Employment, Social Policy, Health and Consumer Affairs Council (3/3): Extracts from the press conference by the Lithuanian Presidency and the European Commission

Type: News   Reference: i-084503   Duration: 00:04:20  Lieu: Brussels, Belgium - Council / Justus Lipsius
End production: 10/12/2013   First transmission: 10/12/2013
On Tuesday the 10th of December, the EPSCO Council have exchanged views on two draft regulations concerning medical devices. Ministers have also adopted conclusions on the "Reflection process on modern, responsive and sustainable health system".

Only the original language version is authentic and it prevails in the event of its differing from the translated versions.
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TIME DESCRIPTION DURATION
00:00:00 Title 00:00:05
00:00:05 Arrival of the speakers 00:00:08
00:00:13 SOUNDBITE by Vytenis Povilas Andriukaitis, Lithuanian Minister for Health and President in office of the Council (In LITHUANIAN) saying that: I would like to say that we can basically say that medical devices regulation system should be updated. We discussed a lot on this topic of medical devices and in vitro diagnostic devices and today we had very useful discussions in the Council, we had an exchange of views and I think that a lot of technically complicated dossiers have been finalized. 00:00:35
00:00:48 Cutaway of the speakers 00:00:04
00:00:52 SOUNDBITE by Neven Mimica, Member of the EC in charge of Consumer Policy (In ENGLISH) saying that: We need to proceed with a revision of the legislation because the action plan we have in place with a better market surveillance and the scrutiny of notified bodies when dealing with an assessment especially of the high risk medical devices. Even if the action plan is fully implemented we need to fill the regulatory gap by a new revision of the medical devices legislation. 00:00:28
00:01:20 Cutaway of the audience 00:00:04
00:01:24 SOUNDBITE by Neven Mimica (In ENGLISH) saying that: There are 2 major blocks still pending, it is the scrutiny or the second look into the notified bodies decisions and approvals when approving high risk medical devices to enter on the market and the second topic is the reprocessing of the single use medical devices. 00:00:28
00:01:52 Cutaway of photographers 00:00:04
00:01:56 SOUNDBITE by Neven Mimica (In ENGLISH) saying that: There is no such a perfect regulatory framework that could completely avoid or completely prevent fraud but what we would like to have out of this package is to be able all national authorities and the Commission services to be capable of identifying and discovering the fraud on time. 00:00:29
00:02:25 Cutaway of the speakers 00:00:05
00:02:30 SOUNDBITE by Tonio Borg, Member of the EC in charge of Health and Consumer Policy (In ENGLISH) saying that: The Council discussed the progress on 3 pieces of legislation, in particular 2 of them which are extremely important that is to say the revision of the tobacco directive and also the clinical trials regulation and I think a lot of progress have been achieved during the Lithuanian presidency and it is hoped that by Christmas we'll have general lines of a deal between the co-legislators which would be then adapted during the Greek presidency. 00:00:26
00:02:56 Cutaway of the audience 00:00:04
00:03:00 SOUNDBITE by Tonio Borg (In ENGLISH) saying that: On Clinical trials as well I think that the Commission is insisting that deadlines should be accompanied by tacit approval that is to say if the approval is not ready within a certain deadline then there should be consequences including tacit approval of the clinical trial itself and also the pharmacovigilance fees which need to be implemented in order to guarantee the enforcement of our pharmaceutical legislation. 00:00:32
00:03:32 General view of the audience 00:00:04
00:03:36 SOUNDBITE by Tonio Borg (In ENGLISH) saying that: I appeal to member states to transpose the cross border health directive which came into force on the 5th of October and until now, 13 states have transposed it either fully or partly. I'm not pleased by this state of affairs and certainly the commission will take action on the first month of next year if there is no improvement in the number of member states who implement this important right of EU citizens to seek medical treatment abroad and get reimbursed under certain conditions from his home state. 00:00:35
00:04:11 Speakers leaving the press room and handshake between Vytenis Povilas Andriukaitis, Lithuanian Minister for and Neven Mimica 00:00:09
00:04:20 End 00:00:00
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