John Brennan, Eucomed’s Director of Regulatory and Technical Affairs has written an impassioned blog on the industry body’s website challenging the bonkers view that a European PMA is a good idea. You can read it here.
We’re with John on the whole, but in true nit-picking style have a few issues with his arguments.
His fundamental point is that we don’t need a premarket approval process in Europe because the medical devices directive already requires someone to approve a product before (ie pre) it goes to market.
(He’s absolutely on the money, by the way, with his argument that the PIP scandal has derailed sensible discussion on the subject, when he points out that it was a fraud, and that regulatory processes aren’t designed (and shouldn’t be) to prevent fraudulent behaviour.)
But where our paths separate on the regulatory issue is that we believe while a form of pre-market assessment, ergo approval, exists, that form is well off the mark when it comes to really establishing whether products are up to snuff. We believe, and we’re very familiar with the sharp end of the argument, that Notified Body approval may well be a sensible gate-keeping step, but only if they are themselves adequately qualified and specialised in given fields. Let’s face it, medical device technology is an incredibly broad church and one that is not getting any simpler. Notified Bodies often have a distinctly jack-of-all-trades feel about them by definition. Even FDAs device arm doesn’t do all the assessing itself; it passes it onto its specialist panels for assessment before it then reviews the arguments per-approval. So what qualifies a Notified Body with no required medical qualification to pass judgement?
We agree wholeheartedly with some of the conclusions as reported from UK’s Parliamentary select committee last week. Notified Bodies should be better qualified, fewer in number, more tightly assessed by other member states prior to acceptance and above all obligated to share clinical data (among others) used when approving a product for market. We also happen to think that there is a place for expert panels, and indeed the suggestions put forward last week by EU Director of Consumer Affairs at the EU Commission, Jacqueline Minor, had some merit. She suggested that experts would be involved in the progress of a new approval from its very inception through to ultimate approval. Although having re-read that sentence we’re rather getting the collywobbles about what sort of clinician “expert” would end up with that job, how balanced would they be, and moreover how the heck much is it all likely to cost?
On John Brennan’s other salient point, the complexity and diversity of devices meaning they cannot be regulated like pharmaceuticals. Again we agree that a regulatory system that is fit for the purpose of keeping on top of this lot is challenging, very challenging. And because of that, it’s tempting for regulators to raise the entry level requirement in the hope that by so doing, someone in the pantheon of approvers being asked to review the file will be appropriately qualified and pick up every potential issue. But that’s just wrong though isn’t it, and not in the spirit of gaining fast market access for brilliant new technologies?
Nobody’s perfect, and surely without going to the ultimate PMA level, a pre-market process that looks a bit more beefy than the current version will provide the pragmatic and reasonably balanced barrier to entry that will keep out the products it should keep out. And the backstop should be a much more stringent post-marketing assessment process, not just to ensure we remain vigilant enough to spot future all-metal hips, but because we have to accept that a complete knowledge of a product cannot by definition be gained pre-market, so we should be prepared to learn about it post-market… good stuff and bad stuff.
Eucomed’s a great body and has pioneered some fantastic initiatives over the years, but at the end of the day it’s a representative of industry, so is always likely to be tainted with “well they would say that wouldn’t they?”
We, however, represent nobody other than being advocates for the considered and sensible adoption of medical technologies, which we keep getting told is an essential component in the pursuit of affordable future healthcare provision.
In our view, the European system may be the “envy of other jurisdictions”, but when it can take FDA five years longer to approve a life-saving technology than it takes for the nod to be given in Europe we’re, we hope, as healthily sceptical about the lowness of our bar as we are critical about the height of it in USA. Somewhere in the middle might be just right. Unless of course we take the simple step of mandating transparency of clinical data used for Class III approvals under the current regime. That measure alone would remove a chunk of our scepticism… assuming the data passed muster. And if it didn’t, why would we want that device in the market quickly, or at all.
Nick Woods, editor, medlatest