Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-02-15-Speech-2-567-000"
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"en.20110215.29.2-567-000"2
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"Madam President, ladies and gentlemen, we can all imagine the nightmare. Someone we know is ill and in a desperate situation. They are given medicines, but the medicines have no effect, because they have been falsified.
We are grateful to the Commission for producing this proposal. It is true that we have been discussing it for some time. We began our debates in the previous parliamentary term and I would like to thank Mr Adamou, who is no longer a Member of this Parliament, for the preliminary work that he did on behalf of Mrs Matias.
I believe that we have reached a good compromise, as Mrs Grossetête has said. Yes, we could have gone further. We are all impatient and we all want greater safety, but this is a good compromise. What have we achieved? We have made patient safety the central feature of the legislation. The safety measures that we have put in place will ensure that products are traceable throughout the entire distribution chain. Medicines can be traced from the manufacturer to the pharmacist. They will have an identifier which makes it immediately obvious if they are falsified or duplicated or if there are any irregularities, which can then be followed up. We have deliberately done this in such a way that the costs of the system remain at a reasonable level for everyone involved and that the system is not excessive. However, we are also not compromising on patient safety.
This traceability is accompanied by the fact that the packaging must be undamaged, so that a patient who is given a pack can see that it has not been opened because it has an intact seal. In addition, there will be no more packs of medicines which are divided in two, as frequently used to be the case. All of this will improve safety levels and increase patients’ confidence.
What else have we achieved? We have implemented an early warning system. This is excellent because it is the same system which has been in place for decades for foods and which we take for granted. There is an early warning system throughout the European Union for contaminated food. It is hard to believe that we have not had the same thing for medicines. If a falsified medicine is discovered, it is now possible to send out an early warning. The Member States must identify the patients who are affected, inform everyone involved and make sure that the risk involved in a medicine which is in circulation is made public. We take this for granted in the case of cars and food, but it has not been available so far for something as essential as medicines.
As far as the Internet is concerned, anyone who accesses an illegal website must be able to recognise that it is illegal. This is why we must certify legal websites which, in future, will have a link to the website of the national approval body. They will be able to display a logo which will be developed by the European Commission. Everyone who buys medicines on the Internet can do so independently. They can tell whether they are dealing with a safe, legal website or an illegal one.
All of this is a milestone, a quantum leap forward in patient safety. If we adopt this legislation tomorrow, we can be proud of what we have done and we should also make our achievements clear to the general public."@en1
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