Activities of Anne DELVAUX related to 2010/2153(INI)
Plenary speeches (1)
Management of H1N1 influenza (short presentation)
Shadow reports (1)
REPORT on evaluation of the management of H1N1 influenza in 2009-2010 in the EU PDF (194 KB) DOC (128 KB)
Amendments (47)
Amendment 2 #
Motion for a resolution
Citation 23
Citation 23
Amendment 7 #
Motion for a resolution
Recital A
Recital A
Amendment 9 #
Motion for a resolution
Recital A
Recital A
A. whereas the national and international health authorities, including the WHO, were aware as early asstated in May 2009 that the H1N1 influenza was not virulent, wiat the this moderate virulence beime causing confirmed by the very low mortality rate observed as a result of ly mild illness, but that it could only be hoped (thius influenza ‘pandemic’ in comparison with the officially recognised figures for seasonal influenzanot taken for granted) that this pattern would continue,
Amendment 12 #
Motion for a resolution
Recital A a (new)
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 13 #
Motion for a resolution
Recital A b (new)
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 14 #
Motion for a resolution
Recital B
Recital B
Amendment 22 #
Motion for a resolution
Recital B a (new)
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 #
Motion for a resolution
Recital B b (new)
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)
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)
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)
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 28 #
Motion for a resolution
Recital C
Recital C
Amendment 40 #
Motion for a resolution
Recital E
Recital E
Amendment 56 #
Motion for a resolution
Recital G
Recital G
Amendment 60 #
Motion for a resolution
Recital I
Recital I
Amendment 69 #
Motion for a resolution
Recital J
Recital J
Amendment 74 #
Motion for a resolution
Subheading 1
Subheading 1
Amendment 75 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Calls forRequests that the prevention plans established in the EU and its Member States to be revised to make them sufficiently autonomousin order to gain in effectiveness, in coherence and of 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 availableility by a better coordination of the instruments installed but also of the scientific data available. For this purpose, it is in particular advisable to reinforce the mandate of the Committee of Public Health whose action should be more based on an intergovernmental level and whose composition should reflect a better representativeness of the executive decisions;
Amendment 80 #
Motion for a resolution
Paragraph 1 a (new)
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 ;
Amendment 81 #
Motion for a resolution
Paragraph 1 b (new)
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;
Amendment 82 #
Motion for a resolution
Paragraph 1 c (new)
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;
Amendment 83 #
Motion for a resolution
Paragraph 1 d (new)
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;
Amendment 84 #
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Urges the WHO to revise the definition of a pandemic, taking into consideration, when a virus is detected, not only its geographical spread but also its severity;
Amendment 85 #
Motion for a resolution
Paragraph 1 f (new)
Paragraph 1 f (new)
1f. Claims that work on the legal basis relating to the implementation of the joint buying guarantee to the Member States an equitable access and a reasonable price to the most effective vaccines as well as the respect of the European legislation in terms of the manufacturer responsibility;
Amendment 86 #
Motion for a resolution
Paragraph 1 g (new)
Paragraph 1 g (new)
1g. Calls on the Member States to involve health professionals more closely at every stage in the preparation and application of strategies for preventing and combating pandemics;
Amendment 87 #
Motion for a resolution
Paragraph 1 h (new)
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;
Amendment 88 #
Motion for a resolution
Paragraph 1 i (new)
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;
Amendment 89 #
Motion for a resolution
Paragraph 1 j (new)
Paragraph 1 j (new)
1j. Calls for continued investment in national epidemiological, serological and virological surveillance centres;
Amendment 90 #
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 95 #
Motion for a resolution
New subheading 2 a (new)
New subheading 2 a (new)
INDEPENDENCE
Amendment 97 #
Motion for a resolution
Paragraph 3
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;
Amendment 100 #
Motion for a resolution
Paragraph 3 a (new)
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 #
Motion for a resolution
Paragraph 4
Paragraph 4
Amendment 114 #
Motion for a resolution
Paragraph 5
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 correcta full assessment of the benefit-risk profile associated with the use of those medicinal products;
Amendment 117 #
Motion for a resolution
Paragraph 5 a (new)
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 #
Motion for a resolution
Paragraph 5 b (new)
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 #
Motion for a resolution
Paragraph 5 c (new)
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 132 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. ConsidersRecognises that the conflicts of interest apparent in the case of some experts who advise the European institutions to give risecould lead to suspicions of undue influence and to undermine the overallharm 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 147 #
Motion for a resolution
Paragraph 10
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 150 #
Motion for a resolution
Paragraph 10 a (new)
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 #
Motion for a resolution
Paragraph 10 b (new)
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 #
Motion for a resolution
Paragraph 10 c (new)
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 #
Motion for a resolution
Paragraph 10 d (new)
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 155 #
Motion for a resolution
Subheading 3
Subheading 3
Amendment 156 #
Motion for a resolution
Subheading 3 a (new)
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 158 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Demands precise definition ofRequests 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 163 #
Motion for a resolution
Paragraph 12
Paragraph 12