Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-026"
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"en.20081022.2.3-026"2
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"The proposed directive, which will greatly simplify the introduction of pharmaceutical products onto the European market for both human and veterinary use, is very good news for patients and also for the European pharmaceutical industry. Technological progress makes possible the almost continuous improvement of drugs that have been registered already. Every change, however, must go through an approval process, as health and safety is involved. While registration at a purely intra-state level is subject to the same regulatory requirements as registration within the framework of European processes, the regulatory requirements for changes to registration have not, however, been unified. This situation represents an unnecessary administrative burden and brings no added value. Just one declaration will now be enough for the entire internal market.
I therefore warmly welcome the Commission’s proposal and I congratulate the rapporteur for her report, which has improved the proposal and made it more precise. By means of the proposed changes, the administrative burden connected with the process for introducing new products of this kind onto the market will be lightened. Pharmaceutical companies operating at a supra-national level will be better able to cooperate and the result will be faster access to the latest drugs for everyone, especially those most in need.
Europe is, however, facing a very dangerous development in the spread of counterfeit drugs. This is no longer a problem just for Africa or Asia. In Europe, too, people are often purchasing drugs over the internet or from places other than pharmacies. That is why it is so important to ensure high standards for the introduction of drugs onto the market, which will simultaneously make it possible to trace packages back to the producer and to check whether they have actually been registered. It will be necessary for all drugs to be bar-coded and packaged in such a way that even the man in the street will see from the packaging whether they are safe drugs or counterfeits, in case the drugs have been purchased from somewhere other than a pharmacy. In my view, Member States have enough time in these two years to prepare for the introduction of the directive."@en1
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