Distributing pharmaceuticals 2026 Podcast Part 3

Question 3: What is the single most important insight that you can offer for directors and senior managers with respect to personal liability for RP oversight?

 

Victoria Emerton (VE) – Making and Distributing Pharmaceuticals:   

“So, that brings us quite neatly to liability. Being a Company Director carries with it weighty responsibilities, as you said. So, for directors and senior managers in the audience, which I’m sure your audience will consist primarily of because this is really important for them; what’s the single most important insight you hope they walk away with from coming to the event and listening to you with respect to personal liability for RP oversight?”  

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

“I think knowing your RP, knowing your RP’s responsibilities, understanding GDP and commercial quality.  You’ll see job titles from, certainly  big pharma companies, they have commercial quality people. 

I like technical sales people, I like commercial quality people, largely because they can negotiate and understand the biggest issues you will be having.  

If you’re allowing your business and your company to be led by commercial and then quality are brought in at the end, often you’ll find you’ve got Technical Agreements that make no sense. You’ll have unreasonable asks, you’ll have sales people making promises that they can’t commit to and you, as the Licence Holder, are ultimately liable. So, where we see a failing with a Responsible Person and they have a critical deficiency (if that’s systemic and that’s also to do with the fact that the Licence Holder has not had oversight), then the Licence Holder will be cited.  

“Now, I know a lot of companies will hide the letter; they’ll keep it on ‘a need to know’. Personally I don’t like it, I think you should have town hall meetings. We frequently say to people we need to do a town hall, we need to share the content, we need to say how/why things have gone wrong, what we’re going to do to fix it.  

I also believe that when you have inspections, you volunteer your issues and your deficiencies, but, having worked with a number of corporates being interim, you know the general feeling is ‘it’s their job to find it’. 

But, if there are things you know we kind of call it inspectors’ luck. Sometimes they’ll pull a thread and if they pull the right thread, the arm can fall off the jumper. If it’s something that you haven’t dealt with or you’re aware and you’re not happy with, it’s better to give yourself the deficiency and to capture it within the quality system that shows that you know what you’re doing; that you have interest, that you’re open and honest.

“We see a lot of people, you know, sort of sitting there with folded arms, trying to give one-word answers. It doesn’t elicit trust! And I know there’ll be some people who try and elicit fake trust, but you know  most people are like human lie detectors and inspectors even more so. They can smell the the waft of ‘BS’ we’ll say, but I find that you know the inspector won’t be distracted. 

Some people think “oh yeah, if I give them a few of these things it will it will rent space in their head”, generally they will continue to inspect the way that they inspect but they will make a note of it, and I would rather give someone the deficiencies that I know are there because it shows a little honesty. But if you have that quality of culture, then people should come to you and tell you when they’ve made a mistake.  

“Having worked for someone in the past who said you can never make a mistake, you know, these guys or ladies or they/them who rule with an iron fist and say you can’t make mistakes, are creating problems for themselves. Ultimately, people will hide things. They would rather keep things to themselves than risk being in trouble. 

So, when I took over at this particular site, I said to people, “look, I understand how the leader is and how people end up feeling punished if something goes wrong. But I’m different. Come to me, tell me what’s wrong. I’ll fix it. I’ll make it go away. And he doesn’t need to know.” However, if I find that you’ve been hiding things, I will feed you to him on a silver platter. So that gave them a bigger fear! 

I think a lot of people don’t want to look stupid. They don’t want to be wrong. I think after I was told I couldn’t make mistakes, I did a bit of research and in life around 70 to 80% of the decisions we make are going to be wrong. It’s whether you learn from them.  

“So this is the thing: Creating that culture, understanding what your RP is doing, understanding your own responsibilities.
We actually give our Licence Holder training for free sometimes. Our online  is £99 plus VAT. Other people are charging hundreds for a half day.  

You don’t necessarily need to do the training, but you need to understand what are the 12 duties of the RP. What is the RP supposed to be doing? The RP is in place to protect you, protect the company, and protect the licence. 

But then you do also have RPs who end up being anti-business. They’re so scared of taking decisions! If they look at the book …we’ve even seen a contractor who was trying to get the management to sign off every decision and that can be counterproductive. So, I’m hoping that our talk will reach people and give them better insight into the type of person that you need.  

“We try and provide hybrid teams. So, where we provide RPs, we typically have a quality manager. If we have a deputy, that deputy would have an RP number as well so they’re an RP in their own right, and then there’s me! We’ve got about 14 RPs in our team, we’ve got our office, so if their client’s having an issue they can contact us and they’re in that position.

If you only have one person and that person hasn’t been suitably assessed, they haven’t had a kind of more recent gold standard assessment, then there’s a chance that there are big gaps in their knowledge.  

There are chances that they could be doing horrible, horrible things that you’re not aware of. If you’re asleep at the wheel, it could seriously impact your business.  

“Any IAG cases that come to us, we’ve managed to resolve and fix and try and find the right people to take over.
But we’d really love it if management learns about these things rather than coming to us. Although the work is lucrative, it’s hard! 

You know, it’s disappointing; it creates unnecessary work for the inspector. People have been saying, “oh you know they’re not out there inspecting”, it’s not true, you know! There’s a lot of new applications, there’s a lot of revisions. 

There was a loss of a number of senior inspectors a few years ago, and the resources are quite limited, so one of the things that we wanted to do with the UK GDP Association, which is a Community Interest Company, is a not-for-profit.  You know, we can’t claim dividends out of it. We’re hoping it should wash its face this year because it’s been a huge investment of money.  

One of the things that I wanted to do is help support the inspectorate. They’re there to protect us, to make sure that medicines are safe for us, our families, that things are done appropriately. It’s a really thankless job. I did a blog a few years ago, “The MHRA are our friends, even if it doesn’t feel like it”, and you have a lot of people “oh you know they’re just this and that. I told them something and they used it against me”, and I said, “what do you think people are going to do? That you’re going to tell them you’ve done something incredibly stupid and risky and they’re going to let you off? You know they’re here to protect public health!”  

“So, I hope what senior management will recognise is that possibly, they’re unconsciously incompetent and possibly the person that they have in post is not what they think. And this isn’t, as some people say, a cynical grab to try and get more work.  

We love working with people. We love supporting people, doing mentoring work. But if you don’t know what’s going on in your organisation, if your RP decides to leave or retire, you put someone new in, there’s a very good chance that could trigger an inspection. And if you’re found to be wanting, you are then going to be very, very distracted from your path to commerciality and success with this whole storm of regulatory, and the threat of your business being suspended.  

I do have people saying to me, “I like how confident you are to talk to the board about what you’re going to do to fix the issues.” That’s because we’ve done it. 

“I’ve tried to build a team, there’s nearly 30 of us. 
I’ve built a team of people who have specialisms and as many people as I can find who are better at individual topics than me to make sure, you know, , we put in eight people and we start with people who are doing validation, computerised systems, people with specialisms in temperature control boxes, training, auditing, to give this focus. 

Where people call us in before, often we get a call; “Oh, I’ve got a letter. The inspector’s coming in a month. Can you come and see me?” I say, “I’m really happy to, but don’t be surprised when the inspector says, ‘Why didn’t you do it two years ago? Why didn’t you check things now?’ The only reason you’ve done it is because I’m coming.” And often that is the case. 

I think checks and balances are really important, but I’d say for Licence Holders, the main thing; understand what the person is supposed to be doing, understand that they have the strength and the skills and the knowledge, and the expertise in the particular fields that you work in. There are very few people who know 90% of every topic.

“If you’re working as an RP and you’ve never worked in a warehouse, then there are going to be things that you don’t know.
But if you have an outsourced provider who’s doing third party logistics for you, you should know enough to be able to challenge them, to be able to go and audit them. And I think this is the key thing where things fall down, people only see the surface of it. 

“Oh yeah, we need an RP. We need to nominate an RP and that’s it. It’s a tick box.” It certainly isn’t! Business can live and die from who you put in place. I’ve seen a lot of good RPs walk away from companies because they don’t feel supported, they don’t feel resourced, they’re being challenged all the time. 

I think one comment to management will be to support your RP, nurture them, look after them, love them, and certainly get commercial people to understand. If you’ve got commercial people,  very good commercially and horrific at paperwork, then get a QA to support them to come out with their budget. But for me, commercial  should be carrying out the initial activities to check and fully complete the forms. Don’t send something back later with gaps in it! 

How we got the licenses …did the products match …you know, doing some of the due diligence on companies. We’ve had people I think I said earlier, say, “I can’t afford not to do this business.” And we said, “well, we can’t afford to work with you anymore!” 

“If people are doing it for the money (obviously you need to make money), we want people to make money. We try to be as commercially sensitive and sensible as we can, but if it’s outright going to break the law or it’s going to end up with one of my RPs at IAG and the company licence being under threat, then we have to walk away. It’s also useful for the Licence Holders to know and for RPs to know that if there is a dispute between  Licence Holder and RP; the MHRA would expect that  to go to them to resolve.

But I don’t think many people would voluntarily go to the inspectorate for these kinds of things because in general, I would say the majority of the time; the RP is going to be right. But we do also see situations where RPs are acting as commercial blockers; “oh, we can’t do this!” And often it’s their interpretation. 

If the patient is at the end of it and there’s a reasonable justification, there are a lot of things that can be done and typically we would go to the inspector just to get that confirmation. But again, the way a lot of corporates work, the way a lot of other businesses work, “oh no, we can’t speak to them”, they’d rather take the risk of doing something.

We have been in situations where there are decisions that have to be made that may not be ideal from a GDP perspective, but there is a real urgent and definite need for a patient which is always going to be a priority, as long as you can mitigate that risk and justify your actions.
That’s a good thing.”