The bio-pharma industries have one of the more complex supply chains because it needs to include cold chain. In Europe, we are used to it, even though since March 2011 the European Commission issued new rules about many issues including cold chain – the cold chain distribution is imperative because based on projected market growth rates, 7 of the top 10 global pharma products in 2014 will require cold-chain handling.
I have had many talks with big US and Canadian supply chains to explain how the concept of pharmacy is so different between English speaking countries and non-English speaking ones. For instance, take Portugal: I cannot have a vaccine to sell that is not conveniently stored in a cold facility with a temperature range of 3º to 8ºC.
This makes us have very advanced technologies in the pharmacies that are checked by health authorities and double-checked by us every month. Now, I have no use to such a big investment to secure that the vaccine is in perfect good conditions to sell, if I am not sure that it was always kept this way since it left the pharmaceutical industry that produced it.
We have cold chain distribution and I can watch with a special software program all the “route” that vaccine did, and in what cold chain conditions, since that vaccine started its way to my pharmacy. There is a cold chain along the way that assures me that when that vaccine gets into my cold storage, it was never exposed to different temperatures, not even for a second. If I am not happy with what I watched ( I have batch numbers and special coding) I will not accept it in my pharmacy and will not be responsible to sell something that can kill someone because it lacked the cold surveillance/maintenance.
This goes to several other medicines that need cold chain/storage, as well as those that need intermediary cold storage, not the special facility, but a special warehouse within certain temperature and humidity parameters.
This is a vast operation; we all need to have training in cold chain. Furthermore, the supply chain is such that when I order products from my wholesaler and will have them in two hours time max, no matter what and where those products are.
Everything in the pharmacy is behind the counter, you cannot buy any non-prescribed medicine as you wish and in the quantities you may fancy, we are there to assure you take the one you need and in the quantity you need.
It is a total different model and during these conversations I mentioned, I have been astonished many a time and the US and Canadian people too due to the enormity of differences between these two models.
It is going to be a lot more difficult to implement cold chain in these countries, and more expensive too, I mean now because we already have it and still needs to be “trimmed”.
The supply chain has other issues, addressed by the European Commission known as “The ‘Pharmaceutical Package’, and contains three important initiatives:
– a proposal for a directive on how to modernize pharmaco-vigilance in order to improve medicine-safety;
– a proposal to improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain; and
– a directive on the future direction of the supply of health information to patients”
Counterfeiting proved the weakness of the supply chain; the Directive also sets out provisions covering internet sales – however, the reality is that not only can those selling channels not be closed, but counterfeited lifesaving drugs can actually be found in the legitimate supply chain as well.
This means additional costs as it will imply a new process of coding, a “pan-European system to provide unique serial numbers on each genuine medicine pack/ repack” .
This represents great expense to all pharmaceutical industries and pharmaceutical allies, to be met by partnership between manufacturers, logistics providers and wholesalers, to ensure simplicity throughout the cold chain process. Furthermore, each new change will have to bear the “green” stamp, towards a more sustainable environment, with the related additional charges.
cristinaffalcao 