The moment is NOW! And medicinal product trials requirements feedback in medical devices clinical requirements

European ParliamentYet another post! Apologies, I am very productive these days. A lot is happening and I am just trying to keep track because the moment is NOW if we don’t want to get stuck with medical devices regulation in the EU that will not achieve its objectives, hurt innovation and last but not least, make it more difficult to have innovative devices on the market for the benefit of the patient.

Really, if the proposal of Mrs Roth-Behrendt makes it through, you can expect manufacturers to gravitate to the bottom and concentrate their efforts on me-too devices that require little innovation and have a low regulatory risk profile. That will be a development to look forward to. Only the big ones with deep pockets will be able to make innovative products. But why should they if we’re not willing to shell out all the extra costs for the regulatory process? Sounds much like the problems plaguing the pharma approval system that we would like to solve, right? If we know how to do better, then why don’t we.

Where does this rant come from, you ask? Yesterday I had the pleasure of speaking at the Informa conference on Clinical Evaluations and Investigations for Medical Devices and I took the temperature of the mood about the revision of medical devices law among some of the most innovative devices companies in the world. The mood was glum. Companies are in shock. They don’t know what to do with all this zigzagging on the regulation. Companies are now starting to postpone investments because they have no clue what the EU will pull out of its hat next to move the goalposts in regulatory requirements. They’re frustrated, but they can deal with that. The worst is they have no idea where this process is going and therefore cannot plan ahead. And that has consequences for innovations that are currently in the pipeline. I’m not making this up. At this moment almost any other market has a more reliable regulatory outlook than the EU. High five! And who is the biggest loser in this debate? You, me, everybody – because we all end up in the hospital sooner or later and would like the best medical technology to be available then. Companies can go do something else, but patients have no alternatives as Eucomed underlined in their Don’t lose the 3 campaign. We’re in this together.

In the mean time the Irish Presidency was beavering away in the same city on getting the medical devices regulation in shape which (I picked up ) they may not manage because the member states are dragging their tails. The member states are too busy with other things to seriously look at the devices regulations that create so much turmoil in industry and in the European Parliament. This would explain the stealthy behaviour of member states with respect to the outcome of the Dalli Action Plan, which they were supposed to present in the Irish presidency end of January 2013. I get the feeling member states lack sense of urgency to improve things in market surveillance, while the new regulations trickle through the system. If the member states start to look at the draft regulations seriously only in Spring 2014, there is a pretty realistic chance that the regulations are not finished before the European Parliament elections in early summer 2014. That will set the process back considerably, possibly years. Very responsible way to deal with public health issues – if there are any in the first place, because the existing rules are capable of solving all the problems if the member states step up on market surveillance and control of notified bodies as I have argued often on this blog.

At the conference I spoke about the ongoing changes to EU medical devices regulation and the thinking of the European Commission and Parliament to align the clinical requirements more with medicinal products clinical trial requirements, just another interesting gem in the proposed regulation. As you can see in my presentation (below) this conceptually interesting idea is not entirely consistent in its execution and as thought out as it could be. For example, why use different definitions between pharma and devices of ‘sponsor’ with “liability” as delta? “Pah, liability in trials – small detail” you might say. Yeah, just tell your management that and see what happens.

Oh, and it could result in your clinical trial data becoming public if the authorities take ‘alignment’ seriously and the friends in pharma don’t succeed in putting this djinny back in the bottle after the European Parliament’s rapporteur proposed to amend the clinical trials regulation proposal to that effect.

[slideshare id=19895017&style=border:1px solid #CCC;border-width:1px 1px 0;margin-bottom:5px&sc=no]

There’s a lot of detail to this presentation that I don’t have time to write out here, but if you’re interested, I’m happy to explain.

The audience agreed with me that this regime is nothing to look forward to. Parliament people, please please please think things through and ask someone on the outside for a fresh perspective before writing down things that only complicate and confuse matters. Protection of patients is not the same thing as creating legal uncertainty and then crying victory for stricter requirements. And member states, how about some involvement here?!

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