At its final meeting for 2006, the Management Board of the European Medicines Agency adopted the work programme and budget in preparation for a sustained level of activity in 2007.

Adoption of the 2007 work programme The EMEA work programme for next year has been structured to accommodate a number of planned developments, most notably the entry into force of new European Union legislation on paediatric medicines (expected in early 2007), which will give the Agency a significant role in stimulating the availability of safe and effective medicines for use in children. An attendant impact on the workload of the Agency is anticipated.

The second major development will be the accession to the EU of Romania and Bulgaria, on 1 January 2007, which will bring the number of countries participating in the work of the Agency up to 30 (27 EU Member States, plus Iceland, Liechtenstein and Norway).

According to the work programme forecast, the Agency will receive 85 initial marketing authorisation applications for human medicinal products, 65 of which are expected to concern new medicines, including orphan drugs (medicines for rare diseases). This figure is similar to the number of applications received in 2006 (89 applications, 65 of which concerned new medicines), indicating that the high level of activity seen this year will be maintained in 2007. Similarly, activity relating to veterinary medicinal products is forecast to remain constant next year, with 14 initial marketing authorisation applications expected, including 10 for new medicines (2006: 14 applications received, 12 of which for new medicines).

A marked increase (25%) in the number of requests for scientific advice is expected in relation to both human medicines (due in part to the entry into force of the new paediatric legislation) and veterinary medicines. Further increases, too, are expected in relation to post-authorisation activities performed by the Agency. These increases are mainly due to the natural increase over time in the number of centrally authorised products on the market. Adoption of the 2007 budget The Management Board also adopted the 2007 budget, totalling EUR154,538,00 (2006: EUR138,676,000). The maximum permitted number of staff will increase from 424 to 441. The Board approved this increase primarily to allow for additional staff in areas relating to the new paediatric legislation and to the provision of information for patients and healthcare professionals.

Further information on the work of the EMEA, can be found on the EMEA website (www.emea.europa.eu).

Press Release
Briefing Bulletin - The Funding Reality

In a survey carried out by the NCPC in August of NHS funding of specialist palliative care services in the current year as compared with the year to 31 March 2006, it is revealed that the funding gap is widening and that most services are experiencing some erosion of NHS funding that is necessary to support current levels of service, or are likely to do so as and when final agreements are concluded.

Peter Tebbit, NCPC Policy Advisor and Vicki Morrey, Trustee of NCPC and Chair of the Committee representing Independent Hospices presented the findings and their concerns to the All Party Parliamentary Group for Hospice and Palliative Care at the House of Commons this week.

Press Release

Never before has there been such a focus on End of Life Care with Government Initiatives, the Dignity in Care agenda and extensive media coverage making it the most appropriate time for the launch of NCPC’s updated Guidelines for End of Life Care.

Developed originally in 1997, these guidelines have now been updated by multidisciplinary working party led by Professor John Ellershaw. The guidelines have been designed for the use of health care professionals who are caring for dying patients in all settings including primary care, care homes as well as in hospices. The guidelines now include a section on the use of drugs in the last days of life.

The Medicines and Healthcare products Regulatory Agency (MHRA) have recently published a Public Assessent Report on dopamine agonists and pathological gambling, increased libido and hypersexuality. The report is posted in their section on safety information - safety warnings, alerts and recalls, and summarises a review by the Phamacovigilance Working Party (PhVWP) of the European Committee for Medicinal Products for Human Use (CHMP).

The European review has concluded that pathological gambling and increased libido may be class effects of dopamine agonists, which are used to treat Parkinson's disease, restless legs syndrome, and some endocrine disorders. New wording has been recommended for all dopamine agonists. 

In a letter to the EPDA, attention was drawn to key points that the MHRA wished to inform patients. Among these points, it states that 'These side affects appear to be related to the dose of dopamine agonist and happen mainly in patients treated with high doses of the mediine'. 'Patients should seek help from their doctor if they, their family, or their carer, notice that their behavious is unusual. '

The full report can be found on the MHRA website (www.mhra.gov.uk).

Press Release

On 21 September 2006, in order to celebrate the World Alzheimer's Day, Alzheimer Europe published a pan-European report: 'Who cares? The state of dementia care in Europe', which highlights serious gaps in dementia care.

The report summarises the findings of the 'Dementia Carer's Survey' and reveal that more than half of carers surveyed do not have access to services such as home care, day care, or residential/nursing home care, and when these services are available, many carers have to pay themselves.

News Release

Kyoto - October 31, 2006 - New data shows that Stalevo significantly improves quality of life in patients with Parkinson’s disease with no or minimal motor fluctuations, when compared to traditional levodopa therapy. In addition, new analysis suggests that patients treated earlier with enhanced levodopa therapy including entacapone experienced a sustained improvement in symptom control that was not achieved when treatment was delayed by 6 months. The new findings were presented today at the 10^th International Congress of Movement Disorders Society (MDS) of Parkinson’s Disease in Kyoto, Japan.

News Release

30 September, 2006 - Ljubljana, Slovenia - The European Parkinson’s Disease Association (EPDA), with the support of Medtronic Europe, have launched Rewrite Tomorrow, a website dedicated to raising awareness about advanced Parkinson’s disease (PD) and its management.

The website, which has three site sections covering PD management, Deep Brain Stimulation (DBS) and a feedback and networking resource centre, is aimed at people with PD, carers, family and friends, and healthcare professionals.

Press Release

The European Genetic Alliances’ Network EGAN today announces an important development resulting from the work of the EGAN – Roche Working Party. Roche, the Basel, Switzerland based healthcare company active in areas of unmet medical needs like cancer, HIV/AIDS, autoimmune diseases and virology, has decided to extend its already existing internet databases listing its clinical trials and to add information about Roche’s Phase I clinical trials in patients.

Press Release - EN
Press Release - FR
Press Release - DE

Between July and September 2006 EurActiv carried out a survey on “Media perception about interest groups in EU affairs”, together with EFJ (European Federation of Journalists), which is a regional organisation of IFJ (International Federation of Journalists). The aim was to investigate how journalists (mainly the Brussels press corps) choose their stories and cover the activities of interest groups, such as industry federations and NGOs.

The main recommendation for interest groups is to have faster and earlier positions on “hot” policy topics (96% of the respondents) and to have better websites (88%). Christophe Leclercq, EurActiv Publisher and Founder, commented that “journalists working in EU affairs consider online information as crucial to save time. The media landscape is adapting to the internet, other stakeholders need to adapt too”.

Press Release

On 21 September 2006, in order to celebrate the World Alzheimer's Day, Alzheimer Europe published a pan-European report: 'Who cares? The state of dementia care in Europe', which highlights serious gaps in dementia care.

The report summarises the findings of the 'Dementia Carer's Survey' and reveal that more than half of carers surveyed do not have access to services such as home care, day care, or residential/nursing home care, and when these services are available, many carers have to pay themselves.

Full review of the Cannes Symposium

Further information on the symposium will be published in the next edition of the EPDA Plus.

Press release

According to the results of a major European study published in the 31 August issue of The New England Journal of Medicine (NEJM), Activa Deep Brain Stimulation (DBS) Therapy has been shown to be significantly more effective for the treatment of Parkinson's disease than traditional medication alone.

The study reports that patients in the DBS group experienced a 25 percent average improvement in quality of life scores, and a 41 percent average improvement in motor function. These improvements were significant and substantial. This compared with no change on either measure among those patients in the non-DBS group.

Press Release

Glasgow, UK - September 4, 2006 - GlaxoSmithKline (GSK) Plc today announced new data which demonstrate that a new prolonged release, once a day, formulation of ropinirole is at least as effective as currently available ReQuip® (ropinirole immediate release formulation) which is administered three-times daily, in terms of providing effective symptom control for patients with early Parkinson’s disease (PD).

The improved pharmacokinetic profile of ropinirole prolonged release leads to a more continuous stimulation of the dopamine receptors and permits once-daily dosing.  The results were announced at the European Federation of Neurological Societies (EFNS) congress, alongside data from the ‘PD Insights’ survey which highlighted that 85 % of PD patients expressed a preference for a once-daily treatment.

Press Release

London, UK - September 4, 2006 - A selection of narratives from the Parkinson’s disease (PD) community - providing a retrospective review of the last 10 years in Parkinson’s disease, has been launched today.

Entitled ‘WHAT A DECADE CAN DELIVER: Narratives in Parkinson’s Disease’, the compendium consists of a selection of narratives from some of the UK’s leading experts in the field, including neurologists, geriatricians and PD Nurse Specialists (PDNS).

Press Release

Glasgow, Scotland, UK - September 3 2006 - New data presented today at the 10th congress of the European Federation of Neurological Societies demonstrate that 1 mg Azilect (rasagiline) once daily is highly efficacious, both as first-line adjunct treatment to levodopa in patients with moderate Parkinson’s disease (PD) with mild fluctuations, as well as in addition to concomitant therapies in patients with more advanced PD.

Press release

MINNEAPOLIS - August 30, 2006 - According to the results of a major randomized controlled multicenter study published in the Aug. 31 issue of The New England Journal of Medicine (NEJM), Activa® Deep Brain Stimulation (DBS) Therapy combined with medication is significantly more effective than medication alone in improving quality of life and motor symptoms of advanced Parkinson's disease.

Press Release

The National Council for Palliative Care (NCPC) is pleased to announce the release of their new discussion document Exploring Palliative Care for People with Dementia. The aim of this publication is to raise awareness and encourage debate around ensuring that people with dementia can access good quality care at the end of their life, a situation that, as the document highlights, is presently seldom available.

Accessible Portugal, a tourism company offering innovative and quality tourism in Portugal that is accessible to people with reduced mobility, or in wheelchairs, their families and friends, has produced an online magazine.

The magazine is aimed at people with reduced and low mobility and is free until the end of the year, covering themes such as News, Cuisine, Travel, Interviews, Music and many more.

The magazine may be downloaded every month at www.accessibleportugal.com/en/Magazine_ficheiros/RevistaHome.html or via their main website www.accessibleportugal.com and click on the magazine button on the left menu.

Alternatively contact them at info@diverge.com.pt

Around 40 per cent of the patients surveyed who admitted to having depressive symptoms said they 'only occasionally', 'rarely' or 'never' discussed them with their doctor. 

The survey's findings were presented on 13th June in Amsterdam at the 5th International Congress on Mental Dysfunction in Parkinson's disease.  500 people with a mild to moderate form of the disease and 500 specialist physicians were surveyed. 

Although doctors acknowledge patients with Parkinson's disease are likely to suffer depressive symptoms, they often find them difficult to recognise.  Doctors said they did not discuss depression because they felt their patients rated these symptoms as being less important than other aspects of the condition.  By contrast, the patients rated depression as being of equal importance to their motor symptoms.

Mary Baker, President of the European Parkinson's Disease Association, introduced the survey.  She spoke of the pressing need for a dialogue between science and society to help sufferers of the disease, with an anticipated fourfold increase in incidence by 2040. 

Tony Gillam

View Guidelines and more information

Clinical guidelines are recommendations on the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales. Clinical guidelines are based on the best available evidence. Guidelines help healthcare professionals in their work, but they do not replace their knowledge and skills.

The NICE clinical guideline on Parkinson's disease covers:

• the diagnosis of Parkinson's disease and checking the diagnosis regularly
• the way people with Parkinson's disease should receive information
• the medicines that can be used
• other ways of helping with symptoms
• how to care for people whose mental health is affected
• the care people

---

The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

Press Release

The National Council for Palliative Care (NCPC) this week publishes Neurological Conditions: From Diagnosis to Death, the first national survey to explore the interface between the specialties of palliative care, neurology and rehabilitation in the management of people with long term neurological conditions.

Press Release

Milan, Italy – June 19, 2006 – Newron Pharmaceuticals SpA, a late-stage discovery and development company focusing on novel CNS therapies, today announced the preliminary results of a six-month phase III trial with its leading drug, safinamide, in development as an adjunct treatment for Parkinson’s patients.

This double blind placebo controlled trial was conducted in Europe, South America and Asia with 270 early stage Parkinson’s disease patients being treated with safinamide as an adjunctive treatment to a stable dose of a single dopamine agonist.

Press Release

Amsterdam - 13 June 2006, 11:30 (CET) – Over 80 percent of surveyed people with Parkinson’s disease (PD) ‘often’ or ‘sometimes’ suffer from depressive symptoms as part of their condition, a pan-European  survey has revealed today. In some cases, these mood symptoms can impact patients’ quality of life as much as the traditionally known ‘motor symptoms’ of the condition, such as tremor. Despite this, there seems to be a barrier between patients and their doctors when it comes to discussing depressive symptoms during consultations.

Press Release
View Article

A report authored by a group of Parkinson’s Disease (PD) experts, published in the latest issue of Geriatric Medicine (GM), discusses the disparity that may exist between evidence based medicine and the reality of clinical practice.1 The PD experts reviewed recent clinical studies and prescribing data and the role of biological versus chronological age in treatment decisions.

EPDA's president, Mary G Baker, MBE, has accepted an invitation to become an Honorary member of the PDMDS along with Professors Yoshikuni Mizuno and Jin-Soo Khim.

"It is for me a very great honour and one I am very proud to accept".

The Parkinson’s Disease and Movement Disorder Society was formed in the year 2001 and is an all India body serving to link the various support groups for Parkinson’s disease and other movement disorders in India. The main objectives are to improve the care and treatment of patients with Parkinson’s disease and movement disorders and to disseminate knowledge and understanding of Parkinson’s disease and movement disorders amongst the medical community, public, patients and the caretakers.

Further information about the PDMDS can be found on their website: www.parkinsonssocietyindia.com

Press Release

Copenhagen, Denmark, Jerusalem, Israel - May 15, 2006 - Azilect (rasagiline 1mg) once daily monotherapy improves the quality of life (QoL) of patients suffering from early Parkinson’s disease (PD), according to new data published in Movement Disorders. Azilect is the first drug to demonstrate improvement in QoL in the treatment of this chronic progressive disease, compared to placebo.

Press Release

Copenhagen, Denmark and Jerusalem, Israel - May 15 2006 - Azilect (rasagiline 1mg) once daily does not increase the risk of adverse events in elderly people with Parkinson’s disease (PD) compared to placebo, according to new data published in Neurology. Indeed, Azilect is well tolerated by PD patients regardless of age and requires no special precautions in people over the age of 70. The analysis is one of the first to compare the adverse event profiles of anti-Parkinsonian drugs in elderly and younger patients.

Last September, the Medtronic Patient Link Workshop was organized in Switzerland to gather together patient organizations from Europe working in pain and movement disorders. The objective of this meeting was to allow the associations to establish relationships and share experiences. Medtronic Foundation are presently organizing the next Patient Link Workshop. In the meantime, to enhance and support the workshop, they have launched the European Patient Link Newsletter.

This periodic electronic newsletter is aimed at providing a platform to share best practices and projects. Contributions to the newsletter and ideas for what to include in future issues are welcomed. Through this tool, Medtronic Foundation hope to encourage patients to contact each other, exchange ideas, and develop a strong network.

Click on the links below to access the articles in this first issue.

NETWORKING

• Medtronic Foundation Patient Link Blog : a way to stay linked
• Eurordis: Addition of German as a sixth language to the E-newsletter
• International Alliance of Patients' Organizations (IAPO): Congress in Barcelona

GUIDELINES and HEALTH SYSTEMS

• Dutch CRPS (Complex Regional Pain Syndrome) Association: new guidelines for CRPS
• German Pain League: alliance with physicians against new regulations in health policies

PATIENTS: DISEASE MANAGEMENT

• European Parkinson's disease Association (EPDA): focus on younger people with parkinson's disease
• The Irish Chronic Pain Association and the Pain Association Scotland collaborated to run workshops on patient self-management methods
• The Swiss Pain Patients Association: enhance the networking between healthcare professionals and pain patients

COMMUNICATION

Ireland: successful communication initiatives

Complementary to this approach, another networking tool: the Patient Link Blog has been created to exchange ideas with their many member patient organizations in Europe, Canada and the U.S.

Results for:		TERENCE W. KAVANAGH
Runner No.:		12849
Nationality:		GBR
Club:		HAVERING 90 JOGGERS
Position (Overall):		28213
Position (Gender):		20560
Position (Age group):		386
Splits
KM10:	1:02:53		KM20:	2:12:24
HALF:	2:19:37		KM30:	3:33:07
KM40:	5:01:15		FINISH:	5:17:59
Source: http://www.london-marathon.co.uk/site/results/

Congratulations to Terry on completing the 2006 Flora London Marathon in
5 hrs : 17 mins : 59 secs.

Terry, who has had PD for the last nineteen years completed the 14th Flora London Marathonin support of the EPDA and raised a fantastic £868 for the EPDA.

The EPDA is so grateful for his continued support and energy!!!!

Despite relentless rain, Terry joined almost 34,500 participants from 50 nations lined up for the race, with about 80% of participants raising money for charity.

Aged from 18 to their 80s, the runners ran to complete the 26-mile (42km) course, starting at Blackheath and ending in the Mall.

PRESS RELEASE

Date: 7th April 2006

World Parkinson’s Day 2006 will take place on 11th April. To mark the occasion, the Parkinson’s Association of Ireland (PAI) has developed a unique Parkinson’s educational campaign entitled “More Than Meets the Eye”. This campaign has been endorsed by the Irish Pharmaceutical Union (IPU) and will consist of an information pack for patients, to be distributed to pharmacies throughout Ireland.

This information pack is designed as an educational resource about Parkinson’s. In particular, it focuses on “wearing-off” in Parkinson’s, how to recognise the symptoms and the various management options. Wearing off occurs when a patient's drug regimen begins to lose its effect, and symptoms re-emerge. Wearing off may be difficult to recognise, for both patient and doctor, and this campaign hopes to address this issue, and enable patients to achieve better control of their symptoms. It is important for people living with Parkinson’s that they should be well informed about their treatment options, both pharmacological and non pharmacological, to have a more fulfilling lifestyle.

The pack also contains information about the Parkinson’s Association of Ireland (PAI) and the support services which they provide. For example, the PAI offers access to support groups, important information about Parkinson’s and local events for families and caregivers.

The campaign will be launched on April 11th, with posters advising patients to ask their pharmacist for the pack during the month of May.

Commenting on the initiative, Una Anderson-Ryan, Chairperson of the PAI said “Hopefully upon reading through the contents of this information pack, people will know more about Parkinson's. Primarily it should help the person with Parkinson’s, or the carer, to recognize the symptoms of wearing off and seek appropriate help to manage these symptoms. By actively participating in the management of your Parkinson’s you can get whatever help you may need to assist you in living as well as possible. We also hope that they learn more about the Parkinson’s Association of Ireland, and recognise that joining the association is to their advantage in many ways. It is important to remember that you can draw a great deal of strength from seeing others survive, and survive well with Parkinson’s.”

This special pack has been funded by an unrestricted grant from Orion Pharma.

For more information about the “More Than Meets the Eye” Patient Packs,

Contact Ann Keilthy, PRO

Press Release

Cape Town, South Africa - April 3 2006 - A comprehensive guide to living with Parkinson’s disease for patients and carers, developed in close cooperation with the European Parkinson’s Disease Association (EPDA), is being launched today on the 10th World Parkinson’s Disease Day.

The Guide is available as in hardcopy by order and as a downloadable acrobat document and will shortly be available in web format.

Please contact lizzie@epda.eu.com  for further information.

Press Release

Basel, Switzerland - March 8, 2006 - Novartis announced today that Exelon® (rivastigmine tartrate) has been granted European marketing authorization by the European Commission for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease (PD) in all 25 European member states.

This makes Exelon, currently indicated for Alzheimer’s dementia, the first medication available to treat dementia in Parkinson’s patients in the European Union and the only cholinesterase inhibitor to be authorized for more than one type of dementia. Exelon has already received marketing authorization for dementia associated with PD in Switzerland and several Latin American countries, including Brazil.

An intimate study of a man with Parkinson's disease, The Bridge at Midnight Trembles has just been voted Winner for the BEST AUSTRALIAN DOCUMENTARY at the Real Life Film Festival. Melbourne. 2006.

“

I cannot tell you the emotional roller coaster that I felt while watching it. I felt so many different emotions - sadness, anger, relief, happiness and admiration ... The Bridge At Midnight Trembles was mesmerizing, moving, and inspiring ... Rasheda Ali-Walsh, author of “I'll hold your hand so you won't fall: A child's guide to Parkinson's Disease”

”

“

I was moved to the bone. This film gives you an insight into the daily life of a patient with Parkinson's Disease, which is a view you don't get as a doctor in a clinical practice. We think we know what Parkinson's is but it made me realise we don't. My initial reaction came straight from the heart - that this should actually be compulsory watching for people who are involved ... with parkisnon's Disease. I was very moved. Dr Baastian Bloem MD, PhD. Dept. of Neurology, Radboud University, Njmegan, The Netherlands

”

 

For further information about this film, please email storm@a1.com.au or visit www.storm.net.au/trembles.htm

A$3.00 from every DVD purchased will be donated to Parkinson Victoria

Press Release

WE MOVE announce the availability of its "PD Workbook: The WE MOVE Clinicians' Guide to Parkinson's Disease," a new self-study continuing medical education activity, created with general neurologists and primary care physicians in mind.

Press Release

Basel, Switzerland - January 27, 2006 - Novartis announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending that the European Commission grant a marketing authorization for Exelon® (rivastigmine tartrate) for the symptomatic treatment of mild to moderately severe dementia associated with idiopathic Parkinson's disease (PD) later this year.

The closing date for entries for the Children and Patients Art Competition: 31st March 2006, with the announcement of winners taking place on World Parkinson's Day, 3rd April 2006.

The art competition is endorsed by the European Parkinson’s Disease Association and Novartis Pharma/Orion Pharma.

First Prize: DisneyLand Paris entrance tickets for family of 4 people including travel and accommodation

Second Prize: Apple iPod and US$200 worth of professional art materials

Third Prize: Apple iPod and US$100 worth of professional art materials

How you can participate:

Due to the diverse range of applicants entering the competition, the format of the competition has been amended to ensure all entrants have the opportunity to win one of the fantastic prizes on offer. All entries will now be entered into a combined International competition, with prizes for each age category.

By participating in this art competition, you will help increase awareness and the understanding of Parkinson's disease in both your country and on an international level. Furthermore, attractive prizes await the winners of the national and international sections.

For a copy of the official rules, please click here or visit the ParkinsonPoly web site for more information.

To download a poster advertising the competition please click here.

Register at www.parkinsonpoly.com