Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-13-Speech-3-625-000"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| lpv:document identification number |
"en.20120613.33.3-625-000"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:translated text |
"Madam President, I would like to thank all Members for their comments on this very important issue.
It was unbelievable to hear – and I am an accountant by profession, so for me it was even worse – that all audits held by the notifying bodies on companies were all pre-notified two months in advance! It is unbelievable that this could happen!
This was all due to their interpretation that this was what was required in our legal process – which is not the case. In fact, in the letter I have written to the ministers, I have told them that this is not the case, that non-notified audits are provided for in our legislation today, and they should also be making sure that this is happening with marketing controls today. We do not need to wait two years until this legislative process that we will be launching very soon is finished.
We are pushing for transparency; transparency not only in the information that is given to everybody who might be deciding on making any type of procedure, but transparency also in the vigilance aspect so that all incidents that happen within the medical devices sector have to be reported back. A database will be set up to put all this information together so that we can really take the necessary actions.
The traceability of medical devices, which we are also proposing and will be proposing, as was mentioned here again today – and I am pleased that it was because this is also a very important aspect – and especially of risky medical devices, would also be part of the proposal.
Therefore, we are keeping our word on this. We will be coming back in September with a robust proposal that will drastically improve our safety issues – and without going overboard, without overreacting to an incident and trying to find a way of transmitting the sense that we are doing something by really doing something where it is not indicated that it needs to be done.
The problem of the PIP fraud was not authorisation. It lay in market controls, and this is where we need to really put our foot down and really ensure that we introduce a robust market control procedure.
We all agree that patient health comes first and foremost in our policy deliberations. This is exactly what we are doing too when we insist that we must continue to have a flexible system that delivers innovation as fast as possible to our patients, because that is also a function of patient health.
Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.
So when I was asked by Mr Pargneaux why I would not be pushing for pre-marketing authorisation, this is why: because I do not believe we need it. We do not need to go the way of pre-market authorisation. We have a system in Europe that has worked in the past. We are enforcing this system so it works even better. We are ensuring the competence of all the bodies that are involved in the authorisation process and this is the package that we will be proposing to this Parliament and to Council just after the summer. This, Mr Tarabella, is what the outcome is, and what my position is on this issue.
We have been deliberating, we have been studying and we have been stress testing what we have done because of the PIP case, and we will be coming forward with a formal, concrete proposal in a few months time, around September.
When we talk about authorisation, what we are saying here is: let us continue to keep the flexibility that we have in Europe; let us enforce and make sure that whoever is involved in the process is competent to do so; let us make the competent authorities in the Member States more involved in what is happening in their own countries within this process, and then let us have a Europe-wide expert group that will ensure the consistency, all across Europe, of a standard level of authorisation.
The PIP case is not about authorisation. The PIP case has nothing to do with authorisation. The PIP case is a fraud which could have happened under the most robust authorisation process you could possibly have.
The PIP case is an indication of the weaknesses we have in our processes: not necessarily in the legislation itself, though the legislation will be strengthened as well, but more in the way it was being implemented in market controls after authorisation.
As some of you have said, competent authorities in Member States simply let the medical devices that were in use in their countries not be subject to any kind of controls, and this is what is wrong."@en1
|
| lpv:unclassifiedMetadata | |
| lpv:videoURI |
Named graphs describing this resource:
The resource appears as object in 2 triples