Building confidence of pharma sector on air transport of temperature-sensitive products3 November 2017
Air cargo stakeholders are working hard to build the pharmaceutical industry’s confidence in its capacity to transport temperature-sensitive products. The International Air Transport Association’s Andrea Gruber discusses what progress has been made with Elly Earls.
A concerted effort has been made by various industry stakeholders over the past four years to improve the air cargo sector’s reputation for transporting temperature-sensitive pharmaceutical products. As the International Air Transport Association (IATA) and its partners continue to build understanding and raise awareness of what needs to change to reduce the number of temperature deviations on the tarmac, the hope is that the sector’s processes will become safer, streamlined and more transparent.
The benefits of shipping pharmaceuticals via air rather than sea are largely related to speed and flexibility; products arrive quickly, routes can be easily changed and action is taken faster in emergencies. Yet, all of this is moot if, by the time products reach patients, they have been rendered unusable because they have not been stored or transported at the right temperature.
Historically, this has been an issue for the air cargo sector. While the market for temperature management services is expected to rise from $8.36 billion in 2014 to $10.28 billion by 2018, the statistics for the air cargo sector’s share of the transportation of pharmaceutical products has been following the opposite trajectory. In 2000, it accounted for 17% of transport, but this figure dropped to 11% by 2013, with more than half of all temperature excursions occurring while products were in the hands of airlines and airports.
For Andrea Gruber, senior manager of special cargo at IATA, the blame cannot solely be laid at the sector’s door. “If we look at it one way, it seems that our industry is not performing well,” she says. “However, it needs to be emphasised that an airport is a very complex environment and there are many different stakeholders involved.”
“What we’ve been doing is engaging with the industry to actually understand what is happening within airports. Temperature excursions can happen, but you have to understand why they have happened, and what led to those situations – there are many, many different scenarios.”
Gruber believes that the industry has made great strides in this area. “Just a couple of years back, you had airlines, ground handlers and airports operating and moving products, but how aware were they of temperature-sensitive healthcare products? In the same way, pharmaceutical manufacturers were sending their products to their freight forwarders without trying to understand who was actually going to be in charge of those highly sensitive, valuable products,” she states.
Matters have improved significantly thanks to increased-regulatory requirements for the transport of temperature-sensitive products, and IATA’s proactive work to engage different industry stakeholders and help them to comply with those regulations.
“We are addressing the challenges and the concerns of our stakeholders very seriously, and the airline industry is now far more aware of the importance of temperature-sensitive healthcare products than it has been in the past,” explains Gruber.
“We’re also discussing these issues with pharmaceutical companies. Often, it’s down to knowledge, training, infrastructure and packaging. IATA, together with the industry, has taken this call to action very seriously and is pushing all stakeholders to raise the bar.”
The CEIV Pharma programme
At the heart of this march towards a more streamlined, transparent and consistent supply chain has been the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV) programme, which was established by IATA to help air carriers, freight forwarders, ground handlers and airports to provide state-of-the-art handling of pharmaceutical products that meets the requirements of manufacturers.
The programme’s approach includes an in-depth and on-site assessment of pharmaceutical processes and/or facilities against international standards, guidelines and regulations; a review of current training and personnel standards; a report of any gaps, complete with recommendations to address them and training courses on temperature-controlled cargo operations; and audit, quality and risk management.
“CEIV’s main objective is to ensure that product integrity is maintained throughout the supply chain,” says Gruber, who leads the programme. She adds that, as IATA has no enforcement mechanism, the establishment of CEIV’s recognised pharmaceutical-product-handling certification is a good way for the body to assess the industry in order to ensure that new regulations are actually implemented.
Much progress has been made since the programme was launched with a pilot and ground handler in Singapore at the end of 2013. Brussels Airport, for example, decided to take a community approach, getting everyone in the airport involved. Gruber believes this step started to build momentum and made the industry sit up and take notice. Miami International Airport has since followed suit.
“One of the main achievements of the programme has been far better communication between the different stakeholders in the supply chain,” she says. “People are starting to investigate and push the discussion not only with their direct business partners but throughout the supply chain.”
Manufacturers, for instance, are not only talking to freight forwarders but are also bringing up issues with airlines and ground handlers. “It’s really led people to better understand the roles, responsibilities and constraints that exist, and to pinpoint the areas that need to be improved,” adds Gruber. “There is still a way to go in terms of sharing more information, but CEIV Pharma has already led to a greater understanding of how important it is to transport temperature-sensitive healthcare products, and what it means to handle and transport them. We’ve also seen better communication, visibility and transparency.”
Progress in the developing world
While developed countries have led the way – Brussels Airport and Miami International Airport, for example, became the first and second IATA-designated pharmaceutical-hub airports in the world – the industry is also working hard to ensure that developing countries are not left out.
Again, communication is the key to identifying areas for improvement. “You can’t expect everyone within the supply chain to have state-of-the-art warehouses and temperature-controlled rooms,” states Gruber, “but manufacturers do need to understand what the capacities are at origin, at the destination and in transit. Then they can assess their product and the packaging of the product and adapt it accordingly.
“For example, if there are no temperature-controlled rooms, they can pack using different methods. What we want to ensure is that people have the right level of understanding and risk assessment when it comes to infrastructure.”
Some companies in developing countries are also finding interesting ways to address these issues. One ground handler in Africa, for instance, has organised regular site visits from pharmacists to ensure that products are being stored properly.
Countries with more advanced capabilities are also on hand to help. Brussels and Miami have launched the Pharma.Aero initiative, which focuses on improving pharma handling and quality in the air cargo industry worldwide. The idea is that pharmaceutical shippers and other industry stakeholders that are, or are in the course of being, certified by CEIV Pharma, can share best practices and expertise.
“The initiative taking the CEIV to another level,” says Gruber. “Why reinvent the wheel if there are some implementations that have been successful in one area, and can be shared in others? This collaborative approach is something that we really see growing.”
The association’s three current strategic airport members are Singapore Changi Airport, Sharjah International Airport and Mumbai’s Chhatrapati Shivaji International Airport.
For IATA’s part, the consultancy side of the CEIV Pharma programme is also proving useful for stakeholders in the developing world. “CEIV is an interesting way to help them benchmark their activities against what is required globally,” says Gruber. “They need to understand not only what needs to be done but also what the industry’s expectations are, and what the expectations of manufacturers in those countries are as well. It needs to be looked at from a dual perspective, because sometimes we, as an industry, think we need to move one way, but the shipper community and manufacturers have different expectations. It’s important to align those expectations to develop things more efficiently.”
Everyone around the table
For Gruber, the key to maintaining the momentum that has been built over the past four years is continued collaboration. It is something that IATA encourages through its Time and Temperature Task Force (TTTF), through which stakeholders from across the industry meet to identify, investigate and address their concerns.
“What’s unique about the task force is that every stakeholder is represented: manufacturers, freight forwarders, airlines, ground handlers, airports, packaging manufacturers, tracking device manufacturers and regulators,” Gruber explains. “Everyone is around the table and this provides an interesting perspective on where we should be developing more standards or better, more comprehensive guidelines to allow the industry to be even more ready than we are today.”
In the meantime, there is no doubt that serious progress has already been made. “At present, CEIV Pharma has more than 160 completed certifications and more than 75 in progress,” concludes Gruber. “The momentum is there, the industry is seeing value in the programme and it’s on the way to being seen as an industry standard.”