Local view for "http://purl.org/linkedpolitics/eu/plenary/2014-04-02-Speech-3-027-000"
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"en.20140402.15.3-027-000"2
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"Mr President, first of all thank you to all the shadow rapporteurs for their excellent support and cooperation. Together we have been able to negotiate a great deal for Parliament. I also want to thank the Lithuanian Presidency for the huge amount of work it did to deliver a compromise in time, and to the Commission for coming forward with a good proposal and being so helpful in our discussions.
I want to start with why I first got involved with this legislation. Three years ago I went to a childhood brain tumour centre in Nottingham. There I met children and teenagers suffering from rare cancers, including a young man called Sam White. They told me that too often no treatment existed for their conditions, they had to use drugs that had not been tested in children or, for some, a clinical trial might be their only hope of survival.
For rare diseases often there are not enough patients in one country to make a clinical trial viable, which makes working together across Europe essential. At the moment it is just too difficult and expensive. This new regulation, harmonising rules across the EU, creating a single application portal and a clear system for cooperation between Member States, would radically change that.
Sadly, Sam White passed away last September but his work goes on. He was a great inspiration and I hope that what we have managed to achieve will help to improve life for others and treatment for others in Sam’s situation, and push up survival rates for childhood cancers and rare diseases.
But we have to make sure that all trials contribute towards better medicine. Currently only half of clinical trials are published and positive results are more likely to be published than negative results. This can give a biased picture about the safety and efficacy of medicines and can lead to unnecessary or even dangerous trials being repeated. So the transparency measures this law will put in place are a huge step forward.
All trials – positive, negative or inconclusive – will need to upload a summary of results to a publicly accessible database one year after completion and, once marketing authorisation is applied for, the full clinical study reports will be uploaded. We also have a clear statement that these reports should not be seen as commercially confidential and I hope that will support the EMA in their quest to publish the data they already hold.
We should all be proud that the EU will now be leading the way globally in clinical trial transparency, which is good for patient safety, good for scientific progress and good for public trust in medicines. But we have to ensure that clinical trials take place here in Europe. They provide opportunities for new treatments, as well as supporting thousands of skilled research jobs. We know that since 2007 clinical trials carried out in the EU have dropped by 25%. I hope this regulation will reverse that trend. By facilitating cross-border trials we can cut unnecessary bureaucracy; with clear and forcible timelines we provide certainty to companies and academics; and by introducing the concept of low-intervention trials we make simple, less risky trials much less burdensome to conduct.
But at the heart of the legislation is patient protection. We have made it clear that ethics committees will always be involved in assessing clinical trials and have the power to stop them going ahead. We also have a comprehensive text on protecting vulnerable populations and ensuring that patients are fully informed before participating in a trial. Of course, we are voting on a compromise and there are areas where I would have liked to have gone further. I would have liked even more patient involvement and shorter approval times but I understand that Member States had strong views on these issues and overall I think we have reached an excellent compromise.
Once again, thank you to everyone who has helped us get to this stage and I hope the whole Parliament can give the regulation their support today."@en1
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