The European Medicines Agency is committed to working with its stakeholders and in this video you can hear patient and healthcare professional representatives talk about how important it is to ensure your voice is added to the regulatory dialogue.
We are pleased to announce the release of a new video on our YouTube channel, about the Brain Awareness Week Outreach event held at the European Parliament in Strasbourg on 16th March 2017.
The title of the event: "Expanding Brain Research in Europe: A societal Need?" prompted excellent debate and discussion among the speakers and audience throughout the meeting. Key speakers included: Monica Di Luca (Vice President of EBC, and President of FENS), Marion LeBoyer (Professor of Psychiatry at the University of Paris) and Ann Little (President of The European Federation of Neurological Associations, EFNA, deputising for Joke Jaarsma.
The European Union spends just over three euro a year per patient on research into brain disorders – while levels of access to treatment in many Member States are becoming worse, not better, a medical conference organised by the European Brain Council (EBC) heard today.
The EBC unveiled a new report, “The Value of Treatment for Brain Disorders”, which highlights the need for more investment into research on neurological and mental diseases and the wide disparities between and within countries relating to treatments, detection and intervention.
More than 165 million Europeans are living with brain disorders such as epilepsy, Alzheimer`s disease, depression and multiple sclerosis; the burden on national health budgets is staggering – rising to more than 800 billion euro a year in direct and indirect costs such as lost earnings and lost tax revenues.
Commenting on the new report, EBC President Professor David Nutt said: “Up to eight out of ten people affected by brain disorders remain untreated, even though effective treatments exist in many cases. Inequality of access to treatment is a growing problem and knows no borders.”
“We must address the treatment gap. Differentiated access to healthcare should no longer exist in 21st century Europe – European citizens have a right to the treatment they need,” added Ann Little, President of the European Federation of Neurological Associations (EFNA).
EBC says the European Commission has significantly increased funding for research on brain diseases, with 5.3 billion euro ear-marked between 2007 and 2017. This sum, shared between the 165 million sufferers in Europe, works out at just 2 euro and 48 cents per person per year. In terms of the number of sufferers, this is still a small sum – less than the price of a cup of coffee,” added Little.
The report highlights the need for early intervention and detection. Timely intervention brings measurable health gains such as improved survival rates, reduced complications and disability, better quality of life and lower treatment costs.
In addition to epilepsy, Alzheimer’s disease and multiple sclerosis, the VoT report also assesses the full scale of unmet healthcare needs in Europe regarding schizophrenia, headache, stroke, Parkinson`s disease, restless legs syndrome (RSL) and normal pressure hydrocephalus (NPH). The report includes case studies based on data sets from the United Kingdom, France, Germany, Italy, Spain, Luxembourg, Czech Republic, Sweden, Switzerland and Russia.
EBC’s key recommendations:
- Invest in more basic and clinical & translational neuroscientific research
- Increase brain disease awareness, patient empowerment and training for health care providers at all levels of care
- Address prevention and timely intervention as a priority based on needs
- Address health care services delivery and support clear patient pathways
- Foster seamless care through validated models of care & tools implementation, legislation and incentives
The EARLS members met at the General Assembly in Brussels to discuss the many issues at stake. Major development was the handover of the Presidency. After six years the term of office of the sitting president – Joke Jaarsma – was finished. Daragh Bogan of the UK group has now taken over.
On October 14th 2015 the first part of a patient study in which many RLS patients in Europe participated was presented in the European Parliament. The first part of the study, analysed by Professor Matilde Leonardi from Milan, Italy, was about "Stigma and neurological illness, the patient experience".
A total of 4847 patients took part in the study from a variety of illnesses: headache/migraine, MS, ME, epilepsy, poliomyelitis, ataxia, Huntington disease, and others. Out of the total number of questionnaires, no less than 1368 (28.2%!!) were from RLS patients. Once again a clear indication that RLS patients have a story to tell.
57% of all patients felt that they had experienced stigma at one stage or another, at work, socially, and generally speaking. Four diseases were dominant in this respect: RLS, MS, ME and headache.
Having these data presented in the European Parliament, with many members of the Parliament as well as people from science and industry, present, was important for RLS awareness.
On Sunday, June 21, 2015, a Public Awareness Day was organised around the theme Diagnosing, Treating and Managing Headache and Sleep Disorders at the Neurology Lecture Hall in the Alte Nervenklinik at the Charité Campus. The meeting was a joint initiative by EAN and EFNA, the European Umbrella Patient group for neurological illness. In spite of the good weather on this Sunday afternoon, some 40 people attended the meeting.
The afternoon was moderated by Professor Wolfgang Oertel. After the opening by Professor Günther Deuschl, President of EAN, the topics headache and Restless Legs Syndrome (RLS), and how these can be diagnosed, treated and managed effectively, were presented: Prof. Uwe Reuter spoke about the various forms of headache, their causes and triggers, possible treatment, and coping tips. Professor Claudia Trenkwalder presented the case of restless legs syndrome, the symptoms, cause and treatment.
For both topics, patients had been invited to talk about how they managed their conditions, and how these disorders had greatly impacted on their home, work and social lives: Jakob Terhaag, Cluster Headache Patient and Dr Hartmut Stoye, Restless Legs Patient.
Following the peronal testimonies a lively general discussion was led by Professors David B. Vodušek and Wolfgang Oertel. The severity and high prevalence of RLS was highlighted. The Restless Legs case was emphasised by showing that in Germany out of 10,000 medical students leaving university each year, less than 20 write their thesis about RLS; that at a recent (2015) movement disorders meeting with some 5,000 delegates there was not a single main lecture addressing the topic RLS; and that among general practitioners there is very little knowledge of augmentation, the main side effect of the dopamine agonists. He made a strong plea for especially Restless Legs patients to be active in asking for attention for their disease, from their own GP’s but also from their local and European politicians.
A high level of health protection; the right to benefit from medical treatment; access to preventative healthcare; diagnostic and curative treatment regardless of financial means, gender or nationality...
These principles are enshrined in the European Union Treaty and its Charter of Fundamental Rights, and EU institutions are bound to these principles in their actions.
But how much do you know about your rights as a patient when visiting another EU member state?
What if you are travelling and need to get a prescription?
We have added a patient information document to our website, so you can better understand your patient rights as an EU citizen.
The EARL's General Assembly was held in Brussels on 23 February. Exciting plans for the coming year were discussed, details of which you will find on this page in the future.
EARLS is delighted to welcome l'Association France Ekbom (AFE) as an EARLS member. We are most confident that AFE's contribution to our work will be extremely valuable and we look forward to working together.
In the picture above: Back L-R: Sten Sevborn (Sweden), Daragh Bogan (United Kingdom), Catherine Geyer (France), Mirose Gard (France), Esperanza López (Spain), Peter Reijngoud (Holland). Front L-R: Britt Berntsen (Norway), Joke Jaarsma (Holland) Not in picture Manuela Garcia (Spain)
A black triangle will start appearing on product information this autumn to encourage reporting of suspected adverse reactions.
The European Medicines Agency has published a video and a factsheet in all official European Union (EU) languages today explaining the meaning of the black triangle, which is now starting to appear in the product information of certain authorised medicines in the EU. The black triangle has recently been introduced in the EU as part of the concept of medicines under additional monitoring and is an important deliverable of the new European pharmacovigilance legislation.
During the recent meeting of the World Association of Sleep Medicine (WASM), EARLS proudly presented the results of the study of 11,731 RLS patients from nine European countries as well as the USA and Canada. The WASM organizing committee had accepted threeEARLS presentations: 1. Diagnosis of RLS, 2. Sick leave and disability due to RLS, and 3. dosages used of RLS medicines. The posters attracted a lot of attention. Many lively discussions took place and new ideas were brought forward. The delegates were much impressed by the vast number of questionnaires analysed and the accuracy with which these had been submitted by the RLS patients. The EARLS study was considered special because the population studied were all members of patient organizations.
Thus, EARLS have once again asked for urgent attention for the problems RLS patients are facing in getting a proper diagnosis, in having to stay home from work, and of topics such as augmentation when too high doses of the dopamine agonists are given - which the study has shown occurs all too often.
For the first time, a Patient Corner was organized in conjunction with other neurology groups in the Exhibition Centre at the World Congress of Neurology. EARLS had secured a prominent place and was able to distribute information and network with the delegates from across the world. Other participants included European Headache Alliance, European Huntington’s Association, European Polio Union, International Brain Tumour Alliance, Danish Trigeminal Neuralgia Association, ADHD Europe, Pain Alliance Europe, Euro-Ataxia, European Multiple Sclerosis Platform.
EARLS used this opportunity to promote our work and increase awareness for Restless Legs among the 7,500 delegates. Many new contacts were made. On September 23rd, International RLS Awareness Day, we organized a RLS Quiz (bottom left). Nine questions on RLS were asked, ranging from the obvious to the more detailed or the latest information. Prize to be won was a bottle of real good Austrian wine. Many delegates gave this a try, but there was only one person, a young neurologist from South Africa (large image left), who knew all the answers. Second and third prizes went to neurologists from India (bottom right). Doing this proved to be an excellent way of attracting people to the booth and talking with them about the RLS situation in their respective countries. New contacts were made in many countries where EARLS are not yet present.
The long-term treatment of restless legs syndrome/Willis–Ekbom disease: evidence-based guidelines and clinical consensus best practice guidance: a report from the International Restless Legs Syndrome Study Group.
The Executive Committee of the International Restless Legs Syndrome Study Group (IRLSSG) decided two years ago to create two a task force to perform an evidence-based review of the long-term efficacy and toxicity of RLS treatments. The main reason was that long-term treatment of this disorder has specific problems that may affect efficacy and are normally not addressed in shorter studies.
In addition, the task force considered it important to come to a consensus and establish recommendations based on experienced on those issues where no specific data were available. The results of this were presented and approved at the annual IRLSSG Meeting in Boston 2012 and were shown on our web page as Summary Recommendations for the long-Term Treatment of RLS/Willis-Ekbom disease.
In the meantime, the full manuscript has been peer reviewed and published in Sleep Medicine where it can be freely downloaded at the www.irlssg.org website. The report contains important recommendations such as which treatment to start first and when, how to manage loss of efficacy and augmentation, and how to handle the main side effects of long-term treatment.