The European Commission has issued a press release detailing the adoption of certain measures which it says will help in the avoidance of events like the recent PIP scandal. The focus of the measures lies firmly in the appointment and control over the activities of Notified Bodies, the entities with ultimate front-line responsibility for enactment of much of the regulatory rules concerning medical devices.
What really smacks one in the face when reading the commission’s press release is the fact that it singles out the PIP scandal for attention, rather than simply saying the rules need to be beefed up and here’s how. As we’ve said on numerous occasions, together with other commentators, the plain fact is that employing Notified Bodies to implement the rules, while not being a fundamentally flawed concept, is close to it. Yes, PIP brought that to all our attentions, but the truth is that PIP, while it may have been avoidable if these new rules had been in place, might well have been replaced by another piece of mischief. It’s like that game where the rodent keeps popping up and you have to hit it on the head. You might get it this time, but the pesky critter will reappear in another place any time soon.
But in any event let’s have a look at the Notified Body measures that are now concreted into statute.
- First the bit that hopes to stop variable quality and variable enforcement…. you know, the bit that currently allows companies to find the softest Notified Body. Well, now a “Member State shall only designate a Notified Body after a ‘joint assessment’ conducted with experts from the Commission and other Member States. The assessment reports shall be made available to all other Member States.”
- Now the bit that makes sure Notified Bodies stay on track: “Member States are required to carry out surveillance and monitoring of the Notified Bodies at certain intervals to ensure that they continuously live up to the requirements. If this is not the case, the Member State must withdraw the designation as notified body.”
- Not forgetting the bit that ensures Notified Body staff are not muppets: “Knowledge and experience requirements of the staff of the Notified Bodies to be required by Member States are clarified.”
- And finally the bit that might have stopped Monsieur Mas and his band of merry men from doing whatever they thought fit: “It is now required that Notified Bodies shall randomly perform unannounced factory audits and, in this context, check adequate samples from the production. Failure to carry out random checks will result in the suspension or the withdrawal of the designation of the notified body.”
- And the final belt and braces: “Where risks might be caused by the substitution or adulteration of raw-materials, such as in the PIP-case, a Notified Body shall also check that the quantity of finished products corresponds to the quantity of the crucial raw material purchased.”
That’s all fair enough, but is so focused on one specific crime that one really wonders whether it might be a missed opportunity to pick up on a few non-PIP issues.
“PMA in Disguise”
Speaking of non-PIP issues, medtech industry body Eucomed is sounding pretty livid in its instant retort to the news that the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI) is also looking like adopting a form of “pre-marketing authorisation system that is bureaucratic, combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised approval”.
Part of the objection comes from the approval process now involving the replacement of a proposed 28 person “expert committee” with an “almost Kafkaesque” body of over 600 medical experts chosen from across Europe across 21 sub-committees.
If you want to share the despair, enjoy the Eucomed release here. It’s a brilliant unpicking of what Eucomed says is a new rule book that is unduly rushed in order to “satisfy the time pressure that Parliament feels ahead of the European elections.”
Here are a few priceless snippets:
“The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe’s 25,000 small and medium-sized device makers”.
“For several political groups, the outcome also represents a drastic shift away from their pro-innovation, pro-competitiveness platforms on which they are campaigning for re-election in 2014”.
Read it for yourself, please. Enjoy words and phrases such as “PMA in disguise”, “bureaucratic behemoth”, “FDA-like system would kill patients and kill innovative companies”, “cobbled together” and “another seemingly blind spot to reality and the needs of patients”.
Eucomed’s really not happy and its strident defence of medtech companies and patients alike leaves its boss, Sergio Bernasconi pleadingly to state; “The political groups in the parliament still have time to assess the impact of the system on patients, innovation and resource implications and fix this rushed deal into a right deal when the vote enters the plenary session in October.”
At medlatest we’re all fans of appropriate regulatory control. We discuss regulatory issues all the time and have followed the passage of a new set of rules with great interest over what has been a significant period of time. It’s a shame, but we have to agree with Eucomed’s assessment that a lot of good work has been seemingly chucked out at the last minute in the interest of ticking a host of politicians boxes. We did warn of Eurocrats getting in the way and it looks awfully like we’re ending up with that hurriedly designed camel coming out of what was intended to be a thoroughbred horse.
Source: Eucomed, Europa Press release database.