The European Parliament voted on two issues
which are of importance for CEOC members:
hazards involving dangerous substances (Report) - accepted
silicone gel breast implants made by French company PIP (Motion for Resolution)
involving dangerous substances
The European Parliament voted on and
approved the report for the revision of the EU´s
Seveso Directive on controlling major industrial accidents involving
dangerous substances and mixtures of chemicals which applies to around 10 000
establishments in the European Union. The main goal of the revision is to maintain a high level of protection and to
implement the lessons learnt from recent industrial accidents in the EU.
The vote concerned an agreement with the Council which puts in place the
new rules to strengthen the protection against
risks, to ensure effective prevention and inspection policy, to limit
the consequences to human health and to the environment, and to improve
citizens’ access to key information about potentially dangerous sites.
The key elements of the report are:
- Scope (new general EU system for classification,
labelling and packaging of chemicals);
- Direct access to information (ensure transparency, the
rights of citizens to be informed and public participation in decision-making);
- Inspections (introducing stricter standards, more
frequency and transparency of inspections);
- Security measures (updating of safety management
system and prevention rules for dangerous substance sites).
You can find
the full report here:
Defective silicone gel breast implants made by French
The European Parliament approved a Motion
for Resolution regarding the defective silicone gel breast implants made by
French company PIP. This means that the parliament calls on the European
Commission to take action with regards to this topic. The members of the
parliament request the establishment of a
pre-market authorisation system for certain categories of medical
devices which complies with the requirements for
medicinal products; the use of mandatory
unannounced inspections; increased
traceability of implanted medical devices; increased coordination between Member States when it comes
to reporting on, and warning about, serious side effects or damage caused by
medical devices; enhanced control of notified
bodies; and additional sample testing of
products already on the market.
On the day before the vote John Dalli,
European Commissioner for Health and Consumer, was answering questions of
members of the parliament on the issue. He pointed out that in the PIP
case the problem was not with authorisation but
with market control. A pre-market authorisation system would thus not
prevent cases like this one from happening again in the future. The proposal of
the European Commission, which will be presented after the summer break, suggests
the following improvements to the current system:
- tightened market control;
- strengthened designation, monitoring and functioning
of Notified Bodies;
- strengthened role of competent authorities in pre- and
- pre-market scrutiny mechanisms for high risk devices on a case by case basis by establishing
a committee of Member State expert to
control the product assessment made by certain Notified Bodies before the
products are put on the market;
- improved traceability requirements for medical devices
(single registration system).
Commissioner Dalli said that with regards to Notified Bodies particular
attention will be paid to the obligation of unannounced
inspections, the testing of products and the rotation of auditors.
Information about the audit will be given to the national authorities should
the outcome of the audit be negative.
In Dalli’s opinion the problem is not the current system as such (i.e.
the legislation) but the fact that it is not properly implemented and enforced.
The PIP case has shown that competent national authorities have not interpreted
the legislation in the way it was meant to be (unannounced visits to
manufacturers are foreseen in the legislation and should thus also happen in
practice). This problem needs to be solved now
by the national authorities and not only when the revision of the Medical
Devices Directive is completed in two years.
You can find
the parliament’s Resolution for Motion here:
in the parliament with Commissioner John Dalli can be watched here:
the link to read the official press release:
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