CEIV vs. GDP: Which air pharma standard will prevail?

After five years of CEIV-Pharma certs in hand, will there eventually be just one set of regulations that all stakeholders can agree on? A report by Randy Woods.

Seven years ago, the concept of shipping pharmaceuticals by air was on shaky ground. While air cargo companies had been sending more temperature-sensitive healthcare materials by that point, millions of dollars’ worth of pharmaceutical supplies had sat cooking on airport tarmacs or languishing in warehouses outside of required temperature ranges. 


The pharmaceutical industry had begun to take notice, too. According to a report from consulting firm Seabury, airfreight’s market share of the global pharma industry had fallen from 17 percent in 2000 to just 11 percent in 2013. 


Stung badly by the pharma-related criticism, the International Air Transport Association (IATA) launched its Center of Excellence for Independent Validators (CEIV) program in 2014 – an amalgamation of IATA’s own temperature-control guidelines, the European Union’s Good Distribution Practices (GDP), and local and regional guidelines. The result, IATA said, would become a new set of global standards.


In air cargo, pharmaceuticals are by far the most expensive and least forgiving of commodities. According to IATA, although they account for only 1.9 percent of volume shipped by air, in 2017 they contributed US$1.4 billion to airline cargo revenues, representing 9.4 percent of the value of all air cargo goods. Yet the tiniest of mistakes can reduce the value to zero – or even cost lives – if the narrow temperature range of just a few degrees Celsius is breached, even for a few minutes. 


Meanwhile, other supply chains have stayed with the older, less-expensive GDP program devised by the EU and the World Health Organization. The question is, after five years of CEIV-Pharma certs in hand, will there eventually be just one set of regulations that all stakeholders can agree on?


The era of CEIV

When CEIV was first launched, the industry was initially doubtful. Its origins in IATA made some assume the CEIV standards were more of an expensive fund-raising gimmick for the organization. What can’t be denied, however, is the program’s popularity. 


Since launching six years ago, the CEIV-Pharma program has swelled to more than 200 entities across dozens of countries, with another 75 still in the works, as of 2018. First embraced by airports, the program has attracted airlines, forwarders, ground handlers, and shippers – virtually all parts of the airfreight supply chain, enabling each sector to know exactly what the others are doing during transport.


Liège Air Cargo Handling Services (LACHS), owned by CAL Cargo Airlines, was one of the early adopters of CEIV. “Thanks to the IATA CEIV-Pharma certification, LACHS has become a master in temperature-controlled cargo operations,” said Thomas Debay, truck and pharma manager for LACHS.


One of the more recent additions to the CEIV-Pharma program is German logistics firm Dachser, which earned the cert for its Atlanta (ATL) branch in the United States in December 2019. Ground-handling firm dnata, based in Dubai, also received the CEIV certification last year for its pharma-handling processes at Dubai World Central (DWC) and Dubai International (DXB) airports. 

Brazil’s Galeão International Airport (GIG)


Some recent converts have even begun re-certifying after benefitting from the CEIV standards. Brazil’s Galeão International Airport (GIG), in Rio de Janeiro, first earned its CEIV-Pharma cert in 2016 and then went on to complete its re-certification in November 2019. Since joining CEIV, pharma imports account for 17 percent of cargo terminal handling at GIG, the airport said, making pharma products the second among the top five imports at the airport.


Some recent converts have even begun re-certifying after benefitting from the CEIV standards. Brazil’s Galeão International Airport (GIG), in Rio de Janeiro, first earned its CEIV-Pharma cert in 2016 and then went on to complete its re-certification in November 2019. Since joining CEIV, pharma imports account for 17 percent of cargo terminal handling at GIG, the airport said, making pharma products the second among the top five imports at the airport.


The case for staying with GDP

For several other players in the air cargo supply chain, however, the basic tenets of careful handling found in the Euro-centric GDP regulations are considered enough to make their shipper customers feel safe. 


“CEIV is a standard that is primarily set by the airlines,” explained Stephan Haltmayer, CEO of Frankfurt-based Quick Cargo Service GmbH (QCS). “You would see more airlines setting their standards to CEIV, as the forwarders have. The GDP is an accreditation that the forwarders set their standards to, but it is not an official standard.” 


QCS went through the German technical inspection training to set its standards based on GDP guidelines. “All our partners have to prove GDP compliance,” Haltmayer said, adding that QCS grew its pharma business since it went through the GDP process.


The language of GDP is sufficient to ensure that all pharma shipments by air are safe, said George Gibbons, marketing manager of U.K.-based logistics firm Biocair, which has also adopted IATA’s Time and Temperature Sensitive Label program.


Roberto Colucci, founder and managing director of GDP-certified World Cargo Srl, an Italian forwarder based in Rome, said the company has not yet considered seeking CEIV-Pharma certification so far, citing the time and expense required to earn one. “In the recent past, many forwarders have thrown themselves into pharma for lack of general cargo profits, causing a decrease in the margins,” Colucci said. “To this add the costs of getting these certifications.”


Hybrid certification?

While the debate over which set of regulations should be adopted worldwide continues, some supply chain stakeholders are relying more on their own programs to determine the quality of their services to pharma shippers.

Henrik Ambak, senior vice president of worldwide cargo operations for Emirates.

Emirates Airlines, one of the largest cargo carriers in the world, chose to focus on developing “fit for purpose” infrastructure, rather than on achieving a particular certification, said Henrik Ambak, senior vice president of worldwide cargo operations for Emirates.


Ambak encouraged a hybrid certification approach, merging parts of GDP and CEIV-Pharma. “The challenge is that the GDP guidelines are not necessarily prescriptive enough to ensure that the right infrastructure is put in place,” he said. While Emirates SkyCargo’s new facility at Chicago O’Hare (ORD) airport has been certified as compliant to GDP regulations, some of the handlers in the carrier’s 25-station “pharma corridors” have earned CEIV certs.


“We audit potential sites ourselves,” Ambak explained. “We never go with just the certification. What is important for us is a thorough and robust evaluation that our handling partner is capable of delivering to our stringent requirements for the transportation of pharma.”

Emirates SkyCargo


Since the introduction of Emirates’ dedicated facilities for pharma handling, “we have been able to counter the preconception that shippers used to have about Dubai as a pharma transit to be avoided in summer,” Ambak said. “We have seen our pharma volumes grow from around 10,000 tonnes a year to more than 70,000 tonnes a year, just in the last five years.” 


With this emphasis on using the CEIV or GDP certifications as guidelines for developing unique pharma quality programs suited to each stakeholder, it appears the hybrid approach to ensuring the safe transport of temperature-sensitive materials is beginning to take hold in today’s pharma environment.   


As Emirates’ Ambak noted, “a certification is, of course, important as a validation. However, it is first important to develop some purposeful infrastructure and capabilities on which the certification is based. A certification is no more valuable than the least capable entity that has achieved it.” 

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