Interesting legal decision at the European Court of Justice on COVID vaccines

It is being interpreted as doctors having the right to offer or refuse the vaccines, and if there is liability for injuries, it is the doctors themselves that will be liable, not the licensing agency

 
 
 

This is the France Soir magazine interpretation, with some AI thrown in plus google translate—so make of it what you will. The main thrust is that if doctors are assigned liability, they will in future hesitate to offer dangerous products. And they cannot hide behind the skirts of the government and say they were just following orders. They are trained professionals who have a “learned intermediary” duty to present the products accurately to the patients, and withhold offering drugs and vaccines if they are not beneficial.

Dr. Frajese, the plaintiff, was a presenter at the International COVID Summits (where I too presented). He was challenging the licenses (“marketing authorizations”) of the Pfizer and Moderna vaccines, and got an unexpected judgement.

https://francesoir.fr/societe-justice-sante/vaccins-covid-19-la-cour-de-justice-de-l-ue-tranche-prescription-obligatoire

Below is only the first section: please go to the URL above for the entire article.

On 30 January 2025, the Court of Justice of the European Union (CJEU), sitting in the Eighth Chamber, delivered a judgment in Case C-586/23 P, between Giovanni Frajese, an Italian doctor, and the European Commission. This judgment, which is part of the marketing authorisations (MA) for Spikevax (Moderna) and Comirnaty (Pfizer/BioNTech) vaccines, raises crucial questions about doctors’ obligations, the need for medical prescription for these vaccines and their freedom to prescribe or advise against them. While the COVID-19 pandemic marked a turning point in European public health management, this decision provides valuable legal clarification, while revealing the limitations of individual remedies against EU regulatory acts. This article discusses the context of the case, analyses the key points of the judgment and explores its consequences, particularly for doctors.

Summary of the Frajese case v. Commission (CJEU, 30 January 2025)

The Court of Justice of the European Union (CJEU) has confirmed the inadmissibility of the action of Giovanni Frajese, an Italian doctor, against the marketing authorisations (MAs) for the Spikevax (Moderna) and Comirnaty (Pfizer/BioNTech) vaccines.

What you need to know about the CJEU decision

  1. Lack of interest and standing: Frajese could not contest the marketing authorisations, as they did not impose any obligation on him or her and did not directly change his legal situation.

  2. Independence of the judges: his argument on possible bias of the Tribunal was rejected for lack of evidence.

  3. Compulsory medical prescription: the Court recalls that these vaccines require a medical prescription.

  4. Physicians’ freedom: Physicians have no obligation to prescribe or administer these vaccines. They remain free to recommend them or not.

  5. Effective judicial protection: the Court considers that doctors can challenge national measures before their courts, which can then refer the matter to the CJEU.

Consequences for doctors

  • Compulsory prescription: doctors remain the guarantors of the administration of vaccines.

  • Freedom of choice: no doctor is required to prescribe these vaccines.

  • Medical liability: it depends only on prescription or administration procedures, not on the marketing authorisations themselves.

Outstanding and critical issues

The case raises doubts about access to information for regulatory agencies and parliamentarians on vaccine contracts. Censored documents would have prevented a full assessment of side effects and contract terms that are beneficial to manufacturers.

  • Lack of transparency: vaccine contracts have been partially redacted, preventing real democratic control.

  • Failure of the chain of confidence: neither parliamentarians nor health agencies would have had access to all the data essential for being able to claim to have taken an informed decision in the interests of citizens.

  • Growing trust: 80% of French people believe that the government is not acting in their interest (France-Soir/BonSens.org poll).

  • International reactions: Trump and Robert Kennedy Jr. would consider withdrawing the marketing of COVID-19 vaccines because of their many side effects.

The case confirms the freedom of doctors, but points to a lack of transparency in health decisions that have led to potentially incomplete vaccination obligations.