In Pharmaceuticals, Things Are Rarely Black And White

WellcomeI spent a good part of my working life as an independent pharmaceuticals consultant, but I learned my trade working for manufacturing companies. The first two were based only in the UK, but the third – and final – company I worked for was The Wellcome Foundation, back in the days before it was swallowed by Glaxo. Wellcome had products being made all around the world, either in its own factories or under licence in local firms. There was a single specification for each product, wherever it was being made and companies had to achieve high quality standards before they were permitted to make drugs with the once famous Unicorn logo on the box. We demanded state-of-the-art facilities and could afford to be choosy in picking our partners.

So when I left corporate life to work for myself, I thought I had all the answers. I knew how drugs should be made in the late twentieth century and I knew what was not acceptable.

DSC01902One of my early contracts was for a Serbian company which had just bought three factories in Russia and wanted help bringing them up to scratch. So I jumped on a plane and headed off to Moscow, thinking I was going to save the world. One of the companies, in Kursk, was already known to me. The other two were in St Petersburg – a beautiful city, but suffering, like the rest of the country with economic problems following the collapse of the Soviet Union – and Chelyabinsk – an old industrial city in the Ural Mountains.

Both factories were about sixty or so years old, in very poor condition. And although they operated according to the same set of Gost Standards, governmental rules, as the rest of the industry, there were very few recognisable hygiene measures in place. These were certainly not the sort of place Wellcome would ever have agreed to work with – and they were making so-called sterile injections.

SyringeIn the old days, I would have closed the factory down – or at least, pulled our contracts away from them. But these were no longer the old days – and I had no power at all. Added to which, it was pointed out to me that these two factories between them made forty per cent of the injections currently on sale in Russia. The cost of stopping production, not just financially, but more importantly in health terms, was incalculable. And the cost of replacing the antiquated technology with new state-of-the-art equipment was astronomical.

I learned a valuable lesson that day. State of the art may be the best possible option, but it is not necessarily the only option. That was the day ‘Basic Minimum Standard’ became part of my vocabulary and I have remembered ever since that in the pharmaceuticals industry, as indeed in life in general, things are rarely black and white.

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By Elizabeth Ducie

Elizabeth Ducie was a successful international manufacturing consultant, when she decided to give it all up and start telling lies for a living instead.

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