Further delays to EU Clinical Trials Portal mean UK patients may not benefit at all from new regulation before Brexit

Mr Guido Rasi,
Director
European Medicines Agency

13th July 2017

Dear Mr Guido Rasi,

I am writing to express my serious concerns about the consequences of the further delays to the development of the EU Clinical Trials Portal and Database (EUPD), as announced by the EMA earlier this month.

As you know, I worked on bringing about the new Clinical Trials Regulation which was adopted on the 16 April 2014 and was due to come into force on 28th May 2016.

The new rules which myself and many of my colleagues worked hard to put in place will bring numerous tangible benefits to patients across the EU. Most notably, the regulation will streamline and simplify the process for approving cross border trials by introducing one single application form with a single set of EU rules. This will facilitate the development of new trials, particularly for non-commercial sponsors such as the National Health Service, Cancer Research and public universities. This new regulation will provide a lifeline to the thousands of European citizens who have been diagnosed with rare diseases, such as childhood cancer, and are relying on clinical trials as their only hope of survival. The new database will also ensure transparency for the results of all clinical trials, whether positive, negative or inconclusive.  This is a vital step forward for patient safety and good science.

However, all of the important benefits of this new regulation depend on the successful implementation of the EUPD, as the Regulation cannot come into force until the portal and database are operational. The original timeline for the development of the EUPD, endorsed by the EMA Management Board, established that the database would be up and running by 2016.

Yet in 2016, the implementation of the EUPD incurred a significant delay as the EMA announced a transition to a new IT framework contract. As a result, to our frustration, its implementation was pushed back until the end of 2017. We now learn, following your recent announcement, that the timeline for the execution of the EUPD has encountered a further setback due to additional shortcomings from the EMA’s IT service provider. Whilst you have informed me that the root problems have been identified and measures are being taken to address the issue, this further delay to the timetable is hugely disappointing to all of those involved in bringing about this important piece of legislation.

Not only does this mean that all the important benefits of the CTR will be delayed, I am particularly concerned that the CTR may now not come into force until after the UK has officially withdrawn from the EU. 

In light of the serious ramifications of this setback, I would like to ask if there is anything that can be done to speed up the process.

I look forward to hearing back from you.

Dame Glenis Willmott MEP

 

 

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