BETA


2010/2153(INI) Evaluation of the management of H1N1 influenza in 2009-2010 in the EU

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI RIVASI Michèle (icon: Verts/ALE Verts/ALE) DELVAUX Anne (icon: PPE PPE), MCAVAN Linda (icon: S&D S&D), LEPAGE Corinne (icon: ALDE ALDE), YANNAKOUDAKIS Marina (icon: ECR ECR)
Lead committee dossier:
Legal Basis:
RoP 54

Events

2011/09/12
   EC - Commission response to text adopted in plenary
Documents
2011/03/08
   EP - Results of vote in Parliament
2011/03/08
   EP - Decision by Parliament
Details

The European Parliament adopted a resolution on the evaluation of the management of H1N1 influenza in 2009-2010 in the European Union.

The resolution recall that according to the figures provided by the European Centre for Disease Prevention and Control (ECDC) at the end of April 2010, influenza A(H1N1) 2009 caused 2 900 deaths in Europe. These figures are low in comparison to the official mortality estimates for seasonal influenza, which the Commission put at 40 000 deaths in a moderate year and 220 000 in a particularly severe season. They are also significantly less than the most optimistic forecasts suggested by the health services of the EU Member States.

On the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly using what resources they had available to implement public health action plans. The move to the highest level of alert, indicating the presence of a pandemic, gave rise in some cases to public health decisions that were disproportionate.

The following recommendations are made:

Enhanced cooperation : Parliament calls for the prevention plans established in the EU and its Member States for future influenza pandemics to be revised in order to gain in effectiveness and coherence and to make them sufficiently autonomous and flexible to be adapted as swiftly as possible and on a case-by-case basis to the actual risk, based on up-to date relevant information. It r equests clarification, and if necessary review, of the roles, duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management of medical threats and that this information be made available to the public. The resolution e mphasises the need to reinforce cooperation between Member States, and coordination of Member States with the European Centre for Disease Prevention and Control (ECDC).

Members express its approval for the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis.

They recall that according to current Union legislation on medicinal products, liability for the quality, safety and efficacy concerning the authorised indications of a medicinal product rests with the manufacturer. They call for full application of this rule by Member States in all contracts for the procurement of vaccines.

The resolution urges the WHO to revise the definition of a pandemic , taking into consideration not only its geographical spread but also its severity.

More independence : Parliament takes the view that the European Centre for Disease Prevention and Control (ECDC) has to exercise its powers as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks.

The resolution underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage.

According to Members, it is necessary to ensure that scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality. They request the development of a European code of conduct relating to the exercise of the function of a scientific expert in any European authority in charge of safety and of the management and anticipation of risks.

The Commission, along with the support of the EMA, is invited to improve the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in such a way that proper clinical trials are carried out before a pandemic occurs.

Increased transparency : Parliament calls for an assessment of the influenza vaccination strategies recommended in the EU and applied in Member States, covering the efficacy of the vaccines, their risk-benefit balance and the different target groups recommended, with a view to safe and effective use.

Members call for a summary report about the information on the number of doses purchased and used in different Member States, as well as on the illness and the adverse effects of the vaccinations and anti-viral treatments against H1N1 to be prepared by the Commission, before 8 March 2012, based on information presented by the Member States. This resolution should be made publicly available as an important contribution to the review of the current pandemic influenza preparedness plans.

Parliament recognises that conflicts of interest among experts who advise European public health authorities lead to suspicions of undue influence. It considers that all conflicts of interest must be avoided. It c alls for the declarations of interest of all experts who advise the European public health authorities to be published.

Lastly, the resolution insists on the need to communicate risks and benefits more clearly and transparently to the public. It underlines the necessity to arrive at a coherent message to the citizens as soon as a health hazard is evaluated (e.g. the nature of the virus, the nature of the risk, how best to prevent it and the risks and benefits of prevention and/or treatment). Parliament calls for a global European strategic approach for the so-called ‘at-risk’ groups on how to reach them and communicate with them in case of pandemics.

Documents
2011/03/08
   EP - End of procedure in Parliament
2011/03/07
   EP - Debate in Parliament
2011/02/09
   EP - Committee report tabled for plenary, single reading
Documents
2011/02/09
   EP - Committee report tabled for plenary
Documents
2011/01/25
   EP - Vote in committee
Details

The Committee on the Environment, Public Health and Food Safety adopted the own-initiative report drafted by Michèle RIVASI (Greens/EFA, FR) on the evaluation of the management of H1N1 influenza in 2009-2010 in the EU.

According to the figures provided by the European Centre for Disease Prevention and Control (ECDC) at the end of April 2010, influenza A(H1N1) 2009 caused 2 900 deaths in Europe. These figures are low in comparison to the official mortality estimates for seasonal influenza, which the Commission put at 40 000 deaths in a moderate year and 220 000 in a particularly severe season. They are also significantly less than the most optimistic forecasts suggested by the health services of the EU Member States.

On the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly using what resources they had available to implement public health action plans. The move to the highest level of alert, indicating the presence of a pandemic, gave rise in some cases to public health decisions that were disproportionate.

The following recommendations are made:

Enhanced cooperation : the committee calls for the prevention plans established in the EU and its Member States for future influenza pandemics to be revised . It r equests clarification, and if necessary review, of the roles, duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management of medical threats and that this information be made available to the public.

The report e mphasises the need to reinforce cooperation between Member States, and coordination of Member States with the European Centre for Disease Prevention and Control (ECDC).

Members express its approval for the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis.

They recall that according to current Union legislation on medicinal products, liability for the quality, safety and efficacy concerning the authorised indications of a medicinal product rests with the manufacturer. They call for full application of this rule by Member States in all contracts for the procurement of vaccines.

The report urges the WHO to revise the definition of a pandemic , taking into consideration not only its geographical spread but also its severity.

More independence : Members take the view that the European Centre for Disease Prevention and Control (ECDC) has to exercise its powers as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks.

The report underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage.

According to Members, it is necessary to ensure that scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality. They request the development of a European code of conduct relating to the exercise of the function of a scientific expert in any European authority in charge of safety and of the management and anticipation of risks.

The Commission, along with the support of the EMA, is invited to improve the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in such a way that proper clinical trials are carried out before a pandemic occurs.

Increased transparency : the committee calls for an assessment of the influenza vaccination strategies recommended in the EU and applied in Member States, covering the efficacy of the vaccines, their risk-benefit balance and the different target groups recommended, with a view to safe and effective use.

A summary report about the information on the number of doses purchased and used in different Member States, as well as on the illness and the adverse effects of the vaccinations and anti-viral treatments against H1N1 shall be prepared by the Commission in the 12 months after the adoption of this Parliament resolution based on information presented by the Member States. This report should be made publicly available as an important contribution to the review of the current pandemic influenza preparedness plans.

Members recognise that conflicts of interest among experts who advise European public health authorities lead to suspicions of undue influence. They consider that all conflicts of interest must be avoided. They c all for the declarations of interest of all experts who advise the European public health authorities to be published.

Lastly, the report insists on the need to communicate risks and benefits more clearly and transparently to the public. It underlines the necessity to arrive at a coherent message to the citizens as soon as a health hazard is evaluated (e.g. the nature of the virus, the nature of the risk, how best to prevent it and the risks and benefits of prevention and/or treatment).

2011/01/19
   EP - Amendments tabled in committee
Documents
2010/12/20
   EP - Amendments tabled in committee
Documents
2010/10/15
   EP - Committee draft report
Documents
2010/09/09
   EP - Committee referral announced in Parliament
2010/07/14
   EP - RIVASI Michèle (Verts/ALE) appointed as rapporteur in ENVI

Documents

AmendmentsDossier
172 2010/2153(INI)
2010/12/20 ENVI 172 amendments...
source: PE-454.473

History

(these mark the time of scraping, not the official date of the change)

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  • date: 2011-01-25T00:00:00 body: EP committees: body: EP shadows: group: PPE name: DELVAUX Anne group: S&D name: MCAVAN Linda group: ALDE name: LEPAGE Corinne group: ECR name: YANNAKOUDAKIS Marina responsible: True committee: ENVI date: 2010-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: Verts/ALE name: RIVASI Michèle type: Vote in committee, 1st reading/single reading
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  • date: 2011-09-12T00:00:00 docs: url: /oeil/spdoc.do?i=19550&j=0&l=en title: SP(2011)5426 type: Commission response to text adopted in plenary
events
  • date: 2010-09-09T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2011-01-25T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary: The Committee on the Environment, Public Health and Food Safety adopted the own-initiative report drafted by Michèle RIVASI (Greens/EFA, FR) on the evaluation of the management of H1N1 influenza in 2009-2010 in the EU. According to the figures provided by the European Centre for Disease Prevention and Control (ECDC) at the end of April 2010, influenza A(H1N1) 2009 caused 2 900 deaths in Europe. These figures are low in comparison to the official mortality estimates for seasonal influenza, which the Commission put at 40 000 deaths in a moderate year and 220 000 in a particularly severe season. They are also significantly less than the most optimistic forecasts suggested by the health services of the EU Member States. On the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly using what resources they had available to implement public health action plans. The move to the highest level of alert, indicating the presence of a pandemic, gave rise in some cases to public health decisions that were disproportionate. The following recommendations are made: Enhanced cooperation : the committee calls for the prevention plans established in the EU and its Member States for future influenza pandemics to be revised . It r equests clarification, and if necessary review, of the roles, duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management of medical threats and that this information be made available to the public. The report e mphasises the need to reinforce cooperation between Member States, and coordination of Member States with the European Centre for Disease Prevention and Control (ECDC). Members express its approval for the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis. They recall that according to current Union legislation on medicinal products, liability for the quality, safety and efficacy concerning the authorised indications of a medicinal product rests with the manufacturer. They call for full application of this rule by Member States in all contracts for the procurement of vaccines. The report urges the WHO to revise the definition of a pandemic , taking into consideration not only its geographical spread but also its severity. More independence : Members take the view that the European Centre for Disease Prevention and Control (ECDC) has to exercise its powers as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks. The report underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage. According to Members, it is necessary to ensure that scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality. They request the development of a European code of conduct relating to the exercise of the function of a scientific expert in any European authority in charge of safety and of the management and anticipation of risks. The Commission, along with the support of the EMA, is invited to improve the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in such a way that proper clinical trials are carried out before a pandemic occurs. Increased transparency : the committee calls for an assessment of the influenza vaccination strategies recommended in the EU and applied in Member States, covering the efficacy of the vaccines, their risk-benefit balance and the different target groups recommended, with a view to safe and effective use. A summary report about the information on the number of doses purchased and used in different Member States, as well as on the illness and the adverse effects of the vaccinations and anti-viral treatments against H1N1 shall be prepared by the Commission in the 12 months after the adoption of this Parliament resolution based on information presented by the Member States. This report should be made publicly available as an important contribution to the review of the current pandemic influenza preparedness plans. Members recognise that conflicts of interest among experts who advise European public health authorities lead to suspicions of undue influence. They consider that all conflicts of interest must be avoided. They c all for the declarations of interest of all experts who advise the European public health authorities to be published. Lastly, the report insists on the need to communicate risks and benefits more clearly and transparently to the public. It underlines the necessity to arrive at a coherent message to the citizens as soon as a health hazard is evaluated (e.g. the nature of the virus, the nature of the risk, how best to prevent it and the risks and benefits of prevention and/or treatment).
  • date: 2011-02-09T00:00:00 type: Committee report tabled for plenary, single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2011-35&language=EN title: A7-0035/2011
  • date: 2011-03-07T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20110307&type=CRE title: Debate in Parliament
  • date: 2011-03-08T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=19550&l=en title: Results of vote in Parliament
  • date: 2011-03-08T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2011-77 title: T7-0077/2011 summary: The European Parliament adopted a resolution on the evaluation of the management of H1N1 influenza in 2009-2010 in the European Union. The resolution recall that according to the figures provided by the European Centre for Disease Prevention and Control (ECDC) at the end of April 2010, influenza A(H1N1) 2009 caused 2 900 deaths in Europe. These figures are low in comparison to the official mortality estimates for seasonal influenza, which the Commission put at 40 000 deaths in a moderate year and 220 000 in a particularly severe season. They are also significantly less than the most optimistic forecasts suggested by the health services of the EU Member States. On the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly using what resources they had available to implement public health action plans. The move to the highest level of alert, indicating the presence of a pandemic, gave rise in some cases to public health decisions that were disproportionate. The following recommendations are made: Enhanced cooperation : Parliament calls for the prevention plans established in the EU and its Member States for future influenza pandemics to be revised in order to gain in effectiveness and coherence and to make them sufficiently autonomous and flexible to be adapted as swiftly as possible and on a case-by-case basis to the actual risk, based on up-to date relevant information. It r equests clarification, and if necessary review, of the roles, duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management of medical threats and that this information be made available to the public. The resolution e mphasises the need to reinforce cooperation between Member States, and coordination of Member States with the European Centre for Disease Prevention and Control (ECDC). Members express its approval for the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis. They recall that according to current Union legislation on medicinal products, liability for the quality, safety and efficacy concerning the authorised indications of a medicinal product rests with the manufacturer. They call for full application of this rule by Member States in all contracts for the procurement of vaccines. The resolution urges the WHO to revise the definition of a pandemic , taking into consideration not only its geographical spread but also its severity. More independence : Parliament takes the view that the European Centre for Disease Prevention and Control (ECDC) has to exercise its powers as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks. The resolution underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage. According to Members, it is necessary to ensure that scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality. They request the development of a European code of conduct relating to the exercise of the function of a scientific expert in any European authority in charge of safety and of the management and anticipation of risks. The Commission, along with the support of the EMA, is invited to improve the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in such a way that proper clinical trials are carried out before a pandemic occurs. Increased transparency : Parliament calls for an assessment of the influenza vaccination strategies recommended in the EU and applied in Member States, covering the efficacy of the vaccines, their risk-benefit balance and the different target groups recommended, with a view to safe and effective use. Members call for a summary report about the information on the number of doses purchased and used in different Member States, as well as on the illness and the adverse effects of the vaccinations and anti-viral treatments against H1N1 to be prepared by the Commission, before 8 March 2012, based on information presented by the Member States. This resolution should be made publicly available as an important contribution to the review of the current pandemic influenza preparedness plans. Parliament recognises that conflicts of interest among experts who advise European public health authorities lead to suspicions of undue influence. It considers that all conflicts of interest must be avoided. It c alls for the declarations of interest of all experts who advise the European public health authorities to be published. Lastly, the resolution insists on the need to communicate risks and benefits more clearly and transparently to the public. It underlines the necessity to arrive at a coherent message to the citizens as soon as a health hazard is evaluated (e.g. the nature of the virus, the nature of the risk, how best to prevent it and the risks and benefits of prevention and/or treatment). Parliament calls for a global European strategic approach for the so-called ‘at-risk’ groups on how to reach them and communicate with them in case of pandemics.
  • date: 2011-03-08T00:00:00 type: End of procedure in Parliament body: EP
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  • date: 2011-03-08T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=19550&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2011-77 type: Decision by Parliament, 1st reading/single reading title: T7-0077/2011 body: EP type: Results of vote in Parliament
committees
  • body: EP shadows: group: PPE name: DELVAUX Anne group: S&D name: MCAVAN Linda group: ALDE name: LEPAGE Corinne group: ECR name: YANNAKOUDAKIS Marina responsible: True committee: ENVI date: 2010-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: Verts/ALE name: RIVASI Michèle
links
other
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: DALLI John
procedure
dossier_of_the_committee
ENVI/7/03231
reference
2010/2153(INI)
title
Evaluation of the management of H1N1 influenza in 2009-2010 in the EU
legal_basis
Rules of Procedure of the European Parliament EP 052
stage_reached
Procedure completed
subtype
Initiative
Modified legal basis
Rules of Procedure of the European Parliament EP 150
type
INI - Own-initiative procedure
subject