- Mandatory patient involvement
· Partial harmonisation of the requirements for informed consent and information to patients, including reference to “core quality criteria” and recommending review by patient representatives
· Core elements of information and best practice for informed consent to be defined at European level in a collaborative process involving patient organisations
· Voluntary cooperation for ethics committees to improve coordination and reduce fragmentation, facilitated by the European Commission
· National indemnification mechanism to reduce the cost burden of obtaining private insurance – particularly important for non-commercial trials
· More transparency on the results of clinical trials and of the assessment process, including a lay person summary the presentation and content of which would be defined at European level.
How can you help the EPF?
1. We recommend that you contact your national Ministry of Health and ideally ask for a meeting in the next days to discuss the clinical trials proposal.
2. If you are not able to do this, we ask you to send a letter letting your minister know that the patient community wants to see certain key provisions in the legislation. A sample letteris attached with this briefing, you can insert your own logo next to EPF logo. A list of EU ministries of health can be found on the all trials website here. Please verify that the information pertaining to your country is correct as we are not able to check this.
EFCCA is pleased to inform you that Crohn’s and Colitis UK is organising an impressive awareness campaign taking in place in May, part of the WORLD IBD DAY set of events all over the world!
The UK's theme this year is IBD Sports and Fitness, using the public interest in the London Olympics to highlight how IBD affects fitness and participation in Sport. Through a special website Crohn's and Colitis UK conducted a survey of nearly 1,000 members which found that about one third do not take part in any exercise or sporting activities and a quarter said their fitness was low. 80% had had to give up a sport at some time either temporarily or permanently.
As part of the UK media campaign five sporting champions who have IBD have spoken about their life with Crohn’s or Colitis. You can see their stories on the campaign website at www.ibdsportsandfitness.co.uk.
We are delighted to announce that EFCCA moved into a brand new, independent and bigger office!
It is located in Rue des Chartreux 33-35 in Brussels, very close to the “old” one.
FEEDBACK FROM THE WORLD IBD DAY
Brussels, 19 May 2011
The sky is cloudy but weather forecasts are not very bad… fingers crossed.
9.45 AM – Marco Greco, Isabella Haaf and myself enter the Berlaymont building a little bit excited.
At 10.00 AM - Mrs Darmanin the head of the Cabinet of the Commissioner on Health and Consumers’ protection, Mr Dalli, is waiting for us.
It is the first time that EFCCA has the chance of presenting its mission and goals. More than one hour meeting: a very productive one, the agreement of seeking for stronger collaboration and the promise of visiting us in autumn.
EFCCA IS GLAD TO ANNOUNCE THAT THE WORLD IBD DAY WILL BE CELEBRATED IN BRUSSELS ON THE 19TH OF MAY ! IT’’S THE FIRST TIME WE ALL HAVE THE CHANCE TO RAISE AWARENESS AND GIVE PEOPLE WITH IBD A LOUDER VOICE IN EUROPE!