Innovation and regulation

I’m not sure why, but I seem to spend more time looking at ‘quality’ than I do at ‘science’ these days. I’m not sure how I feel about that, but it seems to fill my blog nicely with Crunches, Tides and Roots and perhaps even the patriotic/lab-iotic/idiotic(?) Warriors. Anyway, some time ago I was reading two documents at the same time, and when my brain numbed out to the first one, I’d jumpstart it again by reading the second one. The contrast between the two documents couldn’t have be more stark.

A Tale of Two Documents

The first document was a mind-map of the pharmaceutical quality system based on Eudralex Volume 4 (all 3 parts, 9 chapters and 19 annexes!). The second document – ‘Complexity and the Adoption of Innovation in Health Care’ (CAIHC)- is a summary of ideas relating to how change and innovation and initiated, developed, disseminated and adopted throughout large organisations. The second document was full of wonderful ideas like ‘attractor patterns’ and ‘inherent non-linearity’. Reading these two I oscillated between a system that just seems to change by becoming more and more complicated (hoping that more words will bring about better processes!) and a system where ideas originating from any part of a organisation can lead to life changing adaptions. One passage from ‘CAIHC’ that leaps out at me is:

“First, do no harm” is an example of an internalized rule that might be behind an individual’s reluctance to embrace the risk of an innovative change.”

This seems to chime with so many of the conversations I’ve had about change within a pharmaceutical quality system: at times I’m the innovator, and at the times the reluctant individual who’s internal rules, or perceptions of the external rules, make me think change is impossible.

Innovation and regulation

In my old job we operated on the border between development and manufacture. We needed to use experimentation to develop the products and quality assurance to manufacture the products. What really got me thinking me was the mind-map diagram of ‘premises and equipment’: it lists areas to produce stuff, store stuff, test stuff and fix stuff. There’s nothing in it to say you need a facility to ‘develop’ stuff. While the Eudralex doesn’t tell you mustn’t innovate, it doesn’t tell you that you should. Thankfully the pharmaceutical companies don’t seem to be letting the absence of provision for innovation in the Eudralex stop their R&D activities: according to Fortune, Merck, Johnson & Johnson, Novartis and Roche all seem to be big spenders in this area. I suspect these high numbers reflect the drive to develop brand new drugs.

But, innovation isn’t just about new blockbuster medicines, is about developing better process that affect the whole industry, from development, to production and all the way to sales and post-marketing surveillance. Pharma has some serious production issues: very long cash-to-cash cycles (in some cases it can be 2 years from buying supplies of raw materials to actually selling the product and recouping the money); low yields (as low as 1% of the raw materials actually makes up the end product) and high failure rates (I recently saw a comparison of pharma’s 6% failure rate against the car industry’s 0.003% failure rate). Pharma needs innovation at all levels: from drug development to production. But googling “Eudralex Volume 4 innovation” shows that the introductory chapter 1 mentions the word only once. There’s nothing in the rest of the Eudralex to persuade manufacturers to invest in and run a development lab or facility, or pull together an innovation team. The Eudralex and our regulatory framework does nothing to encourage manufacturers to ‘…embrace the risk of innovative change’. The Eudralex has changed recently, but I’m not sure if the new approaches to pharmaceutical quality management with tools like Quality by Design and Risk Management (which I think are quite exciting) will result in the kind of inventiveness we need.

And in 5 years time…

As long as the Eudralex just satisfies itself with it current ‘cursory nod’ to innovation, I suspect that all we’ll (that’s everyone involved in pharmaceuticals) do is return the same ‘cranial inclination’: so that in five years time we’ll all wonder why pharma’s still the same and why all the big healthcare benefits are coming from smart-watches and wearable sensor tech produced by the electronics industries.


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