Quote:
Originally Posted by diebitter
Actually let's get specific.
Clinical trials directive
Before it came in, britain had 12% of world market.
After first version of directive kicked in, it fell to 1%.
Cos red tape.
Sounds detrimental to me.
QED?
It would make a great case study but it's not QED. Wondered if this would ever come up, I worked in clinical trials during the relevant period and have to be a bit careful what I say. Few things though:
The regulation of clinical trials were dreadful imo (and everyone's as far as I know). It's been a terrible burden on the industry and on progress in drug development while often actually making things worse.
Rather than argue the above - let's suppose it's true. You want to blame the clinical trials directive but the reality is that the regulations from Europe and the FDA were being imposed on us whatever we did. That's because our clients (drug companies) had to meet their own regulatory requirements and, crucially, that increasingly included making sure their suppliers (i.e. us) met their regulatory standards. We were increasingly being forced to meet all the regulations by our clients regulators even if our own regulators had done nothing. So argue against the regulations but there was no opt out for us by being outside the EU - all we can lose is influence in global regulations. The burden on our company (starkly obvious by the fast growing regulatory group) was obviously going to hurt us a great deal but also obviously unavoidable.
I think we can very justifiably criticise our government for not doing enough to shape the regulations and for ignoring the concerns of the industry but being out of the EU wasn't going to help.