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EU judgment on vaccine claims: Vaccine confidence breaker or trust builder?

12 Jul, 2017
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With Shalini Anand reporting from India

A recent landmark judgment by the European Court of Justice (ECJ) has shaken the global health community. Scientists from all over the world have voiced dissent, as the ruling threatens to undermine science-based evidence and impact on vaccine confidence.

The judgement came in response to a series of litigations around a vaccine compensation claim by a French national, who alleged that hepatitis B vaccination had caused him to develop multiple sclerosis. In 2006, he and his family pressed legal charges seeking compensation from the vaccine maker, Sanofi Pasteur. Although he initially won in the lower court, this verdict was later overturned based on the lack of scientific evidence supporting the link between the vaccine and the multiple sclerosis.

As the case has raised questions around what is considered ‘acceptable evidence’, the case moved to France’s highest civil and criminal court, the Court of Cassation, which in turn sought advice from the European Court of Justice.

The ECJ has ruled that, in situations where there is a lack of scientific consensus on the issue, ‘circumstantial evidence’ can be considered. This means that the fact that the disease occurred soon after vaccination, along with other factors, may be used to attribute it to the vaccine. Several studies have already been conducted over the last decade to investigate suspected link between hepatitis B vaccine and multiple sclerosis. The majority have found the vaccine to be safe although some experts still have doubts, contributing to questions around scientific consensus.

Amidst the flurry of concerns about the precedent that the ECJ ruling may set, an article in Nature brings another perspective, pointing out that this ECJ judgement is only part of the evidence which the French courts are considering, quoting one lawyer who concludes that, in light of the available evidence, ‘ “the manufacturer will win the case and the plaintiffs will lose”, even with the latest ECJ ruling.’

This is also not the first time that vaccine side effects have been legally disputed. More than 18,000 such petitions have been filed in the US alone over the last 30 years, according to the CDC. But far fewer are scientifically validated. India faced similar legal battles in 2013, when adverse events following immunization (AEFIs) were reported following pentavalent vaccine use. The Indian court sought recommendations from the country’s highest expert body on immunization and cleared the vaccine for further use, in a win for the scientific as well as public health community.

Nevertheless, with hundreds of vaccine safety cases reported each year globally, with different countries struggling with similar public health investigations, the judgement by the EU Court of Justice may cause further ambiguity into what is already a complicated issue. Even if it does not automatically apply to all future cases, it may influence other legal frameworks even outside of Europe.

There may be some positive sides to this. The ECJ ruling puts a challenge to vaccine safety science and related processes to strengthen, not only the science, but scientific consensus. And, for the public, although the ECJ judgement may contribute to uncertainty and potentially lower vaccine confidence, the ECJ ruling may actually build trust in the larger system by allowing recourse, acknowledging that the public’s concerns and experience do matter and that they will be taken into account. 

Shalini is a former television health journalist from India. She currently works with the Center For Disease Dynamics, Economics & Policy in New Delhi.

This entry was posted on Wednesday, July 12th, 2017 at 3:49 pm and is filed under Blog.

Literature Literature archive

S Krishnaswamy, P Lambach, ML Giles 2019 HUMAN VACCINES & IMMUNOTHERAPEUTICS VOL. 15, NO. 4, 942–950
Editorial 2019 Lancet Adolescent Health Vol 3: 281
AHviid, JVinsløv Hansen, M Frisch,, et al 2019 Ann Intern Med 170(8):513-520.

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