advisor for the Miami-Dade Aviation Department

Q: Why did you decide to certify the cold chain of your hub?

A: We started this process about a year ago, it was shortly after IATA’s initial announcement of the CEIV Pharma program. It coincided with our analysis of the pharmaceutical industry which demonstrated that it is growing industry. We looked at the demographics of the regions of the world that the Miami airport currently reaches, which is almost everywhere, but we paid particular attention to Latin America, specifically Brazil, as well as some of our Asia partners, and we anticipated an increase in pharmaceuticals handling.

We currently handle $3.3 billion of imports/exports at the airport and we know that this is probably anywhere from a $100-$300 billion industry, therefore we saw an opportunity to grow our business here. When the CEIV Program was announced, we saw it as the way of the future and so early on we developed a strategy where getting our airport’s community supply chain certified. It would be the basis of a strategy to grow our business for MIA with a secondary goal for the airport to serve as a catalyst to increase the pharmaceutical business here in South Florida, not just at the airport, but the overall business community in Miami Dade County and South Florida.

Q: What is critical to fostering a strong airport community, in terms of pharmaceutical handling?

A: Well I think there’s a few things but they all revolve around the word ‘common’. I think you have to have a common vision and goal, and then subsequently, you will have a common way forward. Therefore it is critical to bring together the airport community, explain to them what the benefits of the program are, that there are benefits for both the airport and for the supply chain, and as I indicated in my previous answer, that this is probably the way of the future.

I think we’ve been able to do that and that’s been the reason that we’ve been so successful in a relatively short period of time. Being clear and elaborating on the strategy in order to get everybody on board to have a common vision, a common goal, and a common way forward for this. Thus, by getting everybody on the same page on establishing this as a strategy, we’re able to improve the business for everybody.

Q: Do you see the CEIV Pharma program as a global solution?

A: Yes, absolutely. I believe that pharmaceutical companies are going to gravitate to entities that are certified or that have some sort of a validation process for their handling and so we certainly think that it’s a global solution because the industry has demanded it. Although the pharmaceutical industry is an over-regulated industry, there was no certification or validation program that could be potentially be global and we see the CEIV Pharma program as a global solution and, again, as the way of the future. Therefore establishing a global standard is the way to go and we certainly want to be part of that.

Q: How was your CEIV Pharma certification experience?

A: I’ll just tell you right off hand it wasn’t easy and it required, just like any major plan or major strategy, a lot of communication. Therefore, we first had to develop the strategy, then we had to convince all the parties involved that this was a good strategy. First, we got our department, the aviation department on board, we all understood very quickly the benefits of this strategy and once we started communicating with the other entities in the supply chain, it didn’t take long for everybody to understand. When you lay out the facts and the prognosis for the transportation of pharmaceuticals and that it certainly is a growth industry, it’s just a matter of establishing a strategy and being able to communicate properly. But it took a lot of communication because a lot of the entities, their initial response, although they understood the strategy, was: “We’re not doing it now, so why do we need to pay money and undertake this process?” Therefore, after continual engagement they understood that, again, this is the way of the future, hence it’s better to get on board early, rather than later. And as a matter of fact, since our announcement with IATA, several other entities have come forward and said: “We want to get on board with this!” Consequently, I think the hard part is done, I think everybody understands now what the rationale behind doing this is and that this is the way to go for the future. Hence, I expect it’s going to be a lot easier to get entities on board from here on out.

Biography

Ricardo Aitken, Airport Project Manager, IATA Consulting

Ricardo Aitken is a project manager at IATA Consulting. He is responsible for projects in the areas of:

• Air Cargo Business Planning & Infrastructure Development
• Air Cargo Operations and Logistics
• Master Planning

Before joining IATA, Ricardo worked at Lufthansa Consulting, a world-class German aviation and management consulting firm, as a consultant to diverse projects across the globe. Mr. Aitken has worked on-site for projects in Brazil, Djibouti, Ecuador, Germany, Kazakhstan, Luxembourg, Rwanda and Trinidad. Mr. Aitken has four engineering degrees.

Michal Wielgus, Marketing, IATA Consulting

Michal Wielgus is a communications specialist. He has over a decade of experience in building communications and marketing strategies for both corporate and non-profit organisations. Passionate and dedicated, Michal provides clients with innovative and results-driven campaigns. During the course of his career he has worked with internationally renowned companies such as IATA, CAE, Evenko, Cirque du Soleil, United Way, the UFC and the Canadian Football League amongst others.