Halloween’s coming early this year, and in true scary movie style the victim is blissfully unaware of the knife-wielding werewolf that is now only inches away.
It’s behind you!
I could mix metaphors all day long, but the plain fact is that the medtech industry is showing no signs of recognising what is about to happen to it in Europe. While all eyes are, as usual, on the “American Pie”, medtech industry’s lifelong battle with the FDA and its current bid to see the sales tax repealed, there’s just about to be blood spilt in Europe that will affect the entirety of the global medical device industry.
Yet very few commentators are drawing our attention to this. Yes, Eucomed, medtech’s European industry body is waving its flag furiously with repeated press releases and blogs. And this very morning I read a nice piece from Erik Vollebregt from medicaldeviceslegal.com (find that here). But from actual device companies…. nothing. Don’t say I didn’t warn you. I’ve been banging this drum for ages.
As if we haven’t had enough deadlines recently, fiscal cliffs, budget approvals and all that, tomorrow’s the day folks. It’s medtech’s very own fiscal cliff, because tomorrow sees the European Parliament put its ENVI committee proposals to a plenary vote. And it’s looking like it’ll be a nod through for a set of proposals that will change the global medtech landscape. For the worse. Much worse.
Building new rules around avoidance of PIP scandals is a big mistake
I wrote recently that the PIP scandal was having a knock-on effect that would impact on far more than implant patients and the cosmetic surgery industry. That piece is here, and in it I argue that the only net effect of the proposed changes to the medical devices directive would be more bureaucracy, more expense and slower approval. I cannot honestly point to more than this one bad thing that has happened that couldn’t still happen under the new rules. Would PIP have been avoided? Well let’s get this straight. PIP was a deliberate piece of skullduggery that played on regulatory laxity for sure. The new rules have been drafted in such a way that the PIP-specific deception would be picked up. Notified bodies will be mandated to perform unannounced spot checks, including measuring quantities of materials that have gone into batches of devices just to make sure they haven’t been substituting the seat padding from the sofa. So yes, that specific situation may well have been avoided. But let’s be straight here. PIP was a total one-off. Unless someone can point me at another example, it seems that the entire medical device industry is being shackled with a new set of rules because of one case. Talk about one Swallow not making a Summer. And what’s worse is that the determined fraudster will still find ways to bend the rules unless the authorities set up permanent camp in every facility…Oh no, perhaps I’m giving them ideas!
Cost more, deliver less, extinguish innovation
I hinted at costs earlier, and we’ve seen one example already with the concept of the unannounced site visit and detailed audit. Additional costs that are about to be dumped on the medical device industry in order for it to play ball in Europe has been estimated in a Eucomed member survey to amount to €17.5m for the PMA (or shall we call it EMA) bit alone. I wrote about that here. That figure may be right. It may be wrong. But it’s inconceivable that all this extra bureaucracy at every level of medical device regulation will be cheap. What I said at the time was that significant additional costs would simply kill medtech innovation on a global scale. The SME, the lifeblood of new stuff, will start its life so far from the end of the tunnel that it will never see the light. And this is US as well as EU SMEs by the way. For as long as our FDA friends continue to protect their behinds with rules that shackle industry with multi-thousand patient studies and years of iteration, the EU represents the single biggest non-US market from which to derive revenue. In the past this has driven the defensive-sounding FDA device boss Jeffrey Shuren to suggest EU patients are little more than guinea pigs for high risk devices. And of course I’d concur that regulatory toughness in the US is no excuse for laxity in Europe. But the plain fact is that the EU is looked on enviously by many US physicians and patients for the access we have to the very latest technologies. While US physicians are labouring on with generation one transcatheter heart valves, we’re on version 3 which addresses the problems of its ancestor. Give me guinea pig status every day.
So are we agreed the SME developing class III devices will cease to exist? If so, maybe we can console ourselves with the knowledge that we’ll never again face all those pesky device-related problems. Except…. aside from PIP, the big four problems in recent years have been as big in the US as they have in Europe. All metal hips, externalising ICD leads, vaginally inserted pelvic floor meshes and spinal bone void fillers. In fact, on at least one of these, the metal-on-metal hip disaster, it was UK and Australian and Irish registry data that first drew it to our attention.
PIP has made them aim at the wrong target
It may not sound like it, but I’m a fan of change. I’ve lived through many many notified body audits and even in our prim and proper UK regulatory world can see how they could become tick box exercises, open to abuse in less well behaved jurisdictions. I can see the need for greater specialisation and better competent authority control over notified bodies. I am a massive fan of data transparency. The studies undertaken by companies and used to support their approvals simply must be in the public domain. Companies mustn’t be able to pick and choose the good data. And the big one, post-marketing surveillance, must be beefed up. If we’re to be “guinea pigs” we should be followed up to check progress continually. Companies would moan about any additional requirements placed on them, but at least they’d be gaining revenue and with it a bunch of data that would ensure the fittest survive.
So, a final plea
So, as Erik Vollebregt puts it, “stricter doesn’t make it better”. Dead right.
I think his closing words sum it up rather well so I’ll paste them in here…
“Everybody agrees that the system had to change, but let’s change it for the better – not for the worse. The worse is the way we are heading, and we have no one to blame but ourselves. I hope you remember that when you are traveling to Singapore to receive therapy that’s not available in the EU, or are informed by your doctor that you have contracted hepatitis or HIV from a badly reprocessed single use device.
“I can only hope, as a family member, as a future patient and as someone who knows a thing or two about EU medical devices regulation, that the Parliament’s plenary and the member states in the Council will apply some reason. For all of our sakes”.
Thanks Erik. If only we had a few more keen observers commenting on these events. Perhaps we’d have seen the knife-wielding werewolf coming sooner.
Oh, why werewolf I hear you ask? Well, werewolf or Jekyll and Hyde, pick your own metaphor, but the principle of having one face that appears to be doing good stuff while the other does bad stuff holds true. I’m sure the Eurocrats are well-intentioned, but the net effect of what they’re about to sign up to contains too much that is bad for industry, physicians and ultimately patients.