Verbatim report of proceedings

Tuesday, 12 April 2005 - Strasbourg

30. Global threat of a flu epidemic

  President. The next item is the Commission statement on the global threat of a flu epidemic.

  Kyprianou, Member of the Commission. Madam President, I cannot say that I am happy to be here discussing this issue with you because it is not a pleasant one, but at the same time I think it is useful that we have the opportunity to exchange views and present to you what we in the Commission are planning for the future and what actions we are taking.

It is true that the influenza pandemic is a threat and, as the scientists advise, it is no longer a question of ‘if’ but ‘when’. It is overdue, it is something that happens every so many years, it should have happened already. How we deal with this is therefore a top priority, both at Community level, coordinating the Member States, but also working together with WHO, not only in Europe, but also worldwide, and with some of our partners such as the United States, which shares our concerns.

We have undertaken work in many fields. Some of it concerns, for example, measures directed at the source of human infection. We are discussing the plans of the Member States and how we can coordinate them at EU level. We are looking at vaccines and antiviral drugs and at surveillance and diagnostics in inter-connected laboratories to identify a pandemic strain. We need, of course, to identify the potential sources of this problem.

As you know, one of these potential sources is avian flu, which is a real problem. It already exists in Asia and many people have already died from it. But the main concern is that this disease has become endemic. It is not an epidemic that will simply go away; it is there, it is rooted and its eradication cannot be considered a short-term objective. We have also taken measures to try to deal with this problem. The Commission has adopted a new directive on measures for the control of avian influenza to ensure that the Member States can apply the most appropriate surveillance and control measures. In this way we hope we can reduce the risk when major outbreaks occur in the Community in the future.

We have a plan at Community level, but we also need to have national plans at Member State level. In March, together with the World Health Organization, we organised a workshop where we could discuss and exchange views on these plans. It was a useful exercise. We helped Member States to update and improve their national preparedness plans. At the same time we identified those Member States that do not yet have plans and we will help them develop such plans. This is very important because we have a plan at Community level but the actual implementation of plans is up to the Member States. We are happy to say that the response by the Member States showed that the public health services are taking this problem very seriously. We are considering how best to implement the Community plan. Its aspects include communication, isolation and vaccination, the use of drugs, restrictions on public gatherings, and information to the public.

We are planning a Europe-wide exercise, a kind of military-style exercise, that will put these plans to the test and, we hope, see how they work on a fake scenario. We intend to conduct this exercise before the next influenza season in order to test the plans and see what is lacking, what the problems are, so that we can correct the plans and coordinate them better.

A very important problem, as I am sure you are aware, is the issue of vaccines. With vaccines we have three problems. The first is the issue of actually identifying the strain, because in the case of a pandemic we expect a new strain. Then there is the issue of developing the vaccine and, just as important, of having the capacity to produce enough vaccines to cover the population in the event of a pandemic. Because the strain will be a new one, stockpiling vaccines is no solution and does not help.

We have met with representatives of the Member States and we have agreed a way of engaging the industry in a kind of public-private partnership to facilitate the rapid production of pandemic vaccines in time of need. I am optimistic that we will reach an agreement with the industry. The basic principle is that the Member States will increase their level of purchase of vaccines at this stage, so as to justify enough investment to increase the capacity of the Member States in the event of a pandemic. At the same time the Member States have pledged to redouble their efforts to stick to their vaccine recommendations, so as to achieve high uptake rates among the relevant population groups, i.e. the high-risk groups.

We, for our part, are ready to work on the drawing-up of proposals for EU recommendations that can be issued by the Council on who is to be vaccinated on public health grounds. Another possible way to increase capacity – and the industry has promised to look into this – is by converting other facilities, such as those used for veterinary medicine production, for the rapid production of vaccines in a pandemic situation.

We, the Member States, the vaccine industry and the European Medicines Agency will work together to create a favourable situation for such production, but also for a more rapid licensing procedure. Of course all these moves may not completely resolve the problem of supply of vaccines for the Member States, but they certainly make huge strides in the right direction.

A similar process has been started with the manufacturers of antivirals. It will bring the Member States and the industry together to seek a common position. I will report back to you on this as soon as we have the outline of a solution to the problem of shortages of production and stockpiling. But we encourage Member States to proceed with stockpiling and many of them, mostly the larger Member States, are already doing so. We feel that it is a process that all Member States have to engage in, because despite all the drawbacks and all the problems that may exist in regard to the effectiveness of the antivirals, it will be the first line of defence. It will be our first means of dealing with the virus, with the disease, in the event of a pandemic. We will need to have this breathing space until we manage to develop the new vaccine and increase the capacity to actually produce it, disseminate it and use it. Since antivirals will be the first line of defence, they are worth the investment, worth the effort.

Let me draw your attention to a positive development, to the decisions we took last week at the Commission, in relation to the financial perspectives. We also adopted the regulation on the solidarity fund, which will include a line relating to public health threats. The decisions fall within the context of the legislative instruments and will cover the next financial perspectives. They concern the general availability of funds for health preparedness and vaccines in case of major public health threats.

The solidarity fund will have a ceiling, a volume of about EUR 1 billion a year. We believe that it will have enough flexibility to cope with health emergencies, while it will also be able to help those Member States that meet the requirements to fund the effort of acquiring and using the vaccines in case of pandemic. I hope very much, indeed I am certain, that the European Parliament and the Council will make every effort towards a speedy agreement of this proposal.

Finally, another very important issue is early detection. As I said, it takes time to identify a new strain of virus and develop vaccines to deal with it. The sooner we manage to detect it, the easier it will be to deal with the problem and even to contain it as far as possible.

To this end we have set up a network of communication with the Member States and with the World Health Organization. However, our main instrument in this effort is the early warning and response system. Under this system Member States will inform each other and the community in case of a problem.

Let me also mention the European Centre for Disease Prevention and Control, which is becoming operational now. Of course, it will take another year or so until it can function at full capacity. When the time comes, that centre will take over and operate the early warning and response system and manage health threats of this kind.

We are concerned about the influenza pandemic. We expect it to be unprecedented if it occurs and unless we take the necessary measures. Even in an optimistic scenario, the figures given to us by scientists are very worrying, with deaths worldwide in the range of about 8 million at least. But the worst-case scenarios suggest deaths in the range of 30 million. Therefore this is now one of our top priorities; it is a major concern, and we will continue working on it and making great endeavours to put all the mechanisms and structures in place.

However, our success will depend heavily on strong political commitment and support on the part of the Council, Member States, the Commission and of course the European Parliament. I am confident that I can count on your support.

  Bowis, on behalf of the PPE-DE Group. – Madam President, as the Commissioner has said, some countries have no plans and many countries have inadequate plans. It is therefore right that he has come here this evening to discuss this issue with us, and we welcome what he said and the plans he is making. We will certainly give him all the support we can.

Last year Europe and the world were lucky. SARS and avian flu did not develop into pandemics. In the last century we were not so lucky. In 1918, in 1957, and in 1968, with Asian flu, Spanish flu, and with Hong Kong flu, we were less lucky. A million died in each of the latter two and 50 million died in 1918, a quarter of a million in my country, the United Kingdom.

Now Dr Omi of the World Health Organisation has warned that another pandemic is imminent. For months we have been calling for urgent action in Parliament to prepare for this, and yet, certainly amongst Member States, we have not seen the sense of urgency that we have looked for. For some six months or more, the United States has been stockpiling antiviral drugs and it has placed orders for four million vaccines. Italy and France have both ordered two million vaccines. Canada, Australia and Japan have all been stockpiling. As Dr Omi rightly says, although we cannot know the strain, even the existing vaccines and drugs will mitigate and protect the vulnerable, particularly children and the elderly, and key workers.

But what about the other countries? The United Kingdom is not buying any vaccines. It has announced that is not its policy. It is only planning to protect 20% of our population with antivirals. And yet London, a global hub for travel, for migration, and for disease, has inadequate plans for protection through drugs and quarantine. My fears are twofold: that the pandemic will strike first from Asia to Africa or to low-income countries ill-equipped to respond; then move rapidly on into Europe, and that panic in countries that are ill-prepared could lead to international crime and violence within the European Union, including in cities such as London where 80% of people are expected to be unprotected.

We have worked hard in Parliament, along with the Commission and Council, and passed in a single reading my report establishing the European Centre for Disease Prevention and Control. We have approved an excellent choice of director in Zsuzsanna Jakab. We now need to be assured that the first great challenge to this collaborative centre will be met in terms of rapid alert as Dr Omi says, antiviral and vaccine planning and placement, port and airport precautions and quarantine facilities. We need to work closely with the WHO, with the authorities in China, Vietnam and other affected countries in Asia, with international NGOs, with the pharmaceutical industry and with vulnerable countries in the ACP and elsewhere.

I shall be attending the ACP-EU Joint Parliamentary Assembly next week. I want to take with me a message of help and support, but also assurance that Europe has taken note, is acting and will help the world protect itself from this pandemic.

  McAvan, on behalf of the PSE Group. – Madam President, I am glad that the Commissioner is here tonight and I am glad that this issue has now been given some sense of urgency. As you said, nobody is talking about ‘if’. It is only a question of ‘when’ there will be a pandemic.

Citizens will not expect the European Union to micro-manage a pandemic, but they will expect it to add value. They know that diseases travel and they will expect the European Union quickly to put into place measures concerning people travelling and the movement of animals. We would like to hear that those measures are in place so that such arrangements could be made quickly. I would be interested to hear feedback on your planning for a real exercise. It would be useful for us to know how it goes.

On the issue of vaccines, I am pleased with what you said. We need a coordinated approach to vaccines. If we can get the pharmaceutical companies to work with Member States and the Commission we are more likely to get a quicker reaction if the pandemic breaks out. We need a prototype.

I understand that we cannot stockpile the vaccine, but I understand that it is possible to develop prototype vaccines in advance, which can then be very quickly adapted for the strain when it emerges.

Mr Bowis is right that we have a primary responsibility to our citizens to get these things right. What worries me is the impact that this will have on the poorest people on our planet. In 1918 one of the reasons why so many millions died was because so many lived in dire poverty, both in the area that is now the European Union and across the rest of the world.

Commissioner, you did not mention anything about inter-service consultations with the Development Commissioner. Is there anything that is being done in the Commission to look at aid policies for the developing countries and to make sure that the EU sees some solidarity with those countries, as well as planning for what would happen within the European Union?

  Maaten, on behalf of the ALDE Group. – (NL) It might be said that we are talking to the wrong person today. Commissioner, you are asking us for our support, and we do, of course, give it to you without reserve, because I think that you deal with the issue very well within the limits imposed on you by the framework of the Treaties, by which – whether we like it or not – we are bound. It is actually with the Council that we should be discussing this subject. It has been commented before that one does not get the feeling that the Council is aware of an enormous threat against which something must be done. Despite the discussions, coordination attempts and study groups here and there, one does not get the impression that something is actually being done.

Is that such a bad thing? Yes, of course this is, in today’s society, and certainly in the European Union, a very serious thing, for if something goes wrong in one Member State, it has repercussions for the others. It follows that it is in our interest that everything should go well across the EU. In the case of an outbreak of an animal disease, the Commissioner for Agriculture can take far-reaching decisions straight away. Immediately, streets are blocked off, whole areas sealed off and a great deal is done. If something similar were to happen among people, we would not be able to do anything. I think that you, Commissioner, should be able to take contingency measures within 24 hours as regards issues such as quarantine, disinfection measures at airports and flights from certain regions, but also where travel restrictions are concerned.

Needless to say, it would be far preferable if all Member States, in an upsurge of solidarity and unanimity, were to take such measures collectively and simultaneously, but frankly I do not hold out any hopes of this happening. I therefore believe that the Public Health Ministers should be granting you those powers. You were right in saying that, according to the WHO, it is not a question of ‘if’ the pandemic were to break out, but of ‘when’ it will. Their estimate was 8 million casualties, but that could also be 30 million. Children and people over 50 would, of course, be at high risk, and we do not have enough vaccines and antiviral medicines. Here, too, European intervention is crucial. Where should this take place? Maybe this should be undertaken in one of the EU’s neighbouring countries rather than in the EU itself. This is where I think the Ministers should once again be granting you far-reaching powers. One final thought. If travel were to be restricted, what would become of the meetings of the Council and of this House?

  Sinnott, on behalf of the IND/DEM Group. – Madam President, an outbreak does not become an epidemic in a healthy society. If we are truly in danger of an epidemic, even a pandemic, in the developed world, then we should look very carefully at ourselves.

We have the wealthiest societies in the history of the world. With this, we should have the healthiest societies. Do we? No. Ever-increasing rates of chronic illness such as asthma and diabetes indicate that we are not the healthiest society. Junk food, chemicals, pollution and addictions are doing our immune systems no favours.

If these are leaving us vulnerable to an epidemic, we should do something about it. We should have our health and use our wealth to prevent an epidemic in poor countries by improving water, sanitation and nutrition: the reasons for which epidemics spread. We should be anticipating a flu outbreak in the West. We are inexcusably expecting an epidemic.

  Belohorská, (NI) .– (SK) We have already heard from the Commission representative, and that was very well put, that this is not a matter of whether but of when. It should be noted, however, that two principal prerequisites of a pandemic are already there. Namely, the virus is spreading among animals where it is mutating in a way that enables the virus to infect humans and jeopardise their lives. The next, third and last, step would be for the virus to start spreading among humans. We know now how avian flu was identified. Following additional potential mutations, the implicated strain, H5N1, was also used as the basis for developing a vaccine. This has only served to reconfirm something I have several times cautioned against here at the European Parliament. It is inappropriate that healthcare systems are subject to the subsidiarity principle and to national governments. Disease knows no borders, and it is the impending threat of a pandemic that has genuinely put the issue in the spotlight. It is commendable that the WHO stands ready, but I have doubts as to whether national governments are prepared to deal with this issue.

  Grossetête (PPE-DE). – (FR) Madam President, Commissioner, I am one of several Members here to have been seriously concerned, for months, about the risk of a flu pandemic and to have been sounding the alarm bell, because both the pharmaceutical industry and The Vaccine Fund are particularly worried. At present we do not have the necessary means to address such a risk, because we are not able to anticipate it. In fact, we know that the question is not whether an epidemic will break out one day, but when it will do so.

You have given us a number of explanations and when you tell us that it takes six months to develop a vaccine, I wonder whether the pharmaceutical laboratories really are devoting all the necessary resources to, on the one hand, preparing antiviral drugs and, on the other, trying, once we have an isolated stem cell, to develop the appropriate vaccines.

The European Union should provide financial support, both to help to develop vaccines and carry out studies on them and to encourage mass production.

A condition for receiving this funding would be for the laboratories to speed up their work on vaccines. The idea of using the solidarity fund also seems excellent, because it should also make it possible to ensure that vaccines are made available fairly and to involve the Member States.

Have we, in close cooperation with the Member States, already drawn up an appropriate emergency plan in case of an epidemic? Has the Commission carried out simulations to coordinate action with the Member States, so as, on the one hand, to avoid widespread panic and to combat the trafficking that will inevitably ensue if there really is a serious risk, and, on the other, to determine the priority areas to isolate, that is to say the places where quarantine measures should be applied, to draw up lists of the groups of people to be vaccinated as a priority and to ensure that products are distributed fairly and to everyone.

I should also like us to reflect on a framework guaranteeing the rapid and unhindered export of products from the producer countries to the non-producer countries. We expect immediate answers, because this is about preventing a disaster not only for public health but also for the economy.

  Attard-Montalto (PSE). – Madam President, we have all been talking about ‘when’ and ‘if’. I am going to use a different word. Pandemics are not the exception, they have become almost the rule. But they do not obey any rules in themselves. They are difficult to identify before they break out and we are therefore up against an unseen problem. You have called it a problem, Commissioner, but it is more than that.

We have to use all our resources. We have to use our resources for production and our resources for research, and I would appreciate if the Commissioner could perhaps tell us more about this particular issue. The international scientific community has a role to play; and it is important to have reliable networking so that all the stakeholders can cooperate when the pandemic breaks out, because, as everybody knows, although we may try and have military exercises as an example of what may happen, it is extremely difficult to anticipate when it will break out.

  Gaľa (PPE-DE). – (SK) It has already been pointed out that the flu is a disease with grave health, social and economic implications; it also has ramifications in the defence sector and politics. The greatest danger, however, is posed by various flu pandemics that may break out when a new flu virus subtype emerges that is transferable from one human to another. A flu virus of type A that causes flu not only in humans but also in animals, especially birds, pigs and horses, is the only one capable of giving rise to new virus subtypes. A new human flu virus subtype emerges as a result of recombination in an animal carrier between human and animal strains of flu virus type A. This gives rise to what is known as ‘antigen shift’. As humans are not immune to the new subtype, the disease spreads swiftly, leading to an epidemic, evolving in a matter of several months into a pandemic. Recently the WHO has indicated that we are now closer to a flu pandemic than ever before. The WHO has also urged governments to set up national boards that would deal with a potential flu pandemic and adopt national action plans. To the extent possible, my country, the Slovak Republic, has heeded this call. Vaccines constitute a sensible preventive measure, but they have their limits. As the Commissioner has pointed out, it is necessary to identify the virus, develop a vaccine, produce and market the vaccine, as well as carry out an extensive vaccination campaign. A vaccine is not effective when the disease is at an advanced stage, as it depends on the body to form necessary antibodies. Therefore, one cannot count on a vaccine in dealing with the first wave of a pandemic. At the same time, a vaccine has a short shelf life. Antiviral drugs, by contrast, appear to be an appropriate complement to vaccination since, in addition to prevention, they are also efficacious in treating advanced forms of the disease and seem essential as part of a therapeutic response to a pandemic. As they have a longer shelf life – up to five years – antiviral drugs could be stockpiled in advance. The statement by Commissioner Kyprianou gives me hope that developments will be monitored closely, and that in the best case, no emergency action will be needed.

  Kyprianou, Member of the Commission. Madam President, I think we all see eye to eye on this and that is very encouraging. However, Member States have now come to realise the problem. When I went to my first Health Council as a Commissioner and I presented this problem, not all shared the concerns or the sense of urgency that existed at that moment. Sometimes that is one of the realities of life: however much we rang the alarm bell, it was not taken seriously, but when WHO rang it, it was. However, what counts is the fact that the message got through. In the ensuing meetings with ministers they showed that they had already taken steps.

Tomorrow I will be going to Paris, where the French Government is organising a conference on three major problems: Aids, cancer and influenza. We now have the commitment on the part of the Member States. It is true that we do not yet have the legal competence, but we will get it, to a certain extent, with the Constitution, because that will give the Commission, the Community and Parliament the authority to act when there is a cross-border threat to health. Therefore, we will be able to take some of the measures that Mr Maaten said I, not Mrs Fischer Boel, can take in the case of animal health. We can currently take emergency measures, but not for humans. The Constitution will at least allow us to do this.

It is right that even though we do not have the legal competence at the moment, we cannot underestimate the fact that these diseases know no borders and that there is therefore a need for coordinated action by all Member States, plus those outside the European Union. The Commission can offer this coordination and representation when we talk with countries outside the Union.

I should like to say two things on the issue of poor countries. Firstly, there was the Vietnam Conference on avian flu. The WHO, the FAO, the World Organisation for Animal Health and the European Union will deal with avian flu. For the time being it is an animal health problem but we all know that it is a major possible pandemic. We will take measures and find ways to help the countries involved. Toward the end of the year I plan to visit the area to see how we can work with those governments. My colleague, Mr Michel, is preparing a communication on this issue. It will not be the one we approved today but a new one that will also cover the issue of health threats. This is a brief reference today but there will be more coming soon.

Research on vaccines is going well. The private sector can handle the matter from that point of view. The question is about building capacity. It is an investment that has to be made by the Member States and it will be a kind of private and public partnership. It is an investment that will also be of benefit to today’s population because investments are being made to purchase more vaccines to treat the groups at risk now. That will benefit the population and will at the same time be an investment in building future capacity for manufacturing sufficient quantities of vaccines.

I can assure you that this is one of my main concerns. It is an issue I keep raising in all international fora, but mostly now within the Council. It is an issue taken up by the health ministers. Perhaps the next time it will the finance ministers who will have to pay for this investment. I am optimistic, however, that under the circumstances we are on the right track. We have not solved the problem, but we have started the procedure. We are getting there, but we still have a long way to go. Time is running out. That is why all the efforts are concentrated. We will take every step possible before the next influenza season next winter.

  President. The debate is closed.