BETA

28 Amendments of Françoise GROSSETÊTE related to 2010/2153(INI)

Amendment 7 #
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 confirmed by the very low mortality rate observed as a result of this influenza ‘pandemic’ in 1 http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/print.html comparison with the officially recognised figures for seasonal influenza,deleted
2010/12/20
Committee: ENVI
Amendment 12 #
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,
2010/12/20
Committee: ENVI
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,
2010/12/20
Committee: ENVI
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
2010/12/20
Committee: ENVI
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;
2010/12/20
Committee: ENVI
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
2010/12/20
Committee: ENVI
Amendment 40 #
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 56 #
Motion for a resolution
Recital G
G. whereas significant changes are required to the current healthcare system in the EU and its Member States in order to achieve general public health objectives, as opposed to a purely pharmacological approach,deleted
2010/12/20
Committee: ENVI
Amendment 60 #
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 69 #
Motion for a resolution
Recital J
J. whereas information has been garnered by various parliamentary committees and evaluation missions conducted in the EU Member States on the action taken to combat H1N1 influenza,deleted
2010/12/20
Committee: ENVI
Amendment 72 #
Motion for a resolution
Recital J a (new)
Ja. whereas the vaccines’ benefit-risk ratio has now been demonstrated in tolerance and immunogenicity studies based on actual use,
2010/12/20
Committee: ENVI
Amendment 74 #
Motion for a resolution
Subheading 1
INDEPENDENCECOOPERATION
2010/12/20
Committee: ENVI
Amendment 80 #
Motion for a resolution
Paragraph 1 a (new)
1a. Emphasises the need to reinforce cooperation between Member States within the EU in the management of the response to a pandemic, within the framework of WHO, according to the International Health Regulation of 2005 ;
2010/12/20
Committee: ENVI
Amendment 81 #
Motion for a resolution
Paragraph 1 b (new)
1b. Wants to reinforce the collaboration between Member States by ensuring coherent risk assessment and risk management for fast evolving threats at EU level by putting in place, where necessary, additional structures and coordination mechanisms;
2010/12/20
Committee: ENVI
Amendment 82 #
Motion for a resolution
Paragraph 1 c (new)
1c. Is delighted about the fact that the Commission committed itself studying the possibility of a revision and, should this happen, a long-term reinforcement of the legal base of Health Security Committee;
2010/12/20
Committee: ENVI
Amendment 83 #
Motion for a resolution
Paragraph 1 d (new)
1d. Requests to give a special attention to the preparation between sectors within the framework of the co-operation between Member States within the Health Security Committee;
2010/12/20
Committee: ENVI
Amendment 87 #
Motion for a resolution
Paragraph 1 h (new)
1h. Urges the European Union to allot more means to the research and the development while conforming to the objective which it assigned to allocate 3% of the European GDP to the R & D; more specifically claim an increase in the investments dedicated to a better evaluation and anticipation of the impact of an influenza virus as well in period between pandemic as at the beginning of a pandemic;
2010/12/20
Committee: ENVI
Amendment 88 #
Motion for a resolution
Paragraph 1 i (new)
1i. Welcomes the Commission's commitment to develop a mechanism for joint procurement of vaccines and antiviral medication which allows Member States, on a voluntary basis, a common acquisition of these products or common approaches to contract negotiations with the pharmaceutical industry; Recalls that only the seeking for joint solutions for a common purchasing of vaccines and antiviral medications will ensure equitable access, at the lowest price for the Member States;
2010/12/20
Committee: ENVI
Amendment 89 #
Motion for a resolution
Paragraph 1 j (new)
1j. Calls for continued investment in national epidemiological, serological and virological surveillance centres;
2010/12/20
Committee: ENVI
Amendment 90 #
Motion for a resolution
Paragraph 2
2. Takes the view that the powers of the European Centre for Disease Prevention and Control (ECDC) should be reinforced so that the EU has 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;deleted
2010/12/20
Committee: ENVI
Amendment 97 #
Motion for a resolution
Paragraph 3
3. Demands that robust, crediblePoints out the need for and effective scientific procedures be introduced for the evaluation of medicinal products recommended in the event of health emergencies, and more particularly in genuine pandemic, independent, transparent and balanced scientific report for the evaluation of the drugs including in health emergency situations;
2010/12/20
Committee: ENVI
Amendment 101 #
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
2010/12/20
Committee: ENVI
Amendment 111 #
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;deleted
2010/12/20
Committee: ENVI
Amendment 119 #
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 ;
2010/12/20
Committee: ENVI
Amendment 130 #
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;
2010/12/20
Committee: ENVI
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;
2010/12/20
Committee: ENVI
Amendment 151 #
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;
2010/12/20
Committee: ENVI
Amendment 156 #
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;
2010/12/20
Committee: ENVI