Distributing Pharmaceuticals 2026 Podcast Part 4

Question 4:
What are the strategies for Licence Holders to verify an RP’s competence when they aren’t in touch with their RP very often? 

 

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:  

“You’ve talked about how, basically, you need to trust your RP in as much as they’re incredibly important to your business. But how does a manager, a director, a Licence Holder cope when they’re not seeing their RP very often? They may be under contract, or they’re working remotely. So, what are the strategies for Licence Holders to verify competence when they’re really not in touch with their RP very often? How do you find what works best?” 

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

“Well, contact would probably be the best thing,  being active in the quality system!
We like to do a monthly quality and improvement meeting. We like to try and cover as many elements of management review and self-inspection within each of these . So, we might look at changes to people, processes, and we might look at third party provider performance. We might be looking at changes in business environment, so you’re doing it little and often.  

If (as a means of assessing RP competency) you only do a management review and self-inspection, for most people, they’ll do it once a year. Some people may break it down into chunks and it will depend on the resource that you have. As far as I’m concerned, if the MD or the Licence Holder or the Licence Holder’s representative (and I think the board), understood that they could face two years in jail for something going horribly wrong, they would support it too.  

“The Licence Holder should be there at a minimum for half of those meetings; you know, or once a quarter we’d back it off to, but they should get those minutes, they should review them, and make sure they’re feeding information into the system.  

Often, in the past, we’ve been working with companies and  say, “oh, we’re about to make an acquisition”. Okay, how long have you been working on this? “Eight months”. Why didn’t you tell us? “Oh, it’s commercially sensitive”. Okay. We’ve seen people buy companies that are not fit for purpose. If they’d involved the RP and the quality team, we could have risk assessed it, we could have reviewed them, we could have audited them. We can put placeholder change controls in, and we can call it something else.  

“We’ve seen various different projects on this or that, names that have gone in place. We can put that placeholder in there and work in the background. But I think what people don’t do enough of is actively be involved and think that quality is “that thing in the corner.” It’s the pillar of what you do. In pharmaceuticals, it’s the spine of your business.  

“Strange analogy: Maybe the Licence Holder is the brain of the operation, but the RP and the quality team are kind of a beating heart. If you don’t involve them, you don’t support them. I think with anyone, more reciprocity. People don’t feel appreciated and looked after; they’re being thrown under the bus with commercial.  

You’ll see commercial guys siding with the client when you’ve got customers, particularly in places like the Caribbean where they don’t have, shall we say, the same respect to GDP that we do here; say, “Oh, why are we doing that? Why are we doing this?” And then they say to the customer, “oh, I don’t know”. Only then do they go back to the quality team to ask, “why are you doing this? Why are you doing that?” If quality comes from the top, if you’re the leader and you’re saying to people, “quality is our business.” Our business is getting the right medicine to the right person at the right time, making sure it’s safe, making sure it’s efficacious. If people are challenging you on this, quality should be cited by commercial. Commercial should go back to them and say, “well, the reason we do this is we’re following the regulations”.  

“Anyone who isn’t doing this is either working to a lower standard or they’re skirting regulations for profit. The reason that we cost more is that our medicines come from one of the most regulated and respected supply chains in the world. We’ve got one of the leading regulators, the MHRA.  

“Other people will look to go and set up licences in countries where the regulations are less effective for ease, but the supply chains there can be pretty crazy.
You know, we see a lot of product that goes out, it’s then diverted back into the supply chain through Eastern Europe or through Turkey into Bulgaria.  

But I think certainly for license holders, being that leader, being that quality leader and also being able to push back up to the board and say, “well as the representative, I’m keeping us all out of prison, we need to be present”. So, even if the Licence Holder isn’t able to attend these meetings sending them a Docusign or Adobe sign, Dropbox or on whatever it is, to review it and actually put their stamp on it, that is very important. You don’t want to be receiving an inspection and then, particularly if you’ve got an RP that they almost never see, (who does see that RP?); there are these kind of ghost RPs that are on a license? 

“There was a gentleman, years and years ago, I won’t mention his name, I saw his name on a licence, and nobody had seen him! He was getting a monthly stipend; I think he was probably down at the pub or something! If there’s no evidence of the RP being involved in the quality system (one consultancy was cited on that a few years ago. They kind of had figurehead RPs and then you’d have a quality manager and an office person and this person), you know, he was listed as an RP but there was no evidence of him being involved in the quality system! And that will go very poorly .  

So certainly, it’s in the interest of the Licence Holders to want to stay out of the press, out of jail and out of situations that can compromise the licence of the company that they work for. If you’re known to be the guy that crashed the company, your career prospects are going to be quite poor.”