GE Healthcare's Rob Dekkers on the Ultimate Distribution Challenge
Rob Dekkers' current role is Logistics and Distribution Leader - EMEA Working for GE Healthcare. He faces perhaps what could be described as the ultimate distribution challenge: radiopharmaceuticals. Facing a ticking clock, a temperature sensitive cargo and strict regulations, Rob must ensure that these products make it safely across Europe. How can the risks be mitigated, and the legislation be complied with while staying on schedule? In this exclusive podcast we explore the unique and fascinating role of Rob Dekkers.
Pharma IQ: In your role what are the trends that you’re seeing in the industry in regard to regulation?
R Dekkers: Our area of industry is a very particular one because we have three main, let’s say, regulations focusses that we have to look at. One obviously is the pharmaceutical part and we’ll talk about that later, but that’s where the GDP regulations come in that are relevant for us. Then the second part is that our products are, apart from being pharmaceutical, are radioactive and that means they are dangerous goods in the sense of the Dangerous Goods Regulations. They’re classed as radioactive material, so we have to comply with the regulations on dangerous goods.
And then the third element is that since we produce these products and in some cases they are very urgent, we also have to look at the security regulations because we need to ship quickly and we cannot have hold ups at the airport. So everything that has to do with the authorised economic operator status or the known consignor status that also applies to us. So when you ask me about regulations, we need to look at all three of these areas and obviously from the pharmaceutical point of view, the GDP regulations that have been published this year are very much a topic that we are looking at.
Again, if I look at the products we make I should probably give you a bit more background. The radioactive products they have a very short shelf life so we have products that you have to use within eight hours, that is the shortest one, and we have products that you have to use within a few days, so most of those products are not products that you produce and put them in stock and then supply from stock, which is, let’s say, the more common way of distributing pharmaceuticals. Our products are made to order and that means that when a customer in a hospital, and that would be a nuclear medicine department, orders the product, the patient is already planned for that product and when the customer needs this radioactive pharmaceutical they will order it and we will make it on demand.
The supply chain for these products is that some of them you produce on a Monday, let’s say, in the Netherlands and they're being used in the rest of Europe on a Tuesday. So the supply chain that we are in is a very short one. It’s extremely short. If you look at the new GDP guidelines it covers everything, it covers the whole process of pharmaceuticals, but it does not really fit the model that we are operating in because it is assuming a product is produced by a manufacturer, it’s being quality controlled, it’s being released, it’s then being sent to a warehouse – it could be their own or it could be an outsource warehouse or a wholesaler – and then it’s being shipped to the end customer.
Now that doesn’t apply to our kind of product which means that some elements in the regulations are really difficult to comply with. So if you look at the challenges for the next year is to make sure that we comply in a sufficient way with the regulation without jeopardising the supply of these products to the end customer.
Pharma IQ: So how do you deal with the difficulties of distributing radioactive pharmaceuticals?
R Dekkers: If you look at the GDP guidelines and the relevance to our products, one is the whole aspect of temperature controlled shipping and that has become now our main topic. When we ship our products they can go on a van, for example, and then from a van go into an aircraft and from the aircraft go on a van and then go to the customer. Now obviously we cannot control everything that is happening in an airport. If we would consider what happens at the airport, we’d have to be fully GDP compliant; we would have to train every person working at an airport, which is impossible. So the only way of dealing with that is that you look at your product and you look at the temperature requirement of your product and you do excursion studies on the product, so you heat the product to a certain to a certain temperature, to a higher temperature, and you show in studies that the product will be stable at higher temperatures.
You then do a risk analysis on your route, so let’s say we ship from the Netherlands to Spain, we look at the vehicle, we look at the airport, we look at the flights, we look at the local transport in Spain, and if we can show in the risk analysis that the products will not be exposed to higher temperatures than we looked for in the excursion studies, then based on the risk analysis you say that the product is safe to ship in that way.
But that’s quite a complex way of dealing, because in the standard pharmaceuticals you would simply order a temperature controlled vehicle and you have a cold supply chain and that would just be sufficient. In our case that would not apply. So we look at different ways of covering the guidelines, but within the guidelines. The word risk assessment is part of the guidelines and that’s something that we are focussing on at the moment.
Pharma IQ: Why is it important for the pharmaceutical supply chain to be flexible?
R Dekkers: If we’re not flexible that would really jeopardise the supply to the patient because our supply chain is depending on availability of, for example, airlines. We have limited choice of airlines that transport radioactive pharmaceuticals and there are big airlines that do not transport radio pharmaceuticals, so the amount of flights, for example, that you have available are limited, and that means you have to be able to switch from one route to another route within sometimes a day. If in the summer schedule the flights change in Europe, and the availability of certain flights is no longer there, then that could actually mean that some parts of Europe we can no longer supply.
So we need to be able to switch to other carriers, to other modes of transport, very quickly which is, I think, in the standard conventional pharmaceutical world less relevant. There are standard supply chains, standard cold supply chain. In our area you have to really be able to react to the existing situation and to give you a very interesting example, when we had the volcano outburst a few years ago, the whole supply chain of radio pharmaceuticals almost stopped because there were simply no flights available and because of the short shelf life, you cannot use a truck from, let’s say, the Netherlands to Italy because the product would already be out of shelf life before it even reaches the customer. So we need to be very flexible in the way we distribute our products.
Pharma IQ: How do you think this sector will change in the next 18 to 24 months?
R Dekkers: That’s almost difficult to say, but I think what we see is that there is an increased pressure caused by the regulations, so also the new GDP guidelines will force us to have more stringent contracts with carriers. They will have to have more quality control systems in place, so one thing that we expect is that the cost of our supply chain will increase. If I look at my own area we mainly operate in Europe, but even in Europe the regulations are not harmonised so what applies in one country does not automatically apply in another country and that poses I would say confusion, but it also probably increases the costs.
So we need to really manage the regulations. We need to have the overview of what is necessary per country and that goes for pharmaceutical regulations that can be different, but also for the dangerous goods regulations, and what we see is an increased pressure on our products and, to be honest, one element which is not the pharmaceutical point, but also the security part where we have to ship with airlines and the whole focus on terrorism and avoiding terrorism and having increased security measures that also apply to us. We have to train more people, we have to comply with more regulations, so there’s an increased burden of regulations and that will also have an increased cost impact.
Pharma IQ: Thank you very much, Rob, for sharing your insights and your time with us today. We look forward to hearing more from you at the Pharmaceutical Distribution event.
If you would like to find out more about this topic and the Pharmaceutical Distribution Conference in Amsterdam this September 23rd to 25th, visit us at www.distributioneurope.com.
Interview conducted by Gerald Clarke, Pharma IQ.
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