Distributing Pharmaceuticals 2026 Podcast Part 2

Question 2:

“Will you be challenging the assumption that Licence Holders are competent by default if their RP is on the licence and providing a definition of what competence actually looks like in practice?” 

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:  

”In your talk, you’re going to be challenging that assumption and providing a clearer definition of what competence actually looks like in practice. Are you going to be helping people out on that?” 

Dave Ruston (DR) – Paradigm Shift Consulting/UK GDP Association: 

“Oh, yes! We know what happens when we assume; it makes an ass out of you and me! I think the thing is, as a Licence Holder, it is your legal responsibility. I think a lot of other people don’t realise that when they have a WDA (Wholesale Distribution Authorisation), they see the name on the WDA, that is the Licence Holder. 

That’s not the case. The Licence Holder is the company, the name on the license is the contact. So, we’ve been into situations where possibly the director of the company or a general manager is, in their opinion, the Licence Holder. I tell them, “no the Licence Holder is the body corporate.” Anybody who’s named on Companies House is effectively a Licence Holder. 

“So, if you are delegating your Licence Holder responsibilities, you should make sure that whoever you give that to is on point.
The Human Medicines Regulations [2012 as amended] does state up to two years in prison for infractions. So, let’s say you have a Licence Holder representative who is very commercially focused, who’s only interested in hitting the numbers, where the majority of their company is made up of commercial people, and they don’t understand the responsibility.  

“Often, they’ll just try and get someone cheap to tick a box. RP rates are very high, but there are not many people on the market available at the moment who, you know, it’s kind of potluck! If someone’s instantly available, typically you’d wonder why nobody wants them. Sometimes you know, there may have been a settlement and they’ve left . 

“We find a lot of people, including Heads of Quality. When they’re working in a toxic environment and they’re not being supported, they will run. People say, “oh, you should whistle blow!” But if you whistle blow, then potentially you’ll find yourself out of your job. You’ll find other people out of a job. It’s a very difficult position!

I think, in manufacturing and in distribution, the two most hated groups of people are probably engineers and quality because we say “no”! So, if someone says, “oh, it’s only out of tolerance by 0.05%”, you know, it’s still out of tolerance.  

“We frequently see people sometimes say, “why can’t we do this? Why can’t we do that? Or I can’t afford not to do it.” And those are exactly the types of clients that we try to avoid. Frequently (not to bash commercial ), the critical deficiencies we’ve seen relate to commercial , either not controlling the customers who are supplying products, who are supplying to customers , particularly things around controlled substances.  

“We see people getting a Regulation 30 letter from the MHRA. We’ve had evidence that thousands of packs of diazepam have been shipped internationally, and they want to know why. The MHRA had a bit of a sting operation a few years back where they managed to reduce the amount of 10 milligram diazepam on the market by 64%. So much of that product was leaking into the  market. 

“If you’re the Licence Holder of a company that supplies controlled drugs, you should make sure that you really are on top of it. Because let’s say those drugs leak (they go illegally to someone who’s buying them off the internet they die), you could be in a position where you end up in court and that would be a very unpleasant place to be.  

Also, the PR would be horrific! And if you look at what happened with Perdue Pharma trying to promote their drugs, lobbying through doctors saying they’re ‘less addictive’; “Our opioids are less addictive, they’re better for you.” They’ve ultimately been sued, I think, by all 51 states in the USA for creating horrific addictions. Now people are turning to heroin when their healthcare insurance won’t cover it.”