European initiative on Alzheimer's disease and other dementias - Asthma inhalers (debate)
President
The next item is what I must say is a strange joint debate on the following:
the report by Mrs Matias, on behalf of the Committee on the Environment, Public Health and Food Safety, on a European initiative on Alzheimer's disease and other dementias, and
the oral question by Mrs Mazzoni, on behalf of the Committee on Petitions, on asthma inhalers - B7-0666/2010).
Marisa Matias
Mr President, I should like to start by giving what seems to me a clear example of the urgency of this initiative. We began work in Parliament exactly six months ago: six months have passed between starting work on the report and the time of voting, during which more than 700 000 people have developed Alzheimer's or some other form of dementia. This figure on its own shows how important and urgent it is to take action in this area. That is why the Commission Communication is timely.
All people suffering from Alzheimer's and other dementias in Europe must be treated the same. There are more than 7 million people with Alzheimer's and almost 10 million suffering from dementias as a whole.
If we were talking about numbers, we would be talking about the scale of a medium-sized country. We cannot discriminate against a disease in the same way that we cannot discriminate against a country. We must treat them all equally. It is for this very reason that it is urgently necessary to take action in several areas. In the area of research, we know that the number of people suffering this disease doubles every 20 years.
We know that if the age range considered is over 65, the number doubles every four years, which is exactly why we need to tackle the causes and discover the causes, because we have no other way to take action against a problem if we do not have a good knowledge of it. To achieve this, we need more research, more cooperation and more epidemiological data.
We need to know more about how to take action in terms of prevention and of controlling risk factors. We need early diagnosis, we need specialised care and we need to train carers. We need to give support to families and to not stigmatise sufferers: we need to give them rights and to give them dignity. We need all countries to have national action plans so that we can then cooperate at European level. We need to combat inequalities between the Member States and within the Member States. We cannot accept that there should be first- and second-class patients: they must all be equal, regardless of sex, age, place of residence or any other criterion.
That is why, Mr President, it is very, very important for our health services to have the maximum coverage possible. We cannot avoid talking about these urgent needs just because we are in crisis and are always talking about the disease's costs. The social and economic costs of failing to treat this problem are far larger, far greater than those of facing up to it. That is why we have to face up to this problem and invest: invest in people; invest, as I said, in preventing and giving support to the families and carers who are so often forgotten.
We know that, for every person suffering from Alzheimer's, three people are needed to care for them. A person suffering from Alzheimer's cannot go one hour unaccompanied. This must serve as a lesson to us: we cannot continue without the Member States linking up in their response to this problem; without cooperation and, moreover, cooperation on the basis of solidarity.
That is why I would like to say the following: on the subject of cooperation, we all know that none of this work can be done in isolation and here in Parliament, too, it has been undertaken in cooperation with all the shadow rapporteurs from all the parliamentary groups; with the support of the three women who helped me in the Committee on the Environment, Public Health and Food Safety, in my parliamentary group, and in my delegation.
That is why I should like to thank all these women, and perhaps it is no accident that it was only women who worked on this report: this is because women are the most affected, dealing both with reports about Alzheimer's and with sufferers of Alzheimer's, including men. I therefore also want to draw attention to the types of discrimination obscured by the lack of treatment or response to these issues.
I will finish by saying that I should like to question Commissioner Dalli directly, so as to ask him which of the proposals included in this report the Commission is prepared to accept, and when it will be prepared to accept and take action against an emergency of the scale that we are currently experiencing.
Erminia Mazzoni
Mr President, ladies and gentlemen, I have to say that I, too, am puzzled about why this question has been combined with the previous report, but the important thing, to my mind, is that this House is today focusing on the issue contained in the question I tabled on behalf of the Committee on Petitions.
This question refers to a case in which a small European business has been denied justice because of the inertia that the Commission has unfortunately demonstrated from 1997 until now. This finding is supported by the Committee on Legal Affairs, which has been asked to issue an opinion by the committee which I chair.
The issue concerns a medical device - specifically an asthma inhaler - which was patented in 1990 and lawfully placed on the market. This product is regulated by Directive 93/42/EEC, which stipulates that manufacturers must certify that they have complied with requirements and which empowers the national authorities to verify that this self-certification is valid, through monitoring and sample checks.
The product, which was successfully distributed on the market for six years - thus, until 1996 - and for which not a single specific complaint or comment was recorded in over 15 years, was submitted for an inspection by the government of Upper Bavaria, which asked the commission of Magdeburg to review the authorisation granted to the company.
In December of that year, the commission and the Minister for Health in Saxony-Anhalt carried out this inspection and concluded the procedure by stating that the product fully complied with the legislative requirements in force. At the end of the procedure, they also questioned the legitimacy of the request made by the government of Upper Bavaria and invited it to initiate the safeguard clause procedure pursuant to the aforesaid directive if it continued to have doubts.
The following year, there was a series of undocumented activities about which we were only indirectly informed, and then, suddenly, in 1997, without any communication with the manufacturer, the Federal Minister for Health ordered the product to be withdrawn from the market.
The Ministry initiated the procedure - the procedure pursuant to Article 8 of the aforesaid directive - at the end of 1997, but it drew a blank, because no information was provided and the process of consulting the manufacturer was not initiated. Amid the general silence, in mid-2003, the manufacturer, thinking that this silence meant that the German authorities' unexplained comments had clearly been refuted, placed the product back on the market.
Unfortunately, in 2005 - and again without any communication - the German authorities ordered the product to be withdrawn from the market once more. To be clear, despite repeated requests, there has been no explanation to this day for why the product was withdrawn.
Hence, there has been no communication, no investigation and no opportunity for the manufacturer to legitimately challenge the other party's findings. This has had a serious economic impact on the manufacturer, because he has been waiting for a response for more than 15 years and cannot place his product on the market.
I would also add that, during the six years in which the product was distributed - and there are documents on this, including ones provided by the Commission - it was found that significant savings were made in public health expenditure due to the low cost of the product, and that the product had a positive impact on asthma sufferers.
In 2008, having seen all his attempts to get somewhere with the other authorities fail, Mr Klein, the manufacturer, turned to the Committee on Petitions. The committee is initiating the procedure during this legislative term. Moreover, in view of the length of time the matter referred to in the petition has been going on, it is also launching an informal consultation process with the Commissioner to request that a response be provided within a shorter timeframe, because the petitioner is requesting confirmation that his product complies with European legislation or, failing that, at least to have a ruling that he can challenge before the Court and which will therefore allow him to have justice.
None of this has happened, and during the debate within the Committee on Petitions, the European Commission unfortunately avoided answering our questions once again. Hence, the committee has taken the unanimous decision to come to Parliament and ask the Commission to provide clear answers in this House, because this affair undeniably raises serious doubts with regard to a violation of the Charter of Fundamental Rights. This is not only because of the Commission's inertia; it is also and, above all, because of the petitioner Mr Klein's inability to take legal action.
The affair raises obvious doubts with regard to the violation of market rules and the protection afforded to small businesses, which is why we are insisting that answers be provided, here, to the points raised in our question.
President
Mrs Mazzoni, I would like to thank you, above all, for having shared my confusion as to how the two subjects overlapped. This does not, of course, imply any contempt on my part for an important question, which, moreover, you are putting in your capacity as Chair of the Committee on Petitions, of which I am part, and I am therefore extremely interested in what it does.
It will be very difficult for both the Commissioner and the speakers to combine two subjects that are so different in nature, and it is therefore worth questioning whether it is reasonable to plan the debate as it has been planned on the agenda.
John Dalli
Member of the Commission. - Mr President, honourable Members, first allow me to pay tribute to Parliament, in particular, to the rapporteur, Mrs Matias, for your commitment to addressing Alzheimer's and other dementias.
The Commission fully shares your concern. Dementia means great suffering for millions of Europeans and their families. With a population ageing fast, now is the time for Europe to act.
This is why the Commission put forward a Communication on Alzheimer's and other dementias in 2009 with action to improve prevention and diagnosis, research and best practice exchange.
I am delighted that Parliament is supporting ongoing work in this context and presenting a comprehensive set of recommendations. This report and its recommendations are very timely at a moment when the Commission is about to launch a joint action with the Member States on Alzheimer's in April, the so-called ALCOVE (ALzheimer COoperative Valuation in Europe).
I am persuaded that this joint action will deliver on many of the recommendations that you are adopting here today.
The joint action will focus on prevention - an area which Parliament underlines in this report - and also on improving knowledge and data and sharing good practices. It will also address another area where Parliament is calling for action: the rights of people living with dementia. I agree with you that we need fully coordinated research to understand better how to prevent or delay the onset of dementia. This is why the Commission has launched a joint programming initiative on combating neurodegenerative diseases, in particular, Alzheimer's.
For the first time, 23 countries are working together to tackle Alzheimer's. There are good practices across Europe on diagnosis and treatment for Alzheimer's and the Commission is fostering exchange of knowledge and good practice.
As recommended by Parliament, I can also confirm that the Innovation Union initiative under the Europe 2020 strategy will take as its first pilot area for the new European innovation partnership the topic of active and healthy ageing.
Action to support people suffering from dementia could be developed in this context. A good example could be the ongoing Parliament initiative on carers. We hope to be able to support further innovative actions in this area which may also address the issues of Alzheimer's and other dementias.
Finally, the Commission looks favourably at a number of other recommendations, including declaring 2014 as European Year of the Brain. Let me assure you that the Commission is committed to doing its share to address dementia.
Let me now address the second topic in this debate: the petition filed by Mr Klein, the inventor and producer of the inhaler 'Effecto'.
The placing on the market of the device in question was originally refused in Germany in 1997. This decision was not pursued further, either by the Commission, the German authorities, or the manufacturer. The then distributor indicated at the time that it would conduct further studies before placing the product on the market again.
The device was placed back on the market in 2002 under a new name. When the product was again prohibited by the German authorities in 2005, the Commission carefully analysed the case and concluded the procedure by formal letter to the German authorities and the manufacturer in July 2007.
The Commission analysis was that the prohibition by the German authorities was justified because the clinical data provided by the manufacturer was insufficient to demonstrate the safety of the device.
According to the Medical Device Directive, safety has to be demonstrated by the manufacturer in order for him to be allowed to use the CE marking. This meant that the applicable legal provision was Article 18 of the directive which addresses cases where a product is placed on the market with improperly affixed CE marking. In this case, there is no formal Commission decision.
Since, in the Commission's view, the case is not one to which the safeguard clause procedure applies, it has no reason to request notification of the 2005 prohibition adopted by the German authorities.
The obstacle which the petitioner faces in placing the product on the market is the decision of the German authorities (the 2005 prohibition) and not a decision of the Commission. The petitioner had clear legal avenues which he could pursue at national level and, indeed, he has made use of these opportunities. His claims, however, were rejected by the German courts.
I would like to stress that the Commission has, since 2007, invited the petitioner to bring the device into compliance by providing the missing clinical data and has facilitated contacts between him and the German authorities to that end. To the Commission's knowledge, no action has been taken by the petitioner so far.
Elena Oana Antonescu
Mr President, I am going to talk about Alzheimer's disease and other forms of dementia. I would like to congratulate the rapporteur, Mrs Matias, on the fine job she has done. As shadow rapporteur for the Group of the European People's Party (Christian Democrats) for this dossier, I also want to thank all my fellow Members who made their contributions. The attention enjoyed by this dossier indicates what an important subject it is and, at the same time, the severity of this phenomenon.
The number of people suffering from dementia is up to 9.9 million, with Alzheimer's patients accounting for the majority. By 2020, we expect this number to increase dramatically at a time when the disease is still underdiagnosed in the European Union. Inequalities exist between Member States with regard to prevention, access to treatment and care. Action is fragmented and responses are unequal in terms of research into and fighting against this disease.
The report marks an important step in the fight against this disease in the European Union and is essential for introducing a new form of cooperation between Member States, enabling coordinated measures to be taken to combat certain problems affecting the whole of Europe. The report supports solidarity between states and the exchange of good practices to avoid duplication of effort and wasting resources. I would like to stress the importance of preventive diagnosis and early intervention at the initial stages of the disease. I believe that this is key to making progress in the fight against this illness.
Furthermore, I would also like to recall the importance of adopting a multidisciplinary approach to research in this area. Compartmentalisation between disciplines and the tenuous link between primary and clinical research, public health and social research influence how scientific discoveries are transferred into medical practice and the provision of care. The fact that all these are carried out at national level increases fragmentation. This is why we must focus on the multidisciplinary approach and on transferring discoveries and knowledge at EU level.
Nessa Childers
on behalf of the S&D Group. - Mr President, nearly 10 million Europeans suffer today from dementia, with Alzheimer's the most common form. One of those statistics was my own mother who passed away last year. I therefore strongly welcome this European initiative on dementia.
We should be very concerned that only half of cases are estimated to have been diagnosed. We should be very concerned that twice as many women as men suffer from dementia, and we should be very concerned that with an ageing European population, the number of sufferers will double in the next 20 years.
Given that a five-year delay in the onset of Alzheimer's means 50% less prevalence rates, I welcome the focus on prevention and early detection by the Commission. I welcome the focus on better research in Europe, especially as we know that 85% of research today is without EU coordination. I also welcome the focus on the sharing of best practices and the rights of sufferers and their families.
I, and my fellow Social Democrat MEPs, focused on the social aspects of dementia in our amendments and we urge the following:
We call for a strong focus on the specific needs of women, who account for twice the number of sufferers and a disproportionate number of carers, in the areas of medical and social research, health, employment and social policies.
We renew our call on the Commission to legislate for mental-health-at-work policies, as part of their health and safety at work responsibility to incorporate persons with mental disorders into the labour market in the best way possible.
We recommend an examination of the use of living wills across European borders, which are so badly needed.
Finally we also highlight the importance, in all awareness and education campaigns, of the ability to recognise the symptoms of dementia.
To conclude, I should like to congratulate the rapporteur, Maria Matias, and thank her and my fellow shadow rapporteurs for their work on this report.
Frédérique Ries
Mr President, the fight against Alzheimer's disease has become a European priority in recent years and not before time! Let me add that I welcome all the initiatives that have just been announced by Commissioner Dalli.
This form of cerebral ageing is experiencing explosive growth in Europe and worldwide: more than 7 million people are affected, with this figure rising to 10 million if one considers other types of neurodegenerative illnesses. We can, and should, welcome the current EU funding of 32 research projects, but we must do better, much better, especially in terms of the coordination of research into Alzheimer's in the Eighth Research Framework Programme as early as 2014. This is clearly specified in point 21 of our resolution.
It is also vital to focus on a multidisciplinary approach embracing diagnosis, prevention, treatment and support for the recipients of care and for their families; this is covered in points 2 and 20, which are very important. In this regard, moreover, a recent study, which has just been published in France, reveals the considerable socio-economic costs resulting from this disease: more than EUR 10 million a month for the medical care and supervision of patients alone. And that does not include the enormous dedication of the patients' loved ones and families, who devote more than six hours a day to the care and management of the patient.
Helping these patients also means getting the diagnosis right. The scientific world tells us that international criteria must now be changed because, through the strict application of often obsolete criteria, too many patients who have other forms of dementia are often included.
At European level, which is covered by point 64 of our resolution, it is crucial that Parliament finally responds to the appeal from researchers. More volunteers are needed for the clinical studies if we hope to find a cure one day, which we must. The upcoming revision of the Clinical Trials Directive is therefore a golden opportunity to provide a concrete response and to give hope to the families affected.
Gerald Häfner
Mr President, whoever arranged for these debates to be combined has hardly done Parliament a service - still less the subjects concerned.
All over Europe, the costs of medicines and health insurance are rising, and everybody is trying to find ways of bringing them down. Medical progress is making medicines more and more expensive. The case we are dealing with here is different. There are 30 million asthmatics in Europe and we have a small manufacturer that has developed a device that makes inhalation - which can be a life-saver for asthmatics and is extremely important in their treatment - better, faster, more efficient and, above all, cheaper. This manufacturer has been denied access to the market for 14 years. The manufacturer turned to the Commission back in 1996 and the Committee on Petitions has been dealing with the matter since 2006. Commissioner Dalli, it is the Commission's job to help enforce the law and to be on the citizens' side. In this case, that is not being done; instead, the Commission is refusing to make a clear decision - a decision that would help the petitioner.
I would like to address you quite personally, Commissioner Dalli, for you will recall that we invited you along to meet with the Committee on Petitions and discuss the matter. You told us that you did not have time for that, but that you could find time for a personal conversation. We came to you and spoke to you personally. You personally promised me that you would take care of the matter and find a solution very quickly. To date, I have heard nothing. I wrote you another letter, but I have received no reply. You have also tried to prevent the next debate. That is not the way the Commission should act.
I would like to state very clearly that the European Parliament expects the Commission to be on the side of the law and of the citizen - and we will be voting together on this resolution tomorrow. We expect you to guarantee that such small manufacturers are protected from those who wish to deny them access to the market. There is a lot of money at stake here, but more particularly, it is also about people's health. We are aware of the problems. We cannot understand your actions, Commissioner Dalli. We know all your arguments. I have looked through mountains of files, but I have yet to find a clear argument to substantiate your position. We are talking about a medical product. A full 30 000 are in use - people have inhaled millions of times, with excellent results. We have letters from insurance companies asking us to allow access to the market so that costs can be saved here. I expect the Commission to finally do its job and reach a positive decision on this matter.
(The speaker agreed to take a blue card question under Rule 149(8))
William
Mr President, I would like to ask Mr Häfner if he would agree that the Commissioner's comments on the matter of BronchoAir that we heard earlier have been thoroughly evasive and unhelpful to the company in particular and to asthma suffers in general?
Gerald Häfner
(DE) Mr President, if you will allow me to give a brief but personal answer, it is my impression that the Commissioner has not yet availed himself of the opportunity to personally acquaint himself with the matter and form his own new impression. However, this is the perfect opportunity, Commissioner Dalli, for you to take a fresh look at the matter and reach a new conclusion after all the years of procrastination - and I would suggest that you use different members of your staff to those that have been responsible for the protracted proceedings thus far. I would be happy to discuss this with you or, even better, I would like to see you get together with the petitioner and come up with a solution.
I agree with my fellow Member entirely.
Marina Yannakoudakis
on behalf of the ECR Group. - Mr President, 750 000 people in the UK suffer from dementia; over 50% of these will have Alzheimer's. The effects are common but everyone's experience is different. There is no cure for this condition which often holds hostage both patient and carer regardless of age. But what can be done in the EU? Legislation is clearly secondary in what primarily needs local support.
However, firstly by bringing this topic to this Chamber, we can bring it to the forefront, open discussion and increase public awareness. Leading from this, Member States can decide on its prioritisation and sharing of best practice. Secondly, awareness can lead to a greater understanding of the symptoms and, consequently, early diagnosis. There are drugs on the market that can assist here and, if taken at the correct time, can slow down the process. The important point is this: sufferers are helped, families have information and support and, ultimately, the patients are helped to retain their dignity through this difficult illness.
William  Dartmouth
on behalf of the EFD Group. - Mr President, apparently, a small German company, BronchoAir of Munich, has produced an inhaler which can actually improve the life of asthma sufferers who rely on such devices to breathe. This product has been shut out of the market for over 14 years, and the Commissioner's account of why this has been was very different from that of the Chair of the Committee on Petitions who opened the debate. The Committee on Legal Affairs has stated, and I quote: 'the company has been the victim of a flagrant denial of justice' on the part of the Commission.
Why does the Commission favour the big pharmaceutical companies and their lobbyists? In this case, the UK Independence Party, which I have the honour to represent, strongly supports the immediate setting up of an inquiry into the Commission's handling of this matter.
Diane Dodds
Mr President, as has already been stated in this Chamber today, in the United Kingdom, almost three-quarters of a million people currently suffer from some form of dementia. Sixteen thousand of those live in my constituency in Northern Ireland.
Alzheimer's is a cruel disease. It strips sufferers of their personality, it takes away their independence and robs them eventually of their relationship with family and friends. It is a devastating disease which places huge burdens on families and carers, who are often isolated and in poor health because of the burdens they face. As has already been mentioned in this House, many of those who care are women.
In the United Kingdom, by 2050, the number of those with dementia is estimated to soar to approximately 1.7 million. The estimated cost of health and social care by 2018 will be GBP 27 billion. These are staggering figures, which make research absolutely vital and the careful targeting of resources in medical and social care an absolute imperative. I also believe that we should recognise the contribution of the voluntary and community sector in this.
Commissioner, you have made much of healthy and active ageing and I am proud to highlight the work of the Mullen Mews scheme in Belfast, which has driven off international competition to win awards for its social inclusion and improvement of the lives of those who live with dementia and their families and carers.
Peter Jahr
(DE) Mr President, Commissioner Dalli, I agree that it is exasperating that we are having to keep switching between two topics. I would have liked to have seen these matters being dealt with one after the other at least.
I am returning to Mr Klein's petition. I am pleased that we have the opportunity to talk about it, because the Committee on Petitions has been dealing with this petition for some considerable time. What has happened in that time? Here was an innovative manufacturer which developed an inhaler for asthmatics. It was good for patients because it was easier to use. It was good for the insurance companies because it was cheaper. The manufacturer quite rightly won an award for it. Then came a sudden blow: the inhaler was banned by the German authorities, as a result of which the European Commission began a safeguard clause procedure.
Without going into all the details once more, I am convinced that the initial 1996 ban on the inhaler was not legitimately imposed. The Commission would have been required to conclude the safeguard clause procedure with findings, in order to allow the party concerned to appeal. As a result, Mr Klein - and I am quoting the position of our own Committee on Legal Affairs here - has been the victim of a flagrant denial of justice. Commissioner, I am not in the business of apportioning blame. What is important here is to find a solution as soon as possible to deal with the problem once and for all. I am simply asking you to respect the unanimous vote of our Committee on Petitions. I am hoping and relying on your cooperation and assistance - not just in the interests of the petitioner, but also in the interests of patients throughout the European Union.
Daciana Octavia Sârbu
(RO) Mr President, there is still a great deal of uncertainty and much that we do not know nowadays about Alzheimer's disease. Unfortunately, the situation continues to deteriorate now that Europe's population is ageing. We obviously need to carry out research and more studies into the causes of and treatments for dementia. However, as in the case of non-transmissible diseases, there is evidence indicating that a number of simple measures in terms of lifestyle choice can prevent many disorders. This is why I have asked in the amendments which have been tabled for much more importance to be attached to carrying out research into the impact nutrition has on the occurrence of Alzheimer's disease.
Many of us will certainly know at least one person affected by this disease or another form of dementia. We know that, in actual fact, the personal cost is much higher than the social or financial cost. We are all concerned about the very widespread, devastating effects of dementia on such a large number of people. As a result, we have an extremely comprehensive report which contains all the key issues. What we want is a positive response not only from the Commission, but from Member States as well.
Antonyia Parvanova
Mr President, I, too, regret that we are joining one debate to another one: it is like having a joint debate on shipping and fishing because both of them happen in the marine environment. However, I would like to congratulate the rapporteur, Marisa Matias, and it is indeed of the utmost importance that the European Union should address, in a concrete manner, the challenge of Alzheimer's disease as one of its health priorities.
The current medical and social burden of this disease represents a serious threat to the sustainability of our healthcare and social systems. Several other chronic diseases will significantly increase in the coming years and it is crucial that we should also address them in a comprehensive way with an appropriate preparedness plan. I sincerely hope that the Commission will take the lead in building on the European initiative on Alzheimer's disease, and will support Member States in addressing the public health challenges of our ageing population. I particularly welcome the focus on a multidisciplinary approach.
Finally, I would like to stress the need to focus on research, and on targeted investment in this field, with one priority in mind: not to serve business interests but to deliver concrete public health outcomes for patients and citizens.
With regard to the oral questions, I think we are witnessing here a method of lobbying aimed at increasing pressure on the German authorities and contesting EU safety requirements and regulations. It does not matter whether the companies concerned are big or small: the only question of importance for us is the safety of patients.
Satu Hassi
(FI) Mr President, ladies and gentlemen, my sincerest thanks go to the rapporteur, Mrs Matias, for her excellent work on the Alzheimer's report. Alzheimer's disease and dementias are a very big issue for society. The human and financial cost are enormous. It is estimated that it costs more than EUR 100 billion a year to treat Alzheimer's disease. That is more than what the Commission estimates it would cost if we tightened up our target to cut greenhouse gas emissions to 30%. The number of Alzheimer's patients is thought to double every 20 years.
I wish to stress the importance of early diagnosis and making prevention a priority. In particular, I hope that there will be more research into how chemicals that hinder the development of the nervous system might contribute to the incidence of Alzheimer's and the risk of other diseases that cause deterioration of the nervous system. In any case, the precautionary principle dictates that there should be a reduction in the use of these chemicals as pesticides in our gardens and in fields.
Miroslav Ouzký
(CS) Mr President, I would also like to talk about Alzheimer's disease. We know that this report does not have a specific legislative impact, nor is it too contentious. I hope that it will not divide this sitting. However, we know that this is a very serious health condition with very serious financial consequences, and it is therefore also a very serious social problem. It is very closely related to the ageing of Europe's population, and its increase in Europe is beginning to resemble a kind of neurological epidemic. What can we do about this? We can emphasise prevention, which saves resources and improves health, we can improve the dietary habits of Europeans, we can unify our scientific base in Europe and coordinate the work of individual Member States, we can support voluntary organisations and organisations of family members, and we can help to establish specialised centres in Europe.
Philippe Juvin
(FR) Mr President, ladies and gentlemen, there is so much to say on Alzheimer's disease.
Let me focus on two aspects. The first is the issue of home support for patients who are seriously ill. We know that, for medical reasons, it is important for patients not to suffer any upheaval in their environment, which may aggravate the disease and its symptoms and make things much more difficult.
One of our priorities must be to enable patients to stay as long as possible in their usual environment. For this to happen, families and those family members who help the patients must, in turn, be helped. In other words, the families must not be left to fend for themselves. This is my first point.
My second point concerns research. Why? Because, ultimately, for Alzheimer's disease, the hope is to find a drug and, to find this drug, effective research is needed. I have heard people say that more resources are needed for research. That is doubtless true! Most of all, however, before we talk about resources, we need to talk about the use of these resources.
Research has so far been too fragmented and spread too thinly. No priority has been defined. People do not work together and do not talk to each other. In the future, the cellular biologist must talk with the physiologist, with the radiologist, with the neurologist. We must get people to work together better. I therefore call on the Commission to throw all its weight behind the joint research programme, which was launched during the French Presidency.
Finally, I should like to conclude by saying to patients and their families that things are moving forward. They must have faith, they are not alone. They are no longer alone!
Glenis Willmott
Mr President, I would like to thank the rapporteur and the shadow rapporteurs for their good work on this report.
Whilst this report on Alzheimer's is very important, we know that the power for implementing policy lies mainly with the Member States. But the ageing population is one of the most pressing challenges for the future and we know that dementia is one of the main causes of disability and dependence among the elderly.
Currently, the main responsibility of care tends to lie with the spouse or child of the dementia patient, which can be extremely hard work and emotionally gruelling. This is why our amendments that call on the Commission to consider the opportunities for creating jobs from a better care sector in the EU 2020 strategy are so important. It is also important that we focus not only on providing research funding into new drugs to treat diseases, but also look at simple preventive measures that everybody can take such as a change in diet and lifestyle. Nutrition is increasingly being shown to be an important factor in the development of Alzheimer's and other dementias and we need to dedicate some of our resources into investigating this further.
The cost of dementias in the EU was EUR 130 billion in 2005 and it affected 19 million people - that is, sufferers and carers. So it makes sense, both morally and economically, to ensure that we put more funds into work into this terrible disease.
Jorgo Chatzimarkakis
(DE) Mr President, the Communication and the report are very good, and I would therefore like to express my thanks to Commissioner Dalli and Mrs Matias.
Alzheimer's is a plague of our times, and our biggest problem is that we simply know too little about Alzheimer's. That is why we need research, research, and more research. We need to pool our strengths and I therefore welcome the Commission's initiative to create an innovation partnership on the subject of healthy ageing; Alzheimer's fits in with this perfectly.
Many years ago, the US Government designated the fight against cancer as a lighthouse project. They have not conquered cancer, but a great many medicines and a great many therapies have emerged as a result. That is the kind of thing that we need here, and I therefore welcome the fact that we are to concentrate on Alzheimer's. We need to know how to take preventive action. What can we do in the future to combat Alzheimer's? That is why we cannot continue to adopt the watering can principle in European research policy. We need to concentrate on specific areas. Alzheimer's could be one of the major themes that we get to grips with.
Frieda Brepoels
(NL) Mr President, as Vice-President of the European Alzheimer's Alliance in the European Parliament, I warmly welcome the report by Mrs Matias. It contains the most important issues that need to be addressed as a matter of priority. I would like to touch on two things in this short time.
First of all, the importance of prevention and early diagnosis. Campaigns raising awareness of the first symptoms are essential, so that patients and their carers are able to benefit at the earliest possible stage from any treatment and support that is already available. However, in addition, the importance of joint programming of research resources cannot be overstated. Many of you have already mentioned that 85% of public investment in research is nowadays made without any European coordination and this inevitably leads to fragmentation and duplication. Therefore, a common strategic research agenda could ensure a more efficient use of resources and a greater understanding of the causes, treatment options and the social impact of diseases such as Alzheimer's.
Miroslav Mikolášik
(SK) Mr President, the Commission Communication concerning the European Initiative for Alzheimer's Disease and other Dementias improves the current piecemeal measures and existing differences as far as access to treatment is concerned, and leads us to better health and social conditions for the ever increasing number of such patients, the proportion of whom is also increasing in relation to Europe's ageing population.
The directive also addresses health workers in this area, and provides specialised training, which I warmly welcome, and support for family members. We already have problems, with up to 1.4 million new cases of some form of dementia every year, and we must take energetic action over timely diagnosis, prevention and other related issues, such as patient dignity.
Here, too, there are affected people, especially family members, who face a lot of social stigmas. Society should also give assistance and financial help to those who look after dementia patients at home.
Justas Vincas Paleckis
(LT) Mr President, I would like to congratulate the rapporteurs, who have done an excellent job. It has to be acknowledged that with the ageing of Europe's population, Alzheimer's and other forms of dementia are spreading at a dangerous rate. Often, the symptoms of these diseases are incorrectly diagnosed or detected too late and patients do not receive adequate treatment. The invitation to declare dementias one of the priority areas of healthcare is right. Only by disseminating information as broadly as possible and increasing society's awareness of the disease, its symptoms and early methods of diagnosis, will we be able to deal with the rising wave of dementia. Unfortunately, in the majority of the new European Union Member States, including Lithuania, care for dementia patients is particularly unsatisfactory. The greatest burden usually falls on patients' relatives and family members. The Member States should give credit to their work by regarding, as far as possible, time spent caring for relatives as a period of employment, and providing social guarantees.
Gay Mitchell
Mr President, I just want to make the point that we are talking about Alzheimer's disease and old people, yet I have experience in my constituency with the case of a 48-year-old man who had to be looked after by his elderly widowed father because the young man had Alzheimer's. I will not abuse the opportunity to speak but I thank you for it, and I want to say that I support innovation in relation to ageing. This is mainly an ageing-related issue, but not simply an ageing-related issue.
Wolfgang Kreissl-Dörfler
(DE) Mr President, Commissioner, ladies and gentlemen, my comments concern the petition. I have been looking into this case since spring 2007. In autumn 2007, I addressed a question to the Commission. The answer was more than unsatisfactory.
I have had many discussions with the German Ministry of Health and with other authorities. Everything was always very vague and unformed. From your answer, Commissioner Dalli - from what you read out - I take it that you have no inclination whatsoever to look into this case in more detail. It did not happen during your period of office, but there is such a thing as collective responsibility, and I would ask you - also on behalf of the Committee on Legal Affairs and the Committee on Petitions - to make available to us all the documentation on which your decision was based. Moreover, looking at the device, I would like to know - although I can imagine the answer - why certain companies have no interest in a different product coming onto the market. Installing this plastic part in the inhaler is relatively cheap, but the margins lie in overall sales.
Looking at the lobbying engaged in by the pharmaceuticals industry, and looking carefully at the financial interests that certain parties have in keeping small companies out of the market, the answers are sometimes all too apparent.
I urge you to make your position clear here and now as to whether you will make the documentation available to us and whether you are prepared to have a proper discussion with us in the Committee on Petitions and the Committee on Legal Affairs, rather than simply pushing the matter aside. Our citizens have a right to be treated properly - and that includes those that may not be particularly wealthy or large.
Elżbieta Katarzyna Łukacijewska
(PL) Mr President, the European Union has an ageing population and the percentage of people suffering from age-related diseases is rising. Statistics show that one person out of every five above the age of 80 suffers from Alzheimer's disease. Not everyone is aware of the fact that this is an incurable disease, but with appropriate preventive measures and early diagnosis, its effects can be delayed. According to the World Alzheimer Report 2009, 28% of the global population suffering from dementia lives in Europe, second only to Asia in this regard. In Poland, the country which I represent, about 250 000 people suffer from Alzheimer's, and specialists estimate that by 2040, this figure will have trebled. As you can appreciate, these statistics are disturbing.
Dementia not only brings social and economic consequences, but also affects patients as well as their families. This is why I am happy that we have discussed this important problem today. Only cooperation, highly specialised research and a widespread campaign of information, will enable rapid diagnosis and better prevention.
Vilija Blinkevičiūt
(LT) Mr President, I agree with the specific action proposed in the initiative on Alzheimer's disease, that it is essential to promote early diagnosis and quality of life, to support cooperation between the Member States through sharing best practices and clinical studies, and to respect the rights of people living with this difficult disease. As the European Union does not currently have at its disposal sufficiently precise statistics concerning Alzheimer's disease, studies should be carried out on the basis of common, strictly defined indicators. Furthermore, it is necessary to invest in scientific research and efficient approaches to care systems. Particular attention must be paid to healthcare professionals, providers, and training and support for families coping with Alzheimer's disease on a daily basis. I would like to stress that in combating this difficult disease, it is vital to pay much attention to prevention and to target efforts at obtaining the earliest possible diagnosis. Therefore, there is a need to draw up a preventive strategy on Alzheimer's disease, linked to encouraging healthier lifestyles, informing people about this disease and exchanging medical practices.
Pat the Cope Gallagher
(GA) Mr President, I want to thank you for giving me the opportunity to talk about Alzheimer's disease.
Alzheimer's is a disease that is the most common cause of dementia, affecting 44 000 people in Ireland and nearly ten million people across Europe. It is a progressive disease, which means that over time, more parts of the brain will become damaged and, as this occurs, the symptoms become worse.
Unfortunately, due to the ageing population in Europe, more and more people are likely to be affected by this disease in the future. Therefore, better coordination between EU Member States, in terms of research into the causes of dementia and best practice in terms of a care system, is essential. The burden of care is often placed on the shoulders of close family members and in Ireland, 50 000 people care for people with dementia on a daily basis.
In conclusion, I would like to pay special tribute to those carers and to the Alzheimer's society of Ireland who provide incredible support to people affected by dementia.
Margrete Auken
(DA) Mr President, I would like to address Commissioner Dalli. Here you see the plastic gadget that this is all about. It is the large multinational pharmaceuticals industry that has decided, in the German case, that this plastic gadget and the medicine belong together. Here is the medicine. This is what has to undergo the major testing. The plastic gadget is just like using a syringe. However, it is clear that the pharmaceuticals industry makes a huge amount of money from the fact that the two products must always be sold together. Society, on the other hand, saves a great deal of money by being able to reuse something again and again. I think it is absolutely scandalous that the Commission is continuing to maintain that this simple product is to undergo the same substantial test procedure - as if it necessarily belonged in the same test system - as the medicine - not exactly the same as the medicine itself, I know, but still as a device that belongs to it. It is simply appalling that we have not received a clear response in this matter. There are so many people, including many societies and health insurers, who are suffering as a result of the fact that this simple plastic object was not approved a long time ago. It has never created any problems other than financial ...
(The President cut off the speaker)
Paolo Bartolozzi
(IT) Mr President, ladies and gentlemen, neurodegenerative diseases, and Alzheimer's disease in particular, are an EU health priority.
The disease in question has serious consequences for sufferers, and not just in health terms. The costs incurred for direct and informal care are, in fact, high. Indeed, Alzheimer's disease affects not only the sufferers, but all those who care for them, too.
Therefore, we need a European response to the problem, a coordinated response by all the Member States, a synergy of concerted measures that concern, in particular, the fields of science and research and that are responsible for strengthening prevention and diagnosis so as to improve the treatment - including innovative treatment - available, as well as the dissemination of information among the Member States on the results achieved nationally, thereby raising public awareness of the disease.
John Dalli
Member of the Commission. - Mr President, honourable Members, I again thank Parliament and the Members who have taken the floor for their engagement with the important cause of Alzheimer's and other forms of dementia.
The Commission welcomes Parliament's report and its recommendations. Let me take this opportunity to stress that the Commission is fully committed to doing its share to address Alzheimer's and other forms of dementia. These conditions are, unfortunately, part of the ageing process for many European citizens.
I believe it is our collective responsibility to work together to minimise their burden and to invest in innovation to prevent, diagnose, treat and manage these conditions.
I look forward to supporting Member States in their efforts to work closely with Parliament in addressing Alzheimer's disease and other forms of dementia.
On the 'Effecto' Klein petition, I must state first of all - referring to Mrs Mazzoni's statement that the Commission's job is to stand by the citizens - that I can assure you my job is to stand by the patient. It is very important for me, as Commissioner responsible for health, not to compromise on patient safety, not to take any shortcuts and short-circuit the processes and procedures that we have in place to ensure that any device to be used in any medical way is properly tested and its safety assured.
The issue here is not how to deliver a medicine with a piece of plastic, as has been said. The issue is that we need clinical evidence that the product is safe and to do this, the petitioner, in this case Mr Klein, was requested to conduct clinical studies on 24 patients. That is the extent of the clinical tests that were requested.
Why is there a resistance to providing these clinical tests? What is causing this resistance? This is something that I am asking myself. We need to know, for example, is this product universal in application, is it to be used with one specific medicine, is it to be used with different types of medicines? If it is, do these medicines require different dosages? Is there an adjustment system in the device to adjust the dosage? As a layman, if I had to use a device like this, these are the questions that I would ask myself. This is the kind of thing the authorities have been asking themselves. They have been asking for proof that this device would be safe in the hands of patients at large.
There is, as I said, a proper safety assurance procedure, and I will be not short-circuiting that. It has been said that I promised to look into the case. I promised to look into the case, and I did look into the case. I have had a lot of details about the case. Naturally, these are details that I had to learn from others who have been here in the Commission since 1987. When Mr Klein asked for a meeting with me or my cabinet, I immediately agreed. My 'chef de cabinet' informed him that we were prepared to have a meeting to explain it. He sent an e-mail back setting a lot of conditions, amongst which he stated that as a basis for this meeting, the EU Commission should completely take over the expenses. This included the flights and overnight stays in Brussels for him and his staff, and I could not accommodate this.
Marisa Matias
Mr President, Commissioner, ladies and gentlemen, I should like to start by expressing my gratitude for all the words that have been said about the report that Parliament is tabling on Alzheimer's and other dementias. We all know that the situation that we are experiencing is very tragic and that it is also very underdiagnosed, which has already been mentioned here.
I just want to mention one issue that cut across all the speeches that were made, but which was probably not emphasised enough, which is the issue of the dignity of the patients and their rights, but not just those of the patients: also those of their family members, of those caring for them, whether these be formal or informal carers, and of the professionals associated with this type of disease.
I am happy, really happy, with what you said, Commissioner, about sharing the same concerns as the European Parliament, and that the European Commission views all the recommendations tabled by Parliament in the report positively and will do everything in its power to implement them.
We know that every day that passes is later than the last in this area, given the urgency of what we have before us. Therefore, we also know that Parliament is going to make an announcement on this subject tomorrow. We will await the result of the vote, Commissioner, but we know that the European public is expecting a great deal more of us than solidarity and moral reassurance. Europeans expect specific and suitable measures, Commissioner, and I really hope that you and the Commission - which has initiative that this House unfortunately lacks - will make this issue as much of a priority as you say you will, and that you transform it into a legislative initiative, so that the rights of Europeans and their families are respected and all of them are treated with the equality and dignity that they deserve.
President
The debate is closed.
The vote will take place tomorrow (Wednesday, 19 January 2011).
Written statements (Rule 149)
Liam Aylward
It is estimated that 9.9 million people in Europe suffer from a neurodegenerative disease, such as Alzheimer's disease. With Europe's population ageing, Eurostat estimates that twice as many people will be suffering from a neurodegenerative disease in 2050 as were in 1995. Moreover, since the burden of care falls on family members, it is estimated that the disease affects three members of a patient's family. In this regard, it must be ensured that action is taken at EU level to help Member States to give appropriate assistance to patients and their families.
I totally agree that EU health policy should prioritise dementia. Proper recognition must be given to patient and carer organisations, and those same organisations must be involved in information campaigns and in the preparation of research programmes. The EU gives a considerable amount of money - EUR 159 million - to 34 neurodegenerative disease research programmes, but since there will be a huge increase in these diseases, research projects under the Eighth Framework Programme must be broadened to include research on behavioural, cognitive and non-drug therapies.
Vasilica Viorica Dăncilă
The data on the prevalence of Alzheimer's disease and other forms of dementia is available in European Union countries and was collected by Alzheimer Europe. Alzheimer's disease was, and is, the main cause of dementia in all countries. It accounts for 74.5% of dementia cases in North America, 61.4% in Europe and 46.5% in Asia. However, there are cases of Alzheimer's disease in the European Union which are undiagnosed. According to the recent epidemiological data available, only half of the people suffering from this disease have been identified at the moment. In this context, I think that Member States must develop long-term policies and action plans for speeding up access to research funding in the field of dementia and Alzheimer's, including research into prevention, at a level commensurate with these illnesses' economic impact on society. They must also anticipate and prevent social and demographic trends and focus on the support provided to the families of the patients being cared for by them, thereby affording social protection to vulnerable people suffering from dementia.
Elisabetta Gardini
The resolution tabled renews our commitment to the fight against a serious disease that still affects one in five people over the age of 85. I am of the opinion that an effective, coordinated Europe-wide action is needed to make further progress in research and the collection of epidemiological data on this disease. Proper coordination between Member States can contribute to the sharing of best practices in patient treatment and help make citizens more aware of the importance of prevention and early intervention. Investment and cooperation are essential in this field not only to reduce the social costs of these diseases but also, and above all, to ensure that those affected can be given the hope of leading an increasingly dignified life. In this vein, I should like to point out that dementias do not, of course, only affect sufferers; they also affect the people around them, such as family members and healthcare workers. The European strategy should therefore aim at ensuring more effective and practical support for those who have to face the daily task of helping these people, closing the gaps that exist in professional training and launching campaigns to raise awareness of the realities of living with Alzheimer's.
Louis Grech
in writing. - To date, the EU still does not have an adequate response to Alzheimer's, neither has it concluded a single policy on its prevention. Moreover, it is worrying that countries like Malta still do not offer any refund for medication needed by patients suffering from the disease. Notwithstanding that the Commission cannot interfere with the organisation of national health insurance schemes, the Commission should step up its efforts to put pressure on Member States to guarantee that any person suffering from Alzheimer's is getting the necessary treatment. I call on the Commission to truly make the fight against dementia a European priority and conclude the below-mentioned proposals within a reasonable timeframe: (1) promote cardiovascular health and invest in a healthier workforce; (2) promote initiatives that ensure social and intellectual engagement of the elderly; (3) encourage Member States to implement systematic routine screening which allows for early diagnosis of the disease, as well as providing easy access to medication and treatment once the disease has set in; (4) ensure that regular epidemiological studies at a European level are carried out; (5) prompt Member States to make better use of Assistive Technology (AT).
Jim Higgins
in writing. - I welcome this report as an important step forward in the battle against dementia. At present, one in 20 people over the age of 65 and one in five over 80 suffer from dementia. It is estimated that more than 8 million Europeans aged between 30 and 99 suffer from neurodegenerative diseases, and scientists anticipate that this number could double every 20 years. Alzheimer's disease represents 50% of these cases. Nearly ten million Europeans suffer today from dementia, with Alzheimer's the most common form. There are 44 000 people in Ireland with dementia. There are over 50 000 carers for dementia suffers and an estimated 100 000 people are directly affected by dementia. Given that a five-year delay on the onset of Alzheimer's means 50% less prevalence rates, I welcome the focus on prevention and early detection by the European Commission. I welcome the focus on better research in Europe, especially as we know 85% of research today is without EU coordination. For any European strategy in this area to work, it is crucial that the various countries give priority to drawing up national action plans. A European strategy must also seek to safeguard the existence of services that guarantee maximum possible coverage and equal conditions and treatment for all patients.
Anneli Jäätteenmäki
Diseases causing memory loss are a common problem in Europe. Approximately 10 million Europeans suffer from them at the present time. The majority of them have Alzheimer's disease. Many factors influence people's ability to remember things and learn something new. They include stress, depression, sorrow, heavy drinking, a poor nutritional state and medications. More attention needs to be paid to the prevention of these diseases from the time when people reach adolescence. Exercise, mental activity, healthy food options and avoidance of intoxicants will protect people from developing diseases that cause memory loss. By dealing with the risk factors associated with these diseases, we will, at the same time, be dealing with those associated with cardio-cerebrovascular conditions. In future, the importance of information and NGOs in the fight against memory loss diseases needs to be emphasised. Organisations do very valuable work. They should be given more support to enable those who suffer from these diseases to receive help more satisfactorily. Furthermore, more attention must be paid in the future to treatment centres and their quality. Unfortunately, those that exist do not now meet the demand. In Finland, for example, there is a lack of peer support and suitable centres offering day care and longterm care. Finally, I would like bring to everyone's attention the importance of support for professional staff specialised in the treatment of memory loss diseases, their proper training, and the development of their skills and competence. Thank you.
Sirpa Pietikäinen
I would like to thank Mrs Matias for her commendable owninitiative report on a European initiative on Alzheimer's disease and other dementias. Every one in five Europeans will contract a disease that causes memory loss. These diseases continually put more pressure on healthcare systems that struggle to cope with an ageing population, but also on sufferers and their relatives when faced with a situation that is new to them. There is no consensus on the pathogenesis of these diseases, but early intervention in their progress is considered vital. This report will help make memory loss diseases a priority among the EU's health objectives. The result of the vote will send the right message, which is that research into these diseases and their treatment will require cooperation at panEuropean level. Although it is older people who mainly suffer, with improvements in diagnosis, the early symptoms of these diseases will be detected more and more frequently among the working population. In order to tighten cooperation in Europe, we also need national memory programmes, which have already started in some Member States. National memory programmes play a significant role in the spread of knowledge and best practices and in reducing the number of actions that overlap with one another.
Richard Seeber
10 million people in Europe suffer from dementia; half of them are Alzheimer's patients. These figures will continue to rise as a result of increasing life expectancy. The own-initiative report is moving in the right direction with its call for a more efficient approach to the treatment of dementia, and especially of Alzheimer's. Particular attention should be paid here to prevention. Early diagnosis, free screenings for risk groups and, above all, making the population better informed have a key part to play in this, since Alzheimer's is generally identified at too late a stage in the EU. The continued spread of dementia calls for a European strategy that, as far as possible, offers comprehensive structures which provide patients with equal access to information and treatment options. It should not be forgotten that support for relatives and carers is also a part of this. Furthermore, broad epidemiological and clinical studies as well as better research into dementia and Alzheimer's are important factors in the fight against dementias.
Olga Sehnalová
Dementia and Alzheimer's disease in particular are not only serious medical problems, but also a hugely sensitive ethical and social problem, the severity of which will continue to increase in relation to the ageing of Europe's population. In the document submitted, attention is quite rightly focused on various aspects of this condition, and especially on support for early diagnosis, research and improvements in actual patient care. However, no less important in my view is the area of support for the families of dementia sufferers, and an emphasis on non-discriminatory access to high quality health and social care is fundamental. The role of local authorities, whether municipal or regional, is of key importance here, as are the voluntary organisations, which can respond operationally to the growing need for these services. The European initiative on Alzheimer's disease and other dementias is also very important for starting a serious and open social debate on this condition in the broadest sense of the word. I therefore warmly welcome and support this initiative.