Management of H1N1 influenza (short presentation) 
President
The next item is the report by Mrs Rivasi, on behalf of the Committee on the Environment, Public Health and Food Safety, on evaluation of the management of H1N1 influenza in the EU in 2009-2010.
Michèle Rivasi
Mr President, we all remember that H1N1 influenza was big news in 2009. The first cases were reported almost two years ago - on 25 March 2009 - and the WHO declared a phase 6 alert level on 11 June 2009.
This maximum alert level issued by the WHO triggered a series of measures in Europe, including the activation of immunisation campaigns in several Member States which not only were very costly but were also overestimated in relation to the known severity of the virus, which, as the WHO stated at that time in May 2009, was moderate.
As regards severity, up to the end of April 2010, this flu had caused around 2 900 deaths in Europe, in other words, a much lower mortality rate than that related to seasonal flu, which causes an estimated 40 000 - 220 000 deaths per year depending on the year.
Meanwhile, the estimated costs were close to EUR 1.3 billion in the United Kingdom and over EUR 700 million in France according to the latest Court of Auditors report.
The evaluation of the management of H1N1 influenza shows that there was a disproportionate response in the European Union and the Member States. I and my colleagues, whom I would like to thank for their amendments, have therefore tried to produce a constructive report which aims to restore the confidence of European citizens in their health institutions.
The report is structured around three major themes: cooperation, transparency and independence.
In terms of cooperation, we are keen to stress the need for coherence, effectiveness, autonomy and flexibility. Future flu prevention plans, for example, must be revised in such a way as to guarantee greater coherence and effectiveness and must be made self-contained and flexible enough that they can be adapted in real time according to the latest available data. This kind of flexibility would have saved our public purses a good deal of unnecessary expense. At the same time, it is important to clearly define the roles and responsibilities of the key players responsible for managing health risks. The definition of a pandemic itself must be revised so that it includes the concept of severity and does not just take account of geographical spread. Indeed, the WHO has informed us that it has this in hand. Group purchasing of vaccines is a possibility, provided that the manufacturers remain liable for the quality, safety and efficacy of their products. Under no circumstances must governments be made liable for side effects of vaccines that are supposed to be safe.
As regards independence, the fast-track authorisation procedure has highlighted the problem of the lack of available scientific data. Research into vaccines and antiviral treatments must be conducted with complete independence from the pharmaceutical companies.
In terms of transparency, total transparency is needed concerning the evaluation of drugs used for health emergencies, with full access to the clinical trials available. All declarations of interest on the part of the experts responsible for the evaluations must be made public. I have one regret: I would have preferred them to be checked by the agencies who recruit these experts, but this amendment was not adopted.
Finally, I would like to highlight the cases of narcolepsy that have been reported in children in Finland and Sweden following vaccination with GSK's H1N1 influenza vaccine. These cases need our attention.
In the first instance, they clearly demonstrate that there are still grey areas, both in relation to the actual toxicity of the vaccines and adjuvants and in relation to possible risks as yet unknown to the manufacturers themselves. Finland has suspended the use of this vaccine until more information is available. This is not the position of the European Medicines Agency (EMA), which has decided instead to wait until more information is available before issuing any opinion on restricting the use of this vaccine. I would like to see the Commission adopt the same position as Finland. It is time that the precautionary principle benefited patients for once instead of always benefiting the companies.
Anne Delvaux
(FR) Mr President, are we prepared for coping with a pandemic in Europe? The answer is 'yes, but'. During the H1N1 flu episode in 2009-2010, we saw each Member State act alone, with very little cohesion or even solidarity.
As shadow rapporteur on this dossier, I think it was necessary to make these observations but, above all, to go further, to be constructive and to take practical steps on behalf of our citizens, who, it has to be said, and I think this is one of the most harmful consequences, have no doubt lost a certain degree of trust in public health messages.
Mrs Rivasi's report, which we will vote on tomorrow, takes these fundamental priorities into consideration. They include systematically strengthening cooperation between Member States, more effective coordination with European health institutions, clarifying the roles of the European risk management structures and evaluating the immunisation and communication strategies implemented in the Member States.
It is a good report therefore, and I congratulate the rapporteur. However, we must, of course, ensure that it does not fall on deaf ears. This is the responsibility of our Member States, which have most of the jurisdiction in this area, and they therefore have a serious responsibility towards our fellow citizens.
Csaba Sándor Tabajdi
(HU) Mr President, during the 2009 influenza pandemic, EU Member States were the most prepared. At the same time, I completely agree with the speaker before me: there was a complete lack of coordination amongst Member States. This may have provoked the internal affairs crisis in my country, even though the former socialist government in power at that time took successful steps to tackle the epidemic. There is, however, no left-wing or right-wing H1N1 virus; it must be fought with a joint effort. I fully agree with the report where it states that Member States must coordinate the acquisition of vaccines, exchange information and create better transparency. We must exchange information not only on the geographical extent of the epidemic, but also on its severity and mortality. If we succeed in doing so, in the future, we can take considerable steps in this area to ...
(The President cut off the speaker)
Marina Yannakoudakis
Mr President, over a year ago, a group of MEPs, the rapporteur and myself got together in Brussels for an informal meeting with a common aim - to do something about H1N1.
As the meetings continued, I found that our objectives were the same, but that we had a different approach. The own-initiative report was an opportunity for Parliament to take positive action in preparation for an epidemic. I fear it has been an opportunity lost.
There are many points in this report that are of questionable value. It proposes a role for the ECDC which is not feasible, and it could lead to a false sense of security. What was needed was a 'lessons learned' approach and a basis to build on that. What we got was partly a name and shame report, which I fear will alienate many of the stakeholders. What we got was a report that was more political than practical.
João Ferreira
(PT) Mr President, among the lessons to be taken from the problems with managing H1N1 influenza is that we must acknowledge the need on the part of countries for public health systems, along with expansion services in the field of public health, that are able to intervene in a wide range of areas. Examples of these areas include the evaluation of information on recommended medication in the case of a health emergency, especially in pandemic situations, and the preparation and evaluation of scientific studies - independent of the pharmaceutical industry - of recommended target groups on the effectiveness, safety, and risk-benefit relationship of vaccines and antiviral medications. It is also important to reinforce the capacity for managing and anticipating risks, and the capacity for research and development into these areas, as well as into preventative public health measures. Finally, it is also important to improve cooperation between the various national services, and between such services and relevant institutions and organisations, at international and regional level.
Jaroslav Paška
(SK) Mr President, in April 2009, the first case of swine influenza in humans was reported in Mexico. Two months later, the World Health Organisation (WHO) declared an influenza pandemic.
The catastrophic scenario presented by health authorities, including the WHO and the European Centre for Disease Prevention and Control (ECDC), led to a situation where countries began to vie with one another to get the most vaccines possible as quickly as possible, in order to protect their citizens.
In accordance with WHO and ECDC recommendations, Slovakia also purchased more than 1 million vaccines, which were delivered at the start of 2010. However, when the chief medical officer of the Slovak Republic called on the public to get vaccinated, it became a joke and no one believed him. They did not believe him, nor did they believe our renowned health organisation, the ECDC. By that time, everyone knew that the H1N1 virus did not represent such a risk as it seemed to at first. However, the WHO and the ECDC have maintained a stubborn silence.
No reassessment of the situation, no additional recommendations, simply nothing ...
(The President cut off the speaker)
Anna Záborská
(SK) Mr President, I would like to thank Mrs Rivasi for an exhaustive report. She has uncovered the weak points of healthcare systems, not only at the European level, but also at the global level.
The report also provides a long list of measures that must be adopted in order to avoid repeating the situation in 2009-2010. It is a scandal what happened with the declaration of the H1N1 influenza pandemic.
The EU Member States, including Slovakia, wasted hundreds of millions of euro to prove that they were protecting their citizens from a non-existent threat. It would be interesting to find out who benefited from this, not to mention who will take responsibility for the ensuing situation.
All that was missing for me in the report was a proposal on how to introduce personal responsibility into the healthcare system. After all, buck-passing may not be fatal, but it does spread even more rapidly than influenza.
Åsa Westlund
(SV) Mr President, I think we would all agree that having different recommendations in different Member States was very confusing. For example, in the Committee on the Environment, Public Health and Food Safety, we had a visit from the Swedish minister - who was President-in-Office of the European Council at the time - to deal with this issue the same day that we had the director of the European Centre for Disease Prevention and Control there, and these two people said completely different things. One of them recommended that children be vaccinated and the other said that it would be dangerous for children to be vaccinated.
It was extremely confusing and very contradictory for parents who were seeking reliable information. However, there were also very major differences in how the issue was handled from a practical point of view in the Member States. In my country, there was a high demand for vaccines, which resulted in extremely chaotic scenes outside health centres. Health centres that were open lacked the vaccine and health centres that were closed had huge stocks of vaccine. We need to look more closely at the implementation itself.
Zuzana Roithová
(CS) Mr President, today, in hindsight, we can see that the expenditure of thousands of billions of euro on the battle against the H1N1 virus was excessive given the actual severity of the influenza outbreak. As a doctor, I think it is particularly telling that in Poland, where the government did not bow to pressure to carry out a nationwide vaccination programme, the mortality rate was no higher than in countries with high vaccination coverage. I thank Mrs Rivasi for this useful report and I would hope that Member States and all international organisations have learned from it; in particular, that drugs should be purchased jointly. More importantly, I hope they improve the evaluation methods of epidemiological statistics and that they restore the people's faith in recommendations made to citizens in the European Union.
Edite Estrela
(PT) Mr President, doubts about the H1N1 influenza vaccine have already been mentioned here. It is natural that the public should ask questions and be a little suspicious since, in 2009, there was a publicity campaign in all the Member States, large-scale investment was made in vaccines, and the World Health Organisation declared it a pandemic, and then the situation seems suddenly to have changed completely. In other words, in 2010, there was practically no talk of H1N1 influenza. It is therefore natural that people should ask questions about whether we were being alarmist then or are not taking it seriously enough now. The question is ...
(The President cut off the speaker)
Karin Kadenbach
(DE) Mr President, Commissioner, we can consider ourselves fortunate today that the epidemic did not take the course we had feared, which was that it would cause many deaths. Every single death is tragic enough.
I would like to thank all those who have contributed to the debate. This debate has reflected the situation in the EU very clearly: national experiences have varied greatly. We have different health systems. The structure and provision of healthcare is a national matter, but in the case of an epidemic or a pandemic, we need to work together at European level. We have seen that we still have a lot of lessons to learn and a lot of catching up to do in many areas here.
As has already been mentioned today more than once, we need, in any event, to regain the confidence of the population. The handling of the H1N1 situation has shown that there are shortcomings here. We need better coordination in future.
Maria Damanaki
Member of the Commission. - Mr President, I would like to thank the rapporteur, Mrs Rivasi, for this report, which really makes a valuable contribution to our efforts to learn from the 2009 pandemic. I agree with you that we have to learn from this pandemic and also that we need to critically review our response. To ensure the protection of European citizens against such health threats, we need to improve our preparedness and planning to manage similar cross-border threats to health.
The EU already had in place independent capacity and expertise on pandemic influenza. In the field of research alone, the European Commission has funded over 50 projects on influenza since 2000, an investment of EUR 150 million. Our agencies, the European Centre for Disease Prevention and Control and the European Medicines Agency, provided scientific advice during the pandemic to support the Union and its Member States.
In addition, Commission services actively supported the Member States in managing the threat through the EU Health Security Committee. However, I have to admit that, along with Parliament's report, various evaluations of our response have identified a series of shortfalls and challenges which need to be addressed.
These include the procurement of pandemic vaccines, the need to better coordinate vaccination strategies, the need for greater flexibility in our preparedness plans and the need for better communication with the public. The Commission, with the support of the scientific agencies and with the Member States, because this is a shared competence with the Member States, is committed to moving forward on these issues.
These challenges will be addressed by us under two initiatives. First, the Commission will present a health security initiative before the end of this year reinforcing our coordination capacities, and second, the Commission will also initiate a joint procurement mechanism for pandemic vaccines and antivirals for those Member States who wish to join. This would strengthen solidarity within the EU by guaranteeing a minimum level of equitable access to vaccines. This would also reinforce our purchasing power to obtain better contractual terms.
The Commission welcomes the support expressed by the rapporteur for such initiatives. The Commission also plans to fund additional research addressing behaviour aspects and communication strategies, notably, to improve vaccine update.
Finally, concerning the transparency and independence issues raised, we consider these to be very important and I really think we have to do something here. The Commission and the relevant agencies will work together to improve our procedures on declarations of interests and potential conflicts of interest.
We believe we need to continue to pull together towards our common aim of ensuring that we are better prepared to protect our citizens against future health threats.
President
The debate is closed.
The vote will take place at midday on Tuesday, 8 March.
Written statements (Rule 149)
János Áder
The most important lesson of the well-known H1N1 scandal is that people's faith has been shaken. The World Health Organisation cried wolf and, with its hysteria-fuelling forecasts, forced Member States to take steps that were disproportionate to the known and experienced severity of the H1N1 epidemic. In the end, considerably fewer people got sick and died from the H1N1 strain of flu worldwide than from ordinary seasonal flu, while individual countries spent unbelievable sums of public money to acquire vaccines that were up to two to three times more expensive than the average vaccine. Poland's case deserves mention here: the government did not vaccinate the population against H1N1, yet the mortality rate was not higher than in countries whose population was vaccinated. This happened in a context where the vaccine manufacturer, despite its hefty profits, had the audacity to refuse to take responsibility for the vaccine's side effects. It is an utterly disgraceful act to prey on people's fears and their sense of responsibility towards their families and loved ones, solely on the basis of abject greed for profits. The fact that, with its unfounded warnings of a pandemic, the WHO even assisted in this entire matter requires that the EU take the most resolute action. Lessons must be learned, and the EU must be given a higher degree of independence when evaluating cases that raise the possibility of an epidemic similar to H1N1. After all, the wolf may actually appear one day.
Sergio Berlato
Member States and the European institutions have implemented a series of costly measures that were, in many cases, out of all proportion to the true severity of H1N1 influenza. In Europe, according to estimates by the European Centre for Disease Control and Prevention, H1N1 influenza caused about 2 900 deaths in 2009. These figures are significantly lower than official estimates of deaths caused by seasonal flu alone and stand as testimony to the moderate severity of this influenza virus.
I therefore urge that the greatest attention should be paid to this issue so that the World Health Organisation (WHO) can conduct a review to issue a new definition of the criteria used for issuing a global pandemic alert, which takes into account not only the geographical spread of the disease, but also of its virulence. In addition, an analysis of the H1N1 crisis management by the EU clearly reveals to me an emerging need for strengthening cooperation among health authorities of Member States and the European institutions.
Finally, since I believe that to ensure the success or failure of a trial, it is essential to conduct studies on vaccines and antiviral drugs that are independent of pharmaceutical companies, I fully agree with the rapporteur's request to make public the names of all the experts who are consulted by the European public health authorities.
Jolanta Emilia Hibner
When it comes to the assessment of epidemiological risks, one should use the knowledge of independent experts who are not affiliated with pharmaceutical companies. The independence of the European Union in assessing the severity of AH1N1 influenza and the resulting risk is crucial. We must not rely solely on studies of experts funded by pharmaceutical companies.
Another puzzling aspect is the fast-track procedure used to introduce vaccines against H1N1, which had not been sufficiently tested and examined, to the market. In 2009, the pharmaceutical companies assessed the risk associated with the virus as very high, while it turned out to be less dangerous than ordinary flu. Back in May 2009, the WHO reported that the virus was not that dangerous. However, due to conflicting information, many countries gave in to the pressure and bought millions of expensive vaccines, which have not been used, and have by now become unusable. There is a need for a greater transparency of EU institutions in the field of disease management and a review of existing procedures. Greater and closer cooperation between countries is also essential to strengthen our negotiating position with regard to vaccine purchases.
I would like to mention that my home country, Poland, has set an example from the very beginning of how not to succumb to panic and how to demand a guarantee of the vaccines' safety.
Bogusław Sonik
The work on the report on the A/H1N1 virus pandemic in 2009-2010 lasted nearly one year. The discussion initiated in the European Parliament ended with an own-initiative report by the Committee on the Environment, Public Health and Food Safety on swine flu, which contained points emphasising the ethical and procedural irregularities which occurred while fighting the disease.
We were concerned about the ways the pharmaceutical companies publicised the issue of swine flu, presenting the virus as very dangerous and virulent. The virus proved to be much less dangerous than ordinary flu. The number of deaths stood at 2 900, while the estimated number of cases attributable to seasonal influenza amounts to 40 000 per year.
The report on the evaluation of the management of H1N1 influenza in the European Union calls for the independence of the EU when it comes to developing its own assessment of the seriousness of threats and the risks arising from them, rather than relying on the research of experts funded by pharmaceutical companies. At the same time, the suspect fast-track procedure used to introduce vaccines against H1N1 to the market, without sufficient tests and examinations, also raises criticism.
I would like to emphasise the need for increased transparency concerning the activities of EU institutions in the field of disease management, a review of existing procedures and their amendment towards greater flexibility, and the avoidance of conflicts of interest among evaluators and decision makers. I consider the call for the cooperation of countries to strengthen their negotiating position when buying drugs a priority. However, I would like to maintain the voluntary principle when it comes to the purchase of vaccines.
Artur Zasada
I congratulate Mrs Rivasi on the well-prepared report. I agree that a system should be developed to allow for accurately determining the magnitude of the risk and the strength of the virus in order to avoid future expenditure which would be disproportionate to the threat. I am very pleased that the Polish Government has not succumbed to panic on this issue, or rather, to the effective lobbying of the pharmaceutical companies.
I consider it particularly important for experts and researchers who provide opinions on the need to purchase drugs or vaccines to be completely independent of pharmaceutical companies. I support the rapporteur's proposal for specialists working in the pharmaceutical industry to only be consulted and to be excluded from the decision-making process. I must note with regret that tens of millions of doses of vaccines have still not been used in some Member States to this very day. This resulted in huge financial losses, while the lost funds could have been successfully used in a more thoughtful and effective way in protecting the health of Europe's citizens.
