Just as we think we're sorted, the regulators shift the goalposts...
Regulation aims to keep the public safe and the playing field level. We used to marginalise it, as an irksome extra task, its only function to satisfy the regulators. That was bad business, because compliance – being seen to do the right thing – doesn’t come cheap. And when you invest in any activity, you have to see added value.
Today, most companies are integrating PV (pharmocovigilance) into the mainstream operation. It brings performance benefits, and compliance data come out automatically. The industry is less defensive, too: we’ve learned that when things go wrong, it’s no good wriggling. We simply own up and fix it. But what’s this? Just as we think we’re sorted, the regulators (starting with the FDA) shift the goalposts. No, don’t groan yet: wait till you’ve heard the plan!
The new approach concentrates on outcomes instead of processes. ‘Doing the right thing’ is no longer about owning up after the event, nor about meticulous admin. It’s about running your business in a way that prevents major adverse events from ever happening. The new question is “why didn’t you see it coming?” not “did you fill in all the forms?” The premise is, if it went wrong, you’re responsible. The worse the impact of an AE, the more we should worry – about how to prevent a repetition, not about the legal consequences.
True, there’s no such thing as one hundred per cent foresight. Things will go wrong. To my mind, it’s no great problem when someone comes out in an allergic rash, or complains of nausea or headache, if no permanent harm is done and we learn from the mistake. But when people are harmed or even die, that’s serious. We have failed in our duty – whether or not we met the letter of the regulations. For me, ‘more justice than law’ is the phrase that best sums up this new style of regulation. You get nul points if the treatment’s legit but the patient dies. Pharmaco responsibility goes way beyond legal niceties. Disagree? Try asking your customers how they see it: it’s the outcome that counts.
So, how do we ensure the best outcomes? The potential benefits of systematic Risk Management are clear. But do we always pursue it with sufficient rigour? Maybe not, yet it can be done. Aerospace succeeded. Their mistakes are all too visible, so they made air travel the safest form of mass transport. Learn from them. You need a formal and well‑structured system of risk assessment and management, a system that discriminates between levels and kinds of risk, taking into account the likely severity of consequences, the probability of occurrence, and the difficulty of early detection. A system based on constant improvement, which becomes fundamental to the way you run your business.
From your risk assessments will flow commensurate risk management measures: with a focus on risks that are serious on all counts. Then your (few) AEs should all be little ones…reaping you reputation and performance benefit. It’s just what the regulator ordered – and it can’t hurt the approval cycle either! Enlightened self‑interest? Personally, I’m all for it. Yes, some investment will be required, but it will soon pay off in enhanced product safety and efficacy. Don’t panic; build on what you already do. For sure, this focus on outcome is great, great stuff. It’s good for the customers, it’s good for the industry, and it deserves to be embraced wholeheartedly. Still fancy that groan?