Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-008"
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"en.20081022.2.3-008"2
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Mr President, honourable Members, today’s debate takes place in the context of a development in the health sector that changes a great deal.
Parliament then continued: ‘measures to tackle counterfeiting need to be taken in the area of criminal enforcement […] and drug regulation by strengthening the regulatory capacity of the national authorities and not by increasing levels of intellectual property protection’. In its work on its proposal on the fight against counterfeit medicines, the Commission has been guided precisely by the deliberations presented by you, honourable Members.
Over the next few weeks, the Commission will present legislation to strengthen the existing legal framework. This is intended to ensure, with a probability verging on certainty, that is, where humanly possible, that no more counterfeit medicines can be smuggled into the legal supply and distribution chain. As you know, the Commission has not yet dealt with the proposal. I have not even presented it to the Commission as yet, as a large number of very difficult issues has still to be clarified, and I should also like to include the outcome of today’s debate in my final decision on the proposal. What I can describe to you already, however, are the most important elements, the foundations.
As has already been mentioned, the distribution chain must be strengthened in the first instance. Therefore, we must ensure that it is possible to verify the authenticity of every single pack at all times on its way from the manufacturer to the consumer – that is, the patient. This requires the origin of the pack and of the medicine to be traceable at all times throughout their journey from the manufacturer to the patient. You can guess what that means. It is a very ambitious demand that will make tough technical demands on all links in the distribution chain, from the manufacturer to the chemist’s shop, and will require large-scale investment. I am happy to say, however, that all parties concerned consider it right and necessary, and that the technical solutions concerning the traceability of medicines do exist.
Secondly, the rules for products passing through the hands of importers must be absolutely clear, and all parties concerned must be subject to stricter supervision. In this regard, it must be made quite clear that, naturally, the risk at our borders may be even greater than the risk within the European Union; i.e., that there is the risk of counterfeit medicines being brought into the EU from outside. This is a problem best combated directly at the external borders. The proposal will also therefore contain the relevant improvements.
Finally, a further important point consists in ensuring that the active ingredients, that is, the most important components of the medicine, be produced according to legislation with safety standards corresponding to those within the EU. Honourable Members, why should that be a problem? Incidentally, I was surprised when I saw this: it is a fact that the active ingredients, the most important components of the medicine, very often, indeed even usually, originate from non-European countries, third countries. In this regard, we must ensure that the active ingredients, wherever they may be produced, are manufactured to the same standards as our own. This, in turn, will be a very ambitious, difficult task.
However, I believe that, in our globalised world, Europe needs a dynamic, competitive pharmaceutical industry in order to take advantage of the opportunities presented by globalisation. Yet we must also take up the associated public-health challenges.
The forthcoming Commission proposal will be moderate, sound and balanced, but also determined and clear wherever determination is called for. Our society is entitled to the most effective protection possible against counterfeit medicines. When, very shortly, in just a few weeks’ time, we are in a position to discuss the Commission proposal, I would ask that you judge it precisely on the basis of the following principle: are we doing our best here to protect Europeans effectively against counterfeit products?
The development concerned is the ever increasing number of senior citizens in our societies, whose supreme concern will be the issue of health. This must be understood. The more senior citizens in society – and this group will keep on growing – the more important the issue of health, of how to deal with care for these people and with therapies and medicinal products; and, incidentally, the more important the issue of how to ensure that these people obtain the information they need in order to not only stay abreast of their state of health but also to do what is necessary to remain in good health. Such is the background to today’s debate.
The issue we are dealing with directly today is the Variations Regulation. I am very pleased that a compromise has been reached on this. The Regulation governs any variations required – be it on public-health or economic grounds – after a medicinal product has already been authorised. We cannot just stand by and watch as variations – of any kind – are made to a medicinal product after its authorisation. It goes without saying that regulation and scrutiny are required. Your decision today, honourable Members, will contribute significantly to ensuring that medicinal products continue to be safe and effective in future.
The existing legislation has brought a number of problems, which we have analysed. For example, the current legislation entails considerable financial and administrative burdens on all parties concerned. This can result in certain variations not being implemented – and we have examples of this – even though, in themselves, they are necessary in the interests of patients.
For example, there have been cases where medicinal products have required further development at a certain point but this has not happened because the costs associated with putting variations through the authorisation procedure are too high. For this reason, it is very important that the proposal to be adopted here today improves the existing legislation in terms of simplicity, precision and flexibility. This will also mean that this solution is in keeping with our better law-making agenda.
I should like to express my sincere thanks to Mrs Grossetête and all those who have contributed to her report for their work on this difficult dossier. I should also like to thank the House for the massive support the European Parliament has already given me on many occasions with regard to the fight against counterfeit medicines. I understand Mrs Grossetête’s impatience to see this proposal adopted, which I share, but in this case, too, of course, quality is more important than speed. In a moment I shall be saying a few things about the timetable. The pressure Parliament is exerting in the matter of the fight against counterfeit medicines is helpful and important. Please do not think that this bothers me; quite the reverse, I feel strengthened by it.
How do things stand? We are currently having to contend with an alarming increase in counterfeit medicines discovered in the European Union itself. Previously, we had always assumed that Europe was a transit area for illegal products destined for third countries. I remember that when we discussed the matter here for the first time that I took the view that this was not, in fact, a problem for Europe, but one for Africa and other less developed parts of the world in particular.
This situation has changed: it has now become a problem for us, too. The European market itself is increasingly becoming a destination for counterfeit medicines. This represents a very serious threat to public health. It can cost many lives, and so the Commission is determined to act.
Parliament’s very important resolution of 12 July 2007 contained a very significant statement on which I, too, base my deliberations, namely ‘that counterfeiting of medicines is not a patent issue as such’. This is a very important point to note. Under discussion here are not intellectual property rights, nor patent rights, but criminal offences. Counterfeiting of medicines constitutes criminal wrongdoing whether or not the medicine concerned is still under patent; that aspect is completely irrelevant in this regard. Counterfeiting is counterfeiting and, in the case of medicines, should always be classed as criminal behaviour."@en1
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