The European Court of Justice (CJUE) has in a ruling on January 30, 2025, a case of Giovanni Frajese v. Commission (C-586/23 P) proved that doctors who pushed the COVID-injections are solely responsible for the consequences of the vaccines for their patients.
The European Medicines Agency (EMA) is the centralized EU regulatory body responsible for evaluating the safety, efficacy, and quality of medicines, including vaccines, before they can be authorized for use in the EU. Before a vaccine (like Spikevax or Comirnaty) can be marketed, the EMA conducts a rigorous scientific assessment based on clinical trial data, manufacturing standards, and other relevant information submitted by the pharmaceutical company. If the EMA determines that the vaccine meets the necessary standards, it recommends granting a marketing authorization (AMM), which is then formally approved by the European Commission. This authorization allows the vaccine to be legally sold and distributed across EU member states.
Frajese, an Italian doctor challenged the marketing authorizations (AMMs) for Moderna’s Spikevax and the Comirnaty from Pfizer/BioNTech, granted in October, 2022, that replaced the conditional AMMs from 2020 and 2021. Represented by lawyers Olga Milanese and Andrea Montanari, Frajese sought annulment, arguing these AMMs imposed undue obligations on doctors to assess vaccine safety, exposing them to liability for adverse effects. The European Court of Justice dismissed his appeal as inadmissible, confirming he lacked standing since the AMMs, directed at Moderna and BioNTech, did not directly affect his legal situation or impose obligations on him as a physician.
With that the court’s ruling clarified that a medical prescription is, and was, mandatory for administering these vaccines, as it is stipulated in the AMM annexes, reinforcing doctors’ responsability in their roles as protectors of their patients. What is so crucial is that it affirms the freedom doctors have to choose whether to prescribe or administer the vaccines, or even the right to advise against them, based on their professional judgment in their patient’s best interest. This freedom, the CJUE emphasized, means doctors bear civil and criminal liability only for their specific actions – prescribing or administering – rather than the mere existence of the AMMs. The European Medicines Agency (EMA), not individual doctors, is the one institution responsible for verifying vaccine safety and efficacy before authorization, limiting doctors’ roles to clinical application.
This decision has profound implications. It challenges disciplinary and criminal proceedings against doctors who opposed Covid vaccinations, potentially dismantling charges against them in Italy and beyond, where national judges are bound by CJUE rulings. Conversely, it places significant responsibility on doctors who vaccinated without hesitation, risking adverse events due to inadequate risk assessment or failure to issue prescriptions—often absent during millions of administrations, rendering them unlawful (contra legem). This absence invalidates the “penal shield” meant to protect healthcare professionals, as it applies only when vaccines are administered per authorization guidelines, including prescriptions and correct dosages, which were frequently disregarded.
Frajese’s legal team, aware of the slim chance of overcoming admissibility hurdles, pursued the case to exhaust appeal options and highlight systemic issues. Milanese noted their extensive preparation, including compiling scientific studies with Professor Marco Cosentino, a pharmacologist, to argue the AMMs’ authorization process violated EU regulations and principles of precaution. Though the CJUE did not review these merits, its affirmation of doctors’ autonomy was a “secondary victory.” Milanese suggested this could prompt Italy’s medical federation (Fnomceo), which historically pushed vaccination campaigns, to reconsider its stance and address harm to doctors disciplined for opposition, aligning with the Hippocratic Oath.
The ruling also raises broader concerns about transparency in the vaccine authorization process. Redacted contracts between the EU and manufacturers, limiting regulators’ and parliamentarians’ access to critical data on side effects and liability clauses favoring companies – issues echoed in a French case by BonSens.org, where only redacted contracts were provided. This opacity fueled public distrust, with 80% of French citizens believing the government prioritizes other interests, per a France-Soir/BonSens.org survey. Internationally, figures like Trump and Robert Kennedy Jr. reportedly consider withdrawing these AMMs due to side effects.
For ongoing legal battles, particularly involving suspended or struck-off healthcare workers, the CJUE’s principles could influence outcomes if cases correctly invoke EU law violations over national mandates. Milanese hopes Italy’s parliamentary Covid inquiry will leverage the ruling and their documentation to scrutinize the vaccination campaign.
The cort’s decision underscores doctors’ ethical duty to prioritize patient health, showing the accountability of doctors across the EU.
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