Maintaining the integrity of pharmaceuticals through air transport: the US $12.5 BN struggle
Industry highlight - Q3 2014
The pharmaceutical industry relies heavily on airlines for their speed and efficiency in transporting its high-value, time-sensitive cargo. Over the past 10 years, air carriers, handlers and freight forwarders have responded with branded products and services to grab a share of this lucrative, niche market.
According to pharmaceutical commerce, over US $7.5 billion of the overall US $64 billion pharmaceutical logistics spend for 2013 was dedicated to temperature management during transport. The market for cold-chain logistics services is projected to rise to US $9.3 billion by 2017.
An external service provider indicated that nearly all vaccines and almost three quarters of biotech products need to be stored and transported within the range of 2-8° Celsius. Many diagnostics and products from large pharmaceutical companies have to be handled similarly, and it is estimated that annually US $2.5-12.5 billion are attributed to product loss.
Transporting healthcare products by air requires the establishment of complex logistical methods to maintain a shipment’s integrity. It requires specific equipment, storage facilities, harmonized handling procedures and, above all, strong cooperation among cold chain partners. Based on the current state of the industry, pharmaceutical companies expect a damage rate of up to 30% attributed to logistics issues associated with their products.
Regulators, such as the EC and US FDA, and international organizations, including the WHO, International Federation of Pharmaceutical Manufacturers and Associations, and IATA, are conscious of such risks.
To prevent sanitary and health issues caused by the poor handling and transportation of pharmaceutical products, regulators have issued guidelines on “Good Distribution Practice of Medicinal Products for Human Use” and “Temperature Control Regulations.”
Specialized pharmaceutical handling training
IATA aims to improve the safety of patients who consume medicines that have been transported by air. The objective is to prevent any sanitary issues caused by excess temperature variations during air transport.
To that end, IATA created a Center of Excellence for Independent Validators (CEIV) in Pharmaceutical Handling with the aim of helping the industry improve the transport and handling of pharmaceutical products to meet the requirements of shippers and manufacturers.
The CEIV Pharma program includes an assessment of airlines’, handlers’ and forwarders’ cool chain processes and facilities to ensure compliance with international standards and guidelines, and provides specialized training for their employees.
IATA Training and Development Institute offers the four following specialized courses to prepare ground handlers, freight forwarders and airlines meet these high pharmaceutical industry requirements:
1. Temperature Controlled Cargo Handling
2. Temperature Controlled Container Operations
3. Risk Management for Temperature Controlled Cargo
4. Audit and quality for Temperature Controlled Cargo
Upon successful completion of the four courses, participants will obtain an IATA Pharmaceutical Handling Diploma.
As the representative association of the world’s international airlines, IATA is at the forefront of commercial aviation, has a deep understanding of pharmaceutical handling, and offers: unbiased analysis; professional expertise drawn from appropriate functional areas; and access to the latest trends and best practices.