Distributing Pharmaceuticals 2026 Podcast Part 6

Question 6: How do you plan to address the Licence Holders role in protecting the RPs independence in relation to GDP requirements and meeting commercial targets?

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:

“I want to talk about the push and pull between commercial targets and what the RP does. The RP may be seen to be at odds to achieving commercial targets. How do you plan to address the Licence Holder’s role in protecting the RP’s independence? The RP needs to do what they need to do. The company needs to make money and there has to be a path found through both of those activities so that everybody fulfills their function.”

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

“I think finding the balance is really key and I think also recognising that quality can save you money. Quality can protect you from bad business decisions. can look at waste within the organisation and try and reduce that; it can try and streamline things.

Some people might say, “oh, well, why is it taking six weeks to qualify this customer?” and you say, “well, you didn’t give us the information we’ve asked for” or “you’ve not completed the forms properly”. I see a lot of quality teams that would just say “I’m just going to do it myself”, and I think “no, you have got to be strong!” The whole point should be that the quality and commercial work together. Commercial may bring in the money, but quality are the people that will maintain the licence. With no licence there is no business. Also with no commercial, there is no business if you are not making money.

“We always try and look at what is sensible, what is pragmatic, what is outright crazy or illegal, which you cannot do. I think having it where there is no “butting of heads”! I hear from so many people, “oh, bloody hell, I had the commercial guy coming to me, nagging at me, ‘why aren’t you doing this, why aren’t you doing that?’” It is generally because commercial don’t understand if you hire people and their main role is to sell things for profit, there’s no buy-in.

Having commercial KPIs (key performance indicators), having their bonus tied in with an element of that quality function, even if they’ve got a QA person to do it for them. You may have a super salesperson who is appalling at paperwork, in which case, don’t lose that person to someone else; they’re probably quite dangerous if they aren’t controlled, and we’ve seen so many companies that have been at IAG because of commercial and their shenanigans. But I would say if they’re given the mechanism to deliver it, then that would be the best thing. Commercial and quality need to work in harmony. Having a Licence Holder, a leader who understands that is so, so important.

If it’s too far one way or too far the other, we can quality the heck out of things. We were recently asked to do a piece of work. We were asked to check in every day, give an update on everything we are doing. I said, “we can do it, but it’s going to cost you two or three times the amount of money because every time we do something, we’re going to have to stop and update you.” After a few weeks, they agreed our way was better. Particularly when you have a really bad situation; it’s kind of getting the rough diamond and then just gradually trying to polish it into something shiny. So going for that rough compliance and trying to bring it in …it doesn’t have to be overnight.

“You don’t want to traumatise your commercial people saying, “right, you’re going on these courses, you’re doing this, you’re doing that.” we also see a lot of boring and irrelevant content. People are being trained in things that have very little relevance to commercial. I saw an online training for drivers. It was about six hours, and it was talking about the importance of clinical trials! Most drivers that I know would have very little interest in this. There might be some who, for their own knowledge , but it doesn’t relate to the work that they do, and it doesn’t relate to the job that they do. But giving them the knowledge and understanding that you need to sell quality, and when people complain about why we’re doing this? It is what sets us apart, this is what puts us at a higher standard than anyone who is not following the regulations or does not have the same regulations as us. They may be sourcing things from suspicious supply chains, they may not be delivering them appropriately under temperature control, which can affect the quality of the product. Can you afford to risk your patients? Can you afford to risk your business with substandard, potentially falsified products? I think that is how I would try and tackle it.

“I do understand commercial. I worked in commercial. I was a massive under-achiever! I was too honest to be a salesman. And for me, does this fit your need? So, we often get people who come to us and say, “I want to get a licence, I want to do this, and I want to do that” and after a few questions; “have you got experience of quality management? Have you worked in wholesale before?” And a lot of times the answer is no, no, no!

“The killer question is ‘do you have any customers’?” Often the answer is nepotistic. “So, oh, my brother-in-law works for this five-star hospital in Dubai, and they need to get good quality products.” We can do something with that. We can work backwards from that. Obviously, no brown envelopes or money into their Swiss bank account, which was something we were asked. We were asked to go and scope out a job for setting up a facility in the Gulf. My associate went to the meeting, this guy turned up in a Bugatti. He was the general manager for the company and they said, how much are you charging? And we told him, he basically said, “I’m going to double it, but I want the other half in my London bank account.” My guy got up and said nothing and walked out.

“So the key thing, I think with commercial, is it does drive a lot of things. But if you’re fighting your quality team and they’re the people who are trying to protect you, protect your job, if there is no licence, there’s no work for anybody.”