Naomi Landman: Pharma game changers
19 / 06 / 2017
All specialist product areas have their particular regulations and jargon, but they seem to proliferate in pharmaceuticals more than in any other sector.
Naomi Landman, director commercial development for IJS Global GEFCO, says the current hot topic is serialisation. These are rules that say that each pharmaceutical package has to have a barcode that can facilitate a global track and trace capability.
The idea is to protect against counterfeit drugs, and regulators all over the world are lining up to implement the new measures. The US is imposing serialisation on all drug products at the saleable unit and case level from November 2017, with repackagers to follow in 2018, while in the European Union serialisation will be a requirement from 2019. China and Brazil already have programmes in place.
What this will mean for airfreight is not yet entirely clear; Landman says details are still being finalised.
“But it may mean products will need to be scanned at various points. And if a forwarder stores pharmaceuticals, like we do, they may need to scan them and check them against a European database.
“That would mean that a pallet would have to be stacked so as to make barcodes accessible from the outside. Since it is not until 2019 we don’t have all the details yet, but we are investigating what procedures and training we might need to have in place.”
IJS Global GEFCO has also been busy recently meeting the Good Distribution Practice (GDP) standards of the European Union, themselves derived from World Health Organization (WHO) guidelines.
The forwarder received its certificate from the Dutch Ministry of Health on April 18. Previously, in 2014, IJS Global Netherlands was awarded Wholesale Distribution Authorisation (WDA), allowing it to store medicinal products.
And then there is CEIV − the Centre of Excellence for Independent Validators in Pharmaceutical Logistics, an IATA programme that takes the GDP legislation and fleshes out its implications for forwarders and handlers. IJS Global GEFCO is part of a Schiphol-wide project in which ten companies are combining to create a CEIV-certified airport.
Launched at the World Cargo Symposium in March, the initiative has been branded “Pharma Gateway Amsterdam — Qualified and Transparent”, and has the support of Air Cargo Netherlands, the Dutch air cargo industry association, as well as participants such as Air France-KLM-Martinair Cargo, handlers dnata and Swissport, and trucker Jan de Rijk.
“We are doing it as a community − airlines, forwarders and everyone involved in the chain,” Landman says.
“The idea is to get all partners in the supply chain up to a certain level, so that every one of the stakeholders understands their role and the impact it has on others.
“For example, the handling company has to have the same detailed procedures as the forwarder, knowing what the correct labelling is and storing the shipment at the correct temperature. Both need to measure time on the tarmac and keep it to a minimum, and so avoid temperature excursions.”
Ultimately, she reckons, it is all about seeing the supply chain through the eyes of the customer.
“Then you get a whole different dialogue. For the customer it is about getting a product to its final destination at the right temperature and integrity. What is important is that the drugs reach the patient in the right condition, and that matters because the patient is you, me, everyone.”
With all these speci-alist programmes and standards to contend with, it is not surprising that IJS Global GEFCO has dedicated teams who work only on pharmaceutical shipments.
“That is important as it requires a different mindset and also working with the right partners to develop knowledge and procedures together,” Landman points out.
The company also has to be prepared to invest in equipment, training and certification.
Asked if it gets a return on that investment, she reframes the question.
“If you want to do these products, you have to meet these requirements,” Land-man says. “We are a service-orientated company with many years of experience in this sector throughout the world and this is an area where we can and do add value.”
There have been various reports of pharmaceutical companies shifting product from airfreight to sea, and Landman does not deny that there is such a trend: “Ten years ago pharmaceutical customers did not speak much about ocean freight, but they do now.”
But she is not sure how far it will go, and sees airfreight as still holding some cards.
One is that it is more advanced than ocean freight in meeting GDP requirements and another is that an entire 40ft container packed with pharmaceuticals is a lot of stock to be moving at once or have tied up in one place.
“The cost of airfreight is higher, but the cost of keeping stock on the ocean for 30 days is also significant. Also, if there is a problem on the ocean − for example if a reefer breaks down – then how long does it take to get the product off the boat or into a different container? With airfreight you have temperature deviations too, but usually over shorter timeframes and in places where you can do something about it.”
Asked what airfreight could do to improve its offering, Landman is clear about the answer. “It would be good to have more transparency and monitoring in transit,” she remarks. “The question is technology − a willingness to invest, but also a willingness to share the information.”
Standards and procedures also have to be applied globally: “Although lots of airfreight companies have put effort into their pharmaceutical product, there are often still gaps. For example an airline may have invested at their hub airport, but not always at every destination they fly to. It has to be on every lane.”
Landman understands this is about creating CEIV-audited lanes.
“Singapore has already been audited, work is underway in Miami and Amsterdam is coming up, so it is spreading.”
India is one of the growth markets that Landman identifies for pharmaceutical traffic, with manufacturing of generic drugs there and across Asia increasing.
“We also see a trend towards repackaging products − preparing them for local markets. For example Singapore is a distribution point for product into Asia.
“A lot of product is also being combined with delivery devices − for example asthma drugs in vaporisers.
“And temperature-controlled is ever increasing.
“More and more product is temperature-controlled which used to be sent as general cargo.”
IJS Global’s recent merger with French logistics company GEFCO is also creating new opportunities for the pharmaceutical team. “There are a lot of great benefits,” Landman enthuses.
“GEFCO is in countries such as Russia, Brazil, and in eastern Europe where it was not present before. Equally, it has a Europe to Asia and Asia to Europe rail solution and we are investigating if that would be suitable for the pharmaceutical business. Both directions would be interesting, but particularly Asia to Europe.”