Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-480"
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"en.20100921.18.2-480"2
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"Mr President, I am sure everybody in this room has taken pharmaceutical products at some time or other. The safety of those products is of paramount importance for public health.
Finally, I would like to thank the people who have helped us get where we are today, as well as my shadow rapporteurs. It is a very complex dossier and we were very lucky to have such expert colleagues amongst us. Dolores Montero, from the Spanish Council Presidency, is here with us today. She and her team did an excellent job, as did the Parliament’s secretariat, Jo Wood from the Socialist Group and my own researcher, Kiri Hanks, who made a major contribution to getting the issues clarified, on the table, and helping us.
I should also like to thank the Commission and Council secretariats, and the many organisations who sent in information and who helped us to understand the issues from their point of view – patients’ organisations, pharmacists’ groups, doctors, companies and the national regulators.
This has been a great team effort and we now have to work together to implement the legislation properly.
Last week, at a meeting of experts to talk about this new legislation, we were reminded that 2010 marks the 50th anniversary of thalidomide. Anybody my age will certainly remember what thalidomide meant: the images of children born with no limbs. Lessons were learned from that experience, and, over the years, governments developed pharmacovigilance systems to monitor the safety of medicines, because it became clear that clinical trials alone would never be enough to ensure that, when we put medicines out into the public domain, we would know all the side effects in advance.
Improvements have been made. Last week, experts told us that, with the improvements we have already made, it would have taken only a handful of cases of thalidomide to actually identify the problem. In the 1960s, it took 2 000 cases before the problem was picked up.
In recent years in Europe, we have been working at European level to develop a coherent system between Member States and the European Medicines Agency in London on pharmacovigilance. It is very clear that we need to work together. With a pool of 500 million people, it is much easier and quicker to pick up an adverse reaction than working separately at national level.
The creation of the Medicines Agency, a network of agencies in each country, underpinned by EU law, has helped us to make such progress. The practical tools we have created – like the EudraVigilance database, the biggest in the world – help us to reduce the amount of time we need to identify adverse reactions.
But we need further improvements. Since thalidomide in the 1960s, we have seen problems with drugs like Vioxx and, very recently, with the diabetes drug Avandia. I believe that the package of laws that MEPs and the Council have agreed on, negotiated at first reading, and to be put to this House tomorrow, is a very good package and one which will further improve pharmacovigilance in the European Union.
What are the key changes? First, there is the creation of the Pharmacovigilance Risk Assessment Committee, which is a beefed-up safety committee that separates medicine safety from the approval of medical products. It will include experts, not just from national governments, but also from among patients and healthcare professionals. We are improving information to patients, direct patient reporting to national authorities, and a notice on patient information leaflets encouraging people to report any adverse reactions.
There will be a black symbol on new products. At the moment, healthcare professionals know when they give you, as a patient, a new product. They know they should be looking out especially for adverse reactions but you, as a patient, do not know this.
There will be better public information: a one-stop-shop web portal on medicines, bringing together all the different information about medicine safety, the patient information leaflet – the kind of information that, at the moment, you have got to spend hours putting together. There will be gains for companies in terms of streamlining procedures, cutting out duplication in reporting and freeing up resources for more important research work. These are changes which I believe will vastly improve the whole system of pharmacovigilance in Europe."@en1
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