On Monday I was worried. I foresaw the EU parliament’s plenary vote spelling out a bleak future for European patients. I’m not sure I was completely off the mark, many commentators sharing the view that an ill-considered rush to close the stable door in the aftermath of the PIP scandal would leave industry shackled by rules that would squeeze out its lifeblood, especially at the level of the SME sector which is so important in the delivery of new and improved ways of doing things.
So what happened?
Well, I wasn’t there, so my commentary is based on that of others (plus watching the debate online), but what appears to have transpired is a plenary vote in favour of taking the ENVI proposals to the next step. During the debate the beast has morphed into something altogether more benign. The key elements of Notified Body revolution appear to have survived, thank goodness. As have measures that demand greater transparency and traceability (again, thank goodness). But the threat of what had become known as the European PMA for higher risk devices has not. And one other big fruit left hanging appears to be the issue of reprocessing of single use devices.
Back to the PMA though, this was the proposal that had probably prompted the greatest debate in the run up to the vote. What is interesting to read in the aftermath of yesterday’s events, is European medtech industry representative Eucomed acknowledging that the vote “creates a good basis for constructive discussions and further improvements with Member States.”
What appears to have happened is that the ENVI proposal for pre-market approval of higher risk devices, that was looking so burdensome, bureaucratic, slow and expensive, has been met with a pragmatic response from politicians. Whether for reasons of common sense, patient protection or lobbying from industry is obviously not clear, although we know where the supporters stand.
Mrs Roth-Behrendt probably woke up this morning cursing self-interested parties for watering down the jewel in her crown. And what strikes me is the resort to finger-pointing and name calling in this whole evolving discussion. Somehow it’s all about big business looking after itself, lobbying like crazy and somehow always winning. The combatants on that end of the debate can’t see past the notion that everyone’s got evil intent. I’ve absolutely no doubt there’s an industry component to this. The Irish contingent, for one, are hardly likely to vote for proposals that would hurt their burgeoning medtech sector. But it’s not all about business. Not being able to see the downside of a future in which the enterprising clinician with an idea is prevented from doing anything with it because of the financial burden of red-tape, is naive. Many brilliant ideas that help patients would have been strangled at birth by too strict a regime, with little evidence that things would even have improved.
Hopefully a sensible outcome will eventuate here. What happens next, following yesterday’s plenary vote is that negotiations with Council of Member States will now begin. Possible first-reading agreements would then be put to a vote in the Public Health committee before seeking final approval by the full House.
In the meantime Eucomed is breathing a sigh of relief, and to be honest, so should all sensible folk. Of course innovation for innovation’s sake is not good, especially if it’s only designed to fill company coffers. But that’s not a reason to squash it, as seems to have been recognised was the risk. Nobody wants problems like the infamous PIPs or metal-on-metal hips or ICD leads or pelvic floor meshes. But neither do we want catgut and silk.