BETA

Activities of Marina YANNAKOUDAKIS related to 2010/2153(INI)

Plenary speeches (1)

Management of H1N1 influenza (short presentation)
2016/11/22
Dossiers: 2010/2153(INI)

Shadow reports (1)

REPORT on evaluation of the management of H1N1 influenza in 2009-2010 in the EU PDF (194 KB) DOC (128 KB)
2016/11/22
Committee: ENVI
Dossiers: 2010/2153(INI)
Documents: PDF(194 KB) DOC(128 KB)

Amendments (18)

Amendment 16 #
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
2010/12/20
Committee: ENVI
Amendment 27 #
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,
2010/12/20
Committee: ENVI
Amendment 29 #
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
2010/12/20
Committee: ENVI
Amendment 35 #
Motion for a resolution
Recital D
D. whereas the expenditure committed by thecertain Member States to the response plans drawn up is mainly in connection with the purchase of vast quantities of vaccines,
2010/12/20
Committee: ENVI
Amendment 42 #
Motion for a resolution
Recital E
E. whereas this systematic vaccination strategy is based essentially on an approach that relies on blind faith in the effectiveness of influenza vaccines, without taking into account scientific data that contradict that belief (see Cochrane journals), and the majority of the studies available on the efficacy of the medicinal products, including vaccines, have been conducted by pharmaceutical companies, meaning that no objective proof has been provided of the efficacy of influenza vaccines,deleted
2010/12/20
Committee: ENVI
Amendment 50 #
Motion for a resolution
Recital E b (new)
Eb. whereas in the event of a future influenza pandemic, more work needs to be done to improve the performance of influenza vaccines, especially for high risk groups and against drifted variants,
2010/12/20
Committee: ENVI
Amendment 59 #
Motion for a resolution
Recital G
G. whereas Member States need to make significant changes are required to their current healthcare system in the EU and its Member Statess and need to co-ordinate better in preparing against epidemics, in order to achieve general public health objectives, as opposed to a purely pharmacological approach,
2010/12/20
Committee: ENVI
Amendment 63 #
Motion for a resolution
Recital I
I. whereas confidence in vaccines against H1N1 influenza was also undermined by the partial transfer from the manufacturer to the Member State, in the purchase contracts, of liability for any side effects,deleted
2010/12/20
Committee: ENVI
Amendment 77 #
Motion for a resolution
Paragraph 1
1. Calls for the prevention plans established in the EU and its Member States for future influenza pandemics to be revis-examined, 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 not least on the latest scientific information available;
2010/12/20
Committee: ENVI
Amendment 92 #
Motion for a resolution
Paragraph 2
2. Takes the view that the powersmandate of the European Centre for Disease Prevention and Control (ECDC) should be reinforced so that the EU hasinclude its own means of assessing the severity of infection risk, by establishing, if necessary, its own health alert scale independent of international organisations such as the WHO;
2010/12/20
Committee: ENVI
Amendment 105 #
Motion for a resolution
Paragraph 4
4. Calls for immediate clarifican 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;
2010/12/20
Committee: ENVI
Amendment 123 #
Motion for a resolution
Paragraph 6
6. Calls on the Commission to launch an 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;
2010/12/20
Committee: ENVI
Amendment 127 #
Motion for a resolution
Paragraph 7
7. Reminds tThe EMA of theas 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;
2010/12/20
Committee: ENVI
Amendment 133 #
Motion for a resolution
Paragraph 8
8. Considers the conflicts of interest apparent in the case of somealls for the declarations of interest of all experts who advise the European institutions to give rise tobe 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;
2010/12/20
Committee: ENVI
Amendment 142 #
Motion for a resolution
Paragraph 9
9. Calls for the publication of the names, roles and potential conflictdeclarations 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;
2010/12/20
Committee: ENVI
Amendment 144 #
Motion for a resolution
Paragraph 10
10. Calls for full liability for the quality, safety and effectivenessicacy of a medicinal product to rest with the manufacturer, bearing in mind the exceptional circumstances a pandemic constitutes;
2010/12/20
Committee: ENVI
Amendment 160 #
Motion for a resolution
Paragraph 11
11. DemandEstablishes 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;
2010/12/20
Committee: ENVI
Amendment 164 #
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
2010/12/20
Committee: ENVI