Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-11-22-Speech-1-152"
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"en.20101122.17.1-152"2
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"Mr President, during my hearing as Commissioner-designate, I made it clear that information to patients is a very important topic for me. Patients are highly interested in their own health and wellbeing. But today, the availability of information on medicines in Europe is very diverse: you could even say very unfair.
Several of Parliament’s amendments concern information from sources other than industry sources. In this context, let me stress that I fully agree with the political ambition to place the proposals on industry-generated information on medicines, which we are discussing today, in a broader and more comprehensive agenda on patient information. Yes, there are other very important sources which have to be exploited as fully as possible, but the proposals are not the right place to address them.
The Commission is already obliged to draft a report on the readability of the package leaflet. Therefore, any changes regarding this issue would be premature. Nor is it feasible to introduce, for each clinical study mentioned in the summary of the European Public Assessment Report, a link to the Eurydice Database on clinical trials. A general link between databases would suffice.
The public summary of the assessment report should not be annexed to the European marketing authorisation, as it is already publicly available through the EMA website. I recognise that, in addition to information provided by industry, there are already a number of European and national databases and portals providing information on medicinal products. What we lack is interlinkage between them. I propose that the future European medicinal web portal recently created by the Pharmacovigilance Directive be used as a central point to access information.
In this context, I fully recognise the need for broader information about diseases and their prevention. Patients are interested in all different treatment options, not just learning about medicines. However, this cannot be addressed through the present proposals, which focus on medicines. Nevertheless, the Commission is well placed to serve as a European information switchboard. I see our role as connecting other reliable information providers such as Member States or patient organisations. European action can add value, and many information tools such as the EU health portal are already in place.
Honourable Members, you will not be surprised that there are some amendments that the Commission, after careful reflection, cannot support. The right of citizens to lodge complaints, for example, is a fundamental EU principle. It is neither appropriate nor necessary to restate this. The level of penalties should be determined at national level and not at European legislative level. A list of the Commission’s positions on all the proposed amendments has been made available to Parliament.
Let me conclude by again thanking Parliament and Mr Fjellner and the shadow rapporteurs for your important contribution. I hope this week’s vote will help strengthen patients’ access to information and convince the Council of the need to start in-depth discussions of the proposals.
Whether patients obtain the relevant information depends on languages, IT skills and often even social class and networks. For a Europe that strives to overcome today’s health and inequalities, this is not sustainable. The key ambition of the Commission’s initial proposal therefore remains justified, and I applaud Parliament and, in particular, your rapporteur, Mr Fjellner, on taking this important proposal forward.
However, I strongly believe – as I also stressed during my hearing – that we have to address this file from a patient’s angle. We have to ask what information patients need, not what information industry may wish to provide. We have to ensure that we do not drift into direct-to-consumer advertising, which patients clearly do not want.
Again, I applaud Parliament for taking exactly this stance. This will allow the Commission to accept many of your key amendments when we present our modified proposals. This concerns, in particular, the obligation to publish information, the question of what information is covered, the information distribution channels and the control mechanisms.
Firstly, I support the amendment stating that industry must have the obligation and not just the right to make certain information on medicinal products available. This is a very important change.
Secondly, as regards what information is published, I generally agree that information should not cover comparisons between medicinal products, as this could be seen as promotional. Of course, this information is highly relevant for patients and healthcare professionals but, due to its potential abuse for promotion, it needs a strict framework. We are cooperating with Member States on such a framework in the area of health technology assessments.
I also share the view that the proposals should concern the information made available by industry and not by third parties such as journalists and scientists. However, we know that there is a grey zone which leaves room for abuse. I therefore believe that such parties should be obliged to declare whether they have received financial or other benefits from industry.
Thirdly, as regards the information channels, I partially agree with your amendments. However, not everybody uses the Internet; we must avoid corroborating inequalities by excluding those who do not use digital communication tools from access to medical information. I consider, therefore, that it should be possible for industry to draft printed material on its own initiative and not only by request. This draft information could be used on request by the public or via healthcare professionals.
Fourthly, on the control of information, I agree that information which has not already been approved during the marketing authorisation process must be pre-approved by competent authorities as a matter of principle. However, I believe that Europe should play close attention to the constitutional concerns that some Member States raise as regards the compatibility of pre-vetting with freedom of expression. It should be possible for these Member States to provide for exposed control, irrespective of whether they already have such exposed control in place."@en1
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