Originally Posted by
Bread
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Sorry for the lengthy post ...
I work exclusively in the Pharma Industry and Medical Device Industry and have done for over 20 years. I've worked in manufacturing (including batch release), validation (process, instrumentation, CSV, cleaning, electrical, mechanical and control).
I've worked in supply chain (and ESO), R&D, clinical trials, drug development, technology transfer and commercial.
I do project management, quality management, auditing and compliance across all regulatory areas, specialising in IT system, mainly SAP (global enterprise) and I'm currently implementing a global e-commerce solution for the supply of medical devices on-line, using SAP Hybris.
My clients include Alcon, Novartis, GSK, Astra Zeneca, Pfizer, Sanofi, Johnson and Johnson, Depuy and Janssen (plus others).
Before this I was a regulatory compliance consultant working in the USA, Germany, Sweden, Switzerland and UK providing audit remediation, working with regulators (such as FDA, MHRA and Swiss Medic) to remediate manufacturing plants after inspections.
So....
The utter bullshit that people are coming out with regarding Brexit and the Pharma Industry is irresponsible, incorrect, and dangerous.
The biggest problems with Brexit and Pharma are :
1. Mind the Gap - between the UK registering in the WTO our participation in the Pharmaceutical Tariff Elimination Agreement.
To get round this, the Pharma companies are increasing warehousing around Europe (stock piling as Project Fear likes to call it). We do this anyway - it's part of "disaster planning" where patients are safeguarded for supply in the events of everything from outbreak, earthquake, Calais going on fire etc etc. There is enough stock in some of these warehouses to keep deliveries going for years.
This avoids the tariffs until the registration is complete.
The UK can eliminate incoming tariffs on products coming from anywhere else in the meantime.
2. Delays ....
A lot of products must be transported within a pre-defined specification with regards to temperature, humidity, air pressure etc etc.
This is what we call "Cool Chain Monitoring" and in each batch of product we put a "data logger" in the box that takes readings every so often (usually 15 minutes or so). These data loggers are GPS enables as well so they can track exactly where the vehicle has been.
When the product gets to the destination, the local health authority can upload the results of the loggers and determine if the products are "in specification" (OK to release to patients) or "out of specification" (because they got too hot or there was too much moisture).
If they are out of specification (OOS) then they can be quarantined and incinerated, returned to the manufacturer or, in cooperation with the manufacturer released to patients. This normally happens if the OOS is so marginal or, say, the temperature was too high for a very short period of time. This can happen when transporting to places such as Dubai where the upper limit is 50 degrees and it went to 50.5 degrees for 15 iminutes (say).
A delay can (in some cases) cause the out of specifications to happen... but not always and the shelf life of most products are measured in years not days.
For blood products and "living products" we have air transport and can use other ports / routes so this is also covered - it is also against the WTO rules to frustrate trade at a border, as we have seen with Calais clarifying their position, that they will not hold anything up after Brexit.
To overcome this - warehousing has been increased in each country where the products are supplied.
My girlfriend is a pharmacist - she gets people coming into her pharmacy every day asking for extra prescriptions for stock-piling because of Brexit. This means she has to talk them down, waste a lot of time when she could be serving other people and costing the NHS a huge amount of extra money.
Then there are the real worriers seeing their GP and getting prescriptions for stuff they might not need ... more money that needs to be paid for by the NHS and the tax payer. Once we leave, most of those drugs will go down the toilet or get binned because of expiry dates or simply because they are "not needed anymore" and thrown in the bin.
In one case my girlfriend had about £7K of unused medicines returned in a bin bag after a patient died but never needed the medicine or stopped their prescription. All of that went off to be incinerated, unopened and unused.
If you are genuinely concerned about anything on here regarding drug products, brexit and your safety, speak to your pharmacist or mention it when you see your GP. The irresponsibility of people promoting fear about medicine and Brexit is simply not true.
The industry has this well under control.