Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-011"
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"en.20081022.2.3-011"2
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".
Mr President, ladies and gentlemen, I wish to express my sincere thanks to Mrs Grossetête for her work on this report. It has been a pleasure to work with her, and she has undoubtedly achieved two things with the compromise she has reached. Firstly, she has made a procedure simpler and less bureaucratic and, secondly, she has met the needs and requirements of small enterprises in individual Member States with purely national systems and authorisations in a flexible manner, and done them a great favour.
The report by Mrs Grossetête is also connected with patient safety, and this is another issue we are discussing today. We are speaking broadly about the safety of individuals, patient safety. Commissioner Verheugen rightly pointed out that, with the ageing of society, people’s health needs and fear of illness have grown ever larger. Fear is something that has already been growing in society for a long time, and it is up to us, where we have competence and where we are able, to keep this fear to a minimum or to tackle or resolve it as far as possible.
A great many of the measures necessary to this end are ones on which we have competence and are able to give advice. One among very many issues is undoubtedly patient information and the safety of medicinal products. Patients are entitled to be fully informed about their illness; and, if they are fully informed and able to act on a par with medical practitioners, they must be entitled to safe medicinal products and safe treatment methods.
This is not the case in the European Union at present, and we are conscious of a growing danger. I am really not one to dramatise; I may sometimes be rather emotional, but I do not dramatise. I am also the last person who would arouse fear. Yet I would caution against overlooking, or closing our eyes to, a problem that exists. The banking crisis is a good current example of what happens if we omit to solve small problems we are capable of solving, if we wait too long: we find ourselves overcome by a giant wave of almost tsunami proportions.
That is why I thank Commissioner Verheugen for his words here today, and also urge him to be true to them and combat counterfeit medicines. There are no simple solutions to this problem, and those who believe that patient safety and the safety of medicinal products are an issue only with regard to parallel trade – I glance up at the gallery, but it is probably a little too early for the representatives of parallel trade – take too narrow a view and insult my intelligence and that of my fellow Members.
What we must endeavour to do here is to protect patients. This can be done by means of various measures, for example, by checking whether the packaging of the medicinal product is intact. What would you say if you were to buy a product in your home country whose packaging was in a language you did not understand, with only a small sticker on it, and small, chopped-up blister packs inside? Would you have confidence in the product? I ended up with a pack such as this, containing an urgently needed medicine, and I can tell you that I did not have confidence in it. This is something we must prohibit, and I am sure that parallel traders – for it is they who evidently believe we wish to threaten their livelihoods, which is not the case – will have enough intelligence to find an alternative. They will come up with new packaging, or will at least stop cutting up blister packs.
As Commissioner Verheugen pointed out, there are technical solutions. The medicinal products industry is prepared for a complete traceability system, with a bar code enabling the tracing of each medicinal product. In addition, there is a pilot project. Switzerland and Belgium have demonstrated that it is possible. It is our task to give patients this security.
I should like to say a final word about ingredients, where the issue is not only with counterfeit medicines. As you know, there was a major scandal involving heparin – a blood-thinner. When people use a counterfeit medicine, they can die; it is extremely dangerous. We obtained these counterfeit preparations from China. It is also our task to ensure that no counterfeit preparations or active ingredients are produced in our third-country trading partners and that our markets are properly protected.
Two things are needed to this end: we must properly protect our borders, we need traceability systems and we must ensure safety in these countries."@en1
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