Negotiations on the better regulation of Medical Devices and Medical Diagnostics (IVD) in the EU successfully concluded on Wednesday evening, according to EPP Group lead negotiators, Dr Peter Liese MEP and Mairead McGuinness MEP.
"We are delighted that a deal is finally done. Following some deeply worrying scandals, including that of defective PIP breast implants in 2011, action was needed to ensure patient safety."
“The new Regulation is good news for patients, and by tackling fraudulent producers we will strengthen reputable producers of medical devices, an important industry and employer in Europe," said MEP Liese, EPP Group health spokesperson and Rapporteur for Diagnostic Devices, after lengthy, tough negotiations between the European Parliament and Council.
“The new Regulation tackles the gaps in the outdated existing laws with a clear focus on patient safety at every stage of the process from product development, to market placement and surveillance,” added European Parliament Vice-President McGuinness, who led negotiations on the Medical Devices file for the EPP Group.
Read more: Medical Devices law strengthened - better for patients and industry
Today, the European Commission presented its proposal for a new control system for cars and thereby drew the right consequences from the emissions scandal. Internal market spokesman, Dr. Andreas Schwab, and environmental policy spokesman, Dr. Peter Liese, of the EPP-Group in the European Parliament welcomed the proposal. According to them, it is right that the European Commission takes a close look on the member states' inspection work. In addition, it is planned that Member States may check each other, which means that. That means, for example when in Paris fine dust alarm appears, the German authorities can check if German or Italian cars actually comply with the pollution limit.
"The European Commission's proposal on the re-approval of the controversial plant protection product glyphosate does no longer have any chance". This declared the health policy spokesman of the biggest political group in the European Parliament (EPP), Dr Peter Liese. The European Parliament will vote on this question next week. "There are still different opinions among the political groups. Some are in favour of an immediate ban. Our Christian democratic group declares itself in favour of a temporally limited renewal of the authorisation under strict conditions. Thus, as the proposal is also highly controversial among Member States and could not find a majority there, the Commission's initial proposal is politically dead. Besides, the responsible Commissioner for Health Andriukaitis announced that he will not act against political majorities in both institutions, the Parliament and the Council. The Christian democrats speak out against an immediate prohibition. They acknowledge that glyphosate is a problematical substance; however they do not want to run the risk that, in the case of its prohibition, glyphosate will be substituted by even more poisonous substances. "We therefore need a prudent strategy. We want to prohibit, in particular, the pre-harvest use of glyphosate on crops to determine the date of harvesting as well as its use just before the harvest aiming at making the use of harvesting machines easier. In Germany, these particular treatments have been prohibited for a couple of years already. If the pesticide is used just before harvest, the danger of residues on food is of course much higher than when using it earlier". Furthermore, the 15-year authorisation should be shortened and the Commission is asked to prohibit dangerous co-formulants as soon as possible.
The European Commission is drawing drastic consequences from the emissions scandal. After the VW scandal and recently discovered further manipulations on cars, the EU Commission will shortly propose a completely new monitoring system. This was announced by the responsible Commissioner Elżbieta Bienkowska in a letter to the spokesperson of the largest group in the European Parliament (EPP Christian Democrats) in the environmental committee Dr. Peter Liese. Among other things, it is proposed that the European authority takes a good look on the member states' inspection work. Previously this was purely a national task. In addition, member states may check each other. That means, for example if in Paris fine dust alarm appears, German authorities can check if French or Italian cars actually comply with the pollution limit. Moreover, economic relations between testing companies and the car industry shell are unbundled. It has been widely criticized in the past that dependencies of the testing companies to single car companies do exist. "I highly welcome the announcement by the Commissioner. It was shameful for the EU and its member states that we were dependent on the assistance of the United States, to detect the manipulation at VW. This has revealed the weaknesses of our system. We need to pay more attention in Europe to the implementation of existing laws. This has always been a priority of my group. 400.000 people die prematurely because of air pollution. We may not leave municipalities which have difficulties complying with European clean air policy on their own" Liese said.