2010/2153(INI)
Evaluation of the management of H1N1 influenza in 2009-2010 in the EU
Evaluation of the management of H1N1 influenza in 2009-2010 in the EU 2010/2153(INI)
Lead committee dossier: ENVI/7/03231
Legal basis: RoP 048
| ENVI | |
| Lead Rapporteur | RIVASI Michèle (Verts/ALE) |
| Opinion Rapporteur(s) |
Legal basis: RoP 048
Procedure completed
2010/2153(INI) Evaluation of the management of H1N1 influenza in 2009-2010 in the EU
Lead committee dossier: ENVI/7/03231
Legal Basis RoP 048
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI | RIVASI Michèle (Verts/ALE) | DELVAUX Anne (EPP), MCAVAN Linda (S&D), LEPAGE Corinne (ALDE), YANNAKOUDAKIS Marina (ECR) |
Legal Basis RoP 048
Subjects
Activites
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2011/03/08
Text adopted by Parliament, single reading
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T7-0077/2011
summary
The European Parliament adopted a resolution on the evaluation of the management of H1N1 influenza in 2009-2010 in the European Union. The resolution recall that according to the figures provided by the European Centre for Disease Prevention and Control (ECDC) at the end of April 2010, influenza A(H1N1) 2009 caused 2 900 deaths in Europe. These figures are low in comparison to the official mortality estimates for seasonal influenza, which the Commission put at 40 000 deaths in a moderate year and 220 000 in a particularly severe season. They are also significantly less than the most optimistic forecasts suggested by the health services of the EU Member States. On the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly using what resources they had available to implement public health action plans. 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. The following recommendations are made: Enhanced cooperation: Parliament calls for the prevention plans established in the EU and its Member States for future influenza pandemics to be revised in order to gain in effectiveness and coherence and 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 on up-to date relevant information. It requests clarification, and if necessary review, of the roles, duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management of medical threats and that this information be made available to the public. The resolution emphasises the need to reinforce cooperation between Member States, and coordination of Member States with the European Centre for Disease Prevention and Control (ECDC). Members express its approval for the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis. They recall that according to current Union legislation on medicinal products, liability for the quality, safety and efficacy concerning the authorised indications of a medicinal product rests with the manufacturer. They call for full application of this rule by Member States in all contracts for the procurement of vaccines. The resolution urges the WHO to revise the definition of a pandemic, taking into consideration not only its geographical spread but also its severity. More independence: Parliament takes the view that the European Centre for Disease Prevention and Control (ECDC) has to exercise its powers as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks. The resolution underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage. According to Members, it is necessary to ensure that scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality. They request the development of a European code of conduct relating to the exercise of the function of a scientific expert in any European authority in charge of safety and of the management and anticipation of risks. The Commission, along with the support of the EMA, is invited to improve the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in such a way that proper clinical trials are carried out before a pandemic occurs. Increased transparency: Parliament calls for an assessment of the influenza vaccination strategies recommended in the EU and applied in Member States, covering the efficacy of the vaccines, their risk-benefit balance and the different target groups recommended, with a view to safe and effective use. Members call for a summary report about the information on the number of doses purchased and used in different Member States, as well as on the illness and the adverse effects of the vaccinations and anti-viral treatments against H1N1 to be prepared by the Commission, before 8 March 2012, based on information presented by the Member States. This resolution should be made publicly available as an important contribution to the review of the current pandemic influenza preparedness plans. Parliament recognises that conflicts of interest among experts who advise European public health authorities lead to suspicions of undue influence. It considers that all conflicts of interest must be avoided. It calls for the declarations of interest of all experts who advise the European public health authorities to be published. Lastly, the resolution insists on the need to communicate risks and benefits more clearly and transparently to the public. It underlines the necessity to arrive at a coherent message to the citizens as soon as a health hazard is evaluated (e.g. the nature of the virus, the nature of the risk, how best to prevent it and the risks and benefits of prevention and/or treatment). Parliament calls for 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.
- Results of vote in Parliament
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T7-0077/2011
summary
-
2011/03/08
Commission response to text adopted in plenary
- SP(2011)5426
- DG Health and Consumers, DALLI John
-
2011/03/07
Debate in Parliament
- 2011/02/09 Committee report tabled for plenary, single reading
- 2011/02/09 Committee report tabled for plenary, single reading
- 2011/01/25 Vote in committee, 1st reading/single reading
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2010/12/01
Deadline Amendments
- 2010/10/15 Committee draft report
- 2010/09/09 Committee referral announced in Parliament, 1st reading/single reading
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2010/09/02
EP officialisation
Documents
- Committee draft report: PE450.913
- Committee report tabled for plenary, single reading: A7-0035/2011
- Committee report tabled for plenary, single reading: A7-0035/2011
- Decision by Parliament, 1st reading/single reading: T7-0077/2011
- Results of vote in Parliament: Results of vote in Parliament
- Commission response to text adopted in plenary: SP(2011)5426
| Amendments | Dossier |
| 172 |
2010/2153(INI) Evaluation of the management of H1N1 influenza in 2009-2010 in the EU
2010/12/20
ENVI
172 amendments...
Amendment 1 #
Motion for a resolution 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 2 #
Motion for a resolution Citation 23 Amendment 3 #
Motion for a resolution Citation 26 a (new) - having regard to the Commission Staff Working Document of 18 November 2010[1] on lessons learnt from the H1N1 pandemic and on health security in the European Union, [1] SEC (2010) 1440 final, http://ec.europa.eu/health/preparedness_r esponse/docs/commission_staff_lessonsh1 n1_en.pdf
Amendment 4 #
Motion for a resolution Citation 26 b (new) - having regard to the "Annual epidemiological report on communicable diseases in Europe 2010" by the ECDC[1] [1] http://www.ecdc.europa.eu/en/publicatio ns/Publications/1011_SUR_Annual_Epid emiological_Report_on_Communicable_ Diseases_in_Europe.pdf
Amendment 5 #
Motion for a resolution Citation 26 c (new) - whereas the WHO called an end to the state of alert concerning H1N1 influenza only in August 2010 (statement by the WHO Director-General of 10 August 20101),
Amendment 6 #
Motion for a resolution 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 7 #
Motion for a resolution Recital A Amendment 8 #
Motion for a resolution Recital A A. whereas
Amendment 9 #
Motion for a resolution Recital A A. whereas the national and international health authorities, including the WHO,
Amendment 10 #
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
Amendment 11 #
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
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,
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,
Amendment 14 #
Motion for a resolution Recital B Amendment 15 #
Motion for a resolution Recital B Amendment 16 #
Motion for a resolution Recital B Amendment 17 #
Motion for a resolution Recital B B. whereas the criteria for defining a
Amendment 18 #
Motion for a resolution Recital B B. whereas the criteria for defining a
Amendment 19 #
Motion for a resolution Recital B B. whereas the criteria for defining a ‘pandemic’, as adopted by the WHO in 2009, a
Amendment 20 #
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
Amendment 21 #
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
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;
Amendment 23 #
Motion for a resolution 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) 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) 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) 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 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,
Amendment 28 #
Motion for a resolution Recital C Amendment 29 #
Motion for a resolution Recital C Amendment 30 #
Motion for a resolution Recital C C. whereas the
Amendment 31 #
Motion for a resolution Recital C C. whereas the
Amendment 32 #
Motion for a resolution Recital C C. whereas the
Amendment 33 #
Motion for a resolution Recital C C. whereas the exaggerated costs arising from the management of this crisis in the Member States are
Amendment 34 #
Motion for a resolution Recital D D. whereas the expenditure committed by
Amendment 35 #
Motion for a resolution Recital D D. whereas the expenditure committed by
Amendment 36 #
Motion for a resolution Recital D D. whereas the expenditure committed by the Member States to the response plans drawn up is mainly in connection with the purchase of vast quantities of vaccines
Amendment 37 #
Motion for a resolution Recital D a (new) Da. whereas there were significant price disparities among the Member States that had prior purchase agreements for vaccines, based, among other factors, to the differentiated liability conditions of each agreement.
Amendment 38 #
Motion for a resolution 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 39 #
Motion for a resolution Recital D c (new) Dc. whereas the EU currently lacks the capacity to independently appraise the virulence, severity and possible mortality of a virus, therefore it cannot make autonomous decisions on the alert level taking into consideration the regional specificities of the European Union,
Amendment 40 #
Motion for a resolution Recital E Amendment 41 #
Motion for a resolution Recital E Amendment 42 #
Motion for a resolution Recital E Amendment 43 #
Motion for a resolution Recital E Amendment 44 #
Motion for a resolution Recital E Amendment 45 #
Motion for a resolution Recital E E. whereas
Amendment 46 #
Motion for a resolution Recital E E. whereas
Amendment 47 #
Motion for a resolution Recital E E. whereas th
Amendment 48 #
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,
Amendment 49 #
Motion for a resolution Recital E a (new) Ea. whereas Poland's decision not to order or offer vaccinations against H1N1 influenza did not significantly increase the mortality rate in that country,
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,
Amendment 51 #
Motion for a resolution Recital E c (new) Ec. whereas due to the early acquisition of vaccines and systematic vaccination strategies, especially among the most vulnerable groups, the EU was the best prepared region in the world, however considerable differences emerged between the preparedness of EU Member States and the lack of genuine cooperation weakened the EU’s overall preparedness,
Amendment 52 #
Motion for a resolution 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
Amendment 53 #
Motion for a resolution Recital F F. whereas the
Amendment 54 #
Motion for a resolution Recital F a (new) Fa. whereas assessments of the vaccines differed,
Amendment 55 #
Motion for a resolution Recital F b (new) Fb. whereas the limited cooperation among Member States, especially the lack of joint public procurement of vaccines, the lack of joint stockpiles, the lack of a solidarity and brokerage mechanism between Member States, the absence of prior purchase agreements in several Member States were the main factors undermining the EU’s better preparedness,
Amendment 56 #
Motion for a resolution Recital G Amendment 57 #
Motion for a resolution Recital G Amendment 58 #
Motion for a resolution Recital G Amendment 59 #
Motion for a resolution Recital G G. whereas Member States need to make significant changes
Amendment 60 #
Motion for a resolution Recital I Amendment 61 #
Motion for a resolution Recital I Amendment 62 #
Motion for a resolution Recital I Amendment 63 #
Motion for a resolution Recital I Amendment 64 #
Motion for a resolution Recital I I. whereas
Amendment 65 #
Motion for a resolution 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 66 #
Motion for a resolution Recital I a (new) Ia. whereas in that connection the influence exerted on the WHO and the EU by lobbyists working on behalf of international pharmaceuticals companies should be examined more closely,
Amendment 67 #
Motion for a resolution Recital I b (new) Ib. Whereas information and communication around H1N Influenza in 2009-2010 in the EU have demonstrated the crucial role played by media in relaying public health precautions and recommendations, but also in emphasizing selected aspects of the outbreak and its consequences - such as the events of death - without necessarily and systematically putting them into perspective, thus potentially altering public opinion perceptions and public authorities responses
Amendment 68 #
Motion for a resolution Recital I c (new) Ic. whereas lawsuits were taken in various Member States, alleging corruption and conspiracy on the part of civil servants in relation to contracts signed in summer 2009 between ministries of public health and manufacturers of A/H1N1 influenza vaccines,
Amendment 69 #
Motion for a resolution Recital J Amendment 70 #
Motion for a resolution Recital J Amendment 71 #
Motion for a resolution Recital J J. whereas information has been garnered by various parliamentary committees and
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,
Amendment 73 #
Motion for a resolution Recital J b (new) Jb. whereas the serious accusations of conflicts of interest involving consultants/experts working on behalf of the European institutions need to be investigated in greater detail,
Amendment 75 #
Motion for a resolution Paragraph 1 1.
Amendment 76 #
Motion for a resolution 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
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 re
Amendment 78 #
Motion for a resolution Paragraph 1 1. Calls for the prevention plans established in the EU and its Member States to be revised to make them
Amendment 79 #
Motion for a resolution 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
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 ;
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;
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;
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;
Amendment 84 #
Motion for a resolution 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) 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) 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) 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) 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) 1j. Calls for continued investment in national epidemiological, serological and virological surveillance centres;
Amendment 90 #
Motion for a resolution Paragraph 2 Amendment 91 #
Motion for a resolution Paragraph 2 2.
Amendment 92 #
Motion for a resolution Paragraph 2 2. Takes the view that the
Amendment 93 #
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 in
Amendment 94 #
Motion for a resolution Paragraph 2 2. Takes the view that the powers of and funding for 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;
Amendment 96 #
Motion for a resolution Paragraph 3 Amendment 97 #
Motion for a resolution Paragraph 3 3.
Amendment 98 #
Motion for a resolution Paragraph 3 3. Demands that robust, credible and effective scientific procedures be
Amendment 99 #
Motion for a resolution Paragraph 3 3. Demands that robust, credible, independent, quick 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 situations;
Amendment 100 #
Motion for a resolution 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 Amendment 102 #
Motion for a resolution Paragraph 4 Amendment 103 #
Motion for a resolution Paragraph 4 4. Calls for an immediate
Amendment 104 #
Motion for a resolution Paragraph 4 4. Calls for
Amendment 105 #
Motion for a resolution Paragraph 4 4. Calls for
Amendment 106 #
Motion for a resolution Paragraph 4 4. Calls for
Amendment 107 #
Motion for a resolution Paragraph 4 4. Calls for immediate clarifications on the effectiveness of the influenza vaccination strategies recommended in the EU
Amendment 108 #
Motion for a resolution Paragraph 4 4. Calls for immediate independent data collection and corresponding 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;
Amendment 109 #
Motion for a resolution Paragraph 4 a (new) 4a. Calls on the Commission and the Member States to supply details of the following: (1) the number of doses of vaccine ultimately purchased by each Member State; (2) total expenditure on the purchase of vaccines in each Member State; (3) the number of doses of vaccine actually used in each Member State; (4) the number of doses of vaccine which were, respectively, placed in storage, the subject of reimbursement, and sold to other Member States;
Amendment 110 #
Motion for a resolution Paragraph 4 b (new) 4b. Calls for steps to be taken to determine whether or not the European Union was involved in funding the purchase of doses of vaccine and/or in commissioning studies or research in this area;
Amendment 111 #
Motion for a resolution Paragraph 5 Amendment 112 #
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
Amendment 113 #
Motion for a resolution Paragraph 5 5. Calls in particular on the E
Amendment 114 #
Motion for a resolution 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
Amendment 115 #
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, and to draw up corresponding proposals for a revision of these authorisation procedures;
Amendment 116 #
Motion for a resolution Paragraph 5 5. Calls in particular on the EMA to
Amendment 117 #
Motion for a resolution 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) 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) 5c. Requests the installation of a definition of the conflict of interest which is common to all the European agencies ;
Amendment 120 #
Motion for a resolution Paragraph 5 a (new) 5a. That the ECDC be requested to assemble an expert and independent group of scientists and health care professionals are tasked with providing advice on non-pharmaceutical approaches that might be employed by Member States and the public to reduce the risk of infection or transmission and the severity of symptoms associated with infection;
Amendment 121 #
Motion for a resolution Paragraph 6 Amendment 122 #
Motion for a resolution Paragraph 6 6. Calls on the Commission to launch an audit of the
Amendment 123 #
Motion for a resolution Paragraph 6 6. Calls on the Commission to launch a
Amendment 124 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the Commission to launch an audit of the operation of the EMA and the ECDC with regards to H1N1 management.
Amendment 125 #
Motion for a resolution Paragraph 7 7.
Amendment 126 #
Motion for a resolution 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 127 #
Motion for a resolution Paragraph 7 7.
Amendment 128 #
Motion for a resolution Paragraph 7 a (new) 7a. Calls on the Commission to review the Clinical Trials Directive (Directive 2001/20/EC) regarding the public availability of results of clinical trials, so as to increase public access to information and public awareness.
Amendment 129 #
Motion for a resolution Paragraph 8 Amendment 130 #
Motion for a resolution Paragraph 8 8. Considers th
Amendment 131 #
Motion for a resolution Paragraph 8 8. Considers
Amendment 132 #
Motion for a resolution Paragraph 8 8.
Amendment 133 #
Motion for a resolution Paragraph 8 8. C
Amendment 134 #
Motion for a resolution Paragraph 8 8. Considers the conflicts of interest apparent in the case of some experts who advise
Amendment 135 #
Motion for a resolution 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 136 #
Motion for a resolution 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 on the European Anti- Fraud Office (OLAF) to carry out a thoroughgoing review of these screening procedures;
Amendment 137 #
Motion for a resolution Paragraph 8 a (new) 8a. Calls for such conflicts of interest to be brought to Parliament's attention by means of an internal investigation carried out by the Committee on Budgetary Control with a view to determining whether payments to the aforementioned experts were made in a correct and transparent manner and whether the procedures normally employed by the European institutions to forestall such conflicts of interest were followed;
Amendment 138 #
Motion for a resolution Paragraph 9 Amendment 139 #
Motion for a resolution 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 140 #
Motion for a resolution 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; calls on OLAF to investigate these statements concerning the falsification of or the failure to provide important information;
Amendment 141 #
Motion for a resolution Paragraph 9 9. Calls
Amendment 142 #
Motion for a resolution Paragraph 9 9. Calls for the publication of the names, roles and
Amendment 143 #
Motion for a resolution Paragraph 10 10.
Amendment 144 #
Motion for a resolution Paragraph 10 10. Calls for full liability for the quality, safety and eff
Amendment 145 #
Motion for a resolution Paragraph 10 10. Calls for full liability for the quality, safety and effectiveness of
Amendment 146 #
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, while taking account of the different legal arrangements for compulsory vaccinations;
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;
Amendment 148 #
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 once it has been established that the product is defective and that compensation is therefore payable;
Amendment 149 #
Motion for a resolution Paragraph 9 a (new) 9a. Regrets that the apparent lack of transparency has lead to loss of credibility of EU institutions' decisions, including by health professionals.
Amendment 150 #
Motion for a resolution 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) 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) 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) 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 154 #
Motion for a resolution Paragraph 10 e (new) 10e. Recommends EMA and ECDC to develop targeted communication toolkits and organise specific information sessions in order to further sensitise journalists and media professionals on the issue of pandemic and communicable diseases managements at local, national and international level
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;
Amendment 157 #
Motion for a resolution Paragraph 11 Amendment 158 #
Motion for a resolution Paragraph 11 11.
Amendment 159 #
Motion for a resolution Paragraph 11 11. Demands precise definition of the roles, duties, remits, limits, relations and responsibilities of the Commission, the ECDC, the EMA and the Member States
Amendment 160 #
Motion for a resolution Paragraph 11 11.
Amendment 161 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls for the continuation and improvement of cooperation and coordination among Member States, institutions and international and regional organisations, particularly in the early stages of a virus outbreak, in order to define its severity and proceed to pertinent management decisions.
Amendment 162 #
Motion for a resolution Paragraph 11 b (new) 11b. Expects, on this regard, a more comprehensive collection and rapid submission of coherent data from national health monitoring authorities to competent EU authorities.
Amendment 163 #
Motion for a resolution Paragraph 12 Amendment 164 #
Motion for a resolution Paragraph 12 Amendment 165 #
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
Amendment 166 #
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
Amendment 167 #
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 by independent experts and indisputable, in order to obtain, for a given product, advantageous rates approaching its cost price;
Amendment 168 #
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 and to avoid limitations of the manufacturer's liability;
Amendment 169 #
Motion for a resolution Paragraph 12 a (new) 12a. Requests the development and release of an independent and comprehensive public health strategy including non-pharmaceutical approaches for the prevention and management of infectious diseases, including those caused by influenza viruses, in order to assist European citizens, health care professionals and health authorities in Member States;
Amendment 170 #
Motion for a resolution Paragraph 12 a (new) 12a. Calls on the Commission to examine the possibility of creating joint vaccine- stocks, setting up a solidarity and brokerage mechanism between Member States and drawing up a European model contract for prior purchase agreements of vaccines;
Amendment 171 #
Motion for a resolution Paragraph 13 13. Considers it essential for
Amendment 172 #
Motion for a resolution Paragraph 14 14. Instructs its President to forward this resolution to the Council, the Commission, the WHO and national parliaments.
source: PE-454.473
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