Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-385-000"
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"en.20120911.32.2-385-000"2
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"The laws we voted on today will strengthen the existing legislation in terms of patient safety, ensuring that new drugs are properly monitored for unexpected side-effects.
Pharmaceutical companies will have to disclose when they withdraw products due to safety reasons and concerns about drug safety will trigger an automatic investigation by European regulators, instead of being left to the discretion of individual national regulators. This will ensure that serious risks to patient health are picked up on and dealt with early, and that patients across the EU can expect the same level of protection.
The laws will also mean that medicines that are still being monitored for safety will have to carry a black ‘warning’ symbol on the packaging and on the information leaflet, so that patients are properly informed about the safety of their medication. In the cases of Thalidomide or the diabetes drug Mediator in France, serious side-effects were not picked up on for years, leading to unnecessary suffering for thousands. This legislation will ensure that medicines are monitored and health risks picked up on and addressed long before another such tragedy happens."@en1
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