Tag Archives: vaccines

Italian Laws on HCPs & Vaccination

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With a law decree decided yesterday, the Italian Government enacted two interesting new rules aimed at health care professionals (“HCPs“):

  1. Criminal liability of HCPs administering vaccines for the crimes of manslaughter and personal injuries is excluded, provided that the vaccinations follow the indications of the authorization of the specific vaccine and the decisions of the Ministry of Health;
  2. The obligation of HCPs to be vaccinated is introduced: HCPs refusing to undergo vaccination may be assigned to different duties or her/his remuneration may be suspended. The constitutionality of this obligation has been often discussed, but most scholars believe that – on the basis of the Constitutional Court jurisprudence (especially decision no. 5 of 2018, drafted by Ms. Cartabia, who is now part of the government) – there is no doubt about compliance of this provision with the Italian Constitution. Vaccination is in fact aimed at not only preserving health for the individual who is vaccinated, but also other people’s health, and consequences of vaccination are tolerable.

Hopefully the above provisions will help the vaccination campaign move faster. I certainly cannot wait to roll up my sleeve!

Happy Easter!

Vaccines: the Italian Constitutional Court rules in favor of mandatory vaccination imposed by national law

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The polarized debate over vaccines sees the Italian Constitutional Court taking an important step into the discussion, shortly before the last notable rebellion against compulsory vaccination in Italy. Only a few days ago, in fact, the Mayor of Rome, Ms. Raggi (together with the members her Council, unanimously), approved a motion contradicting the mandatory nature of the 10 (originally 12) vaccinations, made compulsory for school-age children by a recently enacted Italian law. Nevertheless, the “rebels” in Rome probably did not take into the appropriate account the decision of the Italian Constitutional Court, which ruled in favor of the vaccines imposition under Italian law.

The Court – in deciding a constitutional challenge brought by the Veneto Region against the imposition of vaccination by the State – explains its views in a straightforward way.

First of all, the Court makes it very clear that, when it comes to vaccines, fundamental health care rights are involved and, to such regard, no difference is constitutionally acceptable between different areas of the Italian territory. In other words, when a healthcare measure is imposed by a national law in the public interest, Regions and local authorities do not have a say about it.

Furthermore, and most importantly, the Court clarifies that – also taking into account the worrisome drop in vaccination rates in recent years – the choice of tightening up legislation to compel vaccinations is not unreasonable.

True, persuasive techniques – such as the ones that Veneto Region would like to implement – can, ideally, represent a better option, but only when the herd immunity result is somehow guaranteed. Conversely, when vaccination rates drop, obligations and sanctions by law – as the California example showed – are not only reasonable (and constitutional), but much more effective.

Well, when the going gets tough, the law gets going. And that’s reasonable, Italian Constitutional Court says.

Vaccination: an Issue between Policy, Science, Justice and Evidence.

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The issue of vaccination, once simply relegated to the realm of medical science, has become increasingly political in the past few years. All of a sudden, you must be either strongly pro or fiercely against vaccines, as if this were a religious or civil rights issue. (Welcome to our new, polarized world).

THE EUROPEAN UNION COURT OF JUSTICE ON EVIDENCE AND VACCINES.  An interesting decision on this subject matter was issued a few days ago by the European Court of Justice. The case involved a French citizen, “Mr. W”, who “was vaccinated against hepatitis B through three injections, administered on 26 December 1998, 29 January 1999 and 8 July 1999, of a vaccine produced by Sanofi Pasteur. From August 1999, Mr W began to present with various troubles, which led to a diagnosis of multiple sclerosis in November 2000”. The case of Mr. W has been decided many times in France, where in some instance a causal link was found, while it was denied in other decisions.

The EU Court was requested to provide guidance on two questions relating to the interpretation of EU law on product liability and based its decision on the assumption that “medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim’s disease”.

The EU Court concluded that:

  1. National evidentiary rules are not precluded by EU product liability law so long as the burden of proof remains on the plaintiff who must prove the damage, the defect and the causal relationship between the defect and the damage; and

 

  1. National evidentiary rules are precluded based on presumptions according to which the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim will always be considered to be established when certain predetermined causation-related factual evidence is presented.

 

The decision was harshly criticized as possibly opening the floodgates of vaccines litigation without requiring the plaintiff to actually prove a causal link. In this New York Times article, Dr. Paul Offit of the University of Pennsylvania, commented the decision by pointing out that “Using those criteria, you could reasonably make the case that someone should be compensated for developing leukemia after eating a peanut butter sandwich“. Many scientists have roared against the decision, and some pointed out that “Courtrooms are generally not a good place to decide issues of science”.

In my view, the European Court of Justice did what it usually does: interpret EU law and define the boundary between EU mandatory principles and national law. Civil procedure evidence rules are not harmonized between Member States, so I am not overly surprised by the ruling.

ITALY ESTABLISHES MANDATORY VACCINATION.  Italy has recently taken sides on the vaccination debate when on June 7, 2017 the Ministry of Health issued a law decree (n. 73) which renders 12 different vaccines mandatory (for free) for children between 0 and 16 years old. The aim of the decree is to achieve the so called “herd immunity” after which such diseases pose no threat to the entire community, as recommended by the World Health Organization. As explained by the same WHO, “Herd protection of the unvaccinated occurs when a sufficient proportion of the group is immune”.

The fear that there may be a link between vaccines and autism originated from an article appeared on Lancet in 1998 by Dr. Andrew Wakefield and his colleagues (Lancet 1998;351[9103]:637–41), which later the same British medical journal retracted since based on data that “are incorrect, contrary to the findings of an earlier investigation.” Yet, many courts have awarded damages to plaintiffs claiming to be victims of vaccination and many parents have failed to vaccinate their children.

The Italian vaccination decree arises out of a worrisome drop in vaccination rates in recent years. Anti-vaccination sentiments have been strongly voiced by the 5 Star Movement, the main populist political party in Italy with approval rates around 30%, even though they predate the rise of such movement. In the United States, a similar opinion has been held by Mr. Trump (a 2014 tweet of his read: “Healthy young child goes to doctor, gets pumped with massive shot of many vaccines, doesn’t feel good and changes – AUTISM. Many such cases!”, although his position has somewhat evolved) and consistently disputed by the medical community. The populist opposition to “big pharma”, who are allegedly making more money from vaccines than from people getting sick, often results in an anti-vaccination stance.

As the Editorial Board of the New York Times puts it, “One of the tragedies of these post-truth times is that the lies, conspiracy theories and illusions spread by social media and populist politicians can be downright dangerous. The denial of human responsibility for climate change is one obvious example; another is opposition to vaccination.”