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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

 

 

My resignation letter to Labour Party members

Dear friends,

I have served as your Labour MEP for the East Midlands for almost 12 years. In that time I have also been the Leader of Labour’s MEPs and, during this last year, I have had the privilege to serve as Chair of the Labour Party NEC.

However, the best part of the job has always been working with you, Labour Party members, throughout our region.

That’s why I wanted to let you know directly about my decision to retire as an MEP in October following Labour Party Conference.

It has been an honour and a privilege to serve as your MEP in the East Midlands and thank you for the fantastic support you have given me over the years.

I have been a trade union member since age 16 and a Labour Party member for 40 years. There is no doubt that the British people desperately need a Labour Government, our public services desperately need a Labour Government, and only we can deliver a better future for the British people, particularly young people. I know we will rise to the challenge.

So while I will be stepping down from my role in the European Parliament, I look forward to continuing to campaign with you for the Labour and the values that we all share.  

Thanks again for everything.

Glenis

Labour MEP welcomes huge investment in Rolls-Royce Derby site

Dame Glenis Willmott MEP, has welcomed today’s announcement that the Derby Rolls-Royce site has been selected to develop and test the next generation of aero engines.

Labour MEP for the East Midlands, Dame Glenis Willmott MEP, said:

“This announcement is great news for the future of the Derby site. I have been working with Unite trade union reps for the past few years, calling on Rolls-Royce to make Derby the home of the new engine test bed.”

The £150m investment in new and existing civil aerospace facilities in the UK by Rolls-Royce, aims to support the planned ramp-up in production of engines. The investment, which will be made over the next few years, is part of Rolls-Royce’s ongoing industrial transformation and will also provide additional capacity.

Dame Glenis Willmott MEP added:

“This investment is great news for thousands of local workers dependent on the future of the Rolls-Royce site in Derby.  Aerospace is an area which will be greatly affected by a bad Brexit deal and we can’t afford to lose these highly-skilled quality jobs. 

 “I will continue to campaign for the best deal for Britain, which puts jobs and the economy at the heart of the ongoing Brexit negotiations.”

Disgrace that Queen’s Speech fails to guarantee EU citizens’ rights after Brexit

Labour MEPs have condemned the government for failing to put forward legislation in the Queen’s Speech today that will guarantee EU citizens’ rights after Brexit – as UK and other EU citizens petitioned the European Parliament to safeguard their rights.

Glenis Willmott, Labour MEP for the East Midlands, said:

“It is absolutely disgraceful that the government has failed to put forward legislation in the Queen’s Speech that will guarantee the rights of EU citizens after Brexit. The three million EU citizens currently resident in the UK, and the 1.2 million British citizens living in the rest of the European Union are still being used as pawns in the Brexit negotiations.

“Brexit is about more than politics, it’s about people. We have seen a high volume of petitions from British citizens who worry that an important part of their life will be taken away from them when Brexit is completed. It had been hoped the start of Brexit negotiations would provide more clarity and some concrete answers on life after Brexit, yet we are still waiting.

“Labour MEPs will continue to represent the voices of ordinary people and push the agenda in the European Parliament, so that not a single right is revoked. But the UK government must now follow suit, so that a deal that works for everyone can be secured. Theresa May says ‘no deal’ is a viable option – make no mistake, this would be disastrous, for the public, for the economy, for everyone.”

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