Activities of Karin KADENBACH related to 2010/2153(INI)
Plenary speeches (1)
Management of H1N1 influenza (short presentation)
Amendments (21)
Amendment 6 #
Motion for a resolution
Citation 28 a (new)
Citation 28 a (new)
- having regard to the Workshop on the Influenza Pandemic A (H1N1) - The response of Member States and the European Union of the Environment, Public Health and Food Committee of the European Parliament on Oct 5th 2010-
Amendment 15 #
Motion for a resolution
Recital B
Recital B
Amendment 31 #
Motion for a resolution
Recital C
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 WHOconsiderable. A review of the expenditure involved would be a useful investment for future pandemic preparedness plans,
Amendment 34 #
Motion for a resolution
Recital D
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 45 #
Motion for a resolution
Recital E
Recital E
E. whereas this systematic vaccination strategy is baspandemic prepared nessentially on an approach that relies on blind faith i planning relies on 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 vaccineshereas European legislation allows for an accelerated assessment for the authorisation of vaccines in the case where a pandemic is declared; whereas positive benefit-risk balance of a vaccine using this procedure must always be demonstrated,
Amendment 52 #
Motion for a resolution
Recital F
Recital F
F. whereas the differing recommendations made within the EU and Member States on the subject of the priority groups targeted for vaccination illustrate the huge uncertainties surrounding the evaluation of the H1N1 vaccines recommended, appropriate response to a pandemic, which is why coordinated pandemic preparedness strategies are of utmost importance,
Amendment 57 #
Motion for a resolution
Recital G
Recital G
Amendment 65 #
Motion for a resolution
Recital I
Recital I
I. whereas confidence in vaccines against H1N1 influenza was also undermined by the confidential partial transfer from the manufacturer to the Member State, in the purchase contracts, of liability for any side effects, and due to the lack of balanced communication on the benefits of vaccination and the potential risks of pandemic influenza to the public,
Amendment 70 #
Motion for a resolution
Recital J
Recital J
Amendment 79 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Calls for the prevention plans established in the EU and its Member States to be revised 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;
Amendment 91 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. TakWelcomes the view that the powerswork of the European Centre for Disease Prevention and Control (ECDC) should be reinforced so that the EU has, invites the ECDC to review its procedures to ensure that the evaluation of a pandemic 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;undertaken on the basis of independent expert opinion. Also requests the ECDC to review best practice on national preparedness plans, which would include making recommendations on best practice in areas such as crisis management techniques and communication strategies.
Amendment 98 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Demands that robust, credible and effective scientific procedures be introduenforced for the evaluation of medicinal products recommended in the event of health emergencies, and more particularly in genuine pandemic situations;
Amendment 102 #
Motion for a resolution
Paragraph 4
Paragraph 4
Amendment 113 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls in particular on the EMA to reviewuropean 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 correcta full assessment of the benefit-risk profile associated with the use of those medicinal products;
Amendment 121 #
Motion for a resolution
Paragraph 6
Paragraph 6
Amendment 125 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Reminds the EMA ofNotes 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 134 #
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 institutionpublic health authorities to give rise to suspicions of undue influence and to undermine the overall credibility of the Europeanpublic health agencuthorities 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 139 #
Motion for a resolution
Paragraph 9
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 145 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for full liability for the quality, safety and effectiveness of a medicinal productvaccines to rest with the manufacturer; bearing in mind the exceptional circumstances a pandemic constitutes;
Amendment 157 #
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 171 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Considers it essential for its Members and the European public to be informed of these revisthe 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.