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New Airline Regulations
New IATA regulations will affect temperature-sensitive medicinal freight
By Kevin O'Donnell
The International Air Transport Association (IATA) -- the 240 global member inter-airline organization promoting safe, reliable, secure and economical air services for the benefit of the world's consumers -- has undertaken a significant step for improving the handling of temperature-sensitive pharmaceutical products. The organization, representing more than 140 nations, has added a separate chapter to its 7th Edition of the Perishable Cargo Regulations, specifically addressing air transport logistics for temperature-sensitive healthcare products. The regulations became effective July 1, 2007.
Previous editions of the manual offered excellent and detailed procedures for handling perishables of the flora and fauna variety, but guidelines for handling medicinal products were vague, incomplete, and peppered throughout the manual, with a heavy emphasis on vaccine and blood products. The safe transport of these items is certainly important, and they do have unique requirements and constitute high volume for the airlines, but they are hardly representative of the majority of healthcare freight.
Global Changes in Drug Manufacturing
During the past decade, the growth of healthcare manufacturing has largely gone from intra-plant to international, experiencing unparalleled change and challenges, with ever-increasing government controls and ever-advancing technology. It is not uncommon for a drug to go through a complex creation cycle: from an active pharmaceutical ingredient (API), to a finished product, in multiple steps across multiple countries. As a result, the requirements for packaging, storing, transporting and distributing drugs have, like the drugs and treatments themselves, become more sophisticated. Additionally, the ability to maintain precise temperature control has become more critical.
International transport of healthcare products now includes API, bulk reagents and intermediates, in addition to finished product. The packaging for transporting these goods has diversified, too. Their sophisticated designs are often highly engineered and expensive -- capable of protecting the sensitive and valuable product from the rigors of transportation and environmental extremes. Packages can range from small, single boxes to pallet-sized bulk insulated containers. These include passive packaging systems and active, or mechanical units. They are used to transport everything from prescription drugs, such as pills and capsules, to injectibles like insulin and vaccines, as well as diagnostic reagents, medical devices, blood products, organs and tissues.
The airline industry has at last recognized the need for new guidance and handling procedures and through the IATA Live Animals & Perishables Board (LAPB) has demonstrated extraordinary cooperation with members of the pharmaceutical industry and their shared service providers for establishing concise, practical guidelines for shippers handling healthcare products to ensure an industry-wide standard of excellence.
Late last summer I was contacted by Eric Raemdonck, secretary of the LAPB, and manager of Special Cargo Standards for IATA. Eric is responsible for publishing the Perishable Cargo Regulations. As a representative of the Pharmaceutical Cold-Chain Interest Group of the Parenteral Drug Association (PCCIG-PDA), I agreed to form and chair a cross-industry committee to assist in writing updated and relevant guidance for air transport of medicinal freight. The 11-member committee consisted of representatives of pharmaceutical manufacturers, freight-forwarders, airlines and other industry service providers, whose purpose was defined as:
- providing information on the factors that affect temperature-sensitive healthcare products,
- indicating critical control points in the air transport logistics that can impact products, and
- providing best practices conforming to regulatory agencies requirements.
All parties of the committee soon realized that revamping the existing guidance was a far bigger task than anyone anticipated. Sifting through the assumptions and fallacies the various industries had about one another prompted the committee to suggest to the LAPB that a separate chapter would be needed to properly address the concerns of the pharmaceutical industry.
The sweeping and significant changes to the document are obvious on the front cover. Previous editions were titled Perishable Cargo Manual and were intended to serve as a guideline to airlines and supporting industries. The new 7th Edition is called Perishable Cargo Regulations, and is binding to its members, making the dramatic leap from guidance to requirements.
This is a significant stroke of good fortune for the pharmaceutical industry since this portion of the distribution chain has long been identified as difficult to predict and control by those knowledgeable in healthcare freight logistics. It is a segment rife for mishandling, with significant risk of exposure to temperature extremes and improper storage. This unpredictability, lack of control and, to an equal extent, lack of understanding as to what happens to a package once it has been surrendered to an airline, has resulted in development of over-engineered packaging on the part of the generally conservative pharmaceutical and biotech companies. This is not surprising given the extraordinary value of the products, long development times, the peculiarities of global distribution and the quest to protect market share.
But a little education can go a long way in implementing properly engineered packaging for temperature-sensitive items. If airline handlers and medicinal product manufacturers don't have a clear, reciprocal understanding and appreciation for the transportation of these items, know the limits of environmental exposure, risk and vulnerability, it will result in having to over-compensate with protective packaging. Effective and efficient packaging can be developed and qualified that can maximize performance while minimizing costs.
IATA member airlines have agreed to meet this challenge by implanting the regulations outlined in the 7th Edition of the Perishable Cargo Regulations. It is incumbent upon drug manufacturers to work with their airline partners to shepherd them through the unique handling requirements of temperature-sensitive medicinal products.
Healthcare's Critical Dependence on IATA
In his opening remarks at this year's World Cargo Symposium in Mexico City, Giovanni Bisignani, director general and chief executive officer of IATA, shared that cargo freight revenues accounted for a mere 12% of the total revenue generated by the airlines in 2006. Nearly 40% of the world's freight by value, not by volume, travels by air, and that air cargo is critical to the world economy on many levels.
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Healthcare freight constitutes a very small piece of the overall IATA revenue pie. According to IATA, less than 5% of their cargo volume (0.84% of airline revenue) is perishable freight, which consists of fruits, vegetables, flowers, seafood, meat, plants, live animals and healthcare. Healthcare products represent less than 5% of all perishable freight (or 0.042% of airline revenue). These numbers can be inverted when it comes to value comparison. Pharmaceu-tical and biotech products have the highest value in dollars per kilo of lift than any other cargo handled by the airlines. Nearly all time- and temperature-sensitive medicinal freight travels by air at some point during distribution. Yet, medicinal products have received short-shrift consideration from the airlines, whose general practice has been to lump medicinal freight in with all other perishable freight. Clearly, they have very different handling requirements. Chapter 17 in the 7th Edition of the Perishable Cargo Regulations is intended to address that issue.
A New Era
Improvements to the process will not likely be immediate but they should be positive. The successful implementation of Chapter 17 of the IATA Perishable Cargo Regulations, "Air Transport Logistics for Temperature-Sensitive Healthcare Products" is going to depend largely on IATA and the individual member airlines themselves. Education is the key: unlike IATA's stringently enforced Dangerous Goods Regulations, where packages that don't adhere to the letter of the regulations could be delayed or frustrated during shipment, Chapter 17 is going to require a paradigm shift. It will likely fall to pharmaceutical and biotech manufacturers -- those with a vested interest in their goods -- to provide the archetype. There must be cooperation on all sides of the industry to educate, facilitate and successfully implement the new regulations.
The 7th Edition of the IATA Perishable Goods Regulations is intended to improve the integrity of the perishable goods segment of the supply chain; more specifically, medicinal products. It will require refinement and updating to make it more practical for its intended users as the respective industries evolve and as regulations change.
Copies are available for purchase online at IATA.org
