Milestones :: Perspectives
Editor’s Note
Some observers suggest we are already in a “post-truth era.” We observe that the judgement by the Court of Justice of the European Union suggests it might better be termed the “post-evidence era.” I was reminded of an undergraduate logic course [from many decades ago before the post-truth era] and one of the first fallacies we engaged: “post hoc, ergo propter hoc” [after this, therefore because of this]. We will monitor and report on any balanced legal/policy analysis of this judgement and its implications for vaccine injury litigation.
Court of Justice of the European Union
PRESS RELEASE No 66/2017
Luxembourg, 21 June 2017 Judgment in Case C-621/15
>W and Others v Sanofi Pasteur MSD and Others
Where there is a lack of scientific consensus, the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence
[Full text, Editor’s text bolding]
The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, where applicable, constitute sufficient evidence to make out such proof
Between the end of 1998 and the middle of 1999 Mr J. W was vaccinated against hepatitis B using a vaccine produced by Sanofi Pasteur. In August 1999, Mr W began to present with various troubles, which led to a diagnosis of multiple sclerosis in November 2000. Mr W died in 2011. Earlier, in 2006, he and his family had brought legal proceedings against Sanofi Pasteur to obtain compensation for the damage they claim Mr W suffered due to the vaccine.
The case was sent before the cour d’appel de Paris (Court of Appeal, Paris, France), which observed, inter alia, that there was no scientific consensus supporting a causal relationship between the vaccination against hepatitis B and the occurrence of multiple sclerosis. It held that no such causal link had been demonstrated and dismissed the action.
The French Cour de cassation (Court of Cassation), before which an appeal against the judgment of the Cour d’appel de Paris was brought, asks the Court of Justice whether, despite there being no scientific consensus and given that, under the EU directive on liability for defective products, [1] the injured person is required to prove the damage, the defect and the causal relationship, the court may base itself on serious, specific and consistent evidence enabling it to conclude that there is a causal link between the defect in a vaccine and that there is a causal link between the vaccine and the disease. Reference has been made in particular to Mr W’s previous excellent state of health, the lack of family antecedents and the close temporal connection between the vaccination and the appearance of the disease.
In today’s judgment, the Court holds that evidentiary rules allowing the court, where there is not certain and irrefutable evidence, to conclude that there is a defect in a vaccine and a causal link between the defect and a disease on the basis of a set of evidence the seriousness, specificity and consistency of which allows it to consider, with a sufficiently high degree of probability, that such a conclusion corresponds to the reality of the situation, are compatible with the Directive.
Such evidentiary rules do not bring about a reversal of the burden of proof which it is for the victim to discharge, since that system places the burden on the victim to prove the various elements of his case which, taken together, will provide the court hearing the case with a basis for its conclusion as to the existence of a defect in the vaccine and a causal link between that defect and the damage suffered.
Moreover, excluding any method of proof other than certain proof based on medical research, could make it excessively difficult in many situations or, where it is common ground that medical research neither confirms nor rules out the existence of a causal link, impossible to establish producer liability, thereby undermining the effectiveness of the Directive and its objectives, which are to protect consumer health and safety and ensure a fair apportionment between the injured person and the producer of the risks inherent in modern technological production.
The Court nevertheless adds that national courts must ensure that the evidence adduced is sufficiently serious, specific and consistent to warrant the conclusion that, having regard also to the evidence produced and the arguments put forward by the producer, a defect in the product appears to be the most plausible explanation for the occurrence of the damage. National courts must also safeguard their own freedom of assessment in determining whether such proof has been made out to the requisite legal standard, until such time as they consider themselves in a position to draw a definitive conclusion on the matter.
In the present case, the Court considers that the temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together, may lead a national court to consider that a victim has discharged his burden of proof. That could be the case inter alia where that evidence leads the court to consider, first, that the administering of the vaccine is the most plausible explanation for the occurrence of the disease and, second, that the vaccine therefore does not offer the safety that one is entitled to expect.
The Court adds that it is not possible for the national legislature or the national courts to introduce a method of proof under which the existence of a causal link between the defect attributed to a vaccine and the damage suffered by the victim will automatically be established when certain predetermined causation-related factual evidence is presented, as that would have the consequence of the burden of proof provided for in the Directive being undermined.
1 Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ 1985, L 210, p. 29).
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Vaccination in acute humanitarian emergencies: a framework for decision making
World Health Organization, Geneva
June, 2017 :: 96 pages
PDF: http://apps.who.int/iris/bitstream/10665/255575/1/WHO-IVB-17.03-eng.pdf
EXECUTIVE SUMMARY
Humanitarian emergencies, regardless of type and cause, have a number of common risk factors for communicable diseases inextricably linked to excess risk of morbidity and mortality which can come from vaccine–preventable diseases (VPDs). The reduction of VPDs is a significant aim of public-health interventions during crises.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization carried out a comprehensive review of evidence on vaccination decision-making processes and considerations in humanitarian emergencies. This review resulted with decision-making framework which provides a transparent, evidence-based, and rigorous methodology for deciding on vaccination options in acute humanitarian emergencies. It consists of three essential steps: 1) assessing the local epidemiological risks of VPDs among the affected population, 2) vaccine selection and characteristics to consider, and 3) local contextual constraints that further assist in effective and timely decisions. The diagram below provides a schematic representation of this three-step approach in decision-making process.
This framework is intended to guide decision making on vaccination interventions immediately after the onset or during planning in anticipation of a possible or likely acute emergency. It may be applied in emerging humanitarian emergencies, or crisis of short duration, and in long-standing crisis and conflicts resulting in protracted humanitarian emergencies. The concept of “acute” emergency does not imply that the emergency in itself is short-lived, as in a protracted crisis situations can emerge and be considered as “acute”. An acute emergency signifies a situation meeting one or more of the following conditions: sudden unplanned displacement of a large proportion of the population, direct exposure of the civilian population to new or exacerbated and sustained episodes of armed conflict, impending or already occurred sudden deterioration of nutritional status, natural or industrial disasters, and/or sudden breakdown of critical administrative and management functions which result in large-scale disruption of public health and related services.
This decision-making framework is intended for senior-level government and partner organization officials who are expected to work together to reach a decision regarding the need of vaccine antigen(s) in a given humanitarian emergency. It makes part of a package which also includes “Vaccination in Humanitarian Emergencies Implementation Guide”. Both documents are supported with electronic versions to ensure that the most up-to-date vaccine and disease-specific data, and references to additional information and guidance are provided.
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POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 21 June 2017 [GPEI]
:: In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases in the country to 17. Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate. All cases had onset of paralysis between 3 March and 23 May.
:: The 14th report of the Independent Monitoring Board (IMB) has been published, following the group’s meeting in May.[see below]
:: Summary of newly-reported viruses this week: Syria – 15 new circulating vaccine-derived poliovirus type 2 (cVDPV2) were isolated from acute flaccid paralysis (AFP) cases, and four new cVDPV2 isolated from healthy community contacts. Pakistan – one new wild poliovirus type 1 (WPV1) isolated from an environmental sample
Weekly country updates as of 21 June 2017
:: Syrian Arab Republic
In Syria, 15 new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in the past week, bringing the total number of cVDPV2 cases to 17. Sixteen of the 17 cases are from Mayadeen district, Deir-Al-Zour governorate, and one case is from Raqua district, Raqua governorate. All cases had onset of paralysis between 3 March and 23 May. Additionally, four cVDPV2s were also isolated from healthy community contacts, all from Mayadeen (collected in April and May).
Of a total of 65 acute flaccid paralysis (AFP) cases detected in Deir-Al-Zour since the start of 2017, 16 have now tested positive for cVDPV2 (with the 17th case from Raqua), 22 have tested negative, 5 are pending for final laboratory results and 22 specimens are en route to a laboratory for processing.
Confirmation of these latest cases is not unexpected at this time and does not change the operational situation, as outbreak response plans are being finalized, in line with internationally-agreed outbreak response protocols. Although access to Deir-Al-Zour is compromised due to insecurity, the Governorate has been partially reached by several vaccination campaigns against polio and other vaccine-preventable diseases since the beginning of 2016. Most recently, two campaigns have been conducted in March and April 2017 using the bivalent oral polio vaccine (OPV). However, only limited coverage was possible through these campaigns.
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EVERY LAST VIRUS
INDEPENDENT MONITORING BOARD OF THE GLOBAL POLIO ERADICATION INITIATIVE – FOURTEENTH REPORT: JUNE 2017 :: 34 pages
PDF: http://polioeradication.org/wp-content/uploads/2017/06/14th-IMB-Report-FINAL.pdf
The Independent Monitoring Board provides an independent assessment of the progress being made by the Global Polio Eradication Initiative in the detection and interruption of polio transmission globally. This report follows the IMB’s meeting held in London on 2 and 3 May
2017.
[Excerpt]
CONCLUSIONS AND RECOMMENDATIONS [p.20]
The Polio Programme has reached a level of performance where there is room for optimism that 2017 will be the year when poliovirus transmission globally is permanently interrupted. Nigeria has a strong programme that pioneered the use of an Emergency Operations Centre to integrate a diverse range of partners to drive up the level of performance. Pakistan has benefitted from the exceptional leadership of the Health Minister and the Prime Minister’s Focal Person on Polio Eradication. The transformation of the Polio Programme in that country from being judged “a disaster” in a previous IMB report is quite remarkable. The Afghanistan Programme has done well to achieve what it has despite serious problems of access due to conflict.
All this is commendable, but the Polio Programme in the three endemic countries and globally is not there yet. The optimism must be tempered with a realism about the risks and challenges that remain. Only if the appropriate balance is struck can the programme succeed soon.
If the narrative and statistical analysis in this IMB Report is read carefully, five major priorities for action jump out:
:: An innovative and transformational solution must be found to vaccinate the large numbers of so-called “Guest children” who are within the large high-risk mobile population in Pakistan; continuing with the current approach will not reduce the numbers of “still missed” children from hundreds of thousands to hundreds in less than six months.
:: A dramatic and immediate turnaround is needed in the low level of routine immunisation coverage in the polio reservoirs in Pakistan and Afghanistan; the current position is a stain on the Programme’s record of improved performance.
:: The Nigeria Programme has not yet realised that it must become an exemplar in how to operate as a high resilience enterprise; all its efforts should be directed to strengthening the defenses against any poliovirus breaking through.
:: The whole region around northern Nigeria, Lake Chad and surrounding countries has become a red zone in which there is a high-risk of the re-emergence of circulating poliovirus; leaders at the highest political level should be on full alert and completely engaged.
:: The quality and integrity of surveillance data across the Polio Programme, particularly in northern Nigeria and other parts of Africa, which may harbour another unwelcome, long-unrecognised outbreak, is not what it should be. This is compromising the ability of the Polio
Programme to be sure that transmission has ended.
These are major problems threatening the successful completion of polio eradication. They are problems awaiting solutions. The tried and trusted methods that are being used are still necessary but matching these problems with solutions that bring transformation is the missing ingredient….
[10 action recommendations follow]
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vaccines and global health :: ethics and policy 