2010/2153(INI) | [ParlTrack]

Motion for a resolution
Citation 6 a (new)

- having regard to the ECDC threat assessment of 30 April 2009 on ‘Implication for Europe of the identification in North America of human cases of influenza A/H1N1, with a unique gene segment combination’ (x), x http://ecdc.europa.eu/en/healthtopics/H1 N1/Documents/1001_RA_090430.pdf

Amendment 10 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU

Motion for a resolution
Recital A

A. whereas the national and international health authorities, including the WHO, were aware as early as May 2009 that the H1N1 influenza ~~was not~~had rapidly lost its initial high virulentce, with this moderate virulence being confirmed by the very low mortality rate observed as a result of this influenza ‘pandemic’ in comparison with the officially recognised figures for seasonal influenza,

Amendment 100 #

Motion for a resolution
Paragraph 3 a (new)

3a. Underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage;

Amendment 101 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE

Motion for a resolution
Paragraph 4

4. Calls for immediate clarifications on the effectiveness of the influenza vaccination strategies recommended in the EU, given the weight of evidence casting doubt on their effectiveness, the absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit- risk profile;deleted

Amendment 102 #

Motion for a resolution
Paragraph 4

Amendment 103 #

Antonyia PARVANOVA

Motion for a resolution
Paragraph 4

4. Calls for an immediate ~~clarifications~~assessment onf the effectiveness of the H1N1 influenza vaccination strateg~~ies~~y recommended ~~in the EU, given the weight of evidence casting doubt~~at EU level and developed by Member States, including a detailed evaluation onf their cost-effectiveness, of the ~~absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit-risk profile;~~measures taken and activities implemented, also taking into account the risk-benefit profile of the different approaches and strategies in fighting extraordinary influenza outbreaks

Amendment 104 #

Motion for a resolution
Paragraph 4

4. Calls for ~~immediate clarifications~~an in-depth assessment onf the eff~~ectiveness~~icacy of the influenza vaccination strategies recommended in the EU, given the ~~weight of evidence casting doubt on~~ambiguous conclusions about their eff~~ectiveness, the absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit-risk profile~~icacy of influenza vaccines in major scientific reviews, and for clear proof of a positive risk-benefit balance for such vaccines;

Amendment 105 #

Motion for a resolution
Paragraph 4

4. Calls for ~~immediate clarific~~an investigations on the effectiveness of the influenza vaccination strategies recommended in the EU~~, given the weight of evidence casting doubt on their effectiveness, the absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit-risk profile~~;

Amendment 106 #

Frédérique RIES

Motion for a resolution
Paragraph 4

4. Calls for ~~immediate clarifications on~~all the relevant lessons swiftly to be learned from the ineffectiveness of the A/H1N1 influenza vaccination strateg~~ies~~y recommended in the EU~~, given the weight of evidence casting doubt on their effectiveness,~~ and introduced in the 27 Member States in an uncoordinated manner, given the absence of reliable data guaranteeing ~~that~~its effectiveness and the lingering uncertainties surrounding ~~their~~its benefit-risk profile;

Amendment 107 #

Motion for a resolution
Paragraph 4

Amendment 108 #

Giommaria UGGIAS, Corinne LEPAGE

Motion for a resolution
Paragraph 4

4. Calls for immediate independent data collection and corresponding clarifications on the effectiveness of the influenza vaccination strategies recommended in the EU, given the weight of evidence casting doubt on their effectiveness, the absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit-risk profile;

Amendment 109 #

Motion for a resolution
Paragraph 4 a (new)

4a. Calls on the Commission and the Member States to supply details of the following: (1) the number of doses of vaccine ultimately purchased by each Member State; (2) total expenditure on the purchase of vaccines in each Member State; (3) the number of doses of vaccine actually used in each Member State; (4) the number of doses of vaccine which were, respectively, placed in storage, the subject of reimbursement, and sold to other Member States;

Amendment 11 #

Motion for a resolution
Recital A

A. whereas the national and international health authorities, including the WHO, were aware as early as May 2009 that the H1N1 influenza was not virulent, with this moderate virulence ~~being~~having since been confirmed by the ~~very~~ low mortality rate observed as a result of this influenza ‘pandemic’ in comparison with the officially recognised figures for seasonal influenza,

Amendment 110 #

Giommaria UGGIAS

Motion for a resolution
Paragraph 4 b (new)

4b. Calls for steps to be taken to determine whether or not the European Union was involved in funding the purchase of doses of vaccine and/or in commissioning studies or research in this area;

Amendment 111 #

Françoise GROSSETÊTE

Motion for a resolution
Paragraph 5

Amendment 112 #

Motion for a resolution
Paragraph 5

5. Calls in particular on the EMA to review the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in ~~order to ensure correct~~ter alia by making it suitable for different influenza strains, varying levels of severity and differences in target groups so that proper clinical trials have been carried out before a pandemic occurs, in order to ensure proper assessment of the risk-benefit~~-risk profil~~ balance associated with the use of those medicinal products;

Amendment 113 #

Anne DELVAUX, Richard SEEBER, Elena Oana ANTONESCU

Motion for a resolution
Paragraph 5

5. Calls in particular on the E~~MA to review~~uropean Commission to produce a report with recommendations on the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in order to ensure ~~correct~~a full assessment of the benefit-risk profile associated with the use of those medicinal products;

Amendment 114 #

Motion for a resolution
Paragraph 5

5. Calls in particular on the European Commission and the EMA to review the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in order to ensure ~~correct~~a full assessment of the benefit-risk profile associated with the use of those medicinal products;

Amendment 115 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU

Motion for a resolution
Paragraph 5

5. Calls in particular on the EMA to review the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in order to ensure correct assessment of the benefit-risk profile associated with the use of those medicinal products, and to draw up corresponding proposals for a revision of these authorisation procedures;

Amendment 116 #

Philippe JUVIN

Motion for a resolution
Paragraph 5

5. Calls in particular on the EMA to ~~review~~improve the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in order to ensure correct assessment of the benefit-risk profile associated with the use of those medicinal products;

Amendment 117 #

Motion for a resolution
Paragraph 5 a (new)

5a. Wants to ensure that the scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality; Request the development of a European code of conduct relating to the exercise of the scientific function of expert in any European authority in charge of safety, of the management and the anticipation of the risks ; require that each expert subscribe to the ethical principles of this code of conduct before any taking up the duties ;

Amendment 118 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU

Motion for a resolution
Paragraph 5 b (new)

5b. Asks that experts who are involved in the pharmaceutical sector could be consulted but should be excluded from decision-making ;

Amendment 119 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE, Elena Oana ANTONESCU

Motion for a resolution
Paragraph 5 c (new)

5c. Requests the installation of a definition of the conflict of interest which is common to all the European agencies ;

Amendment 12 #

Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE, Elena Oana ANTONESCU

Motion for a resolution
Recital A a (new)

Aa. whereas, under the International Health Regulations (IHR) – a legal instrument binding on the states parties to it – the remit of the WHO includes public health surveillance, coordinating international public health measures and, in relation to potentially pandemic viruses, determining current phases of alert on a scale of one to six,

Amendment 120 #

Motion for a resolution
Paragraph 5 a (new)

5a. That the ECDC be requested to assemble an expert and independent group of scientists and health care professionals are tasked with providing advice on non-pharmaceutical approaches that might be employed by Member States and the public to reduce the risk of infection or transmission and the severity of symptoms associated with infection;

Amendment 121 #

Motion for a resolution
Paragraph 6

~~6. Calls on the Commission to launch an audit of the operation of the EMA and the ECDC, and of the overall cost of the management of H1N1 influenza in the EU;~~deleted

Amendment 122 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to launch an audit of the ~~operation of the EMA and the ECDC, and of the~~ overall cost of the management of H1N1 influenza in the EU;

Amendment 123 #

Motion for a resolution
Paragraph 6

6. Calls on the Commission to launch a~~n audit~~ review of the operation of the EMA and the ECDC, and of the overall cost of the management of H1N1 influenza in the EU;

Amendment 124 #

Motion for a resolution
Paragraph 6 a (new)

6a. Calls on the Commission to launch an audit of the operation of the EMA and the ECDC with regards to H1N1 management.

Amendment 125 #

Motion for a resolution
Paragraph 7

7. ~~Reminds the EMA of~~Notes that the regulatory requirement to make access available to all the documents relating to clinical trials, research protocols and the undesirable effects of the medicinal products evaluated by its experts, including the vaccines and anti-viral drugs recommended as a means of combating H1N1 influenza; are stipulated in the newly adopted pharmacovigilance legislation.

Amendment 126 #

Motion for a resolution
Paragraph 7

7. Reminds the EMA of the regulatory requirement to make access available to all the documents relating to clinical trials, research protocols and the undesirable effects of the medicinal products evaluated by its experts, including the vaccines and anti-viral drugs recommended as a means of combating H1N1 influenza; welcomes the new rules on access to documents adopted by the EMA in October and calls on the EMA to apply them without delay;

Amendment 127 #

Motion for a resolution
Paragraph 7

7. ~~Reminds t~~The EMA ~~of the~~as a regulatory requirement toshould make ~~access~~ available to all the documents relating to clinical trials, research protocols and the undesirable effects of the medicinal products evaluated by its experts, including the vaccines and anti-viral drugs recommended as a means of combating H1N1 influenza;

Amendment 128 #

Motion for a resolution
Paragraph 7 a (new)

7a. Calls on the Commission to review the Clinical Trials Directive (Directive 2001/20/EC) regarding the public availability of results of clinical trials, so as to increase public access to information and public awareness.

Amendment 129 #

Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE, Elena Oana ANTONESCU

Motion for a resolution
Paragraph 8

Amendment 13 #

Motion for a resolution
Recital A b (new)

Ab. whereas the phases of a global pandemic are determined in accordance with the provisions of the IHR and in consultation with other organisations and institutions and with the Member States affected,

Amendment 130 #

Françoise GROSSETÊTE

Motion for a resolution
Paragraph 8

8. Considers theat all conflicts of interest apparent in the case of some experts who advise the European institutions to give rise to suspicions of undue influence and to undermine the overall credibility of the European health agencies and their recommendations; calls in particular for the EMA and ECDC to revise forthwith their current and future expert screening procedures to ensure completemust be avoided; welcomes the new European Medical Agency (EMA) rules, which make for greater transparency;

Amendment 131 #

Frédérique RIES

Motion for a resolution
Paragraph 8

8. Considers ~~the conflicts of interest apparent in the case of some experts who advise the European institutions to give rise to susp~~it normal and not in itself reprehensible that experts who work for public authorities should have links, through other consultancy work, with manufacturers of mediciones o~~f undue influence and to undermine the overall credibility of the European health agencies and their recommendations; calls in~~r vaccines, but also considers it essential, in order to avoid any risk of conflicts of interest, for the relevant authorities at both national and European level, and particular ~~for~~ly the EMA and ECDC, to ~~revise forthwith their current and future expert screening procedures to ensure complete transparency~~make sure that their experts proceed in a fully transparent and independent manner, following all the steps of a clearly identified procedure, from the stage of declaring interests through to the approval of opinions to be issued;

Amendment 132 #

Motion for a resolution
Paragraph 8

8. ~~Considers~~Recognises that the conflicts of interest apparent in the case of some experts ~~who advise the European institutions to give rise~~could lead to suspicions of undue influence and ~~to undermine the overall~~harm the credibility of the European health agencies and their recommendations; ~~calls in particular for the EMA and ECDC to revise forthwith their current and future expert screening procedures to ensure complete transparency;~~

Amendment 133 #

Motion for a resolution
Paragraph 8

8. C~~onsiders the conflicts of interest apparent in the case of some~~alls for the declarations of interest of all experts who advise the European institutions to ~~give rise to~~be published to avoid suspicions of undue influence ~~and to~~, which would undermine the overall credibility of the European health agencies and their recommendations; calls in particular for the EMA and ECDC to revise forthwith their current and future expert screening procedures to ensure complete transparency;

Amendment 134 #

Motion for a resolution
Paragraph 8

8. Considers the conflicts of interest apparent in the case of some experts who advise ~~the European institution~~public health authorities to give rise to suspicions of undue influence and to undermine the overall credibility of ~~the European~~public health a~~genc~~uthorities and their recommendations; calls in particular for the EMA and ECDC to revise forthwith their current and future expert screening procedures to ensure complete transparency;

Amendment 135 #

Motion for a resolution
Paragraph 8

8. Considers the conflicts of interest apparent in the case of some experts who advise the European institutions to give rise to suspicions of undue influence and to undermine the overall credibility of the European health agencies and their recommendations; calls in particular for the EMA and ECDC to revise forthwith their current and future expert screening procedures to ensure complete transparency; calls too on the Commission and the agencies concerned to introduce procedures for checking declarations of interest, if necessary by setting up a monitoring body that would be independent of the agencies but linked to the Commission’s Register of Expert Groups;

Amendment 136 #

Motion for a resolution
Paragraph 8

8. Considers the conflicts of interest apparent in the case of some experts who advise the European institutions to give rise to suspicions of undue influence and to undermine the overall credibility of the European health agencies and their recommendations; calls in particular for the EMA and ECDC to revise forthwith their current and future expert screening procedures to ensure complete transparency; calls on the European Anti- Fraud Office (OLAF) to carry out a thoroughgoing review of these screening procedures;

Amendment 137 #

Giommaria UGGIAS

Motion for a resolution
Paragraph 8 a (new)

8a. Calls for such conflicts of interest to be brought to Parliament's attention by means of an internal investigation carried out by the Committee on Budgetary Control with a view to determining whether payments to the aforementioned experts were made in a correct and transparent manner and whether the procedures normally employed by the European institutions to forestall such conflicts of interest were followed;

Amendment 138 #

Motion for a resolution
Paragraph 9

Amendment 139 #

Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther DE LANGE, Françoise GROSSETÊTE

Motion for a resolution
Paragraph 9

9. Calls for the publication of the names, roles and potential conflicts of interest of senior officials who are members of informal groups such as the EU's Health Security Committee, the Health Emergency Operational Facility (HEOF) and the ‘vaccines’ task force; at the time they are working for public health authorities in order to assess who advises and to guarantee transparency;

Amendment 14 #

Motion for a resolution
Recital B

B. whereas the criteria for defining a ‘pandemic’, adopted by the WHO in 2009 and based solely on the propagation of the virus while discounting the severity of the infection, distorted the meaning of the word ‘pandemic’ and triggered a false alarm worldwide, with that alarmism giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States,deleted

Amendment 140 #

Corinne LEPAGE, Giommaria UGGIAS

Motion for a resolution
Paragraph 9

9. Calls for the publication of the names, roles and potential conflicts of interest of senior officials who are members of informal groups such as the EU’s Health Security Committee, the Health Emergency Operational Facility (HEOF) and the ‘vaccines’ task force; calls on OLAF to investigate these statements concerning the falsification of or the failure to provide important information;

Amendment 141 #

Motion for a resolution
Paragraph 9

9. Calls ~~for~~on the ~~publication of~~Commission to publish the names, roles and potential conflicts of interest of senior officials who are members of informal groups such as the EU’s Health Security Committee, the Health Emergency Operational Facility (HEOF) and the ‘vaccines’ task force;

Amendment 142 #

Motion for a resolution
Paragraph 9

9. Calls for the publication of the names, roles and ~~potential conflict~~declarations of interest of senior officials who are members of informal groups such as the EU's Health Security Committee, the Health Emergency Operational Facility (HEOF) and the ‘vaccines’ task force;

Amendment 143 #

Motion for a resolution
Paragraph 10

10. CRecalls ~~for full liability for the quality, safety and effectivenes~~that according to current Union legislation on medicinal products, the liability for the quality, safety and efficacy concerning the authorised indications of a medicinal product to rests with the manufacturer and calls for full application of this by Member States in all procurement of vaccines as an important element to maintain/regain citizens trust in vaccine safety;

Amendment 144 #

Motion for a resolution
Paragraph 10

10. Calls for full liability for the quality, safety and eff~~ectiveness~~icacy of a medicinal product to rest with the manufacturer, bearing in mind the exceptional circumstances a pandemic constitutes;

Amendment 145 #

Anne DELVAUX, Richard SEEBER, Françoise GROSSETÊTE

Motion for a resolution
Paragraph 10

10. Calls for full liability for the quality, safety and effectiveness of ~~a medicinal product~~vaccines to rest with the manufacturer; bearing in mind the exceptional circumstances a pandemic constitutes;

Amendment 146 #

Philippe JUVIN

Motion for a resolution
Paragraph 10

10. Calls for full liability for the quality, safety and effectiveness of a medicinal product to rest with the manufacturer, while taking account of the different legal arrangements for compulsory vaccinations;

Amendment 147 #

Motion for a resolution
Paragraph 10

10. Calls for full liability for the quality, safety and effectiveness of a medicinal product to rest with the manufacturer, as required by EU law;

Amendment 148 #

Frédérique RIES

Motion for a resolution
Paragraph 10

10. Calls for full liability for the quality, safety and effectiveness of a medicinal product to rest with the manufacturer once it has been established that the product is defective and that compensation is therefore payable;

Amendment 149 #

Motion for a resolution
Paragraph 9 a (new)

9a. Regrets that the apparent lack of transparency has lead to loss of credibility of EU institutions' decisions, including by health professionals.

Amendment 15 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU

Motion for a resolution
Recital B

Amendment 150 #

Motion for a resolution
Paragraph 10 a (new)

10a. Is aware of the need to communicate more clearly and transparently to help the publics to facilitate the risk communication; Underlines the necessity to arrive to only one and single message bound for the citizens as soon as the health hazard was evaluated ; insists on the importance of consistent communication of the Member States regarding the informative contents of the message (as for the nature of the virus, with the nature of the risk and in the manner of securing and curing);

Amendment 151 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Esther DE LANGE, Françoise GROSSETÊTE

Motion for a resolution
Paragraph 10 b (new)

10b. Requires 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;

Amendment 152 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN

Motion for a resolution
Paragraph 10 c (new)

10c. Calls to build relationships of trust with the media concerned with disseminating public health messages; Request the setting-up of a select group of available experts to answer questions from journalists at all times, as well as the availability of a spokesperson;

Amendment 153 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU

Motion for a resolution
Paragraph 10 d (new)

10d. Stresses the need for accountability of information professionals and the prudence required in the processing of health information messages a fortiori in the context of a pandemic;

Amendment 154 #

Antonyia PARVANOVA

Motion for a resolution
Paragraph 10 e (new)

10e. Recommends EMA and ECDC to develop targeted communication toolkits and organise specific information sessions in order to further sensitise journalists and media professionals on the issue of pandemic and communicable diseases managements at local, national and international level

Amendment 155 #

Anne DELVAUX

Motion for a resolution
Subheading 3

~~COOPERATION~~deleted

Amendment 156 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE

Motion for a resolution
Subheading 3 a (new)

Within the framework of the common and liable management of supply of vaccines, request to think over the possibility of easing the access of developing countries to vaccinal products in case of a pandemic;

Amendment 157 #

Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Elena Oana ANTONESCU

Motion for a resolution
Paragraph 11

11. Demands precise definition of the roles, duties, remits, limits, relations and responsibilities of the Commission, the ECDC, the EMA and the Member States and also of more informal entities such as the Health Security Committee, the HEOF and the ‘public health’ group, composed of senior officials able to intervene in the decision-making process regarding the management of a health crisis;deleted

Amendment 158 #

Motion for a resolution
Paragraph 11

11. ~~Demands precise definition of~~Requests to specify and clarify the roles, duties, remits, limits, relations and responsibilities of the key actors and the structures of management of the medical threats at the level of the EU which are the European Commission, the ECDC, the EMA and the Member States and also of more informal entities such as the Health Security Committee, the HEOF and the ‘public health’ group, composed of senior officials able to intervene in the decision- making process regarding the management of a health crisis;

Amendment 159 #

Motion for a resolution
Paragraph 11

Amendment 16 #

Motion for a resolution
Recital B

Amendment 160 #

Motion for a resolution
Paragraph 11

11. ~~Demand~~Establishes precise definition of the roles, duties, remits, limits, relations and responsibilities of the Commission, the ECDC, the EMA and the Member States and also of more informal entities such as the Health Security Committee, the HEOF and the ‘public health’ group, composed of senior officials able to intervene in the decision-making process regarding the management of a health crisis;

Amendment 161 #

Motion for a resolution
Paragraph 11 a (new)

11a. Calls for the continuation and improvement of cooperation and coordination among Member States, institutions and international and regional organisations, particularly in the early stages of a virus outbreak, in order to define its severity and proceed to pertinent management decisions.

Amendment 162 #

Anne DELVAUX, Richard SEEBER, Philippe JUVIN

Motion for a resolution
Paragraph 11 b (new)

11b. Expects, on this regard, a more comprehensive collection and rapid submission of coherent data from national health monitoring authorities to competent EU authorities.

Amendment 163 #

Motion for a resolution
Paragraph 12

12. Expresses its approval of the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis where the positive benefit-risk profile of their preventive/therapeutic effect is clearly demonstrated and indisputable, in order to obtain, for a given product, advantageous rates approaching its cost price;deleted

Amendment 164 #

Motion for a resolution
Paragraph 12

Amendment 165 #

Motion for a resolution
Paragraph 12

12. Expresses its approval of the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis ~~where the positive benefit-risk profile of their preventive/therapeutic effect is clearly demonstrated and indisputable~~, in order to obtain, for a given product, advantageous rates approaching its cost price;

Amendment 166 #

Motion for a resolution
Paragraph 12

12. Expresses its approval of the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis where the positive benefit-risk profile of their preventive/therapeutic effect is ~~clearly~~ demonstrated ~~and indisputa~~independently, conclusively and plausibley, in order to obtain, for a given product, advantageous rates approaching its cost price;

Amendment 167 #

Motion for a resolution
Paragraph 12

12. Expresses its approval of the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis where the positive benefit-risk profile of their preventive/therapeutic effect is clearly demonstrated by independent experts and indisputable, in order to obtain, for a given product, advantageous rates approaching its cost price;

Amendment 168 #

Motion for a resolution
Paragraph 12

Amendment 169 #

Motion for a resolution
Paragraph 12 a (new)

12a. Requests the development and release of an independent and comprehensive public health strategy including non-pharmaceutical approaches for the prevention and management of infectious diseases, including those caused by influenza viruses, in order to assist European citizens, health care professionals and health authorities in Member States;

Amendment 17 #

Motion for a resolution
Recital B

B. whereas the criteria for defining a ‘pandemic~~’, adopted~~ by the WHO i~~n 2009 and based solely on the propagat~~s based on the decisions of the ~~virus while discounting the severity of the infection, distorted the meaning of the word ‘~~organisation's participatory countries, and the WHO issued its pandemic’ a~~nd triggered a false alarm worldwide, with that alarmism giving rise to inappropriate public health decisions and a disproportionate~~lert declaration in line with these decisions, following 144 respo~~nse among the public and administrations of the European Union and its Member States~~rted deaths from 74 countries around the globe,

Amendment 170 #

Motion for a resolution
Paragraph 12 a (new)

12a. Calls on the Commission to examine the possibility of creating joint vaccine- stocks, setting up a solidarity and brokerage mechanism between Member States and drawing up a European model contract for prior purchase agreements of vaccines;

Amendment 171 #

Motion for a resolution
Paragraph 13

13. Considers it essential for ~~its Members and the European public to be informed of these revis~~the Commission and member states to focus on building trust by developing better communication strategies in order to build confidence in public health strategies that encourage vaccinations and ~~details at the earliest opportunity;~~ seek to prepare and prevent pandemics.

Amendment 172 #

Corinne LEPAGE, Giommaria UGGIAS

Motion for a resolution
Paragraph 14

14. Instructs its President to forward this resolution to the Council, the Commission, the WHO and national parliaments.

Amendment 18 #

Motion for a resolution
Recital B

B. whereas the criteria for defining a ‘pandemic’, adopted by the WHO in 2009 in its guidance document on ‘Pandemic influenza preparedness and response’ and based solely on the propagation of the virus while discounting the severity of the infection, ~~distorted the meaning of the word ‘pandemic’ and triggered a false alarm worldwide, with th~~led authorities at EU level and in the Member States to take inappropriate a~~larmism giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States~~nd disproportionate public health decisions and gave rise to public alarmism,

Amendment 19 #

Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Elena Oana ANTONESCU

Motion for a resolution
Recital B

B. whereas the criteria for defining a ‘pandemic’, as adopted by the WHO in 2009, andre based solely on the propagation of the virus while discounting the severity of the infection, distorted the meaning of the word ‘pandemic’ and triggered a false alarm worldwide, with that alarmism giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States,

Amendment 2 #

Motion for a resolution
Citation 23

– having regard to the report by the French Senate's committee of inquiry into influenza A entitled ‘Influenza A (H1N1)v: reflections on the first pandemic of the 21st Century’, published on 29 July 201012 , 12 http://www.senat.fr/notice- rapport/2009/r09-685-1-notice.htmldeleted

Amendment 20 #

Motion for a resolution
Recital B

B. whereas the criteria for defining a ‘pandemic’, adopted by the WHO in 2009 and based solely on the ~~propagation~~transmission capacity of the virus while discounting the severity of the infection, distorted the meaning of the word ‘pandemic’ and triggered a false alarm worldwide, ~~with that alarmism~~ giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States,

Amendment 21 #

Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther DE LANGE, Françoise GROSSETÊTE

Motion for a resolution
Recital B

B. whereas the criteria for defining a ‘pandemic’, adopted by the WHO in 2009 and based solely on the propagation of the virus while discounting the severity of the infection, - in contrast to earlier definitions, based on high morbidity and mortality rates - distorted the meaning of the word ‘pandemic’ and triggered a false alarm worldwide, with that alarmism giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States,

Amendment 22 #

Motion for a resolution
Recital B a (new)

Ba. Considering the high degree of unforeseeability and severity of how the pandemic was going to unfold, always with the possibility that the pandemic might worsen in Europe, as it did in 1918 and 1968;

Amendment 23 #

Anne DELVAUX, Richard SEEBER, Esther DE LANGE

Motion for a resolution
Recital B b (new)

Bb. whereas, on the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly, in line with the precautionary principle, using what resources they had available to implement public health action plans; whereas 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;

Amendment 24 #

Motion for a resolution
Recital B c (new)

Bc. Considering that under the principle of subsidiarity, the preparation and the reaction towards the health risks in the European Union fall within the competence of the Member States; that the treaty of Lisbon exhorts the Member States to strengthen the co-operation, the division of information and good practices within the framework of the WHO and the existing structures of the EU; that the reinforcement of the measurements of coordination taken by the Commission and the Member States, with the support of the ECDC and the EMEA within the framework of WHO, reinforces the effectiveness of the national measures.

Amendment 25 #

Motion for a resolution
Recital B d (new)

Bd. Considering that the pharmaceutical industry had to answer to a sudden, pressing and exponential request of supply of vaccines requested by the Member States; that this one had to develop in a very great urgency a new vaccine likely to answer the virus;

Amendment 26 #

Motion for a resolution
Recital B e (new)

Be. Considering that some Member States had more means than others to answer and to anticipate this emergency; that some, more than others, could, because of their financial capacities, to supply themselves before others in vaccine supplies; considering that the initial recommendations of vaccination required the acquisition of double doses before the good immunogenicity of the vaccine showed that only one amount was enough;

Amendment 27 #

Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE

Motion for a resolution
Recital B f (new)

Bf. whereas Member States, the European Commission and external bodies such as WHO should take into account the virulence of a future influenza outbreak as well as the propagation of the virus when making public health decisions which may affect public health and social policies in Member States,

Amendment 28 #

Motion for a resolution
Recital C

C. whereas the exaggerated costs arising from the management of this crisis in the Member States are primarily a direct consequence of the EU's lack of independence and critical acumen in relation to the risk evaluation conducted by the WHO,deleted

Amendment 29 #

Motion for a resolution
Recital C

Amendment 3 #

Motion for a resolution
Citation 26 a (new)

- having regard to the Commission Staff Working Document of 18 November 2010[1] on lessons learnt from the H1N1 pandemic and on health security in the European Union, [1] SEC (2010) 1440 final, http://ec.europa.eu/health/preparedness_r esponse/docs/commission_staff_lessonsh1 n1_en.pdf

Amendment 30 #

Motion for a resolution
Recital C

C. whereas the ~~exaggerated costs arising from the management of this crisis in the Member States are primarily a direct consequence of the EU's lack of independence and critical ac~~spreading alarmism can be primarily attributed to the poor communication of the WHO and other competent authorities, also to the media, which misinterpreted the pandemic alert, left out of consideration the moderate assessments of the WHO on the expected losses in humean ~~in relation to the risk evaluation conducted by the WHO~~life, therefore overstated the virulence and the mortality rate of the virus,

Amendment 31 #

Motion for a resolution
Recital C

C. whereas the ~~exaggerated~~ costs arising from the management of this crisis in the Member States awere ~~primarily a direct consequence of the EU's lack of independence and critical acumen in relation to the risk evaluation conducted by the WHO~~considerable. A review of the expenditure involved would be a useful investment for future pandemic preparedness plans,

Amendment 32 #

Corinne LEPAGE, Giommaria UGGIAS

Motion for a resolution
Recital C

C. whereas the ~~exaggerated~~ costs arising from the management of this crisis in the Member States ~~are primarily a direct consequence of the EU’s lack of independence and critical acumen in relation to the risk evaluation con~~could perhaps have been reducted ~~by the WHO~~,

Amendment 33 #

Motion for a resolution
Recital C

C. whereas the exaggerated costs arising from the management of this crisis in the Member States are ~~primarily a direct~~to some extent a consequence of the EU’s lack of independence and critical acumen in relation to the risk evaluation conducted by the WHO,

Amendment 34 #

Motion for a resolution
Recital D

D. whereas the expenditure committed by thsome Member States to the response plans drawn up is mainly in connection with the purchase of vast quantities of vaccines,

Amendment 35 #

Antonyia PARVANOVA, Corinne LEPAGE, Giommaria UGGIAS

Motion for a resolution
Recital D

D. whereas the expenditure committed by ~~the~~certain Member States to the response plans drawn up is mainly in connection with the purchase of vast quantities of vaccines,

Amendment 36 #

Motion for a resolution
Recital D

D. whereas the expenditure committed by the Member States to the response plans drawn up is mainly in connection with the purchase of vast quantities of vaccines, and antiviral treatments, and whereas purchasing procedures have led to serious concerns in terms of transparency and public procurement rules compliance in several Member States

Amendment 37 #

Motion for a resolution
Recital D a (new)

Da. whereas there were significant price disparities among the Member States that had prior purchase agreements for vaccines, based, among other factors, to the differentiated liability conditions of each agreement.

Amendment 38 #

Motion for a resolution
Recital D b (new)

Dd. whereas the most authoritative independent reviews of healthcare interventions, the Cochrane reviews[1], find the following on the efficacy of anti- influenza vaccines: - in the elderly (65 years and more): “according to reliable evidence the usefulness of vaccines in the community is modest”. - in the healthy adult : “There is not enough evidence to decide whether routine vaccination to prevent influenza in healthy adults is effective” - in healthy children: “If immunisation in children is to be recommended as a public health policy, large-scale studies assessing important outcomes and directly comparing vaccine types are urgently required.” [1] http://www.cochrane.org/reviews/clibintro .htm

Amendment 39 #

Motion for a resolution
Recital D c (new)

Dc. whereas the EU currently lacks the capacity to independently appraise the virulence, severity and possible mortality of a virus, therefore it cannot make autonomous decisions on the alert level taking into consideration the regional specificities of the European Union,

Amendment 4 #