Pharma: The human factor
20 / 03 / 2015
There has been a lot of interest in pharmaceutical shipments in the air freight industry in recent years as airlines and forwarders search for traffic that can give them those elusive higher yields. As a result some thirty airlines now offer pharmaceutical products and many are investing in expanding their coolchain facilities.
But do carriers really understand what is involved in handling pharmaceutical shipments? Are they underestimating the challenges that pharma presents? In particular are they missing out on one of the key components of a pharmaceutical supply chain – the human expertise that has to match the investment in facilities and containers?
Tony Wright thinks that in some cases they are. Formerly with British Airways and coolchain container company Envirotainer, he is now CEO of Exelsius, a consultancy that addresses "the gap between what transport companies understand about the pharmaceutical sector and what shippers want". A key part is training staff to really understand the pharmaceutical business and the good distribution practices that regulators are increasingly requiring of it.
Good distribution practice – or GDP – is a complex area, comprising a blizzard of regulations and directives, most of them issued over the past decade. It is an area full of acronyms – the FDA, the EU, the MHRA, the WHO, the PDA, and a whole host of organisations all over the world who have sought to define the way pharmaceuticals should be moved.
Airlines have to understand all these regulations, and be able to conform to increasingly stringent audits on this topic. In particular, the European Commission, World Health Organisation, MHRA (the UK’s Medicines and Healthcare Products Regulatory Agency) and the US Food and Drug Administration have all updated their regulations recently. "There is increased focus on risk-based assessment of distribution, written agreements with supply chain participants, licence holder and responsible person roles, and quality management systems," Wright notes.
To take just one recent regulation, new EU guidelines – EU343/01 – say pharmaceutical shippers have to do a transport qualification, part of which is that they have to audit whether airlines can really do what they say they can. "There is a dividing line between those airlines that can do this and those that are not yet doing it to the same degree," Wright says. "A number of airlines are realising it is not an easy path – it requires investment in people, equipment, processes, even trucking and aircraft."
It is also not always clear who is responsible for auditing or checking on good performance. Certification programmes are one way forward, and at least one European airport – Luxembourg – has gone down this route. "They saw an opportunity to develop a pharamceutical hub by building the right facilities and by having the right people and training." Wright notes. "So they got an outside company to come in and audit that process."
IATA is also getting into certifying airports – they have done so already for Singapore and they are about to do it in Brussels, something Wright applauds. But he says may not be the right option for all organisations. "From an industry standpoint what IATA is doing is the right move, but certification is an expensive process. There is a difference between certification and qualification. As long as companies follow the guidelines, that is OK."
It would be a great mistake to think that good distribution practice is only about ensuring products are transported at the right temperature. "It is no good having the best coolers in the world if you don’t have the right processes and procedures to go with them," Wright says.
"Nothing happens without a set of good practices and procedures, and they need to be separate from the standard cargo practices. You need the right facilities, yes, but also quality management systems. So airlines need to focus more on processes, procedures and training. It is this soft part that matters, pulling these things together."
He says that training also needs to include updates and refresher courses. "Staff need to be not just initially trained, but regularly trained. And courses need to be not just classroom-based, but also include practical experience." He cites a course he put together for IAG Cargo which included going onto the ramp to see what really happened when an aircraft was loaded. "Only if you understand the risks can you understand how to mitigate them."
It is also important for product managers to really understand the different pharmaceuticals they are moving. "For example, if you know it is a treatment for Crohn’s Disease, you handle it differently. Clearly handling staff don’t need to know all the particulars, but they need to look at the label and store it appropriately. And everyone needs to remember that there is always a patient at the end of this process."
Wright reckons that of the thirty or so airlines offering pharmaceutical products, maybe as few as a dozen really can do all of this. But he is optimistic. "The others all understand that they need to do these things, and as an industry we have made great strides. We are taking about pharmaceuticals much more than we did years ago, but we have got to keep up that momentum. That is not easy, but we have got to maintain standards, close gaps in our knowledge, and know what part each of us needs to play."
To this end, Wright has been working with Air Cargo News to organise a Life Sciences and Pharmaceuticals Conference at the Lancaster London Hotel in London on 14 -16 December this year. His aim is to truly bring together all participants in the pharmaceutical supply chain and to engender a debate about what needs to be done.
"There are lots of conferences on this subject, but to me they have started to become a bit samey," he says. "There was a need for something different, and our idea was to to try and create a forum where each section – airlines, forwarders, pharmaceutical companies, service providers – would quiz and challenge each other and come up with a forward direction.
"We have the CEOs of all three container companies coming – Envirotainer, CSafe and Va-Q-Tec – which I think is a first. But the idea is not just to listen to presentations but to open up the debate – have a clearer conversation about air cargo processes and come up with a better idea of how we can achieve the supply chain the regulators want."
For those that can achieve the required level, Wright is sure that the rewards will be there. He dismisses talk of a shift of pharmaceuticals traffic from air to sea, saying most of that has already happened. "Most experts say that the real growth is in biotech, oncology drugs, vaccines and so on, for which you would not use sea freight. The risk associated with the temperature is too great, and there is a risk of putting £30m of product on the sea. So air is more appropriate and controllable."
Meanwhile while he concedes that there is a risk that as more airlines launch pharma products then yields in the sector could be eroded, he says there will still be relatively few who can achieve a standard that pharmaceutical companies can really rely on.
"One other thing that will also keep yields from declining is continued regulatory pressure, which is always making new demands. That will keep pharmaceuticals as a premium product."