9 Amendments of Michèle RIVASI related to 2010/2153(INI)
Amendment 1 #
Motion for a resolution
Citation 6 a (new)
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 38 #
Motion for a resolution
Recital D b (new)
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 46 #
Motion for a resolution
Recital E
Recital E
E. whereas this systematicprevailing vaccination strategy is based essentially on an approach thaties presuppose the efficacy of influenza vaccines; whereas major relviews 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 vaccinthe efficacy of influenza vaccines come to less affirmative conclusions (see Cochrane reviews); whereas there is a need for studies that are independent from the pharmaceutical companies on vaccines and antiviral medications so as to have a balance between industry-sponsored and independent large publicly funded studies,
Amendment 104 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls for immediate clarificationsan in-depth assessment onf the effectivenessicacy of the influenza vaccination strategies recommended in the EU, given the weight of evidence casting doubt onambiguous conclusions about their effectiveness, the absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit-risk profileicacy of influenza vaccines in major scientific reviews, and for clear proof of a positive risk-benefit balance for such vaccines;
Amendment 112 #
Motion for a resolution
Paragraph 5
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 correctter 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 126 #
Motion for a resolution
Paragraph 7
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 135 #
Motion for a resolution
Paragraph 8
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 143 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. CRecalls for full liability for the quality, safety and effectivenesthat 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 168 #
Motion for a resolution
Paragraph 12
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 and to avoid limitations of the manufacturer's liability;