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       EU Policies 14/06/2012
 
European Parliament votes on major-accident hazards involving dangerous substances and on defective silicone gel breast implants
The European Parliament voted on two issues which are of importance for CEOC members:                      

  • Major-accident hazards involving dangerous substances (Report) - accepted
  • Defective silicone gel breast implants made by French company PIP (Motion for Resolution) - accepted
Major-accident hazards 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:

http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPORT+A7-2011-0339+0+DOC+PDF+V0//EN

 

Defective silicone gel breast implants made by French company PIP

 

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 post-market phases;
  • 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:

http://www.europarl.europa.eu/sides/getDoc.do?type=MOTION&reference=B7-2012-0302&language=EN

The discussion in the parliament with Commissioner John Dalli can be watched here:

http://www.europarl.europa.eu/ep-live/en/plenary/video?mode=chapter&vodId=1339612343489

Please follow the link to read the official press release:

http://www.europarl.europa.eu/news/en/pressroom/content/20120613IPR46787/html/Breast-implants-Parliament-proposes-stricter-safety-checks

 

For further information please contact   dagmar.kotova@ceoc.com or franziska.kassler@ceoc.com

 

 
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